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© European Medicines Agency, 2017. Reproduction is authorised provided the source is acknowledged.
30 November 2017 EMA/812634/2017 Human Medicines Evaluation Division
List of nationally authorised medicinal products
Active substance: Etoricoxib
Procedure no.: PSUSA/00001334/201703
List of nationally authorised medicinal products EMA/812634/2017 Page 2/231
Product Name (in authorisation country)
MRP/DCP Authorisation Number
National Authorisation Number
MAH of product in the Member State
Member State where product is authorised
ACOXXEL 120 mg comprimidos recubiertos con película
UK/H/3190/004 71.590 MERCK SHARP & DOHME DE ESPAÑA, S.A
ES
ACOXXEL 30 mg comprimidos recubiertos con película
UK/H/3190/001 71.587 MERCK SHARP & DOHME DE ESPAÑA, S.A
ES
ACOXXEL 60 mg comprimidos recubiertos con película
UK/H/3190/002 71.588 MERCK SHARP & DOHME DE ESPAÑA, S.A
ES
ACOXXEL 90 mg comprimidos recubiertos con película
UK/H/3190/003 71.589 MERCK SHARP & DOHME DE ESPAÑA, S.A
ES
ACOXXEL® 30 mg film-coated tablets
UK/H/3190/001 PL 0025/0524 MERCK SHARP & DOHME LTD.
UK
ACOXXEL® 60 mg film-coated tablets
UK/H/3190/002 PL 0025/0525 MERCK SHARP & DOHME LTD.
UK
ACOXXEL® 90 mg film-coated tablets
UK/H/3190/003 PL 0025/0526 MERCK SHARP & DOHME LTD.
UK
ACOXXEL®120 mg film-coated tablets
UK/H/3190/004 PL 0025/0527 MERCK SHARP & DOHME LTD.
UK
ALGIX 120 mg compresse rivestite con film
UK/H/0533/004 035821293 NEOPHARMED GENTILI S.R.L.
IT
ALGIX 120 mg compresse rivestite con film
UK/H/0533/004 035821317 NEOPHARMED GENTILI S.R.L.
IT
ALGIX 120 mg compresse rivestite con film
UK/H/0533/004 035821329 NEOPHARMED GENTILI S.R.L.
IT
ALGIX 120 mg compresse rivestite con film
UK/H/0533/004 035821331 NEOPHARMED GENTILI S.R.L.
IT
ALGIX 120 mg compresse rivestite con film
UK/H/0533/004 035821343 NEOPHARMED GENTILI S.R.L.
IT
ALGIX 120 mg compresse rivestite con film
UK/H/0533/004 035821356 NEOPHARMED GENTILI S.R.L.
IT
List of nationally authorised medicinal products EMA/812634/2017 Page 3/231
Product Name (in authorisation country)
MRP/DCP Authorisation Number
National Authorisation Number
MAH of product in the Member State
Member State where product is authorised
ALGIX 120 mg compresse rivestite con film
UK/H/0533/004 035821368 NEOPHARMED GENTILI S.R.L.
IT
ALGIX 120 mg compresse rivestite con film
UK/H/0533/004 035821370 NEOPHARMED GENTILI S.R.L.
IT
ALGIX 120 mg compresse rivestite con film
UK/H/0533/004 035821382 NEOPHARMED GENTILI S.R.L.
IT
ALGIX 120 mg compresse rivestite con film
UK/H/0533/004 035821394 NEOPHARMED GENTILI S.R.L.
IT
ALGIX 120 mg compresse rivestite con film
UK/H/0533/001-004 035821406 NEOPHARMED GENTILI S.R.L.
IT
ALGIX 120 mg compresse rivestite con film
UK/H/0533/004 035821418 NEOPHARMED GENTILI S.R.L.
IT
ALGIX 120 mg compresse rivestite con film
UK/H/0533/004 035821420 NEOPHARMED GENTILI S.R.L.
IT
ALGIX 120 mg compresse rivestite con film
UK/H/0533/004 035821305 NEOPHARMED GENTILI S.R.L.
IT
ALGIX 30 mg compresse rivestite con film
UK/H/0533/001 035821444 NEOPHARMED GENTILI S.R.L.
IT
ALGIX 30 mg compresse rivestite con film
UK/H/0533/001 035821432 NEOPHARMED GENTILI S.R.L.
IT
ALGIX 60 mg compresse rivestite con film
UK/H/0533/002 035821014 NEOPHARMED GENTILI S.R.L.
IT
ALGIX 60 mg compresse rivestite con film
UK/H/0533/002 035821026 NEOPHARMED GENTILI S.R.L.
IT
ALGIX 60 mg compresse rivestite con film
UK/H/0533/002 035821038 NEOPHARMED GENTILI S.R.L.
IT
ALGIX 60 mg compresse rivestite con film
UK/H/0533/002 035821040 NEOPHARMED GENTILI S.R.L.
IT
List of nationally authorised medicinal products EMA/812634/2017 Page 4/231
Product Name (in authorisation country)
MRP/DCP Authorisation Number
National Authorisation Number
MAH of product in the Member State
Member State where product is authorised
ALGIX 60 mg compresse rivestite con film
UK/H/0533/002 035821053 NEOPHARMED GENTILI S.R.L.
IT
ALGIX 60 mg compresse rivestite con film
UK/H/0533/002 035821077 NEOPHARMED GENTILI S.R.L.
IT
ALGIX 60 mg compresse rivestite con film
UK/H/0533/002 035821089 NEOPHARMED GENTILI S.R.L.
IT
ALGIX 60 mg compresse rivestite con film
UK/H/0533/002 035821091 NEOPHARMED GENTILI S.R.L.
IT
ALGIX 60 mg compresse rivestite con film
UK/H/0533/002 035821103 NEOPHARMED GENTILI S.R.L.
IT
ALGIX 60 mg compresse rivestite con film
UK/H/0533/002 035821115 NEOPHARMED GENTILI S.R.L.
IT
ALGIX 60 mg compresse rivestite con film
UK/H/0533/002 035821127 NEOPHARMED GENTILI S.R.L.
IT
ALGIX 60 mg compresse rivestite con film
UK/H/0533/002 035821139 NEOPHARMED GENTILI S.R.L.
IT
ALGIX 60 mg compresse rivestite con film
UK/H/0533/002 035821141 NEOPHARMED GENTILI S.R.L.
IT
ALGIX 60 mg compresse rivestite con film
UK/H/0533/002 035821065 NEOPHARMED GENTILI S.R.L.
IT
ALGIX 90 mg compresse rivestite con film
UK/H/0533/003 035821154 NEOPHARMED GENTILI S.R.L.
IT
ALGIX 90 mg compresse rivestite con film
UK/H/0533/003 035821166 NEOPHARMED GENTILI S.R.L.
IT
ALGIX 90 mg compresse rivestite con film
UK/H/0533/003 035821178 NEOPHARMED GENTILI S.R.L.
IT
ALGIX 90 mg compresse rivestite con film
UK/H/0533/003 035821180 NEOPHARMED GENTILI S.R.L.
IT
List of nationally authorised medicinal products EMA/812634/2017 Page 5/231
Product Name (in authorisation country)
MRP/DCP Authorisation Number
National Authorisation Number
MAH of product in the Member State
Member State where product is authorised
ALGIX 90 mg compresse rivestite con film
UK/H/0533/003 035821192 NEOPHARMED GENTILI S.R.L.
IT
ALGIX 90 mg compresse rivestite con film
UK/H/0533/003 035821216 NEOPHARMED GENTILI S.R.L.
IT
ALGIX 90 mg compresse rivestite con film
UK/H/0533/003 035821228 NEOPHARMED GENTILI S.R.L.
IT
ALGIX 90 mg compresse rivestite con film
UK/H/0533/003 035821230 NEOPHARMED GENTILI S.R.L.
IT
ALGIX 90 mg compresse rivestite con film
UK/H/0533/003 035821242 NEOPHARMED GENTILI S.R.L.
IT
ALGIX 90 mg compresse rivestite con film
UK/H/0533/003 035821255 NEOPHARMED GENTILI S.R.L.
IT
ALGIX 90 mg compresse rivestite con film
UK/H/0533/003 035821267 NEOPHARMED GENTILI S.R.L.
IT
ALGIX 90 mg compresse rivestite con film
UK/H/0533/003 035821279 NEOPHARMED GENTILI S.R.L.
IT
ALGIX 90 mg compresse rivestite con film
UK/H/0533/003 035821281 NEOPHARMED GENTILI S.R.L.
IT
ALGIX 90 mg compresse rivestite con film
UK/H/0533/003 035821204 NEOPHARMED GENTILI S.R.L.
IT
ARCOXIA 120 mg apvalkotās tabletes
UK/H/0532/003 03-0005 MERCK SHARP & DOHME LATVIJA SIA
LV
ARCOXIA 120 mg comprimate filmate
not available 854/2008/03 MERCK SHARP & DOHME ROMANIA SRL
RO
ARCOXIA 120 mg comprimate filmate
not available 854/2008/02 MERCK SHARP & DOHME ROMANIA SRL
RO
ARCOXIA 120 mg comprimate filmate
not available 854/2008/01 MERCK SHARP & DOHME ROMANIA SRL
RO
List of nationally authorised medicinal products EMA/812634/2017 Page 6/231
Product Name (in authorisation country)
MRP/DCP Authorisation Number
National Authorisation Number
MAH of product in the Member State
Member State where product is authorised
ARCOXIA 120 mg comprimate filmate
not available 854/2008/04 MERCK SHARP & DOHME ROMANIA SRL
RO
ARCOXIA 120 mg comprimidos recubiertos con película
UK/H/0532/003 64.930 MERCK SHARP & DOHME DE ESPAÑA, S.A
ES
Arcoxia 120 mg comprimidos revestidos por película
UK/H/0532/003 4107280 MERCK SHARP & DOHME, LDA.
PT
Arcoxia 120 mg comprimidos revestidos por película
UK/H/0532/003 4242780 MERCK SHARP & DOHME, LDA.
PT
Arcoxia 120 mg comprimidos revestidos por película
UK/H/0532/003 4107181 MERCK SHARP & DOHME, LDA.
PT
Arcoxia 120 mg comprimidos revestidos por película
UK/H/0532/003 4106985 MERCK SHARP & DOHME, LDA.
PT
Arcoxia 120 mg comprimidos revestidos por película
UK/H/0532/003 4107082 MERCK SHARP & DOHME, LDA.
PT
Arcoxia 120 mg comprimidos revestidos por película
UK/H/0532/003 4106084 MERCK SHARP & DOHME, LDA.
PT
Arcoxia 120 mg comprimidos revestidos por película
UK/H/0532/003 4106886 MERCK SHARP & DOHME, LDA.
PT
Arcoxia 120 mg comprimidos revestidos por película
UK/H/0532/003 4106381 MERCK SHARP & DOHME, LDA.
PT
Arcoxia 120 mg comprimidos revestidos por película
UK/H/0532/003 4106787 MERCK SHARP & DOHME, LDA.
PT
Arcoxia 120 mg comprimidos revestidos por película
UK/H/0532/003 4107389 MERCK SHARP & DOHME, LDA.
PT
Arcoxia 120 mg comprimidos revestidos por película
UK/H/0532/003 4106480 MERCK SHARP & DOHME, LDA.
PT
Arcoxia 120 mg comprimidos revestidos por película
UK/H/0532/003 4106282 MERCK SHARP & DOHME, LDA.
PT
List of nationally authorised medicinal products EMA/812634/2017 Page 7/231
Product Name (in authorisation country)
MRP/DCP Authorisation Number
National Authorisation Number
MAH of product in the Member State
Member State where product is authorised
Arcoxia 120 mg comprimidos revestidos por película
UK/H/0532/003 4242889 MERCK SHARP & DOHME, LDA.
PT
Arcoxia 120 mg comprimidos revestidos por película
UK/H/0532/003 4106183 MERCK SHARP & DOHME, LDA.
PT
Arcoxia 120 mg comprimidos revestidos por película
UK/H/0532/003 4106589 MERCK SHARP & DOHME, LDA.
PT
Arcoxia 120 mg comprimidos revestidos por película
UK/H/0532/003 4106688 MERCK SHARP & DOHME, LDA.
PT
ARCOXIA 120 mg film-coated tablets
UK/H/0532/003 19446 MERCK SHARP & DOHME BV CY
Arcoxia 120 mg Film-coated tablets
UK/H/0532/003 PA 1997/1/4 MERCK SHARP & DOHME BV IE
ARCOXIA 120 mg film-coated tablets
UK/H/0532/003 MA224/00303 MERCK SHARP & DOHME BV MT
Arcoxia 120 mg filmdragerade tabletter
UK/H/0532/003 17275 MERCK SHARP & DOHME BV FI
Arcoxia 120 mg filmdragerade tabletter
UK/H/0532/003 18367 MERCK SHARP & DOHME BV SE
ARCOXIA 120 mg filmdrasjerte tabletter
UK/H/0532/003 02-1052 MERCK SHARP & DOHME BV NO
ARCOXIA 120 mg filmom obalené tablety
UK/H/0532/003 29/0005/03-S MERCK SHARP & DOHME BV SK
ARCOXIA 120 mg filmomhulde tabletten
UK/H/0532/003 RVG 27707 MERCK SHARP & DOHME BV NL
ARCOXIA 120 mg filmsko obložene tablete
UK/H/0532/003 H/02/00207/042 MERCK SHARP & DOHME INOVATIVNA ZDRAVILA D.O.O.
SI
List of nationally authorised medicinal products EMA/812634/2017 Page 8/231
Product Name (in authorisation country)
MRP/DCP Authorisation Number
National Authorisation Number
MAH of product in the Member State
Member State where product is authorised
ARCOXIA 120 mg filmsko obložene tablete
UK/H/0532/003 H/02/00207/043 MERCK SHARP & DOHME INOVATIVNA ZDRAVILA D.O.O.
SI
ARCOXIA 120 mg filmsko obložene tablete
UK/H/0532/003 H/02/00207/044 MERCK SHARP & DOHME INOVATIVNA ZDRAVILA D.O.O.
SI
ARCOXIA 120 mg filmsko obložene tablete
UK/H/0532/003 H/02/00207/045 MERCK SHARP & DOHME INOVATIVNA ZDRAVILA D.O.O.
SI
ARCOXIA 120 mg filmsko obložene tablete
UK/H/0532/003 H/02/00207/046 MERCK SHARP & DOHME INOVATIVNA ZDRAVILA D.O.O.
SI
ARCOXIA 120 mg filmsko obložene tablete
UK/H/0532/003 H/02/00207/047 MERCK SHARP & DOHME INOVATIVNA ZDRAVILA D.O.O.
SI
ARCOXIA 120 mg filmsko obložene tablete
UK/H/0532/003 H/02/00207/048 MERCK SHARP & DOHME INOVATIVNA ZDRAVILA D.O.O.
SI
ARCOXIA 120 mg filmsko obložene tablete
UK/H/0532/003 H/02/00207/049 MERCK SHARP & DOHME INOVATIVNA ZDRAVILA D.O.O.
SI
ARCOXIA 120 mg filmsko obložene tablete
UK/H/0532/003 H/02/00207/050 MERCK SHARP & DOHME INOVATIVNA ZDRAVILA D.O.O.
SI
ARCOXIA 120 mg filmsko obložene tablete
UK/H/0532/003 H/02/00207/051 MERCK SHARP & DOHME INOVATIVNA ZDRAVILA D.O.O.
SI
List of nationally authorised medicinal products EMA/812634/2017 Page 9/231
Product Name (in authorisation country)
MRP/DCP Authorisation Number
National Authorisation Number
MAH of product in the Member State
Member State where product is authorised
ARCOXIA 120 mg filmsko obložene tablete
UK/H/0532/003 H/02/00207/052 MERCK SHARP & DOHME INOVATIVNA ZDRAVILA D.O.O.
SI
ARCOXIA 120 mg filmsko obložene tablete
UK/H/0532/003 H/02/00207/053 MERCK SHARP & DOHME INOVATIVNA ZDRAVILA D.O.O.
SI
ARCOXIA 120 mg filmsko obložene tablete
UK/H/0532/003 H/02/00207/054 MERCK SHARP & DOHME INOVATIVNA ZDRAVILA D.O.O.
SI
ARCOXIA 120 mg filmsko obložene tablete
UK/H/0532/003 H/02/00207/055 MERCK SHARP & DOHME INOVATIVNA ZDRAVILA D.O.O.
SI
ARCOXIA 120 mg filmsko obložene tablete
UK/H/0532/003 H/02/00207/056 MERCK SHARP & DOHME INOVATIVNA ZDRAVILA D.O.O.
SI
ARCOXIA 120 mg filmsko obložene tablete
UK/H/0532/003 H/02/00207/057 MERCK SHARP & DOHME INOVATIVNA ZDRAVILA D.O.O.
SI
ARCOXIA 120 mg filmsko obložene tablete
UK/H/0532/003 H/02/00207/058 MERCK SHARP & DOHME INOVATIVNA ZDRAVILA D.O.O.
SI
Arcoxia 120 mg Filmtabletten UK/H/0532/003 1-24676 MERCK SHARP & DOHME BV AT ARCOXIA 120 mg Filmtabletten UK/H/0532/003 59863.02.00 MERCK SHARP & DOHME BV DE ARCOXIA 120 mg filmuhúðaðar töflur
UK/H/0532/003 IS/1/02/025/03 MERCK SHARP & DOHME BV IS
ARCOXIA 120 mg plėvele dengtos tabletės
UK/H/0532/003 LT/1/08/1419/011 MERCK SHARP & DOHME, UAB
LT
ARCOXIA 120 mg plėvele dengtos tabletės
UK/H/0532/003 LT/1/08/1419/009 MERCK SHARP & DOHME, UAB
LT
List of nationally authorised medicinal products EMA/812634/2017 Page 10/231
Product Name (in authorisation country)
MRP/DCP Authorisation Number
National Authorisation Number
MAH of product in the Member State
Member State where product is authorised
ARCOXIA 120 mg plėvele dengtos tabletės
UK/H/0532/003 LT/1/08/1419/010 MERCK SHARP & DOHME, UAB
LT
ARCOXIA 120 mg plėvele dengtos tabletės
UK/H/0532/003 LT/1/08/1419/008 MERCK SHARP & DOHME, UAB
LT
Arcoxia 120 mg tabletti, kalvopäällysteinen
UK/H/0532/003 17275 MERCK SHARP & DOHME BV FI
ARCOXIA 120 mg επικαλυμμένα με λεπτό υμένιο δισκία
UK/H/0532/003 19446 MERCK SHARP & DOHME BV CY
ARCOXIA 120 mg επικαλυμμένα με λεπτό υμένιο δισκία
UK/H/0532/003 71849/06-11-2013 VIANEX S.A. GR
ARCOXIA 120 mg compresse rivestite con film
UK/H/0532/003 035820378 MSD ITALIA S.R.L. IT
ARCOXIA 120 mg compresse rivestite con film
UK/H/0532/003 035820380 MSD ITALIA S.R.L. IT
ARCOXIA 120 mg compresse rivestite con film
UK/H/0532/003 035820327 MSD ITALIA S.R.L. IT
ARCOXIA 120 mg compresse rivestite con film
UK/H/0532/003 035820341 MSD ITALIA S.R.L. IT
ARCOXIA 120 mg compresse rivestite con film
UK/H/0532/003 035820291 MSD ITALIA S.R.L. IT
ARCOXIA 120 mg compresse rivestite con film
UK/H/0532/003 035820339 MSD ITALIA S.R.L. IT
ARCOXIA 120 mg compresse rivestite con film
UK/H/0532/003 035820303 MSD ITALIA S.R.L. IT
ARCOXIA 120 mg compresse rivestite con film
UK/H/0532/003 035820392 MSD ITALIA S.R.L. IT
ARCOXIA 120 mg compresse rivestite con film
UK/H/0532/003 035820354 MSD ITALIA S.R.L. IT
List of nationally authorised medicinal products EMA/812634/2017 Page 11/231
Product Name (in authorisation country)
MRP/DCP Authorisation Number
National Authorisation Number
MAH of product in the Member State
Member State where product is authorised
ARCOXIA 120 mg compresse rivestite con film
UK/H/0532/003 035820366 MSD ITALIA S.R.L. IT
ARCOXIA 120 mg compresse rivestite con film
UK/H/0532/003 035820315 MSD ITALIA S.R.L. IT
ARCOXIA 120 mg compresse rivestite con film
UK/H/0532/003 035820416 MSD ITALIA S.R.L. IT
ARCOXIA 120 mg compresse rivestite con film
UK/H/0532/003 035820428 MSD ITALIA S.R.L. IT
ARCOXIA 120 mg compresse rivestite con film
UK/H/0532/003 035820404 MSD ITALIA S.R.L. IT
Arcoxia 120 mg filmtabletta UK/H/0532/003 OGYI-T-8825/58 MSD PHARMA HUNGARY KFT.
HU
Arcoxia 120 mg filmtabletta UK/H/0532/003 OGYI-T-8825/12 MSD PHARMA HUNGARY KFT.
HU
Arcoxia 120 mg filmtabletta UK/H/0532/003 OGYI-T-8825/16 MSD PHARMA HUNGARY KFT.
HU
Arcoxia 120 mg filmtabletta UK/H/0532/003 OGYI-T-8825/01 MSD PHARMA HUNGARY KFT.
HU
Arcoxia 120 mg filmtabletta UK/H/0532/003 OGYI-T-8825/10 MSD PHARMA HUNGARY KFT.
HU
Arcoxia 120 mg filmtabletta UK/H/0532/003 OGYI-T-8825/14 MSD PHARMA HUNGARY KFT.
HU
Arcoxia 120 mg filmtabletta UK/H/0532/003 OGYI-T-8825/11 MSD PHARMA HUNGARY KFT.
HU
Arcoxia 120 mg filmtabletta UK/H/0532/003 OGYI-T-8825/04 MSD PHARMA HUNGARY KFT.
HU
Arcoxia 120 mg filmtabletta UK/H/0532/003 OGYI-T-8825/03 MSD PHARMA HUNGARY KFT.
HU
List of nationally authorised medicinal products EMA/812634/2017 Page 12/231
Product Name (in authorisation country)
MRP/DCP Authorisation Number
National Authorisation Number
MAH of product in the Member State
Member State where product is authorised
Arcoxia 120 mg filmtabletta UK/H/0532/003 OGYI-T-8825/13 MSD PHARMA HUNGARY KFT.
HU
Arcoxia 120 mg filmtabletta UK/H/0532/003 OGYI-T-8825/15 MSD PHARMA HUNGARY KFT.
HU
Arcoxia 120 mg filmtabletta UK/H/0532/003 OGYI-T-8825/18 MSD PHARMA HUNGARY KFT.
HU
Arcoxia 120 mg filmtabletta UK/H/0532/003 OGYI-T-8825/02 MSD PHARMA HUNGARY KFT.
HU
Arcoxia 120 mg filmtabletta UK/H/0532/003 OGYI-T-8825/17 MSD PHARMA HUNGARY KFT.
HU
Arcoxia 120 mg filmtabletta UK/H/0532/003 OGYI-T-8825/20 MSD PHARMA HUNGARY KFT.
HU
Arcoxia 120 mg filmtabletta UK/H/0532/003 OGYI-T-8825/19 MSD PHARMA HUNGARY KFT.
HU
Arcoxia 120 mg filmtabletta UK/H/0532/003 OGYI-T-8825/21 MSD PHARMA HUNGARY KFT.
HU
ARCOXIA 30 mg apvalkotās tabletes
UK/H/0532/004 07-0353 MERCK SHARP & DOHME LATVIJA SIA
LV
ARCOXIA 30 mg comprimate filmate
not available 7877/2015/04 MERCK SHARP & DOHME ROMANIA SRL
RO
ARCOXIA 30 mg comprimate filmate
not available 7877/2015/01 MERCK SHARP & DOHME ROMANIA SRL
RO
ARCOXIA 30 mg comprimate filmate
not available 7877/2015/02 MERCK SHARP & DOHME ROMANIA SRL
RO
ARCOXIA 30 mg comprimate filmate
not available 7877/2015/03 MERCK SHARP & DOHME ROMANIA SRL
RO
ARCOXIA 30 mg comprimidos recubiertos con película
UK/H/0532/004 69.376 MERCK SHARP & DOHME DE ESPAÑA, S.A
ES
List of nationally authorised medicinal products EMA/812634/2017 Page 13/231
Product Name (in authorisation country)
MRP/DCP Authorisation Number
National Authorisation Number
MAH of product in the Member State
Member State where product is authorised
Arcoxia 30 mg comprimidos revestidos por película
UK/H/0532/004 5118625 MERCK SHARP & DOHME, LDA.
PT
Arcoxia 30 mg comprimidos revestidos por película
UK/H/0532/004 5063037 MERCK SHARP & DOHME, LDA.
PT
Arcoxia 30 mg comprimidos revestidos por película
UK/H/0532/004 5715032 MERCK SHARP & DOHME, LDA.
PT
ARCOXIA 30 mg film-coated tablets
UK/H/0532/004 20338 MERCK SHARP & DOHME BV CY
Arcoxia 30 mg Film-coated tablets UK/H/0532/004 PA 1997/1/1 MERCK SHARP & DOHME BV IE Arcoxia 30 mg filmdragerade tabletter
UK/H/0532/004 22403 MERCK SHARP & DOHME BV FI
ARCOXIA 30 mg filmdragerade tabletter
UK/H/0532/004 24178 MERCK SHARP & DOHME BV SE
ARCOXIA 30 mg filmdrasjerte tabletter
UK/H/0532/004 06-4274 MERCK SHARP & DOHME BV NO
ARCOXIA 30 mg filmomhulde tabletten
UK/H/0532/004 RVG 34279 MERCK SHARP & DOHME BV NL
ARCOXIA 30 mg filmsko obložene tablete
UK/H/0532/004 H/02/00207/001 MERCK SHARP & DOHME INOVATIVNA ZDRAVILA D.O.O.
SI
ARCOXIA 30 mg filmsko obložene tablete
UK/H/0532/004 H/02/00207/002 MERCK SHARP & DOHME INOVATIVNA ZDRAVILA D.O.O.
SI
ARCOXIA 30 mg filmsko obložene tablete
UK/H/0532/004 H/02/00207/003 MERCK SHARP & DOHME INOVATIVNA ZDRAVILA D.O.O.
SI
ARCOXIA 30 mg filmsko obložene tablete
UK/H/0532/004 H/02/00207/004 MERCK SHARP & DOHME INOVATIVNA ZDRAVILA D.O.O.
SI
List of nationally authorised medicinal products EMA/812634/2017 Page 14/231
Product Name (in authorisation country)
MRP/DCP Authorisation Number
National Authorisation Number
MAH of product in the Member State
Member State where product is authorised
ARCOXIA 30 mg filmsko obložene tablete
UK/H/0532/004 H/02/00207/005 MERCK SHARP & DOHME INOVATIVNA ZDRAVILA D.O.O.
SI
ARCOXIA 30 mg filmsko obložene tablete
UK/H/0532/004 H/02/00207/006 MERCK SHARP & DOHME INOVATIVNA ZDRAVILA D.O.O.
SI
ARCOXIA 30 mg filmsko obložene tablete
UK/H/0532/004 H/02/00207/007 MERCK SHARP & DOHME INOVATIVNA ZDRAVILA D.O.O.
SI
ARCOXIA 30 mg filmsko obložene tablete
UK/H/0532/004 H/02/00207/059 MERCK SHARP & DOHME INOVATIVNA ZDRAVILA D.O.O.
SI
Arcoxia 30 mg Filmtabletten UK/H/0532/004 1-27325 MERCK SHARP & DOHME BV AT ARCOXIA 30 mg Filmtabletten UK/H/0532/004 66968.00.00 MERCK SHARP & DOHME BV DE ARCOXIA 30 mg filmuhúðaðar töflur
UK/H/0532/004 IS/1/06/050/01 MERCK SHARP & DOHME BV IS
ARCOXIA 30 mg plėvele dengtos tabletės
UK/H/0532/004 LT/1/08/1419/013 MERCK SHARP & DOHME, UAB
LT
ARCOXIA 30 mg plėvele dengtos tabletės
UK/H/0532/004 LT/1/08/1419/001 MERCK SHARP & DOHME, UAB
LT
ARCOXIA 30 mg plėvele dengtos tabletės
UK/H/0532/004 LT/1/08/1419/015 MERCK SHARP & DOHME, UAB
LT
ARCOXIA 30 mg plėvele dengtos tabletės
UK/H/0532/004 LT/1/08/1419/014 MERCK SHARP & DOHME, UAB
LT
ARCOXIA 30 mg plėvele dengtos tabletės
UK/H/0532/004 LT/1/08/1419/012 MERCK SHARP & DOHME, UAB
LT
ARCOXIA 30 mg plėvele dengtos tabletės
UK/H/0532/004 LT/1/08/1419/016 MERCK SHARP & DOHME, UAB
LT
List of nationally authorised medicinal products EMA/812634/2017 Page 15/231
Product Name (in authorisation country)
MRP/DCP Authorisation Number
National Authorisation Number
MAH of product in the Member State
Member State where product is authorised
ARCOXIA 30 mg plėvele dengtos tabletės
UK/H/0532/004 LT/1/08/1419/017 MERCK SHARP & DOHME, UAB
LT
ARCOXIA 30 mg plėvele dengtos tabletės
UK/H/0532/004 LT/1/08/1419/018 MERCK SHARP & DOHME, UAB
LT
Arcoxia 30 mg tabletti, kalvopäällysteinen
UK/H/0532/004 22403 MERCK SHARP & DOHME BV FI
ARCOXIA 30 mg επικαλυμμένα με λεπτό υμένιο δισκία
UK/H/0532/004 20338 MERCK SHARP & DOHME BV CY
ARCOXIA 30 mg επικαλυμμένα με λεπτό υμένιο δισκία
UK/H/0532/004 71850/06-11-2013 VIANEX S.A. GR
ARCOXIA 30 mg, comprimé pelliculé
UK/H/0532/004 34009 387 977 7 0 MERCK SHARP & DOHME BV FR
ARCOXIA 30 mg, comprimé pelliculé
UK/H/0532/004 34009 387 978 3 1 MERCK SHARP & DOHME BV FR
ARCOXIA 30 mg, comprimé pelliculé
UK/H/0532/004 34009 387 980 8 1 MERCK SHARP & DOHME BV FR
ARCOXIA 30 mg, comprimé pelliculé
UK/H/0532/004 34009 387 976 0 2 MERCK SHARP & DOHME BV FR
ARCOXIA 30 mg, comprimé pelliculé
UK/H/0532/004 34009 573 530 9 4 MERCK SHARP & DOHME BV FR
ARCOXIA 30 mg, comprimé pelliculé
UK/H/0532/004 34009 387 974 8 0 MERCK SHARP & DOHME BV FR
ARCOXIA 30 mg, comprimé pelliculé
UK/H/0532/004 34009 300 043 0 2 MERCK SHARP & DOHME BV FR
ARCOXIA 30 mg, filmom obalené tablety
UK/H/0532/004 29/0125/08-S MERCK SHARP & DOHME BV SK
ARCOXIA 30 mg compresse rivestite con film
UK/H/0532/004 035820442 MSD ITALIA S.R.L. IT
List of nationally authorised medicinal products EMA/812634/2017 Page 16/231
Product Name (in authorisation country)
MRP/DCP Authorisation Number
National Authorisation Number
MAH of product in the Member State
Member State where product is authorised
ARCOXIA 30 mg compresse rivestite con film
UK/H/0532/004 035820430 MSD ITALIA S.R.L. IT
ARCOXIA 30 mg compresse rivestite con film
UK/H/0532/004 035820568 MSD ITALIA S.R.L. IT
ARCOXIA 30 mg film-coated tablets
UK/H/0532/004 MA224/00304 MERCK SHARP & DOHME BV MT
Arcoxia 30 mg filmtabletta UK/H/0532/004 OGYI-T-8825/55 MSD PHARMA HUNGARY KFT.
HU
Arcoxia 30 mg filmtabletta UK/H/0532/004 OGYI-T-8825/25 MSD PHARMA HUNGARY KFT.
HU
Arcoxia 30 mg filmtabletta UK/H/0532/004 OGYI-T-8825/26 MSD PHARMA HUNGARY KFT.
HU
Arcoxia 30 mg filmtabletta UK/H/0532/004 OGYI-T-8825/23 MSD PHARMA HUNGARY KFT.
HU
Arcoxia 30 mg filmtabletta UK/H/0532/004 OGYI-T-8825/24 MSD PHARMA HUNGARY KFT.
HU
Arcoxia 30 mg filmtabletta UK/H/0532/004 OGYI-T-8825/05 MSD PHARMA HUNGARY KFT.
HU
Arcoxia 30 mg filmtabletta UK/H/0532/004 OGYI-T-8825/22 MSD PHARMA HUNGARY KFT.
HU
Arcoxia 30 mg filmtabletta UK/H/0532/004 OGYI-T-8825/59 MSD PHARMA HUNGARY KFT.
HU
ARCOXIA 60 mg apvalkotās tabletes
UK/H/0532/001 03-0003 MERCK SHARP & DOHME LATVIJA SIA
LV
ARCOXIA 60 mg comprimate filmate
not available 852/2008/02 MERCK SHARP & DOHME ROMANIA SRL
RO
ARCOXIA 60 mg comprimate filmate
not available 852/2008/01 MERCK SHARP & DOHME ROMANIA SRL
RO
List of nationally authorised medicinal products EMA/812634/2017 Page 17/231
Product Name (in authorisation country)
MRP/DCP Authorisation Number
National Authorisation Number
MAH of product in the Member State
Member State where product is authorised
ARCOXIA 60 mg comprimate filmate
not available 852/2008/04 MERCK SHARP & DOHME ROMANIA SRL
RO
ARCOXIA 60 mg comprimate filmate
not available 852/2008/03 MERCK SHARP & DOHME ROMANIA SRL
RO
ARCOXIA 60 mg comprimidos recubiertos con película
UK/H/0532/001 64.928 MERCK SHARP & DOHME DE ESPAÑA, S.A
ES
Arcoxia 60 mg comprimidos revestidos por película
UK/H/0532/001 4108189 MERCK SHARP & DOHME, LDA.
PT
Arcoxia 60 mg comprimidos revestidos por película
UK/H/0532/001 4107587 MERCK SHARP & DOHME, LDA.
PT
Arcoxia 60 mg comprimidos revestidos por película
UK/H/0532/001 4108783 MERCK SHARP & DOHME, LDA.
PT
Arcoxia 60 mg comprimidos revestidos por película
UK/H/0532/001 4108585 MERCK SHARP & DOHME, LDA.
PT
Arcoxia 60 mg comprimidos revestidos por película
UK/H/0532/001 4108288 MERCK SHARP & DOHME, LDA.
PT
Arcoxia 60 mg comprimidos revestidos por película
UK/H/0532/001 4108387 MERCK SHARP & DOHME, LDA.
PT
Arcoxia 60 mg comprimidos revestidos por película
UK/H/0532/001 4242483 MERCK SHARP & DOHME, LDA.
PT
Arcoxia 60 mg comprimidos revestidos por película
UK/H/0532/001 4107686 MERCK SHARP & DOHME, LDA.
PT
Arcoxia 60 mg comprimidos revestidos por película
UK/H/0532/001 4107488 MERCK SHARP & DOHME, LDA.
PT
Arcoxia 60 mg comprimidos revestidos por película
UK/H/0532/001 4107983 MERCK SHARP & DOHME, LDA.
PT
Arcoxia 60 mg comprimidos revestidos por película
UK/H/0532/001 4242384 MERCK SHARP & DOHME, LDA.
PT
List of nationally authorised medicinal products EMA/812634/2017 Page 18/231
Product Name (in authorisation country)
MRP/DCP Authorisation Number
National Authorisation Number
MAH of product in the Member State
Member State where product is authorised
Arcoxia 60 mg comprimidos revestidos por película
UK/H/0532/001 4108080 MERCK SHARP & DOHME, LDA.
PT
Arcoxia 60 mg comprimidos revestidos por película
UK/H/0532/001 4108684 MERCK SHARP & DOHME, LDA.
PT
Arcoxia 60 mg comprimidos revestidos por película
UK/H/0532/001 4108486 MERCK SHARP & DOHME, LDA.
PT
Arcoxia 60 mg comprimidos revestidos por película
UK/H/0532/001 4107884 MERCK SHARP & DOHME, LDA.
PT
Arcoxia 60 mg comprimidos revestidos por película
UK/H/0532/001 4107785 MERCK SHARP & DOHME, LDA.
PT
ARCOXIA 60 mg film-coated tablets
UK/H/0532/001 19444 MERCK SHARP & DOHME BV CY
Arcoxia 60 mg Film-coated tablets UK/H/0532/001 PA 1997/1/2 MERCK SHARP & DOHME BV IE Arcoxia 60 mg filmdragerade tabletter
UK/H/0532/001 17273 MERCK SHARP & DOHME BV FI
Arcoxia 60 mg filmdragerade tabletter
UK/H/0532/001 18365 MERCK SHARP & DOHME BV SE
ARCOXIA 60 mg filmdrasjerte tabletter
UK/H/0532/001 02-1050 MERCK SHARP & DOHME BV NO
ARCOXIA 60 mg filmom obalené tablety
UK/H/0532/001 29/0003/03-S MERCK SHARP & DOHME BV SK
ARCOXIA 60 mg filmomhulde tabletten
UK/H/0532/001 RVG 27705 MERCK SHARP & DOHME BV NL
ARCOXIA 60 mg filmsko obložene tablete
UK/H/0532/001 H/02/00207/010 MERCK SHARP & DOHME INOVATIVNA ZDRAVILA D.O.O.
SI
ARCOXIA 60 mg filmsko obložene tablete
UK/H/0532/001 H/02/00207/009 MERCK SHARP & DOHME INOVATIVNA ZDRAVILA D.O.O.
SI
List of nationally authorised medicinal products EMA/812634/2017 Page 19/231
Product Name (in authorisation country)
MRP/DCP Authorisation Number
National Authorisation Number
MAH of product in the Member State
Member State where product is authorised
ARCOXIA 60 mg filmsko obložene tablete
UK/H/0532/001 H/02/00207/008 MERCK SHARP & DOHME INOVATIVNA ZDRAVILA D.O.O.
SI
ARCOXIA 60 mg filmsko obložene tablete
UK/H/0532/001 H/02/00207/011 MERCK SHARP & DOHME INOVATIVNA ZDRAVILA D.O.O.
SI
ARCOXIA 60 mg filmsko obložene tablete
UK/H/0532/001 H/02/00207/012 MERCK SHARP & DOHME INOVATIVNA ZDRAVILA D.O.O.
SI
ARCOXIA 60 mg filmsko obložene tablete
UK/H/0532/001 H/02/00207/013 MERCK SHARP & DOHME INOVATIVNA ZDRAVILA D.O.O.
SI
ARCOXIA 60 mg filmsko obložene tablete
UK/H/0532/001 H/02/00207/014 MERCK SHARP & DOHME INOVATIVNA ZDRAVILA D.O.O.
SI
ARCOXIA 60 mg filmsko obložene tablete
UK/H/0532/001 H/02/00207/015 MERCK SHARP & DOHME INOVATIVNA ZDRAVILA D.O.O.
SI
ARCOXIA 60 mg filmsko obložene tablete
UK/H/0532/001 H/02/00207/016 MERCK SHARP & DOHME INOVATIVNA ZDRAVILA D.O.O.
SI
ARCOXIA 60 mg filmsko obložene tablete
UK/H/0532/001 H/02/00207/017 MERCK SHARP & DOHME INOVATIVNA ZDRAVILA D.O.O.
SI
ARCOXIA 60 mg filmsko obložene tablete
UK/H/0532/001 H/02/00207/018 MERCK SHARP & DOHME INOVATIVNA ZDRAVILA D.O.O.
SI
List of nationally authorised medicinal products EMA/812634/2017 Page 20/231
Product Name (in authorisation country)
MRP/DCP Authorisation Number
National Authorisation Number
MAH of product in the Member State
Member State where product is authorised
ARCOXIA 60 mg filmsko obložene tablete
UK/H/0532/001 H/02/00207/019 MERCK SHARP & DOHME INOVATIVNA ZDRAVILA D.O.O.
SI
ARCOXIA 60 mg filmsko obložene tablete
UK/H/0532/001 H/02/00207/020 MERCK SHARP & DOHME INOVATIVNA ZDRAVILA D.O.O.
SI
ARCOXIA 60 mg filmsko obložene tablete
UK/H/0532/001 H/02/00207/021 MERCK SHARP & DOHME INOVATIVNA ZDRAVILA D.O.O.
SI
ARCOXIA 60 mg filmsko obložene tablete
UK/H/0532/001 H/02/00207/022 MERCK SHARP & DOHME INOVATIVNA ZDRAVILA D.O.O.
SI
ARCOXIA 60 mg filmsko obložene tablete
UK/H/0532/001 H/02/00207/023 MERCK SHARP & DOHME INOVATIVNA ZDRAVILA D.O.O.
SI
ARCOXIA 60 mg filmsko obložene tablete
UK/H/0532/001 H/02/00207/024 MERCK SHARP & DOHME INOVATIVNA ZDRAVILA D.O.O.
SI
ARCOXIA 60 mg filmsko obložene tablete
UK/H/0532/001 H/02/00207/060 MERCK SHARP & DOHME INOVATIVNA ZDRAVILA D.O.O.
SI
Arcoxia 60 mg Filmtabletten UK/H/0532/001 1-24674 MERCK SHARP & DOHME BV AT ARCOXIA 60 mg Filmtabletten UK/H/0532/001 59863.00.00 MERCK SHARP & DOHME BV DE ARCOXIA 60 mg filmuhúðaðar töflur
UK/H/0532/001 IS/1/02/025/01 MERCK SHARP & DOHME BV IS
ARCOXIA 60 mg plėvele dengtos tabletės
UK/H/0532/001 LT/1/08/1419/002 MERCK SHARP & DOHME, UAB
LT
ARCOXIA 60 mg plėvele dengtos tabletės
UK/H/0532/001 LT/1/08/1419/003 MERCK SHARP & DOHME, UAB
LT
List of nationally authorised medicinal products EMA/812634/2017 Page 21/231
Product Name (in authorisation country)
MRP/DCP Authorisation Number
National Authorisation Number
MAH of product in the Member State
Member State where product is authorised
ARCOXIA 60 mg plėvele dengtos tabletės
UK/H/0532/001 LT/1/08/1419/004 MERCK SHARP & DOHME, UAB
LT
ARCOXIA 60 mg plėvele dengtos tabletės
UK/H/0532/001 LT/1/08/1419/019 MERCK SHARP & DOHME, UAB
LT
Arcoxia 60 mg tabletti, kalvopäällysteinen
UK/H/0532/001 17273 MERCK SHARP & DOHME BV FI
ARCOXIA 60 mg επικαλυμμένα με λεπτό υμένιο δισκία
UK/H/0532/001 19444 MERCK SHARP & DOHME BV CY
ARCOXIA 60 mg επικαλυμμένα με λεπτό υμένιο δισκία
UK/H/0532/001 71847/06-11-2013 VIANEX S.A. GR
ARCOXIA 60 mg, comprimé pelliculé
UK/H/0532/001 34009 573 512 0 5 MERCK SHARP & DOHME BV FR
ARCOXIA 60 mg, comprimé pelliculé
UK/H/0532/001 34009 573 503 1 4 MERCK SHARP & DOHME BV FR
ARCOXIA 60 mg, comprimé pelliculé
UK/H/0532/001 34009 387 947 0 0 MERCK SHARP & DOHME BV FR
ARCOXIA 60 mg, comprimé pelliculé
UK/H/0532/001 34009 387 949 3 9 MERCK SHARP & DOHME BV FR
ARCOXIA 60 mg, comprimé pelliculé
UK/H/0532/001 34009 573 511 4 4 MERCK SHARP & DOHME BV FR
ARCOXIA 60 mg, comprimé pelliculé
UK/H/0532/001 34009 573 501 9 2 MERCK SHARP & DOHME BV FR
ARCOXIA 60 mg, comprimé pelliculé
UK/H/0532/001 34009 573 502 5 3 MERCK SHARP & DOHME BV FR
ARCOXIA 60 mg, comprimé pelliculé
UK/H/0532/001 34009 387 948 7 8 MERCK SHARP & DOHME BV FR
ARCOXIA 60 mg, comprimé pelliculé
UK/H/0532/001 34009 573 513 7 3 MERCK SHARP & DOHME BV FR
List of nationally authorised medicinal products EMA/812634/2017 Page 22/231
Product Name (in authorisation country)
MRP/DCP Authorisation Number
National Authorisation Number
MAH of product in the Member State
Member State where product is authorised
ARCOXIA 60 mg, comprimé pelliculé
UK/H/0532/001 34009 573 510 8 3 MERCK SHARP & DOHME BV FR
ARCOXIA 60 mg, comprimé pelliculé
UK/H/0532/001 34009 387 950 1 1 MERCK SHARP & DOHME BV FR
ARCOXIA 60 mg, comprimé pelliculé
UK/H/0532/001 34009 387 925 7 7 MERCK SHARP & DOHME BV FR
ARCOXIA 60 mg, comprimé pelliculé
UK/H/0532/001 34009 387 928 6 7 MERCK SHARP & DOHME BV FR
ARCOXIA 60 mg, comprimé pelliculé
UK/H/0532/001 34009 387 923 4 8 MERCK SHARP & DOHME BV FR
ARCOXIA 60 mg, comprimé pelliculé
UK/H/0532/001 34009 387 926 3 8 MERCK SHARP & DOHME BV FR
ARCOXIA 60 mg, comprimé pelliculé
UK/H/0532/001 34009 387 924 0 9 MERCK SHARP & DOHME BV FR
ARCOXIA 60 mg, comprimé pelliculé
UK/H/0532/001 34009 275 698 9 0 MERCK SHARP & DOHME BV FR
ARCOXIA 60 mg compresse rivestite con film
UK/H/0532/001 035820063 MSD ITALIA S.R.L. IT
ARCOXIA 60 mg compresse rivestite con film
UK/H/0532/001 035820051 MSD ITALIA S.R.L. IT
ARCOXIA 60 mg compresse rivestite con film
UK/H/0532/001 035820048 MSD ITALIA S.R.L. IT
ARCOXIA 60 mg compresse rivestite con film
UK/H/0532/001 035820024 MSD ITALIA S.R.L. IT
ARCOXIA 60 mg compresse rivestite con film
UK/H/0532/001 035820012 MSD ITALIA S.R.L. IT
ARCOXIA 60 mg compresse rivestite con film
UK/H/0532/001 035820036 MSD ITALIA S.R.L. IT
List of nationally authorised medicinal products EMA/812634/2017 Page 23/231
Product Name (in authorisation country)
MRP/DCP Authorisation Number
National Authorisation Number
MAH of product in the Member State
Member State where product is authorised
ARCOXIA 60 mg compresse rivestite con film
UK/H/0532/001 035820075 MSD ITALIA S.R.L. IT
ARCOXIA 60 mg compresse rivestite con film
UK/H/0532/001 035820099 MSD ITALIA S.R.L. IT
ARCOXIA 60 mg compresse rivestite con film
UK/H/0532/001 035820101 MSD ITALIA S.R.L. IT
ARCOXIA 60 mg compresse rivestite con film
UK/H/0532/001 035820113 MSD ITALIA S.R.L. IT
ARCOXIA 60 mg compresse rivestite con film
UK/H/0532/001 035820125 MSD ITALIA S.R.L. IT
ARCOXIA 60 mg compresse rivestite con film
UK/H/0532/001 035820137 MSD ITALIA S.R.L. IT
ARCOXIA 60 mg compresse rivestite con film
UK/H/0532/001 035820149 MSD ITALIA S.R.L. IT
ARCOXIA 60 mg compresse rivestite con film
UK/H/0532/001 035820087 MSD ITALIA S.R.L. IT
ARCOXIA 60 mg compresse rivestite con film
UK/H/0532/001 035820570 MSD ITALIA S.R.L. IT
ARCOXIA 60 mg film-coated tablets
UK/H/0532/001 MA224/00302 MERCK SHARP & DOHME BV MT
Arcoxia 60 mg filmtabletta UK/H/0532/001 OGYI-T-8825/56 MSD PHARMA HUNGARY KFT.
HU
Arcoxia 60 mg filmtabletta UK/H/0532/001 OGYI-T-8825/29 MSD PHARMA HUNGARY KFT.
HU
Arcoxia 60 mg filmtabletta UK/H/0532/001 OGYI-T-8825/37 MSD PHARMA HUNGARY KFT.
HU
Arcoxia 60 mg filmtabletta UK/H/0532/001 OGYI-T-8825/06 MSD PHARMA HUNGARY KFT.
HU
List of nationally authorised medicinal products EMA/812634/2017 Page 24/231
Product Name (in authorisation country)
MRP/DCP Authorisation Number
National Authorisation Number
MAH of product in the Member State
Member State where product is authorised
Arcoxia 60 mg filmtabletta UK/H/0532/001 OGYI-T-8825/38 MSD PHARMA HUNGARY KFT.
HU
Arcoxia 60 mg filmtabletta UK/H/0532/001 OGYI-T-8825/34 MSD PHARMA HUNGARY KFT.
HU
Arcoxia 60 mg filmtabletta UK/H/0532/001 OGYI-T-8825/32 MSD PHARMA HUNGARY KFT.
HU
Arcoxia 60 mg filmtabletta UK/H/0532/001 OGYI-T-8825/27 MSD PHARMA HUNGARY KFT.
HU
Arcoxia 60 mg filmtabletta UK/H/0532/001 OGYI-T-8825/35 MSD PHARMA HUNGARY KFT.
HU
Arcoxia 60 mg filmtabletta UK/H/0532/001 OGYI-T-8825/28 MSD PHARMA HUNGARY KFT.
HU
Arcoxia 60 mg filmtabletta UK/H/0532/001 OGYI-T-8825/31 MSD PHARMA HUNGARY KFT.
HU
Arcoxia 60 mg filmtabletta UK/H/0532/001 OGYI-T-8825/30 MSD PHARMA HUNGARY KFT.
HU
Arcoxia 60 mg filmtabletta UK/H/0532/001 OGYI-T-8825/36 MSD PHARMA HUNGARY KFT.
HU
Arcoxia 60 mg filmtabletta UK/H/0532/001 OGYI-T-8825/39 MSD PHARMA HUNGARY KFT.
HU
Arcoxia 60 mg filmtabletta UK/H/0532/001 OGYI-T-8825/33 MSD PHARMA HUNGARY KFT.
HU
Arcoxia 60 mg filmtabletta UK/H/0532/001 OGYI-T-8825/07 MSD PHARMA HUNGARY KFT.
HU
Arcoxia 60 mg filmtabletta UK/H/0532/001 OGYI-T-8825/40 MSD PHARMA HUNGARY KFT.
HU
Arcoxia 60 mg filmtabletta UK/H/0532/001 OGYI-T-8825/60 MSD PHARMA HUNGARY KFT.
HU
List of nationally authorised medicinal products EMA/812634/2017 Page 25/231
Product Name (in authorisation country)
MRP/DCP Authorisation Number
National Authorisation Number
MAH of product in the Member State
Member State where product is authorised
ARCOXIA 90 mg apvalkotās tabletes
UK/H/0532/002 03-0004 MERCK SHARP & DOHME LATVIJA SIA
LV
ARCOXIA 90 mg comprimate filmate
not available 853/2008/02 MERCK SHARP & DOHME ROMANIA SRL
RO
ARCOXIA 90 mg comprimate filmate
not available 853/2008/03 MERCK SHARP & DOHME ROMANIA SRL
RO
ARCOXIA 90 mg comprimate filmate
not available 853/2008/01 MERCK SHARP & DOHME ROMANIA SRL
RO
ARCOXIA 90 mg comprimate filmate
not available 853/2008/04 MERCK SHARP & DOHME ROMANIA SRL
RO
ARCOXIA 90 mg comprimidos recubiertos con película
UK/H/0532/002 64.929 MERCK SHARP & DOHME DE ESPAÑA, S.A
ES
Arcoxia 90 mg comprimidos revestidos por película
UK/H/0532/002 4109385 MERCK SHARP & DOHME, LDA.
PT
Arcoxia 90 mg comprimidos revestidos por película
UK/H/0532/002 4109484 MERCK SHARP & DOHME, LDA.
PT
Arcoxia 90 mg comprimidos revestidos por película
UK/H/0532/002 4110086 MERCK SHARP & DOHME, LDA.
PT
Arcoxia 90 mg comprimidos revestidos por película
UK/H/0532/002 4109187 MERCK SHARP & DOHME, LDA.
PT
Arcoxia 90 mg comprimidos revestidos por película
UK/H/0532/002 4109781 MERCK SHARP & DOHME, LDA.
PT
Arcoxia 90 mg comprimidos revestidos por película
UK/H/0532/002 4109088 MERCK SHARP & DOHME, LDA.
PT
Arcoxia 90 mg comprimidos revestidos por película
UK/H/0532/002 4242681 MERCK SHARP & DOHME, LDA.
PT
Arcoxia 90 mg comprimidos revestidos por película
UK/H/0532/002 4108882 MERCK SHARP & DOHME, LDA.
PT
List of nationally authorised medicinal products EMA/812634/2017 Page 26/231
Product Name (in authorisation country)
MRP/DCP Authorisation Number
National Authorisation Number
MAH of product in the Member State
Member State where product is authorised
Arcoxia 90 mg comprimidos revestidos por película
UK/H/0532/002 4109880 MERCK SHARP & DOHME, LDA.
PT
Arcoxia 90 mg comprimidos revestidos por película
UK/H/0532/002 4109583 MERCK SHARP & DOHME, LDA.
PT
Arcoxia 90 mg comprimidos revestidos por película
UK/H/0532/002 4242582 MERCK SHARP & DOHME, LDA.
PT
Arcoxia 90 mg comprimidos revestidos por película
UK/H/0532/002 4108981 MERCK SHARP & DOHME, LDA.
PT
Arcoxia 90 mg comprimidos revestidos por película
UK/H/0532/002 4110185 MERCK SHARP & DOHME, LDA.
PT
Arcoxia 90 mg comprimidos revestidos por película
UK/H/0532/002 4109989 MERCK SHARP & DOHME, LDA.
PT
Arcoxia 90 mg comprimidos revestidos por película
UK/H/0532/002 4109286 MERCK SHARP & DOHME, LDA.
PT
Arcoxia 90 mg comprimidos revestidos por película
UK/H/0532/002 4109682 MERCK SHARP & DOHME, LDA.
PT
ARCOXIA 90 mg film-coated tablets
UK/H/0532/002 19445 MERCK SHARP & DOHME BV CY
Arcoxia 90 mg Film-coated tablets UK/H/0532/002 PA 1997/1/3 MERCK SHARP & DOHME BV IE ARCOXIA 90 mg film-coated tablets
UK/H/0532/002 MA224/00301 MERCK SHARP & DOHME BV MT
Arcoxia 90 mg filmdragerade tabletter
UK/H/0532/002 17274 MERCK SHARP & DOHME BV FI
Arcoxia 90 mg filmdragerade tabletter
UK/H/0532/002 18366 MERCK SHARP & DOHME BV SE
ARCOXIA 90 mg filmdrasjerte tabletter
UK/H/0532/002 02-1051 MERCK SHARP & DOHME BV NO
ARCOXIA 90 mg filmom obalené tablety
UK/H/0532/002 29/0004/03-S MERCK SHARP & DOHME BV SK
List of nationally authorised medicinal products EMA/812634/2017 Page 27/231
Product Name (in authorisation country)
MRP/DCP Authorisation Number
National Authorisation Number
MAH of product in the Member State
Member State where product is authorised
ARCOXIA 90 mg filmomhulde tabletten
UK/H/0532/002 RVG 27706 MERCK SHARP & DOHME BV NL
ARCOXIA 90 mg filmsko obložene tablete
UK/H/0532/002 H/02/00207/025 MERCK SHARP & DOHME INOVATIVNA ZDRAVILA D.O.O.
SI
ARCOXIA 90 mg filmsko obložene tablete
UK/H/0532/002 H/02/00207/026 MERCK SHARP & DOHME INOVATIVNA ZDRAVILA D.O.O.
SI
ARCOXIA 90 mg filmsko obložene tablete
UK/H/0532/002 H/02/00207/027 MERCK SHARP & DOHME INOVATIVNA ZDRAVILA D.O.O.
SI
ARCOXIA 90 mg filmsko obložene tablete
UK/H/0532/002 H/02/00207/028 MERCK SHARP & DOHME INOVATIVNA ZDRAVILA D.O.O.
SI
ARCOXIA 90 mg filmsko obložene tablete
UK/H/0532/002 H/02/00207/029 MERCK SHARP & DOHME INOVATIVNA ZDRAVILA D.O.O.
SI
ARCOXIA 90 mg filmsko obložene tablete
UK/H/0532/002 H/02/00207/030 MERCK SHARP & DOHME INOVATIVNA ZDRAVILA D.O.O.
SI
ARCOXIA 90 mg filmsko obložene tablete
UK/H/0532/002 H/02/00207/031 MERCK SHARP & DOHME INOVATIVNA ZDRAVILA D.O.O.
SI
ARCOXIA 90 mg filmsko obložene tablete
UK/H/0532/002 H/02/00207/032 MERCK SHARP & DOHME INOVATIVNA ZDRAVILA D.O.O.
SI
ARCOXIA 90 mg filmsko obložene tablete
UK/H/0532/002 H/02/00207/033 MERCK SHARP & DOHME INOVATIVNA ZDRAVILA D.O.O.
SI
List of nationally authorised medicinal products EMA/812634/2017 Page 28/231
Product Name (in authorisation country)
MRP/DCP Authorisation Number
National Authorisation Number
MAH of product in the Member State
Member State where product is authorised
ARCOXIA 90 mg filmsko obložene tablete
UK/H/0532/002 H/02/00207/034 MERCK SHARP & DOHME INOVATIVNA ZDRAVILA D.O.O.
SI
ARCOXIA 90 mg filmsko obložene tablete
UK/H/0532/002 H/02/00207/035 MERCK SHARP & DOHME INOVATIVNA ZDRAVILA D.O.O.
SI
ARCOXIA 90 mg filmsko obložene tablete
UK/H/0532/002 H/02/00207/036 MERCK SHARP & DOHME INOVATIVNA ZDRAVILA D.O.O.
SI
ARCOXIA 90 mg filmsko obložene tablete
UK/H/0532/002 H/02/00207/037 MERCK SHARP & DOHME INOVATIVNA ZDRAVILA D.O.O.
SI
ARCOXIA 90 mg filmsko obložene tablete
UK/H/0532/002 H/02/00207/038 MERCK SHARP & DOHME INOVATIVNA ZDRAVILA D.O.O.
SI
ARCOXIA 90 mg filmsko obložene tablete
UK/H/0532/002 H/02/00207/039 MERCK SHARP & DOHME INOVATIVNA ZDRAVILA D.O.O.
SI
ARCOXIA 90 mg filmsko obložene tablete
UK/H/0532/002 H/02/00207/040 MERCK SHARP & DOHME INOVATIVNA ZDRAVILA D.O.O.
SI
ARCOXIA 90 mg filmsko obložene tablete
UK/H/0532/002 H/02/00207/041 MERCK SHARP & DOHME INOVATIVNA ZDRAVILA D.O.O.
SI
Arcoxia 90 mg Filmtabletten UK/H/0532/002 1-24675 MERCK SHARP & DOHME BV AT ARCOXIA 90 mg Filmtabletten UK/H/0532/002 59863.01.00 MERCK SHARP & DOHME BV DE ARCOXIA 90 mg filmuhúðaðar töflur
UK/H/0532/002 IS/1/02/025/02 MERCK SHARP & DOHME BV IS
List of nationally authorised medicinal products EMA/812634/2017 Page 29/231
Product Name (in authorisation country)
MRP/DCP Authorisation Number
National Authorisation Number
MAH of product in the Member State
Member State where product is authorised
ARCOXIA 90 mg plėvele dengtos tabletės
UK/H/0532/002 LT/1/08/1419/005 MERCK SHARP & DOHME, UAB
LT
ARCOXIA 90 mg plėvele dengtos tabletės
UK/H/0532/002 LT/1/08/1419/007 MERCK SHARP & DOHME, UAB
LT
ARCOXIA 90 mg plėvele dengtos tabletės
UK/H/0532/002 LT/1/08/1419/006 MERCK SHARP & DOHME, UAB
LT
Arcoxia 90 mg tabletti, kalvopäällysteinen
UK/H/0532/002 17274 MERCK SHARP & DOHME BV FI
ARCOXIA 90 mg επικαλυμμένα με λεπτό υμένιο δισκία
UK/H/0532/002 19445 MERCK SHARP & DOHME BV CY
ARCOXIA 90 mg επικαλυμμένα με λεπτό υμένιο δισκία
UK/H/0532/002 71848/06-11-2013 VIANEX S.A. GR
ARCOXIA 90 mg compresse rivestite con film
UK/H/0532/002 035820164 MSD ITALIA S.R.L. IT
ARCOXIA 90 mg compresse rivestite con film
UK/H/0532/002 035820152 MSD ITALIA S.R.L. IT
ARCOXIA 90 mg compresse rivestite con film
UK/H/0532/002 035820176 MSD ITALIA S.R.L. IT
ARCOXIA 90 mg compresse rivestite con film
UK/H/0532/002 035820188 MSD ITALIA S.R.L. IT
ARCOXIA 90 mg compresse rivestite con film
UK/H/0532/002 035820253 MSD ITALIA S.R.L. IT
ARCOXIA 90 mg compresse rivestite con film
UK/H/0532/002 035820289 MSD ITALIA S.R.L. IT
ARCOXIA 90 mg compresse rivestite con film
UK/H/0532/002 035820238 MSD ITALIA S.R.L. IT
ARCOXIA 90 mg compresse rivestite con film
UK/H/0532/002 035820190 MSD ITALIA S.R.L. IT
List of nationally authorised medicinal products EMA/812634/2017 Page 30/231
Product Name (in authorisation country)
MRP/DCP Authorisation Number
National Authorisation Number
MAH of product in the Member State
Member State where product is authorised
ARCOXIA 90 mg compresse rivestite con film
UK/H/0532/002 035820226 MSD ITALIA S.R.L. IT
ARCOXIA 90 mg compresse rivestite con film
UK/H/0532/002 035820277 MSD ITALIA S.R.L. IT
ARCOXIA 90 mg compresse rivestite con film
UK/H/0532/002 035820214 MSD ITALIA S.R.L. IT
ARCOXIA 90 mg compresse rivestite con film
UK/H/0532/002 035820265 MSD ITALIA S.R.L. IT
ARCOXIA 90 mg compresse rivestite con film
UK/H/0532/002 035820240 MSD ITALIA S.R.L. IT
ARCOXIA 90 mg compresse rivestite con film
UK/H/0532/002 035820202 MSD ITALIA S.R.L. IT
Arcoxia 90 mg filmtabletta UK/H/0532/002 OGYI-T-8825/57 MSD PHARMA HUNGARY KFT.
HU
Arcoxia 90 mg filmtabletta UK/H/0532/002 OGYI-T-8825/46 MSD PHARMA HUNGARY KFT.
HU
Arcoxia 90 mg filmtabletta UK/H/0532/002 OGYI-T-8825/53 MSD PHARMA HUNGARY KFT.
HU
Arcoxia 90 mg filmtabletta UK/H/0532/002 OGYI-T-8825/42 MSD PHARMA HUNGARY KFT.
HU
Arcoxia 90 mg filmtabletta UK/H/0532/002 OGYI-T-8825/51 MSD PHARMA HUNGARY KFT.
HU
Arcoxia 90 mg filmtabletta UK/H/0532/002 OGYI-T-8825/54 MSD PHARMA HUNGARY KFT.
HU
Arcoxia 90 mg filmtabletta UK/H/0532/002 OGYI-T-8825/52 MSD PHARMA HUNGARY KFT.
HU
Arcoxia 90 mg filmtabletta UK/H/0532/002 OGYI-T-8825/50 MSD PHARMA HUNGARY KFT.
HU
List of nationally authorised medicinal products EMA/812634/2017 Page 31/231
Product Name (in authorisation country)
MRP/DCP Authorisation Number
National Authorisation Number
MAH of product in the Member State
Member State where product is authorised
Arcoxia 90 mg filmtabletta UK/H/0532/002 OGYI-T-8825/49 MSD PHARMA HUNGARY KFT.
HU
Arcoxia 90 mg filmtabletta UK/H/0532/002 OGYI-T-8825/47 MSD PHARMA HUNGARY KFT.
HU
Arcoxia 90 mg filmtabletta UK/H/0532/002 OGYI-T-8825/44 MSD PHARMA HUNGARY KFT.
HU
Arcoxia 90 mg filmtabletta UK/H/0532/002 OGYI-T-8825/41 MSD PHARMA HUNGARY KFT.
HU
Arcoxia 90 mg filmtabletta UK/H/0532/002 OGYI-T-8825/43 MSD PHARMA HUNGARY KFT.
HU
Arcoxia 90 mg filmtabletta UK/H/0532/002 OGYI-T-8825/48 MSD PHARMA HUNGARY KFT.
HU
Arcoxia 90 mg filmtabletta UK/H/0532/002 OGYI-T-8825/08 MSD PHARMA HUNGARY KFT.
HU
Arcoxia 90 mg filmtabletta UK/H/0532/002 OGYI-T-8825/09 MSD PHARMA HUNGARY KFT.
HU
Arcoxia 90 mg filmtabletta UK/H/0532/002 OGYI-T-8825/45 MSD PHARMA HUNGARY KFT.
HU
Arcoxia, 120 mg õhukese polümeerikattega tabletid
UK/H/0532/003 393002 MERCK SHARP & DOHME OU EE
ARCOXIA, 120 mg, tabletki powlekane
UK/H/0532/003 11468 MSD POLSKA SP. Z O.O. PL
Arcoxia, 30 mg õhukese polümeerikattega tabletid
UK/H/0532/004 572308 MERCK SHARP & DOHME OU EE
ARCOXIA, 30 mg, tabletki powlekane
UK/H/0532/004 22580 MSD POLSKA SP. Z O.O. PL
Arcoxia, 60 mg õhukese polümeerikattega tabletid
UK/H/0532/001 393202 MERCK SHARP & DOHME OU EE
List of nationally authorised medicinal products EMA/812634/2017 Page 32/231
Product Name (in authorisation country)
MRP/DCP Authorisation Number
National Authorisation Number
MAH of product in the Member State
Member State where product is authorised
ARCOXIA, 60 mg, tabletki powlekane
UK/H/0532/001 11466 MSD POLSKA SP. Z O.O. PL
Arcoxia, 90 mg õhukese polümeerikattega tabletid
UK/H/0532/002 393102 MERCK SHARP & DOHME OU EE
ARCOXIA, 90 mg, tabletki powlekane
UK/H/0532/002 11467 MSD POLSKA SP. Z O.O. PL
Arcoxia, filmovertrukne tabletter UK/H/0532/001 33573 MERCK SHARP & DOHME BV DK Arcoxia, filmovertrukne tabletter UK/H/0532/002 33574 MERCK SHARP & DOHME BV DK Arcoxia, filmovertrukne tabletter UK/H/0532/003 33575 MERCK SHARP & DOHME BV DK Arcoxia, filmovertrukne tabletter UK/H/0532/004 39698 MERCK SHARP & DOHME BV DK ARCOXIA® 120 mg comprimés pelliculés
UK/H/0532/003 BE239556 MERCK SHARP & DOHME BV BE
ARCOXIA® 120 mg comprimés pelliculés
UK/H/0532/003 BE387405 MERCK SHARP & DOHME BV BE
ARCOXIA® 120 mg comprimés pelliculés
UK/H/0532/003 2008019636 MERCK SHARP & DOHME BV LU
ARCOXIA® 120 mg film-coated tablets
UK/H/0532/003 PL 04900/0004 MERCK SHARP & DOHME BV UK
ARCOXIA® 120 mg filmom obložene tablete
not available UP/I-530-09/12-02/63 MERCK SHARP & DOHME D.O.O.
HR
ARCOXIA® 120 mg filmomhulde tabletten
UK/H/0532/003 BE387405 MERCK SHARP & DOHME BV BE
ARCOXIA® 120 mg filmomhulde tabletten
UK/H/0532/003 BE239556 MERCK SHARP & DOHME BV BE
ARCOXIA® 120 mg Filmtabletten UK/H/0532/003 BE387405 MERCK SHARP & DOHME BV BE ARCOXIA® 120 mg Filmtabletten UK/H/0532/003 BE239556 MERCK SHARP & DOHME BV BE ARCOXIA® 120 mg, potahované tablety
UK/H/0532/003 29/078/03-C MERCK SHARP & DOHME BV CZ
List of nationally authorised medicinal products EMA/812634/2017 Page 33/231
Product Name (in authorisation country)
MRP/DCP Authorisation Number
National Authorisation Number
MAH of product in the Member State
Member State where product is authorised
ARCOXIA® 30 mg comprimés pelliculés
UK/H/0532/004 BE303886 MERCK SHARP & DOHME BV BE
ARCOXIA® 30 mg comprimés pelliculés
UK/H/0532/004 2008020011 MERCK SHARP & DOHME BV LU
ARCOXIA® 30 mg film-coated tablets
UK/H/0532/004 PL 04900/0001 MERCK SHARP & DOHME BV UK
ARCOXIA® 30 mg filmom obložene tablete
not available UP/I-530-09/12-02/60 MERCK SHARP & DOHME D.O.O.
HR
ARCOXIA® 30 mg filmomhulde tabletten
UK/H/0532/004 BE303886 MERCK SHARP & DOHME BV BE
ARCOXIA® 30 mg Filmtabletten UK/H/0532/004 BE303886 MERCK SHARP & DOHME BV BE ARCOXIA® 30 mg, potahované tablety
UK/H/0532/004 29/617/08-C MERCK SHARP & DOHME BV CZ
ARCOXIA® 60 mg comprimés pelliculés
UK/H/0532/001 BE387387 MERCK SHARP & DOHME BV BE
ARCOXIA® 60 mg comprimés pelliculés
UK/H/0532/001 BE239531 MERCK SHARP & DOHME BV BE
ARCOXIA® 60 mg comprimés pelliculés
UK/H/0532/001 2008019634 MERCK SHARP & DOHME BV LU
ARCOXIA® 60 mg film-coated tablets
UK/H/0532/001 PL 04900/0002 MERCK SHARP & DOHME BV UK
ARCOXIA® 60 mg filmom obložene tablete
not available UP/I-530-09/12-02/61 MERCK SHARP & DOHME D.O.O.
HR
ARCOXIA® 60 mg filmomhulde tabletten
UK/H/0532/001 BE239531 MERCK SHARP & DOHME BV BE
ARCOXIA® 60 mg filmomhulde tabletten
UK/H/0532/001 BE387387 MERCK SHARP & DOHME BV BE
ARCOXIA® 60 mg Filmtabletten UK/H/0532/001 BE239531 MERCK SHARP & DOHME BV BE ARCOXIA® 60 mg Filmtabletten UK/H/0532/001 BE387387 MERCK SHARP & DOHME BV BE
List of nationally authorised medicinal products EMA/812634/2017 Page 34/231
Product Name (in authorisation country)
MRP/DCP Authorisation Number
National Authorisation Number
MAH of product in the Member State
Member State where product is authorised
ARCOXIA® 60 mg, potahované tablety
UK/H/0532/001 29/076/03-C MERCK SHARP & DOHME BV CZ
ARCOXIA® 90 mg comprimés pelliculés
UK/H/0532/002 BE239547 MERCK SHARP & DOHME BV BE
ARCOXIA® 90 mg comprimés pelliculés
UK/H/0532/002 BE387396 MERCK SHARP & DOHME BV BE
ARCOXIA® 90 mg comprimés pelliculés
UK/H/0532/002 2008019635 MERCK SHARP & DOHME BV LU
ARCOXIA® 90 mg film-coated tablets
UK/H/0532/002 PL 04900/0003 MERCK SHARP & DOHME BV UK
ARCOXIA® 90 mg filmom obložene tablete
not available UP/I-530-09/12-02/62 MERCK SHARP & DOHME D.O.O.
HR
ARCOXIA® 90 mg filmomhulde tabletten
UK/H/0532/002 BE239547 MERCK SHARP & DOHME BV BE
ARCOXIA® 90 mg filmomhulde tabletten
UK/H/0532/002 BE387396 MERCK SHARP & DOHME BV BE
ARCOXIA® 90 mg Filmtabletten UK/H/0532/002 BE239547 MERCK SHARP & DOHME BV BE ARCOXIA® 90 mg Filmtabletten UK/H/0532/002 BE387396 MERCK SHARP & DOHME BV BE ARCOXIA® 90 mg, potahované tablety
UK/H/0532/002 29/077/03-C MERCK SHARP & DOHME BV CZ
AUXIB® 120 mg film-coated tablets
UK/H/0533/004 PL 0025/0427 MERCK SHARP & DOHME LTD.
UK
AUXIB® 30 mg film-coated tablets UK/H/0533/001 PL 0025/0479 MERCK SHARP & DOHME LTD.
UK
AUXIB® 60 mg film-coated tablets UK/H/0533/002 PL 0025/0425 MERCK SHARP & DOHME LTD.
UK
AUXIB® 90 mg film-coated tablets UK/H/0533/003 PL 0025/0426 MERCK SHARP & DOHME LTD.
UK
List of nationally authorised medicinal products EMA/812634/2017 Page 35/231
Product Name (in authorisation country)
MRP/DCP Authorisation Number
National Authorisation Number
MAH of product in the Member State
Member State where product is authorised
Bericox 120 mg apvalkotās tabletes
HU/H/0435/004 16-0213 KRKA, D.D., NOVO MESTO LV
Bericox 120 mg plėvele dengtos tabletės
HU/H/0435/004 LT/1/16/3998/033 KRKA, D.D., NOVO MESTO LT
Bericox 120 mg plėvele dengtos tabletės
HU/H/0435/004 LT/1/16/3998/034 KRKA, D.D., NOVO MESTO LT
Bericox 120 mg plėvele dengtos tabletės
HU/H/0435/004 LT/1/16/3998/035 KRKA, D.D., NOVO MESTO LT
Bericox 120 mg plėvele dengtos tabletės
HU/H/0435/004 LT/1/16/3998/036 KRKA, D.D., NOVO MESTO LT
Bericox 120 mg plėvele dengtos tabletės
HU/H/0435/004 LT/1/16/3998/037 KRKA, D.D., NOVO MESTO LT
Bericox 120 mg plėvele dengtos tabletės
HU/H/0435/004 LT/1/16/3998/038 KRKA, D.D., NOVO MESTO LT
Bericox 120 mg plėvele dengtos tabletės
HU/H/0435/004 LT/1/16/3998/039 KRKA, D.D., NOVO MESTO LT
Bericox 120 mg plėvele dengtos tabletės
HU/H/0435/004 LT/1/16/3998/040 KRKA, D.D., NOVO MESTO LT
Bericox 120 mg plėvele dengtos tabletės
HU/H/0435/004 LT/1/16/3998/041 KRKA, D.D., NOVO MESTO LT
Bericox 120 mg plėvele dengtos tabletės
HU/H/0435/004 LT/1/16/3998/042 KRKA, D.D., NOVO MESTO LT
Bericox 120 mg plėvele dengtos tabletės
HU/H/0435/004 LT/1/16/3998/043 KRKA, D.D., NOVO MESTO LT
Bericox 30 mg apvalkotās tabletes HU/H/0435/001 16-0210 KRKA, D.D., NOVO MESTO LV Bericox 30 mg plėvele dengtos tabletės
HU/H/0435/001 LT/1/16/3998/001 KRKA, D.D., NOVO MESTO LT
Bericox 30 mg plėvele dengtos tabletės
HU/H/0435/001 LT/1/16/3998/002 KRKA, D.D., NOVO MESTO LT
List of nationally authorised medicinal products EMA/812634/2017 Page 36/231
Product Name (in authorisation country)
MRP/DCP Authorisation Number
National Authorisation Number
MAH of product in the Member State
Member State where product is authorised
Bericox 30 mg plėvele dengtos tabletės
HU/H/0435/001 LT/1/16/3998/003 KRKA, D.D., NOVO MESTO LT
Bericox 30 mg plėvele dengtos tabletės
HU/H/0435/001 LT/1/16/3998/004 KRKA, D.D., NOVO MESTO LT
Bericox 30 mg plėvele dengtos tabletės
HU/H/0435/001 LT/1/16/3998/005 KRKA, D.D., NOVO MESTO LT
Bericox 30 mg plėvele dengtos tabletės
HU/H/0435/001 LT/1/16/3998/006 KRKA, D.D., NOVO MESTO LT
Bericox 30 mg plėvele dengtos tabletės
HU/H/0435/001 LT/1/16/3998/007 KRKA, D.D., NOVO MESTO LT
Bericox 30 mg plėvele dengtos tabletės
HU/H/0435/001 LT/1/16/3998/008 KRKA, D.D., NOVO MESTO LT
Bericox 30 mg plėvele dengtos tabletės
HU/H/0435/001 LT/1/16/3998/009 KRKA, D.D., NOVO MESTO LT
Bericox 60 mg apvalkotās tabletes HU/H/0435/002 16-0211 KRKA, D.D., NOVO MESTO LV Bericox 60 mg plėvele dengtos tabletės
HU/H/0435/002 LT/1/16/3998/010 KRKA, D.D., NOVO MESTO LT
Bericox 60 mg plėvele dengtos tabletės
HU/H/0435/002 LT/1/16/3998/011 KRKA, D.D., NOVO MESTO LT
Bericox 60 mg plėvele dengtos tabletės
HU/H/0435/002 LT/1/16/3998/012 KRKA, D.D., NOVO MESTO LT
Bericox 60 mg plėvele dengtos tabletės
HU/H/0435/002 LT/1/16/3998/013 KRKA, D.D., NOVO MESTO LT
Bericox 60 mg plėvele dengtos tabletės
HU/H/0435/002 LT/1/16/3998/014 KRKA, D.D., NOVO MESTO LT
Bericox 60 mg plėvele dengtos tabletės
HU/H/0435/002 LT/1/16/3998/015 KRKA, D.D., NOVO MESTO LT
Bericox 60 mg plėvele dengtos tabletės
HU/H/0435/002 LT/1/16/3998/016 KRKA, D.D., NOVO MESTO LT
List of nationally authorised medicinal products EMA/812634/2017 Page 37/231
Product Name (in authorisation country)
MRP/DCP Authorisation Number
National Authorisation Number
MAH of product in the Member State
Member State where product is authorised
Bericox 60 mg plėvele dengtos tabletės
HU/H/0435/002 LT/1/16/3998/017 KRKA, D.D., NOVO MESTO LT
Bericox 60 mg plėvele dengtos tabletės
HU/H/0435/002 LT/1/16/3998/018 KRKA, D.D., NOVO MESTO LT
Bericox 60 mg plėvele dengtos tabletės
HU/H/0435/002 LT/1/16/3998/019 KRKA, D.D., NOVO MESTO LT
Bericox 60 mg plėvele dengtos tabletės
HU/H/0435/002 LT/1/16/3998/020 KRKA, D.D., NOVO MESTO LT
Bericox 90 mg apvalkotās tabletes HU/H/0435/003 16-0212 KRKA, D.D., NOVO MESTO LV Bericox 90 mg plėvele dengtos tabletės
HU/H/0435/003 LT/1/16/3998/021 KRKA, D.D., NOVO MESTO LT
Bericox 90 mg plėvele dengtos tabletės
HU/H/0435/003 LT/1/16/3998/022 KRKA, D.D., NOVO MESTO LT
Bericox 90 mg plėvele dengtos tabletės
HU/H/0435/003 LT/1/16/3998/023 KRKA, D.D., NOVO MESTO LT
Bericox 90 mg plėvele dengtos tabletės
HU/H/0435/003 LT/1/16/3998/024 KRKA, D.D., NOVO MESTO LT
Bericox 90 mg plėvele dengtos tabletės
HU/H/0435/003 LT/1/16/3998/025 KRKA, D.D., NOVO MESTO LT
Bericox 90 mg plėvele dengtos tabletės
HU/H/0435/003 LT/1/16/3998/026 KRKA, D.D., NOVO MESTO LT
Bericox 90 mg plėvele dengtos tabletės
HU/H/0435/003 LT/1/16/3998/027 KRKA, D.D., NOVO MESTO LT
Bericox 90 mg plėvele dengtos tabletės
HU/H/0435/003 LT/1/16/3998/028 KRKA, D.D., NOVO MESTO LT
Bericox 90 mg plėvele dengtos tabletės
HU/H/0435/003 LT/1/16/3998/029 KRKA, D.D., NOVO MESTO LT
Bericox 90 mg plėvele dengtos tabletės
HU/H/0435/003 LT/1/16/3998/030 KRKA, D.D., NOVO MESTO LT
List of nationally authorised medicinal products EMA/812634/2017 Page 38/231
Product Name (in authorisation country)
MRP/DCP Authorisation Number
National Authorisation Number
MAH of product in the Member State
Member State where product is authorised
Bericox 90 mg plėvele dengtos tabletės
HU/H/0435/003 LT/1/16/3998/031 KRKA, D.D., NOVO MESTO LT
Bericox 90 mg plėvele dengtos tabletės
HU/H/0435/003 LT/1/16/3998/032 KRKA, D.D., NOVO MESTO LT
Caretor 120 mg Filmtabletten NL/H/3269/004 93089.00.00 SYNTHON BV DE Caretor 30 mg Filmtabletten NL/H/3269/001 93086.00.00 SYNTHON BV DE Caretor 60 mg Filmtabletten NL/H/3269/002 93087.00.00 SYNTHON BV DE Caretor 90 mg Filmtabletten NL/H/3269/003 93088.00.00 SYNTHON BV DE Coxerit 120 mg filmuhúðaðar töflur
NL/H/3269/004 IS/1/17/004/04 WILLIAMS & HALLS EHF IS
Coxerit 30 mg filmuhúðaðar töflur NL/H/3269/001 IS/1/17/004/01 WILLIAMS & HALLS EHF IS Coxerit 60 mg filmuhúðaðar töflur NL/H/3269/002 IS/1/17/004/02 WILLIAMS & HALLS EHF IS Coxerit 90 mg filmuhúðaðar töflur NL/H/3269/003 IS/1/17/004/03 WILLIAMS & HALLS EHF IS Coxeta 120 mg filmom obložene tablete
DE/H/5031/004 HR-H-189772606 PLIVA HRVATSKA D.O.O. HR
Coxeta 120 mg filmsko obložene tablete
DE/H/5031/004 H/16/02155/031 TEVA B.V SI
Coxeta 30 mg filmom obložene tablete
DE/H/5031/001 HR-H-547635349 PLIVA HRVATSKA D.O.O. HR
Coxeta 30 mg filmsko obložene tablete
DE/H/5031/001 H/16/02155/002 TEVA B.V SI
Coxeta 30 mg filmsko obložene tablete
DE/H/5031/001 H/16/02155/009 TEVA B.V SI
Coxeta 60 mg filmom obložene tablete
DE/H/5031/002 HR-H-072514188 PLIVA HRVATSKA D.O.O. HR
Coxeta 60 mg filmsko obložene tablete
DE/H/5031/002 H/16/02155/019 TEVA B.V SI
Coxeta 90 mg filmom obložene tablete
DE/H/5031/003 HR-H-328272058 PLIVA HRVATSKA D.O.O. HR
List of nationally authorised medicinal products EMA/812634/2017 Page 39/231
Product Name (in authorisation country)
MRP/DCP Authorisation Number
National Authorisation Number
MAH of product in the Member State
Member State where product is authorised
Coxient 120 mg comprimate filmate
IS/H/0244/004 9285/2016/01 ALVOGEN MALTA OPERATIONS (ROW) LTD
RO
Coxient 120 mg comprimate filmate
IS/H/0244/004 9285/2016/02 ALVOGEN MALTA OPERATIONS (ROW) LTD
RO
Coxient 120 mg comprimate filmate
IS/H/0244/004 9285/2016/03 ALVOGEN MALTA OPERATIONS (ROW) LTD
RO
Coxient 120 mg comprimate filmate
IS/H/0244/004 9285/2016/04 ALVOGEN MALTA OPERATIONS (ROW) LTD
RO
Coxient 120 mg comprimate filmate
IS/H/0244/004 9285/2016/05 ALVOGEN MALTA OPERATIONS (ROW) LTD
RO
COXIENT 120 mg filmuhúðaðar töflur
IS/H/0244/004 IS/1/16/070/04 ALVOGEN MALTA OPERATIONS (ROW) LTD
IS
COXIENT 120 mg filmuhúðaðar töflur
IS/H/0244/004 IS/1/16/070/04 ALVOGEN MALTA OPERATIONS (ROW) LTD
IS
COXIENT 120 mg filmuhúðaðar töflur
IS/H/0244/004 IS/1/16/070/04 ALVOGEN MALTA OPERATIONS (ROW) LTD
IS
COXIENT 120 mg filmuhúðaðar töflur
IS/H/0244/004 IS/1/16/070/04 ALVOGEN MALTA OPERATIONS (ROW) LTD
IS
COXIENT 120 mg filmuhúðaðar töflur
IS/H/0244/004 IS/1/16/070/04 ALVOGEN MALTA OPERATIONS (ROW) LTD
IS
Coxient 30 mg comprimate filmate IS/H/0244/001 9282/2016/01 ALVOGEN MALTA OPERATIONS (ROW) LTD
RO
Coxient 30 mg comprimate filmate IS/H/0244/001 9282/2016/02 ALVOGEN MALTA OPERATIONS (ROW) LTD
RO
Coxient 30 mg comprimate filmate IS/H/0244/001 9282/2016/03 ALVOGEN MALTA OPERATIONS (ROW) LTD
RO
Coxient 30 mg comprimate filmate IS/H/0244/001 9282/2016/05 ALVOGEN MALTA OPERATIONS (ROW) LTD
RO
List of nationally authorised medicinal products EMA/812634/2017 Page 40/231
Product Name (in authorisation country)
MRP/DCP Authorisation Number
National Authorisation Number
MAH of product in the Member State
Member State where product is authorised
Coxient 30 mg comprimate filmate IS/H/0244/001 9282/2016/04 ALVOGEN MALTA OPERATIONS (ROW) LTD
RO
COXIENT 30 mg filmuhúðaðar töflur
IS/H/0244/001 IS/1/16/070/01 ALVOGEN MALTA OPERATIONS (ROW) LTD
IS
COXIENT 30 mg filmuhúðaðar töflur
IS/H/0244/001 IS/1/16/070/01 ALVOGEN MALTA OPERATIONS (ROW) LTD
IS
COXIENT 30 mg filmuhúðaðar töflur
IS/H/0244/001 IS/1/16/070/01 ALVOGEN MALTA OPERATIONS (ROW) LTD
IS
COXIENT 30 mg filmuhúðaðar töflur
IS/H/0244/001 IS/1/16/070/01 ALVOGEN MALTA OPERATIONS (ROW) LTD
IS
COXIENT 30 mg filmuhúðaðar töflur
IS/H/0244/001 IS/1/16/070/01 ALVOGEN MALTA OPERATIONS (ROW) LTD
IS
Coxient 60 mg comprimate filmate IS/H/0244/002 9283/2016/05 ALVOGEN MALTA OPERATIONS (ROW) LTD
RO
Coxient 60 mg comprimate filmate IS/H/0244/002 9283/2016/01 ALVOGEN MALTA OPERATIONS (ROW) LTD
RO
Coxient 60 mg comprimate filmate IS/H/0244/002 9283/2016/02 ALVOGEN MALTA OPERATIONS (ROW) LTD
RO
Coxient 60 mg comprimate filmate IS/H/0244/002 9283/2016/03 ALVOGEN MALTA OPERATIONS (ROW) LTD
RO
Coxient 60 mg comprimate filmate IS/H/0244/002 9283/2016/04 ALVOGEN MALTA OPERATIONS (ROW) LTD
RO
COXIENT 60 mg filmuhúðaðar töflur
IS/H/0244/002 IS/1/16/070/02 ALVOGEN MALTA OPERATIONS (ROW) LTD
IS
COXIENT 60 mg filmuhúðaðar töflur
IS/H/0244/002 IS/1/16/070/02 ALVOGEN MALTA OPERATIONS (ROW) LTD
IS
COXIENT 60 mg filmuhúðaðar töflur
IS/H/0244/002 IS/1/16/070/02 ALVOGEN MALTA OPERATIONS (ROW) LTD
IS
List of nationally authorised medicinal products EMA/812634/2017 Page 41/231
Product Name (in authorisation country)
MRP/DCP Authorisation Number
National Authorisation Number
MAH of product in the Member State
Member State where product is authorised
COXIENT 60 mg filmuhúðaðar töflur
IS/H/0244/002 IS/1/16/070/02 ALVOGEN MALTA OPERATIONS (ROW) LTD
IS
COXIENT 60 mg filmuhúðaðar töflur
IS/H/0244/002 IS/1/16/070/02 ALVOGEN MALTA OPERATIONS (ROW) LTD
IS
Coxient 90 mg comprimate filmate IS/H/0244/003 9284/2016/05 ALVOGEN MALTA OPERATIONS (ROW) LTD
RO
Coxient 90 mg comprimate filmate IS/H/0244/003 9284/2016/04 ALVOGEN MALTA OPERATIONS (ROW) LTD
RO
Coxient 90 mg comprimate filmate IS/H/0244/003 9284/2016/03 ALVOGEN MALTA OPERATIONS (ROW) LTD
RO
Coxient 90 mg comprimate filmate IS/H/0244/003 9284/2016/02 ALVOGEN MALTA OPERATIONS (ROW) LTD
RO
Coxient 90 mg comprimate filmate IS/H/0244/003 9284/2016/01 ALVOGEN MALTA OPERATIONS (ROW) LTD
RO
COXIENT 90 mg filmuhúðaðar töflur
IS/H/0244/003 IS/1/16/070/03 ALVOGEN MALTA OPERATIONS (ROW) LTD
IS
COXIENT 90 mg filmuhúðaðar töflur
IS/H/0244/003 IS/1/16/070/03 ALVOGEN MALTA OPERATIONS (ROW) LTD
IS
COXIENT 90 mg filmuhúðaðar töflur
IS/H/0244/003 IS/1/16/070/03 ALVOGEN MALTA OPERATIONS (ROW) LTD
IS
COXIENT 90 mg filmuhúðaðar töflur
IS/H/0244/003 IS/1/16/070/03 ALVOGEN MALTA OPERATIONS (ROW) LTD
IS
COXIENT 90 mg filmuhúðaðar töflur
IS/H/0244/003 IS/1/16/070/03 ALVOGEN MALTA OPERATIONS (ROW) LTD
IS
Coxiloc 120 mg tabletti, kalvopäällysteinen
NL/H/3269/004 32553 AVANSOR PHARMA OY FI
Coxiloc 30 mg tabletti, kalvopäällysteinen
NL/H/3269/001 32550 AVANSOR PHARMA OY FI
List of nationally authorised medicinal products EMA/812634/2017 Page 42/231
Product Name (in authorisation country)
MRP/DCP Authorisation Number
National Authorisation Number
MAH of product in the Member State
Member State where product is authorised
Coxiloc 60 mg tabletti, kalvopäällysteinen
NL/H/3269/002 32551 AVANSOR PHARMA OY FI
Coxiloc 90 mg tabletti, kalvopäällysteinen
NL/H/3269/003 32552 AVANSOR PHARMA OY FI
COXITOR DE/H/3908/001 869415 SANDOZ PHARMACEUTICALS D.D.
EE
COXITOR DE/H/3908/002 869515 SANDOZ PHARMACEUTICALS D.D.
EE
COXITOR DE/H/3908/003 869215 SANDOZ PHARMACEUTICALS D.D.
EE
COXITOR DE/H/3908/004 869315 SANDOZ PHARMACEUTICALS D.D.
EE
Coxitor 120 mg apvalkotās tabletes
DE/H/3908/004 15-0104 SANDOZ PHARMACEUTICALS D.D.
LV
Coxitor 120 mg plėvelė dengtos tabletės
DE/H/3908/004 LT/1/15/3721/097 SANDOZ PHARMACEUTICALS D.D.
LT
Coxitor 120 mg plėvelė dengtos tabletės
DE/H/3908/004 LT/1/15/3721/098 SANDOZ PHARMACEUTICALS D.D.
LT
Coxitor 120 mg plėvelė dengtos tabletės
DE/H/3908/004 LT/1/15/3721/099 SANDOZ PHARMACEUTICALS D.D.
LT
Coxitor 120 mg plėvelė dengtos tabletės
DE/H/3908/004 LT/1/15/3721/100 SANDOZ PHARMACEUTICALS D.D.
LT
Coxitor 120 mg plėvelė dengtos tabletės
DE/H/3908/004 LT/1/15/3721/101 SANDOZ PHARMACEUTICALS D.D.
LT
Coxitor 120 mg plėvelė dengtos tabletės
DE/H/3908/004 LT/1/15/3721/102 SANDOZ PHARMACEUTICALS D.D.
LT
Coxitor 120 mg plėvelė dengtos tabletės
DE/H/3908/004 LT/1/15/3721/103 SANDOZ PHARMACEUTICALS D.D.
LT
List of nationally authorised medicinal products EMA/812634/2017 Page 43/231
Product Name (in authorisation country)
MRP/DCP Authorisation Number
National Authorisation Number
MAH of product in the Member State
Member State where product is authorised
Coxitor 120 mg plėvelė dengtos tabletės
DE/H/3908/004 LT/1/15/3721/104 SANDOZ PHARMACEUTICALS D.D.
LT
Coxitor 120 mg plėvelė dengtos tabletės
DE/H/3908/004 LT/1/15/3721/105 SANDOZ PHARMACEUTICALS D.D.
LT
Coxitor 120 mg plėvelė dengtos tabletės
DE/H/3908/004 LT/1/15/3721/106 SANDOZ PHARMACEUTICALS D.D.
LT
Coxitor 120 mg plėvelė dengtos tabletės
DE/H/3908/004 LT/1/15/3721/107 SANDOZ PHARMACEUTICALS D.D.
LT
Coxitor 120 mg plėvelė dengtos tabletės
DE/H/3908/004 LT/1/15/3721/109 SANDOZ PHARMACEUTICALS D.D.
LT
Coxitor 120 mg plėvelė dengtos tabletės
DE/H/3908/004 LT/1/15/3721/110 SANDOZ PHARMACEUTICALS D.D.
LT
Coxitor 120 mg plėvelė dengtos tabletės
DE/H/3908/004 LT/1/15/3721/111 SANDOZ PHARMACEUTICALS D.D.
LT
Coxitor 120 mg plėvelė dengtos tabletės
DE/H/3908/004 LT/1/15/3721/112 SANDOZ PHARMACEUTICALS D.D.
LT
Coxitor 120 mg plėvelė dengtos tabletės
DE/H/3908/004 LT/1/15/3721/113 SANDOZ PHARMACEUTICALS D.D.
LT
Coxitor 120 mg plėvelė dengtos tabletės
DE/H/3908/004 LT/1/15/3721/114 SANDOZ PHARMACEUTICALS D.D.
LT
Coxitor 120 mg plėvelė dengtos tabletės
DE/H/3908/004 LT/1/15/3721/115 SANDOZ PHARMACEUTICALS D.D.
LT
Coxitor 120 mg plėvelė dengtos tabletės
DE/H/3908/004 LT/1/15/3721/116 SANDOZ PHARMACEUTICALS D.D.
LT
Coxitor 120 mg plėvelė dengtos tabletės
DE/H/3908/004 LT/1/15/3721/119 SANDOZ PHARMACEUTICALS D.D.
LT
Coxitor 120 mg plėvelė dengtos tabletės
DE/H/3908/004 LT/1/15/3721/118 SANDOZ PHARMACEUTICALS D.D.
LT
List of nationally authorised medicinal products EMA/812634/2017 Page 44/231
Product Name (in authorisation country)
MRP/DCP Authorisation Number
National Authorisation Number
MAH of product in the Member State
Member State where product is authorised
Coxitor 120 mg plėvelė dengtos tabletės
DE/H/3908/004 LT/1/15/3721/120 SANDOZ PHARMACEUTICALS D.D.
LT
Coxitor 120 mg plėvelė dengtos tabletės
DE/H/3908/004 LT/1/15/3721/121 SANDOZ PHARMACEUTICALS D.D.
LT
Coxitor 120 mg plėvelė dengtos tabletės
DE/H/3908/004 LT/1/15/3721/122 SANDOZ PHARMACEUTICALS D.D.
LT
Coxitor 120 mg plėvelė dengtos tabletės
DE/H/3908/004 LT/1/15/3721/123 SANDOZ PHARMACEUTICALS D.D.
LT
Coxitor 120 mg plėvelė dengtos tabletės
DE/H/3908/004 LT/1/15/3721/124 SANDOZ PHARMACEUTICALS D.D.
LT
Coxitor 120 mg plėvelė dengtos tabletės
DE/H/3908/004 LT/1/15/3721/125 SANDOZ PHARMACEUTICALS D.D.
LT
Coxitor 120 mg plėvelė dengtos tabletės
DE/H/3908/004 LT/1/15/3721/126 SANDOZ PHARMACEUTICALS D.D.
LT
Coxitor 120 mg plėvelė dengtos tabletės
DE/H/3908/004 LT/1/15/3721/127 SANDOZ PHARMACEUTICALS D.D.
LT
Coxitor 120 mg plėvelė dengtos tabletės
DE/H/3908/004 LT/1/15/3721/128 SANDOZ PHARMACEUTICALS D.D.
LT
Coxitor 120 mg plėvelė dengtos tabletės
DE/H/3908/004 LT/1/15/3721/117 SANDOZ PHARMACEUTICALS D.D.
LT
Coxitor 120 mg plėvelė dengtos tabletės
DE/H/3908/004 LT/1/15/3721/108 SANDOZ PHARMACEUTICALS D.D.
LT
Coxitor 30 mg plėvelė dengtos tabletės
DE/H/3908/001 LT/1/15/3721/001 SANDOZ PHARMACEUTICALS D.D.
LT
Coxitor 30 mg plėvelė dengtos tabletės
DE/H/3908/001 LT/1/15/3721/002 SANDOZ PHARMACEUTICALS D.D.
LT
Coxitor 30 mg plėvelė dengtos tabletės
DE/H/3908/001 LT/1/15/3721/003 SANDOZ PHARMACEUTICALS D.D.
LT
List of nationally authorised medicinal products EMA/812634/2017 Page 45/231
Product Name (in authorisation country)
MRP/DCP Authorisation Number
National Authorisation Number
MAH of product in the Member State
Member State where product is authorised
Coxitor 30 mg plėvelė dengtos tabletės
DE/H/3908/001 LT/1/15/3721/004 SANDOZ PHARMACEUTICALS D.D.
LT
Coxitor 30 mg plėvelė dengtos tabletės
DE/H/3908/001 LT/1/15/3721/005 SANDOZ PHARMACEUTICALS D.D.
LT
Coxitor 30 mg plėvelė dengtos tabletės
DE/H/3908/001 LT/1/15/3721/006 SANDOZ PHARMACEUTICALS D.D.
LT
Coxitor 30 mg plėvelė dengtos tabletės
DE/H/3908/001 LT/1/15/3721/007 SANDOZ PHARMACEUTICALS D.D.
LT
Coxitor 30 mg plėvelė dengtos tabletės
DE/H/3908/001 LT/1/15/3721/008 SANDOZ PHARMACEUTICALS D.D.
LT
Coxitor 30 mg plėvelė dengtos tabletės
DE/H/3908/001 LT/1/15/3721/012 SANDOZ PHARMACEUTICALS D.D.
LT
Coxitor 30 mg plėvelė dengtos tabletės
DE/H/3908/001 LT/1/15/3721/010 SANDOZ PHARMACEUTICALS D.D.
LT
Coxitor 30 mg plėvelė dengtos tabletės
DE/H/3908/001 LT/1/15/3721/009 SANDOZ PHARMACEUTICALS D.D.
LT
Coxitor 30 mg plėvelė dengtos tabletės
DE/H/3908/001 LT/1/15/3721/013 SANDOZ PHARMACEUTICALS D.D.
LT
Coxitor 30 mg plėvelė dengtos tabletės
DE/H/3908/001 LT/1/15/3721/014 SANDOZ PHARMACEUTICALS D.D.
LT
Coxitor 30 mg plėvelė dengtos tabletės
DE/H/3908/001 LT/1/15/3721/011 SANDOZ PHARMACEUTICALS D.D.
LT
Coxitor 30 mg plėvelė dengtos tabletės
DE/H/3908/001 LT/1/15/3721/015 SANDOZ PHARMACEUTICALS D.D.
LT
Coxitor 30 mg plėvelė dengtos tabletės
DE/H/3908/001 LT/1/15/3721/016 SANDOZ PHARMACEUTICALS D.D.
LT
Coxitor 30 mg plėvelė dengtos tabletės
DE/H/3908/001 LT/1/15/3721/017 SANDOZ PHARMACEUTICALS D.D.
LT
List of nationally authorised medicinal products EMA/812634/2017 Page 46/231
Product Name (in authorisation country)
MRP/DCP Authorisation Number
National Authorisation Number
MAH of product in the Member State
Member State where product is authorised
Coxitor 30 mg plėvelė dengtos tabletės
DE/H/3908/001 LT/1/15/3721/018 SANDOZ PHARMACEUTICALS D.D.
LT
Coxitor 30 mg plėvelė dengtos tabletės
DE/H/3908/001 LT/1/15/3721/019 SANDOZ PHARMACEUTICALS D.D.
LT
Coxitor 30 mg plėvelė dengtos tabletės
DE/H/3908/001 LT/1/15/3721/020 SANDOZ PHARMACEUTICALS D.D.
LT
Coxitor 30 mg plėvelė dengtos tabletės
DE/H/3908/001 LT/1/15/3721/021 SANDOZ PHARMACEUTICALS D.D.
LT
Coxitor 30 mg plėvelė dengtos tabletės
DE/H/3908/001 LT/1/15/3721/022 SANDOZ PHARMACEUTICALS D.D.
LT
Coxitor 30 mg plėvelė dengtos tabletės
DE/H/3908/001 LT/1/15/3721/023 SANDOZ PHARMACEUTICALS D.D.
LT
Coxitor 30 mg plėvelė dengtos tabletės
DE/H/3908/001 LT/1/15/3721/024 SANDOZ PHARMACEUTICALS D.D.
LT
Coxitor 30 mg plėvelė dengtos tabletės
DE/H/3908/001 LT/1/15/3721/025 SANDOZ PHARMACEUTICALS D.D.
LT
Coxitor 30 mg plėvelė dengtos tabletės
DE/H/3908/001 LT/1/15/3721/026 SANDOZ PHARMACEUTICALS D.D.
LT
Coxitor 30 mg plėvelė dengtos tabletės
DE/H/3908/001 LT/1/15/3721/027 SANDOZ PHARMACEUTICALS D.D.
LT
Coxitor 30 mg plėvelė dengtos tabletės
DE/H/3908/001 LT/1/15/3721/028 SANDOZ PHARMACEUTICALS D.D.
LT
Coxitor 30 mg plėvelė dengtos tabletės
DE/H/3908/001 LT/1/15/3721/029 SANDOZ PHARMACEUTICALS D.D.
LT
Coxitor 30 mg plėvelė dengtos tabletės
DE/H/3908/001 LT/1/15/3721/031 SANDOZ PHARMACEUTICALS D.D.
LT
Coxitor 30 mg plėvelė dengtos tabletės
DE/H/3908/001 LT/1/15/3721/030 SANDOZ PHARMACEUTICALS D.D.
LT
List of nationally authorised medicinal products EMA/812634/2017 Page 47/231
Product Name (in authorisation country)
MRP/DCP Authorisation Number
National Authorisation Number
MAH of product in the Member State
Member State where product is authorised
Coxitor 30 mg plėvelė dengtos tabletės
DE/H/3908/001 LT/1/15/3721/032 SANDOZ PHARMACEUTICALS D.D.
LT
Coxitor 60 mg apvalkotās tabletes DE/H/3908/002 15-0102 SANDOZ PHARMACEUTICALS D.D.
LV
Coxitor 60 mg plėvelė dengtos tabletės
DE/H/3908/002 LT/1/15/3721/033 SANDOZ PHARMACEUTICALS D.D.
LT
Coxitor 60 mg plėvelė dengtos tabletės
DE/H/3908/002 LT/1/15/3721/034 SANDOZ PHARMACEUTICALS D.D.
LT
Coxitor 60 mg plėvelė dengtos tabletės
DE/H/3908/002 LT/1/15/3721/035 SANDOZ PHARMACEUTICALS D.D.
LT
Coxitor 60 mg plėvelė dengtos tabletės
DE/H/3908/002 LT/1/15/3721/036 SANDOZ PHARMACEUTICALS D.D.
LT
Coxitor 60 mg plėvelė dengtos tabletės
DE/H/3908/002 LT/1/15/3721/037 SANDOZ PHARMACEUTICALS D.D.
LT
Coxitor 60 mg plėvelė dengtos tabletės
DE/H/3908/002 LT/1/15/3721/038 SANDOZ PHARMACEUTICALS D.D.
LT
Coxitor 60 mg plėvelė dengtos tabletės
DE/H/3908/002 LT/1/15/3721/039 SANDOZ PHARMACEUTICALS D.D.
LT
Coxitor 60 mg plėvelė dengtos tabletės
DE/H/3908/002 LT/1/15/3721/040 SANDOZ PHARMACEUTICALS D.D.
LT
Coxitor 60 mg plėvelė dengtos tabletės
DE/H/3908/002 LT/1/15/3721/041 SANDOZ PHARMACEUTICALS D.D.
LT
Coxitor 60 mg plėvelė dengtos tabletės
DE/H/3908/002 LT/1/15/3721/042 SANDOZ PHARMACEUTICALS D.D.
LT
Coxitor 60 mg plėvelė dengtos tabletės
DE/H/3908/002 LT/1/15/3721/043 SANDOZ PHARMACEUTICALS D.D.
LT
Coxitor 60 mg plėvelė dengtos tabletės
DE/H/3908/002 LT/1/15/3721/044 SANDOZ PHARMACEUTICALS D.D.
LT
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Product Name (in authorisation country)
MRP/DCP Authorisation Number
National Authorisation Number
MAH of product in the Member State
Member State where product is authorised
Coxitor 60 mg plėvelė dengtos tabletės
DE/H/3908/002 LT/1/15/3721/045 SANDOZ PHARMACEUTICALS D.D.
LT
Coxitor 60 mg plėvelė dengtos tabletės
DE/H/3908/002 LT/1/15/3721/046 SANDOZ PHARMACEUTICALS D.D.
LT
Coxitor 60 mg plėvelė dengtos tabletės
DE/H/3908/002 LT/1/15/3721/047 SANDOZ PHARMACEUTICALS D.D.
LT
Coxitor 60 mg plėvelė dengtos tabletės
DE/H/3908/002 LT/1/15/3721/048 SANDOZ PHARMACEUTICALS D.D.
LT
Coxitor 60 mg plėvelė dengtos tabletės
DE/H/3908/002 LT/1/15/3721/049 SANDOZ PHARMACEUTICALS D.D.
LT
Coxitor 60 mg plėvelė dengtos tabletės
DE/H/3908/002 LT/1/15/3721/050 SANDOZ PHARMACEUTICALS D.D.
LT
Coxitor 60 mg plėvelė dengtos tabletės
DE/H/3908/002 LT/1/15/3721/051 SANDOZ PHARMACEUTICALS D.D.
LT
Coxitor 60 mg plėvelė dengtos tabletės
DE/H/3908/002 LT/1/15/3721/052 SANDOZ PHARMACEUTICALS D.D.
LT
Coxitor 60 mg plėvelė dengtos tabletės
DE/H/3908/002 LT/1/15/3721/053 SANDOZ PHARMACEUTICALS D.D.
LT
Coxitor 60 mg plėvelė dengtos tabletės
DE/H/3908/002 LT/1/15/3721/054 SANDOZ PHARMACEUTICALS D.D.
LT
Coxitor 60 mg plėvelė dengtos tabletės
DE/H/3908/002 LT/1/15/3721/055 SANDOZ PHARMACEUTICALS D.D.
LT
Coxitor 60 mg plėvelė dengtos tabletės
DE/H/3908/002 LT/1/15/3721/056 SANDOZ PHARMACEUTICALS D.D.
LT
Coxitor 60 mg plėvelė dengtos tabletės
DE/H/3908/002 LT/1/15/3721/058 SANDOZ PHARMACEUTICALS D.D.
LT
Coxitor 60 mg plėvelė dengtos tabletės
DE/H/3908/002 LT/1/15/3721/059 SANDOZ PHARMACEUTICALS D.D.
LT
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Product Name (in authorisation country)
MRP/DCP Authorisation Number
National Authorisation Number
MAH of product in the Member State
Member State where product is authorised
Coxitor 60 mg plėvelė dengtos tabletės
DE/H/3908/002 LT/1/15/3721/057 SANDOZ PHARMACEUTICALS D.D.
LT
Coxitor 60 mg plėvelė dengtos tabletės
DE/H/3908/002 LT/1/15/3721/060 SANDOZ PHARMACEUTICALS D.D.
LT
Coxitor 60 mg plėvelė dengtos tabletės
DE/H/3908/002 LT/1/15/3721/061 SANDOZ PHARMACEUTICALS D.D.
LT
Coxitor 60 mg plėvelė dengtos tabletės
DE/H/3908/002 LT/1/15/3721/062 SANDOZ PHARMACEUTICALS D.D.
LT
Coxitor 60 mg plėvelė dengtos tabletės
DE/H/3908/002 LT/1/15/3721/063 SANDOZ PHARMACEUTICALS D.D.
LT
Coxitor 60 mg plėvelė dengtos tabletės
DE/H/3908/002 LT/1/15/3721/064 SANDOZ PHARMACEUTICALS D.D.
LT
Coxitor 90 mg apvalkotās tabletes DE/H/3908/003 15-0103 SANDOZ PHARMACEUTICALS D.D.
LV
Coxitor 90 mg plėvelė dengtos tabletės
DE/H/3908/003 LT/1/15/3721/065 SANDOZ PHARMACEUTICALS D.D.
LT
Coxitor 90 mg plėvelė dengtos tabletės
DE/H/3908/003 LT/1/15/3721/072 SANDOZ PHARMACEUTICALS D.D.
LT
Coxitor 90 mg plėvelė dengtos tabletės
DE/H/3908/003 LT/1/15/3721/073 SANDOZ PHARMACEUTICALS D.D.
LT
Coxitor 90 mg plėvelė dengtos tabletės
DE/H/3908/003 LT/1/15/3721/074 SANDOZ PHARMACEUTICALS D.D.
LT
Coxitor 90 mg plėvelė dengtos tabletės
DE/H/3908/003 LT/1/15/3721/075 SANDOZ PHARMACEUTICALS D.D.
LT
Coxitor 90 mg plėvelė dengtos tabletės
DE/H/3908/003 LT/1/15/3721/076 SANDOZ PHARMACEUTICALS D.D.
LT
Coxitor 90 mg plėvelė dengtos tabletės
DE/H/3908/003 LT/1/15/3721/077 SANDOZ PHARMACEUTICALS D.D.
LT
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Product Name (in authorisation country)
MRP/DCP Authorisation Number
National Authorisation Number
MAH of product in the Member State
Member State where product is authorised
Coxitor 90 mg plėvelė dengtos tabletės
DE/H/3908/003 LT/1/15/3721/078 SANDOZ PHARMACEUTICALS D.D.
LT
Coxitor 90 mg plėvelė dengtos tabletės
DE/H/3908/003 LT/1/15/3721/079 SANDOZ PHARMACEUTICALS D.D.
LT
Coxitor 90 mg plėvelė dengtos tabletės
DE/H/3908/003 LT/1/15/3721/080 SANDOZ PHARMACEUTICALS D.D.
LT
Coxitor 90 mg plėvelė dengtos tabletės
DE/H/3908/003 LT/1/15/3721/081 SANDOZ PHARMACEUTICALS D.D.
LT
Coxitor 90 mg plėvelė dengtos tabletės
DE/H/3908/003 LT/1/15/3721/082 SANDOZ PHARMACEUTICALS D.D.
LT
Coxitor 90 mg plėvelė dengtos tabletės
DE/H/3908/003 LT/1/15/3721/083 SANDOZ PHARMACEUTICALS D.D.
LT
Coxitor 90 mg plėvelė dengtos tabletės
DE/H/3908/003 LT/1/15/3721/084 SANDOZ PHARMACEUTICALS D.D.
LT
Coxitor 90 mg plėvelė dengtos tabletės
DE/H/3908/003 LT/1/15/3721/085 SANDOZ PHARMACEUTICALS D.D.
LT
Coxitor 90 mg plėvelė dengtos tabletės
DE/H/3908/003 LT/1/15/3721/086 SANDOZ PHARMACEUTICALS D.D.
LT
Coxitor 90 mg plėvelė dengtos tabletės
DE/H/3908/003 LT/1/15/3721/087 SANDOZ PHARMACEUTICALS D.D.
LT
Coxitor 90 mg plėvelė dengtos tabletės
DE/H/3908/003 LT/1/15/3721/088 SANDOZ PHARMACEUTICALS D.D.
LT
Coxitor 90 mg plėvelė dengtos tabletės
DE/H/3908/003 LT/1/15/3721/089 SANDOZ PHARMACEUTICALS D.D.
LT
Coxitor 90 mg plėvelė dengtos tabletės
DE/H/3908/003 LT/1/15/3721/090 SANDOZ PHARMACEUTICALS D.D.
LT
Coxitor 90 mg plėvelė dengtos tabletės
DE/H/3908/003 LT/1/15/3721/091 SANDOZ PHARMACEUTICALS D.D.
LT
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Product Name (in authorisation country)
MRP/DCP Authorisation Number
National Authorisation Number
MAH of product in the Member State
Member State where product is authorised
Coxitor 90 mg plėvelė dengtos tabletės
DE/H/3908/003 LT/1/15/3721/092 SANDOZ PHARMACEUTICALS D.D.
LT
Coxitor 90 mg plėvelė dengtos tabletės
DE/H/3908/003 LT/1/15/3721/093 SANDOZ PHARMACEUTICALS D.D.
LT
Coxitor 90 mg plėvelė dengtos tabletės
DE/H/3908/003 LT/1/15/3721/094 SANDOZ PHARMACEUTICALS D.D.
LT
Coxitor 90 mg plėvelė dengtos tabletės
DE/H/3908/003 LT/1/15/3721/095 SANDOZ PHARMACEUTICALS D.D.
LT
Coxitor 90 mg plėvelė dengtos tabletės
DE/H/3908/003 LT/1/15/3721/096 SANDOZ PHARMACEUTICALS D.D.
LT
Coxitor 90 mg plėvelė dengtos tabletės
DE/H/3908/003 LT/1/15/3721/066 SANDOZ PHARMACEUTICALS D.D.
LT
Coxitor 90 mg plėvelė dengtos tabletės
DE/H/3908/003 LT/1/15/3721/067 SANDOZ PHARMACEUTICALS D.D.
LT
Coxitor 90 mg plėvelė dengtos tabletės
DE/H/3908/003 LT/1/15/3721/068 SANDOZ PHARMACEUTICALS D.D.
LT
Coxitor 90 mg plėvelė dengtos tabletės
DE/H/3908/003 LT/1/15/3721/069 SANDOZ PHARMACEUTICALS D.D.
LT
Coxitor 90 mg plėvelė dengtos tabletės
DE/H/3908/003 LT/1/15/3721/070 SANDOZ PHARMACEUTICALS D.D.
LT
Coxitor 90 mg plėvelė dengtos tabletės
DE/H/3908/003 LT/1/15/3721/071 SANDOZ PHARMACEUTICALS D.D.
LT
Coxolin, 120 mg filmdragerade tabletter
NL/H/3271/004 55246 SYNTHON BV SE
Coxolin, 30 mg filmdragerade tabletter
NL/H/3271/001 55243 SYNTHON BV SE
Coxolin, 60 mg filmdragerade tabletter
NL/H/3271/002 55244 SYNTHON BV SE
List of nationally authorised medicinal products EMA/812634/2017 Page 52/231
Product Name (in authorisation country)
MRP/DCP Authorisation Number
National Authorisation Number
MAH of product in the Member State
Member State where product is authorised
Coxolin, 90 mg filmdragerade tabletter
NL/H/3271/003 55245 SYNTHON BV SE
Doloxib 120 mg comprimate filmate
EE/H/0211/004 8956/2016/04 ZENTIVA, K.S. RO
Doloxib 120 mg comprimate filmate
EE/H/0211/004 8956/2016/03 ZENTIVA, K.S. RO
Doloxib 120 mg comprimate filmate
EE/H/0211/004 8956/2016/05 ZENTIVA, K.S. RO
Doloxib 120 mg comprimate filmate
EE/H/0211/004 8956/2016/02 ZENTIVA, K.S. RO
Doloxib 120 mg comprimate filmate
EE/H/0211/004 8956/2016/01 ZENTIVA, K.S. RO
Doloxib 120 mg comprimate filmate
EE/H/0211/004 8956/2016/04 ZENTIVA, K.S. RO
Doloxib 120 mg comprimate filmate
EE/H/0211/004 8956/2016/03 ZENTIVA, K.S. RO
Doloxib 120 mg comprimate filmate
EE/H/0211/004 8956/2016/05 ZENTIVA, K.S. RO
Doloxib 120 mg comprimate filmate
EE/H/0211/004 8956/2016/02 ZENTIVA, K.S. RO
Doloxib 120 mg comprimate filmate
EE/H/0211/004 8956/2016/01 ZENTIVA, K.S. RO
Doloxib 30 mg comprimate filmate EE/H/0211/001 8953/2016/02 ZENTIVA, K.S. RO Doloxib 30 mg comprimate filmate EE/H/0211/001 8953/2016/01 ZENTIVA, K.S. RO Doloxib 30 mg comprimate filmate EE/H/0211/001 8953/2016/03 ZENTIVA, K.S. RO Doloxib 30 mg comprimate filmate EE/H/0211/001 8953/2016/02 ZENTIVA, K.S. RO Doloxib 30 mg comprimate filmate EE/H/0211/001 8953/2016/01 ZENTIVA, K.S. RO Doloxib 30 mg comprimate filmate EE/H/0211/001 8953/2016/03 ZENTIVA, K.S. RO Doloxib 60 mg comprimate filmate EE/H/0211/002 8954/2016/04 ZENTIVA, K.S. RO
List of nationally authorised medicinal products EMA/812634/2017 Page 53/231
Product Name (in authorisation country)
MRP/DCP Authorisation Number
National Authorisation Number
MAH of product in the Member State
Member State where product is authorised
Doloxib 60 mg comprimate filmate EE/H/0211/002 8954/2016/02 ZENTIVA, K.S. RO Doloxib 60 mg comprimate filmate EE/H/0211/002 8954/2016/03 ZENTIVA, K.S. RO Doloxib 60 mg comprimate filmate EE/H/0211/002 8954/2016/05 ZENTIVA, K.S. RO Doloxib 60 mg comprimate filmate EE/H/0211/002 8954/2016/06 ZENTIVA, K.S. RO Doloxib 60 mg comprimate filmate EE/H/0211/002 8954/2016/01 ZENTIVA, K.S. RO Doloxib 60 mg comprimate filmate EE/H/0211/002 8954/2016/04 ZENTIVA, K.S. RO Doloxib 60 mg comprimate filmate EE/H/0211/002 8954/2016/02 ZENTIVA, K.S. RO Doloxib 60 mg comprimate filmate EE/H/0211/002 8954/2016/03 ZENTIVA, K.S. RO Doloxib 60 mg comprimate filmate EE/H/0211/002 8954/2016/05 ZENTIVA, K.S. RO Doloxib 60 mg comprimate filmate EE/H/0211/002 8954/2016/06 ZENTIVA, K.S. RO Doloxib 60 mg comprimate filmate EE/H/0211/002 8954/2016/01 ZENTIVA, K.S. RO Doloxib 90 mg comprimate filmate EE/H/0211/003 8955/2016/04 ZENTIVA, K.S. RO Doloxib 90 mg comprimate filmate EE/H/0211/003 8955/2016/05 ZENTIVA, K.S. RO Doloxib 90 mg comprimate filmate EE/H/0211/003 8955/2016/02 ZENTIVA, K.S. RO Doloxib 90 mg comprimate filmate EE/H/0211/003 8955/2016/03 ZENTIVA, K.S. RO Doloxib 90 mg comprimate filmate EE/H/0211/003 8955/2016/06 ZENTIVA, K.S. RO Doloxib 90 mg comprimate filmate EE/H/0211/003 8955/2016/01 ZENTIVA, K.S. RO Doloxib 90 mg comprimate filmate EE/H/0211/003 8955/2016/04 ZENTIVA, K.S. RO Doloxib 90 mg comprimate filmate EE/H/0211/003 8955/2016/05 ZENTIVA, K.S. RO Doloxib 90 mg comprimate filmate EE/H/0211/003 8955/2016/02 ZENTIVA, K.S. RO Doloxib 90 mg comprimate filmate EE/H/0211/003 8955/2016/03 ZENTIVA, K.S. RO Doloxib 90 mg comprimate filmate EE/H/0211/003 8955/2016/06 ZENTIVA, K.S. RO Doloxib 90 mg comprimate filmate EE/H/0211/003 8955/2016/01 ZENTIVA, K.S. RO Doloxib, 120 mg, tabletki powlekane
EE/H/0211/004 23384 ZENTIVA, K.S. PL
Doloxib, 120 mg, tabletki powlekane
EE/H/0211/004 23384 ZENTIVA, K.S. PL
List of nationally authorised medicinal products EMA/812634/2017 Page 54/231
Product Name (in authorisation country)
MRP/DCP Authorisation Number
National Authorisation Number
MAH of product in the Member State
Member State where product is authorised
Doloxib, 120 mg, tabletki powlekane
EE/H/0211/004 23384 ZENTIVA, K.S. PL
Doloxib, 120 mg, tabletki powlekane
EE/H/0211/004 23384 ZENTIVA, K.S. PL
Doloxib, 120 mg, tabletki powlekane
EE/H/0211/004 23384 ZENTIVA, K.S. PL
Doloxib, 120 mg, tabletki powlekane
EE/H/0211/004 23384 ZENTIVA, K.S. PL
Doloxib, 120 mg, tabletki powlekane
EE/H/0211/004 23384 ZENTIVA, K.S. PL
Doloxib, 120 mg, tabletki powlekane
EE/H/0211/004 23384 ZENTIVA, K.S. PL
Doloxib, 120 mg, tabletki powlekane
EE/H/0211/004 23384 ZENTIVA, K.S. PL
Doloxib, 120 mg, tabletki powlekane
EE/H/0211/004 23384 ZENTIVA, K.S. PL
Doloxib, 30 mg, tabletki powlekane
EE/H/0211/001 23381 ZENTIVA, K.S. PL
Doloxib, 30 mg, tabletki powlekane
EE/H/0211/001 23381 ZENTIVA, K.S. PL
Doloxib, 30 mg, tabletki powlekane
EE/H/0211/001 23381 ZENTIVA, K.S. PL
Doloxib, 30 mg, tabletki powlekane
EE/H/0211/001 23381 ZENTIVA, K.S. PL
Doloxib, 30 mg, tabletki powlekane
EE/H/0211/001 23381 ZENTIVA, K.S. PL
Doloxib, 30 mg, tabletki powlekane
EE/H/0211/001 23381 ZENTIVA, K.S. PL
List of nationally authorised medicinal products EMA/812634/2017 Page 55/231
Product Name (in authorisation country)
MRP/DCP Authorisation Number
National Authorisation Number
MAH of product in the Member State
Member State where product is authorised
Doloxib, 60 mg, tabletki powlekane
EE/H/0211/002 23382 ZENTIVA, K.S. PL
Doloxib, 60 mg, tabletki powlekane
EE/H/0211/002 23382 ZENTIVA, K.S. PL
Doloxib, 60 mg, tabletki powlekane
EE/H/0211/002 23382 ZENTIVA, K.S. PL
Doloxib, 60 mg, tabletki powlekane
EE/H/0211/002 23382 ZENTIVA, K.S. PL
Doloxib, 60 mg, tabletki powlekane
EE/H/0211/002 23382 ZENTIVA, K.S. PL
Doloxib, 60 mg, tabletki powlekane
EE/H/0211/002 23382 ZENTIVA, K.S. PL
Doloxib, 60 mg, tabletki powlekane
EE/H/0211/002 23382 ZENTIVA, K.S. PL
Doloxib, 60 mg, tabletki powlekane
EE/H/0211/002 23382 ZENTIVA, K.S. PL
Doloxib, 60 mg, tabletki powlekane
EE/H/0211/002 23382 ZENTIVA, K.S. PL
Doloxib, 60 mg, tabletki powlekane
EE/H/0211/002 23382 ZENTIVA, K.S. PL
Doloxib, 60 mg, tabletki powlekane
EE/H/0211/002 23382 ZENTIVA, K.S. PL
Doloxib, 60 mg, tabletki powlekane
EE/H/0211/002 23382 ZENTIVA, K.S. PL
Doloxib, 90 mg, tabletki powlekane
EE/H/0211/003 23383 ZENTIVA, K.S. PL
Doloxib, 90 mg, tabletki powlekane
EE/H/0211/003 23383 ZENTIVA, K.S. PL
List of nationally authorised medicinal products EMA/812634/2017 Page 56/231
Product Name (in authorisation country)
MRP/DCP Authorisation Number
National Authorisation Number
MAH of product in the Member State
Member State where product is authorised
Doloxib, 90 mg, tabletki powlekane
EE/H/0211/003 23383 ZENTIVA, K.S. PL
Doloxib, 90 mg, tabletki powlekane
EE/H/0211/003 23383 ZENTIVA, K.S. PL
Doloxib, 90 mg, tabletki powlekane
EE/H/0211/003 23383 ZENTIVA, K.S. PL
Doloxib, 90 mg, tabletki powlekane
EE/H/0211/003 23383 ZENTIVA, K.S. PL
Doloxib, 90 mg, tabletki powlekane
EE/H/0211/003 23383 ZENTIVA, K.S. PL
Doloxib, 90 mg, tabletki powlekane
EE/H/0211/003 23383 ZENTIVA, K.S. PL
Doloxib, 90 mg, tabletki powlekane
EE/H/0211/003 23383 ZENTIVA, K.S. PL
Doloxib, 90 mg, tabletki powlekane
EE/H/0211/003 23383 ZENTIVA, K.S. PL
Doloxib, 90 mg, tabletki powlekane
EE/H/0211/003 23383 ZENTIVA, K.S. PL
Doloxib, 90 mg, tabletki powlekane
EE/H/0211/003 23383 ZENTIVA, K.S. PL
Ecoxyton 120 mg tabletten NL/H/3269/004 RVG 116021 SYNTHON BV NL Ecoxyton 30 mg tabletten NL/H/3269/001 RVG 116018 SYNTHON BV NL Ecoxyton 60 mg tabletten NL/H/3269/002 RVG 116019 SYNTHON BV NL Ecoxyton 90 mg tabletten NL/H/3269/003 RVG 116020 SYNTHON BV NL Etori - 1 A Pharma 120 mg Filmtabletten
DE/H/3908/004 90438.00.00 1 A PHARMA GMBH DE
Etori - 1 A Pharma 30 mg Filmtabletten
DE/H/3908/001 90435.00.00 1 A PHARMA GMBH DE
List of nationally authorised medicinal products EMA/812634/2017 Page 57/231
Product Name (in authorisation country)
MRP/DCP Authorisation Number
National Authorisation Number
MAH of product in the Member State
Member State where product is authorised
Etori - 1 A Pharma 60 mg Filmtabletten
DE/H/3908/002 90436.00.00 1 A PHARMA GMBH DE
Etori - 1 A Pharma 90 mg Filmtabletten
DE/H/3908/003 90437.00.00 1 A PHARMA GMBH DE
Etoriax 120 mg filmtabletta HU/H/0443/004 OGYI-T-23100/04 KRKA, D.D., NOVO MESTO HU Etoriax 30 mg filmtabletta HU/H/0443/001 OGYI-T-23100/01 KRKA, D.D., NOVO MESTO HU Etoriax 60 mg filmtabletta HU/H/0443/002 OGYI-T-23100/02 KRKA, D.D., NOVO MESTO HU Etoriax 90 mg filmtabletta HU/H/0443/003 OGYI-T-23100/03 KRKA, D.D., NOVO MESTO HU Etoriax® 120 mg Filmtabletten HU/H/0435/004 96358.00.00 TAD PHARMA GMBH DE Etoriax® 30 mg Filmtabletten HU/H/0435/001 96355.00.00 TAD PHARMA GMBH DE Etoriax® 60 mg Filmtabletten HU/H/0435/002 96356.00.00 TAD PHARMA GMBH DE Etoriax® 90 mg Filmtabletten HU/H/0435/003 96357.00.00 TAD PHARMA GMBH DE Etorican® 120 mg Filmtabletten DE/H/4691/004 97259.00.00 HORMOSAN PHARMA GMBH DE Etorican® 30 mg Filmtabletten DE/H/4691/001 97256.00.00 HORMOSAN PHARMA GMBH DE Etorican® 60 mg Filmtabletten DE/H/4691/002 97257.00.00 HORMOSAN PHARMA GMBH DE Etorican® 90 mg Filmtabletten DE/H/4691/003 97258.00.00 HORMOSAN PHARMA GMBH DE Etoricox-AbZ 120 mg Filmtabletten DE/H/5031/004 92037.00.00 ABZ-PHARMA GMBH DE Etoricox-AbZ 30 mg Filmtabletten DE/H/5031/001 92034.00.00 ABZ-PHARMA GMBH DE Etoricox-AbZ 60 mg Filmtabletten DE/H/5031/002 92035.00.00 ABZ-PHARMA GMBH DE Etoricox-AbZ 90 mg Filmtabletten DE/H/5031/003 92036.00.00 ABZ-PHARMA GMBH DE Etoricox-HEXAL 120 mg Filmtabletten
DE/H/3909/004 90486.00.00 HEXAL AG DE
Etoricox-HEXAL 30 mg Filmtabletten
DE/H/3909/001 90483.00.00 HEXAL AG DE
Etoricox-HEXAL 60 mg Filmtabletten
DE/H/3909/002 90484.00.00 HEXAL AG DE
Etoricox-HEXAL 90 mg Filmtabletten
DE/H/3909/003 90485.00.00 HEXAL AG DE
List of nationally authorised medicinal products EMA/812634/2017 Page 58/231
Product Name (in authorisation country)
MRP/DCP Authorisation Number
National Authorisation Number
MAH of product in the Member State
Member State where product is authorised
Etoricoxib "Krka", filmovertrukne tabletter
HU/H/0435/001 56836 KRKA, D.D., NOVO MESTO DK
Etoricoxib "Krka", filmovertrukne tabletter
HU/H/0435/002 56837 KRKA, D.D., NOVO MESTO DK
Etoricoxib "Krka", filmovertrukne tabletter
HU/H/0435/003 56838 KRKA, D.D., NOVO MESTO DK
Etoricoxib "Krka", filmovertrukne tabletter
HU/H/0435/004 56839 KRKA, D.D., NOVO MESTO DK
Etoricoxib 120 mg Film-coated Tablets
ES/H/0264/004 PA 0688/032/004 CHANELLE MEDICAL IE
Etoricoxib 120 mg Film-coated Tablets
NL/H/3151/004 PA0405/140/004 GENERICS [UK] LIMITED IE
Etoricoxib 120 mg Film-coated tablets
DE/H/3908/004 PA0711/232/004 ROWEX LTD IE
Etoricoxib 120 mg Film-coated Tablets
ES/H/0264/004 PA 0688/032/004 CHANELLE MEDICAL IE
Etoricoxib 120 mg Film-coated Tablets
ES/H/0264/004 MA1026/00104 CHANELLE MEDICAL MT
Etoricoxib 120 mg Film-coated Tablets
ES/H/0264/004 MA1026/00104 CHANELLE MEDICAL MT
Etoricoxib 120 mg film-coated tablets
NL/H/3461/004 PL 42357/0170 AMNEAL PHARMA EUROPE LIMITED
UK
Etoricoxib 120 mg film-coated tablets
DE/H/3469/004 PL 31596/0004 ZYDUS FRANCE UK
Etoricoxib 120 mg film-coated tablets
HU/H/0435/004 PL 01656/0217 KRKA, D.D., NOVO MESTO UK
Etoricoxib 120 mg film-coated tablets
EE/H/0211/004 PL 17780/0727 WINTHROP PHARMACEUTICALS UK LTD
UK
List of nationally authorised medicinal products EMA/812634/2017 Page 59/231
Product Name (in authorisation country)
MRP/DCP Authorisation Number
National Authorisation Number
MAH of product in the Member State
Member State where product is authorised
Etoricoxib 120 mg film-coated tablets
EE/H/0211/004 PL 17780/0727 WINTHROP PHARMACEUTICALS UK LTD
UK
Etoricoxib 120 mg film-coated tablets
EE/H/0211/004 PL 17780/0727 WINTHROP PHARMACEUTICALS UK LTD
UK
Etoricoxib 120 mg film-coated tablets
EE/H/0211/004 PL 17780/0727 WINTHROP PHARMACEUTICALS UK LTD
UK
Etoricoxib 120 mg film-coated tablets
EE/H/0211/004 PL 17780/0727 WINTHROP PHARMACEUTICALS UK LTD
UK
Etoricoxib 120 mg film-coated tablets
PT/H/1603/004 PL 16363/0488 MILPHARM LIMITED UK
Etoricoxib 120 mg Film-coated Tablets
DE/H/5092/004 PL 36687/0213 TORRENT PHARMA LTD. UK
Etoricoxib 120 mg film-coated tablets
EE/H/0211/004 PL 17780/0727 WINTHROP PHARMACEUTICALS UK LTD
UK
Etoricoxib 120 mg film-coated tablets
EE/H/0211/004 PL 17780/0727 WINTHROP PHARMACEUTICALS UK LTD
UK
Etoricoxib 120 mg film-coated tablets
EE/H/0211/004 PL 17780/0727 WINTHROP PHARMACEUTICALS UK LTD
UK
Etoricoxib 120 mg film-coated tablets
EE/H/0211/004 PL 17780/0727 WINTHROP PHARMACEUTICALS UK LTD
UK
Etoricoxib 120 mg film-coated tablets
EE/H/0211/004 PL 17780/0727 WINTHROP PHARMACEUTICALS UK LTD
UK
Etoricoxib 120 mg Film-coated Tablets
NL/H/3576/004 PL 25258/0202 GLENMARK PHARMACEUTICALS EUROPE LIMITED
UK
Etoricoxib 120 mg Film-coated Tablets
DE/H/5031/004 PL 00289/1937 TEVA UK LIMITED UK
Etoricoxib 120mg Film-coated Tablets
SE/H/1574/004 PL 30306/0771 ACTAVIS GROUP PTC EHF. UK
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Product Name (in authorisation country)
MRP/DCP Authorisation Number
National Authorisation Number
MAH of product in the Member State
Member State where product is authorised
Etoricoxib 30 mg Film-coated Tablets
ES/H/0264/001 PA 0688/032/001 CHANELLE MEDICAL IE
Etoricoxib 30 mg Film-coated Tablets
NL/H/3151/001 PA0405/104/001 GENERICS [UK] LIMITED IE
Etoricoxib 30 mg Film-coated tablets
DE/H/3908/001 PA0711/232/001 ROWEX LTD IE
Etoricoxib 30 mg Film-coated Tablets
ES/H/0264/001 PA 0688/032/001 CHANELLE MEDICAL IE
Etoricoxib 30 mg Film-coated Tablets
ES/H/0264/001 MA1026/00101 CHANELLE MEDICAL MT
Etoricoxib 30 mg Film-coated Tablets
ES/H/0264/001 MA1026/00101 CHANELLE MEDICAL MT
Etoricoxib 30 mg film-coated tablets
NL/H/3461/001 PL 42357/0167 AMNEAL PHARMA EUROPE LIMITED
UK
Etoricoxib 30 mg film-coated tablets
DE/H/3469/001 PL 31596/0001 ZYDUS FRANCE UK
Etoricoxib 30 mg film-coated tablets
HU/H/0435/001 PL 01656/0214 KRKA, D.D., NOVO MESTO UK
Etoricoxib 30 mg film-coated tablets
EE/H/0211/001 PL 17780/0724 WINTHROP PHARMACEUTICALS UK LTD
UK
Etoricoxib 30 mg film-coated tablets
EE/H/0211/001 PL 17780/0724 WINTHROP PHARMACEUTICALS UK LTD
UK
Etoricoxib 30 mg film-coated tablets
EE/H/0211/001 PL 17780/0724 WINTHROP PHARMACEUTICALS UK LTD
UK
Etoricoxib 30 mg film-coated tablets
PT/H/1603/001 PL 16363/0485 MILPHARM LIMITED UK
Etoricoxib 30 mg Film-coated Tablets
DE/H/5092/001 PL 36687/0210 HEUMANN PHARMA GMBH & CO. GENERICA KG
UK
List of nationally authorised medicinal products EMA/812634/2017 Page 61/231
Product Name (in authorisation country)
MRP/DCP Authorisation Number
National Authorisation Number
MAH of product in the Member State
Member State where product is authorised
Etoricoxib 30 mg film-coated tablets
EE/H/0211/001 PL 17780/0724 WINTHROP PHARMACEUTICALS UK LTD
UK
Etoricoxib 30 mg film-coated tablets
EE/H/0211/001 PL 17780/0724 WINTHROP PHARMACEUTICALS UK LTD
UK
Etoricoxib 30 mg film-coated tablets
EE/H/0211/001 PL 17780/0724 WINTHROP PHARMACEUTICALS UK LTD
UK
Etoricoxib 30 mg Film-coated Tablets
NL/H/3576/001 PL 25258/0199 GLENMARK PHARMACEUTICALS EUROPE LIMITED
UK
Etoricoxib 30 mg Film-coated Tablets
DE/H/5031/001 PL 00289/1934 TEVA UK LIMITED UK
Etoricoxib 30mg Film-coated Tablets
SE/H/1574/001 PL 30306/0768 ACTAVIS GROUP PTC EHF. UK
Etoricoxib 60 mg Film-coated Tablets
ES/H/0264/002 PA 0688/032/002 CHANELLE MEDICAL IE
Etoricoxib 60 mg Film-coated Tablets
NL/H/3151/002 PA0405/140/002 GENERICS [UK] LIMITED IE
Etoricoxib 60 mg Film-coated tablets
DE/H/3908/002 PA0711/232/002 ROWEX LTD IE
Etoricoxib 60 mg Film-coated Tablets
ES/H/0264/002 PA 0688/032/002 CHANELLE MEDICAL IE
Etoricoxib 60 mg Film-coated Tablets
ES/H/0264/002 MA1026/00102 CHANELLE MEDICAL MT
Etoricoxib 60 mg Film-coated Tablets
ES/H/0264/002 MA1026/00102 CHANELLE MEDICAL MT
Etoricoxib 60 mg film-coated tablets
NL/H/3461/002 PL 42357/0168 AMNEAL PHARMA EUROPE LIMITED
UK
Etoricoxib 60 mg film-coated tablets
DE/H/3469/002 PL 31596/0002 ZYDUS FRANCE UK
List of nationally authorised medicinal products EMA/812634/2017 Page 62/231
Product Name (in authorisation country)
MRP/DCP Authorisation Number
National Authorisation Number
MAH of product in the Member State
Member State where product is authorised
Etoricoxib 60 mg film-coated tablets
HU/H/0435/002 PL 01656/0215 KRKA, D.D., NOVO MESTO UK
Etoricoxib 60 mg film-coated tablets
EE/H/0211/002 PL 17780/0725 WINTHROP PHARMACEUTICALS UK LTD
UK
Etoricoxib 60 mg film-coated tablets
EE/H/0211/002 PL 17780/0725 WINTHROP PHARMACEUTICALS UK LTD
UK
Etoricoxib 60 mg film-coated tablets
EE/H/0211/002 PL 17780/0725 WINTHROP PHARMACEUTICALS UK LTD
UK
Etoricoxib 60 mg film-coated tablets
EE/H/0211/002 PL 17780/0725 WINTHROP PHARMACEUTICALS UK LTD
UK
Etoricoxib 60 mg film-coated tablets
EE/H/0211/002 PL 17780/0725 WINTHROP PHARMACEUTICALS UK LTD
UK
Etoricoxib 60 mg film-coated tablets
EE/H/0211/002 PL 17780/0725 WINTHROP PHARMACEUTICALS UK LTD
UK
Etoricoxib 60 mg film-coated tablets
PT/H/1603/002 PL 16363/0486 MILPHARM LIMITED UK
Etoricoxib 60 mg Film-coated Tablets
DE/H/5092/002 PL 36687/0211 TORRENT PHARMA LTD. UK
Etoricoxib 60 mg film-coated tablets
EE/H/0211/002 PL 17780/0725 WINTHROP PHARMACEUTICALS UK LTD
UK
Etoricoxib 60 mg film-coated tablets
EE/H/0211/002 PL 17780/0725 WINTHROP PHARMACEUTICALS UK LTD
UK
Etoricoxib 60 mg film-coated tablets
EE/H/0211/002 PL 17780/0725 WINTHROP PHARMACEUTICALS UK LTD
UK
Etoricoxib 60 mg film-coated tablets
EE/H/0211/002 PL 17780/0725 WINTHROP PHARMACEUTICALS UK LTD
UK
Etoricoxib 60 mg film-coated tablets
EE/H/0211/002 PL 17780/0725 WINTHROP PHARMACEUTICALS UK LTD
UK
List of nationally authorised medicinal products EMA/812634/2017 Page 63/231
Product Name (in authorisation country)
MRP/DCP Authorisation Number
National Authorisation Number
MAH of product in the Member State
Member State where product is authorised
Etoricoxib 60 mg film-coated tablets
EE/H/0211/002 PL 17780/0725 WINTHROP PHARMACEUTICALS UK LTD
UK
Etoricoxib 60 mg Film-coated Tablets
NL/H/3576/002 PL 25258/0200 GLENMARK PHARMACEUTICALS EUROPE LIMITED
UK
Etoricoxib 60 mg Film-coated Tablets
DE/H/5031/003 PL 00289/1935 TEVA UK LIMITED UK
Etoricoxib 60mg Film-coated Tablets
SE/H/1574/002 PL 30306/0769 ACTAVIS GROUP PTC EHF. UK
Etoricoxib 90 mg Film-coated Tablets
ES/H/0264/003 PA 0688/032/003 CHANELLE MEDICAL IE
Etoricoxib 90 mg Film-coated Tablets
NL/H/3151/003 PA0405/140/003 GENERICS [UK] LIMITED IE
Etoricoxib 90 mg Film-coated tablets
DE/H/3908/003 PA0711/232/003 ROWEX LTD IE
Etoricoxib 90 mg Film-coated Tablets
ES/H/0264/003 PA 0688/032/003 CHANELLE MEDICAL IE
Etoricoxib 90 mg Film-coated Tablets
ES/H/0264/003 MA1026/00103 CHANELLE MEDICAL MT
Etoricoxib 90 mg Film-coated Tablets
ES/H/0264/003 MA1026/00103 CHANELLE MEDICAL MT
Etoricoxib 90 mg film-coated tablets
NL/H/3461/003 PL 42357/0169 AMNEAL PHARMA EUROPE LIMITED
UK
Etoricoxib 90 mg film-coated tablets
DE/H/3469/003 PL 31596/0003 ZYDUS FRANCE UK
Etoricoxib 90 mg film-coated tablets
HU/H/0435/003 PL 01656/0216 KRKA, D.D., NOVO MESTO UK
Etoricoxib 90 mg film-coated tablets
EE/H/0211/003 PL 17780/0726 WINTHROP PHARMACEUTICALS UK LTD
UK
List of nationally authorised medicinal products EMA/812634/2017 Page 64/231
Product Name (in authorisation country)
MRP/DCP Authorisation Number
National Authorisation Number
MAH of product in the Member State
Member State where product is authorised
Etoricoxib 90 mg film-coated tablets
EE/H/0211/003 PL 17780/0726 WINTHROP PHARMACEUTICALS UK LTD
UK
Etoricoxib 90 mg film-coated tablets
EE/H/0211/003 PL 17780/0726 WINTHROP PHARMACEUTICALS UK LTD
UK
Etoricoxib 90 mg film-coated tablets
EE/H/0211/003 PL 17780/0726 WINTHROP PHARMACEUTICALS UK LTD
UK
Etoricoxib 90 mg film-coated tablets
EE/H/0211/003 PL 17780/0726 WINTHROP PHARMACEUTICALS UK LTD
UK
Etoricoxib 90 mg film-coated tablets
EE/H/0211/003 PL 17780/0726 WINTHROP PHARMACEUTICALS UK LTD
UK
Etoricoxib 90 mg film-coated tablets
PT/H/1603/003 PL 16363/0487 MILPHARM LIMITED UK
Etoricoxib 90 mg Film-coated Tablets
DE/H/5092/003 PL 36687/0212 TORRENT PHARMA LTD. UK
Etoricoxib 90 mg film-coated tablets
EE/H/0211/003 PL 17780/0726 WINTHROP PHARMACEUTICALS UK LTD
UK
Etoricoxib 90 mg film-coated tablets
EE/H/0211/003 PL 17780/0726 WINTHROP PHARMACEUTICALS UK LTD
UK
Etoricoxib 90 mg film-coated tablets
EE/H/0211/003 PL 17780/0726 WINTHROP PHARMACEUTICALS UK LTD
UK
Etoricoxib 90 mg film-coated tablets
EE/H/0211/003 PL 17780/0726 WINTHROP PHARMACEUTICALS UK LTD
UK
Etoricoxib 90 mg film-coated tablets
EE/H/0211/003 PL 17780/0726 WINTHROP PHARMACEUTICALS UK LTD
UK
Etoricoxib 90 mg film-coated tablets
EE/H/0211/003 PL 17780/0726 WINTHROP PHARMACEUTICALS UK LTD
UK
Etoricoxib 90 mg Film-coated Tablets
NL/H/3576/003 PL 25258/0201 GLENMARK PHARMACEUTICALS EUROPE LIMITED
UK
List of nationally authorised medicinal products EMA/812634/2017 Page 65/231
Product Name (in authorisation country)
MRP/DCP Authorisation Number
National Authorisation Number
MAH of product in the Member State
Member State where product is authorised
Etoricoxib 90 mg Film-coated Tablets
DE/H/5031/003 PL 00289/1936 TEVA UK LIMITED UK
Etoricoxib 90mg Film-coated Tablets
SE/H/1574/003 PL 30306/0770 ACTAVIS GROUP PTC EHF. UK
Etoricoxib Actavis 120 mg apvalkotās tabletes
SE/H/1574/004 17-0037 ACTAVIS GROUP PTC EHF. LV
Etoricoxib Actavis 120 mg film-coated tablets
SE/H/1574/004 MA628/15703 ACTAVIS GROUP PTC EHF. MT
Etoricoxib Actavis 120 mg filmdragerade tabletter
SE/H/1574/004 53664 ACTAVIS GROUP PTC EHF. SE
Etoricoxib Actavis 120 mg filmuhúðaðar töflur
SE/H/1574/004 IS/1/17/001/04 ACTAVIS GROUP PTC EHF. IS
Etoricoxib Actavis 120 mg plėvele dengtos tabletės
SE/H/1574/004 LT/1/17/4026/034 ACTAVIS GROUP PTC EHF. LT
Etoricoxib Actavis 120 mg plėvele dengtos tabletės
SE/H/1574/004 LT/1/17/4026/038 ACTAVIS GROUP PTC EHF. LT
Etoricoxib Actavis 120 mg plėvele dengtos tabletės
SE/H/1574/004 LT/1/17/4026/033 ACTAVIS GROUP PTC EHF. LT
Etoricoxib Actavis 120 mg plėvele dengtos tabletės
SE/H/1574/004 LT/1/17/4026/043 ACTAVIS GROUP PTC EHF. LT
Etoricoxib Actavis 120 mg plėvele dengtos tabletės
SE/H/1574/004 LT/1/17/4026/044 ACTAVIS GROUP PTC EHF. LT
Etoricoxib Actavis 120 mg plėvele dengtos tabletės
SE/H/1574/004 LT/1/17/4026/036 ACTAVIS GROUP PTC EHF. LT
Etoricoxib Actavis 120 mg plėvele dengtos tabletės
SE/H/1574/004 LT/1/17/4026/037 ACTAVIS GROUP PTC EHF. LT
Etoricoxib Actavis 120 mg plėvele dengtos tabletės
SE/H/1574/004 LT/1/17/4026/042 ACTAVIS GROUP PTC EHF. LT
List of nationally authorised medicinal products EMA/812634/2017 Page 66/231
Product Name (in authorisation country)
MRP/DCP Authorisation Number
National Authorisation Number
MAH of product in the Member State
Member State where product is authorised
Etoricoxib Actavis 120 mg plėvele dengtos tabletės
SE/H/1574/004 LT/1/17/4026/035 ACTAVIS GROUP PTC EHF. LT
Etoricoxib Actavis 120 mg plėvele dengtos tabletės
SE/H/1574/004 LT/1/17/4026/040 ACTAVIS GROUP PTC EHF. LT
Etoricoxib Actavis 120 mg plėvele dengtos tabletės
SE/H/1574/004 LT/1/17/4026/039 ACTAVIS GROUP PTC EHF. LT
Etoricoxib Actavis 120 mg plėvele dengtos tabletės
SE/H/1574/004 LT/1/17/4026/041 ACTAVIS GROUP PTC EHF. LT
Etoricoxib Actavis 30 mg apvalkotās tabletes
SE/H/1574/001 17-0034 ACTAVIS GROUP PTC EHF. LV
Etoricoxib Actavis 30 mg film-coated tablets
SE/H/1574/001 MA628/15704 ACTAVIS GROUP PTC EHF. MT
Etoricoxib Actavis 30 mg filmdragerade tabletter
SE/H/1574/001 53661 ACTAVIS GROUP PTC EHF. SE
Etoricoxib Actavis 30 mg filmuhúðaðar töflur
SE/H/1574/001 IS/1/17/001/01 ACTAVIS GROUP PTC EHF. IS
Etoricoxib Actavis 30 mg plėvele dengtos tabletės
SE/H/1574/001 LT/1/17/4026/004 ACTAVIS GROUP PTC EHF. LT
Etoricoxib Actavis 30 mg plėvele dengtos tabletės
SE/H/1574/001 LT/1/17/4026/005 ACTAVIS GROUP PTC EHF. LT
Etoricoxib Actavis 30 mg plėvele dengtos tabletės
SE/H/1574/001 LT/1/17/4026/003 ACTAVIS GROUP PTC EHF. LT
Etoricoxib Actavis 30 mg plėvele dengtos tabletės
SE/H/1574/001 LT/1/17/4026/002 ACTAVIS GROUP PTC EHF. LT
Etoricoxib Actavis 30 mg plėvele dengtos tabletės
SE/H/1574/001 LT/1/17/4026/001 ACTAVIS GROUP PTC EHF. LT
Etoricoxib Actavis 30 mg plėvele dengtos tabletės
SE/H/1574/001 LT/1/17/4026/006 ACTAVIS GROUP PTC EHF. LT
List of nationally authorised medicinal products EMA/812634/2017 Page 67/231
Product Name (in authorisation country)
MRP/DCP Authorisation Number
National Authorisation Number
MAH of product in the Member State
Member State where product is authorised
Etoricoxib Actavis 60 mg apvalkotās tabletes
SE/H/1574/002 17-0035 ACTAVIS GROUP PTC EHF. LV
Etoricoxib Actavis 60 mg film-coated tablets
SE/H/1574/002 MA628/15701 ACTAVIS GROUP PTC EHF. MT
Etoricoxib Actavis 60 mg filmdragerade tabletter
SE/H/1574/002 53662 ACTAVIS GROUP PTC EHF. SE
Etoricoxib Actavis 60 mg filmuhúðaðar töflur
SE/H/1574/002 IS/1/17/001/02 ACTAVIS GROUP PTC EHF. IS
Etoricoxib Actavis 60 mg plėvele dengtos tabletės
SE/H/1574/002 LT/1/17/4026/007 ACTAVIS GROUP PTC EHF. LT
Etoricoxib Actavis 60 mg plėvele dengtos tabletės
SE/H/1574/002 LT/1/17/4026/010 ACTAVIS GROUP PTC EHF. LT
Etoricoxib Actavis 60 mg plėvele dengtos tabletės
SE/H/1574/002 LT/1/17/4026/012 ACTAVIS GROUP PTC EHF. LT
Etoricoxib Actavis 60 mg plėvele dengtos tabletės
SE/H/1574/002 LT/1/17/4026/009 ACTAVIS GROUP PTC EHF. LT
Etoricoxib Actavis 60 mg plėvele dengtos tabletės
SE/H/1574/002 LT/1/17/4026/019 ACTAVIS GROUP PTC EHF. LT
Etoricoxib Actavis 60 mg plėvele dengtos tabletės
SE/H/1574/002 LT/1/17/4026/016 ACTAVIS GROUP PTC EHF. LT
Etoricoxib Actavis 60 mg plėvele dengtos tabletės
SE/H/1574/002 LT/1/17/4026/011 ACTAVIS GROUP PTC EHF. LT
Etoricoxib Actavis 60 mg plėvele dengtos tabletės
SE/H/1574/002 LT/1/17/4026/018 ACTAVIS GROUP PTC EHF. LT
Etoricoxib Actavis 60 mg plėvele dengtos tabletės
SE/H/1574/002 LT/1/17/4026/020 ACTAVIS GROUP PTC EHF. LT
Etoricoxib Actavis 60 mg plėvele dengtos tabletės
SE/H/1574/002 LT/1/17/4026/014 ACTAVIS GROUP PTC EHF. LT
List of nationally authorised medicinal products EMA/812634/2017 Page 68/231
Product Name (in authorisation country)
MRP/DCP Authorisation Number
National Authorisation Number
MAH of product in the Member State
Member State where product is authorised
Etoricoxib Actavis 60 mg plėvele dengtos tabletės
SE/H/1574/002 LT/1/17/4026/015 ACTAVIS GROUP PTC EHF. LT
Etoricoxib Actavis 60 mg plėvele dengtos tabletės
SE/H/1574/002 LT/1/17/4026/017 ACTAVIS GROUP PTC EHF. LT
Etoricoxib Actavis 60 mg plėvele dengtos tabletės
SE/H/1574/002 LT/1/17/4026/008 ACTAVIS GROUP PTC EHF. LT
Etoricoxib Actavis 60 mg plėvele dengtos tabletės
SE/H/1574/002 LT/1/17/4026/013 ACTAVIS GROUP PTC EHF. LT
Etoricoxib Actavis 90 mg apvalkotās tabletes
SE/H/1574/003 17-0036 ACTAVIS GROUP PTC EHF. LV
Etoricoxib Actavis 90 mg film-coated tablets
SE/H/1574/003 MA628/15702 ACTAVIS GROUP PTC EHF. MT
Etoricoxib Actavis 90 mg filmdragerade tabletter
SE/H/1574/003 53663 ACTAVIS GROUP PTC EHF. SE
Etoricoxib Actavis 90 mg filmuhúðaðar töflur
SE/H/1574/003 IS/1/17/001/03 ACTAVIS GROUP PTC EHF. IS
Etoricoxib Actavis 90 mg plėvele dengtos tabletės
SE/H/1574/003 LT/1/17/4026/022 ACTAVIS GROUP PTC EHF. LT
Etoricoxib Actavis 90 mg plėvele dengtos tabletės
SE/H/1574/003 LT/1/17/4026/030 ACTAVIS GROUP PTC EHF. LT
Etoricoxib Actavis 90 mg plėvele dengtos tabletės
SE/H/1574/003 LT/1/17/4026/021 ACTAVIS GROUP PTC EHF. LT
Etoricoxib Actavis 90 mg plėvele dengtos tabletės
SE/H/1574/003 LT/1/17/4026/027 ACTAVIS GROUP PTC EHF. LT
Etoricoxib Actavis 90 mg plėvele dengtos tabletės
SE/H/1574/003 LT/1/17/4026/026 ACTAVIS GROUP PTC EHF. LT
Etoricoxib Actavis 90 mg plėvele dengtos tabletės
SE/H/1574/003 LT/1/17/4026/028 ACTAVIS GROUP PTC EHF. LT
List of nationally authorised medicinal products EMA/812634/2017 Page 69/231
Product Name (in authorisation country)
MRP/DCP Authorisation Number
National Authorisation Number
MAH of product in the Member State
Member State where product is authorised
Etoricoxib Actavis 90 mg plėvele dengtos tabletės
SE/H/1574/003 LT/1/17/4026/031 ACTAVIS GROUP PTC EHF. LT
Etoricoxib Actavis 90 mg plėvele dengtos tabletės
SE/H/1574/003 LT/1/17/4026/024 ACTAVIS GROUP PTC EHF. LT
Etoricoxib Actavis 90 mg plėvele dengtos tabletės
SE/H/1574/003 LT/1/17/4026/025 ACTAVIS GROUP PTC EHF. LT
Etoricoxib Actavis 90 mg plėvele dengtos tabletės
SE/H/1574/003 LT/1/17/4026/023 ACTAVIS GROUP PTC EHF. LT
Etoricoxib Actavis 90 mg plėvele dengtos tabletės
SE/H/1574/003 LT/1/17/4026/032 ACTAVIS GROUP PTC EHF. LT
Etoricoxib Actavis 90 mg plėvele dengtos tabletės
SE/H/1574/003 LT/1/17/4026/029 ACTAVIS GROUP PTC EHF. LT
Etoricoxib Actavis, 120 mg õhukese polümeerikattega tabletid
SE/H/1574/004 931517 ACTAVIS GROUP PTC EHF. EE
Etoricoxib Actavis, 30 mg õhukese polümeerikattega tabletid
SE/H/1574/001 931217 ACTAVIS GROUP PTC EHF. EE
Etoricoxib Actavis, 60 mg õhukese polümeerikattega tabletid
SE/H/1574/002 931317 ACTAVIS GROUP PTC EHF. EE
Etoricoxib Actavis, 90 mg õhukese polümeerikattega tabletid
SE/H/1574/003 931417 ACTAVIS GROUP PTC EHF. EE
Etoricoxib AL 120 mg Filmtabletten DE/H/4251/004 93721.00.00 ALIUD PHARMA GMBH DE Etoricoxib AL 30 mg Filmtabletten DE/H/4251/001 93718.00.00 ALIUD PHARMA GMBH DE Etoricoxib AL 60 mg Filmtabletten DE/H/4251/002 93719.00.00 ALIUD PHARMA GMBH DE Etoricoxib AL 90 mg Filmtabletten DE/H/4251/003 93720.00.00 ALIUD PHARMA GMBH DE Etoricoxib Alchemia 120 mg filmdragerad tablett
SE/H/1575/04 53668 ALCHEMIA LIMITED SE
Etoricoxib Alchemia 120 mg Filmtabletten
SE/H/1575/004 96699.00.00 ALCHEMIA LIMITED DE
List of nationally authorised medicinal products EMA/812634/2017 Page 70/231
Product Name (in authorisation country)
MRP/DCP Authorisation Number
National Authorisation Number
MAH of product in the Member State
Member State where product is authorised
Etoricoxib Alchemia 30 mg filmdragerad tablett
SE/H/1575/01 53665 ALCHEMIA LIMITED SE
Etoricoxib Alchemia 30 mg Filmtabletten
SE/H/1575/001 96696.00.00 ALCHEMIA LIMITED DE
Etoricoxib Alchemia 60 mg filmdragerad tablett
SE/H/1575/02 53666 ALCHEMIA LIMITED SE
Etoricoxib Alchemia 60 mg Filmtabletten
SE/H/1575/002 96697.00.00 ALCHEMIA LIMITED DE
Etoricoxib Alchemia 90 mg filmdragerad tablett
SE/H/1575/03 53667 ALCHEMIA LIMITED SE
Etoricoxib Alchemia 90 mg Filmtabletten
SE/H/1575/003 96698.00.00 ALCHEMIA LIMITED DE
Etoricoxib Alembic 120 mg comprimidos recubiertos con película EFG
DE/H/5092/003 81465 ALEMBIC PHARMACEUTICALS EUROPE LTD
ES
Etoricoxib Alembic 30 mg comprimidos recubiertos con película EFG
DE/H/5092/001 81463 ALEMBIC PHARMACEUTICALS EUROPE LTD
ES
Etoricoxib Alembic 60 mg comprimidos recubiertos con película EFG
DE/H/5092/002/DC 81462 ALEMBIC PHARMACEUTICALS EUROPE LTD
ES
Etoricoxib Alembic 90 mg comprimidos recubiertos con película EFG
DE/H/5092/003/DC 81464 ALEMBIC PHARMACEUTICALS EUROPE LTD
ES
Etoricoxib Alter 120 mg comprimidos recubiertos con película EFG
ES/H/0411/004 81.827 LABORATORIOS ALTER, S.A. ES
List of nationally authorised medicinal products EMA/812634/2017 Page 71/231
Product Name (in authorisation country)
MRP/DCP Authorisation Number
National Authorisation Number
MAH of product in the Member State
Member State where product is authorised
Etoricoxib Alter 30 mg comprimidos recubiertos con película EFG
ES/H/0411/001 81.824 LABORATORIOS ALTER, S.A. ES
Etoricoxib Alter 60 mg comprimidos recubiertos con película EFG
ES/H/0411/002 81.825 LABORATORIOS ALTER, S.A. ES
Etoricoxib Alter 90 mg comprimidos recubiertos con película EFG
ES/H/0411/003 81.826 LABORATORIOS ALTER, S.A. ES
Etoricoxib Amneal 120 mg comprimidos recubiertos con película EFG
NL/H/3461/004 81.201 AMNEAL PHARMA EUROPE LIMITED
ES
Etoricoxib Amneal 120 mg filmdragerade tabletter
NL/H/3461/004 52506 AMNEAL PHARMA EUROPE LIMITED
SE
Etoricoxib Amneal 120 mg filmdrasjerte tabletter
NL/H/3461/004 15-10555 AMNEAL PHARMA EUROPE LIMITED
NO
Etoricoxib Amneal 120 mg Filmtabletten
NL/H/3461/004 94327.00.00 AMNEAL PHARMA EUROPE LIMITED
DE
Etoricoxib Amneal 120 mg tabletti, kalvopäällysteinen
NL/H/3461/004 33114 AMNEAL PHARMA EUROPE LIMITED
FI
Etoricoxib Amneal 120 mg, filmomhulde tabletten
NL/H/3461/004 RVG 116935 AMNEAL PHARMA EUROPE LIMITED
NL
Etoricoxib Amneal 30 mg comprimidos recubiertos con película EFG
NL/H/3461/001 81.198 AMNEAL PHARMA EUROPE LIMITED
ES
Etoricoxib Amneal 30 mg filmdragerade tabletter
NL/H/3461/001 52503 AMNEAL PHARMA EUROPE LIMITED
SE
Etoricoxib Amneal 30 mg filmdrasjerte tabletter
NL/H/3461/001 15-10552 AMNEAL PHARMA EUROPE LIMITED
NO
List of nationally authorised medicinal products EMA/812634/2017 Page 72/231
Product Name (in authorisation country)
MRP/DCP Authorisation Number
National Authorisation Number
MAH of product in the Member State
Member State where product is authorised
Etoricoxib Amneal 30 mg Filmtabletten
NL/H/3461/001 94324.00.00 AMNEAL PHARMA EUROPE LIMITED
DE
Etoricoxib Amneal 30 mg tabletti, kalvopäällysteinen
NL/H/3461/001 33111 AMNEAL PHARMA EUROPE LIMITED
FI
Etoricoxib Amneal 30 mg, filmomhulde tabletten
NL/H/3461/001 RVG 116932 AMNEAL PHARMA EUROPE LIMITED
NL
Etoricoxib Amneal 60 mg comprimidos recubiertos con película EFG
NL/H/3461/002 81.199 AMNEAL PHARMA EUROPE LIMITED
ES
Etoricoxib Amneal 60 mg filmdragerade tabletter
NL/H/3461/002 52504 AMNEAL PHARMA EUROPE LIMITED
SE
Etoricoxib Amneal 60 mg filmdrasjerte tabletter
NL/H/3461/002 15-10553 AMNEAL PHARMA EUROPE LIMITED
NO
Etoricoxib Amneal 60 mg Filmtabletten
NL/H/3461/002 94325.00.00 AMNEAL PHARMA EUROPE LIMITED
DE
Etoricoxib Amneal 60 mg tabletti, kalvopäällysteinen
NL/H/3461/002 33112 AMNEAL PHARMA EUROPE LIMITED
FI
Etoricoxib Amneal 60 mg, filmomhulde tabletten
NL/H/3461/002 RVG 116933 AMNEAL PHARMA EUROPE LIMITED
NL
Etoricoxib Amneal 90 mg comprimidos recubiertos con película EFG
NL/H/3461/003 81.200 AMNEAL PHARMA EUROPE LIMITED
ES
Etoricoxib Amneal 90 mg filmdragerade tabletter
NL/H/3461/003 52505 AMNEAL PHARMA EUROPE LIMITED
SE
Etoricoxib Amneal 90 mg filmdrasjerte tabletter
NL/H/3461/003 15-10554 AMNEAL PHARMA EUROPE LIMITED
NO
Etoricoxib Amneal 90 mg Filmtabletten
NL/H/3461/003 94326.00.00 AMNEAL PHARMA EUROPE LIMITED
DE
List of nationally authorised medicinal products EMA/812634/2017 Page 73/231
Product Name (in authorisation country)
MRP/DCP Authorisation Number
National Authorisation Number
MAH of product in the Member State
Member State where product is authorised
Etoricoxib Amneal 90 mg tabletti, kalvopäällysteinen
NL/H/3461/003 33113 AMNEAL PHARMA EUROPE LIMITED
FI
Etoricoxib Amneal 90 mg, filmomhulde tabletten
NL/H/3461/003 RVG 116934 AMNEAL PHARMA EUROPE LIMITED
NL
Etoricoxib Apotex 120 mg comprimidos recubiertos con película EFG
not available 81060 APOTEX EUROPE B.V. ES
Etoricoxib Apotex 30 mg comprimidos recubiertos con película EFG
not available 81052 APOTEX EUROPE B.V. ES
Etoricoxib Apotex 60 mg comprimidos recubiertos con película EFG
not available 81053 APOTEX EUROPE B.V. ES
Etoricoxib Apotex 90 mg comprimidos recubiertos con película EFG
not available 81059 APOTEX EUROPE B.V. ES
Etoricoxib Aurobindo 120 mg comprimate filmate
PT/H/1603/004 9898/2017/01 AUROBINDO PHARMA ROMÂNIA S.R.L.
RO
Etoricoxib Aurobindo 120 mg comprimate filmate
PT/H/1603/004 9898/2017/02 AUROBINDO PHARMA ROMÂNIA S.R.L.
RO
Etoricoxib Aurobindo 120 mg comprimate filmate
PT/H/1603/004 9898/2017/03 AUROBINDO PHARMA ROMÂNIA S.R.L.
RO
Etoricoxib Aurobindo 120 mg comprimate filmate
PT/H/1603/004 9898/2017/04 AUROBINDO PHARMA ROMÂNIA S.R.L.
RO
Etoricoxib Aurobindo 120 mg comprimate filmate
PT/H/1603/004 9898/2017/05 AUROBINDO PHARMA ROMÂNIA S.R.L.
RO
Etoricoxib Aurobindo 120 mg comprimate filmate
PT/H/1603/004 9898/2017/06 AUROBINDO PHARMA ROMÂNIA S.R.L.
RO
List of nationally authorised medicinal products EMA/812634/2017 Page 74/231
Product Name (in authorisation country)
MRP/DCP Authorisation Number
National Authorisation Number
MAH of product in the Member State
Member State where product is authorised
Etoricoxib Aurobindo 120 mg comprimate filmate
PT/H/1603/004 9898/2017/07 AUROBINDO PHARMA ROMÂNIA S.R.L.
RO
Etoricoxib Aurobindo 120 mg comprimate filmate
PT/H/1603/004 9898/2017/08 AUROBINDO PHARMA ROMÂNIA S.R.L.
RO
Etoricoxib Aurobindo 120 mg, filmomhulde tabletten
PT/H/1603/004 RVG 118782 AUROBINDO PHARMA B.V. NL
Etoricoxib Aurobindo 30 mg comprimate filmate
PT/H/1603/001 9895/2017/01 AUROBINDO PHARMA ROMÂNIA S.R.L.
RO
Etoricoxib Aurobindo 30 mg comprimate filmate
PT/H/1603/001 9895/2017/02 AUROBINDO PHARMA ROMÂNIA S.R.L.
RO
Etoricoxib Aurobindo 30 mg comprimate filmate
PT/H/1603/001 9895/2017/03 AUROBINDO PHARMA ROMÂNIA S.R.L.
RO
Etoricoxib Aurobindo 30 mg comprimate filmate
PT/H/1603/001 9895/2017/04 AUROBINDO PHARMA ROMÂNIA S.R.L.
RO
Etoricoxib Aurobindo 30 mg comprimate filmate
PT/H/1603/001 9895/2017/05 AUROBINDO PHARMA ROMÂNIA S.R.L.
RO
Etoricoxib Aurobindo 30 mg comprimate filmate
PT/H/1603/001 9895/2017/06 AUROBINDO PHARMA ROMÂNIA S.R.L.
RO
Etoricoxib Aurobindo 30 mg comprimate filmate
PT/H/1603/001 9895/2017/07 AUROBINDO PHARMA ROMÂNIA S.R.L.
RO
Etoricoxib Aurobindo 30 mg comprimate filmate
PT/H/1603/001 9895/2017/08 AUROBINDO PHARMA ROMÂNIA S.R.L.
RO
Etoricoxib Aurobindo 30 mg, filmomhulde tabletten
PT/H/1603/001 RVG 118779 AUROBINDO PHARMA B.V. NL
Etoricoxib Aurobindo 60 mg comprimate filmate
PT/H/1603/002 9896/2017/01 AUROBINDO PHARMA ROMÂNIA S.R.L.
RO
Etoricoxib Aurobindo 60 mg comprimate filmate
PT/H/1603/002 9896/2017/02 AUROBINDO PHARMA ROMÂNIA S.R.L.
RO
List of nationally authorised medicinal products EMA/812634/2017 Page 75/231
Product Name (in authorisation country)
MRP/DCP Authorisation Number
National Authorisation Number
MAH of product in the Member State
Member State where product is authorised
Etoricoxib Aurobindo 60 mg comprimate filmate
PT/H/1603/002 9896/2017/03 AUROBINDO PHARMA ROMÂNIA S.R.L.
RO
Etoricoxib Aurobindo 60 mg comprimate filmate
PT/H/1603/002 9896/2017/04 AUROBINDO PHARMA ROMÂNIA S.R.L.
RO
Etoricoxib Aurobindo 60 mg comprimate filmate
PT/H/1603/002 9896/2017/05 AUROBINDO PHARMA ROMÂNIA S.R.L.
RO
Etoricoxib Aurobindo 60 mg comprimate filmate
PT/H/1603/002 9896/2017/06 AUROBINDO PHARMA ROMÂNIA S.R.L.
RO
Etoricoxib Aurobindo 60 mg comprimate filmate
PT/H/1603/002 9896/2017/07 AUROBINDO PHARMA ROMÂNIA S.R.L.
RO
Etoricoxib Aurobindo 60 mg comprimate filmate
PT/H/1603/002 9896/2017/08 AUROBINDO PHARMA ROMÂNIA S.R.L.
RO
Etoricoxib Aurobindo 60 mg, filmomhulde tabletten
PT/H/1603/002 RVG 118780 AUROBINDO PHARMA B.V. NL
Etoricoxib Aurobindo 90 mg comprimate filmate
PT/H/1603/003 9897/2017/01 AUROBINDO PHARMA ROMÂNIA S.R.L.
RO
Etoricoxib Aurobindo 90 mg comprimate filmate
PT/H/1603/003 9897/2017/02 AUROBINDO PHARMA ROMÂNIA S.R.L.
RO
Etoricoxib Aurobindo 90 mg comprimate filmate
PT/H/1603/003 9897/2017/03 AUROBINDO PHARMA ROMÂNIA S.R.L.
RO
Etoricoxib Aurobindo 90 mg comprimate filmate
PT/H/1603/003 9897/2017/04 AUROBINDO PHARMA ROMÂNIA S.R.L.
RO
Etoricoxib Aurobindo 90 mg comprimate filmate
PT/H/1603/003 9897/2017/05 AUROBINDO PHARMA ROMÂNIA S.R.L.
RO
Etoricoxib Aurobindo 90 mg comprimate filmate
PT/H/1603/003 9897/2017/06 AUROBINDO PHARMA ROMÂNIA S.R.L.
RO
Etoricoxib Aurobindo 90 mg comprimate filmate
PT/H/1603/003 9897/2017/07 AUROBINDO PHARMA ROMÂNIA S.R.L.
RO
List of nationally authorised medicinal products EMA/812634/2017 Page 76/231
Product Name (in authorisation country)
MRP/DCP Authorisation Number
National Authorisation Number
MAH of product in the Member State
Member State where product is authorised
Etoricoxib Aurobindo 90 mg comprimate filmate
PT/H/1603/003 9897/2017/08 AUROBINDO PHARMA ROMÂNIA S.R.L.
RO
Etoricoxib Aurobindo 90 mg, filmomhulde tabletten
PT/H/1603/003 RVG 118781 AUROBINDO PHARMA B.V. NL
Etoricoxib Aurovitas 120 mg comprimidos recubiertos con película EFG
PT/H/1614/004 81.890 AUROVITAS SPAIN,S.A.U. ES
Etoricoxib Aurovitas 120 mg comprimidos revestidos por película
not available 5704846 AUROVITAS UNIPESSOAL, LDA.
PT
Etoricoxib Aurovitas 120 mg comprimidos revestidos por película
not available 16/H/0015/004 AUROVITAS UNIPESSOAL, LDA.
PT
Etoricoxib Aurovitas 120 mg comprimidos revestidos por película
not available 16/H/0015/004 AUROVITAS UNIPESSOAL, LDA.
PT
Etoricoxib Aurovitas 30 mg comprimidos recubiertos con película EFG
PT/H/1614/001 81.887 AUROVITAS SPAIN,S.A.U. ES
Etoricoxib Aurovitas 30 mg comprimidos revestidos por película
not available 16/H/0015/001 AUROVITAS UNIPESSOAL, LDA.
PT
Etoricoxib Aurovitas 30 mg comprimidos revestidos por película
not available 5704465 AUROVITAS UNIPESSOAL, LDA.
PT
Etoricoxib Aurovitas 30 mg comprimidos revestidos por película
not available 16/H/0015/001 AUROVITAS UNIPESSOAL, LDA.
PT
List of nationally authorised medicinal products EMA/812634/2017 Page 77/231
Product Name (in authorisation country)
MRP/DCP Authorisation Number
National Authorisation Number
MAH of product in the Member State
Member State where product is authorised
Etoricoxib Aurovitas 60 mg comprimidos recubiertos con película EFG
PT/H/1614/002 81.889 AUROVITAS SPAIN,S.A.U. ES
Etoricoxib Aurovitas 60 mg comprimidos revestidos por película
not available 16/H/0015/002 AUROVITAS UNIPESSOAL, LDA.
PT
Etoricoxib Aurovitas 60 mg comprimidos revestidos por película
not available 5704820 AUROVITAS UNIPESSOAL, LDA.
PT
Etoricoxib Aurovitas 60 mg comprimidos revestidos por película
not available 16/H/0015/002 AUROVITAS UNIPESSOAL, LDA.
PT
Etoricoxib Aurovitas 90 mg comprimidos recubiertos con película EFG
PT/H/1614/003 81.888 AUROVITAS SPAIN,S.A.U. ES
Etoricoxib Aurovitas 90 mg comprimidos revestidos por película
not available 16/H/0015/003 AUROVITAS UNIPESSOAL, LDA.
PT
Etoricoxib Aurovitas 90 mg comprimidos revestidos por película
not available 5704812 AUROVITAS UNIPESSOAL, LDA.
PT
Etoricoxib Aurovitas 90 mg comprimidos revestidos por película
not available 16/H/0015/003 AUROVITAS UNIPESSOAL, LDA.
PT
Etoricoxib beta 120 mg Filmtabletten
DE/H/4864/004 97658.00.00 BETAPHARM ARZNEIMITTEL GMBH
DE
Etoricoxib beta 30 mg Filmtabletten
DE/H/4864/001 97655.00.00 BETAPHARM ARZNEIMITTEL GMBH
DE
List of nationally authorised medicinal products EMA/812634/2017 Page 78/231
Product Name (in authorisation country)
MRP/DCP Authorisation Number
National Authorisation Number
MAH of product in the Member State
Member State where product is authorised
Etoricoxib beta 60 mg Filmtabletten
DE/H/4864/002 97656.00.00 BETAPHARM ARZNEIMITTEL GMBH
DE
Etoricoxib beta 90 mg Filmtabletten
DE/H/4864/003 97657.00.00 BETAPHARM ARZNEIMITTEL GMBH
DE
Etoricoxib Bluepharma 120 mg comprimidos revestidos por película
not available 5693841 BLUEPHARMA GENÉRICOS - COMÉRCIO DE MEDICAMENTOS, S.A.
PT
Etoricoxib Bluepharma 120 mg comprimidos revestidos por película
not available 5693858 BLUEPHARMA GENÉRICOS - COMÉRCIO DE MEDICAMENTOS, S.A.
PT
Etoricoxib Bluepharma 120 mg comprimidos revestidos por película
not available 16/H/0071/004 BLUEPHARMA GENÉRICOS - COMÉRCIO DE MEDICAMENTOS, S.A.
PT
Etoricoxib Bluepharma 120 mg comprimidos revestidos por película
not available 16/H/0071/004 BLUEPHARMA GENÉRICOS - COMÉRCIO DE MEDICAMENTOS, S.A.
PT
Etoricoxib Bluepharma 30 mg comprimidos revestidos por película
not available 5693809 BLUEPHARMA GENÉRICOS - COMÉRCIO DE MEDICAMENTOS, S.A.
PT
Etoricoxib Bluepharma 30 mg comprimidos revestidos por película
not available 5693817 BLUEPHARMA GENÉRICOS - COMÉRCIO DE MEDICAMENTOS, S.A.
PT
Etoricoxib Bluepharma 30 mg comprimidos revestidos por película
not available 16/H/0071/001 BLUEPHARMA GENÉRICOS - COMÉRCIO DE MEDICAMENTOS, S.A.
PT
Etoricoxib Bluepharma 30 mg comprimidos revestidos por película
not available 16/H/0071/001 BLUEPHARMA GENÉRICOS - COMÉRCIO DE MEDICAMENTOS, S.A.
PT
List of nationally authorised medicinal products EMA/812634/2017 Page 79/231
Product Name (in authorisation country)
MRP/DCP Authorisation Number
National Authorisation Number
MAH of product in the Member State
Member State where product is authorised
Etoricoxib Bluepharma 60 mg comprimidos revestidos por película
not available 5693767 BLUEPHARMA GENÉRICOS - COMÉRCIO DE MEDICAMENTOS, S.A.
PT
Etoricoxib Bluepharma 60 mg comprimidos revestidos por película
not available 5693775 BLUEPHARMA GENÉRICOS - COMÉRCIO DE MEDICAMENTOS, S.A.
PT
Etoricoxib Bluepharma 60 mg comprimidos revestidos por película
not available 16/H/0071/002 BLUEPHARMA GENÉRICOS - COMÉRCIO DE MEDICAMENTOS, S.A.
PT
Etoricoxib Bluepharma 60 mg comprimidos revestidos por película
not available 16/H/0071/002 BLUEPHARMA GENÉRICOS - COMÉRCIO DE MEDICAMENTOS, S.A.
PT
Etoricoxib Bluepharma 90 mg comprimidos revestidos por película
not available 5693825 BLUEPHARMA GENÉRICOS - COMÉRCIO DE MEDICAMENTOS, S.A.
PT
Etoricoxib Bluepharma 90 mg comprimidos revestidos por película
not available 5693833 BLUEPHARMA GENÉRICOS - COMÉRCIO DE MEDICAMENTOS, S.A.
PT
Etoricoxib Bluepharma 90 mg comprimidos revestidos por película
not available 16/H/0071/003 BLUEPHARMA GENÉRICOS - COMÉRCIO DE MEDICAMENTOS, S.A.
PT
Etoricoxib Bluepharma 90 mg comprimidos revestidos por película
not available 16/H/0071/003 BLUEPHARMA GENÉRICOS - COMÉRCIO DE MEDICAMENTOS, S.A.
PT
Etoricoxib CF 120 mg, filmomhulde tabletten
DE/H/4251/004 RVG 116412 CENTRAFARM B.V. NL
Etoricoxib CF 30 mg, filmomhulde tabletten
DE/H/4251/001 RVG 116409 CENTRAFARM B.V. NL
List of nationally authorised medicinal products EMA/812634/2017 Page 80/231
Product Name (in authorisation country)
MRP/DCP Authorisation Number
National Authorisation Number
MAH of product in the Member State
Member State where product is authorised
Etoricoxib CF 60 mg, filmomhulde tabletten
DE/H/4251/002 RVG 116410 CENTRAFARM B.V. NL
Etoricoxib CF 90 mg, filmomhulde tabletten
DE/H/4251/003 RVG 116411 CENTRAFARM B.V. NL
Etoricoxib Chanelle 120 mg compresse rivestite con film
ES/H/0264/004 043239159 CHANELLE MEDICAL IT
Etoricoxib Chanelle 120 mg compresse rivestite con film
ES/H/0264/004 043239161 CHANELLE MEDICAL IT
Etoricoxib Chanelle 120 mg compresse rivestite con film
ES/H/0264/004 043239173 CHANELLE MEDICAL IT
Etoricoxib Chanelle 120 mg compresse rivestite con film
ES/H/0264/004 043239159 CHANELLE MEDICAL IT
Etoricoxib Chanelle 120 mg compresse rivestite con film
ES/H/0264/004 043239159 CHANELLE MEDICAL IT
Etoricoxib Chanelle 120 mg compresse rivestite con film
ES/H/0264/004 043239161 CHANELLE MEDICAL IT
Etoricoxib Chanelle 120 mg compresse rivestite con film
ES/H/0264/004 043239173 CHANELLE MEDICAL IT
Etoricoxib Chanelle 120 mg compresse rivestite con film
ES/H/0264/004 043239159 CHANELLE MEDICAL IT
Etoricoxib Chanelle 120 mg comprimidos revestidos por película
ES/H/0264/004 5644869 CHANELLE MEDICAL PT
Etoricoxib Chanelle 120 mg comprimidos revestidos por película
ES/H/0264/004 5644877 CHANELLE MEDICAL PT
Etoricoxib Chanelle 120 mg comprimidos revestidos por película
ES/H/0264/004 5644901 CHANELLE MEDICAL PT
List of nationally authorised medicinal products EMA/812634/2017 Page 81/231
Product Name (in authorisation country)
MRP/DCP Authorisation Number
National Authorisation Number
MAH of product in the Member State
Member State where product is authorised
Etoricoxib Chanelle 120 mg comprimidos revestidos por película
ES/H/0264/004 5644851 CHANELLE MEDICAL PT
Etoricoxib Chanelle 120 mg comprimidos revestidos por película
ES/H/0264/004 5644869 CHANELLE MEDICAL PT
Etoricoxib Chanelle 120 mg comprimidos revestidos por película
ES/H/0264/004 5644877 CHANELLE MEDICAL PT
Etoricoxib Chanelle 120 mg comprimidos revestidos por película
ES/H/0264/004 5644901 CHANELLE MEDICAL PT
Etoricoxib Chanelle 120 mg comprimidos revestidos por película
ES/H/0264/004 5644851 CHANELLE MEDICAL PT
Etoricoxib Chanelle 30 mg compresse rivestite con film
ES/H/0264/001 043239019 CHANELLE MEDICAL IT
Etoricoxib Chanelle 30 mg compresse rivestite con film
ES/H/0264/001 043239019 CHANELLE MEDICAL IT
Etoricoxib Chanelle 30 mg comprimidos revestidos por película
ES/H/0264/001 5644919 CHANELLE MEDICAL PT
Etoricoxib Chanelle 30 mg comprimidos revestidos por película
ES/H/0264/001 5644919 CHANELLE MEDICAL PT
Etoricoxib Chanelle 60 mg compresse rivestite con film
ES/H/0264/002 043239021 CHANELLE MEDICAL IT
Etoricoxib Chanelle 60 mg compresse rivestite con film
ES/H/0264/002 043239033 CHANELLE MEDICAL IT
List of nationally authorised medicinal products EMA/812634/2017 Page 82/231
Product Name (in authorisation country)
MRP/DCP Authorisation Number
National Authorisation Number
MAH of product in the Member State
Member State where product is authorised
Etoricoxib Chanelle 60 mg compresse rivestite con film
ES/H/0264/002 043239045 CHANELLE MEDICAL IT
Etoricoxib Chanelle 60 mg compresse rivestite con film
ES/H/0264/002 043239058 CHANELLE MEDICAL IT
Etoricoxib Chanelle 60 mg compresse rivestite con film
ES/H/0264/002 043239060 CHANELLE MEDICAL IT
Etoricoxib Chanelle 60 mg compresse rivestite con film
ES/H/0264/002 043239072 CHANELLE MEDICAL IT
Etoricoxib Chanelle 60 mg compresse rivestite con film
ES/H/0264/002 043239021 CHANELLE MEDICAL IT
Etoricoxib Chanelle 60 mg compresse rivestite con film
ES/H/0264/002 043239033 CHANELLE MEDICAL IT
Etoricoxib Chanelle 60 mg compresse rivestite con film
ES/H/0264/002 043239045 CHANELLE MEDICAL IT
Etoricoxib Chanelle 60 mg compresse rivestite con film
ES/H/0264/002 043239058 CHANELLE MEDICAL IT
Etoricoxib Chanelle 60 mg compresse rivestite con film
ES/H/0264/002 043239060 CHANELLE MEDICAL IT
Etoricoxib Chanelle 60 mg compresse rivestite con film
ES/H/0264/002 043239072 CHANELLE MEDICAL IT
Etoricoxib Chanelle 60 mg comprimidos revestidos por película
ES/H/0264/002 5644802 CHANELLE MEDICAL PT
Etoricoxib Chanelle 60 mg comprimidos revestidos por película
ES/H/0264/002 5644810 CHANELLE MEDICAL PT
Etoricoxib Chanelle 60 mg comprimidos revestidos por película
ES/H/0264/002 5644828 CHANELLE MEDICAL PT
List of nationally authorised medicinal products EMA/812634/2017 Page 83/231
Product Name (in authorisation country)
MRP/DCP Authorisation Number
National Authorisation Number
MAH of product in the Member State
Member State where product is authorised
Etoricoxib Chanelle 60 mg comprimidos revestidos por película
ES/H/0264/002 5644778 CHANELLE MEDICAL PT
Etoricoxib Chanelle 60 mg comprimidos revestidos por película
ES/H/0264/002 5644836 CHANELLE MEDICAL PT
Etoricoxib Chanelle 60 mg comprimidos revestidos por película
ES/H/0264/002 5644844 CHANELLE MEDICAL PT
Etoricoxib Chanelle 60 mg comprimidos revestidos por película
ES/H/0264/002 5644802 CHANELLE MEDICAL PT
Etoricoxib Chanelle 60 mg comprimidos revestidos por película
ES/H/0264/002 5644810 CHANELLE MEDICAL PT
Etoricoxib Chanelle 60 mg comprimidos revestidos por película
ES/H/0264/002 5644828 CHANELLE MEDICAL PT
Etoricoxib Chanelle 60 mg comprimidos revestidos por película
ES/H/0264/002 5644778 CHANELLE MEDICAL PT
Etoricoxib Chanelle 60 mg comprimidos revestidos por película
ES/H/0264/002 5644836 CHANELLE MEDICAL PT
Etoricoxib Chanelle 60 mg comprimidos revestidos por película
ES/H/0264/002 5644844 CHANELLE MEDICAL PT
Etoricoxib Chanelle 90 mg compresse rivestite con film
ES/H/0264/003 043239084 CHANELLE MEDICAL IT
List of nationally authorised medicinal products EMA/812634/2017 Page 84/231
Product Name (in authorisation country)
MRP/DCP Authorisation Number
National Authorisation Number
MAH of product in the Member State
Member State where product is authorised
Etoricoxib Chanelle 90 mg compresse rivestite con film
ES/H/0264/003 043239096 CHANELLE MEDICAL IT
Etoricoxib Chanelle 90 mg compresse rivestite con film
ES/H/0264/003 043239110 CHANELLE MEDICAL IT
Etoricoxib Chanelle 90 mg compresse rivestite con film
ES/H/0264/003 043239122 CHANELLE MEDICAL IT
Etoricoxib Chanelle 90 mg compresse rivestite con film
ES/H/0264/003 043239134 CHANELLE MEDICAL IT
Etoricoxib Chanelle 90 mg compresse rivestite con film
ES/H/0264/003 043239108 CHANELLE MEDICAL IT
Etoricoxib Chanelle 90 mg compresse rivestite con film
ES/H/0264/003 043239146 CHANELLE MEDICAL IT
Etoricoxib Chanelle 90 mg compresse rivestite con film
ES/H/0264/003 043239084 CHANELLE MEDICAL IT
Etoricoxib Chanelle 90 mg compresse rivestite con film
ES/H/0264/003 043239096 CHANELLE MEDICAL IT
Etoricoxib Chanelle 90 mg compresse rivestite con film
ES/H/0264/003 043239110 CHANELLE MEDICAL IT
Etoricoxib Chanelle 90 mg compresse rivestite con film
ES/H/0264/003 043239122 CHANELLE MEDICAL IT
Etoricoxib Chanelle 90 mg compresse rivestite con film
ES/H/0264/003 043239134 CHANELLE MEDICAL IT
Etoricoxib Chanelle 90 mg compresse rivestite con film
ES/H/0264/003 043239108 CHANELLE MEDICAL IT
Etoricoxib Chanelle 90 mg compresse rivestite con film
ES/H/0264/003 043239146 CHANELLE MEDICAL IT
Etoricoxib Chanelle 90 mg comprimidos revestidos por película
ES/H/0264/003 564435 CHANELLE MEDICAL PT
List of nationally authorised medicinal products EMA/812634/2017 Page 85/231
Product Name (in authorisation country)
MRP/DCP Authorisation Number
National Authorisation Number
MAH of product in the Member State
Member State where product is authorised
Etoricoxib Chanelle 90 mg comprimidos revestidos por película
ES/H/0264/003 5644943 CHANELLE MEDICAL PT
Etoricoxib Chanelle 90 mg comprimidos revestidos por película
ES/H/0264/003 5644968 CHANELLE MEDICAL PT
Etoricoxib Chanelle 90 mg comprimidos revestidos por película
ES/H/0264/003 5644927 CHANELLE MEDICAL PT
Etoricoxib Chanelle 90 mg comprimidos revestidos por película
ES/H/0264/003 5644950 CHANELLE MEDICAL PT
Etoricoxib Chanelle 90 mg comprimidos revestidos por película
ES/H/0264/003 5644976 CHANELLE MEDICAL PT
Etoricoxib Chanelle 90 mg comprimidos revestidos por película
ES/H/0264/003 5645007 CHANELLE MEDICAL PT
Etoricoxib Chanelle 90 mg comprimidos revestidos por película
ES/H/0264/003 564435 CHANELLE MEDICAL PT
Etoricoxib Chanelle 90 mg comprimidos revestidos por película
ES/H/0264/003 5644943 CHANELLE MEDICAL PT
Etoricoxib Chanelle 90 mg comprimidos revestidos por película
ES/H/0264/003 5644968 CHANELLE MEDICAL PT
List of nationally authorised medicinal products EMA/812634/2017 Page 86/231
Product Name (in authorisation country)
MRP/DCP Authorisation Number
National Authorisation Number
MAH of product in the Member State
Member State where product is authorised
Etoricoxib Chanelle 90 mg comprimidos revestidos por película
ES/H/0264/003 5644927 CHANELLE MEDICAL PT
Etoricoxib Chanelle 90 mg comprimidos revestidos por película
ES/H/0264/003 5644950 CHANELLE MEDICAL PT
Etoricoxib Chanelle 90 mg comprimidos revestidos por película
ES/H/0264/003 5644976 CHANELLE MEDICAL PT
Etoricoxib Chanelle 90 mg comprimidos revestidos por película
ES/H/0264/003 5645007 CHANELLE MEDICAL PT
Etoricoxib Chanelle Medical 120 mg comprimate filmate
ES/H/0264/004 7269/2014/01 CHANELLE MEDICAL RO
Etoricoxib Chanelle Medical 120 mg comprimate filmate
ES/H/0264/004 7269/2014/02 CHANELLE MEDICAL RO
Etoricoxib Chanelle Medical 120 mg comprimate filmate
ES/H/0264/004 7269/2014/03 CHANELLE MEDICAL RO
Etoricoxib Chanelle Medical 120 mg comprimate filmate
ES/H/0264/004 7269/2014/04 CHANELLE MEDICAL RO
Etoricoxib Chanelle Medical 120 mg comprimate filmate
ES/H/0264/004 7269/2014/01 CHANELLE MEDICAL RO
Etoricoxib Chanelle Medical 120 mg comprimate filmate
ES/H/0264/004 7269/2014/02 CHANELLE MEDICAL RO
Etoricoxib Chanelle Medical 120 mg comprimate filmate
ES/H/0264/004 7269/2014/03 CHANELLE MEDICAL RO
Etoricoxib Chanelle Medical 120 mg comprimate filmate
ES/H/0264/004 7269/2014/04 CHANELLE MEDICAL RO
List of nationally authorised medicinal products EMA/812634/2017 Page 87/231
Product Name (in authorisation country)
MRP/DCP Authorisation Number
National Authorisation Number
MAH of product in the Member State
Member State where product is authorised
Etoricoxib Chanelle Medical 60 mg comprimate filmate
ES/H/0264/002 7267/2014/01 CHANELLE MEDICAL RO
Etoricoxib Chanelle Medical 60 mg comprimate filmate
ES/H/0264/002 7267/2014/02 CHANELLE MEDICAL RO
Etoricoxib Chanelle Medical 60 mg comprimate filmate
ES/H/0264/002 7267/2014/03 CHANELLE MEDICAL RO
Etoricoxib Chanelle Medical 60 mg comprimate filmate
ES/H/0264/002 7267/2014/04 CHANELLE MEDICAL RO
Etoricoxib Chanelle Medical 60 mg comprimate filmate
ES/H/0264/002 7267/2014/05 CHANELLE MEDICAL RO
Etoricoxib Chanelle Medical 60 mg comprimate filmate
ES/H/0264/002 7267/2014/06 CHANELLE MEDICAL RO
Etoricoxib Chanelle Medical 60 mg comprimate filmate
ES/H/0264/002 7267/2014/01 CHANELLE MEDICAL RO
Etoricoxib Chanelle Medical 60 mg comprimate filmate
ES/H/0264/002 7267/2014/02 CHANELLE MEDICAL RO
Etoricoxib Chanelle Medical 60 mg comprimate filmate
ES/H/0264/002 7267/2014/03 CHANELLE MEDICAL RO
Etoricoxib Chanelle Medical 60 mg comprimate filmate
ES/H/0264/002 7267/2014/04 CHANELLE MEDICAL RO
Etoricoxib Chanelle Medical 60 mg comprimate filmate
ES/H/0264/002 7267/2014/05 CHANELLE MEDICAL RO
Etoricoxib Chanelle Medical 60 mg comprimate filmate
ES/H/0264/002 7267/2014/06 CHANELLE MEDICAL RO
Etoricoxib Chanelle Medical 90 mg comprimate filmate
ES/H/0264/003 7268/2014/01 CHANELLE MEDICAL RO
Etoricoxib Chanelle Medical 90 mg comprimate filmate
ES/H/0264/003 7268/2014/02 CHANELLE MEDICAL RO
List of nationally authorised medicinal products EMA/812634/2017 Page 88/231
Product Name (in authorisation country)
MRP/DCP Authorisation Number
National Authorisation Number
MAH of product in the Member State
Member State where product is authorised
Etoricoxib Chanelle Medical 90 mg comprimate filmate
ES/H/0264/003 7268/2014/03 CHANELLE MEDICAL RO
Etoricoxib Chanelle Medical 90 mg comprimate filmate
ES/H/0264/003 7268/2014/04 CHANELLE MEDICAL RO
Etoricoxib Chanelle Medical 90 mg comprimate filmate
ES/H/0264/003 7268/2014/05 CHANELLE MEDICAL RO
Etoricoxib Chanelle Medical 90 mg comprimate filmate
ES/H/0264/003 7268/2014/06 CHANELLE MEDICAL RO
Etoricoxib Chanelle Medical 90 mg comprimate filmate
ES/H/0264/003 7268/2014/07 CHANELLE MEDICAL RO
Etoricoxib Chanelle Medical 90 mg comprimate filmate
ES/H/0264/003 7268/2014/01 CHANELLE MEDICAL RO
Etoricoxib Chanelle Medical 90 mg comprimate filmate
ES/H/0264/003 7268/2014/02 CHANELLE MEDICAL RO
Etoricoxib Chanelle Medical 90 mg comprimate filmate
ES/H/0264/003 7268/2014/03 CHANELLE MEDICAL RO
Etoricoxib Chanelle Medical 90 mg comprimate filmate
ES/H/0264/003 7268/2014/04 CHANELLE MEDICAL RO
Etoricoxib Chanelle Medical 90 mg comprimate filmate
ES/H/0264/003 7268/2014/05 CHANELLE MEDICAL RO
Etoricoxib Chanelle Medical 90 mg comprimate filmate
ES/H/0264/003 7268/2014/06 CHANELLE MEDICAL RO
Etoricoxib Chanelle Medical 90 mg comprimate filmate
ES/H/0264/003 7268/2014/07 CHANELLE MEDICAL RO
Etoricoxib Chanelle Medical30 mg comprimate filmate
ES/H/0264/001 7266/2014/01 CHANELLE MEDICAL RO
Etoricoxib Chanelle Medical30 mg comprimate filmate
ES/H/0264/001 7266/2014/01 CHANELLE MEDICAL RO
List of nationally authorised medicinal products EMA/812634/2017 Page 89/231
Product Name (in authorisation country)
MRP/DCP Authorisation Number
National Authorisation Number
MAH of product in the Member State
Member State where product is authorised
Etoricoxib Ciclum DE/H/4251/003 5692868 CICLUM FARMA UNIPESSOAL LDA.
PT
Etoricoxib Ciclum DE/H/4251/003 5695341 CICLUM FARMA UNIPESSOAL LDA.
PT
Etoricoxib Ciclum DE/H/4251/002 5692843 CICLUM FARMA UNIPESSOAL LDA.
PT
Etoricoxib Ciclum DE/H/4251/002 5692835 CICLUM FARMA UNIPESSOAL LDA.
PT
Etoricoxib Ciclum DE/H/4251/002 5695333 CICLUM FARMA UNIPESSOAL LDA.
PT
Etoricoxib Ciclum DE/H/4251/003 5692850 CICLUM FARMA UNIPESSOAL LDA.
PT
Etoricoxib Ciclum DE/H/4251/002 DE/H/4251/002 CICLUM FARMA UNIPESSOAL LDA.
PT
Etoricoxib Ciclum DE/H/4251/002 DE/H/4251/002 CICLUM FARMA UNIPESSOAL LDA.
PT
Etoricoxib Ciclum DE/H/4251/002 DE/H/4251/002 CICLUM FARMA UNIPESSOAL LDA.
PT
Etoricoxib Ciclum DE/H/4251/002 DE/H/4251/002 CICLUM FARMA UNIPESSOAL LDA.
PT
Etoricoxib Ciclum DE/H/4251/002 DE/H/4251/002 CICLUM FARMA UNIPESSOAL LDA.
PT
Etoricoxib Ciclum DE/H/4251/003 DE/H/4251/003 CICLUM FARMA UNIPESSOAL LDA.
PT
Etoricoxib Ciclum DE/H/4251/003 DE/H/4251/003 CICLUM FARMA UNIPESSOAL LDA.
PT
Etoricoxib Ciclum DE/H/4251/002 DE/H/4251/002 CICLUM FARMA UNIPESSOAL LDA.
PT
List of nationally authorised medicinal products EMA/812634/2017 Page 90/231
Product Name (in authorisation country)
MRP/DCP Authorisation Number
National Authorisation Number
MAH of product in the Member State
Member State where product is authorised
Etoricoxib Ciclum DE/H/4251/003 DE/H/4251/003 CICLUM FARMA UNIPESSOAL LDA.
PT
Etoricoxib Ciclum DE/H/4251/003 DE/H/4251/003 CICLUM FARMA UNIPESSOAL LDA.
PT
Etoricoxib Ciclum DE/H/4251/003 DE/H/4251/003 CICLUM FARMA UNIPESSOAL LDA.
PT
Etoricoxib Ciclum DE/H/4251/003 DE/H/4251/003 CICLUM FARMA UNIPESSOAL LDA.
PT
Etoricoxib Ciclum DE/H/4251/003 DE/H/4251/003 CICLUM FARMA UNIPESSOAL LDA.
PT
Etoricoxib Ciclum 120 mg comprimidos revestidos por película
DE/H/4251/004 DE/H/4251/004 CICLUM FARMA UNIPESSOAL LDA.
PT
Etoricoxib Ciclum 120 mg comprimidos revestidos por película
DE/H/4251/004 DE/H/4251/004 CICLUM FARMA UNIPESSOAL LDA.
PT
Etoricoxib Ciclum 120 mg comprimidos revestidos por película
DE/H/4251/004 DE/H/4251/004 CICLUM FARMA UNIPESSOAL LDA.
PT
Etoricoxib Ciclum 120 mg comprimidos revestidos por película
DE/H/4251/004 5692876 CICLUM FARMA UNIPESSOAL LDA.
PT
Etoricoxib Ciclum 120 mg comprimidos revestidos por película
DE/H/4251/004 DE/H/4251/004 CICLUM FARMA UNIPESSOAL LDA.
PT
Etoricoxib Ciclum 120 mg comprimidos revestidos por película
DE/H/4251/004 DE/H/4251/004 CICLUM FARMA UNIPESSOAL LDA.
PT
List of nationally authorised medicinal products EMA/812634/2017 Page 91/231
Product Name (in authorisation country)
MRP/DCP Authorisation Number
National Authorisation Number
MAH of product in the Member State
Member State where product is authorised
Etoricoxib Ciclum 120 mg comprimidos revestidos por película
DE/H/4251/004 DE/H/4251/004 CICLUM FARMA UNIPESSOAL LDA.
PT
Etoricoxib Ciclum 30 mg comprimidos revestidos por película
DE/H/4251/001 5692751 CICLUM FARMA UNIPESSOAL LDA.
PT
Etoricoxib Ciclum 30 mg comprimidos revestidos por película
DE/H/4251/001 5692769 CICLUM FARMA UNIPESSOAL LDA.
PT
Etoricoxib Ciclum 30 mg comprimidos revestidos por película
DE/H/4251/001 DE/H/4251/001 CICLUM FARMA UNIPESSOAL LDA.
PT
Etoricoxib Ciclum 30 mg comprimidos revestidos por película
DE/H/4251/001 DE/H/4251/001 CICLUM FARMA UNIPESSOAL LDA.
PT
Etoricoxib Ciclum 60 mg comprimidos revestidos por película
DE/H/4251/002 DE/H/4251/002 CICLUM FARMA UNIPESSOAL LDA.
PT
Etoricoxib cinfa 120 mg comprimidos recubiertos con película EFG
not available 80754 LABORATORIOS CINFA, S.A. ES
Etoricoxib cinfa 30 mg comprimidos recubiertos con película EFG
not available 80752 LABORATORIOS CINFA, S.A. ES
Etoricoxib cinfa 60 mg comprimidos recubiertos con película EFG
not available 80751 LABORATORIOS CINFA, S.A. ES
List of nationally authorised medicinal products EMA/812634/2017 Page 92/231
Product Name (in authorisation country)
MRP/DCP Authorisation Number
National Authorisation Number
MAH of product in the Member State
Member State where product is authorised
Etoricoxib cinfa 90 mg comprimidos recubiertos con película EFG
not available 80753 LABORATORIOS CINFA, S.A. ES
ETORICOXIB DOC Generici 120 mg compresse rivestite con film
NL/H/3272/003 043688035 DOC GENERICI S.R.L. IT
Etoricoxib DOC Generici 120 mg film-coated tablets
NL/H/3272/003 RVG 116035 DOC GENERICI S.R.L. NL
ETORICOXIB DOC Generici 60 mg compresse rivestite con film
NL/H/3272/001 043688011 DOC GENERICI S.R.L. IT
Etoricoxib DOC Generici 60 mg film-coated tablets
NL/H/3272/001 RVG 116033 DOC GENERICI S.R.L. NL
ETORICOXIB DOC Generici 90 mg compresse rivestite con film
NL/H/3272/002 043688023 DOC GENERICI S.R.L. IT
Etoricoxib DOC Generici 90 mg film-coated tablets
NL/H/3272/002 RVG 116034 DOC GENERICI S.R.L. NL
Etoricoxib EG 120 mg comprimés pelliculés
DE/H/4251/004 BE500497 EUROGENERICS N.V./S.A. BE
Etoricoxib EG 120 mg comprimés pelliculés
DE/H/4251/004 2017040093 EUROGENERICS N.V./S.A. LU
Etoricoxib EG 120 mg filmomhulde tabletten
DE/H/4251/004 BE500497 EUROGENERICS N.V./S.A. BE
Etoricoxib EG 120 mg Filmtabletten
DE/H/4251/004 BE500497 EUROGENERICS N.V./S.A. BE
Etoricoxib EG 30 mg comprimés pelliculés
DE/H/4251/001 BE500444 EUROGENERICS N.V./S.A. BE
Etoricoxib EG 30 mg comprimés pelliculés
DE/H/4251/001 2017040090 EUROGENERICS N.V./S.A. LU
Etoricoxib EG 30 mg filmomhulde tabletten
DE/H/4251/001 BE500444 EUROGENERICS N.V./S.A. BE
List of nationally authorised medicinal products EMA/812634/2017 Page 93/231
Product Name (in authorisation country)
MRP/DCP Authorisation Number
National Authorisation Number
MAH of product in the Member State
Member State where product is authorised
Etoricoxib EG 30 mg Filmtabletten DE/H/4251/001 BE500444 EUROGENERICS N.V./S.A. BE Etoricoxib EG 60 mg comprimés pelliculés
DE/H/4251/002 BE500453 EUROGENERICS SA BE
Etoricoxib EG 60 mg comprimés pelliculés
DE/H/4251/002 BE500462 EUROGENERICS N.V./S.A. BE
Etoricoxib EG 60 mg comprimés pelliculés
DE/H/4251/002 2017040091 EUROGENERICS N.V./S.A. LU
Etoricoxib EG 60 mg filmomhulde tabletten
DE/H/4251/002 BE500453 EUROGENERICS SA BE
Etoricoxib EG 60 mg filmomhulde tabletten
DE/H/4251/002 BE500462 EUROGENERICS N.V./S.A. BE
Etoricoxib EG 60 mg Filmtabletten DE/H/4251/002 BE500453 EUROGENERICS SA BE Etoricoxib EG 60 mg Filmtabletten DE/H/4251/002 BE500462 EUROGENERICS N.V./S.A. BE Etoricoxib EG 90 mg comprimés pelliculés
DE/H/4251/003 BE500471 EUROGENERICS SA BE
Etoricoxib EG 90 mg comprimés pelliculés
DE/H/4251/003 BE500480 EUROGENERICS N.V./S.A. BE
Etoricoxib EG 90 mg comprimés pelliculés
DE/H/4251/003 2017040092 EUROGENERICS N.V./S.A. LU
Etoricoxib EG 90 mg filmomhulde tabletten
DE/H/4251/003 BE500480 EUROGENERICS N.V./S.A. BE
Etoricoxib EG 90 mg filmomhulde tabletten
DE/H/4251/003 BE500471 EUROGENERICS SA BE
Etoricoxib EG 90 mg Filmtabletten DE/H/4251/003 BE500471 EUROGENERICS SA BE Etoricoxib EG 90 mg Filmtabletten DE/H/4251/003 BE500480 EUROGENERICS N.V./S.A. BE Etoricoxib Empower 120 mg comprimidos revestidos por película
PT/H/1614/004 5710355 EMPOWER PHARMA PT
List of nationally authorised medicinal products EMA/812634/2017 Page 94/231
Product Name (in authorisation country)
MRP/DCP Authorisation Number
National Authorisation Number
MAH of product in the Member State
Member State where product is authorised
Etoricoxib Empower 120 mg comprimidos revestidos por película
PT/H/1614/004 5710355 EMPOWER PHARMA PT
Etoricoxib Empower 30 mg comprimidos revestidos por película
PT/H/1614/001 5710140 EMPOWER PHARMA PT
Etoricoxib Empower 30 mg comprimidos revestidos por película
PT/H/1614/001 5710140 EMPOWER PHARMA PT
Etoricoxib Empower 60 mg comprimidos revestidos por película
PT/H/1614/002 5710231 EMPOWER PHARMA PT
Etoricoxib Empower 60 mg comprimidos revestidos por película
PT/H/1614/002 5710231 EMPOWER PHARMA PT
Etoricoxib Empower 90 mg comprimidos revestidos por película
PT/H/1614/003 5710330 EMPOWER PHARMA PT
Etoricoxib Empower 90 mg comprimidos revestidos por película
PT/H/1614/003 5710330 EMPOWER PHARMA PT
Etoricoxib Farmoz 120 mg comprimidos revestidos por película
not available 5691852 FARMOZ - SOCIEDADE TÉCNICO MEDICINAL, S.A.
PT
Etoricoxib Farmoz 120 mg comprimidos revestidos por película
not available 5691860 FARMOZ - SOCIEDADE TÉCNICO MEDICINAL, S.A.
PT
List of nationally authorised medicinal products EMA/812634/2017 Page 95/231
Product Name (in authorisation country)
MRP/DCP Authorisation Number
National Authorisation Number
MAH of product in the Member State
Member State where product is authorised
Etoricoxib Farmoz 120 mg comprimidos revestidos por película
not available 16/H/0023/004 FARMOZ - SOCIEDADE TÉCNICO MEDICINAL, S.A.
PT
Etoricoxib Farmoz 120 mg comprimidos revestidos por película
not available 16/H/0023/004 FARMOZ - SOCIEDADE TÉCNICO MEDICINAL, S.A.
PT
Etoricoxib Farmoz 30 mg comprimidos revestidos por película
not available 5691712 FARMOZ - SOCIEDADE TÉCNICO MEDICINAL, S.A.
PT
Etoricoxib Farmoz 30 mg comprimidos revestidos por película
not available 5691720 FARMOZ - SOCIEDADE TÉCNICO MEDICINAL, S.A.
PT
Etoricoxib Farmoz 30 mg comprimidos revestidos por película
not available 16/H/0023/001 FARMOZ - SOCIEDADE TÉCNICO MEDICINAL, S.A.
PT
Etoricoxib Farmoz 30 mg comprimidos revestidos por película
not available 16/H/0023/001 FARMOZ - SOCIEDADE TÉCNICO MEDICINAL, S.A.
PT
Etoricoxib Farmoz 60 mg comprimidos revestidos por película
not available 5691811 FARMOZ - SOCIEDADE TÉCNICO MEDICINAL, S.A.
PT
Etoricoxib Farmoz 60 mg comprimidos revestidos por película
not available 5691829 FARMOZ - SOCIEDADE TÉCNICO MEDICINAL, S.A.
PT
Etoricoxib Farmoz 60 mg comprimidos revestidos por película
not available 16/H/0023/002 FARMOZ - SOCIEDADE TÉCNICO MEDICINAL, S.A.
PT
List of nationally authorised medicinal products EMA/812634/2017 Page 96/231
Product Name (in authorisation country)
MRP/DCP Authorisation Number
National Authorisation Number
MAH of product in the Member State
Member State where product is authorised
Etoricoxib Farmoz 60 mg comprimidos revestidos por película
not available 16/H/0023/002 FARMOZ - SOCIEDADE TÉCNICO MEDICINAL, S.A.
PT
Etoricoxib Farmoz 90 mg comprimidos revestidos por película
not available 5691837 FARMOZ - SOCIEDADE TÉCNICO MEDICINAL, S.A.
PT
Etoricoxib Farmoz 90 mg comprimidos revestidos por película
not available 5691845 FARMOZ - SOCIEDADE TÉCNICO MEDICINAL, S.A.
PT
Etoricoxib Farmoz 90 mg comprimidos revestidos por película
not available 16/H/0023/003 FARMOZ - SOCIEDADE TÉCNICO MEDICINAL, S.A.
PT
Etoricoxib Farmoz 90 mg comprimidos revestidos por película
not available 16/H/0023/003 FARMOZ - SOCIEDADE TÉCNICO MEDICINAL, S.A.
PT
Etoricoxib Generis 120 mg comprimidos revestidos por película
PT/H/1603/003/DC PT/H/1603/003/DC GENERIS FARMACÊUTICA, S.A.
PT
Etoricoxib Generis 120 mg comprimidos revestidos por película
PT/H/1603/003/DC PT/H/1603/003/DC GENERIS FARMACÊUTICA, S.A.
PT
Etoricoxib Generis 120 mg comprimidos revestidos por película
PT/H/1603/003/DC PT/H/1603/003/DC GENERIS FARMACÊUTICA, S.A.
PT
Etoricoxib Generis 120 mg comprimidos revestidos por película
PT/H/1603/003/DC PT/H/1603/003/DC GENERIS FARMACÊUTICA, S.A.
PT
List of nationally authorised medicinal products EMA/812634/2017 Page 97/231
Product Name (in authorisation country)
MRP/DCP Authorisation Number
National Authorisation Number
MAH of product in the Member State
Member State where product is authorised
Etoricoxib Generis 120 mg comprimidos revestidos por película
PT/H/1603/004 5704622 GENERIS FARMACÊUTICA, S.A.
PT
Etoricoxib Generis 120 mg comprimidos revestidos por película
PT/H/1603/003/DC PT/H/1603/003/DC GENERIS FARMACÊUTICA, S.A.
PT
Etoricoxib Generis 120 mg comprimidos revestidos por película
PT/H/1603/003/DC PT/H/1603/003/DC GENERIS FARMACÊUTICA, S.A.
PT
Etoricoxib Generis 120 mg comprimidos revestidos por película
PT/H/1603/004 5704648 GENERIS FARMACÊUTICA, S.A.
PT
Etoricoxib Generis 30 mg comprimidos revestidos por película
PT/H/1603/001 5709571 GENERIS FARMACÊUTICA, S.A.
PT
Etoricoxib Generis 30 mg comprimidos revestidos por película
PT/H/1603/001 5704630 GENERIS FARMACÊUTICA, S.A.
PT
Etoricoxib Generis 30 mg comprimidos revestidos por película
PT/H/1603/001 5709605 GENERIS FARMACÊUTICA, S.A.
PT
Etoricoxib Generis 30 mg comprimidos revestidos por película
PT/H/1603/001/DC PT/H/1603/001/DC GENERIS FARMACÊUTICA, S.A.
PT
Etoricoxib Generis 30 mg comprimidos revestidos por película
PT/H/1603/001/DC PT/H/1603/001/DC GENERIS FARMACÊUTICA, S.A.
PT
List of nationally authorised medicinal products EMA/812634/2017 Page 98/231
Product Name (in authorisation country)
MRP/DCP Authorisation Number
National Authorisation Number
MAH of product in the Member State
Member State where product is authorised
Etoricoxib Generis 30 mg comprimidos revestidos por película
PT/H/1603/001/DC PT/H/1603/001/DC GENERIS FARMACÊUTICA, S.A.
PT
Etoricoxib Generis 30 mg comprimidos revestidos por película
PT/H/1603/001/DC PT/H/1603/001/DC GENERIS FARMACÊUTICA, S.A.
PT
Etoricoxib Generis 30 mg comprimidos revestidos por película
PT/H/1603/001/DC PT/H/1603/001/DC GENERIS FARMACÊUTICA, S.A.
PT
Etoricoxib Generis 60 mg comprimidos revestidos por película
PT/H/1603/002 5709902 GENERIS FARMACÊUTICA, S.A.
PT
Etoricoxib Generis 60 mg comprimidos revestidos por película
PT/H/1603/002 5709910 GENERIS FARMACÊUTICA, S.A.
PT
Etoricoxib Generis 60 mg comprimidos revestidos por película
PT/H/1603/002 5704663 GENERIS FARMACÊUTICA, S.A.
PT
Etoricoxib Generis 60 mg comprimidos revestidos por película
PT/H/1603/002/DC PT/H/1603/002/DC GENERIS FARMACÊUTICA, S.A.
PT
Etoricoxib Generis 60 mg comprimidos revestidos por película
PT/H/1603/002/DC PT/H/1603/002/DC GENERIS FARMACÊUTICA, S.A.
PT
Etoricoxib Generis 60 mg comprimidos revestidos por película
PT/H/1603/002/DC PT/H/1603/002/DC GENERIS FARMACÊUTICA, S.A.
PT
List of nationally authorised medicinal products EMA/812634/2017 Page 99/231
Product Name (in authorisation country)
MRP/DCP Authorisation Number
National Authorisation Number
MAH of product in the Member State
Member State where product is authorised
Etoricoxib Generis 60 mg comprimidos revestidos por película
PT/H/1603/002/DC PT/H/1603/002/DC GENERIS FARMACÊUTICA, S.A.
PT
Etoricoxib Generis 60 mg comprimidos revestidos por película
PT/H/1603/002/DC PT/H/1603/002/DC GENERIS FARMACÊUTICA, S.A.
PT
Etoricoxib Generis 90 mg comprimidos revestidos por película
PT/H/1603/003 5709928 GENERIS FARMACÊUTICA, S.A.
PT
Etoricoxib Generis 90 mg comprimidos revestidos por película
PT/H/1603/003 5704671 GENERIS FARMACÊUTICA, S.A.
PT
Etoricoxib Generis 90 mg comprimidos revestidos por película
PT/H/1603/003 5709936 GENERIS FARMACÊUTICA, S.A.
PT
Etoricoxib Generis 90 mg comprimidos revestidos por película
PT/H/1603/003/DC PT/H/1603/003/DC GENERIS FARMACÊUTICA, S.A.
PT
Etoricoxib Generis 90 mg comprimidos revestidos por película
PT/H/1603/003/DC PT/H/1603/003/DC GENERIS FARMACÊUTICA, S.A.
PT
Etoricoxib Generis 90 mg comprimidos revestidos por película
PT/H/1603/003/DC PT/H/1603/003/DC GENERIS FARMACÊUTICA, S.A.
PT
Etoricoxib Generis 90 mg comprimidos revestidos por película
PT/H/1603/003/DC PT/H/1603/003/DC GENERIS FARMACÊUTICA, S.A.
PT
List of nationally authorised medicinal products EMA/812634/2017 Page 100/231
Product Name (in authorisation country)
MRP/DCP Authorisation Number
National Authorisation Number
MAH of product in the Member State
Member State where product is authorised
Etoricoxib Generis 90 mg comprimidos revestidos por película
PT/H/1603/003/DC PT/H/1603/003/DC GENERIS FARMACÊUTICA, S.A.
PT
Etoricoxib Glenmark 120 mg Filmtabletten
NL/H/3576/004 96165.00.00 GLENMARK PHARMACEUTICALS EUROPE LIMITED
DE
Etoricoxib Glenmark 120 mg, filmomhulde tabletten
NL/H/3576/004 RVG 117989 GLENMARK PHARMACEUTICALS EUROPE LIMITED
NL
Etoricoxib Glenmark 30 mg Filmtabletten
NL/H/3576/001 96162.00.00 GLENMARK PHARMACEUTICALS EUROPE LIMITED
DE
Etoricoxib Glenmark 30 mg, filmomhulde tabletten
NL/H/3576/001 RVG 117986 GLENMARK PHARMACEUTICALS EUROPE LIMITED
NL
Etoricoxib Glenmark 60 mg Filmtabletten
NL/H/3576/002 96163.00.00 GLENMARK PHARMACEUTICALS EUROPE LIMITED
DE
Etoricoxib Glenmark 60 mg, filmomhulde tabletten
NL/H/3576/002 RVG 117987 GLENMARK PHARMACEUTICALS EUROPE LIMITED
NL
Etoricoxib Glenmark 90 mg Filmtabletten
NL/H/3576/003 96164.00.00 GLENMARK PHARMACEUTICALS EUROPE LIMITED
DE
Etoricoxib Glenmark 90 mg, filmomhulde tabletten
NL/H/3576/003 RVG 117988 GLENMARK PHARMACEUTICALS EUROPE LIMITED
NL
List of nationally authorised medicinal products EMA/812634/2017 Page 101/231
Product Name (in authorisation country)
MRP/DCP Authorisation Number
National Authorisation Number
MAH of product in the Member State
Member State where product is authorised
Etoricoxib HCS 120 mg comprimidos revestidos por película
HU/H/0435/004 5706924 HCS BVBA PT
Etoricoxib HCS 120 mg comprimidos revestidos por película
HU/H/0435/004 5706932 HCS BVBA PT
Etoricoxib HCS 120 mg comprimidos revestidos por película
HU/H/0435/004 5706940 HCS BVBA PT
Etoricoxib HCS 30 mg comprimidos revestidos por película
HU/H/0435/001 5706742 HCS BVBA PT
Etoricoxib HCS 30 mg comprimidos revestidos por película
HU/H/0435/001 5706759 HCS BVBA PT
Etoricoxib HCS 60 mg comprimidos revestidos por película
HU/H/0435/002 5706775 HCS BVBA PT
Etoricoxib HCS 60 mg comprimidos revestidos por película
HU/H/0435/002 5706809 HCS BVBA PT
Etoricoxib HCS 60 mg comprimidos revestidos por película
HU/H/0435/002 5706817 HCS BVBA PT
Etoricoxib HCS 90 mg comprimidos revestidos por película
HU/H/0435/003 5706833 HCS BVBA PT
List of nationally authorised medicinal products EMA/812634/2017 Page 102/231
Product Name (in authorisation country)
MRP/DCP Authorisation Number
National Authorisation Number
MAH of product in the Member State
Member State where product is authorised
Etoricoxib HCS 90 mg comprimidos revestidos por película
HU/H/0435/003 5706841 HCS BVBA PT
Etoricoxib HCS 90 mg comprimidos revestidos por película
HU/H/0435/003 5706858 HCS BVBA PT
Etoricoxib Heumann 120 mg Filmtabletten
DE/H/5092/004 93517.00.00 HEUMANN PHARMA GMBH & CO. GENERICA KG
DE
Etoricoxib Heumann 30 mg Filmtabletten
DE/H/5092/001 93514.00.00 HEUMANN PHARMA GMBH & CO. GENERICA KG
DE
Etoricoxib Heumann 60 mg Filmtabletten
DE/H/5092/002 93515.00.00 HEUMANN PHARMA GMBH & CO. GENERICA KG
DE
Etoricoxib Heumann 90 mg Filmtabletten
DE/H/5092/003 93516.00.00 HEUMANN PHARMA GMBH & CO. GENERICA KG
DE
Etoricoxib Krka 120 mg comprimés pelliculés
HU/H/0435/004 BE501706 KRKA, D.D., NOVO MESTO BE
Etoricoxib Krka 120 mg comprimidos recubiertos con película EFG
HU/H/0435/004 81717 KRKA, D.D., NOVO MESTO ES
Etoricoxib Krka 120 mg film-coated tablets
HU/H/0435/004 PA1347/064/004 KRKA, D.D., NOVO MESTO IE
Etoricoxib Krka 120 mg filmdragerade tabletter
HU/H/0435/004 53602 KRKA, D.D., NOVO MESTO SE
Etoricoxib Krka 120 mg filmdrasjerte tabletter
HU/H/0435/004 15-10943 KRKA, D.D., NOVO MESTO NO
Etoricoxib Krka 120 mg filmuhúðaðar töflur
HU/H/0435/004 IS/1/16/099/04 KRKA, D.D., NOVO MESTO IS
Etoricoxib Krka 120 mg kalvopäällysteiset tabletit
HU/H/0435/004 33739 KRKA, D.D., NOVO MESTO FI
List of nationally authorised medicinal products EMA/812634/2017 Page 103/231
Product Name (in authorisation country)
MRP/DCP Authorisation Number
National Authorisation Number
MAH of product in the Member State
Member State where product is authorised
Etoricoxib Krka 30 mg comprimés pelliculés
HU/H/0435/001 BE501671 KRKA, D.D., NOVO MESTO BE
Etoricoxib Krka 30 mg comprimidos recubiertos con película EFG
HU/H/0435/001 81709 KRKA, D.D., NOVO MESTO ES
Etoricoxib Krka 30 mg film-coated tablets
HU/H/0435/001 PA1347/064/001 KRKA, D.D., NOVO MESTO IE
Etoricoxib Krka 30 mg filmdragerade tabletter
HU/H/0435/001 53599 KRKA, D.D., NOVO MESTO SE
Etoricoxib Krka 30 mg filmdrasjerte tabletter
HU/H/0435/001 15-10940 KRKA, D.D., NOVO MESTO NO
Etoricoxib Krka 30 mg filmuhúðaðar töflur
HU/H/0435/001 IS/1/16/099/01 KRKA, D.D., NOVO MESTO IS
Etoricoxib Krka 30 mg kalvopäällysteiset tabletit
HU/H/0435/001 33736 KRKA, D.D., NOVO MESTO FI
Etoricoxib Krka 60 mg comprimés pelliculés
HU/H/0435/002 BE501680 KRKA, D.D., NOVO MESTO BE
Etoricoxib Krka 60 mg comprimidos recubiertos con película EFG
HU/H/0435/002 81710 KRKA, D.D., NOVO MESTO ES
Etoricoxib Krka 60 mg film-coated tablets
HU/H/0435/002 PA1347/064/002 KRKA, D.D., NOVO MESTO IE
Etoricoxib Krka 60 mg filmdragerade tabletter
HU/H/0435/002 53600 KRKA, D.D., NOVO MESTO SE
Etoricoxib Krka 60 mg filmdrasjerte tabletter
HU/H/0435/002 15-10941 KRKA, D.D., NOVO MESTO NO
Etoricoxib Krka 60 mg filmuhúðaðar töflur
HU/H/0435/002 IS/1/16/099/02 KRKA, D.D., NOVO MESTO IS
List of nationally authorised medicinal products EMA/812634/2017 Page 104/231
Product Name (in authorisation country)
MRP/DCP Authorisation Number
National Authorisation Number
MAH of product in the Member State
Member State where product is authorised
Etoricoxib Krka 60 mg kalvopäällysteiset tabletit
HU/H/0435/002 33737 KRKA, D.D., NOVO MESTO FI
Etoricoxib Krka 90 mg comprimés pelliculés
HU/H/0435/003 BE501697 KRKA, D.D., NOVO MESTO BE
Etoricoxib Krka 90 mg comprimidos recubiertos con película EFG
HU/H/0435/003 81711 KRKA, D.D., NOVO MESTO ES
Etoricoxib Krka 90 mg film-coated tablets
HU/H/0435/003 PA1347/064/003 KRKA, D.D., NOVO MESTO IE
Etoricoxib Krka 90 mg filmdragerade tabletter
HU/H/0435/003 53601 KRKA, D.D., NOVO MESTO SE
Etoricoxib Krka 90 mg filmdrasjerte tabletter
HU/H/0435/003 15-10942 KRKA, D.D., NOVO MESTO NO
Etoricoxib Krka 90 mg filmuhúðaðar töflur
HU/H/0435/003 IS/1/16/099/03 KRKA, D.D., NOVO MESTO IS
Etoricoxib Krka 90 mg kalvopäällysteiset tabletit
HU/H/0435/003 33738 KRKA, D.D., NOVO MESTO FI
Etoricoxib Libra-Pharm 120 mg Filmtabletten
UK/H/3190/004 77702.00.00 MERCK SHARP & DOHME BV DE
Etoricoxib Libra-Pharm 30 mg Filmtabletten
UK/H/3190/001 77699.00.00 MERCK SHARP & DOHME BV DE
Etoricoxib Libra-Pharm 60 mg Filmtabletten
UK/H/3190/002 77700.00.00 MERCK SHARP & DOHME BV DE
Etoricoxib Libra-Pharm 90 mg Filmtabletten
UK/H/3190/003 77701.00.00 MERCK SHARP & DOHME BV DE
Etoricoxib Micro Labs 120 mg Filmtabletten
ES/H/0264/004 91239.00.00 MICRO LABS GMBH DE
Etoricoxib Micro Labs 120 mg Filmtabletten
ES/H/0264/004 91239.00.00 MICRO LABS GMBH DE
List of nationally authorised medicinal products EMA/812634/2017 Page 105/231
Product Name (in authorisation country)
MRP/DCP Authorisation Number
National Authorisation Number
MAH of product in the Member State
Member State where product is authorised
Etoricoxib Micro Labs 120 mg Filmtabletten
ES/H/0264/004 91239.00.00 MICRO LABS GMBH DE
Etoricoxib Micro Labs 120 mg Filmtabletten
ES/H/0264/004 91239.00.00 MICRO LABS GMBH DE
Etoricoxib Micro Labs 120 mg Filmtabletten
ES/H/0264/004 91239.00.00 MICRO LABS GMBH DE
Etoricoxib Micro Labs 30 mg Filmtabletten
ES/H/0264/001 91236.00.00 MICRO LABS GMBH DE
Etoricoxib Micro Labs 30 mg Filmtabletten
ES/H/0264/001 91236.00.00 MICRO LABS GMBH DE
Etoricoxib Micro Labs 60 mg Filmtabletten
ES/H/0264/002 91237.00.00 MICRO LABS GMBH DE
Etoricoxib Micro Labs 60 mg Filmtabletten
ES/H/0264/002 91237.00.00 MICRO LABS GMBH DE
Etoricoxib Micro Labs 60 mg Filmtabletten
ES/H/0264/002 91237.00.00 MICRO LABS GMBH DE
Etoricoxib Micro Labs 60 mg Filmtabletten
ES/H/0264/002 91237.00.00 MICRO LABS GMBH DE
Etoricoxib Micro Labs 60 mg Filmtabletten
ES/H/0264/002 91237.00.00 MICRO LABS GMBH DE
Etoricoxib Micro Labs 60 mg Filmtabletten
ES/H/0264/002 91237.00.00 MICRO LABS GMBH DE
Etoricoxib Micro Labs 90 mg Filmtabletten
ES/H/0264/003 91238.00.00 MICRO LABS GMBH DE
Etoricoxib Micro Labs 90 mg Filmtabletten
ES/H/0264/003 91238.00.00 MICRO LABS GMBH DE
Etoricoxib Micro Labs 90 mg Filmtabletten
ES/H/0264/003 91238.00.00 MICRO LABS GMBH DE
List of nationally authorised medicinal products EMA/812634/2017 Page 106/231
Product Name (in authorisation country)
MRP/DCP Authorisation Number
National Authorisation Number
MAH of product in the Member State
Member State where product is authorised
Etoricoxib Micro Labs 90 mg Filmtabletten
ES/H/0264/003 91238.00.00 MICRO LABS GMBH DE
Etoricoxib Micro Labs 90 mg Filmtabletten
ES/H/0264/003 91238.00.00 MICRO LABS GMBH DE
Etoricoxib Micro Labs 90 mg Filmtabletten
ES/H/0264/003 91238.00.00 MICRO LABS GMBH DE
Etoricoxib Micro Labs 90 mg Filmtabletten
ES/H/0264/003 91238.00.00 MICRO LABS GMBH DE
Etoricoxib Mylan 120 mg compresse rivestite con film
NL/H/3196/004 043546112 MYLAN S.P.A. IT
Etoricoxib Mylan 120 mg compresse rivestite con film
NL/H/3196/004 043546124 MYLAN S.P.A. IT
Etoricoxib Mylan 120 mg comprimidos recubiertos con película EFG
NL/H/3151/004 80376 MYLAN PHARMACEUTICALS S.L.
ES
Etoricoxib Mylan 120 mg comprimidos revestidos por película
NL/H/3151/004 5662507 MYLAN, LDA PT
Etoricoxib Mylan 120 mg comprimidos revestidos por película
NL/H/3151/004 5662428 MYLAN, LDA PT
Etoricoxib Mylan 120 mg comprimidos revestidos por película
NL/H/3151/004 5662465 MYLAN, LDA PT
Etoricoxib Mylan 120 mg comprimidos revestidos por película
NL/H/3151/004 5662515 MYLAN, LDA PT
List of nationally authorised medicinal products EMA/812634/2017 Page 107/231
Product Name (in authorisation country)
MRP/DCP Authorisation Number
National Authorisation Number
MAH of product in the Member State
Member State where product is authorised
Etoricoxib Mylan 120 mg comprimidos revestidos por película
NL/H/3151/004 5662523 MYLAN, LDA PT
Etoricoxib Mylan 120 mg comprimidos revestidos por película
NL/H/3151/004 5662531 MYLAN, LDA PT
Etoricoxib Mylan 120 mg comprimidos revestidos por película
NL/H/3151/004 5689633 MYLAN, LDA PT
Etoricoxib Mylan 120 mg comprimidos revestidos por película
NL/H/3151/004 5689641 MYLAN, LDA PT
Etoricoxib Mylan 120 mg Film-coated Tablets
NL/H/3151/004 PL 04569/1467 GENERICS [UK] LIMITED UK
Etoricoxib Mylan 120 mg Filmtabletten
NL/H/3151/004 92028.00.00 GENERICS [UK] LIMITED DE
Etoricoxib Mylan 120 mg tabletti, kalvopäällysteinen
NL/H/3151/004 32283 MYLAN AB FI
Etoricoxib Mylan 120 mg, filmomhulde tabletten
NL/H/3151/004 RVG 115517 MYLAN B.V. NL
Etoricoxib Mylan 120 mg, filmomhulde tabletten
NL/H/3196/004 RVG 115521 MYLAN B.V. NL
Etoricoxib Mylan 30 mg compresse rivestite con film
NL/H/3196/001 043546011 MYLAN S.P.A. IT
Etoricoxib Mylan 30 mg compresse rivestite con film
NL/H/3196/001 043546023 MYLAN S.P.A. IT
Etoricoxib Mylan 30 mg compresse rivestite con film
NL/H/3196/001 043546035 MYLAN S.P.A. IT
List of nationally authorised medicinal products EMA/812634/2017 Page 108/231
Product Name (in authorisation country)
MRP/DCP Authorisation Number
National Authorisation Number
MAH of product in the Member State
Member State where product is authorised
Etoricoxib Mylan 30 mg compresse rivestite con film
NL/H/3196/001 043546047 MYLAN S.P.A. IT
Etoricoxib Mylan 30 mg comprimidos recubiertos con película EFG
NL/H/3151/001 80373 MYLAN PHARMACEUTICALS S.L.
ES
Etoricoxib Mylan 30 mg comprimidos revestidos por película
NL/H/3151/001 5662234 MYLAN, LDA PT
Etoricoxib Mylan 30 mg comprimidos revestidos por película
NL/H/3151/001 5662218 MYLAN, LDA PT
Etoricoxib Mylan 30 mg comprimidos revestidos por película
NL/H/3151/001 5662200 MYLAN, LDA PT
Etoricoxib Mylan 30 mg comprimidos revestidos por película
NL/H/3151/001 5662226 MYLAN, LDA PT
Etoricoxib Mylan 30 mg comprimidos revestidos por película
NL/H/3151/001 5662267 MYLAN, LDA PT
Etoricoxib Mylan 30 mg comprimidos revestidos por película
NL/H/3151/001 5662259 MYLAN, LDA PT
Etoricoxib Mylan 30 mg comprimidos revestidos por película
NL/H/3151/001 5662242 MYLAN, LDA PT
Etoricoxib Mylan 30 mg comprimidos revestidos por película
NL/H/3151/001 5662275 MYLAN, LDA PT
List of nationally authorised medicinal products EMA/812634/2017 Page 109/231
Product Name (in authorisation country)
MRP/DCP Authorisation Number
National Authorisation Number
MAH of product in the Member State
Member State where product is authorised
Etoricoxib Mylan 30 mg comprimidos revestidos por película
NL/H/3151/001 5689658 MYLAN, LDA PT
Etoricoxib Mylan 30 mg comprimidos revestidos por película
NL/H/3151/001 5689666 MYLAN, LDA PT
Etoricoxib Mylan 30 mg Film-coated Tablets
NL/H/3151/001 PL 04569/1464 GENERICS [UK] LIMITED UK
Etoricoxib Mylan 30 mg Filmtabletten
NL/H/3151/001 92025.00.00 GENERICS [UK] LIMITED DE
Etoricoxib Mylan 30 mg tabletti, kalvopäällysteinen
NL/H/3151/001 32280 MYLAN AB FI
Etoricoxib Mylan 30 mg, filmomhulde tabletten
NL/H/3151/001 RVG 115514 MYLAN B.V. NL
Etoricoxib Mylan 30 mg, filmomhulde tabletten
NL/H/3196/001 RVG 115518 MYLAN B.V. NL
Etoricoxib Mylan 60 mg compresse rivestite con film
NL/H/3196/002 043546050 MYLAN S.P.A. IT
Etoricoxib Mylan 60 mg compresse rivestite con film
NL/H/3196/002 043546062 MYLAN S.P.A. IT
Etoricoxib Mylan 60 mg comprimidos recubiertos con película EFG
NL/H/3151/002 80374 MYLAN PHARMACEUTICALS S.L.
ES
Etoricoxib Mylan 60 mg comprimidos revestidos por película
NL/H/3151/002 5662309 MYLAN, LDA PT
Etoricoxib Mylan 60 mg comprimidos revestidos por película
NL/H/3151/002 5662325 MYLAN, LDA PT
List of nationally authorised medicinal products EMA/812634/2017 Page 110/231
Product Name (in authorisation country)
MRP/DCP Authorisation Number
National Authorisation Number
MAH of product in the Member State
Member State where product is authorised
Etoricoxib Mylan 60 mg comprimidos revestidos por película
NL/H/3151/002 5662333 MYLAN, LDA PT
Etoricoxib Mylan 60 mg comprimidos revestidos por película
NL/H/3151/002 5662317 MYLAN, LDA PT
Etoricoxib Mylan 60 mg comprimidos revestidos por película
NL/H/3151/002 5662366 MYLAN, LDA PT
Etoricoxib Mylan 60 mg comprimidos revestidos por película
NL/H/3151/002 5662341 MYLAN, LDA PT
Etoricoxib Mylan 60 mg comprimidos revestidos por película
NL/H/3151/002 5662374 MYLAN, LDA PT
Etoricoxib Mylan 60 mg comprimidos revestidos por película
NL/H/3151/002 5662358 MYLAN, LDA PT
Etoricoxib Mylan 60 mg comprimidos revestidos por película
NL/H/3151/002 5689617 MYLAN, LDA PT
Etoricoxib Mylan 60 mg comprimidos revestidos por película
NL/H/3151/002 5689625 MYLAN, LDA PT
Etoricoxib Mylan 60 mg Film-coated Tablets
NL/H/3151/002 PL 04569/1465 GENERICS [UK] LIMITED UK
Etoricoxib Mylan 60 mg Filmtabletten
NL/H/3151/002 92026.00.00 GENERICS [UK] LIMITED DE
List of nationally authorised medicinal products EMA/812634/2017 Page 111/231
Product Name (in authorisation country)
MRP/DCP Authorisation Number
National Authorisation Number
MAH of product in the Member State
Member State where product is authorised
Etoricoxib Mylan 60 mg tabletti, kalvopäällysteinen
NL/H/3151/002 32281 MYLAN AB FI
Etoricoxib Mylan 60 mg, filmomhulde tabletten
NL/H/3151/002 RVG 115515 MYLAN B.V. NL
Etoricoxib Mylan 60 mg, filmomhulde tabletten
NL/H/3196/002 RVG 115519 MYLAN B.V. NL
Etoricoxib Mylan 90 mg compresse rivestite con film
NL/H/3196/003 043546074 MYLAN S.P.A. IT
Etoricoxib Mylan 90 mg compresse rivestite con film
NL/H/3196/003 043546086 MYLAN S.P.A. IT
Etoricoxib Mylan 90 mg compresse rivestite con film
NL/H/3196/003 043546098 MYLAN S.P.A. IT
Etoricoxib Mylan 90 mg compresse rivestite con film
NL/H/3196/003 043546100 MYLAN S.P.A. IT
Etoricoxib Mylan 90 mg comprimidos recubiertos con película EFG
NL/H/3151/003 80375 MYLAN PHARMACEUTICALS S.L.
ES
Etoricoxib Mylan 90 mg comprimidos revestidos por película
NL/H/3151/003 5662416 MYLAN, LDA PT
Etoricoxib Mylan 90 mg comprimidos revestidos por película
NL/H/3151/003 5662432 MYLAN, LDA PT
Etoricoxib Mylan 90 mg comprimidos revestidos por película
NL/H/3151/003 5662408 MYLAN, LDA PT
Etoricoxib Mylan 90 mg comprimidos revestidos por película
NL/H/3151/003 5662424 MYLAN, LDA PT
List of nationally authorised medicinal products EMA/812634/2017 Page 112/231
Product Name (in authorisation country)
MRP/DCP Authorisation Number
National Authorisation Number
MAH of product in the Member State
Member State where product is authorised
Etoricoxib Mylan 90 mg comprimidos revestidos por película
NL/H/3151/003 5662440 MYLAN, LDA PT
Etoricoxib Mylan 90 mg comprimidos revestidos por película
NL/H/3151/003 5662457 MYLAN, LDA PT
Etoricoxib Mylan 90 mg comprimidos revestidos por película
NL/H/3151/003 5689575 MYLAN, LDA PT
Etoricoxib Mylan 90 mg comprimidos revestidos por película
NL/H/3151/003 5689609 MYLAN, LDA PT
Etoricoxib Mylan 90 mg Film-coated Tablets
NL/H/3151/003 PL 04569/1466 GENERICS [UK] LIMITED UK
Etoricoxib Mylan 90 mg Filmtabletten
NL/H/3151/003 92027.00.00 GENERICS [UK] LIMITED DE
Etoricoxib Mylan 90 mg tabletti, kalvopäällysteinen
NL/H/3151/003 32282 MYLAN AB FI
Etoricoxib Mylan 90 mg, filmomhulde tabletten
NL/H/3151/003 RVG 115516 MYLAN B.V. NL
Etoricoxib Mylan 90 mg, filmomhulde tabletten
NL/H/3196/003 RVG 115520 MYLAN B.V. NL
Etoricoxib Normon 120 mg comprimidos revestidos por película
ES/H/0415/004/DC 5711635 LABORATÓRIOS NORMON, S.A.
PT
Etoricoxib Normon 120 mg comprimidos revestidos por película
ES/H/0415/004/DC 5711643 LABORATÓRIOS NORMON, S.A.
PT
List of nationally authorised medicinal products EMA/812634/2017 Page 113/231
Product Name (in authorisation country)
MRP/DCP Authorisation Number
National Authorisation Number
MAH of product in the Member State
Member State where product is authorised
Etoricoxib Normon 120 mg comprimidos revestidos por película
ES/H/0415/004/DC 5711650 LABORATÓRIOS NORMON, S.A.
PT
Etoricoxib Normon 30 mg comprimidos revestidos por película
ES/H/0415/001/DC 5710967 LABORATÓRIOS NORMON, S.A.
ES
Etoricoxib Normon 30 mg comprimidos revestidos por película
ES/H/0415/001/DC 5710975 LABORATÓRIOS NORMON, S.A.
ES
Etoricoxib Normon 30 mg comprimidos revestidos por película
ES/H/0415/001/DC 5710959 LABORATÓRIOS NORMON, S.A.
ES
Etoricoxib Normon 60 mg comprimidos revestidos por película
ES/H/0415/001/DC 5711577 LABORATÓRIOS NORMON, S.A.
ES
Etoricoxib Normon 60 mg comprimidos revestidos por película
ES/H/0415/002/DC 5711551 LABORATÓRIOS NORMON, S.A.
ES
Etoricoxib Normon 60 mg comprimidos revestidos por película
ES/H/0415/002/DC 5711569 LABORATÓRIOS NORMON, S.A.
PT
Etoricoxib Normon 90 mg comprimidos revestidos por película
ES/H/0415/003 5711601 LABORATÓRIOS NORMON, S.A.
PT
Etoricoxib Normon 90 mg comprimidos revestidos por película
ES/H/0415/003 5711619 LABORATÓRIOS NORMON, S.A.
PT
List of nationally authorised medicinal products EMA/812634/2017 Page 114/231
Product Name (in authorisation country)
MRP/DCP Authorisation Number
National Authorisation Number
MAH of product in the Member State
Member State where product is authorised
Etoricoxib Normon 90 mg comprimidos revestidos por película
ES/H/0415/003 5711627 LABORATÓRIOS NORMON, S.A.
PT
Etoricoxib Orion 120 mg filmdragerade tabletter
SE/H/1554/004 33618 ORION CORPORATION FI
Etoricoxib Orion 120 mg filmdragerade tabletter
SE/H/1554/004 53358 ORION CORPORATION SE
Etoricoxib Orion 120 mg filmdrasjerte tabletter
SE/H/1554/004 15-10838 ORION CORPORATION NO
Etoricoxib Orion 120 mg kalvopäällysteiset tabletit
SE/H/1554/004 33618 ORION CORPORATION FI
Etoricoxib Orion 30 mg filmdragerade tabletter
SE/H/1554/001 33615 ORION CORPORATION FI
Etoricoxib Orion 30 mg filmdragerade tabletter
SE/H/1554/001 53355 ORION CORPORATION SE
Etoricoxib Orion 30 mg filmdrasjerte tabletter
SE/H/1554/001 15-10835 ORION CORPORATION NO
Etoricoxib Orion 30 mg kalvopäällysteiset tabletit
SE/H/1554/001 33615 ORION CORPORATION FI
Etoricoxib Orion 60 mg filmdragerade tabletter
SE/H/1554/002 33616 ORION CORPORATION FI
Etoricoxib Orion 60 mg filmdragerade tabletter
SE/H/1554/002 53356 ORION CORPORATION SE
Etoricoxib Orion 60 mg filmdrasjerte tabletter
SE/H/1554/002 15-10836 ORION CORPORATION NO
Etoricoxib Orion 60 mg kalvopäällysteiset tabletit
SE/H/1554/002 33616 ORION CORPORATION FI
Etoricoxib Orion 90 mg filmdragerade tabletter
SE/H/1554/003 33617 ORION CORPORATION FI
List of nationally authorised medicinal products EMA/812634/2017 Page 115/231
Product Name (in authorisation country)
MRP/DCP Authorisation Number
National Authorisation Number
MAH of product in the Member State
Member State where product is authorised
Etoricoxib Orion 90 mg filmdragerade tabletter
SE/H/1554/003 53357 ORION CORPORATION SE
Etoricoxib Orion 90 mg filmdrasjerte tabletter
SE/H/1554/003 15-10837 ORION CORPORATION NO
Etoricoxib Orion 90 mg kalvopäällysteiset tabletit
SE/H/1554/003 33617 ORION CORPORATION FI
Etoricoxib Pensa 120 mg compresse rivestite con film
PT/H/1714/002-004 45220098 PENSA PHARMA S.P.A. IT
Etoricoxib Pensa 120 mg compresse rivestite con film
PT/H/1714/002-004 45220086 PENSA PHARMA S.P.A. IT
Etoricoxib Pensa 120 mg compresse rivestite con film
PT/H/1714/002-004 45220074 PENSA PHARMA S.P.A. IT
Etoricoxib pensa 120 mg comprimidos recubiertos con película EFG
PT/H/1714/004 81.754 PENSA PHARMA, S.A ES
Etoricoxib pensa 30 mg comprimidos recubiertos con película EFG
PT/H/1714/001 81.755 PENSA PHARMA, S.A ES
Etoricoxib Pensa 60 mg compresse rivestite con film
PT/H/1714/002-004 45220011 PENSA PHARMA S.P.A. IT
Etoricoxib Pensa 60 mg compresse rivestite con film
PT/H/1714/002-004 45220023 PENSA PHARMA S.P.A. IT
Etoricoxib Pensa 60 mg compresse rivestite con film
PT/H/1714/002-004 45220035 PENSA PHARMA S.P.A. IT
Etoricoxib pensa 60 mg comprimidos recubiertos con película EFG
PT/H/1714/002 81.756 PENSA PHARMA, S.A ES
Etoricoxib Pensa 90 mg compresse rivestite con film
PT/H/1714/002-004 45220050 PENSA PHARMA S.P.A. IT
List of nationally authorised medicinal products EMA/812634/2017 Page 116/231
Product Name (in authorisation country)
MRP/DCP Authorisation Number
National Authorisation Number
MAH of product in the Member State
Member State where product is authorised
Etoricoxib Pensa 90 mg compresse rivestite con film
PT/H/1714/002-004 45220062 PENSA PHARMA S.P.A. IT
Etoricoxib Pensa 90 mg compresse rivestite con film
PT/H/1714/002-004 45220047 PENSA PHARMA S.P.A. IT
Etoricoxib pensa 90 mg comprimidos recubiertos con película EFG
PT/H/1714/003 81.757 PENSA PHARMA, S.A ES
Etoricoxib Pentafarma 120 mg comprimidos revestidos por película
not available 5693700 PENTAFARMA - SOCIEDADE TECNICO-MEDICINAL S.A.
PT
Etoricoxib Pentafarma 120 mg comprimidos revestidos por película
not available 5693718 PENTAFARMA - SOCIEDADE TECNICO-MEDICINAL S.A.
PT
Etoricoxib Pentafarma 120 mg comprimidos revestidos por película
not available 16/H/0029/004 PENTAFARMA - SOCIEDADE TECNICO-MEDICINAL S.A.
PT
Etoricoxib Pentafarma 120 mg comprimidos revestidos por película
not available 16/H/0029/004 PENTAFARMA - SOCIEDADE TECNICO-MEDICINAL S.A.
PT
Etoricoxib Pentafarma 30 mg comprimidos revestidos por película
not available 5693627 PENTAFARMA - SOCIEDADE TECNICO-MEDICINAL S.A.
PT
Etoricoxib Pentafarma 30 mg comprimidos revestidos por película
not available 5693635 PENTAFARMA - SOCIEDADE TECNICO-MEDICINAL S.A.
PT
Etoricoxib Pentafarma 30 mg comprimidos revestidos por película
not available 16/H/0029/001 PENTAFARMA - SOCIEDADE TECNICO-MEDICINAL S.A.
PT
List of nationally authorised medicinal products EMA/812634/2017 Page 117/231
Product Name (in authorisation country)
MRP/DCP Authorisation Number
National Authorisation Number
MAH of product in the Member State
Member State where product is authorised
Etoricoxib Pentafarma 30 mg comprimidos revestidos por película
not available 16/H/0029/001 PENTAFARMA - SOCIEDADE TECNICO-MEDICINAL S.A.
PT
Etoricoxib Pentafarma 60 mg comprimidos revestidos por película
not available 5693643 PENTAFARMA - SOCIEDADE TECNICO-MEDICINAL S.A.
PT
Etoricoxib Pentafarma 60 mg comprimidos revestidos por película
not available 5693650 PENTAFARMA - SOCIEDADE TECNICO-MEDICINAL S.A.
PT
Etoricoxib Pentafarma 60 mg comprimidos revestidos por película
not available 16/H/0029/002 PENTAFARMA - SOCIEDADE TECNICO-MEDICINAL S.A.
PT
Etoricoxib Pentafarma 60 mg comprimidos revestidos por película
not available 16/H/0029/002 PENTAFARMA - SOCIEDADE TECNICO-MEDICINAL S.A.
PT
Etoricoxib Pentafarma 90 mg comprimidos revestidos por película
not available 5693668 PENTAFARMA - SOCIEDADE TECNICO-MEDICINAL S.A.
PT
Etoricoxib Pentafarma 90 mg comprimidos revestidos por película
not available 5693676 PENTAFARMA - SOCIEDADE TECNICO-MEDICINAL S.A.
PT
Etoricoxib Pentafarma 90 mg comprimidos revestidos por película
not available 16/H/0029/003 PENTAFARMA - SOCIEDADE TECNICO-MEDICINAL S.A.
PT
Etoricoxib Pentafarma 90 mg comprimidos revestidos por película
not available 16/H/0029/003 PENTAFARMA - SOCIEDADE TECNICO-MEDICINAL S.A.
PT
Etoricoxib PharmaSwiss 120 mg comprimate filmate
NL/H/3267/003 8575/2016/01 PHARMASWISS ČESKÁ REPUBLIKA S.R.O.
RO
List of nationally authorised medicinal products EMA/812634/2017 Page 118/231
Product Name (in authorisation country)
MRP/DCP Authorisation Number
National Authorisation Number
MAH of product in the Member State
Member State where product is authorised
Etoricoxib PharmaSwiss 120 mg comprimate filmate
NL/H/3267/003 8575/2016/02 PHARMASWISS ČESKÁ REPUBLIKA S.R.O.
RO
Etoricoxib PharmaSwiss 120 mg comprimate filmate
NL/H/3267/003 8575/2016/03 PHARMASWISS ČESKÁ REPUBLIKA S.R.O.
RO
Etoricoxib PharmaSwiss 120 mg comprimate filmate
NL/H/3267/003 8575/2016/04 PHARMASWISS ČESKÁ REPUBLIKA S.R.O.
RO
Etoricoxib PharmaSwiss 120 mg comprimate filmate
NL/H/3267/003 8575/2016/05 PHARMASWISS ČESKÁ REPUBLIKA S.R.O.
RO
Etoricoxib PharmaSwiss 120 mg comprimate filmate
NL/H/3267/003 8575/2016/06 PHARMASWISS ČESKÁ REPUBLIKA S.R.O.
RO
Etoricoxib PharmaSwiss 120 mg comprimate filmate
NL/H/3267/003 8575/2016/07 PHARMASWISS ČESKÁ REPUBLIKA S.R.O.
RO
Etoricoxib PharmaSwiss 120 mg comprimate filmate
NL/H/3267/003 8575/2016/08 PHARMASWISS ČESKÁ REPUBLIKA S.R.O.
RO
Etoricoxib PharmaSwiss 120 mg comprimate filmate
NL/H/3267/003 8575/2016/09 PHARMASWISS ČESKÁ REPUBLIKA S.R.O.
RO
Etoricoxib PharmaSwiss 120 mg comprimate filmate
NL/H/3267/003 8575/2016/10 PHARMASWISS ČESKÁ REPUBLIKA S.R.O.
RO
Etoricoxib PharmaSwiss 120 mg comprimate filmate
NL/H/3267/003 8575/2016/11 PHARMASWISS ČESKÁ REPUBLIKA S.R.O.
RO
Etoricoxib PharmaSwiss 120 mg comprimate filmate
NL/H/3267/003 8575/2016/12 PHARMASWISS ČESKÁ REPUBLIKA S.R.O.
RO
Etoricoxib PharmaSwiss 120 mg comprimate filmate
NL/H/3267/003 8575/2016/13 PHARMASWISS ČESKÁ REPUBLIKA S.R.O.
RO
Etoricoxib PharmaSwiss 120 mg comprimate filmate
NL/H/3267/003 8575/2016/14 PHARMASWISS ČESKÁ REPUBLIKA S.R.O.
RO
Etoricoxib PharmaSwiss 120 mg comprimate filmate
NL/H/3267/003 8575/2016/15 PHARMASWISS ČESKÁ REPUBLIKA S.R.O.
RO
List of nationally authorised medicinal products EMA/812634/2017 Page 119/231
Product Name (in authorisation country)
MRP/DCP Authorisation Number
National Authorisation Number
MAH of product in the Member State
Member State where product is authorised
Etoricoxib PharmaSwiss 120 mg comprimate filmate
NL/H/3267/003 8575/2016/16 PHARMASWISS ČESKÁ REPUBLIKA S.R.O.
RO
Etoricoxib PharmaSwiss 120 mg comprimate filmate
NL/H/3267/003 8575/2016/17 PHARMASWISS ČESKÁ REPUBLIKA S.R.O.
RO
Etoricoxib PharmaSwiss 60 mg comprimate filmate
NL/H/3267/001 8573/2016/01 PHARMASWISS ČESKÁ REPUBLIKA S.R.O.
RO
Etoricoxib PharmaSwiss 60 mg comprimate filmate
NL/H/3267/001 8573/2016/02 PHARMASWISS ČESKÁ REPUBLIKA S.R.O.
RO
Etoricoxib PharmaSwiss 60 mg comprimate filmate
NL/H/3267/001 8573/2016/03 PHARMASWISS ČESKÁ REPUBLIKA S.R.O.
RO
Etoricoxib PharmaSwiss 60 mg comprimate filmate
NL/H/3267/001 8573/2016/04 PHARMASWISS ČESKÁ REPUBLIKA S.R.O.
RO
Etoricoxib PharmaSwiss 60 mg comprimate filmate
NL/H/3267/001 8573/2016/05 PHARMASWISS ČESKÁ REPUBLIKA S.R.O.
RO
Etoricoxib PharmaSwiss 60 mg comprimate filmate
NL/H/3267/001 8573/2016/06 PHARMASWISS ČESKÁ REPUBLIKA S.R.O.
RO
Etoricoxib PharmaSwiss 60 mg comprimate filmate
NL/H/3267/001 8573/2016/07 PHARMASWISS ČESKÁ REPUBLIKA S.R.O.
RO
Etoricoxib PharmaSwiss 60 mg comprimate filmate
NL/H/3267/001 8573/2016/08 PHARMASWISS ČESKÁ REPUBLIKA S.R.O.
RO
Etoricoxib PharmaSwiss 60 mg comprimate filmate
NL/H/3267/001 8573/2016/09 PHARMASWISS ČESKÁ REPUBLIKA S.R.O.
RO
Etoricoxib PharmaSwiss 60 mg comprimate filmate
NL/H/3267/001 8573/2016/10 PHARMASWISS ČESKÁ REPUBLIKA S.R.O.
RO
Etoricoxib PharmaSwiss 60 mg comprimate filmate
NL/H/3267/001 8573/2016/11 PHARMASWISS ČESKÁ REPUBLIKA S.R.O.
RO
Etoricoxib PharmaSwiss 60 mg comprimate filmate
NL/H/3267/001 8573/2016/12 PHARMASWISS ČESKÁ REPUBLIKA S.R.O.
RO
List of nationally authorised medicinal products EMA/812634/2017 Page 120/231
Product Name (in authorisation country)
MRP/DCP Authorisation Number
National Authorisation Number
MAH of product in the Member State
Member State where product is authorised
Etoricoxib PharmaSwiss 60 mg comprimate filmate
NL/H/3267/001 8573/2016/13 PHARMASWISS ČESKÁ REPUBLIKA S.R.O.
RO
Etoricoxib PharmaSwiss 60 mg comprimate filmate
NL/H/3267/001 8573/2016/14 PHARMASWISS ČESKÁ REPUBLIKA S.R.O.
RO
Etoricoxib PharmaSwiss 60 mg comprimate filmate
NL/H/3267/001 8573/2016/15 PHARMASWISS ČESKÁ REPUBLIKA S.R.O.
RO
Etoricoxib PharmaSwiss 60 mg comprimate filmate
NL/H/3267/001 8573/2016/16 PHARMASWISS ČESKÁ REPUBLIKA S.R.O.
RO
Etoricoxib PharmaSwiss 60 mg comprimate filmate
NL/H/3267/001 8573/2016/17 PHARMASWISS ČESKÁ REPUBLIKA S.R.O.
RO
Etoricoxib PharmaSwiss 90 mg comprimate filmate
NL/H/3267/002 8574/2016/01 PHARMASWISS ČESKÁ REPUBLIKA S.R.O.
RO
Etoricoxib PharmaSwiss 90 mg comprimate filmate
NL/H/3267/002 8574/2016/02 PHARMASWISS ČESKÁ REPUBLIKA S.R.O.
RO
Etoricoxib PharmaSwiss 90 mg comprimate filmate
NL/H/3267/002 8574/2016/03 PHARMASWISS ČESKÁ REPUBLIKA S.R.O.
RO
Etoricoxib PharmaSwiss 90 mg comprimate filmate
NL/H/3267/002 8574/2016/04 PHARMASWISS ČESKÁ REPUBLIKA S.R.O.
RO
Etoricoxib PharmaSwiss 90 mg comprimate filmate
NL/H/3267/002 8574/2016/05 PHARMASWISS ČESKÁ REPUBLIKA S.R.O.
RO
Etoricoxib PharmaSwiss 90 mg comprimate filmate
NL/H/3267/002 8574/2016/06 PHARMASWISS ČESKÁ REPUBLIKA S.R.O.
RO
Etoricoxib PharmaSwiss 90 mg comprimate filmate
NL/H/3267/002 8574/2016/07 PHARMASWISS ČESKÁ REPUBLIKA S.R.O.
RO
Etoricoxib PharmaSwiss 90 mg comprimate filmate
NL/H/3267/002 8574/2016/08 PHARMASWISS ČESKÁ REPUBLIKA S.R.O.
RO
Etoricoxib PharmaSwiss 90 mg comprimate filmate
NL/H/3267/002 8574/2016/09 PHARMASWISS ČESKÁ REPUBLIKA S.R.O.
RO
List of nationally authorised medicinal products EMA/812634/2017 Page 121/231
Product Name (in authorisation country)
MRP/DCP Authorisation Number
National Authorisation Number
MAH of product in the Member State
Member State where product is authorised
Etoricoxib PharmaSwiss 90 mg comprimate filmate
NL/H/3267/002 8574/2016/10 PHARMASWISS ČESKÁ REPUBLIKA S.R.O.
RO
Etoricoxib PharmaSwiss 90 mg comprimate filmate
NL/H/3267/002 8574/2016/11 PHARMASWISS ČESKÁ REPUBLIKA S.R.O.
RO
Etoricoxib PharmaSwiss 90 mg comprimate filmate
NL/H/3267/002 8574/2016/12 PHARMASWISS ČESKÁ REPUBLIKA S.R.O.
RO
Etoricoxib PharmaSwiss 90 mg comprimate filmate
NL/H/3267/002 8574/2016/13 PHARMASWISS ČESKÁ REPUBLIKA S.R.O.
RO
Etoricoxib PharmaSwiss 90 mg comprimate filmate
NL/H/3267/002 8574/2016/14 PHARMASWISS ČESKÁ REPUBLIKA S.R.O.
RO
Etoricoxib PharmaSwiss 90 mg comprimate filmate
NL/H/3267/002 8574/2016/15 PHARMASWISS ČESKÁ REPUBLIKA S.R.O.
RO
Etoricoxib PharmaSwiss 90 mg comprimate filmate
NL/H/3267/002 8574/2016/16 PHARMASWISS ČESKÁ REPUBLIKA S.R.O.
RO
Etoricoxib PharmaSwiss 90 mg comprimate filmate
NL/H/3267/002 8574/2016/17 PHARMASWISS ČESKÁ REPUBLIKA S.R.O.
RO
Etoricoxib PharOS PT/H/1374/001 PT/H/1374/001 PHAROS - PHARMACEUTICAL ORIENTED SERVICES LIMITED
PT
Etoricoxib PharOS PT/H/1374/002 PT/H/1374/002 PHAROS - PHARMACEUTICAL ORIENTED SERVICES LIMITED
PT
Etoricoxib PharOS PT/H/1374/003 PT/H/1374/003 PHAROS - PHARMACEUTICAL ORIENTED SERVICES LIMITED
PT
List of nationally authorised medicinal products EMA/812634/2017 Page 122/231
Product Name (in authorisation country)
MRP/DCP Authorisation Number
National Authorisation Number
MAH of product in the Member State
Member State where product is authorised
Etoricoxib PharOS PT/H/1374/004 PT/H/1374/004 PHAROS - PHARMACEUTICAL ORIENTED SERVICES LIMITED
PT
Etoricoxib PUREN 120 mg Filmtabletten
PT/H/1603/004 97036.00.00 PUREN PHARMA GMBH & CO. KG
DE
Etoricoxib PUREN 30 mg Filmtabletten
PT/H/1603/001 97033.00.00 PUREN PHARMA GMBH & CO. KG
DE
Etoricoxib PUREN 60 mg Filmtabletten
PT/H/1603/002 97034.00.00 PUREN PHARMA GMBH & CO. KG
DE
Etoricoxib PUREN 90 mg Filmtabletten
PT/H/1603/003 97035.00.00 PUREN PHARMA GMBH & CO. KG
DE
Etoricoxib ratiopharm 120 mg comprimidos recubiertos con película EFG
DE/H/5032/004 80964 RATIOPHARM ESPANA SA ES
Etoricoxib ratiopharm 120 mg comprimidos revestidos por película
DE/H/5032/004 5674650 RATIOPHARM-COMERCIO E INDUSTRIA DE PRODUTOS FARMACEUTICOS LDA
PT
Etoricoxib ratiopharm 120 mg comprimidos revestidos por película
DE/H/5032/004 5674643 RATIOPHARM-COMERCIO E INDUSTRIA DE PRODUTOS FARMACEUTICOS LDA
PT
Etoricoxib ratiopharm 120 mg filmdragerade tabletter
DE/H/5032/004 32500 RATIOPHARM GMBH FI
Etoricoxib ratiopharm 120 mg filmuhúðaðar töflur.
DE/H/5032/004 IS/1/16/102/04 RATIOPHARM GMBH IS
Etoricoxib ratiopharm 120 mg tabletti, kalvopäällysteinen
DE/H/5032/004 32500 RATIOPHARM GMBH FI
List of nationally authorised medicinal products EMA/812634/2017 Page 123/231
Product Name (in authorisation country)
MRP/DCP Authorisation Number
National Authorisation Number
MAH of product in the Member State
Member State where product is authorised
Etoricoxib ratiopharm 30 mg comprimidos recubiertos con película EFG
DE/H/5032/001 80961 RATIOPHARM ESPANA SA ES
Etoricoxib ratiopharm 30 mg comprimidos revestidos por película
DE/H/5032/001 5674601 RATIOPHARM-COMERCIO E INDUSTRIA DE PRODUTOS FARMACEUTICOS LDA
PT
Etoricoxib ratiopharm 30 mg comprimidos revestidos por película
DE/H/5032/001 5674577 RATIOPHARM-COMERCIO E INDUSTRIA DE PRODUTOS FARMACEUTICOS LDA
PT
Etoricoxib ratiopharm 30 mg filmdragerade tabletter
DE/H/5032/001 32497 RATIOPHARM GMBH FI
Etoricoxib ratiopharm 30 mg filmuhúðaðar töflur.
DE/H/5032/001 IS/1/16/102/01 RATIOPHARM GMBH IS
Etoricoxib ratiopharm 30 mg tabletti, kalvopäällysteinen
DE/H/5032/001 32497 RATIOPHARM GMBH FI
Etoricoxib ratiopharm 60 mg comprimidos recubiertos con película EFG
DE/H/5032/002 80962 RATIOPHARM ESPANA SA ES
Etoricoxib ratiopharm 60 mg comprimidos revestidos por película
DE/H/5032/002 5674619 RATIOPHARM-COMERCIO E INDUSTRIA DE PRODUTOS FARMACEUTICOS LDA
PT
Etoricoxib ratiopharm 60 mg comprimidos revestidos por película
DE/H/5032/002 5674627 RATIOPHARM-COMERCIO E INDUSTRIA DE PRODUTOS FARMACEUTICOS LDA
PT
Etoricoxib ratiopharm 60 mg comprimidos revestidos por película
DE/H/5032/002 5687157 RATIOPHARM-COMERCIO E INDUSTRIA DE PRODUTOS FARMACEUTICOS LDA
PT
Etoricoxib ratiopharm 60 mg filmdragerade tabletter
DE/H/5032/002 32498 RATIOPHARM GMBH FI
List of nationally authorised medicinal products EMA/812634/2017 Page 124/231
Product Name (in authorisation country)
MRP/DCP Authorisation Number
National Authorisation Number
MAH of product in the Member State
Member State where product is authorised
Etoricoxib ratiopharm 60 mg filmuhúðaðar töflur.
DE/H/5032/002 IS/1/16/102/02 RATIOPHARM GMBH IS
Etoricoxib ratiopharm 60 mg tabletti, kalvopäällysteinen
DE/H/5032/002 32498 RATIOPHARM GMBH FI
Etoricoxib ratiopharm 90 mg comprimidos recubiertos con película EFG
DE/H/5032/003 80963 RATIOPHARM ESPANA SA ES
Etoricoxib ratiopharm 90 mg comprimidos revestidos por película
DE/H/5032/003 5674809 RATIOPHARM-COMERCIO E INDUSTRIA DE PRODUTOS FARMACEUTICOS LDA
PT
Etoricoxib ratiopharm 90 mg comprimidos revestidos por película
DE/H/5032/003 5674635 RATIOPHARM-COMERCIO E INDUSTRIA DE PRODUTOS FARMACEUTICOS LDA
PT
Etoricoxib ratiopharm 90 mg comprimidos revestidos por película
DE/H/5032/003 5687165 RATIOPHARM-COMERCIO E INDUSTRIA DE PRODUTOS FARMACEUTICOS LDA
PT
Etoricoxib ratiopharm 90 mg filmdragerade tabletter
DE/H/5032/003 32499 RATIOPHARM GMBH FI
Etoricoxib ratiopharm 90 mg filmuhúðaðar töflur.
DE/H/5032/003 IS/1/16/102/03 RATIOPHARM GMBH IS
Etoricoxib ratiopharm 90 mg tabletti, kalvopäällysteinen
DE/H/5032/003 32499 RATIOPHARM GMBH FI
Etoricoxib Rontis 120mg Επικαλυμμένα με λεπτό υμένιο δισκία
PT/H/1375/001-004/DC 100427/14 RONTIS HELLAS SA GR
Etoricoxib Rontis 120mg Επικαλυμμένα με λεπτό υμένιο δισκία
PT/H/1375/001-004/DC 100427/14 RONTIS HELLAS SA GR
List of nationally authorised medicinal products EMA/812634/2017 Page 125/231
Product Name (in authorisation country)
MRP/DCP Authorisation Number
National Authorisation Number
MAH of product in the Member State
Member State where product is authorised
Etoricoxib Rontis 30mg Επικαλυμμένα με λεπτό υμένιο δισκία
PT/H/1375/001-004/DC 100431/14 RONTIS HELLAS SA GR
Etoricoxib Rontis 30mg Επικαλυμμένα με λεπτό υμένιο δισκία
PT/H/1375/001-004/DC 100431/14 RONTIS HELLAS SA GR
Etoricoxib Rontis 60mg Επικαλυμμένα με λεπτό υμένιο δισκία
PT/H/1375/001-004/DC 100429/14 RONTIS HELLAS SA GR
Etoricoxib Rontis 60mg Επικαλυμμένα με λεπτό υμένιο δισκία
PT/H/1375/001-004/DC 100429/14 RONTIS HELLAS SA GR
Etoricoxib Rontis 90mg Επικαλυμμένα με λεπτό υμένιο δισκία
PT/H/1375/001-004/DC 100428/14 RONTIS HELLAS SA GR
Etoricoxib Rontis 90mg Επικαλυμμένα με λεπτό υμένιο δισκία
PT/H/1375/001-004/DC 100428/14 RONTIS HELLAS SA GR
ETORICOXIB SANDOZ DE/H/3909/002 043004112 SANDOZ S.P.A. IT ETORICOXIB SANDOZ DE/H/3909/002 043004124 SANDOZ S.P.A. IT ETORICOXIB SANDOZ DE/H/3909/002 043004136 SANDOZ S.P.A. IT ETORICOXIB SANDOZ DE/H/3909/002 043004148 SANDOZ S.P.A. IT ETORICOXIB SANDOZ DE/H/3909/002 043004151 SANDOZ S.P.A. IT ETORICOXIB SANDOZ DE/H/3909/002 043004163 SANDOZ S.P.A. IT ETORICOXIB SANDOZ DE/H/3909/002 043004175 SANDOZ S.P.A. IT ETORICOXIB SANDOZ DE/H/3909/002 043004187 SANDOZ S.P.A. IT ETORICOXIB SANDOZ DE/H/3909/002 043004199 SANDOZ S.P.A. IT ETORICOXIB SANDOZ DE/H/3909/002 043004201 SANDOZ S.P.A. IT ETORICOXIB SANDOZ DE/H/3909/003 043004213 SANDOZ S.P.A. IT
List of nationally authorised medicinal products EMA/812634/2017 Page 126/231
Product Name (in authorisation country)
MRP/DCP Authorisation Number
National Authorisation Number
MAH of product in the Member State
Member State where product is authorised
ETORICOXIB SANDOZ DE/H/3909/003 043004225 SANDOZ S.P.A. IT ETORICOXIB SANDOZ DE/H/3909/003 043004237 SANDOZ S.P.A. IT ETORICOXIB SANDOZ DE/H/3909/003 043004249 SANDOZ S.P.A. IT ETORICOXIB SANDOZ DE/H/3909/003 043004252 SANDOZ S.P.A. IT ETORICOXIB SANDOZ DE/H/3909/003 043004264 SANDOZ S.P.A. IT ETORICOXIB SANDOZ DE/H/3909/003 043004276 SANDOZ S.P.A. IT ETORICOXIB SANDOZ DE/H/3909/003 043004288 SANDOZ S.P.A. IT ETORICOXIB SANDOZ DE/H/3909/003 043004290 SANDOZ S.P.A. IT ETORICOXIB SANDOZ DE/H/3909/003 043004302 SANDOZ S.P.A. IT ETORICOXIB SANDOZ DE/H/3909/004 043004314 SANDOZ S.P.A. IT ETORICOXIB SANDOZ DE/H/3909/004 043004326 SANDOZ S.P.A. IT ETORICOXIB SANDOZ DE/H/3909/004 043004338 SANDOZ S.P.A. IT ETORICOXIB SANDOZ DE/H/3909/004 043004340 SANDOZ S.P.A. IT ETORICOXIB SANDOZ DE/H/3909/004 043004353 SANDOZ S.P.A. IT ETORICOXIB SANDOZ DE/H/3909/004 043004365 SANDOZ S.P.A. IT ETORICOXIB SANDOZ DE/H/3909/004 043004377 SANDOZ S.P.A. IT ETORICOXIB SANDOZ DE/H/3909/004 043004389 SANDOZ S.P.A. IT ETORICOXIB SANDOZ DE/H/3909/004 043004391 SANDOZ S.P.A. IT ETORICOXIB SANDOZ DE/H/3909/004 043004403 SANDOZ S.P.A. IT ETORICOXIB SANDOZ DE/H/3909/001 043004011 SANDOZ S.P.A. IT ETORICOXIB SANDOZ DE/H/3909/001 043004023 SANDOZ S.P.A. IT ETORICOXIB SANDOZ DE/H/3909/001 043004035 SANDOZ S.P.A. IT ETORICOXIB SANDOZ DE/H/3909/001 043004047 SANDOZ S.P.A. IT ETORICOXIB SANDOZ DE/H/3909/001 043004050 SANDOZ S.P.A. IT ETORICOXIB SANDOZ DE/H/3909/001 043004062 SANDOZ S.P.A. IT ETORICOXIB SANDOZ DE/H/3909/001 043004074 SANDOZ S.P.A. IT ETORICOXIB SANDOZ DE/H/3909/001 043004086 SANDOZ S.P.A. IT ETORICOXIB SANDOZ DE/H/3909/001 043004098 SANDOZ S.P.A. IT
List of nationally authorised medicinal products EMA/812634/2017 Page 127/231
Product Name (in authorisation country)
MRP/DCP Authorisation Number
National Authorisation Number
MAH of product in the Member State
Member State where product is authorised
ETORICOXIB SANDOZ DE/H/3909/001 043004100 SANDOZ S.P.A. IT Etoricoxib Sandoz DE/H/3908/001 NONE SANDOZ FARMACÊUTICA
LDA. PT
Etoricoxib Sandoz DE/H/3908/002 5659651 SANDOZ FARMACÊUTICA LDA.
PT
Etoricoxib Sandoz DE/H/3908/002 5659669 SANDOZ FARMACÊUTICA LDA.
PT
Etoricoxib Sandoz DE/H/3908/002 5659677 SANDOZ FARMACÊUTICA LDA.
PT
Etoricoxib Sandoz DE/H/3908/003 5659610 SANDOZ FARMACÊUTICA LDA.
PT
Etoricoxib Sandoz DE/H/3908/003 5659628 SANDOZ FARMACÊUTICA LDA.
PT
Etoricoxib Sandoz DE/H/3908/003 5659636 SANDOZ FARMACÊUTICA LDA.
PT
Etoricoxib Sandoz DE/H/3908/003 5659644 SANDOZ FARMACÊUTICA LDA.
PT
Etoricoxib Sandoz DE/H/3908/004 5659578 SANDOZ FARMACÊUTICA LDA.
PT
Etoricoxib Sandoz DE/H/3908/004 5659602 SANDOZ FARMACÊUTICA LDA.
PT
Etoricoxib Sandoz DE/H/3908/002 5659701 SANDOZ FARMACÊUTICA LDA.
PT
Etoricoxib Sandoz 120 mg – Filmtabletten
DE/H/3908/004 136589 SANDOZ GMBH AT
Etoricoxib Sandoz 120 mg comprimés pelliculés
DE/H/3908/004 2015120187 SANDOZ N.V. LU
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Product Name (in authorisation country)
MRP/DCP Authorisation Number
National Authorisation Number
MAH of product in the Member State
Member State where product is authorised
Etoricoxib Sandoz 120 mg comprimidos recubiertos con película EFG
DE/H/3908/004 80263 SANDOZ FARMACÉUTICA, S.A.
ES
Etoricoxib Sandoz 120 mg filmdragerade tabletter
DE/H/3908/004 49819 SANDOZ A/S SE
Etoricoxib Sandoz 120 mg filmdrasjerte tabletter
DE/H/3908/004 16/11062 SANDOZ A/S NO
Etoricoxib Sandoz 120 mg filmomhulde tabletten
DE/H/3908/004 BE472142 SANDOZ N.V. BE
Etoricoxib Sandoz 120 mg filmomhulde tabletten
DE/H/3908/004 BE472186 SANDOZ N.V. BE
Etoricoxib Sandoz 120 mg tabletti, kalvopäällysteinen
DE/H/3908/004 31733 SANDOZ A/S FI
Etoricoxib Sandoz 120 mg tabletti, kalvopäällysteinen
DE/H/3908/004 31733 SANDOZ A/S FI
Etoricoxib Sandoz 120 mg, filmomhulde tabletten
DE/H/3908/004 RVG 114111 SANDOZ B.V. NL
Etoricoxib Sandoz 30 mg – Filmtabletten
DE/H/3908/001 136586 SANDOZ GMBH AT
Etoricoxib Sandoz 30 mg comprimés pelliculés
DE/H/3908/001 2015120184 SANDOZ N.V. LU
Etoricoxib Sandoz 30 mg comprimidos recubiertos con película EFG
DE/H/3908/001 80265 SANDOZ FARMACÉUTICA, S.A.
ES
Etoricoxib Sandoz 30 mg filmdragerade tabletter
DE/H/3908/001 49816 SANDOZ A/S SE
Etoricoxib Sandoz 30 mg filmdrasjerte tabletter
DE/H/3908/001 16/11059 SANDOZ A/S NO
List of nationally authorised medicinal products EMA/812634/2017 Page 129/231
Product Name (in authorisation country)
MRP/DCP Authorisation Number
National Authorisation Number
MAH of product in the Member State
Member State where product is authorised
Etoricoxib Sandoz 30 mg filmomhulde tabletten
DE/H/3908/001 BE472115 SANDOZ N.V. BE
Etoricoxib Sandoz 30 mg filmomhulde tabletten
DE/H/3908/001 BE472151 SANDOZ N.V. BE
Etoricoxib Sandoz 30 mg filmomhulde tabletten
DE/H/3908/001 RVG 114108 SANDOZ B.V. NL
Etoricoxib Sandoz 30 mg tabletti, kalvopäällysteinen
DE/H/3908/001 31730 SANDOZ A/S FI
Etoricoxib Sandoz 30 mg, filmom obalené tablety
DE/H/3908/001 29/0324/16-S SANDOZ PHARMACEUTICALS D.D.
SK
Etoricoxib Sandoz 60 mg – Filmtabletten
DE/H/3908/002 136587 SANDOZ GMBH AT
Etoricoxib Sandoz 60 mg comprimés pelliculés
DE/H/3908/002 2015120185 SANDOZ N.V. LU
Etoricoxib Sandoz 60 mg comprimidos recubiertos con película EFG
DE/H/3908/002 80262 SANDOZ FARMACÉUTICA, S.A.
ES
Etoricoxib Sandoz 60 mg filmdragerade tabletter
DE/H/3908/002 49817 SANDOZ A/S SE
Etoricoxib Sandoz 60 mg filmdrasjerte tabletter
DE/H/3908/002 16/11060 SANDOZ A/S NO
Etoricoxib Sandoz 60 mg filmomhulde tabletten
DE/H/3908/002 BE472160 SANDOZ N.V. BE
Etoricoxib Sandoz 60 mg filmomhulde tabletten
DE/H/3908/002 BE472124 SANDOZ N.V. BE
Etoricoxib Sandoz 60 mg tabletti, kalvopäällysteinen
DE/H/3908/002 31731 SANDOZ A/S FI
Etoricoxib Sandoz 60 mg, filmomhulde tabletten
DE/H/3908/002 RVG 114109 SANDOZ B.V. NL
List of nationally authorised medicinal products EMA/812634/2017 Page 130/231
Product Name (in authorisation country)
MRP/DCP Authorisation Number
National Authorisation Number
MAH of product in the Member State
Member State where product is authorised
Etoricoxib Sandoz 90 mg – Filmtabletten
DE/H/3908/003 136588 SANDOZ GMBH AT
Etoricoxib Sandoz 90 mg comprimés pelliculés
DE/H/3908/003 2015120186 SANDOZ N.V. LU
Etoricoxib Sandoz 90 mg comprimidos recubiertos con película EFG
DE/H/3908/003 80264 SANDOZ FARMACÉUTICA, S.A.
ES
Etoricoxib Sandoz 90 mg filmdragerade tabletter
DE/H/3908/003 49818 SANDOZ A/S SE
Etoricoxib Sandoz 90 mg filmdrasjerte tabletter
DE/H/3908/003 16/11061 SANDOZ A/S NO
Etoricoxib Sandoz 90 mg filmomhulde tabletten
DE/H/3908/003 BE472177 SANDOZ N.V. BE
Etoricoxib Sandoz 90 mg filmomhulde tabletten
DE/H/3908/003 BE472133 SANDOZ N.V. BE
Etoricoxib Sandoz 90 mg tabletti, kalvopäällysteinen
DE/H/3908/003 31732 SANDOZ A/S FI
Etoricoxib Sandoz 90 mg, filmomhulde tabletten
DE/H/3908/003 RVG 114110 SANDOZ B.V. NL
Etoricoxib Sandoz Farmacêutica not available 5694047 SANDOZ FARMACÊUTICA LDA.
PT
Etoricoxib Sandoz Farmacêutica not available 5694054 SANDOZ FARMACÊUTICA LDA.
PT
Etoricoxib Sandoz Farmacêutica not available 5693940 SANDOZ FARMACÊUTICA LDA.
PT
Etoricoxib Sandoz Farmacêutica not available 5693957 SANDOZ FARMACÊUTICA LDA.
PT
Etoricoxib Sandoz Farmacêutica not available 5694021 SANDOZ FARMACÊUTICA LDA.
PT
List of nationally authorised medicinal products EMA/812634/2017 Page 131/231
Product Name (in authorisation country)
MRP/DCP Authorisation Number
National Authorisation Number
MAH of product in the Member State
Member State where product is authorised
Etoricoxib Sandoz Farmacêutica not available 5694039 SANDOZ FARMACÊUTICA LDA.
PT
Etoricoxib Sandoz Farmacêutica not available 5693965 SANDOZ FARMACÊUTICA LDA.
PT
Etoricoxib Sandoz Farmacêutica not available 5693973 SANDOZ FARMACÊUTICA LDA.
PT
Etoricoxib Sigillata 120 mg film-coated tablets
SE/H/1576/04 53672 SIGILLATA LIMITED SE
Etoricoxib Sigillata 30 mg film-coated tablets
SE/H/1576/01 53669 SIGILLATA LIMITED SE
Etoricoxib Sigillata 60 mg film-coated tablets
SE/H/1576/02 53670 SIGILLATA LIMITED SE
Etoricoxib Sigillata 90 mg film-coated tablets
SE/H/1576/03 53671 SIGILLATA LIMITED SE
Etoricoxib STADA 120 mg comprimate filmate
DE/H/4251/004 9357/2016/06 STADA ARZNEIMITTEL AG RO
Etoricoxib STADA 120 mg comprimate filmate
DE/H/4251/004 9357/2016/01 STADA ARZNEIMITTEL AG RO
Etoricoxib STADA 120 mg comprimate filmate
DE/H/4251/004 9357/2016/07 STADA ARZNEIMITTEL AG RO
Etoricoxib STADA 120 mg comprimate filmate
DE/H/4251/004 9357/2016/02 STADA ARZNEIMITTEL AG RO
Etoricoxib STADA 120 mg comprimate filmate
DE/H/4251/004 9357/2016/03 STADA ARZNEIMITTEL AG RO
Etoricoxib STADA 120 mg comprimate filmate
DE/H/4251/004 9357/2016/04 STADA ARZNEIMITTEL AG RO
Etoricoxib STADA 120 mg comprimate filmate
DE/H/4251/004 9357/2016/05 STADA ARZNEIMITTEL AG RO
List of nationally authorised medicinal products EMA/812634/2017 Page 132/231
Product Name (in authorisation country)
MRP/DCP Authorisation Number
National Authorisation Number
MAH of product in the Member State
Member State where product is authorised
Etoricoxib STADA 120 mg comprimidos recubiertos con película EFG
DE/H/4251/004 81.220 LABORATORIO STADA, S.L. ES
Etoricoxib STADA 120 mg filmdragerade tabletter
DE/H/4251/004 51986 STADA ARZNEIMITTEL AG SE
Etoricoxib STADA 120 mg Filmtabletten
DE/H/4692/004 97254.00.00 STADAPHARM GMBH DE
Etoricoxib STADA 120 mg kalvopäällysteiset tabletit
DE/H/4251/004 32781 STADA ARZNEIMITTEL AG FI
Etoricoxib STADA 30 mg comprimate filmate
DE/H/4251/001 9354/2016/02 STADA ARZNEIMITTEL AG RO
Etoricoxib STADA 30 mg comprimate filmate
DE/H/4251/001 9354/2016/01 STADA ARZNEIMITTEL AG RO
Etoricoxib STADA 30 mg comprimate filmate
DE/H/4251/001 9354/2016/03 STADA ARZNEIMITTEL AG RO
Etoricoxib STADA 30 mg comprimate filmate
DE/H/4251/001 9354/2016/04 STADA ARZNEIMITTEL AG RO
Etoricoxib STADA 30 mg comprimidos recubiertos con película EFG
DE/H/4251/001 81.217 LABORATORIO STADA, S.L. ES
Etoricoxib STADA 30 mg filmdragerade tabletter
DE/H/4251/001 51983 STADA ARZNEIMITTEL AG SE
Etoricoxib STADA 30 mg Filmtabletten
DE/H/4692/001 97251.00.00 STADAPHARM GMBH DE
Etoricoxib STADA 30 mg kalvopäällysteiset tabletit
DE/H/4251/001 32778 STADA ARZNEIMITTEL AG FI
Etoricoxib STADA 60 mg comprimate filmate
DE/H/4251/002 9355/2016/01 STADA ARZNEIMITTEL AG RO
List of nationally authorised medicinal products EMA/812634/2017 Page 133/231
Product Name (in authorisation country)
MRP/DCP Authorisation Number
National Authorisation Number
MAH of product in the Member State
Member State where product is authorised
Etoricoxib STADA 60 mg comprimate filmate
DE/H/4251/002 9355/2016/06 STADA ARZNEIMITTEL AG RO
Etoricoxib STADA 60 mg comprimate filmate
DE/H/4251/002 9355/2016/07 STADA ARZNEIMITTEL AG RO
Etoricoxib STADA 60 mg comprimate filmate
DE/H/4251/002 9355/2016/08 STADA ARZNEIMITTEL AG RO
Etoricoxib STADA 60 mg comprimate filmate
DE/H/4251/002 9355/2016/04 STADA ARZNEIMITTEL AG RO
Etoricoxib STADA 60 mg comprimate filmate
DE/H/4251/002 9355/2016/03 STADA ARZNEIMITTEL AG RO
Etoricoxib STADA 60 mg comprimate filmate
DE/H/4251/002 9355/2016/10 STADA ARZNEIMITTEL AG RO
Etoricoxib STADA 60 mg comprimate filmate
DE/H/4251/002 9355/2016/09 STADA ARZNEIMITTEL AG RO
Etoricoxib STADA 60 mg comprimate filmate
DE/H/4251/002 9355/2016/05 STADA ARZNEIMITTEL AG RO
Etoricoxib STADA 60 mg comprimate filmate
DE/H/4251/002 9355/2016/02 STADA ARZNEIMITTEL AG RO
Etoricoxib STADA 60 mg comprimidos recubiertos con película EFG
DE/H/4251/002 81.218 LABORATORIO STADA, S.L. ES
Etoricoxib STADA 60 mg filmdragerade tabletter
DE/H/4251/002 51984 STADA ARZNEIMITTEL AG SE
Etoricoxib STADA 60 mg Filmtabletten
DE/H/4692/002 97252.00.00 STADAPHARM GMBH DE
Etoricoxib STADA 60 mg kalvopäällysteiset tabletit
DE/H/4251/002 32779 STADA ARZNEIMITTEL AG FI
Etoricoxib STADA 90 mg comprimate filmate
DE/H/4251/003 9356/2016/04 STADA ARZNEIMITTEL AG RO
List of nationally authorised medicinal products EMA/812634/2017 Page 134/231
Product Name (in authorisation country)
MRP/DCP Authorisation Number
National Authorisation Number
MAH of product in the Member State
Member State where product is authorised
Etoricoxib STADA 90 mg comprimate filmate
DE/H/4251/003 9356/2016/08 STADA ARZNEIMITTEL AG RO
Etoricoxib STADA 90 mg comprimate filmate
DE/H/4251/003 9356/2016/06 STADA ARZNEIMITTEL AG RO
Etoricoxib STADA 90 mg comprimate filmate
DE/H/4251/003 9356/2016/02 STADA ARZNEIMITTEL AG RO
Etoricoxib STADA 90 mg comprimate filmate
DE/H/4251/003 9356/2016/09 STADA ARZNEIMITTEL AG RO
Etoricoxib STADA 90 mg comprimate filmate
DE/H/4251/003 9356/2016/01 STADA ARZNEIMITTEL AG RO
Etoricoxib STADA 90 mg comprimate filmate
DE/H/4251/003 9356/2016/10 STADA ARZNEIMITTEL AG RO
Etoricoxib STADA 90 mg comprimate filmate
DE/H/4251/003 9356/2016/07 STADA ARZNEIMITTEL AG RO
Etoricoxib STADA 90 mg comprimate filmate
DE/H/4251/003 9356/2016/03 STADA ARZNEIMITTEL AG RO
Etoricoxib STADA 90 mg comprimate filmate
DE/H/4251/003 9356/2016/05 STADA ARZNEIMITTEL AG RO
Etoricoxib STADA 90 mg comprimidos recubiertos con película EFG
DE/H/4251/003 81.219 LABORATORIO STADA, S.L. ES
Etoricoxib STADA 90 mg filmdragerade tabletter
DE/H/4251/003 51985 STADA ARZNEIMITTEL AG SE
Etoricoxib STADA 90 mg Filmtabletten
DE/H/4692/003 97253.00.00 STADAPHARM GMBH DE
Etoricoxib STADA 90 mg kalvopäällysteiset tabletit
DE/H/4251/003 32780 STADA ARZNEIMITTEL AG FI
List of nationally authorised medicinal products EMA/812634/2017 Page 135/231
Product Name (in authorisation country)
MRP/DCP Authorisation Number
National Authorisation Number
MAH of product in the Member State
Member State where product is authorised
Etoricoxib Synthon 120 mg comprimidos recubiertos con película EFG
NL/H/3269/004 80672 SYNTHON BV ES
Etoricoxib Synthon 30 mg comprimidos recubiertos con película EFG
NL/H/3269/001 80673 SYNTHON BV ES
Etoricoxib Synthon 60 mg comprimidos recubiertos con película EFG
NL/H/3269/002 80674 SYNTHON BV ES
Etoricoxib Synthon 90 mg comprimidos recubiertos con película EFG
NL/H/3269/003 80675 SYNTHON BV ES
Etoricoxib Terapia 120 mg comprimate filmate
DE/H/4557/004 9919/2017/01 TERAPIA S.A. RO
Etoricoxib Terapia 120 mg comprimate filmate
DE/H/4557/004 9919/2017/02 TERAPIA S.A. RO
Etoricoxib Terapia 120 mg comprimate filmate
DE/H/4557/004 9919/2017/03 TERAPIA S.A. RO
Etoricoxib Terapia 120 mg comprimate filmate
DE/H/4557/004 9919/2017/04 TERAPIA S.A. RO
Etoricoxib Terapia 120 mg comprimate filmate
DE/H/4557/004 9919/2017/05 TERAPIA S.A. RO
Etoricoxib Terapia 120 mg comprimate filmate
DE/H/4557/004 9919/2017/06 TERAPIA S.A. RO
Etoricoxib Terapia 120 mg comprimate filmate
DE/H/4557/004 9919/2017/07 TERAPIA S.A. RO
Etoricoxib Terapia 120 mg comprimate filmate
DE/H/4557/004 9919/2017/08 TERAPIA S.A. RO
List of nationally authorised medicinal products EMA/812634/2017 Page 136/231
Product Name (in authorisation country)
MRP/DCP Authorisation Number
National Authorisation Number
MAH of product in the Member State
Member State where product is authorised
Etoricoxib Terapia 120 mg comprimate filmate
DE/H/4557/004 9919/2017/09 TERAPIA S.A. RO
Etoricoxib Terapia 120 mg comprimate filmate
DE/H/4557/004 9919/2017/10 TERAPIA S.A. RO
Etoricoxib Terapia 120 mg comprimate filmate
DE/H/4557/004 9919/2017/11 TERAPIA S.A. RO
Etoricoxib Terapia 30 mg comprimate filmate
DE/H/4557/001 9916/2017/01 TERAPIA S.A. RO
Etoricoxib Terapia 30 mg comprimate filmate
DE/H/4557/001 9916/2017/02 TERAPIA S.A. RO
Etoricoxib Terapia 30 mg comprimate filmate
DE/H/4557/001 9916/2017/03 TERAPIA S.A. RO
Etoricoxib Terapia 30 mg comprimate filmate
DE/H/4557/001 9916/2017/04 TERAPIA S.A. RO
Etoricoxib Terapia 30 mg comprimate filmate
DE/H/4557/001 9916/2017/05 TERAPIA S.A. RO
Etoricoxib Terapia 30 mg comprimate filmate
DE/H/4557/001 9916/2017/06 TERAPIA S.A. RO
Etoricoxib Terapia 30 mg comprimate filmate
DE/H/4557/001 9916/2017/07 TERAPIA S.A. RO
Etoricoxib Terapia 30 mg comprimate filmate
DE/H/4557/001 9916/2017/08 TERAPIA S.A. RO
Etoricoxib Terapia 30 mg comprimate filmate
DE/H/4557/001 9916/2017/09 TERAPIA S.A. RO
Etoricoxib Terapia 60 mg comprimate filmate
DE/H/4557/002 9917/2017/01 TERAPIA S.A. RO
Etoricoxib Terapia 60 mg comprimate filmate
DE/H/4557/002 9917/2017/02 TERAPIA S.A. RO
List of nationally authorised medicinal products EMA/812634/2017 Page 137/231
Product Name (in authorisation country)
MRP/DCP Authorisation Number
National Authorisation Number
MAH of product in the Member State
Member State where product is authorised
Etoricoxib Terapia 60 mg comprimate filmate
DE/H/4557/002 9917/2017/03 TERAPIA S.A. RO
Etoricoxib Terapia 60 mg comprimate filmate
DE/H/4557/002 9917/2017/04 TERAPIA S.A. RO
Etoricoxib Terapia 60 mg comprimate filmate
DE/H/4557/002 9917/2017/05 TERAPIA S.A. RO
Etoricoxib Terapia 60 mg comprimate filmate
DE/H/4557/002 9917/2017/06 TERAPIA S.A. RO
Etoricoxib Terapia 60 mg comprimate filmate
DE/H/4557/002 9917/2017/07 TERAPIA S.A. RO
Etoricoxib Terapia 60 mg comprimate filmate
DE/H/4557/002 9917/2017/08 TERAPIA S.A. RO
Etoricoxib Terapia 60 mg comprimate filmate
DE/H/4557/002 9917/2017/09 TERAPIA S.A. RO
Etoricoxib Terapia 60 mg comprimate filmate
DE/H/4557/002 9917/2017/10 TERAPIA S.A. RO
Etoricoxib Terapia 90 mg comprimate filmate
DE/H/4557/003 9918/2017/01 TERAPIA S.A. RO
Etoricoxib Terapia 90 mg comprimate filmate
DE/H/4557/003 9918/2017/02 TERAPIA S.A. RO
Etoricoxib Terapia 90 mg comprimate filmate
DE/H/4557/003 9918/2017/03 TERAPIA S.A. RO
Etoricoxib Terapia 90 mg comprimate filmate
DE/H/4557/003 9918/2017/04 TERAPIA S.A. RO
Etoricoxib Terapia 90 mg comprimate filmate
DE/H/4557/003 9918/2017/05 TERAPIA S.A. RO
Etoricoxib Terapia 90 mg comprimate filmate
DE/H/4557/003 9918/2017/06 TERAPIA S.A. RO
List of nationally authorised medicinal products EMA/812634/2017 Page 138/231
Product Name (in authorisation country)
MRP/DCP Authorisation Number
National Authorisation Number
MAH of product in the Member State
Member State where product is authorised
Etoricoxib Terapia 90 mg comprimate filmate
DE/H/4557/003 9918/2017/07 TERAPIA S.A. RO
Etoricoxib Terapia 90 mg comprimate filmate
DE/H/4557/003 9918/2017/08 TERAPIA S.A. RO
Etoricoxib Terapia 90 mg comprimate filmate
DE/H/4557/003 9918/2017/09 TERAPIA S.A. RO
Etoricoxib Terapia 90 mg comprimate filmate
DE/H/4557/003 9918/2017/10 TERAPIA S.A. RO
Etoricoxib Terapia 90 mg comprimate filmate
DE/H/4557/003 9918/2017/11 TERAPIA S.A. RO
Etoricoxib Terapia 90 mg comprimate filmate
DE/H/4557/003 9918/2017/12 TERAPIA S.A. RO
Etoricoxib Teva 120 mg apvalkotās tabletes
DE/H/5031/004 16-0063 TEVA B.V LV
ETORICOXIB TEVA 120 mg compresse rivestite con film
DE/H/5031/004 043684226 TEVA ITALIA S.R.L. IT
ETORICOXIB TEVA 120 mg compresse rivestite con film
DE/H/5031/004 043684253 TEVA ITALIA S.R.L. IT
ETORICOXIB TEVA 120 mg compresse rivestite con film
DE/H/5031/004 043684339 TEVA ITALIA S.R.L. IT
ETORICOXIB TEVA 120 mg compresse rivestite con film
DE/H/5031/004 043684240 TEVA ITALIA S.R.L. IT
ETORICOXIB TEVA 120 mg compresse rivestite con film
DE/H/5031/004 043684238 TEVA ITALIA S.R.L. IT
ETORICOXIB TEVA 120 mg compresse rivestite con film
DE/H/5031/004 043684341 TEVA ITALIA S.R.L. IT
ETORICOXIB TEVA 120 mg compresse rivestite con film
DE/H/5031/004 043684277 TEVA ITALIA S.R.L. IT
List of nationally authorised medicinal products EMA/812634/2017 Page 139/231
Product Name (in authorisation country)
MRP/DCP Authorisation Number
National Authorisation Number
MAH of product in the Member State
Member State where product is authorised
ETORICOXIB TEVA 120 mg compresse rivestite con film
DE/H/5031/004 043684265 TEVA ITALIA S.R.L. IT
Etoricoxib Teva 120 mg comprimate filmate
DE/H/5031/004 8805/2016/01 TEVA PHARMACEUTICALS S.R.L
RO
Etoricoxib Teva 120 mg comprimate filmate
DE/H/5031/004 8805/2016/008 TEVA PHARMACEUTICALS S.R.L
RO
Etoricoxib Teva 120 mg comprimate filmate
DE/H/5031/004 8805/2016/004 TEVA PHARMACEUTICALS S.R.L
RO
Etoricoxib Teva 120 mg comprimate filmate
DE/H/5031/004 8805/2016/07 TEVA PHARMACEUTICALS S.R.L
RO
Etoricoxib Teva 120 mg comprimate filmate
DE/H/5031/004 8805/2016/02 TEVA PHARMACEUTICALS S.R.L
RO
Etoricoxib Teva 120 mg comprimate filmate
DE/H/5031/004 8805/2016/05 TEVA PHARMACEUTICALS S.R.L
RO
Etoricoxib Teva 120 mg comprimate filmate
DE/H/5031/004 8805/2016/06 TEVA PHARMACEUTICALS S.R.L
RO
Etoricoxib Teva 120 mg comprimate filmate
DE/H/5031/004 8805/2016/03 TEVA PHARMACEUTICALS S.R.L
RO
Etoricoxib Teva 120 mg comprimidos recubiertos con película EFG
DE/H/5031/004 80948 TEVA PHARMA S.L.U ES
Etoricoxib Teva 120 mg comprimidos revestidos por película
DE/H/5031/004 5674007 TEVA PHARMA – PRODUTOS FARMACÊUTICOS LDA
PT
Etoricoxib Teva 120 mg comprimidos revestidos por película
DE/H/5031/004 5673975 TEVA PHARMA – PRODUTOS FARMACÊUTICOS LDA
PT
Etoricoxib Teva 120 mg Film-coated Tablets
DE/H/5031/004 PA1986/002/004 TEVA B.V IE
List of nationally authorised medicinal products EMA/812634/2017 Page 140/231
Product Name (in authorisation country)
MRP/DCP Authorisation Number
National Authorisation Number
MAH of product in the Member State
Member State where product is authorised
Etoricoxib Teva 120 mg Film-coated Tablets
DE/H/5031/004 MA713/00304 TEVA B.V MT
Etoricoxib Teva 120 mg plėvele dengtos tabletės
DE/H/5031/004 LT/1/16/3888/030 TEVA B.V LT
Etoricoxib Teva 120 mg plėvele dengtos tabletės
DE/H/5031/004 LT/1/16/3888/029 TEVA B.V LT
Etoricoxib Teva 120 mg plėvele dengtos tabletės
DE/H/5031/004 LT/1/16/3888/033 TEVA B.V LT
Etoricoxib Teva 120 mg plėvele dengtos tabletės
DE/H/5031/004 LT/1/16/3888/028 TEVA B.V LT
Etoricoxib Teva 120 mg plėvele dengtos tabletės
DE/H/5031/004 LT/1/16/3888/031 TEVA B.V LT
Etoricoxib Teva 120 mg plėvele dengtos tabletės
DE/H/5031/004 LT/1/16/3888/034 TEVA B.V LT
Etoricoxib Teva 120 mg plėvele dengtos tabletės
DE/H/5031/004 LT/1/16/3888/027 TEVA B.V LT
Etoricoxib Teva 120 mg plėvele dengtos tabletės
DE/H/5031/004 LT/1/16/3888/032 TEVA B.V LT
Etoricoxib Teva 120 mg plėvele dengtos tabletės
DE/H/5031/004 LT/1/16/3888/032 TEVA B.V LT
Etoricoxib Teva 120 mg plėvele dengtos tabletės
DE/H/5031/004 LT/1/16/3888/035 TEVA B.V LT
Etoricoxib Teva 120 mg, filmomhulde tabletten
DE/H/5031/004 RVG 115906 TEVA NEDERLAND B.V. NL
ETORICOXIB TEVA 30 mg compresse rivestite con film
DE/H/5031/001 043684291 TEVA ITALIA S.R.L. IT
ETORICOXIB TEVA 30 mg compresse rivestite con film
DE/H/5031/001 043684289 TEVA ITALIA S.R.L. IT
List of nationally authorised medicinal products EMA/812634/2017 Page 141/231
Product Name (in authorisation country)
MRP/DCP Authorisation Number
National Authorisation Number
MAH of product in the Member State
Member State where product is authorised
ETORICOXIB TEVA 30 mg compresse rivestite con film
DE/H/5031/001 043684036 TEVA ITALIA S.R.L. IT
ETORICOXIB TEVA 30 mg compresse rivestite con film
DE/H/5031/001 043684012 TEVA ITALIA S.R.L. IT
ETORICOXIB TEVA 30 mg compresse rivestite con film
DE/H/5031/001 043684048 TEVA ITALIA S.R.L. IT
ETORICOXIB TEVA 30 mg compresse rivestite con film
DE/H/5031/001 043684024 TEVA ITALIA S.R.L. IT
Etoricoxib Teva 30 mg comprimate filmate
DE/H/5031/001 8802/2016/01-06 TEVA PHARMACEUTICALS S.R.L
RO
Etoricoxib Teva 30 mg comprimidos recubiertos con película EFG
DE/H/5031/001 80944 TEVA PHARMA S.L.U ES
Etoricoxib Teva 30 mg comprimidos revestidos por película
DE/H/5031/001 5673942 TEVA PHARMA – PRODUTOS FARMACÊUTICOS LDA
PT
Etoricoxib Teva 30 mg comprimidos revestidos por película
DE/H/5031/001 5673934 TEVA PHARMA – PRODUTOS FARMACÊUTICOS LDA
PT
Etoricoxib Teva 30 mg Film-coated Tablets
DE/H/5031/001 PA1986/002/001 TEVA B.V IE
Etoricoxib Teva 30 mg Film-coated Tablets
DE/H/5031/001 MA713/00301 TEVA B.V MT
Etoricoxib Teva 30 mg filmdragerade tabletter
DE/H/5031/001 51529 TEVA SWEDEN AB SE
Etoricoxib Teva 30 mg plėvele dengtos tabletės
DE/H/5031/001 LT/1/16/3888/005 TEVA B.V LT
Etoricoxib Teva 30 mg plėvele dengtos tabletės
DE/H/5031/001 LT/1/16/3888/004 TEVA B.V LT
List of nationally authorised medicinal products EMA/812634/2017 Page 142/231
Product Name (in authorisation country)
MRP/DCP Authorisation Number
National Authorisation Number
MAH of product in the Member State
Member State where product is authorised
Etoricoxib Teva 30 mg plėvele dengtos tabletės
DE/H/5031/001 LT/1/16/3888/003 TEVA B.V LT
Etoricoxib Teva 30 mg plėvele dengtos tabletės
DE/H/5031/001 LT/1/16/3888/002 TEVA B.V LT
Etoricoxib Teva 30 mg plėvele dengtos tabletės
DE/H/5031/001 LT/1/16/3888/001 TEVA B.V LT
Etoricoxib Teva 30 mg plėvele dengtos tabletės
DE/H/5031/001 LT/1/16/3888/006 TEVA B.V LT
Etoricoxib Teva 30 mg, filmomhulde tabletten
DE/H/5031/001 RVG 115901 TEVA NEDERLAND B.V. NL
Etoricoxib Teva 60 mg apvalkotas tabletes
DE/H/5031/002 16-0061 TEVA B.V LV
ETORICOXIB TEVA 60 mg compresse rivestite con film
DE/H/5031/002 043684087 TEVA ITALIA S.R.L. IT
ETORICOXIB TEVA 60 mg compresse rivestite con film
DE/H/5031/002 043684099 TEVA ITALIA S.R.L. IT
ETORICOXIB TEVA 60 mg compresse rivestite con film
DE/H/5031/002 043684063 TEVA ITALIA S.R.L. IT
ETORICOXIB TEVA 60 mg compresse rivestite con film
DE/H/5031/002 043684051 TEVA ITALIA S.R.L. IT
ETORICOXIB TEVA 60 mg compresse rivestite con film
DE/H/5031/002 043684075 TEVA ITALIA S.R.L. IT
ETORICOXIB TEVA 60 mg compresse rivestite con film
DE/H/5031/002 043684303 TEVA ITALIA S.R.L. IT
ETORICOXIB TEVA 60 mg compresse rivestite con film
DE/H/5031/002 043684101 TEVA ITALIA S.R.L. IT
ETORICOXIB TEVA 60 mg compresse rivestite con film
DE/H/5031/002 043684113 TEVA ITALIA S.R.L. IT
List of nationally authorised medicinal products EMA/812634/2017 Page 143/231
Product Name (in authorisation country)
MRP/DCP Authorisation Number
National Authorisation Number
MAH of product in the Member State
Member State where product is authorised
ETORICOXIB TEVA 60 mg compresse rivestite con film
DE/H/5031/002 043684125 TEVA ITALIA S.R.L. IT
Etoricoxib Teva 60 mg comprimate filmate
DE/H/5031/001 8803/2016/01 TEVA PHARMACEUTICALS S.R.L
RO
Etoricoxib Teva 60 mg comprimate filmate
DE/H/5031/001 8803/2016/006 TEVA PHARMACEUTICALS S.R.L
RO
Etoricoxib Teva 60 mg comprimate filmate
DE/H/5031/001 8803/2016/004 TEVA PHARMACEUTICALS S.R.L
RO
Etoricoxib Teva 60 mg comprimate filmate
DE/H/5031/002 8803/2016/002 TEVA PHARMACEUTICALS S.R.L
RO
Etoricoxib Teva 60 mg comprimate filmate
DE/H/5031/002 8803/2016/008 TEVA PHARMACEUTICALS S.R.L
RO
Etoricoxib Teva 60 mg comprimate filmate
DE/H/5031/002 8803/2016/003 TEVA PHARMACEUTICALS S.R.L
RO
Etoricoxib Teva 60 mg comprimate filmate
DE/H/5031/002 8803/2016/009 TEVA PHARMACEUTICALS S.R.L
RO
Etoricoxib Teva 60 mg comprimate filmate
DE/H/5031/002 8803/2016/07 TEVA PHARMACEUTICALS S.R.L
RO
Etoricoxib Teva 60 mg comprimate filmate
DE/H/5031/002 8803/2016/05 TEVA PHARMACEUTICALS S.R.L
RO
Etoricoxib Teva 60 mg comprimidos recubiertos con película EFG
DE/H/5031/001 80946 TEVA PHARMA S.L.U ES
Etoricoxib Teva 60 mg comprimidos revestidos por película
DE/H/5031/002 5673959 TEVA PHARMA – PRODUTOS FARMACÊUTICOS LDA
PT
Etoricoxib Teva 60 mg comprimidos revestidos por película
DE/H/5031/002 5673967 TEVA PHARMA – PRODUTOS FARMACÊUTICOS LDA
PT
List of nationally authorised medicinal products EMA/812634/2017 Page 144/231
Product Name (in authorisation country)
MRP/DCP Authorisation Number
National Authorisation Number
MAH of product in the Member State
Member State where product is authorised
Etoricoxib Teva 60 mg comprimidos revestidos por película
DE/H/5031/002 5687132 TEVA PHARMA – PRODUTOS FARMACÊUTICOS LDA
PT
Etoricoxib Teva 60 mg Film-coated Tablets
DE/H/5031/002 PA1986/002/002 TEVA B.V IE
Etoricoxib Teva 60 mg Film-coated Tablets
DE/H/5031/002 MA713/00302 TEVA B.V MT
Etoricoxib Teva 60 mg plėvele dengtos tabletės
DE/H/5031/002 LT/1/16/3888/015 TEVA B.V LT
Etoricoxib Teva 60 mg plėvele dengtos tabletės
DE/H/5031/002 LT/1/16/3888/013 TEVA B.V LT
Etoricoxib Teva 60 mg plėvele dengtos tabletės
DE/H/5031/002 LT/1/16/3888/014 TEVA B.V LT
Etoricoxib Teva 60 mg plėvele dengtos tabletės
DE/H/5031/002 LT/1/16/3888/007 TEVA B.V LT
Etoricoxib Teva 60 mg plėvele dengtos tabletės
DE/H/5031/002 LT/1/16/3888/012 TEVA B.V LT
Etoricoxib Teva 60 mg plėvele dengtos tabletės
DE/H/5031/002 LT/1/16/3888/008 TEVA B.V LT
Etoricoxib Teva 60 mg plėvele dengtos tabletės
DE/H/5031/002 LT/1/16/3888/009 TEVA B.V LT
Etoricoxib Teva 60 mg plėvele dengtos tabletės
DE/H/5031/002 LT/1/16/3888/011 TEVA B.V LT
Etoricoxib Teva 60 mg plėvele dengtos tabletės
DE/H/5031/002 LT/1/16/3888/010 TEVA B.V LT
Etoricoxib Teva 60 mg, filmomhulde tabletten
DE/H/5031/002 RVG 115904 TEVA NEDERLAND B.V. NL
Etoricoxib Teva 90 mg apvalkotās tabletes
DE/H/5031/003 16-0062 TEVA B.V LV
List of nationally authorised medicinal products EMA/812634/2017 Page 145/231
Product Name (in authorisation country)
MRP/DCP Authorisation Number
National Authorisation Number
MAH of product in the Member State
Member State where product is authorised
ETORICOXIB TEVA 90 mg compresse rivestite con film
DE/H/5031/003 043684214 TEVA ITALIA S.R.L. IT
ETORICOXIB TEVA 90 mg compresse rivestite con film
DE/H/5031/003 043684315 TEVA ITALIA S.R.L. IT
ETORICOXIB TEVA 90 mg compresse rivestite con film
DE/H/5031/003 043684176 TEVA ITALIA S.R.L. IT
ETORICOXIB TEVA 90 mg compresse rivestite con film
DE/H/5031/003 043684190 TEVA ITALIA S.R.L. IT
ETORICOXIB TEVA 90 mg compresse rivestite con film
DE/H/5031/003 043684188 TEVA ITALIA S.R.L. IT
ETORICOXIB TEVA 90 mg compresse rivestite con film
DE/H/5031/003 043684152 TEVA ITALIA S.R.L. IT
ETORICOXIB TEVA 90 mg compresse rivestite con film
DE/H/5031/003 043684327 TEVA ITALIA S.R.L. IT
ETORICOXIB TEVA 90 mg compresse rivestite con film
DE/H/5031/003 043684202 TEVA ITALIA S.R.L. IT
ETORICOXIB TEVA 90 mg compresse rivestite con film
DE/H/5031/003 043684164 TEVA ITALIA S.R.L. IT
ETORICOXIB TEVA 90 mg compresse rivestite con film
DE/H/5031/003 043684137 TEVA ITALIA S.R.L. IT
ETORICOXIB TEVA 90 mg compresse rivestite con film
DE/H/5031/003 043684149 TEVA ITALIA S.R.L. IT
Etoricoxib Teva 90 mg comprimate filmate
DE/H/5031/003 8804/2016/01-11 TEVA PHARMACEUTICALS S.R.L
RO
Etoricoxib Teva 90 mg comprimidos recubiertos con película EFG
DE/H/5031/003 80949 TEVA PHARMA S.L.U ES
List of nationally authorised medicinal products EMA/812634/2017 Page 146/231
Product Name (in authorisation country)
MRP/DCP Authorisation Number
National Authorisation Number
MAH of product in the Member State
Member State where product is authorised
Etoricoxib Teva 90 mg comprimidos revestidos por película
DE/H/5031/003 5674353 TEVA PHARMA – PRODUTOS FARMACÊUTICOS LDA
PT
Etoricoxib Teva 90 mg comprimidos revestidos por película
DE/H/5031/003 5674361 TEVA PHARMA – PRODUTOS FARMACÊUTICOS LDA
PT
Etoricoxib Teva 90 mg comprimidos revestidos por película
DE/H/5031/003 5687140 TEVA PHARMA – PRODUTOS FARMACÊUTICOS LDA
PT
Etoricoxib Teva 90 mg Film-coated Tablets
DE/H/5031/003 PA1986/002/003 TEVA B.V IE
Etoricoxib Teva 90 mg Film-coated Tablets
DE/H/5031/003 MA713/00303 TEVA B.V MT
Etoricoxib Teva 90 mg filmdragerade tabletter
DE/H/5031/003 51531 TEVA SWEDEN AB SE
Etoricoxib Teva 90 mg plėvele dengtos tabletės
DE/H/5031/003 LT/1/16/3888/025 TEVA B.V LT
Etoricoxib Teva 90 mg plėvele dengtos tabletės
DE/H/5031/003 LT/1/16/3888/021 TEVA B.V LT
Etoricoxib Teva 90 mg plėvele dengtos tabletės
DE/H/5031/003 LT/1/16/3888/020 TEVA B.V LT
Etoricoxib Teva 90 mg plėvele dengtos tabletės
DE/H/5031/003 LT/1/16/3888/022 TEVA B.V LT
Etoricoxib Teva 90 mg plėvele dengtos tabletės
DE/H/5031/003 LT/1/16/3888/016 TEVA B.V LT
Etoricoxib Teva 90 mg plėvele dengtos tabletės
DE/H/5031/003 LT/1/16/3888/026 TEVA B.V LT
Etoricoxib Teva 90 mg plėvele dengtos tabletės
DE/H/5031/003 LT/1/16/3888/024 TEVA B.V LT
List of nationally authorised medicinal products EMA/812634/2017 Page 147/231
Product Name (in authorisation country)
MRP/DCP Authorisation Number
National Authorisation Number
MAH of product in the Member State
Member State where product is authorised
Etoricoxib Teva 90 mg plėvele dengtos tabletės
DE/H/5031/003 LT/1/16/3888/018 TEVA B.V LT
Etoricoxib Teva 90 mg plėvele dengtos tabletės
DE/H/5031/003 LT/1/16/3888/023 TEVA B.V LT
Etoricoxib Teva 90 mg plėvele dengtos tabletės
DE/H/5031/003 LT/1/16/3888/019 TEVA B.V LT
Etoricoxib Teva 90 mg plėvele dengtos tabletės
DE/H/5031/003 LT/1/16/3888/017 TEVA B.V LT
Etoricoxib Teva 90 mg, filmomhulde tabletten
DE/H/5031/003 RVG 115905 TEVA NEDERLAND B.V. NL
Etoricoxib Teva, 120 mg filmdragerad tablett
DE/H/5031/004 51532 TEVA SWEDEN AB SE
Etoricoxib Teva, 120 mg õhukese polümeerikattega tabletid
DE/H/5031/004 903916 TEVA B.V EE
Etoricoxib Teva, 120 mg, tabletki powlekane
SE/H/1574/004 23645 TEVA PHARMACEUTICALS POLSKA SP. Z O.O.
PL
Etoricoxib Teva, 30 mg õhukese polümeerikattega tabletid
DE/H/5031/001 904116 TEVA B.V EE
Etoricoxib Teva, 30 mg, tabletki powlekane
SE/H/1574/001 23642 TEVA PHARMACEUTICALS POLSKA SP. Z O.O.
PL
Etoricoxib Teva, 60 mg filmdragerad tablett
DE/H/5031/002 51530 TEVA SWEDEN AB SE
Etoricoxib Teva, 60 mg õhukese polümeerikattega tabletid
DE/H/5031/002 904016 TEVA B.V EE
Etoricoxib Teva, 60 mg, tabletki powlekane
SE/H/1574/002 23643 TEVA PHARMACEUTICALS POLSKA SP. Z O.O.
PL
Etoricoxib Teva, 90 mg õhukese polümeerikattega tabletid
DE/H/5031/003 904216 TEVA B.V EE
List of nationally authorised medicinal products EMA/812634/2017 Page 148/231
Product Name (in authorisation country)
MRP/DCP Authorisation Number
National Authorisation Number
MAH of product in the Member State
Member State where product is authorised
Etoricoxib Teva, 90 mg, tabletki powlekane
SE/H/1574/003 23644 TEVA PHARMACEUTICALS POLSKA SP. Z O.O.
PL
Etoricoxib toLife 120 mg comprimidos revestidos por película
PT/H/1714/004 5704614 TOLIFE - PRODUTOS FARMACÊUTICOS, S.A.
PT
Etoricoxib toLife 120 mg comprimidos revestidos por película
PT/H/1714/004 5704606 TOLIFE - PRODUTOS FARMACÊUTICOS, S.A.
PT
Etoricoxib toLife 30 mg comprimidos revestidos por película
PT/H/1714/001 5704507 TOLIFE - PRODUTOS FARMACÊUTICOS, S.A.
PT
Etoricoxib toLife 30 mg comprimidos revestidos por película
PT/H/1714/001 5704515 TOLIFE - PRODUTOS FARMACÊUTICOS, S.A.
PT
Etoricoxib toLife 30 mg comprimidos revestidos por película
PT/H/1714/001 5704473 TOLIFE - PRODUTOS FARMACÊUTICOS, S.A.
PT
Etoricoxib toLife 60 mg comprimidos revestidos por película
PT/H/1714/002 5704523 TOLIFE - PRODUTOS FARMACÊUTICOS, S.A.
PT
Etoricoxib toLife 60 mg comprimidos revestidos por película
PT/H/1714/002 5704549 TOLIFE - PRODUTOS FARMACÊUTICOS, S.A.
PT
Etoricoxib toLife 60 mg comprimidos revestidos por película
PT/H/1714/002 5704531 TOLIFE - PRODUTOS FARMACÊUTICOS, S.A.
PT
Etoricoxib toLife 90 mg comprimidos revestidos por película
PT/H/1714/003 5704556 TOLIFE - PRODUTOS FARMACÊUTICOS, S.A.
PT
List of nationally authorised medicinal products EMA/812634/2017 Page 149/231
Product Name (in authorisation country)
MRP/DCP Authorisation Number
National Authorisation Number
MAH of product in the Member State
Member State where product is authorised
Etoricoxib toLife 90 mg comprimidos revestidos por película
PT/H/1714/003 5704572 TOLIFE - PRODUTOS FARMACÊUTICOS, S.A.
PT
Etoricoxib toLife 90 mg comprimidos revestidos por película
PT/H/1714/003 5704564 TOLIFE - PRODUTOS FARMACÊUTICOS, S.A.
PT
Etoricoxib Zentiva 120 mg apvalkotās tabletes
EE/H/0211/004 16-0083 ZENTIVA, K.S. LV
Etoricoxib Zentiva 120 mg apvalkotās tabletes
EE/H/0211/004 16-0083 ZENTIVA, K.S. LV
Etoricoxib Zentiva 120 mg apvalkotās tabletes
EE/H/0211/004 16-0083 ZENTIVA, K.S. LV
Etoricoxib Zentiva 120 mg apvalkotās tabletes
EE/H/0211/004 16-0083 ZENTIVA, K.S. LV
Etoricoxib Zentiva 120 mg apvalkotās tabletes
EE/H/0211/004 16-0083 ZENTIVA, K.S. LV
Etoricoxib Zentiva 120 mg apvalkotās tabletes
EE/H/0211/004 16-0083 ZENTIVA, K.S. LV
Etoricoxib Zentiva 120 mg apvalkotās tabletes
EE/H/0211/004 16-0083 ZENTIVA, K.S. LV
Etoricoxib Zentiva 120 mg apvalkotās tabletes
EE/H/0211/004 16-0083 ZENTIVA, K.S. LV
Etoricoxib Zentiva 120 mg apvalkotās tabletes
EE/H/0211/004 16-0083 ZENTIVA, K.S. LV
Etoricoxib Zentiva 120 mg apvalkotās tabletes
EE/H/0211/004 16-0083 ZENTIVA, K.S. LV
Etoricoxib Zentiva 120 mg compresse rivestite con film
EE/H/0211/004 043747207 ZENTIVA ITALIA SRL IT
List of nationally authorised medicinal products EMA/812634/2017 Page 150/231
Product Name (in authorisation country)
MRP/DCP Authorisation Number
National Authorisation Number
MAH of product in the Member State
Member State where product is authorised
Etoricoxib Zentiva 120 mg compresse rivestite con film
EE/H/0211/004 043747195 ZENTIVA ITALIA SRL IT
Etoricoxib Zentiva 120 mg compresse rivestite con film
EE/H/0211/004 043747169 ZENTIVA ITALIA SRL IT
Etoricoxib Zentiva 120 mg compresse rivestite con film
EE/H/0211/004 043747183 ZENTIVA ITALIA SRL IT
Etoricoxib Zentiva 120 mg compresse rivestite con film
EE/H/0211/004 043747171 ZENTIVA ITALIA SRL IT
Etoricoxib Zentiva 120 mg compresse rivestite con film
EE/H/0211/004 043747207 ZENTIVA ITALIA SRL IT
Etoricoxib Zentiva 120 mg compresse rivestite con film
EE/H/0211/004 043747195 ZENTIVA ITALIA SRL IT
Etoricoxib Zentiva 120 mg compresse rivestite con film
EE/H/0211/004 043747169 ZENTIVA ITALIA SRL IT
Etoricoxib Zentiva 120 mg compresse rivestite con film
EE/H/0211/004 043747183 ZENTIVA ITALIA SRL IT
Etoricoxib Zentiva 120 mg compresse rivestite con film
EE/H/0211/004 043747171 ZENTIVA ITALIA SRL IT
Etoricoxib Zentiva 120 mg compridos revestidos por película
EE/H/0211/004 5692447 SANOFI - PRODUTOS FARMACEUTICOS LDA
PT
Etoricoxib Zentiva 120 mg compridos revestidos por película
EE/H/0211/004 5694831 SANOFI - PRODUTOS FARMACEUTICOS LDA
PT
Etoricoxib Zentiva 120 mg compridos revestidos por película
EE/H/0211/004 5692454 SANOFI - PRODUTOS FARMACEUTICOS LDA
PT
Etoricoxib Zentiva 120 mg compridos revestidos por película
EE/H/0211/004 5692447 SANOFI - PRODUTOS FARMACEUTICOS LDA
PT
Etoricoxib Zentiva 120 mg compridos revestidos por película
EE/H/0211/004 5694831 SANOFI - PRODUTOS FARMACEUTICOS LDA
PT
List of nationally authorised medicinal products EMA/812634/2017 Page 151/231
Product Name (in authorisation country)
MRP/DCP Authorisation Number
National Authorisation Number
MAH of product in the Member State
Member State where product is authorised
Etoricoxib Zentiva 120 mg compridos revestidos por película
EE/H/0211/004 5692454 SANOFI - PRODUTOS FARMACEUTICOS LDA
PT
Etoricoxib Zentiva 120 mg film-coated tablets
EE/H/0211/004 MA082/08504 SANOFI MALTA LTD MT
Etoricoxib Zentiva 120 mg film-coated tablets
EE/H/0211/004 MA082/08504 SANOFI MALTA LTD MT
Etoricoxib Zentiva 120 mg film-coated tablets
EE/H/0211/004 MA082/08504 SANOFI MALTA LTD MT
Etoricoxib Zentiva 120 mg film-coated tablets
EE/H/0211/004 MA082/08504 SANOFI MALTA LTD MT
Etoricoxib Zentiva 120 mg film-coated tablets
EE/H/0211/004 MA082/08504 SANOFI MALTA LTD MT
Etoricoxib Zentiva 120 mg film-coated tablets
EE/H/0211/004 MA082/08504 SANOFI MALTA LTD MT
Etoricoxib Zentiva 120 mg film-coated tablets
EE/H/0211/004 MA082/08504 SANOFI MALTA LTD MT
Etoricoxib Zentiva 120 mg film-coated tablets
EE/H/0211/004 MA082/08504 SANOFI MALTA LTD MT
Etoricoxib Zentiva 120 mg film-coated tablets
EE/H/0211/004 MA082/08504 SANOFI MALTA LTD MT
Etoricoxib Zentiva 120 mg film-coated tablets
EE/H/0211/004 MA082/08504 SANOFI MALTA LTD MT
Etoricoxib Zentiva 120 mg Filmtabletten
EE/H/0211/004 92974.00.00 ZENTIVA PHARMA GMBH DE
Etoricoxib Zentiva 120 mg Filmtabletten
EE/H/0211/004 92974.00.00 ZENTIVA PHARMA GMBH DE
Etoricoxib Zentiva 120 mg Filmtabletten
EE/H/0211/004 92974.00.00 ZENTIVA PHARMA GMBH DE
List of nationally authorised medicinal products EMA/812634/2017 Page 152/231
Product Name (in authorisation country)
MRP/DCP Authorisation Number
National Authorisation Number
MAH of product in the Member State
Member State where product is authorised
Etoricoxib Zentiva 120 mg Filmtabletten
EE/H/0211/004 92974.00.00 ZENTIVA PHARMA GMBH DE
Etoricoxib Zentiva 120 mg Filmtabletten
EE/H/0211/004 92974.00.00 ZENTIVA PHARMA GMBH DE
Etoricoxib Zentiva 120 mg Filmtabletten
EE/H/0211/004 92974.00.00 ZENTIVA PHARMA GMBH DE
Etoricoxib Zentiva 120 mg Filmtabletten
EE/H/0211/004 92974.00.00 ZENTIVA PHARMA GMBH DE
Etoricoxib Zentiva 120 mg Filmtabletten
EE/H/0211/004 92974.00.00 ZENTIVA PHARMA GMBH DE
Etoricoxib Zentiva 120 mg Filmtabletten
EE/H/0211/004 92974.00.00 ZENTIVA PHARMA GMBH DE
Etoricoxib Zentiva 120 mg Filmtabletten
EE/H/0211/004 92974.00.00 ZENTIVA PHARMA GMBH DE
Etoricoxib Zentiva 120 mg plėvele dengtos tabletės
EE/H/0211/004 LT/1/16/3907/018 ZENTIVA, K.S. LT
Etoricoxib Zentiva 120 mg plėvele dengtos tabletės
EE/H/0211/004 LT/1/16/3907/019 ZENTIVA, K.S. LT
Etoricoxib Zentiva 120 mg plėvele dengtos tabletės
EE/H/0211/004 LT/1/16/3907/017 ZENTIVA, K.S. LT
Etoricoxib Zentiva 120 mg plėvele dengtos tabletės
EE/H/0211/004 LT/1/16/3907/016 ZENTIVA, K.S. LT
Etoricoxib Zentiva 120 mg plėvele dengtos tabletės
EE/H/0211/004 LT/1/16/3907/020 ZENTIVA, K.S. LT
Etoricoxib Zentiva 120 mg plėvele dengtos tabletės
EE/H/0211/004 LT/1/16/3907/018 ZENTIVA, K.S. LT
Etoricoxib Zentiva 120 mg plėvele dengtos tabletės
EE/H/0211/004 LT/1/16/3907/019 ZENTIVA, K.S. LT
List of nationally authorised medicinal products EMA/812634/2017 Page 153/231
Product Name (in authorisation country)
MRP/DCP Authorisation Number
National Authorisation Number
MAH of product in the Member State
Member State where product is authorised
Etoricoxib Zentiva 120 mg plėvele dengtos tabletės
EE/H/0211/004 LT/1/16/3907/017 ZENTIVA, K.S. LT
Etoricoxib Zentiva 120 mg plėvele dengtos tabletės
EE/H/0211/004 LT/1/16/3907/016 ZENTIVA, K.S. LT
Etoricoxib Zentiva 120 mg plėvele dengtos tabletės
EE/H/0211/004 LT/1/16/3907/020 ZENTIVA, K.S. LT
Etoricoxib Zentiva 120 mg, õhukese polümeerikattega tabletid
EE/H/0211/004 906916 ZENTIVA, K.S. EE
Etoricoxib Zentiva 120 mg, õhukese polümeerikattega tabletid
EE/H/0211/004 906916 ZENTIVA, K.S. EE
Etoricoxib Zentiva 120 mg, õhukese polümeerikattega tabletid
EE/H/0211/004 906916 ZENTIVA, K.S. EE
Etoricoxib Zentiva 120 mg, õhukese polümeerikattega tabletid
EE/H/0211/004 906916 ZENTIVA, K.S. EE
Etoricoxib Zentiva 120 mg, õhukese polümeerikattega tabletid
EE/H/0211/004 906916 ZENTIVA, K.S. EE
Etoricoxib Zentiva 120 mg, õhukese polümeerikattega tabletid
EE/H/0211/004 906916 ZENTIVA, K.S. EE
Etoricoxib Zentiva 120 mg, õhukese polümeerikattega tabletid
EE/H/0211/004 906916 ZENTIVA, K.S. EE
Etoricoxib Zentiva 120 mg, õhukese polümeerikattega tabletid
EE/H/0211/004 906916 ZENTIVA, K.S. EE
Etoricoxib Zentiva 120 mg, õhukese polümeerikattega tabletid
EE/H/0211/004 906916 ZENTIVA, K.S. EE
Etoricoxib Zentiva 120 mg, õhukese polümeerikattega tabletid
EE/H/0211/004 906916 ZENTIVA, K.S. EE
Etoricoxib Zentiva 30 mg compresse rivestite con film
EE/H/0211/001 043747029 ZENTIVA ITALIA SRL IT
List of nationally authorised medicinal products EMA/812634/2017 Page 154/231
Product Name (in authorisation country)
MRP/DCP Authorisation Number
National Authorisation Number
MAH of product in the Member State
Member State where product is authorised
Etoricoxib Zentiva 30 mg compresse rivestite con film
EE/H/0211/001 043747031 ZENTIVA ITALIA SRL IT
Etoricoxib Zentiva 30 mg compresse rivestite con film
EE/H/0211/001 043747017 ZENTIVA ITALIA SRL IT
Etoricoxib Zentiva 30 mg compresse rivestite con film
EE/H/0211/001 043747029 ZENTIVA ITALIA SRL IT
Etoricoxib Zentiva 30 mg compresse rivestite con film
EE/H/0211/001 043747031 ZENTIVA ITALIA SRL IT
Etoricoxib Zentiva 30 mg compresse rivestite con film
EE/H/0211/001 043747017 ZENTIVA ITALIA SRL IT
Etoricoxib Zentiva 30 mg compridos revestidos por película
EE/H/0211/001 5692413 SANOFI - PRODUTOS FARMACEUTICOS LDA
PT
Etoricoxib Zentiva 30 mg compridos revestidos por película
EE/H/0211/001 5692405 SANOFI - PRODUTOS FARMACEUTICOS LDA
PT
Etoricoxib Zentiva 30 mg compridos revestidos por película
EE/H/0211/001 5692413 SANOFI - PRODUTOS FARMACEUTICOS LDA
PT
Etoricoxib Zentiva 30 mg compridos revestidos por película
EE/H/0211/001 5692405 SANOFI - PRODUTOS FARMACEUTICOS LDA
PT
Etoricoxib Zentiva 30 mg film-coated tablets
EE/H/0211/001 MA082/08501 SANOFI MALTA LTD MT
Etoricoxib Zentiva 30 mg film-coated tablets
EE/H/0211/001 MA082/08501 SANOFI MALTA LTD MT
Etoricoxib Zentiva 30 mg film-coated tablets
EE/H/0211/001 MA082/08501 SANOFI MALTA LTD MT
Etoricoxib Zentiva 30 mg film-coated tablets
EE/H/0211/001 MA082/08501 SANOFI MALTA LTD MT
Etoricoxib Zentiva 30 mg film-coated tablets
EE/H/0211/001 MA082/08501 SANOFI MALTA LTD MT
List of nationally authorised medicinal products EMA/812634/2017 Page 155/231
Product Name (in authorisation country)
MRP/DCP Authorisation Number
National Authorisation Number
MAH of product in the Member State
Member State where product is authorised
Etoricoxib Zentiva 30 mg film-coated tablets
EE/H/0211/001 MA082/08501 SANOFI MALTA LTD MT
Etoricoxib Zentiva 30 mg Filmtabletten
EE/H/0211/001 92971.00.00 ZENTIVA PHARMA GMBH DE
Etoricoxib Zentiva 30 mg Filmtabletten
EE/H/0211/001 92971.00.00 ZENTIVA PHARMA GMBH DE
Etoricoxib Zentiva 30 mg Filmtabletten
EE/H/0211/001 92971.00.00 ZENTIVA PHARMA GMBH DE
Etoricoxib Zentiva 30 mg Filmtabletten
EE/H/0211/001 92971.00.00 ZENTIVA PHARMA GMBH DE
Etoricoxib Zentiva 30 mg Filmtabletten
EE/H/0211/001 92971.00.00 ZENTIVA PHARMA GMBH DE
Etoricoxib Zentiva 30 mg Filmtabletten
EE/H/0211/001 92971.00.00 ZENTIVA PHARMA GMBH DE
Etoricoxib Zentiva 30 mg plėvele dengtos tabletės
EE/H/0211/001 LT/1/16/3907/003 ZENTIVA, K.S. LT
Etoricoxib Zentiva 30 mg plėvele dengtos tabletės
EE/H/0211/001 LT/1/16/3907/001 ZENTIVA, K.S. LT
Etoricoxib Zentiva 30 mg plėvele dengtos tabletės
EE/H/0211/001 LT/1/16/3907/002 ZENTIVA, K.S. LT
Etoricoxib Zentiva 30 mg plėvele dengtos tabletės
EE/H/0211/001 LT/1/16/3907/003 ZENTIVA, K.S. LT
Etoricoxib Zentiva 30 mg plėvele dengtos tabletės
EE/H/0211/001 LT/1/16/3907/001 ZENTIVA, K.S. LT
Etoricoxib Zentiva 30 mg plėvele dengtos tabletės
EE/H/0211/001 LT/1/16/3907/002 ZENTIVA, K.S. LT
Etoricoxib Zentiva 30 mg, õhukese polümeerikattega tabletid
EE/H/0211/001 907216 ZENTIVA, K.S. EE
List of nationally authorised medicinal products EMA/812634/2017 Page 156/231
Product Name (in authorisation country)
MRP/DCP Authorisation Number
National Authorisation Number
MAH of product in the Member State
Member State where product is authorised
Etoricoxib Zentiva 30 mg, õhukese polümeerikattega tabletid
EE/H/0211/001 907216 ZENTIVA, K.S. EE
Etoricoxib Zentiva 30 mg, õhukese polümeerikattega tabletid
EE/H/0211/001 907216 ZENTIVA, K.S. EE
Etoricoxib Zentiva 30 mg, õhukese polümeerikattega tabletid
EE/H/0211/001 907216 ZENTIVA, K.S. EE
Etoricoxib Zentiva 30 mg, õhukese polümeerikattega tabletid
EE/H/0211/001 907216 ZENTIVA, K.S. EE
Etoricoxib Zentiva 30 mg, õhukese polümeerikattega tabletid
EE/H/0211/001 907216 ZENTIVA, K.S. EE
Etoricoxib Zentiva 60 mg apvalkotās tabletes
EE/H/0211/002 16-0081 ZENTIVA, K.S. LV
Etoricoxib Zentiva 60 mg apvalkotās tabletes
EE/H/0211/002 16-0081 ZENTIVA, K.S. LV
Etoricoxib Zentiva 60 mg apvalkotās tabletes
EE/H/0211/002 16-0081 ZENTIVA, K.S. LV
Etoricoxib Zentiva 60 mg apvalkotās tabletes
EE/H/0211/002 16-0081 ZENTIVA, K.S. LV
Etoricoxib Zentiva 60 mg apvalkotās tabletes
EE/H/0211/002 16-0081 ZENTIVA, K.S. LV
Etoricoxib Zentiva 60 mg apvalkotās tabletes
EE/H/0211/002 16-0081 ZENTIVA, K.S. LV
Etoricoxib Zentiva 60 mg apvalkotās tabletes
EE/H/0211/002 16-0081 ZENTIVA, K.S. LV
Etoricoxib Zentiva 60 mg apvalkotās tabletes
EE/H/0211/002 16-0081 ZENTIVA, K.S. LV
Etoricoxib Zentiva 60 mg apvalkotās tabletes
EE/H/0211/002 16-0081 ZENTIVA, K.S. LV
List of nationally authorised medicinal products EMA/812634/2017 Page 157/231
Product Name (in authorisation country)
MRP/DCP Authorisation Number
National Authorisation Number
MAH of product in the Member State
Member State where product is authorised
Etoricoxib Zentiva 60 mg apvalkotās tabletes
EE/H/0211/002 16-0081 ZENTIVA, K.S. LV
Etoricoxib Zentiva 60 mg apvalkotās tabletes
EE/H/0211/002 16-0081 ZENTIVA, K.S. LV
Etoricoxib Zentiva 60 mg apvalkotās tabletes
EE/H/0211/002 16-0081 ZENTIVA, K.S. LV
Etoricoxib Zentiva 60 mg compresse rivestite con film
EE/H/0211/002 043747043 ZENTIVA ITALIA SRL IT
Etoricoxib Zentiva 60 mg compresse rivestite con film
EE/H/0211/002 043747082 ZENTIVA ITALIA SRL IT
Etoricoxib Zentiva 60 mg compresse rivestite con film
EE/H/0211/002 043747056 ZENTIVA ITALIA SRL IT
Etoricoxib Zentiva 60 mg compresse rivestite con film
EE/H/0211/002 043747094 ZENTIVA ITALIA SRL IT
Etoricoxib Zentiva 60 mg compresse rivestite con film
EE/H/0211/002 043747068 ZENTIVA ITALIA SRL IT
Etoricoxib Zentiva 60 mg compresse rivestite con film
EE/H/0211/002 043747070 ZENTIVA ITALIA SRL IT
Etoricoxib Zentiva 60 mg compresse rivestite con film
EE/H/0211/002 043747043 ZENTIVA ITALIA SRL IT
Etoricoxib Zentiva 60 mg compresse rivestite con film
EE/H/0211/002 043747082 ZENTIVA ITALIA SRL IT
Etoricoxib Zentiva 60 mg compresse rivestite con film
EE/H/0211/002 043747056 ZENTIVA ITALIA SRL IT
Etoricoxib Zentiva 60 mg compresse rivestite con film
EE/H/0211/002 043747094 ZENTIVA ITALIA SRL IT
Etoricoxib Zentiva 60 mg compresse rivestite con film
EE/H/0211/002 043747068 ZENTIVA ITALIA SRL IT
List of nationally authorised medicinal products EMA/812634/2017 Page 158/231
Product Name (in authorisation country)
MRP/DCP Authorisation Number
National Authorisation Number
MAH of product in the Member State
Member State where product is authorised
Etoricoxib Zentiva 60 mg compresse rivestite con film
EE/H/0211/002 043747070 ZENTIVA ITALIA SRL IT
Etoricoxib Zentiva 60 mg compridos revestidos por película
EE/H/0211/002 5692371 SANOFI - PRODUTOS FARMACEUTICOS LDA
PT
Etoricoxib Zentiva 60 mg compridos revestidos por película
EE/H/0211/002 5694807 SANOFI - PRODUTOS FARMACEUTICOS LDA
PT
Etoricoxib Zentiva 60 mg compridos revestidos por película
EE/H/0211/002 5692363 SANOFI - PRODUTOS FARMACEUTICOS LDA
PT
Etoricoxib Zentiva 60 mg compridos revestidos por película
EE/H/0211/002 5692371 SANOFI - PRODUTOS FARMACEUTICOS LDA
PT
Etoricoxib Zentiva 60 mg compridos revestidos por película
EE/H/0211/002 5694807 SANOFI - PRODUTOS FARMACEUTICOS LDA
PT
Etoricoxib Zentiva 60 mg compridos revestidos por película
EE/H/0211/002 5692363 SANOFI - PRODUTOS FARMACEUTICOS LDA
PT
Etoricoxib Zentiva 60 mg film-coated tablets
EE/H/0211/002 MA082/08502 SANOFI MALTA LTD MT
Etoricoxib Zentiva 60 mg film-coated tablets
EE/H/0211/002 MA082/08502 SANOFI MALTA LTD MT
Etoricoxib Zentiva 60 mg film-coated tablets
EE/H/0211/002 MA082/08502 SANOFI MALTA LTD MT
Etoricoxib Zentiva 60 mg film-coated tablets
EE/H/0211/002 MA082/08502 SANOFI MALTA LTD MT
Etoricoxib Zentiva 60 mg film-coated tablets
EE/H/0211/002 MA082/08502 SANOFI MALTA LTD MT
Etoricoxib Zentiva 60 mg film-coated tablets
EE/H/0211/002 MA082/08502 SANOFI MALTA LTD MT
Etoricoxib Zentiva 60 mg film-coated tablets
EE/H/0211/002 MA082/08502 SANOFI MALTA LTD MT
List of nationally authorised medicinal products EMA/812634/2017 Page 159/231
Product Name (in authorisation country)
MRP/DCP Authorisation Number
National Authorisation Number
MAH of product in the Member State
Member State where product is authorised
Etoricoxib Zentiva 60 mg film-coated tablets
EE/H/0211/002 MA082/08502 SANOFI MALTA LTD MT
Etoricoxib Zentiva 60 mg film-coated tablets
EE/H/0211/002 MA082/08502 SANOFI MALTA LTD MT
Etoricoxib Zentiva 60 mg film-coated tablets
EE/H/0211/002 MA082/08502 SANOFI MALTA LTD MT
Etoricoxib Zentiva 60 mg film-coated tablets
EE/H/0211/002 MA082/08502 SANOFI MALTA LTD MT
Etoricoxib Zentiva 60 mg film-coated tablets
EE/H/0211/002 MA082/08502 SANOFI MALTA LTD MT
Etoricoxib Zentiva 60 mg Filmtabletten
EE/H/0211/002 92972.00.00 ZENTIVA PHARMA GMBH DE
Etoricoxib Zentiva 60 mg Filmtabletten
EE/H/0211/002 92972.00.00 ZENTIVA PHARMA GMBH DE
Etoricoxib Zentiva 60 mg Filmtabletten
EE/H/0211/002 92972.00.00 ZENTIVA PHARMA GMBH DE
Etoricoxib Zentiva 60 mg Filmtabletten
EE/H/0211/002 92972.00.00 ZENTIVA PHARMA GMBH DE
Etoricoxib Zentiva 60 mg Filmtabletten
EE/H/0211/002 92972.00.00 ZENTIVA PHARMA GMBH DE
Etoricoxib Zentiva 60 mg Filmtabletten
EE/H/0211/002 92972.00.00 ZENTIVA PHARMA GMBH DE
Etoricoxib Zentiva 60 mg Filmtabletten
EE/H/0211/002 92972.00.00 ZENTIVA PHARMA GMBH DE
Etoricoxib Zentiva 60 mg Filmtabletten
EE/H/0211/002 92972.00.00 ZENTIVA PHARMA GMBH DE
Etoricoxib Zentiva 60 mg Filmtabletten
EE/H/0211/002 92972.00.00 ZENTIVA PHARMA GMBH DE
List of nationally authorised medicinal products EMA/812634/2017 Page 160/231
Product Name (in authorisation country)
MRP/DCP Authorisation Number
National Authorisation Number
MAH of product in the Member State
Member State where product is authorised
Etoricoxib Zentiva 60 mg Filmtabletten
EE/H/0211/002 92972.00.00 ZENTIVA PHARMA GMBH DE
Etoricoxib Zentiva 60 mg Filmtabletten
EE/H/0211/002 92972.00.00 ZENTIVA PHARMA GMBH DE
Etoricoxib Zentiva 60 mg Filmtabletten
EE/H/0211/002 92972.00.00 ZENTIVA PHARMA GMBH DE
Etoricoxib Zentiva 60 mg plėvele dengtos tabletės
EE/H/0211/002 LT/1/16/3907/008 ZENTIVA, K.S. LT
Etoricoxib Zentiva 60 mg plėvele dengtos tabletės
EE/H/0211/002 LT/1/16/3907/004 ZENTIVA, K.S. LT
Etoricoxib Zentiva 60 mg plėvele dengtos tabletės
EE/H/0211/002 LT/1/16/3907/005 ZENTIVA, K.S. LT
Etoricoxib Zentiva 60 mg plėvele dengtos tabletės
EE/H/0211/002 LT/1/16/3907/006 ZENTIVA, K.S. LT
Etoricoxib Zentiva 60 mg plėvele dengtos tabletės
EE/H/0211/002 LT/1/16/3907/007 ZENTIVA, K.S. LT
Etoricoxib Zentiva 60 mg plėvele dengtos tabletės
EE/H/0211/002 LT/1/16/3907/009 ZENTIVA, K.S. LT
Etoricoxib Zentiva 60 mg plėvele dengtos tabletės
EE/H/0211/002 LT/1/16/3907/008 ZENTIVA, K.S. LT
Etoricoxib Zentiva 60 mg plėvele dengtos tabletės
EE/H/0211/002 LT/1/16/3907/004 ZENTIVA, K.S. LT
Etoricoxib Zentiva 60 mg plėvele dengtos tabletės
EE/H/0211/002 LT/1/16/3907/005 ZENTIVA, K.S. LT
Etoricoxib Zentiva 60 mg plėvele dengtos tabletės
EE/H/0211/002 LT/1/16/3907/006 ZENTIVA, K.S. LT
Etoricoxib Zentiva 60 mg plėvele dengtos tabletės
EE/H/0211/002 LT/1/16/3907/007 ZENTIVA, K.S. LT
List of nationally authorised medicinal products EMA/812634/2017 Page 161/231
Product Name (in authorisation country)
MRP/DCP Authorisation Number
National Authorisation Number
MAH of product in the Member State
Member State where product is authorised
Etoricoxib Zentiva 60 mg plėvele dengtos tabletės
EE/H/0211/002 LT/1/16/3907/009 ZENTIVA, K.S. LT
Etoricoxib Zentiva 60 mg, õhukese polümeerikattega tabletid
EE/H/0211/002 907116 ZENTIVA, K.S. EE
Etoricoxib Zentiva 60 mg, õhukese polümeerikattega tabletid
EE/H/0211/002 907116 ZENTIVA, K.S. EE
Etoricoxib Zentiva 60 mg, õhukese polümeerikattega tabletid
EE/H/0211/002 907116 ZENTIVA, K.S. EE
Etoricoxib Zentiva 60 mg, õhukese polümeerikattega tabletid
EE/H/0211/002 907116 ZENTIVA, K.S. EE
Etoricoxib Zentiva 60 mg, õhukese polümeerikattega tabletid
EE/H/0211/002 907116 ZENTIVA, K.S. EE
Etoricoxib Zentiva 60 mg, õhukese polümeerikattega tabletid
EE/H/0211/002 907116 ZENTIVA, K.S. EE
Etoricoxib Zentiva 60 mg, õhukese polümeerikattega tabletid
EE/H/0211/002 907116 ZENTIVA, K.S. EE
Etoricoxib Zentiva 60 mg, õhukese polümeerikattega tabletid
EE/H/0211/002 907116 ZENTIVA, K.S. EE
Etoricoxib Zentiva 60 mg, õhukese polümeerikattega tabletid
EE/H/0211/002 907116 ZENTIVA, K.S. EE
Etoricoxib Zentiva 60 mg, õhukese polümeerikattega tabletid
EE/H/0211/002 907116 ZENTIVA, K.S. EE
Etoricoxib Zentiva 60 mg, õhukese polümeerikattega tabletid
EE/H/0211/002 907116 ZENTIVA, K.S. EE
Etoricoxib Zentiva 60 mg, õhukese polümeerikattega tabletid
EE/H/0211/002 907116 ZENTIVA, K.S. EE
Etoricoxib Zentiva 90 mg apvalkotās tabletes
EE/H/0211/003 16-0082 ZENTIVA, K.S. LV
List of nationally authorised medicinal products EMA/812634/2017 Page 162/231
Product Name (in authorisation country)
MRP/DCP Authorisation Number
National Authorisation Number
MAH of product in the Member State
Member State where product is authorised
Etoricoxib Zentiva 90 mg apvalkotās tabletes
EE/H/0211/003 16-0082 ZENTIVA, K.S. LV
Etoricoxib Zentiva 90 mg apvalkotās tabletes
EE/H/0211/003 16-0082 ZENTIVA, K.S. LV
Etoricoxib Zentiva 90 mg apvalkotās tabletes
EE/H/0211/003 16-0082 ZENTIVA, K.S. LV
Etoricoxib Zentiva 90 mg apvalkotās tabletes
EE/H/0211/003 16-0082 ZENTIVA, K.S. LV
Etoricoxib Zentiva 90 mg apvalkotās tabletes
EE/H/0211/003 16-0082 ZENTIVA, K.S. LV
Etoricoxib Zentiva 90 mg apvalkotās tabletes
EE/H/0211/003 16-0082 ZENTIVA, K.S. LV
Etoricoxib Zentiva 90 mg apvalkotās tabletes
EE/H/0211/003 16-0082 ZENTIVA, K.S. LV
Etoricoxib Zentiva 90 mg apvalkotās tabletes
EE/H/0211/003 16-0082 ZENTIVA, K.S. LV
Etoricoxib Zentiva 90 mg apvalkotās tabletes
EE/H/0211/003 16-0082 ZENTIVA, K.S. LV
Etoricoxib Zentiva 90 mg apvalkotās tabletes
EE/H/0211/003 16-0082 ZENTIVA, K.S. LV
Etoricoxib Zentiva 90 mg apvalkotās tabletes
EE/H/0211/003 16-0082 ZENTIVA, K.S. LV
Etoricoxib Zentiva 90 mg compresse rivestite con film
EE/H/0211/003 043747120 ZENTIVA ITALIA SRL IT
Etoricoxib Zentiva 90 mg compresse rivestite con film
EE/H/0211/003 043747157 ZENTIVA ITALIA SRL IT
Etoricoxib Zentiva 90 mg compresse rivestite con film
EE/H/0211/003 043747132 ZENTIVA ITALIA SRL IT
List of nationally authorised medicinal products EMA/812634/2017 Page 163/231
Product Name (in authorisation country)
MRP/DCP Authorisation Number
National Authorisation Number
MAH of product in the Member State
Member State where product is authorised
Etoricoxib Zentiva 90 mg compresse rivestite con film
EE/H/0211/003 043747106 ZENTIVA ITALIA SRL IT
Etoricoxib Zentiva 90 mg compresse rivestite con film
EE/H/0211/003 043747144 ZENTIVA ITALIA SRL IT
Etoricoxib Zentiva 90 mg compresse rivestite con film
EE/H/0211/003 043747118 ZENTIVA ITALIA SRL IT
Etoricoxib Zentiva 90 mg compresse rivestite con film
EE/H/0211/003 043747120 ZENTIVA ITALIA SRL IT
Etoricoxib Zentiva 90 mg compresse rivestite con film
EE/H/0211/003 043747157 ZENTIVA ITALIA SRL IT
Etoricoxib Zentiva 90 mg compresse rivestite con film
EE/H/0211/003 043747132 ZENTIVA ITALIA SRL IT
Etoricoxib Zentiva 90 mg compresse rivestite con film
EE/H/0211/003 043747106 ZENTIVA ITALIA SRL IT
Etoricoxib Zentiva 90 mg compresse rivestite con film
EE/H/0211/003 043747144 ZENTIVA ITALIA SRL IT
Etoricoxib Zentiva 90 mg compresse rivestite con film
EE/H/0211/003 043747118 ZENTIVA ITALIA SRL IT
Etoricoxib Zentiva 90 mg compridos revestidos por película
EE/H/0211/003 5694823 SANOFI - PRODUTOS FARMACEUTICOS LDA
PT
Etoricoxib Zentiva 90 mg compridos revestidos por película
EE/H/0211/003 5692439 SANOFI - PRODUTOS FARMACEUTICOS LDA
PT
Etoricoxib Zentiva 90 mg compridos revestidos por película
EE/H/0211/003 5692421 SANOFI - PRODUTOS FARMACEUTICOS LDA
PT
Etoricoxib Zentiva 90 mg compridos revestidos por película
EE/H/0211/003 5694823 SANOFI - PRODUTOS FARMACEUTICOS LDA
PT
Etoricoxib Zentiva 90 mg compridos revestidos por película
EE/H/0211/003 5692439 SANOFI - PRODUTOS FARMACEUTICOS LDA
PT
List of nationally authorised medicinal products EMA/812634/2017 Page 164/231
Product Name (in authorisation country)
MRP/DCP Authorisation Number
National Authorisation Number
MAH of product in the Member State
Member State where product is authorised
Etoricoxib Zentiva 90 mg compridos revestidos por película
EE/H/0211/003 5692421 SANOFI - PRODUTOS FARMACEUTICOS LDA
PT
Etoricoxib Zentiva 90 mg film-coated tablets
EE/H/0211/003 MA082/08503 SANOFI MALTA LTD MT
Etoricoxib Zentiva 90 mg film-coated tablets
EE/H/0211/003 MA082/08503 SANOFI MALTA LTD MT
Etoricoxib Zentiva 90 mg film-coated tablets
EE/H/0211/003 MA082/08503 SANOFI MALTA LTD MT
Etoricoxib Zentiva 90 mg film-coated tablets
EE/H/0211/003 MA082/08503 SANOFI MALTA LTD MT
Etoricoxib Zentiva 90 mg film-coated tablets
EE/H/0211/003 MA082/08503 SANOFI MALTA LTD MT
Etoricoxib Zentiva 90 mg film-coated tablets
EE/H/0211/003 MA082/08503 SANOFI MALTA LTD MT
Etoricoxib Zentiva 90 mg film-coated tablets
EE/H/0211/003 MA082/08503 SANOFI MALTA LTD MT
Etoricoxib Zentiva 90 mg film-coated tablets
EE/H/0211/003 MA082/08503 SANOFI MALTA LTD MT
Etoricoxib Zentiva 90 mg film-coated tablets
EE/H/0211/003 MA082/08503 SANOFI MALTA LTD MT
Etoricoxib Zentiva 90 mg film-coated tablets
EE/H/0211/003 MA082/08503 SANOFI MALTA LTD MT
Etoricoxib Zentiva 90 mg film-coated tablets
EE/H/0211/003 MA082/08503 SANOFI MALTA LTD MT
Etoricoxib Zentiva 90 mg film-coated tablets
EE/H/0211/003 MA082/08503 SANOFI MALTA LTD MT
Etoricoxib Zentiva 90 mg Filmtabletten
EE/H/0211/003 92973.00.00 ZENTIVA PHARMA GMBH DE
List of nationally authorised medicinal products EMA/812634/2017 Page 165/231
Product Name (in authorisation country)
MRP/DCP Authorisation Number
National Authorisation Number
MAH of product in the Member State
Member State where product is authorised
Etoricoxib Zentiva 90 mg Filmtabletten
EE/H/0211/003 92973.00.00 ZENTIVA PHARMA GMBH DE
Etoricoxib Zentiva 90 mg Filmtabletten
EE/H/0211/003 92973.00.00 ZENTIVA PHARMA GMBH DE
Etoricoxib Zentiva 90 mg Filmtabletten
EE/H/0211/003 92973.00.00 ZENTIVA PHARMA GMBH DE
Etoricoxib Zentiva 90 mg Filmtabletten
EE/H/0211/003 92973.00.00 ZENTIVA PHARMA GMBH DE
Etoricoxib Zentiva 90 mg Filmtabletten
EE/H/0211/003 92973.00.00 ZENTIVA PHARMA GMBH DE
Etoricoxib Zentiva 90 mg Filmtabletten
EE/H/0211/003 92973.00.00 ZENTIVA PHARMA GMBH DE
Etoricoxib Zentiva 90 mg Filmtabletten
EE/H/0211/003 92973.00.00 ZENTIVA PHARMA GMBH DE
Etoricoxib Zentiva 90 mg Filmtabletten
EE/H/0211/003 92973.00.00 ZENTIVA PHARMA GMBH DE
Etoricoxib Zentiva 90 mg Filmtabletten
EE/H/0211/003 92973.00.00 ZENTIVA PHARMA GMBH DE
Etoricoxib Zentiva 90 mg Filmtabletten
EE/H/0211/003 92973.00.00 ZENTIVA PHARMA GMBH DE
Etoricoxib Zentiva 90 mg Filmtabletten
EE/H/0211/003 92973.00.00 ZENTIVA PHARMA GMBH DE
Etoricoxib Zentiva 90 mg plėvele dengtos tabletės
EE/H/0211/003 LT/1/16/3907/015 ZENTIVA, K.S. LT
Etoricoxib Zentiva 90 mg plėvele dengtos tabletės
EE/H/0211/003 LT/1/16/3907/013 ZENTIVA, K.S. LT
Etoricoxib Zentiva 90 mg plėvele dengtos tabletės
EE/H/0211/003 LT/1/16/3907/011 ZENTIVA, K.S. LT
List of nationally authorised medicinal products EMA/812634/2017 Page 166/231
Product Name (in authorisation country)
MRP/DCP Authorisation Number
National Authorisation Number
MAH of product in the Member State
Member State where product is authorised
Etoricoxib Zentiva 90 mg plėvele dengtos tabletės
EE/H/0211/003 LT/1/16/3907/012 ZENTIVA, K.S. LT
Etoricoxib Zentiva 90 mg plėvele dengtos tabletės
EE/H/0211/003 LT/1/16/3907/014 ZENTIVA, K.S. LT
Etoricoxib Zentiva 90 mg plėvele dengtos tabletės
EE/H/0211/003 LT/1/16/3907/010 ZENTIVA, K.S. LT
Etoricoxib Zentiva 90 mg plėvele dengtos tabletės
EE/H/0211/003 LT/1/16/3907/015 ZENTIVA, K.S. LT
Etoricoxib Zentiva 90 mg plėvele dengtos tabletės
EE/H/0211/003 LT/1/16/3907/013 ZENTIVA, K.S. LT
Etoricoxib Zentiva 90 mg plėvele dengtos tabletės
EE/H/0211/003 LT/1/16/3907/011 ZENTIVA, K.S. LT
Etoricoxib Zentiva 90 mg plėvele dengtos tabletės
EE/H/0211/003 LT/1/16/3907/012 ZENTIVA, K.S. LT
Etoricoxib Zentiva 90 mg plėvele dengtos tabletės
EE/H/0211/003 LT/1/16/3907/014 ZENTIVA, K.S. LT
Etoricoxib Zentiva 90 mg plėvele dengtos tabletės
EE/H/0211/003 LT/1/16/3907/010 ZENTIVA, K.S. LT
Etoricoxib Zentiva 90 mg, õhukese polümeerikattega tabletid
EE/H/0211/003 907016 ZENTIVA, K.S. EE
Etoricoxib Zentiva 90 mg, õhukese polümeerikattega tabletid
EE/H/0211/003 907016 ZENTIVA, K.S. EE
Etoricoxib Zentiva 90 mg, õhukese polümeerikattega tabletid
EE/H/0211/003 907016 ZENTIVA, K.S. EE
Etoricoxib Zentiva 90 mg, õhukese polümeerikattega tabletid
EE/H/0211/003 907016 ZENTIVA, K.S. EE
Etoricoxib Zentiva 90 mg, õhukese polümeerikattega tabletid
EE/H/0211/003 907016 ZENTIVA, K.S. EE
List of nationally authorised medicinal products EMA/812634/2017 Page 167/231
Product Name (in authorisation country)
MRP/DCP Authorisation Number
National Authorisation Number
MAH of product in the Member State
Member State where product is authorised
Etoricoxib Zentiva 90 mg, õhukese polümeerikattega tabletid
EE/H/0211/003 907016 ZENTIVA, K.S. EE
Etoricoxib Zentiva 90 mg, õhukese polümeerikattega tabletid
EE/H/0211/003 907016 ZENTIVA, K.S. EE
Etoricoxib Zentiva 90 mg, õhukese polümeerikattega tabletid
EE/H/0211/003 907016 ZENTIVA, K.S. EE
Etoricoxib Zentiva 90 mg, õhukese polümeerikattega tabletid
EE/H/0211/003 907016 ZENTIVA, K.S. EE
Etoricoxib Zentiva 90 mg, õhukese polümeerikattega tabletid
EE/H/0211/003 907016 ZENTIVA, K.S. EE
Etoricoxib Zentiva 90 mg, õhukese polümeerikattega tabletid
EE/H/0211/003 907016 ZENTIVA, K.S. EE
Etoricoxib Zentiva 90 mg, õhukese polümeerikattega tabletid
EE/H/0211/003 907016 ZENTIVA, K.S. EE
Etoricoxib Zydus 120 mg comprimés pelliculés
DE/H/3469/004 BE445304 ZYDUS FRANCE BE
Etoricoxib Zydus 120 mg comprimidos recubiertos con película EFG
DE/H/3469/004 79986 ZYDUS FRANCE ES
Etoricoxib Zydus 120 mg comprimidos revestidos por película
DE/H/3469/004 5633847 ZYDUS FRANCE PT
Etoricoxib Zydus 120 mg filmomhulde tabletten
DE/H/3469/004 RVG 111531 ZYDUS FRANCE NL
Etoricoxib Zydus 120 mg filmtabletta
DE/H/3469/004 OGYI-T-225771/04 ZYDUS FRANCE HU
Etoricoxib Zydus 120 mg Filmtabletten
DE/H/3469/004 86169.00.00 ZYDUS FRANCE DE
List of nationally authorised medicinal products EMA/812634/2017 Page 168/231
Product Name (in authorisation country)
MRP/DCP Authorisation Number
National Authorisation Number
MAH of product in the Member State
Member State where product is authorised
Etoricoxib Zydus 120 mg επικαλυμμένα με λεπτό υμένιο δισκία
DE/H/3469/004 3018904 ZYDUS FRANCE GR
Etoricoxib Zydus 30 mg comprimés pelliculés
DE/H/3469/001 BE445277 ZYDUS FRANCE BE
Etoricoxib Zydus 30 mg comprimidos recubiertos con película EFG
DE/H/3469/001 79900 ZYDUS FRANCE ES
Etoricoxib Zydus 30 mg comprimidos revestidos por película
DE/H/3469/001 5633821 ZYDUS FRANCE PT
Etoricoxib Zydus 30 mg filmomhulde tabletten
DE/H/3469/001 RVG 111528 ZYDUS FRANCE NL
Etoricoxib Zydus 30 mg filmtabletta
DE/H/3469/001 OGYI-T-225771/01 ZYDUS FRANCE HU
Etoricoxib Zydus 30 mg Filmtabletten
DE/H/3469/001 86166.00.00 ZYDUS FRANCE DE
Etoricoxib Zydus 30 mg επικαλυμμένα με λεπτό υμένιο δισκία
DE/H/3469/001 3018901 ZYDUS FRANCE GR
Etoricoxib Zydus 60 mg comprimés pelliculés
DE/H/3469/002 BE445286 ZYDUS FRANCE BE
Etoricoxib Zydus 60 mg comprimidos recubiertos con película EFG
DE/H/3469/002 79901 ZYDUS FRANCE ES
Etoricoxib Zydus 60 mg comprimidos revestidos por película
DE/H/3469/002 5633813 ZYDUS FRANCE PT
List of nationally authorised medicinal products EMA/812634/2017 Page 169/231
Product Name (in authorisation country)
MRP/DCP Authorisation Number
National Authorisation Number
MAH of product in the Member State
Member State where product is authorised
Etoricoxib Zydus 60 mg filmomhulde tabletten
DE/H/3469/002 RVG 111529 ZYDUS FRANCE NL
Etoricoxib Zydus 60 mg filmtabletta
DE/H/3469/002 OGYI-T-225771/02 ZYDUS FRANCE HU
Etoricoxib Zydus 60 mg Filmtabletten
DE/H/3469/002 86167.00.00 ZYDUS FRANCE DE
Etoricoxib Zydus 60 mg επικαλυμμένα με λεπτό υμένιο δισκία
DE/H/3469/002 3018902 ZYDUS FRANCE GR
Etoricoxib Zydus 90 mg comprimés pelliculés
DE/H/3469/003 BE445295 ZYDUS FRANCE BE
Etoricoxib Zydus 90 mg comprimidos recubiertos con película EFG
DE/H/3469/003 79902 ZYDUS FRANCE ES
Etoricoxib Zydus 90 mg comprimidos revestidos por película
DE/H/3469/003 5633839 ZYDUS FRANCE PT
Etoricoxib Zydus 90 mg filmomhulde tabletten
DE/H/3469/003 RVG 111530 ZYDUS FRANCE NL
Etoricoxib Zydus 90 mg filmtabletta
DE/H/3469/003 OGYI-T-225771/03 ZYDUS FRANCE HU
Etoricoxib Zydus 90 mg Filmtabletten
DE/H/3469/003 86168.00.00 ZYDUS FRANCE DE
Etoricoxib Zydus 90 mg επικαλυμμένα με λεπτό υμένιο δισκία
DE/H/3469/003 3018903 ZYDUS FRANCE GR
Etoricoxib Zydus France 120 mg compresse rivestite con film
DE/H/3469/001 042146047 ZYDUS FRANCE IT
List of nationally authorised medicinal products EMA/812634/2017 Page 170/231
Product Name (in authorisation country)
MRP/DCP Authorisation Number
National Authorisation Number
MAH of product in the Member State
Member State where product is authorised
ETORICOXIB ZYDUS FRANCE 120 mg comprimé pelliculé
DE/H/3469/004 34009 300 202 4 1 ZYDUS FRANCE FR
Etoricoxib Zydus France 30 mg compresse rivestite con film
DE/H/3469/001 042146011 ZYDUS FRANCE IT
ETORICOXIB ZYDUS FRANCE 30 mg comprimé pelliculé
DE/H/3469/001 34009 300 197 9 5 ZYDUS FRANCE FR
Etoricoxib Zydus France 60 mg compresse rivestite con film
DE/H/3469/001 042146023 ZYDUS FRANCE IT
ETORICOXIB ZYDUS FRANCE 60 mg comprimé pelliculé
DE/H/3469/002 34009 300 202 2 7 ZYDUS FRANCE FR
Etoricoxib Zydus France 90 mg compresse rivestite con film
DE/H/3469/001 042146035 ZYDUS FRANCE IT
ETORICOXIB ZYDUS FRANCE 90 mg comprimé pelliculé
DE/H/3469/003 34009 300 202 3 4 ZYDUS FRANCE FR
Etoricoxib Zydus, 120 mg, tabletki powlekane
DE/H/3469/004 22052 ZYDUS FRANCE PL
Etoricoxib Zydus, 30 mg, tabletki powlekane
DE/H/3469/001 22049 ZYDUS FRANCE PL
Etoricoxib Zydus, 60 mg, tabletki powlekane
DE/H/3469/002 22050 ZYDUS FRANCE PL
Etoricoxib Zydus, 90, mg tabletki powlekane
DE/H/3469/003 22051 ZYDUS FRANCE PL
Etoricoxib-ratiopharm 120 mg Filmtabletten
DE/H/5032/004 92420.00.00 RATIOPHARM GMBH DE
Etoricoxib-ratiopharm 120 mg Filmtabletten
DE/H/5032/004 2016110295 RATIOPHARM GMBH LU
Etoricoxib-ratiopharm 30 mg Filmtabletten
DE/H/5032/001 92417.00.00 RATIOPHARM GMBH DE
List of nationally authorised medicinal products EMA/812634/2017 Page 171/231
Product Name (in authorisation country)
MRP/DCP Authorisation Number
National Authorisation Number
MAH of product in the Member State
Member State where product is authorised
Etoricoxib-ratiopharm 30 mg Filmtabletten
DE/H/5032/001 2016110292 RATIOPHARM GMBH LU
Etoricoxib-ratiopharm 60 mg Filmtabletten
DE/H/5032/002 92418.00.00 RATIOPHARM GMBH DE
Etoricoxib-ratiopharm 60 mg Filmtabletten
DE/H/5032/002 2016110293 RATIOPHARM GMBH LU
Etoricoxib-ratiopharm 90 mg Filmtabletten
DE/H/5032/003 92419.00.00 RATIOPHARM GMBH DE
Etoricoxib-ratiopharm 90 mg Filmtabletten
DE/H/5032/003 2016110294 RATIOPHARM GMBH LU
Etorikoksib Lek 90 mg filmsko obložene tablete
DE/H/3908/003 H/15/02067/073 LEK PHARMACEUTICALS D.D. LJUBLJANA
SI
Etorikoksib STADA 120 mg filmsko obložene tablete
DE/H/4251/004 H/17/02292/022 STADA ARZNEIMITTEL AG SI
Etorikoksib STADA 120 mg filmsko obložene tablete
DE/H/4251/004 H/17/02292/021 STADA ARZNEIMITTEL AG SI
Etorikoksib STADA 120 mg filmsko obložene tablete
DE/H/4251/004 H/17/02292/026 STADA ARZNEIMITTEL AG SI
Etorikoksib STADA 120 mg filmsko obložene tablete
DE/H/4251/004 H/17/02292/023 STADA ARZNEIMITTEL AG SI
Etorikoksib STADA 120 mg filmsko obložene tablete
DE/H/4251/004 H/17/02292/027 STADA ARZNEIMITTEL AG SI
Etorikoksib STADA 120 mg filmsko obložene tablete
DE/H/4251/004 H/17/02292/024 STADA ARZNEIMITTEL AG SI
Etorikoksib STADA 120 mg filmsko obložene tablete
DE/H/4251/004 H/17/02292/025 STADA ARZNEIMITTEL AG SI
Etorikoksib STADA 60 mg filmsko obložene tablete
DE/H/4251/002 H/17/02292/004 STADA ARZNEIMITTEL AG SI
List of nationally authorised medicinal products EMA/812634/2017 Page 172/231
Product Name (in authorisation country)
MRP/DCP Authorisation Number
National Authorisation Number
MAH of product in the Member State
Member State where product is authorised
Etorikoksib STADA 60 mg filmsko obložene tablete
DE/H/4251/002 H/17/02292/005 STADA ARZNEIMITTEL AG SI
Etorikoksib STADA 60 mg filmsko obložene tablete
DE/H/4251/002 H/17/02292/006 STADA ARZNEIMITTEL AG SI
Etorikoksib STADA 60 mg filmsko obložene tablete
DE/H/4251/002 H/17/02292/002 STADA ARZNEIMITTEL AG SI
Etorikoksib STADA 60 mg filmsko obložene tablete
DE/H/4251/002 H/17/02292/003 STADA ARZNEIMITTEL AG SI
Etorikoksib STADA 60 mg filmsko obložene tablete
DE/H/4251/002 H/17/02292/007 STADA ARZNEIMITTEL AG SI
Etorikoksib STADA 60 mg filmsko obložene tablete
DE/H/4251/002 H/17/02292/009 STADA ARZNEIMITTEL AG SI
Etorikoksib STADA 60 mg filmsko obložene tablete
DE/H/4251/002 H/17/02292/001 STADA ARZNEIMITTEL AG SI
Etorikoksib STADA 60 mg filmsko obložene tablete
DE/H/4251/002 H/17/02292/008 STADA ARZNEIMITTEL AG SI
Etorikoksib STADA 60 mg filmsko obložene tablete
DE/H/4251/002 H/17/02292/010 STADA ARZNEIMITTEL AG SI
Etorikoksib STADA 90 mg filmsko obložene tablete
DE/H/4251/003 H/17/02292/015 STADA ARZNEIMITTEL AG SI
Etorikoksib STADA 90 mg filmsko obložene tablete
DE/H/4251/003 H/17/02292/014 STADA ARZNEIMITTEL AG SI
Etorikoksib STADA 90 mg filmsko obložene tablete
DE/H/4251/003 H/17/02292/012 STADA ARZNEIMITTEL AG SI
Etorikoksib STADA 90 mg filmsko obložene tablete
DE/H/4251/003 H/17/02292/011 STADA ARZNEIMITTEL AG SI
Etorikoksib STADA 90 mg filmsko obložene tablete
DE/H/4251/003 H/17/02292/018 STADA ARZNEIMITTEL AG SI
List of nationally authorised medicinal products EMA/812634/2017 Page 173/231
Product Name (in authorisation country)
MRP/DCP Authorisation Number
National Authorisation Number
MAH of product in the Member State
Member State where product is authorised
Etorikoksib STADA 90 mg filmsko obložene tablete
DE/H/4251/003 H/17/02292/016 STADA ARZNEIMITTEL AG SI
Etorikoksib STADA 90 mg filmsko obložene tablete
DE/H/4251/003 H/17/02292/013 STADA ARZNEIMITTEL AG SI
Etorikoksib STADA 90 mg filmsko obložene tablete
DE/H/4251/003 H/17/02292/020 STADA ARZNEIMITTEL AG SI
Etorikoksib STADA 90 mg filmsko obložene tablete
DE/H/4251/003 H/17/02292/019 STADA ARZNEIMITTEL AG SI
Etorikoksib STADA 90 mg filmsko obložene tablete
DE/H/4251/003 H/17/02292/017 STADA ARZNEIMITTEL AG SI
Etorilin NL/H/3271/001 58341 SYNTHON BV DK Etorilin NL/H/3271/004 58344 SYNTHON BV DK Etorilin NL/H/3271/002 58342 SYNTHON BV DK Etorilin NL/H/3271/003 58343 SYNTHON BV DK Etoxib 120 mg filmom obložene tablete
HU/H/0435/004 HR-H-399675011 KRKA-FARMA D.O.O. HR
Etoxib 30 mg filmom obložene tablete
HU/H/0435/001 HR-H-568519667 KRKA-FARMA D.O.O. HR
Etoxib 60 mg filmom obložene tablete
HU/H/0435/002 HR-H-352347859 KRKA-FARMA D.O.O. HR
Etoxib 90 mg filmom obložene tablete
HU/H/0435/003 HR-H-589688667 KRKA-FARMA D.O.O. HR
Etoxib, 120 mg õhukese polümeerikattega tabletid
HU/H/0435/004 921816 KRKA, D.D., NOVO MESTO EE
Etoxib, 30 mg õhukese polümeerikattega tabletid
HU/H/0435/001 921516 KRKA, D.D., NOVO MESTO EE
Etoxib, 60 mg õhukese polümeerikattega tabletid
HU/H/0435/002 921616 KRKA, D.D., NOVO MESTO EE
List of nationally authorised medicinal products EMA/812634/2017 Page 174/231
Product Name (in authorisation country)
MRP/DCP Authorisation Number
National Authorisation Number
MAH of product in the Member State
Member State where product is authorised
Etoxib, 90 mg õhukese polümeerikattega tabletid
HU/H/0435/003 921716 KRKA, D.D., NOVO MESTO EE
Evetore 120 mg Filmtabletten NL/H/3271/004 2016060161 SYNTHON BV LU Evetore 120 mg tabletten NL/H/3271/004 RVG 116030 SYNTHON BV NL Evetore 30 mg Filmtabletten NL/H/3271/001 2016060158 SYNTHON BV LU Evetore 30 mg tabletten NL/H/3271/001 RVG 116027 SYNTHON BV NL Evetore 60 mg Filmtabletten NL/H/3271/002 2016060159 SYNTHON BV LU Evetore 60 mg tabletten NL/H/3271/002 RVG 116028 SYNTHON BV NL Evetore 90 mg Filmtabletten NL/H/3271/003 2016060160 SYNTHON BV LU Evetore 90 mg tabletten NL/H/3271/003 RVG 116029 SYNTHON BV NL EXINEF 120 mg compresse rivestite con film
UK/H/0534/004 035822295 ABIOGEN PHARMA S.P.A. IT
EXINEF 120 mg compresse rivestite con film
UK/H/0534/004 035822307 ABIOGEN PHARMA S.P.A. IT
EXINEF 120 mg compresse rivestite con film
UK/H/0534/004 035822319 ABIOGEN PHARMA S.P.A. IT
EXINEF 120 mg compresse rivestite con film
UK/H/0534/004 035822321 ABIOGEN PHARMA S.P.A. IT
EXINEF 120 mg compresse rivestite con film
UK/H/0534/004 035822333 ABIOGEN PHARMA S.P.A. IT
EXINEF 120 mg compresse rivestite con film
UK/H/0534/004 035822345 ABIOGEN PHARMA S.P.A. IT
EXINEF 120 mg compresse rivestite con film
UK/H/0534/004 035822358 ABIOGEN PHARMA S.P.A. IT
EXINEF 120 mg compresse rivestite con film
UK/H/0534/004 035822360 ABIOGEN PHARMA S.P.A. IT
EXINEF 120 mg compresse rivestite con film
UK/H/0534/004 035822372 ABIOGEN PHARMA S.P.A. IT
List of nationally authorised medicinal products EMA/812634/2017 Page 175/231
Product Name (in authorisation country)
MRP/DCP Authorisation Number
National Authorisation Number
MAH of product in the Member State
Member State where product is authorised
EXINEF 120 mg compresse rivestite con film
UK/H/0534/004 035822384 ABIOGEN PHARMA S.P.A. IT
EXINEF 120 mg compresse rivestite con film
UK/H/0534/004 035822396 ABIOGEN PHARMA S.P.A. IT
EXINEF 120 mg compresse rivestite con film
UK/H/0534/004 035822408 ABIOGEN PHARMA S.P.A. IT
EXINEF 120 mg compresse rivestite con film
UK/H/0534/004 035822410 ABIOGEN PHARMA S.P.A. IT
EXINEF 120 mg compresse rivestite con film
UK/H/0534/004 035822422 ABIOGEN PHARMA S.P.A. IT
EXINEF 30 mg compresse rivestite con film
UK/H/0534/001 035822446 ABIOGEN PHARMA S.P.A. IT
EXINEF 30 mg compresse rivestite con film
UK/H/0534/001 035822434 ABIOGEN PHARMA S.P.A. IT
EXINEF 30 mg compresse rivestite con film
UK/H/0534/001 035822459 ABIOGEN PHARMA S.P.A. IT
EXINEF 60 mg compresse rivestite con film
UK/H/0534/002 035822016 ABIOGEN PHARMA S.P.A. IT
EXINEF 60 mg compresse rivestite con film
UK/H/0534/002 035822028 ABIOGEN PHARMA S.P.A. IT
EXINEF 60 mg compresse rivestite con film
UK/H/0534/002 035822030 ABIOGEN PHARMA S.P.A. IT
EXINEF 60 mg compresse rivestite con film
UK/H/0534/002 035822042 ABIOGEN PHARMA S.P.A. IT
EXINEF 60 mg compresse rivestite con film
UK/H/0534/002 035822055 ABIOGEN PHARMA S.P.A. IT
EXINEF 60 mg compresse rivestite con film
UK/H/0534/002 035822067 ABIOGEN PHARMA S.P.A. IT
List of nationally authorised medicinal products EMA/812634/2017 Page 176/231
Product Name (in authorisation country)
MRP/DCP Authorisation Number
National Authorisation Number
MAH of product in the Member State
Member State where product is authorised
EXINEF 60 mg compresse rivestite con film
UK/H/0534/002 035822079 ABIOGEN PHARMA S.P.A. IT
EXINEF 60 mg compresse rivestite con film
UK/H/0534/002 035822081 ABIOGEN PHARMA S.P.A. IT
EXINEF 60 mg compresse rivestite con film
UK/H/0534/002 035822093 ABIOGEN PHARMA S.P.A. IT
EXINEF 60 mg compresse rivestite con film
UK/H/0534/002 035822105 ABIOGEN PHARMA S.P.A. IT
EXINEF 60 mg compresse rivestite con film
UK/H/0534/002 035822117 ABIOGEN PHARMA S.P.A. IT
EXINEF 60 mg compresse rivestite con film
UK/H/0534/002 035822129 ABIOGEN PHARMA S.P.A. IT
EXINEF 60 mg compresse rivestite con film
UK/H/0534/002 035822131 ABIOGEN PHARMA S.P.A. IT
EXINEF 60 mg compresse rivestite con film
UK/H/0534/002 035822143 ABIOGEN PHARMA S.P.A. IT
EXINEF 60 mg compresse rivestite con film
UK/H/0534/002 035822461 ABIOGEN PHARMA S.P.A. IT
EXINEF 90 mg compresse rivestite con film
UK/H/0534/003 035822156 ABIOGEN PHARMA S.P.A. IT
EXINEF 90 mg compresse rivestite con film
UK/H/0534/003 035822168 ABIOGEN PHARMA S.P.A. IT
EXINEF 90 mg compresse rivestite con film
UK/H/0534/003 035822170 ABIOGEN PHARMA S.P.A. IT
EXINEF 90 mg compresse rivestite con film
UK/H/0534/003 035822182 ABIOGEN PHARMA S.P.A. IT
EXINEF 90 mg compresse rivestite con film
UK/H/0534/003 035822194 ABIOGEN PHARMA S.P.A. IT
List of nationally authorised medicinal products EMA/812634/2017 Page 177/231
Product Name (in authorisation country)
MRP/DCP Authorisation Number
National Authorisation Number
MAH of product in the Member State
Member State where product is authorised
EXINEF 90 mg compresse rivestite con film
UK/H/0534/003 035822206 ABIOGEN PHARMA S.P.A. IT
EXINEF 90 mg compresse rivestite con film
UK/H/0534/003 035822218 ABIOGEN PHARMA S.P.A. IT
EXINEF 90 mg compresse rivestite con film
UK/H/0534/003 035822220 ABIOGEN PHARMA S.P.A. IT
EXINEF 90 mg compresse rivestite con film
UK/H/0534/003 035822232 ABIOGEN PHARMA S.P.A. IT
EXINEF 90 mg compresse rivestite con film
UK/H/0534/003 035822244 ABIOGEN PHARMA S.P.A. IT
EXINEF 90 mg compresse rivestite con film
UK/H/0534/003 035822257 ABIOGEN PHARMA S.P.A. IT
EXINEF 90 mg compresse rivestite con film
UK/H/0534/003 035822269 ABIOGEN PHARMA S.P.A. IT
EXINEF 90 mg compresse rivestite con film
UK/H/0534/003 035822271 ABIOGEN PHARMA S.P.A. IT
EXINEF 90 mg compresse rivestite con film
UK/H/0534/003 035822283 ABIOGEN PHARMA S.P.A. IT
EXXIV 120 mg comprimidos revestidos por película
UK/H/0534/003 4110284 BIAL - PORTELA & Cª , SA PT
EXXIV 120 mg comprimidos revestidos por película
UK/H/0534/004 4110383 BIAL - PORTELA & Cª , SA PT
EXXIV 120 mg comprimidos revestidos por película
UK/H/0534/004 4110482 BIAL - PORTELA & Cª , SA PT
EXXIV 120 mg comprimidos revestidos por película
UK/H/0534/004 4110581 BIAL - PORTELA & Cª , SA PT
EXXIV 120 mg comprimidos revestidos por película
UK/H/0534/004 4110680 BIAL - PORTELA & Cª , SA PT
List of nationally authorised medicinal products EMA/812634/2017 Page 178/231
Product Name (in authorisation country)
MRP/DCP Authorisation Number
National Authorisation Number
MAH of product in the Member State
Member State where product is authorised
EXXIV 120 mg comprimidos revestidos por película
UK/H/0534/004 4110789 BIAL - PORTELA & Cª , SA PT
EXXIV 120 mg comprimidos revestidos por película
UK/H/0534/004 4110888 BIAL - PORTELA & Cª , SA PT
EXXIV 120 mg comprimidos revestidos por película
UK/H/0534/004 4110987 BIAL - PORTELA & Cª , SA PT
EXXIV 120 mg comprimidos revestidos por película
UK/H/0534/004 4111084 BIAL - PORTELA & Cª , SA PT
EXXIV 120 mg comprimidos revestidos por película
UK/H/0534/004 4242285 BIAL - PORTELA & Cª , SA PT
EXXIV 120 mg comprimidos revestidos por película
UK/H/0534/004 4111183 BIAL - PORTELA & Cª , SA PT
EXXIV 120 mg comprimidos revestidos por película
UK/H/0534/004 4111282 BIAL - PORTELA & Cª , SA PT
EXXIV 120 mg comprimidos revestidos por película
UK/H/0534/004 4111589 BIAL - PORTELA & Cª , SA PT
EXXIV 120 mg comprimidos revestidos por película
UK/H/0534/004 4242186 BIAL - PORTELA & Cª , SA PT
EXXIV 120 mg comprimidos revestidos por película
UK/H/0534/004 4111381 BIAL - PORTELA & Cª , SA PT
EXXIV 120 mg comprimidos revestidos por película
UK/H/0534/004 4111480 BIAL - PORTELA & Cª , SA PT
EXXIV 120 mg comprimidos recubiertos con película
UK/H/0534/004 64.933 LABORATORIOS ABELLÓ, S.A.
ES
EXXIV 30 mg comprimidos revestidos por película
UK/H/0534/004 5121678 BIAL - PORTELA & Cª , SA PT
EXXIV 30 mg comprimidos revestidos por película
UK/H/0534/001 5063045 BIAL - PORTELA & Cª , SA PT
List of nationally authorised medicinal products EMA/812634/2017 Page 179/231
Product Name (in authorisation country)
MRP/DCP Authorisation Number
National Authorisation Number
MAH of product in the Member State
Member State where product is authorised
EXXIV 30 mg comprimidos recubiertos con película
UK/H/0534/001 72.076 LABORATORIOS ABELLÓ, S.A.
ES
EXXIV 60 mg comprimidos revestidos por película
UK/H/0534/001 4111688 BIAL - PORTELA & Cª , SA PT
EXXIV 60 mg comprimidos revestidos por película
UK/H/0534/002 4111787 BIAL - PORTELA & Cª , SA PT
EXXIV 60 mg comprimidos revestidos por película
UK/H/0534/002 4111886 BIAL - PORTELA & Cª , SA PT
EXXIV 60 mg comprimidos revestidos por película
UK/H/0534/002 4111985 BIAL - PORTELA & Cª , SA PT
EXXIV 60 mg comprimidos revestidos por película
UK/H/0534/002 4112082 BIAL - PORTELA & Cª , SA PT
EXXIV 60 mg comprimidos revestidos por película
UK/H/0534/002 4112181 BIAL - PORTELA & Cª , SA PT
EXXIV 60 mg comprimidos revestidos por película
UK/H/0534/002 4112280 BIAL - PORTELA & Cª , SA PT
EXXIV 60 mg comprimidos revestidos por película
UK/H/0534/002 4112389 BIAL - PORTELA & Cª , SA PT
EXXIV 60 mg comprimidos revestidos por película
UK/H/0534/002 4112488 BIAL - PORTELA & Cª , SA PT
EXXIV 60 mg comprimidos revestidos por película
UK/H/0534/002 4241881 BIAL - PORTELA & Cª , SA PT
EXXIV 60 mg comprimidos revestidos por película
UK/H/0534/002 4112587 BIAL - PORTELA & Cª , SA PT
EXXIV 60 mg comprimidos revestidos por película
UK/H/0534/002 4112686 BIAL - PORTELA & Cª , SA PT
EXXIV 60 mg comprimidos revestidos por película
UK/H/0534/002 4112983 BIAL - PORTELA & Cª , SA PT
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Product Name (in authorisation country)
MRP/DCP Authorisation Number
National Authorisation Number
MAH of product in the Member State
Member State where product is authorised
EXXIV 60 mg comprimidos revestidos por película
UK/H/0534/002 4241782 BIAL - PORTELA & Cª , SA PT
EXXIV 60 mg comprimidos revestidos por película
UK/H/0534/002 4112785 BIAL - PORTELA & Cª , SA PT
EXXIV 60 mg comprimidos revestidos por película
UK/H/0534/002 4112884 BIAL - PORTELA & Cª , SA PT
EXXIV 60 mg comprimidos recubiertos con película
UK/H/0534/002 64.931 LABORATORIOS ABELLÓ, S.A.
ES
EXXIV 90 mg comprimidos revestidos por película
UK/H/0534/002 4113080 BIAL - PORTELA & Cª , SA PT
EXXIV 90 mg comprimidos revestidos por película
UK/H/0534/003 4118584 BIAL - PORTELA & Cª , SA PT
EXXIV 90 mg comprimidos revestidos por película
UK/H/0534/003 4113189 BIAL - PORTELA & Cª , SA PT
EXXIV 90 mg comprimidos revestidos por película
UK/H/0534/003 4113288 BIAL - PORTELA & Cª , SA PT
EXXIV 90 mg comprimidos revestidos por película
UK/H/0534/003 4113387 BIAL - PORTELA & Cª , SA PT
EXXIV 90 mg comprimidos revestidos por película
UK/H/0534/003 4113486 BIAL - PORTELA & Cª , SA PT
EXXIV 90 mg comprimidos revestidos por película
UK/H/0534/003 4113585 BIAL - PORTELA & Cª , SA PT
EXXIV 90 mg comprimidos revestidos por película
UK/H/0534/003 4113684 BIAL - PORTELA & Cª , SA PT
EXXIV 90 mg comprimidos revestidos por película
UK/H/0534/003 4113783 BIAL - PORTELA & Cª , SA PT
EXXIV 90 mg comprimidos revestidos por película
UK/H/0534/003 4242087 BIAL - PORTELA & Cª , SA PT
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Product Name (in authorisation country)
MRP/DCP Authorisation Number
National Authorisation Number
MAH of product in the Member State
Member State where product is authorised
EXXIV 90 mg comprimidos revestidos por película
UK/H/0534/003 4113882 BIAL - PORTELA & Cª , SA PT
EXXIV 90 mg comprimidos revestidos por película
UK/H/0534/003 4113981 BIAL - PORTELA & Cª , SA PT
EXXIV 90 mg comprimidos revestidos por película
UK/H/0534/003 4114286 BIAL - PORTELA & Cª , SA PT
EXXIV 90 mg comprimidos revestidos por película
UK/H/0534/003 4241980 BIAL - PORTELA & Cª , SA PT
EXXIV 90 mg comprimidos revestidos por película
UK/H/0534/003 4114088 BIAL - PORTELA & Cª , SA PT
EXXIV 90 mg comprimidos revestidos por película
UK/H/0534/003 4114187 BIAL - PORTELA & Cª , SA PT
EXXIV 90 mg comprimidos recubiertos con película
UK/H/0534/003 64.932 LABORATORIOS ABELLÓ, S.A.
ES
EXXIV®120 mg film-coated tablets
UK/H/0534/004 PL 0025/0430 MERCK SHARP & DOHME LTD.
UK
EXXIV®30 mg film-coated tablets UK/H/0534/001 PL 0025/0480 MERCK SHARP & DOHME LTD.
UK
EXXIV®60 mg film-coated tablets UK/H/0534/002 PL 0025/0428 MERCK SHARP & DOHME LTD.
UK
EXXIV®90 mg film-coated tablets UK/H/0534/003 PL 0025/0429 MERCK SHARP & DOHME LTD.
UK
Eторикоксиб Актавис 120 mg филмирани таблетки
SE/H/1574/004 20170079 ACTAVIS GROUP PTC EHF. BG
Eторикоксиб Актавис 30 mg филмирани таблетки
SE/H/1574/002 20170077 ACTAVIS GROUP PTC EHF. BG
Eторикоксиб Актавис 30 mg филмирани таблетки
SE/H/1574/001 20170076 ACTAVIS GROUP PTC EHF. BG
List of nationally authorised medicinal products EMA/812634/2017 Page 182/231
Product Name (in authorisation country)
MRP/DCP Authorisation Number
National Authorisation Number
MAH of product in the Member State
Member State where product is authorised
Eторикоксиб Актавис 90 mg филмирани таблетки
SE/H/1574/003 20170078 ACTAVIS GROUP PTC EHF. BG
Halliztolva 120 mg film-coated tablets
SE/H/1633/04 55108 SIGILLATA LIMITED SE
Halliztolva 30 mg film-coated tablets
SE/H/1633/01 55105 SIGILLATA LIMITED SE
Halliztolva 60 mg film-coated tablets
SE/H/1633/02 55106 SIGILLATA LIMITED SE
Halliztolva 90 mg film-coated tablets
SE/H/1633/03 55107 SIGILLATA LIMITED SE
IMESOL 120 mg comprimate filmate
RO/H/0157/004 8568/2016/01 TERAPIA S.A. RO
IMESOL 120 mg comprimate filmate
RO/H/0157/004 8568/2016/02 TERAPIA S.A. RO
IMESOL 30 mg comprimate filmate RO/H/0157/001 8565/2016/01 TERAPIA S.A. RO IMESOL 30 mg comprimate filmate RO/H/0157/001 8565/2016/02 TERAPIA S.A. RO IMESOL 60 mg comprimate filmate RO/H/0157/002 8566/2016/01 TERAPIA S.A. RO IMESOL 60 mg comprimate filmate RO/H/0157/002 8566/2016/02 TERAPIA S.A. RO IMESOL 90 mg comprimate filmate RO/H/0157/003 8567/2016/01 TERAPIA S.A. RO IMESOL 90 mg comprimate filmate RO/H/0157/003 8567/2016/02 TERAPIA S.A. RO Itoroxx 30 mg filmtabletta HU/H/0444/001 OGYI-T-23101/01 KRKA, D.D., NOVO MESTO HU Itoroxx 30 mg filmtabletta HU/H/0444/001 OGYI-T-23101/02 KRKA, D.D., NOVO MESTO HU Itoroxx 30 mg filmtabletta HU/H/0444/001 OGYI-T-23101/03 KRKA, D.D., NOVO MESTO HU Itoroxx 30 mg filmtabletta HU/H/0444/001 OGYI-T-23101/04 KRKA, D.D., NOVO MESTO HU Itoroxx 30 mg filmtabletta HU/H/0444/001 OGYI-T-23101/05 KRKA, D.D., NOVO MESTO HU Itoroxx 60 mg filmtabletta HU/H/0444/002 OGYI-T-23101/06 KRKA, D.D., NOVO MESTO HU Itoroxx 60 mg filmtabletta HU/H/0444/002 OGYI-T-23101/07 KRKA, D.D., NOVO MESTO HU Itoroxx 60 mg filmtabletta HU/H/0444/002 OGYI-T-23101/08 KRKA, D.D., NOVO MESTO HU
List of nationally authorised medicinal products EMA/812634/2017 Page 183/231
Product Name (in authorisation country)
MRP/DCP Authorisation Number
National Authorisation Number
MAH of product in the Member State
Member State where product is authorised
Itoroxx 60 mg filmtabletta HU/H/0444/002 OGYI-T-23101/09 KRKA, D.D., NOVO MESTO HU Itoroxx 60 mg filmtabletta HU/H/0444/002 OGYI-T-23101/10 KRKA, D.D., NOVO MESTO HU KOSTAROX 120 mg comprimate filmate
DE/H/3908/004 7797/2015/01 S.C. SANDOZ S.R.L. RO
KOSTAROX 120 mg comprimate filmate
DE/H/3908/004 7797/2015/02 S.C. SANDOZ S.R.L. RO
KOSTAROX 120 mg comprimate filmate
DE/H/3908/004 7797/2015/03 S.C. SANDOZ S.R.L. RO
KOSTAROX 120 mg comprimate filmate
DE/H/3908/004 7797/2015/04 S.C. SANDOZ S.R.L. RO
KOSTAROX 120 mg comprimate filmate
DE/H/3908/004 7797/2015/05 S.C. SANDOZ S.R.L. RO
KOSTAROX 120 mg comprimate filmate
DE/H/3908/004 7797/2015/06 S.C. SANDOZ S.R.L. RO
KOSTAROX 120 mg comprimate filmate
DE/H/3908/004 7797/2015/07 S.C. SANDOZ S.R.L. RO
KOSTAROX 120 mg comprimate filmate
DE/H/3908/004 7797/2015/08 S.C. SANDOZ S.R.L. RO
KOSTAROX 120 mg comprimate filmate
DE/H/3908/004 7797/2015/09 S.C. SANDOZ S.R.L. RO
KOSTAROX 120 mg comprimate filmate
DE/H/3908/004 7797/2015/10 S.C. SANDOZ S.R.L. RO
KOSTAROX 120 mg comprimate filmate
DE/H/3908/004 7797/2015/11 S.C. SANDOZ S.R.L. RO
KOSTAROX 120 mg comprimate filmate
DE/H/3908/004 7797/2015/12 S.C. SANDOZ S.R.L. RO
KOSTAROX 120 mg comprimate filmate
DE/H/3908/004 7797/2015/13 S.C. SANDOZ S.R.L. RO
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Product Name (in authorisation country)
MRP/DCP Authorisation Number
National Authorisation Number
MAH of product in the Member State
Member State where product is authorised
KOSTAROX 120 mg comprimate filmate
DE/H/3908/004 7797/2015/14 S.C. SANDOZ S.R.L. RO
KOSTAROX 120 mg comprimate filmate
DE/H/3908/004 7797/2015/15 S.C. SANDOZ S.R.L. RO
KOSTAROX 120 mg comprimate filmate
DE/H/3908/004 7797/2015/16 S.C. SANDOZ S.R.L. RO
KOSTAROX 120 mg comprimate filmate
DE/H/3908/004 7797/2015/17 S.C. SANDOZ S.R.L. RO
KOSTAROX 120 mg comprimate filmate
DE/H/3908/004 7797/2015/18 S.C. SANDOZ S.R.L. RO
KOSTAROX 120 mg comprimate filmate
DE/H/3908/004 7797/2015/19 S.C. SANDOZ S.R.L. RO
KOSTAROX 120 mg comprimate filmate
DE/H/3908/004 7797/2015/20 S.C. SANDOZ S.R.L. RO
KOSTAROX 120 mg comprimate filmate
DE/H/3908/004 7797/2015/21 S.C. SANDOZ S.R.L. RO
KOSTAROX 120 mg comprimate filmate
DE/H/3908/004 7797/2015/22 S.C. SANDOZ S.R.L. RO
KOSTAROX 120 mg comprimate filmate
DE/H/3908/004 7797/2015/23 S.C. SANDOZ S.R.L. RO
KOSTAROX 120 mg comprimate filmate
DE/H/3908/004 7797/2015/24 S.C. SANDOZ S.R.L. RO
KOSTAROX 120 mg comprimate filmate
DE/H/3908/004 7797/2015/25 S.C. SANDOZ S.R.L. RO
KOSTAROX 120 mg comprimate filmate
DE/H/3908/004 7797/2015/26 S.C. SANDOZ S.R.L. RO
KOSTAROX 120 mg comprimate filmate
DE/H/3908/004 7797/2015/27 S.C. SANDOZ S.R.L. RO
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Product Name (in authorisation country)
MRP/DCP Authorisation Number
National Authorisation Number
MAH of product in the Member State
Member State where product is authorised
KOSTAROX 120 mg comprimate filmate
DE/H/3908/004 7797/2015/28 S.C. SANDOZ S.R.L. RO
KOSTAROX 120 mg comprimate filmate
DE/H/3908/004 7797/2015/29 S.C. SANDOZ S.R.L. RO
KOSTAROX 120 mg comprimate filmate
DE/H/3908/004 7797/2015/30 S.C. SANDOZ S.R.L. RO
KOSTAROX 120 mg comprimate filmate
DE/H/3908/004 7797/2015/31 S.C. SANDOZ S.R.L. RO
KOSTAROX 120 mg comprimate filmate
DE/H/3908/004 7797/2015/32 S.C. SANDOZ S.R.L. RO
KOSTAROX 120 mg filmom obložene tablete
DE/H/3908/004 HR-H-677376885 SANDOZ D.O.O. HR
KOSTAROX 120 mg filmsko obložene tablete
DE/H/3908/004 H/15/02067/097 LEK PHARMACEUTICALS D.D. LJUBLJANA
SI
KOSTAROX 120 mg filmsko obložene tablete
DE/H/3908/004 H/15/02067/098 LEK PHARMACEUTICALS D.D. LJUBLJANA
SI
KOSTAROX 120 mg filmsko obložene tablete
DE/H/3908/004 H/15/02067/099 LEK PHARMACEUTICALS D.D. LJUBLJANA
SI
KOSTAROX 120 mg filmsko obložene tablete
DE/H/3908/004 H/15/02067/100 LEK PHARMACEUTICALS D.D. LJUBLJANA
SI
KOSTAROX 120 mg filmsko obložene tablete
DE/H/3908/004 H/15/02067/101 LEK PHARMACEUTICALS D.D. LJUBLJANA
SI
KOSTAROX 120 mg filmsko obložene tablete
DE/H/3908/004 H/15/02067/102 LEK PHARMACEUTICALS D.D. LJUBLJANA
SI
KOSTAROX 120 mg filmsko obložene tablete
DE/H/3908/004 H/15/02067/103 LEK PHARMACEUTICALS D.D. LJUBLJANA
SI
KOSTAROX 120 mg filmsko obložene tablete
DE/H/3908/004 H/15/02067/104 LEK PHARMACEUTICALS D.D. LJUBLJANA
SI
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Product Name (in authorisation country)
MRP/DCP Authorisation Number
National Authorisation Number
MAH of product in the Member State
Member State where product is authorised
KOSTAROX 120 mg filmsko obložene tablete
DE/H/3908/004 H/15/02067/105 LEK PHARMACEUTICALS D.D. LJUBLJANA
SI
KOSTAROX 120 mg filmsko obložene tablete
DE/H/3908/004 H/15/02067/106 LEK PHARMACEUTICALS D.D. LJUBLJANA
SI
KOSTAROX 120 mg filmsko obložene tablete
DE/H/3908/004 H/15/02067/107 LEK PHARMACEUTICALS D.D. LJUBLJANA
SI
KOSTAROX 120 mg filmsko obložene tablete
DE/H/3908/004 H/15/02067/108 LEK PHARMACEUTICALS D.D. LJUBLJANA
SI
KOSTAROX 120 mg filmsko obložene tablete
DE/H/3908/004 H/15/02067/109 LEK PHARMACEUTICALS D.D. LJUBLJANA
SI
KOSTAROX 120 mg filmsko obložene tablete
DE/H/3908/004 H/15/02067/110 LEK PHARMACEUTICALS D.D. LJUBLJANA
SI
KOSTAROX 120 mg filmsko obložene tablete
DE/H/3908/004 H/15/02067/111 LEK PHARMACEUTICALS D.D. LJUBLJANA
SI
KOSTAROX 120 mg filmsko obložene tablete
DE/H/3908/004 H/15/02067/112 LEK PHARMACEUTICALS D.D. LJUBLJANA
SI
KOSTAROX 120 mg filmsko obložene tablete
DE/H/3908/004 H/15/02067/113 LEK PHARMACEUTICALS D.D. LJUBLJANA
SI
KOSTAROX 120 mg filmsko obložene tablete
DE/H/3908/004 H/15/02067/114 LEK PHARMACEUTICALS D.D. LJUBLJANA
SI
KOSTAROX 120 mg filmsko obložene tablete
DE/H/3908/004 H/15/02067/115 LEK PHARMACEUTICALS D.D. LJUBLJANA
SI
KOSTAROX 120 mg filmsko obložene tablete
DE/H/3908/004 H/15/02067/116 LEK PHARMACEUTICALS D.D. LJUBLJANA
SI
KOSTAROX 120 mg filmsko obložene tablete
DE/H/3908/004 H/15/02067/117 LEK PHARMACEUTICALS D.D. LJUBLJANA
SI
KOSTAROX 120 mg filmsko obložene tablete
DE/H/3908/004 H/15/02067/118 LEK PHARMACEUTICALS D.D. LJUBLJANA
SI
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Product Name (in authorisation country)
MRP/DCP Authorisation Number
National Authorisation Number
MAH of product in the Member State
Member State where product is authorised
KOSTAROX 120 mg filmsko obložene tablete
DE/H/3908/004 H/15/02067/119 LEK PHARMACEUTICALS D.D. LJUBLJANA
SI
KOSTAROX 120 mg filmsko obložene tablete
DE/H/3908/004 H/15/02067/120 LEK PHARMACEUTICALS D.D. LJUBLJANA
SI
KOSTAROX 120 mg filmsko obložene tablete
DE/H/3908/004 H/15/02067/121 LEK PHARMACEUTICALS D.D. LJUBLJANA
SI
KOSTAROX 120 mg filmsko obložene tablete
DE/H/3908/004 H/15/02067/122 LEK PHARMACEUTICALS D.D. LJUBLJANA
SI
KOSTAROX 120 mg filmsko obložene tablete
DE/H/3908/004 H/15/02067/123 LEK PHARMACEUTICALS D.D. LJUBLJANA
SI
KOSTAROX 120 mg filmsko obložene tablete
DE/H/3908/004 H/15/02067/124 LEK PHARMACEUTICALS D.D. LJUBLJANA
SI
KOSTAROX 120 mg filmsko obložene tablete
DE/H/3908/004 H/15/02067/125 LEK PHARMACEUTICALS D.D. LJUBLJANA
SI
KOSTAROX 120 mg filmsko obložene tablete
DE/H/3908/004 H/15/02067/126 LEK PHARMACEUTICALS D.D. LJUBLJANA
SI
KOSTAROX 120 mg filmsko obložene tablete
DE/H/3908/004 H/15/02067/127 LEK PHARMACEUTICALS D.D. LJUBLJANA
SI
KOSTAROX 120 mg filmsko obložene tablete
DE/H/3908/004 H/15/02067/128 LEK PHARMACEUTICALS D.D. LJUBLJANA
SI
KOSTAROX 30 mg comprimate filmate
DE/H/3908/001 7794/2015/01 S.C. SANDOZ S.R.L. RO
KOSTAROX 30 mg comprimate filmate
DE/H/3908/001 7794/2015/02 S.C. SANDOZ S.R.L. RO
KOSTAROX 30 mg comprimate filmate
DE/H/3908/001 7794/2015/04 S.C. SANDOZ S.R.L. RO
KOSTAROX 30 mg comprimate filmate
DE/H/3908/001 7794/2015/05 S.C. SANDOZ S.R.L. RO
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Product Name (in authorisation country)
MRP/DCP Authorisation Number
National Authorisation Number
MAH of product in the Member State
Member State where product is authorised
KOSTAROX 30 mg comprimate filmate
DE/H/3908/001 7794/2015/06 S.C. SANDOZ S.R.L. RO
KOSTAROX 30 mg comprimate filmate
DE/H/3908/001 7794/2015/07 S.C. SANDOZ S.R.L. RO
KOSTAROX 30 mg comprimate filmate
DE/H/3908/001 7794/2015/08 S.C. SANDOZ S.R.L. RO
KOSTAROX 30 mg comprimate filmate
DE/H/3908/001 7794/2015/09 S.C. SANDOZ S.R.L. RO
KOSTAROX 30 mg comprimate filmate
DE/H/3908/001 7794/2015/10 S.C. SANDOZ S.R.L. RO
KOSTAROX 30 mg comprimate filmate
DE/H/3908/001 7794/2015/11 S.C. SANDOZ S.R.L. RO
KOSTAROX 30 mg comprimate filmate
DE/H/3908/001 7794/2015/12 S.C. SANDOZ S.R.L. RO
KOSTAROX 30 mg comprimate filmate
DE/H/3908/001 7794/2015/13 S.C. SANDOZ S.R.L. RO
KOSTAROX 30 mg comprimate filmate
DE/H/3908/001 7794/2015/14 S.C. SANDOZ S.R.L. RO
KOSTAROX 30 mg comprimate filmate
DE/H/3908/001 7794/2015/15 S.C. SANDOZ S.R.L. RO
KOSTAROX 30 mg comprimate filmate
DE/H/3908/001 7794/2015/16 S.C. SANDOZ S.R.L. RO
KOSTAROX 30 mg comprimate filmate
DE/H/3908/001 7794/2015/17 S.C. SANDOZ S.R.L. RO
KOSTAROX 30 mg comprimate filmate
DE/H/3908/001 7794/2015/18 S.C. SANDOZ S.R.L. RO
KOSTAROX 30 mg comprimate filmate
DE/H/3908/001 7794/2015/19 S.C. SANDOZ S.R.L. RO
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Product Name (in authorisation country)
MRP/DCP Authorisation Number
National Authorisation Number
MAH of product in the Member State
Member State where product is authorised
KOSTAROX 30 mg comprimate filmate
DE/H/3908/001 7794/2015/20 S.C. SANDOZ S.R.L. RO
KOSTAROX 30 mg comprimate filmate
DE/H/3908/001 7794/2015/21 S.C. SANDOZ S.R.L. RO
KOSTAROX 30 mg comprimate filmate
DE/H/3908/001 7794/2015/22 S.C. SANDOZ S.R.L. RO
KOSTAROX 30 mg comprimate filmate
DE/H/3908/001 7794/2015/23 S.C. SANDOZ S.R.L. RO
KOSTAROX 30 mg comprimate filmate
DE/H/3908/001 7794/2015/24 S.C. SANDOZ S.R.L. RO
KOSTAROX 30 mg comprimate filmate
DE/H/3908/001 7794/2015/25 S.C. SANDOZ S.R.L. RO
KOSTAROX 30 mg comprimate filmate
DE/H/3908/001 7794/2015/26 S.C. SANDOZ S.R.L. RO
KOSTAROX 30 mg comprimate filmate
DE/H/3908/001 7794/2015/27 S.C. SANDOZ S.R.L. RO
KOSTAROX 30 mg comprimate filmate
DE/H/3908/001 7794/2015/28 S.C. SANDOZ S.R.L. RO
KOSTAROX 30 mg comprimate filmate
DE/H/3908/001 7794/2015/29 S.C. SANDOZ S.R.L. RO
KOSTAROX 30 mg comprimate filmate
DE/H/3908/001 7794/2015/30 S.C. SANDOZ S.R.L. RO
KOSTAROX 30 mg comprimate filmate
DE/H/3908/001 7794/2015/31 S.C. SANDOZ S.R.L. RO
KOSTAROX 30 mg comprimate filmate
DE/H/3908/001 7794/2015/32 S.C. SANDOZ S.R.L. RO
KOSTAROX 30 mg comprimate filmate
DE/H/3908/001 7794/2015/03 S.C. SANDOZ S.R.L. RO
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Product Name (in authorisation country)
MRP/DCP Authorisation Number
National Authorisation Number
MAH of product in the Member State
Member State where product is authorised
KOSTAROX 30 mg filmom obložene tablete
DE/H/3908/001 HR-H-144691129 SANDOZ D.O.O. HR
KOSTAROX 30 mg filmsko obložene tablete
DE/H/3908/001 H/15/02067/001 LEK PHARMACEUTICALS D.D. LJUBLJANA
SI
KOSTAROX 30 mg filmsko obložene tablete
DE/H/3908/001 H/15/02067/002 LEK PHARMACEUTICALS D.D. LJUBLJANA
SI
KOSTAROX 30 mg filmsko obložene tablete
DE/H/3908/001 H/15/02067/004 LEK PHARMACEUTICALS D.D. LJUBLJANA
SI
KOSTAROX 30 mg filmsko obložene tablete
DE/H/3908/001 H/15/02067/005 LEK PHARMACEUTICALS D.D. LJUBLJANA
SI
KOSTAROX 30 mg filmsko obložene tablete
DE/H/3908/001 H/15/02067/006 LEK PHARMACEUTICALS D.D. LJUBLJANA
SI
KOSTAROX 30 mg filmsko obložene tablete
DE/H/3908/001 H/15/02067/007 LEK PHARMACEUTICALS D.D. LJUBLJANA
SI
KOSTAROX 30 mg filmsko obložene tablete
DE/H/3908/001 H/15/02067/008 LEK PHARMACEUTICALS D.D. LJUBLJANA
SI
KOSTAROX 30 mg filmsko obložene tablete
DE/H/3908/001 H/15/02067/009 LEK PHARMACEUTICALS D.D. LJUBLJANA
SI
KOSTAROX 30 mg filmsko obložene tablete
DE/H/3908/001 H/15/02067/013 LEK PHARMACEUTICALS D.D. LJUBLJANA
SI
KOSTAROX 30 mg filmsko obložene tablete
DE/H/3908/001 H/15/02067/011 LEK PHARMACEUTICALS D.D. LJUBLJANA
SI
KOSTAROX 30 mg filmsko obložene tablete
DE/H/3908/001 H/15/02067/012 LEK PHARMACEUTICALS D.D. LJUBLJANA
SI
KOSTAROX 30 mg filmsko obložene tablete
DE/H/3908/001 H/15/02067/010 LEK PHARMACEUTICALS D.D. LJUBLJANA
SI
KOSTAROX 30 mg filmsko obložene tablete
DE/H/3908/001 H/15/02067/014 LEK PHARMACEUTICALS D.D. LJUBLJANA
SI
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Product Name (in authorisation country)
MRP/DCP Authorisation Number
National Authorisation Number
MAH of product in the Member State
Member State where product is authorised
KOSTAROX 30 mg filmsko obložene tablete
DE/H/3908/001 H/15/02067/015 LEK PHARMACEUTICALS D.D. LJUBLJANA
SI
KOSTAROX 30 mg filmsko obložene tablete
DE/H/3908/001 H/15/02067/018 LEK PHARMACEUTICALS D.D. LJUBLJANA
SI
KOSTAROX 30 mg filmsko obložene tablete
DE/H/3908/001 H/15/02067/020 LEK PHARMACEUTICALS D.D. LJUBLJANA
SI
KOSTAROX 30 mg filmsko obložene tablete
DE/H/3908/001 H/15/02067/022 LEK PHARMACEUTICALS D.D. LJUBLJANA
SI
KOSTAROX 30 mg filmsko obložene tablete
DE/H/3908/001 H/15/02067/028 LEK PHARMACEUTICALS D.D. LJUBLJANA
SI
KOSTAROX 30 mg filmsko obložene tablete
DE/H/3908/001 H/15/02067/030 LEK PHARMACEUTICALS D.D. LJUBLJANA
SI
KOSTAROX 30 mg filmsko obložene tablete
DE/H/3908/001 H/15/02067/029 LEK PHARMACEUTICALS D.D. LJUBLJANA
SI
KOSTAROX 30 mg filmsko obložene tablete
DE/H/3908/001 H/15/02067/023 LEK PHARMACEUTICALS D.D. LJUBLJANA
SI
KOSTAROX 30 mg filmsko obložene tablete
DE/H/3908/001 H/15/02067/025 LEK PHARMACEUTICALS D.D. LJUBLJANA
SI
KOSTAROX 30 mg filmsko obložene tablete
DE/H/3908/001 H/15/02067/027 LEK PHARMACEUTICALS D.D. LJUBLJANA
SI
KOSTAROX 30 mg filmsko obložene tablete
DE/H/3908/001 H/15/02067/031 LEK PHARMACEUTICALS D.D. LJUBLJANA
SI
KOSTAROX 30 mg filmsko obložene tablete
DE/H/3908/001 H/15/02067/024 LEK PHARMACEUTICALS D.D. LJUBLJANA
SI
KOSTAROX 30 mg filmsko obložene tablete
DE/H/3908/001 H/15/02067/003 LEK PHARMACEUTICALS D.D. LJUBLJANA
SI
KOSTAROX 30 mg filmsko obložene tablete
DE/H/3908/001 H/15/02067/016 LEK PHARMACEUTICALS D.D. LJUBLJANA
SI
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Product Name (in authorisation country)
MRP/DCP Authorisation Number
National Authorisation Number
MAH of product in the Member State
Member State where product is authorised
KOSTAROX 30 mg filmsko obložene tablete
DE/H/3908/001 H/15/02067/017 LEK PHARMACEUTICALS D.D. LJUBLJANA
SI
KOSTAROX 30 mg filmsko obložene tablete
DE/H/3908/001 H/15/02067/019 LEK PHARMACEUTICALS D.D. LJUBLJANA
SI
KOSTAROX 30 mg filmsko obložene tablete
DE/H/3908/001 H/15/02067/021 LEK PHARMACEUTICALS D.D. LJUBLJANA
SI
KOSTAROX 30 mg filmsko obložene tablete
DE/H/3908/001 H/15/02067/026 LEK PHARMACEUTICALS D.D. LJUBLJANA
SI
KOSTAROX 30 mg filmsko obložene tablete
DE/H/3908/001 H/15/02067/032 LEK PHARMACEUTICALS D.D. LJUBLJANA
SI
KOSTAROX 60 mg comprimate filmate
DE/H/3908/002 7795/2015/01 S.C. SANDOZ S.R.L. RO
KOSTAROX 60 mg comprimate filmate
DE/H/3908/002 7795/2015/02 S.C. SANDOZ S.R.L. RO
KOSTAROX 60 mg comprimate filmate
DE/H/3908/002 7795/2015/03 S.C. SANDOZ S.R.L. RO
KOSTAROX 60 mg comprimate filmate
DE/H/3908/002 7795/2015/04 S.C. SANDOZ S.R.L. RO
KOSTAROX 60 mg comprimate filmate
DE/H/3908/002 7795/2015/05 S.C. SANDOZ S.R.L. RO
KOSTAROX 60 mg comprimate filmate
DE/H/3908/002 7795/2015/06 S.C. SANDOZ S.R.L. RO
KOSTAROX 60 mg comprimate filmate
DE/H/3908/002 7795/2015/07 S.C. SANDOZ S.R.L. RO
KOSTAROX 60 mg comprimate filmate
DE/H/3908/002 7795/2015/08 S.C. SANDOZ S.R.L. RO
KOSTAROX 60 mg comprimate filmate
DE/H/3908/002 7795/2015/10 S.C. SANDOZ S.R.L. RO
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Product Name (in authorisation country)
MRP/DCP Authorisation Number
National Authorisation Number
MAH of product in the Member State
Member State where product is authorised
KOSTAROX 60 mg comprimate filmate
DE/H/3908/002 7795/2015/11 S.C. SANDOZ S.R.L. RO
KOSTAROX 60 mg comprimate filmate
DE/H/3908/002 7795/2015/12 S.C. SANDOZ S.R.L. RO
KOSTAROX 60 mg comprimate filmate
DE/H/3908/002 7795/2015/13 S.C. SANDOZ S.R.L. RO
KOSTAROX 60 mg comprimate filmate
DE/H/3908/002 7795/2015/14 S.C. SANDOZ S.R.L. RO
KOSTAROX 60 mg comprimate filmate
DE/H/3908/002 7795/2015/15 S.C. SANDOZ S.R.L. RO
KOSTAROX 60 mg comprimate filmate
DE/H/3908/002 7795/2015/16 S.C. SANDOZ S.R.L. RO
KOSTAROX 60 mg comprimate filmate
DE/H/3908/002 7795/2015/17 S.C. SANDOZ S.R.L. RO
KOSTAROX 60 mg comprimate filmate
DE/H/3908/002 7795/2015/18 S.C. SANDOZ S.R.L. RO
KOSTAROX 60 mg comprimate filmate
DE/H/3908/002 7795/2015/19 S.C. SANDOZ S.R.L. RO
KOSTAROX 60 mg comprimate filmate
DE/H/3908/002 7795/2015/20 S.C. SANDOZ S.R.L. RO
KOSTAROX 60 mg comprimate filmate
DE/H/3908/002 7795/2015/21 S.C. SANDOZ S.R.L. RO
KOSTAROX 60 mg comprimate filmate
DE/H/3908/002 7795/2015/22 S.C. SANDOZ S.R.L. RO
KOSTAROX 60 mg comprimate filmate
DE/H/3908/002 7795/2015/23 S.C. SANDOZ S.R.L. RO
KOSTAROX 60 mg comprimate filmate
DE/H/3908/002 7795/2015/24 S.C. SANDOZ S.R.L. RO
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Product Name (in authorisation country)
MRP/DCP Authorisation Number
National Authorisation Number
MAH of product in the Member State
Member State where product is authorised
KOSTAROX 60 mg comprimate filmate
DE/H/3908/002 7795/2015/25 S.C. SANDOZ S.R.L. RO
KOSTAROX 60 mg comprimate filmate
DE/H/3908/002 7795/2015/26 S.C. SANDOZ S.R.L. RO
KOSTAROX 60 mg comprimate filmate
DE/H/3908/002 7795/2015/27 S.C. SANDOZ S.R.L. RO
KOSTAROX 60 mg comprimate filmate
DE/H/3908/002 7795/2015/28 S.C. SANDOZ S.R.L. RO
KOSTAROX 60 mg comprimate filmate
DE/H/3908/002 7795/2015/29 S.C. SANDOZ S.R.L. RO
KOSTAROX 60 mg comprimate filmate
DE/H/3908/002 7795/2015/30 S.C. SANDOZ S.R.L. RO
KOSTAROX 60 mg comprimate filmate
DE/H/3908/002 7795/2015/31 S.C. SANDOZ S.R.L. RO
KOSTAROX 60 mg comprimate filmate
DE/H/3908/002 7795/2015/32 S.C. SANDOZ S.R.L. RO
KOSTAROX 60 mg comprimate filmate
DE/H/3908/002 7795/2015/09 S.C. SANDOZ S.R.L. RO
KOSTAROX 60 mg filmom obložene tablete
DE/H/3908/002 HR-H-034074000 SANDOZ D.O.O. HR
KOSTAROX 60 mg filmsko obložene tablete
DE/H/3908/002 H/15/02067/033 LEK PHARMACEUTICALS D.D. LJUBLJANA
SI
KOSTAROX 60 mg filmsko obložene tablete
DE/H/3908/002 H/15/02067/034 LEK PHARMACEUTICALS D.D. LJUBLJANA
SI
KOSTAROX 60 mg filmsko obložene tablete
DE/H/3908/002 H/15/02067/035 LEK PHARMACEUTICALS D.D. LJUBLJANA
SI
KOSTAROX 60 mg filmsko obložene tablete
DE/H/3908/002 H/15/02067/036 LEK PHARMACEUTICALS D.D. LJUBLJANA
SI
List of nationally authorised medicinal products EMA/812634/2017 Page 195/231
Product Name (in authorisation country)
MRP/DCP Authorisation Number
National Authorisation Number
MAH of product in the Member State
Member State where product is authorised
KOSTAROX 60 mg filmsko obložene tablete
DE/H/3908/002 H/15/02067/042 LEK PHARMACEUTICALS D.D. LJUBLJANA
SI
KOSTAROX 60 mg filmsko obložene tablete
DE/H/3908/002 H/15/02067/037 LEK PHARMACEUTICALS D.D. LJUBLJANA
SI
KOSTAROX 60 mg filmsko obložene tablete
DE/H/3908/002 H/15/02067/043 LEK PHARMACEUTICALS D.D. LJUBLJANA
SI
KOSTAROX 60 mg filmsko obložene tablete
DE/H/3908/002 H/15/02067/039 LEK PHARMACEUTICALS D.D. LJUBLJANA
SI
KOSTAROX 60 mg filmsko obložene tablete
DE/H/3908/002 H/15/02067/041 LEK PHARMACEUTICALS D.D. LJUBLJANA
SI
KOSTAROX 60 mg filmsko obložene tablete
DE/H/3908/002 H/15/02067/040 LEK PHARMACEUTICALS D.D. LJUBLJANA
SI
KOSTAROX 60 mg filmsko obložene tablete
DE/H/3908/002 H/15/02067/038 LEK PHARMACEUTICALS D.D. LJUBLJANA
SI
KOSTAROX 60 mg filmsko obložene tablete
DE/H/3908/002 H/15/02067/044 LEK PHARMACEUTICALS D.D. LJUBLJANA
SI
KOSTAROX 60 mg filmsko obložene tablete
DE/H/3908/002 H/15/02067/045 LEK PHARMACEUTICALS D.D. LJUBLJANA
SI
KOSTAROX 60 mg filmsko obložene tablete
DE/H/3908/002 H/15/02067/046 LEK PHARMACEUTICALS D.D. LJUBLJANA
SI
KOSTAROX 60 mg filmsko obložene tablete
DE/H/3908/002 H/15/02067/048 LEK PHARMACEUTICALS D.D. LJUBLJANA
SI
KOSTAROX 60 mg filmsko obložene tablete
DE/H/3908/002 H/15/02067/049 LEK PHARMACEUTICALS D.D. LJUBLJANA
SI
KOSTAROX 60 mg filmsko obložene tablete
DE/H/3908/002 H/15/02067/050 LEK PHARMACEUTICALS D.D. LJUBLJANA
SI
KOSTAROX 60 mg filmsko obložene tablete
DE/H/3908/002 H/15/02067/051 LEK PHARMACEUTICALS D.D. LJUBLJANA
SI
List of nationally authorised medicinal products EMA/812634/2017 Page 196/231
Product Name (in authorisation country)
MRP/DCP Authorisation Number
National Authorisation Number
MAH of product in the Member State
Member State where product is authorised
KOSTAROX 60 mg filmsko obložene tablete
DE/H/3908/002 H/15/02067/052 LEK PHARMACEUTICALS D.D. LJUBLJANA
SI
KOSTAROX 60 mg filmsko obložene tablete
DE/H/3908/002 H/15/02067/053 LEK PHARMACEUTICALS D.D. LJUBLJANA
SI
KOSTAROX 60 mg filmsko obložene tablete
DE/H/3908/002 H/15/02067/054 LEK PHARMACEUTICALS D.D. LJUBLJANA
SI
KOSTAROX 60 mg filmsko obložene tablete
DE/H/3908/002 H/15/02067/055 LEK PHARMACEUTICALS D.D. LJUBLJANA
SI
KOSTAROX 60 mg filmsko obložene tablete
DE/H/3908/002 H/15/02067/056 LEK PHARMACEUTICALS D.D. LJUBLJANA
SI
KOSTAROX 60 mg filmsko obložene tablete
DE/H/3908/002 H/15/02067/057 LEK PHARMACEUTICALS D.D. LJUBLJANA
SI
KOSTAROX 60 mg filmsko obložene tablete
DE/H/3908/002 H/15/02067/058 LEK PHARMACEUTICALS D.D. LJUBLJANA
SI
KOSTAROX 60 mg filmsko obložene tablete
DE/H/3908/002 H/15/02067/059 LEK PHARMACEUTICALS D.D. LJUBLJANA
SI
KOSTAROX 60 mg filmsko obložene tablete
DE/H/3908/002 H/15/02067/060 LEK PHARMACEUTICALS D.D. LJUBLJANA
SI
KOSTAROX 60 mg filmsko obložene tablete
DE/H/3908/002 H/15/02067/061 LEK PHARMACEUTICALS D.D. LJUBLJANA
SI
KOSTAROX 60 mg filmsko obložene tablete
DE/H/3908/002 H/15/02067/062 LEK PHARMACEUTICALS D.D. LJUBLJANA
SI
KOSTAROX 60 mg filmsko obložene tablete
DE/H/3908/002 H/15/02067/064 LEK PHARMACEUTICALS D.D. LJUBLJANA
SI
KOSTAROX 60 mg filmsko obložene tablete
DE/H/3908/002 H/15/02067/063 LEK PHARMACEUTICALS D.D. LJUBLJANA
SI
KOSTAROX 60 mg filmsko obložene tablete
DE/H/3908/002 H/15/02067/047 LEK PHARMACEUTICALS D.D. LJUBLJANA
SI
List of nationally authorised medicinal products EMA/812634/2017 Page 197/231
Product Name (in authorisation country)
MRP/DCP Authorisation Number
National Authorisation Number
MAH of product in the Member State
Member State where product is authorised
KOSTAROX 90 mg comprimate filmate
DE/H/3908/003 7796/2015/01 S.C. SANDOZ S.R.L. RO
KOSTAROX 90 mg comprimate filmate
DE/H/3908/003 7796/2015/02 S.C. SANDOZ S.R.L. RO
KOSTAROX 90 mg comprimate filmate
DE/H/3908/003 7796/2015/03 S.C. SANDOZ S.R.L. RO
KOSTAROX 90 mg comprimate filmate
DE/H/3908/003 7796/2015/04 S.C. SANDOZ S.R.L. RO
KOSTAROX 90 mg comprimate filmate
DE/H/3908/003 7796/2015/05 S.C. SANDOZ S.R.L. RO
KOSTAROX 90 mg comprimate filmate
DE/H/3908/003 7796/2015/06 S.C. SANDOZ S.R.L. RO
KOSTAROX 90 mg comprimate filmate
DE/H/3908/003 7796/2015/07 S.C. SANDOZ S.R.L. RO
KOSTAROX 90 mg comprimate filmate
DE/H/3908/003 7796/2015/08 S.C. SANDOZ S.R.L. RO
KOSTAROX 90 mg comprimate filmate
DE/H/3908/003 7796/2015/09 S.C. SANDOZ S.R.L. RO
KOSTAROX 90 mg comprimate filmate
DE/H/3908/003 7796/2015/10 S.C. SANDOZ S.R.L. RO
KOSTAROX 90 mg comprimate filmate
DE/H/3908/003 7796/2015/11 S.C. SANDOZ S.R.L. RO
KOSTAROX 90 mg comprimate filmate
DE/H/3908/003 7796/2015/12 S.C. SANDOZ S.R.L. RO
KOSTAROX 90 mg comprimate filmate
DE/H/3908/003 7796/2015/13 S.C. SANDOZ S.R.L. RO
KOSTAROX 90 mg comprimate filmate
DE/H/3908/003 7796/2015/14 S.C. SANDOZ S.R.L. RO
List of nationally authorised medicinal products EMA/812634/2017 Page 198/231
Product Name (in authorisation country)
MRP/DCP Authorisation Number
National Authorisation Number
MAH of product in the Member State
Member State where product is authorised
KOSTAROX 90 mg comprimate filmate
DE/H/3908/003 7796/2015/15 S.C. SANDOZ S.R.L. RO
KOSTAROX 90 mg comprimate filmate
DE/H/3908/003 7796/2015/16 S.C. SANDOZ S.R.L. RO
KOSTAROX 90 mg comprimate filmate
DE/H/3908/003 7796/2015/17 S.C. SANDOZ S.R.L. RO
KOSTAROX 90 mg comprimate filmate
DE/H/3908/003 7796/2015/18 S.C. SANDOZ S.R.L. RO
KOSTAROX 90 mg comprimate filmate
DE/H/3908/003 7796/2015/19 S.C. SANDOZ S.R.L. RO
KOSTAROX 90 mg comprimate filmate
DE/H/3908/003 7796/2015/20 S.C. SANDOZ S.R.L. RO
KOSTAROX 90 mg comprimate filmate
DE/H/3908/003 7796/2015/21 S.C. SANDOZ S.R.L. RO
KOSTAROX 90 mg comprimate filmate
DE/H/3908/003 7796/2015/22 S.C. SANDOZ S.R.L. RO
KOSTAROX 90 mg comprimate filmate
DE/H/3908/003 7796/2015/23 S.C. SANDOZ S.R.L. RO
KOSTAROX 90 mg comprimate filmate
DE/H/3908/003 7796/2015/24 S.C. SANDOZ S.R.L. RO
KOSTAROX 90 mg comprimate filmate
DE/H/3908/003 7796/2015/25 S.C. SANDOZ S.R.L. RO
KOSTAROX 90 mg comprimate filmate
DE/H/3908/003 7796/2015/26 S.C. SANDOZ S.R.L. RO
KOSTAROX 90 mg comprimate filmate
DE/H/3908/003 7796/2015/27 S.C. SANDOZ S.R.L. RO
KOSTAROX 90 mg comprimate filmate
DE/H/3908/003 7796/2015/28 S.C. SANDOZ S.R.L. RO
List of nationally authorised medicinal products EMA/812634/2017 Page 199/231
Product Name (in authorisation country)
MRP/DCP Authorisation Number
National Authorisation Number
MAH of product in the Member State
Member State where product is authorised
KOSTAROX 90 mg comprimate filmate
DE/H/3908/003 7796/2015/29 S.C. SANDOZ S.R.L. RO
KOSTAROX 90 mg comprimate filmate
DE/H/3908/003 7796/2015/31 S.C. SANDOZ S.R.L. RO
KOSTAROX 90 mg comprimate filmate
DE/H/3908/003 7796/2015/30 S.C. SANDOZ S.R.L. RO
KOSTAROX 90 mg comprimate filmate
DE/H/3908/003 7796/2015/32 S.C. SANDOZ S.R.L. RO
KOSTAROX 90 mg filmom obložene tablete
DE/H/3908/003 HR-H-031947675 SANDOZ D.O.O. HR
KOSTAROX 90 mg filmsko obložene tablete
DE/H/3908/003 H/15/02067/065 LEK PHARMACEUTICALS D.D. LJUBLJANA
SI
KOSTAROX 90 mg filmsko obložene tablete
DE/H/3908/003 H/15/02067/066 LEK PHARMACEUTICALS D.D. LJUBLJANA
SI
KOSTAROX 90 mg filmsko obložene tablete
DE/H/3908/003 H/15/02067/067 LEK PHARMACEUTICALS D.D. LJUBLJANA
SI
KOSTAROX 90 mg filmsko obložene tablete
DE/H/3908/003 H/15/02067/068 LEK PHARMACEUTICALS D.D. LJUBLJANA
SI
KOSTAROX 90 mg filmsko obložene tablete
DE/H/3908/003 H/15/02067/069 LEK PHARMACEUTICALS D.D. LJUBLJANA
SI
KOSTAROX 90 mg filmsko obložene tablete
DE/H/3908/003 H/15/02067/070 LEK PHARMACEUTICALS D.D. LJUBLJANA
SI
KOSTAROX 90 mg filmsko obložene tablete
DE/H/3908/003 H/15/02067/071 LEK PHARMACEUTICALS D.D. LJUBLJANA
SI
KOSTAROX 90 mg filmsko obložene tablete
DE/H/3908/003 H/15/02067/072 LEK PHARMACEUTICALS D.D. LJUBLJANA
SI
KOSTAROX 90 mg filmsko obložene tablete
DE/H/3908/003 H/15/02067/073 LEK PHARMACEUTICALS D.D. LJUBLJANA
SI
List of nationally authorised medicinal products EMA/812634/2017 Page 200/231
Product Name (in authorisation country)
MRP/DCP Authorisation Number
National Authorisation Number
MAH of product in the Member State
Member State where product is authorised
KOSTAROX 90 mg filmsko obložene tablete
DE/H/3908/003 H/15/02067/074 LEK PHARMACEUTICALS D.D. LJUBLJANA
SI
KOSTAROX 90 mg filmsko obložene tablete
DE/H/3908/003 H/15/02067/075 LEK PHARMACEUTICALS D.D. LJUBLJANA
SI
KOSTAROX 90 mg filmsko obložene tablete
DE/H/3908/003 H/15/02067/076 LEK PHARMACEUTICALS D.D. LJUBLJANA
SI
KOSTAROX 90 mg filmsko obložene tablete
DE/H/3908/003 H/15/02067/077 LEK PHARMACEUTICALS D.D. LJUBLJANA
SI
KOSTAROX 90 mg filmsko obložene tablete
DE/H/3908/003 H/15/02067/078 LEK PHARMACEUTICALS D.D. LJUBLJANA
SI
KOSTAROX 90 mg filmsko obložene tablete
DE/H/3908/003 H/15/02067/079 LEK PHARMACEUTICALS D.D. LJUBLJANA
SI
KOSTAROX 90 mg filmsko obložene tablete
DE/H/3908/003 H/15/02067/080 LEK PHARMACEUTICALS D.D. LJUBLJANA
SI
KOSTAROX 90 mg filmsko obložene tablete
DE/H/3908/003 H/15/02067/081 LEK PHARMACEUTICALS D.D. LJUBLJANA
SI
KOSTAROX 90 mg filmsko obložene tablete
DE/H/3908/003 H/15/02067/082 LEK PHARMACEUTICALS D.D. LJUBLJANA
SI
KOSTAROX 90 mg filmsko obložene tablete
DE/H/3908/003 H/15/02067/083 LEK PHARMACEUTICALS D.D. LJUBLJANA
SI
KOSTAROX 90 mg filmsko obložene tablete
DE/H/3908/003 H/15/02067/084 LEK PHARMACEUTICALS D.D. LJUBLJANA
SI
KOSTAROX 90 mg filmsko obložene tablete
DE/H/3908/003 H/15/02067/085 LEK PHARMACEUTICALS D.D. LJUBLJANA
SI
KOSTAROX 90 mg filmsko obložene tablete
DE/H/3908/003 H/15/02067/086 LEK PHARMACEUTICALS D.D. LJUBLJANA
SI
KOSTAROX 90 mg filmsko obložene tablete
DE/H/3908/003 H/15/02067/087 LEK PHARMACEUTICALS D.D. LJUBLJANA
SI
List of nationally authorised medicinal products EMA/812634/2017 Page 201/231
Product Name (in authorisation country)
MRP/DCP Authorisation Number
National Authorisation Number
MAH of product in the Member State
Member State where product is authorised
KOSTAROX 90 mg filmsko obložene tablete
DE/H/3908/003 H/15/02067/088 LEK PHARMACEUTICALS D.D. LJUBLJANA
SI
KOSTAROX 90 mg filmsko obložene tablete
DE/H/3908/003 H/15/02067/089 LEK PHARMACEUTICALS D.D. LJUBLJANA
SI
KOSTAROX 90 mg filmsko obložene tablete
DE/H/3908/003 H/15/02067/090 LEK PHARMACEUTICALS D.D. LJUBLJANA
SI
KOSTAROX 90 mg filmsko obložene tablete
DE/H/3908/003 H/15/02067/091 LEK PHARMACEUTICALS D.D. LJUBLJANA
SI
KOSTAROX 90 mg filmsko obložene tablete
DE/H/3908/003 H/15/02067/092 LEK PHARMACEUTICALS D.D. LJUBLJANA
SI
KOSTAROX 90 mg filmsko obložene tablete
DE/H/3908/003 H/15/02067/093 LEK PHARMACEUTICALS D.D. LJUBLJANA
SI
KOSTAROX 90 mg filmsko obložene tablete
DE/H/3908/003 H/15/02067/094 LEK PHARMACEUTICALS D.D. LJUBLJANA
SI
KOSTAROX 90 mg filmsko obložene tablete
DE/H/3908/003 H/15/02067/095 LEK PHARMACEUTICALS D.D. LJUBLJANA
SI
KOSTAROX 90 mg filmsko obložene tablete
DE/H/3908/003 H/15/02067/096 LEK PHARMACEUTICALS D.D. LJUBLJANA
SI
KOSTAROX, 30 mg, tabletki powlekane
DE/H/3908/001 23499 SANDOZ GMBH PL
KOSTAROX, 60 mg, tabletki powlekane
DE/H/3908/002 23500 SANDOZ GMBH PL
KOSTAROX, 90 mg, tabletki powlekane
DE/H/3908/003 23501 SANDOZ GMBH PL
KOSTAROX,120 mg, tabletki powlekane
DE/H/3908/004 23502 SANDOZ GMBH PL
LINZAVO 120 mg filmtabletta DE/H/3908/004 OGYI-T-23054/25 SANDOZ HUNGÁRIA KFT HU LINZAVO 120 mg filmtabletta DE/H/3908/004 OGYI-T -23054/26 SANDOZ HUNGÁRIA KFT HU LINZAVO 120 mg filmtabletta DE/H/3908/004 OGYI-T-23054/27 SANDOZ HUNGÁRIA KFT HU
List of nationally authorised medicinal products EMA/812634/2017 Page 202/231
Product Name (in authorisation country)
MRP/DCP Authorisation Number
National Authorisation Number
MAH of product in the Member State
Member State where product is authorised
LINZAVO 120 mg filmtabletta DE/H/3908/004 OGYI-T-23054/31 SANDOZ HUNGÁRIA KFT HU LINZAVO 120 mg filmtabletta DE/H/3908/004 OGYI-T-23054/29 SANDOZ HUNGÁRIA KFT HU LINZAVO 120 mg filmtabletta DE/H/3908/004 OGYI-T-23054/28 SANDOZ HUNGÁRIA KFT HU LINZAVO 120 mg filmtabletta DE/H/3908/004 OGYI-T -23054/32 SANDOZ HUNGÁRIA KFT HU LINZAVO 120 mg filmtabletta DE/H/3908/004 OGYI-T-23054/30 SANDOZ HUNGÁRIA KFT HU LINZAVO 30 mg filmtabletta DE/H/3908/001 OGYI-T -23054/07 SANDOZ HUNGÁRIA KFT HU LINZAVO 30 mg filmtabletta DE/H/3908/001 OGYI-T-23054/08 SANDOZ HUNGÁRIA KFT HU LINZAVO 30 mg filmtabletta DE/H/3908/001 OGYI-T-23054/04 SANDOZ HUNGÁRIA KFT HU LINZAVO 30 mg filmtabletta DE/H/3908/001 OGYI-T -23054/05 SANDOZ HUNGÁRIA KFT HU LINZAVO 30 mg filmtabletta DE/H/3908/001 OGYI-T-23054/01 SANDOZ HUNGÁRIA KFT HU LINZAVO 30 mg filmtabletta DE/H/3908/001 OGYI-T-23054/02 SANDOZ HUNGÁRIA KFT HU LINZAVO 30 mg filmtabletta DE/H/3908/001 OGYI-T -23054/03 SANDOZ HUNGÁRIA KFT HU LINZAVO 30 mg filmtabletta DE/H/3908/001 OGYI-T-23054/06 SANDOZ HUNGÁRIA KFT HU LINZAVO 60 mg filmtabletta DE/H/3908/002 OGYI-T -23054/09 SANDOZ HUNGÁRIA KFT HU LINZAVO 60 mg filmtabletta DE/H/3908/002 OGYI-T -23054/10 SANDOZ HUNGÁRIA KFT HU LINZAVO 60 mg filmtabletta DE/H/3908/002 OGYI-T -23054/11 SANDOZ HUNGÁRIA KFT HU LINZAVO 60 mg filmtabletta DE/H/3908/002 OGYI-T-23054/12 SANDOZ HUNGÁRIA KFT HU LINZAVO 60 mg filmtabletta DE/H/3908/002 OGYI-T-23054/14 SANDOZ HUNGÁRIA KFT HU LINZAVO 60 mg filmtabletta DE/H/3908/002 OGYI-T-23054/15 SANDOZ HUNGÁRIA KFT HU LINZAVO 60 mg filmtabletta DE/H/3908/002 OGYI-T-23054/16 SANDOZ HUNGÁRIA KFT HU LINZAVO 60 mg filmtabletta DE/H/3908/002 OGYI-T-23054/13 SANDOZ HUNGÁRIA KFT HU LINZAVO 90 mg filmtabletta DE/H/3908/003 OGYI-T -23054/17 SANDOZ HUNGÁRIA KFT HU LINZAVO 90 mg filmtabletta DE/H/3908/003 OGYI-T -23054/18 SANDOZ HUNGÁRIA KFT HU LINZAVO 90 mg filmtabletta DE/H/3908/003 OGYI-T -23054/19 SANDOZ HUNGÁRIA KFT HU LINZAVO 90 mg filmtabletta DE/H/3908/003 OGYI-T -23054/21 SANDOZ HUNGÁRIA KFT HU LINZAVO 90 mg filmtabletta DE/H/3908/003 OGYI-T-23054/22 SANDOZ HUNGÁRIA KFT HU LINZAVO 90 mg filmtabletta DE/H/3908/003 OGYI-T-23054/23 SANDOZ HUNGÁRIA KFT HU LINZAVO 90 mg filmtabletta DE/H/3908/003 OGYI-T-23054/24 SANDOZ HUNGÁRIA KFT HU
List of nationally authorised medicinal products EMA/812634/2017 Page 203/231
Product Name (in authorisation country)
MRP/DCP Authorisation Number
National Authorisation Number
MAH of product in the Member State
Member State where product is authorised
LINZAVO 90 mg filmtabletta DE/H/3908/003 OGYI-T -23054/20 SANDOZ HUNGÁRIA KFT HU Narox 120 mg Film-coated tablets not available 22268 DELORBIS
PHARMACEUTICALS LTD CY
Narox 30 mg Film-coated tablets not available 22265 DELORBIS PHARMACEUTICALS LTD
CY
Narox 60 mg Film-coated tablets not available 22266 DELORBIS PHARMACEUTICALS LTD
CY
Narox 90 mg Film-coated tablets not available 22267 DELORBIS PHARMACEUTICALS LTD
CY
Oxidraxib 120 mg apvalkotās tabletes
NL/H/3267/003 16-0020 PHARMASWISS ČESKÁ REPUBLIKA S.R.O.
LV
Oxidraxib 120 mg filmomhulde tabletten
NL/H/3267/003 RVG 116008 PHARMASWISS ČESKÁ REPUBLIKA S.R.O.
NL
Oxidraxib 120 mg filmsko obložene tablete
NL/H/3267/003 H/16/02096/035 PHARMASWISS ČESKÁ REPUBLIKA S.R.O.
SI
Oxidraxib 120 mg filmsko obložene tablete
NL/H/3267/003 H/16/02096/036 PHARMASWISS ČESKÁ REPUBLIKA S.R.O.
SI
Oxidraxib 120 mg filmsko obložene tablete
NL/H/3267/003 H/16/02096/037 PHARMASWISS ČESKÁ REPUBLIKA S.R.O.
SI
Oxidraxib 120 mg filmsko obložene tablete
NL/H/3267/003 H/16/02096/038 PHARMASWISS ČESKÁ REPUBLIKA S.R.O.
SI
Oxidraxib 120 mg filmsko obložene tablete
NL/H/3267/003 H/16/02096/039 PHARMASWISS ČESKÁ REPUBLIKA S.R.O.
SI
Oxidraxib 120 mg filmsko obložene tablete
NL/H/3267/003 H/16/02096/040 PHARMASWISS ČESKÁ REPUBLIKA S.R.O.
SI
Oxidraxib 120 mg filmsko obložene tablete
NL/H/3267/003 H/16/02096/041 PHARMASWISS ČESKÁ REPUBLIKA S.R.O.
SI
Oxidraxib 120 mg filmsko obložene tablete
NL/H/3267/003 H/16/02096/042 PHARMASWISS ČESKÁ REPUBLIKA S.R.O.
SI
List of nationally authorised medicinal products EMA/812634/2017 Page 204/231
Product Name (in authorisation country)
MRP/DCP Authorisation Number
National Authorisation Number
MAH of product in the Member State
Member State where product is authorised
Oxidraxib 120 mg filmsko obložene tablete
NL/H/3267/003 H/16/02096/043 PHARMASWISS ČESKÁ REPUBLIKA S.R.O.
SI
Oxidraxib 120 mg filmsko obložene tablete
NL/H/3267/003 H/16/02096/044 PHARMASWISS ČESKÁ REPUBLIKA S.R.O.
SI
Oxidraxib 120 mg filmsko obložene tablete
NL/H/3267/003 H/16/02096/045 PHARMASWISS ČESKÁ REPUBLIKA S.R.O.
SI
Oxidraxib 120 mg filmsko obložene tablete
NL/H/3267/003 H/16/02096/046 PHARMASWISS ČESKÁ REPUBLIKA S.R.O.
SI
Oxidraxib 120 mg filmsko obložene tablete
NL/H/3267/003 H/16/02096/047 PHARMASWISS ČESKÁ REPUBLIKA S.R.O.
SI
Oxidraxib 120 mg filmsko obložene tablete
NL/H/3267/003 H/16/02096/048 PHARMASWISS ČESKÁ REPUBLIKA S.R.O.
SI
Oxidraxib 120 mg filmsko obložene tablete
NL/H/3267/003 H/16/02096/049 PHARMASWISS ČESKÁ REPUBLIKA S.R.O.
SI
Oxidraxib 120 mg filmsko obložene tablete
NL/H/3267/003 H/16/02096/050 PHARMASWISS ČESKÁ REPUBLIKA S.R.O.
SI
Oxidraxib 120 mg filmsko obložene tablete
NL/H/3267/003 H/16/02096/051 PHARMASWISS ČESKÁ REPUBLIKA S.R.O.
SI
Oxidraxib 120 mg plėvele dengtos tabletės
NL/H/3267/003 LT/1/16/3889/035 PHARMASWISS ČESKÁ REPUBLIKA S.R.O.
LT
Oxidraxib 120 mg plėvele dengtos tabletės
NL/H/3267/003 LT/1/16/3889/036 PHARMASWISS ČESKÁ REPUBLIKA S.R.O.
LT
Oxidraxib 120 mg plėvele dengtos tabletės
NL/H/3267/003 LT/1/16/3889/037 PHARMASWISS ČESKÁ REPUBLIKA S.R.O.
LT
Oxidraxib 120 mg plėvele dengtos tabletės
NL/H/3267/003 LT/1/16/3889/038 PHARMASWISS ČESKÁ REPUBLIKA S.R.O.
LT
Oxidraxib 120 mg plėvele dengtos tabletės
NL/H/3267/003 LT/1/16/3889/039 PHARMASWISS ČESKÁ REPUBLIKA S.R.O.
LT
List of nationally authorised medicinal products EMA/812634/2017 Page 205/231
Product Name (in authorisation country)
MRP/DCP Authorisation Number
National Authorisation Number
MAH of product in the Member State
Member State where product is authorised
Oxidraxib 120 mg plėvele dengtos tabletės
NL/H/3267/003 LT/1/16/3889/040 PHARMASWISS ČESKÁ REPUBLIKA S.R.O.
LT
Oxidraxib 120 mg plėvele dengtos tabletės
NL/H/3267/003 LT/1/16/3889/041 PHARMASWISS ČESKÁ REPUBLIKA S.R.O.
LT
Oxidraxib 120 mg plėvele dengtos tabletės
NL/H/3267/003 LT/1/16/3889/042 PHARMASWISS ČESKÁ REPUBLIKA S.R.O.
LT
Oxidraxib 120 mg plėvele dengtos tabletės
NL/H/3267/003 LT/1/16/3889/043 PHARMASWISS ČESKÁ REPUBLIKA S.R.O.
LT
Oxidraxib 120 mg plėvele dengtos tabletės
NL/H/3267/003 LT/1/16/3889/044 PHARMASWISS ČESKÁ REPUBLIKA S.R.O.
LT
Oxidraxib 120 mg plėvele dengtos tabletės
NL/H/3267/003 LT/1/16/3889/045 PHARMASWISS ČESKÁ REPUBLIKA S.R.O.
LT
Oxidraxib 120 mg plėvele dengtos tabletės
NL/H/3267/003 LT/1/16/3889/046 PHARMASWISS ČESKÁ REPUBLIKA S.R.O.
LT
Oxidraxib 120 mg plėvele dengtos tabletės
NL/H/3267/003 LT/1/16/3889/047 PHARMASWISS ČESKÁ REPUBLIKA S.R.O.
LT
Oxidraxib 120 mg plėvele dengtos tabletės
NL/H/3267/003 LT/1/16/3889/048 PHARMASWISS ČESKÁ REPUBLIKA S.R.O.
LT
Oxidraxib 120 mg plėvele dengtos tabletės
NL/H/3267/003 LT/1/16/3889/049 PHARMASWISS ČESKÁ REPUBLIKA S.R.O.
LT
Oxidraxib 120 mg plėvele dengtos tabletės
NL/H/3267/003 LT/1/16/3889/050 PHARMASWISS ČESKÁ REPUBLIKA S.R.O.
LT
Oxidraxib 120 mg plėvele dengtos tabletės
NL/H/3267/003 LT/1/16/3889/051 PHARMASWISS ČESKÁ REPUBLIKA S.R.O.
LT
OXIDRAXIB 120 mg επικαλυμμένα με λεπτό υμένιο δισκία
NL/H/3267/003 72609/14/31.08.16 PHARMASWISS ČESKÁ REPUBLIKA S.R.O.
GR
Oxidraxib 60 mg apvalkotās tabletes
NL/H/3267/001 16-0018 PHARMASWISS ČESKÁ REPUBLIKA S.R.O.
LV
List of nationally authorised medicinal products EMA/812634/2017 Page 206/231
Product Name (in authorisation country)
MRP/DCP Authorisation Number
National Authorisation Number
MAH of product in the Member State
Member State where product is authorised
Oxidraxib 60 mg filmomhulde tabletten
NL/H/3267/001 RVG 116006 PHARMASWISS ČESKÁ REPUBLIKA S.R.O.
NL
Oxidraxib 60 mg filmsko obložene tablete
NL/H/3267/001 H/16/02096/001 PHARMASWISS ČESKÁ REPUBLIKA S.R.O.
SI
Oxidraxib 60 mg filmsko obložene tablete
NL/H/3267/001 H/16/02096/002 PHARMASWISS ČESKÁ REPUBLIKA S.R.O.
SI
Oxidraxib 60 mg filmsko obložene tablete
NL/H/3267/001 H/16/02096/003 PHARMASWISS ČESKÁ REPUBLIKA S.R.O.
SI
Oxidraxib 60 mg filmsko obložene tablete
NL/H/3267/001 H/16/02096/004 PHARMASWISS ČESKÁ REPUBLIKA S.R.O.
SI
Oxidraxib 60 mg filmsko obložene tablete
NL/H/3267/001 H/16/02096/005 PHARMASWISS ČESKÁ REPUBLIKA S.R.O.
SI
Oxidraxib 60 mg filmsko obložene tablete
NL/H/3267/001 H/16/02096/006 PHARMASWISS ČESKÁ REPUBLIKA S.R.O.
SI
Oxidraxib 60 mg filmsko obložene tablete
NL/H/3267/001 H/16/02096/007 PHARMASWISS ČESKÁ REPUBLIKA S.R.O.
SI
Oxidraxib 60 mg filmsko obložene tablete
NL/H/3267/001 H/16/02096/008 PHARMASWISS ČESKÁ REPUBLIKA S.R.O.
SI
Oxidraxib 60 mg filmsko obložene tablete
NL/H/3267/001 H/16/02096/009 PHARMASWISS ČESKÁ REPUBLIKA S.R.O.
SI
Oxidraxib 60 mg filmsko obložene tablete
NL/H/3267/001 H/16/02096/010 PHARMASWISS ČESKÁ REPUBLIKA S.R.O.
SI
Oxidraxib 60 mg filmsko obložene tablete
NL/H/3267/001 H/16/02096/011 PHARMASWISS ČESKÁ REPUBLIKA S.R.O.
SI
Oxidraxib 60 mg filmsko obložene tablete
NL/H/3267/001 H/16/02096/012 PHARMASWISS ČESKÁ REPUBLIKA S.R.O.
SI
Oxidraxib 60 mg filmsko obložene tablete
NL/H/3267/001 H/16/02096/013 PHARMASWISS ČESKÁ REPUBLIKA S.R.O.
SI
List of nationally authorised medicinal products EMA/812634/2017 Page 207/231
Product Name (in authorisation country)
MRP/DCP Authorisation Number
National Authorisation Number
MAH of product in the Member State
Member State where product is authorised
Oxidraxib 60 mg filmsko obložene tablete
NL/H/3267/001 H/16/02096/014 PHARMASWISS ČESKÁ REPUBLIKA S.R.O.
SI
Oxidraxib 60 mg filmsko obložene tablete
NL/H/3267/001 H/16/02096/015 PHARMASWISS ČESKÁ REPUBLIKA S.R.O.
SI
Oxidraxib 60 mg filmsko obložene tablete
NL/H/3267/001 H/16/02096/016 PHARMASWISS ČESKÁ REPUBLIKA S.R.O.
SI
Oxidraxib 60 mg filmsko obložene tablete
NL/H/3267/001 H/16/02096/017 PHARMASWISS ČESKÁ REPUBLIKA S.R.O.
SI
Oxidraxib 60 mg plėvele dengtos tabletės
NL/H/3267/001 LT/1/16/3889/001 PHARMASWISS ČESKÁ REPUBLIKA S.R.O.
LT
Oxidraxib 60 mg plėvele dengtos tabletės
NL/H/3267/001 LT/1/16/3889/002 PHARMASWISS ČESKÁ REPUBLIKA S.R.O.
LT
Oxidraxib 60 mg plėvele dengtos tabletės
NL/H/3267/001 LT/1/16/3889/003 PHARMASWISS ČESKÁ REPUBLIKA S.R.O.
LT
Oxidraxib 60 mg plėvele dengtos tabletės
NL/H/3267/001 LT/1/16/3889/004 PHARMASWISS ČESKÁ REPUBLIKA S.R.O.
LT
Oxidraxib 60 mg plėvele dengtos tabletės
NL/H/3267/001 LT/1/16/3889/005 PHARMASWISS ČESKÁ REPUBLIKA S.R.O.
LT
Oxidraxib 60 mg plėvele dengtos tabletės
NL/H/3267/001 LT/1/16/3889/006 PHARMASWISS ČESKÁ REPUBLIKA S.R.O.
LT
Oxidraxib 60 mg plėvele dengtos tabletės
NL/H/3267/001 LT/1/16/3889/007 PHARMASWISS ČESKÁ REPUBLIKA S.R.O.
LT
Oxidraxib 60 mg plėvele dengtos tabletės
NL/H/3267/001 LT/1/16/3889/008 PHARMASWISS ČESKÁ REPUBLIKA S.R.O.
LT
Oxidraxib 60 mg plėvele dengtos tabletės
NL/H/3267/001 LT/1/16/3889/009 PHARMASWISS ČESKÁ REPUBLIKA S.R.O.
LT
Oxidraxib 60 mg plėvele dengtos tabletės
NL/H/3267/001 LT/1/16/3889/010 PHARMASWISS ČESKÁ REPUBLIKA S.R.O.
LT
List of nationally authorised medicinal products EMA/812634/2017 Page 208/231
Product Name (in authorisation country)
MRP/DCP Authorisation Number
National Authorisation Number
MAH of product in the Member State
Member State where product is authorised
Oxidraxib 60 mg plėvele dengtos tabletės
NL/H/3267/001 LT/1/16/3889/011 PHARMASWISS ČESKÁ REPUBLIKA S.R.O.
LT
Oxidraxib 60 mg plėvele dengtos tabletės
NL/H/3267/001 LT/1/16/3889/012 PHARMASWISS ČESKÁ REPUBLIKA S.R.O.
LT
Oxidraxib 60 mg plėvele dengtos tabletės
NL/H/3267/001 LT/1/16/3889/013 PHARMASWISS ČESKÁ REPUBLIKA S.R.O.
LT
Oxidraxib 60 mg plėvele dengtos tabletės
NL/H/3267/001 LT/1/16/3889/014 PHARMASWISS ČESKÁ REPUBLIKA S.R.O.
LT
Oxidraxib 60 mg plėvele dengtos tabletės
NL/H/3267/001 LT/1/16/3889/015 PHARMASWISS ČESKÁ REPUBLIKA S.R.O.
LT
Oxidraxib 60 mg plėvele dengtos tabletės
NL/H/3267/001 LT/1/16/3889/016 PHARMASWISS ČESKÁ REPUBLIKA S.R.O.
LT
Oxidraxib 60 mg plėvele dengtos tabletės
NL/H/3267/001 LT/1/16/3889/017 PHARMASWISS ČESKÁ REPUBLIKA S.R.O.
LT
OXIDRAXIB 60 mg επικαλυμμένα με λεπτό υμένιο δισκία
NL/H/3267/001 72607/14/31.08.16 PHARMASWISS ČESKÁ REPUBLIKA S.R.O.
GR
Oxidraxib 90 mg apvalkotas tabletes
NL/H/3267/002 16-0019 PHARMASWISS ČESKÁ REPUBLIKA S.R.O.
LV
Oxidraxib 90 mg filmomhulde tabletten
NL/H/3267/002 RVG 116007 PHARMASWISS ČESKÁ REPUBLIKA S.R.O.
NL
Oxidraxib 90 mg filmsko obložene tablete
NL/H/3267/002 H/16/02096/018 PHARMASWISS ČESKÁ REPUBLIKA S.R.O.
SI
Oxidraxib 90 mg filmsko obložene tablete
NL/H/3267/002 H/16/02096/019 PHARMASWISS ČESKÁ REPUBLIKA S.R.O.
SI
Oxidraxib 90 mg filmsko obložene tablete
NL/H/3267/002 H/16/02096/020 PHARMASWISS ČESKÁ REPUBLIKA S.R.O.
SI
Oxidraxib 90 mg filmsko obložene tablete
NL/H/3267/002 H/16/02096/021 PHARMASWISS ČESKÁ REPUBLIKA S.R.O.
SI
List of nationally authorised medicinal products EMA/812634/2017 Page 209/231
Product Name (in authorisation country)
MRP/DCP Authorisation Number
National Authorisation Number
MAH of product in the Member State
Member State where product is authorised
Oxidraxib 90 mg filmsko obložene tablete
NL/H/3267/002 H/16/02096/022 PHARMASWISS ČESKÁ REPUBLIKA S.R.O.
SI
Oxidraxib 90 mg filmsko obložene tablete
NL/H/3267/002 H/16/02096/023 PHARMASWISS ČESKÁ REPUBLIKA S.R.O.
SI
Oxidraxib 90 mg filmsko obložene tablete
NL/H/3267/002 H/16/02096/024 PHARMASWISS ČESKÁ REPUBLIKA S.R.O.
SI
Oxidraxib 90 mg filmsko obložene tablete
NL/H/3267/002 H/16/02096/025 PHARMASWISS ČESKÁ REPUBLIKA S.R.O.
SI
Oxidraxib 90 mg filmsko obložene tablete
NL/H/3267/002 H/16/02096/026 PHARMASWISS ČESKÁ REPUBLIKA S.R.O.
SI
Oxidraxib 90 mg filmsko obložene tablete
NL/H/3267/002 H/16/02096/027 PHARMASWISS ČESKÁ REPUBLIKA S.R.O.
SI
Oxidraxib 90 mg filmsko obložene tablete
NL/H/3267/002 H/16/02096/028 PHARMASWISS ČESKÁ REPUBLIKA S.R.O.
SI
Oxidraxib 90 mg filmsko obložene tablete
NL/H/3267/002 H/16/02096/029 PHARMASWISS ČESKÁ REPUBLIKA S.R.O.
SI
Oxidraxib 90 mg filmsko obložene tablete
NL/H/3267/002 H/16/02096/030 PHARMASWISS ČESKÁ REPUBLIKA S.R.O.
SI
Oxidraxib 90 mg filmsko obložene tablete
NL/H/3267/002 H/16/02096/031 PHARMASWISS ČESKÁ REPUBLIKA S.R.O.
SI
Oxidraxib 90 mg filmsko obložene tablete
NL/H/3267/002 H/16/02096/032 PHARMASWISS ČESKÁ REPUBLIKA S.R.O.
SI
Oxidraxib 90 mg filmsko obložene tablete
NL/H/3267/002 H/16/02096/033 PHARMASWISS ČESKÁ REPUBLIKA S.R.O.
SI
Oxidraxib 90 mg filmsko obložene tablete
NL/H/3267/002 H/16/02096/034 PHARMASWISS ČESKÁ REPUBLIKA S.R.O.
SI
Oxidraxib 90 mg plevele dengtos tabletes
NL/H/3267/002 LT/1/16/3889/019 PHARMASWISS ČESKÁ REPUBLIKA S.R.O.
LT
List of nationally authorised medicinal products EMA/812634/2017 Page 210/231
Product Name (in authorisation country)
MRP/DCP Authorisation Number
National Authorisation Number
MAH of product in the Member State
Member State where product is authorised
Oxidraxib 90 mg plevele dengtos tabletes
NL/H/3267/002 LT/1/16/3889/020 PHARMASWISS ČESKÁ REPUBLIKA S.R.O.
LT
Oxidraxib 90 mg plevele dengtos tabletes
NL/H/3267/002 LT/1/16/3889/021 PHARMASWISS ČESKÁ REPUBLIKA S.R.O.
LT
Oxidraxib 90 mg plevele dengtos tabletes
NL/H/3267/002 LT/1/16/3889/022 PHARMASWISS ČESKÁ REPUBLIKA S.R.O.
LT
Oxidraxib 90 mg plevele dengtos tabletes
NL/H/3267/002 LT/1/16/3889/023 PHARMASWISS ČESKÁ REPUBLIKA S.R.O.
LT
Oxidraxib 90 mg plevele dengtos tabletes
NL/H/3267/002 LT/1/16/3889/024 PHARMASWISS ČESKÁ REPUBLIKA S.R.O.
LT
Oxidraxib 90 mg plevele dengtos tabletes
NL/H/3267/002 LT/1/16/3889/025 PHARMASWISS ČESKÁ REPUBLIKA S.R.O.
LT
Oxidraxib 90 mg plevele dengtos tabletes
NL/H/3267/002 LT/1/16/3889/026 PHARMASWISS ČESKÁ REPUBLIKA S.R.O.
LT
Oxidraxib 90 mg plevele dengtos tabletes
NL/H/3267/002 LT/1/16/3889/027 PHARMASWISS ČESKÁ REPUBLIKA S.R.O.
LT
Oxidraxib 90 mg plevele dengtos tabletes
NL/H/3267/002 LT/1/16/3889/028 PHARMASWISS ČESKÁ REPUBLIKA S.R.O.
LT
Oxidraxib 90 mg plevele dengtos tabletes
NL/H/3267/002 LT/1/16/3889/029 PHARMASWISS ČESKÁ REPUBLIKA S.R.O.
LT
Oxidraxib 90 mg plevele dengtos tabletes
NL/H/3267/002 LT/1/16/3889/030 PHARMASWISS ČESKÁ REPUBLIKA S.R.O.
LT
Oxidraxib 90 mg plevele dengtos tabletes
NL/H/3267/002 LT/1/16/3889/031 PHARMASWISS ČESKÁ REPUBLIKA S.R.O.
LT
Oxidraxib 90 mg plevele dengtos tabletes
NL/H/3267/002 LT/1/16/3889/032 PHARMASWISS ČESKÁ REPUBLIKA S.R.O.
LT
Oxidraxib 90 mg plevele dengtos tabletes
NL/H/3267/002 LT/1/16/3889/033 PHARMASWISS ČESKÁ REPUBLIKA S.R.O.
LT
List of nationally authorised medicinal products EMA/812634/2017 Page 211/231
Product Name (in authorisation country)
MRP/DCP Authorisation Number
National Authorisation Number
MAH of product in the Member State
Member State where product is authorised
Oxidraxib 90 mg plevele dengtos tabletes
NL/H/3267/002 LT/1/16/3889/034 PHARMASWISS ČESKÁ REPUBLIKA S.R.O.
LT
Oxidraxib 90 mg plėvele dengtos tabletės
NL/H/3267/002 LT/1/16/3889/018 PHARMASWISS ČESKÁ REPUBLIKA S.R.O.
LT
OXIDRAXIB 90 mg επικαλυμμένα με λεπτό υμένιο δισκία
NL/H/3267/002 72608/14/31.08.16 PHARMASWISS ČESKÁ REPUBLIKA S.R.O.
GR
Oxidraxib, 120 mg õhukese polümeerikattega tabletid
NL/H/3267/003 901616 PHARMASWISS ČESKÁ REPUBLIKA S.R.O.
EE
Oxidraxib, 60 mg õhukese polümeerikattega tabletid
NL/H/3267/001 901516 PHARMASWISS ČESKÁ REPUBLIKA S.R.O.
EE
Oxidraxib, 90 mg õhukese polümeerikattega tabletid
NL/H/3267/002 901716 PHARMASWISS ČESKÁ REPUBLIKA S.R.O.
EE
Roticox 120 mg comprimate filmate
HU/H/0435/004 9484/2016/01 KRKA, D.D., NOVO MESTO RO
Roticox 120 mg comprimate filmate
HU/H/0435/004 9484/2016/02 KRKA, D.D., NOVO MESTO RO
Roticox 120 mg comprimate filmate
HU/H/0435/004 9484/2016/03 KRKA, D.D., NOVO MESTO RO
Roticox 120 mg comprimate filmate
HU/H/0435/004 9484/2016/04 KRKA, D.D., NOVO MESTO RO
Roticox 120 mg comprimate filmate
HU/H/0435/004 9484/2016/05 KRKA, D.D., NOVO MESTO RO
Roticox 120 mg comprimate filmate
HU/H/0435/004 9484/2016/06 KRKA, D.D., NOVO MESTO RO
Roticox 120 mg comprimate filmate
HU/H/0435/004 9484/2016/07 KRKA, D.D., NOVO MESTO RO
Roticox 120 mg comprimate filmate
HU/H/0435/004 9484/2016/08 KRKA, D.D., NOVO MESTO RO
List of nationally authorised medicinal products EMA/812634/2017 Page 212/231
Product Name (in authorisation country)
MRP/DCP Authorisation Number
National Authorisation Number
MAH of product in the Member State
Member State where product is authorised
Roticox 120 mg comprimate filmate
HU/H/0435/004 9484/2016/09 KRKA, D.D., NOVO MESTO RO
Roticox 120 mg comprimate filmate
HU/H/0435/004 9484/2016/10 KRKA, D.D., NOVO MESTO RO
Roticox 120 mg comprimate filmate
HU/H/0435/004 9484/2016/11 KRKA, D.D., NOVO MESTO RO
Roticox 120 mg filmom obalené tablety
HU/H/0435/004 29/0459/16-S KRKA, D.D., NOVO MESTO SK
Roticox 120 mg filmsko obložene tablete
HU/H/0435/004 H/17/02295/033 KRKA, D.D., NOVO MESTO SI
Roticox 120 mg filmsko obložene tablete
HU/H/0435/004 H/17/02295/034 KRKA, D.D., NOVO MESTO SI
Roticox 120 mg filmsko obložene tablete
HU/H/0435/004 H/17/02295/035 KRKA, D.D., NOVO MESTO SI
Roticox 120 mg filmsko obložene tablete
HU/H/0435/004 H/17/02295/036 KRKA, D.D., NOVO MESTO SI
Roticox 120 mg filmsko obložene tablete
HU/H/0435/004 H/17/02295/037 KRKA, D.D., NOVO MESTO SI
Roticox 120 mg filmsko obložene tablete
HU/H/0435/004 H/17/02295/038 KRKA, D.D., NOVO MESTO SI
Roticox 120 mg filmsko obložene tablete
HU/H/0435/004 H/17/02295/039 KRKA, D.D., NOVO MESTO SI
Roticox 120 mg filmsko obložene tablete
HU/H/0435/004 H/17/02295/040 KRKA, D.D., NOVO MESTO SI
Roticox 120 mg filmsko obložene tablete
HU/H/0435/004 H/17/02295/041 KRKA, D.D., NOVO MESTO SI
Roticox 120 mg filmsko obložene tablete
HU/H/0435/004 H/17/02295/042 KRKA, D.D., NOVO MESTO SI
List of nationally authorised medicinal products EMA/812634/2017 Page 213/231
Product Name (in authorisation country)
MRP/DCP Authorisation Number
National Authorisation Number
MAH of product in the Member State
Member State where product is authorised
Roticox 120 mg filmsko obložene tablete
HU/H/0435/004 H/17/02295/043 KRKA, D.D., NOVO MESTO SI
Roticox 120 mg filmtabletta HU/H/0435/004 OGYI-T-23097/33 KRKA, D.D., NOVO MESTO HU Roticox 120 mg filmtabletta HU/H/0435/004 OGYI-T-23097/34 KRKA, D.D., NOVO MESTO HU Roticox 120 mg filmtabletta HU/H/0435/004 OGYI-T-23097/35 KRKA, D.D., NOVO MESTO HU Roticox 120 mg filmtabletta HU/H/0435/004 OGYI-T-23097/36 KRKA, D.D., NOVO MESTO HU Roticox 120 mg filmtabletta HU/H/0435/004 OGYI-T-23097/37 KRKA, D.D., NOVO MESTO HU Roticox 120 mg filmtabletta HU/H/0435/004 OGYI-T-23097/38 KRKA, D.D., NOVO MESTO HU Roticox 120 mg filmtabletta HU/H/0435/004 OGYI-T-23097/39 KRKA, D.D., NOVO MESTO HU Roticox 120 mg filmtabletta HU/H/0435/004 OGYI-T-23097/40 KRKA, D.D., NOVO MESTO HU Roticox 120 mg filmtabletta HU/H/0435/004 OGYI-T-23097/41 KRKA, D.D., NOVO MESTO HU Roticox 120 mg filmtabletta HU/H/0435/004 OGYI-T-23097/42 KRKA, D.D., NOVO MESTO HU Roticox 120 mg filmtabletta HU/H/0435/004 OGYI-T-23097/43 KRKA, D.D., NOVO MESTO HU Roticox 120 mg potahované tablet HU/H/0435/004 29/476/16-C KRKA, D.D., NOVO MESTO CZ Roticox 30 mg comprimate filmate HU/H/0435/001 9481/2016/01 KRKA, D.D., NOVO MESTO RO Roticox 30 mg comprimate filmate HU/H/0435/001 9481/2016/02 KRKA, D.D., NOVO MESTO RO Roticox 30 mg comprimate filmate HU/H/0435/001 9481/2016/03 KRKA, D.D., NOVO MESTO RO Roticox 30 mg comprimate filmate HU/H/0435/001 9481/2016/04 KRKA, D.D., NOVO MESTO RO Roticox 30 mg comprimate filmate HU/H/0435/001 9481/2016/05 KRKA, D.D., NOVO MESTO RO Roticox 30 mg comprimate filmate HU/H/0435/001 9481/2016/06 KRKA, D.D., NOVO MESTO RO Roticox 30 mg comprimate filmate HU/H/0435/001 9481/2016/07 KRKA, D.D., NOVO MESTO RO Roticox 30 mg comprimate filmate HU/H/0435/001 9481/2016/08 KRKA, D.D., NOVO MESTO RO Roticox 30 mg comprimate filmate HU/H/0435/001 9481/2016/09 KRKA, D.D., NOVO MESTO RO Roticox 30 mg filmom obalené tablety
HU/H/0435/001 29/0456/16-S KRKA, D.D., NOVO MESTO SK
Roticox 30 mg filmsko obložene tablete
HU/H/0435/001 H/17/02295/001 KRKA, D.D., NOVO MESTO SI
List of nationally authorised medicinal products EMA/812634/2017 Page 214/231
Product Name (in authorisation country)
MRP/DCP Authorisation Number
National Authorisation Number
MAH of product in the Member State
Member State where product is authorised
Roticox 30 mg filmsko obložene tablete
HU/H/0435/001 H/17/02295/002 KRKA, D.D., NOVO MESTO SI
Roticox 30 mg filmsko obložene tablete
HU/H/0435/001 H/17/02295/003 KRKA, D.D., NOVO MESTO SI
Roticox 30 mg filmsko obložene tablete
HU/H/0435/001 H/17/02295/004 KRKA, D.D., NOVO MESTO SI
Roticox 30 mg filmsko obložene tablete
HU/H/0435/001 H/17/02295/005 KRKA, D.D., NOVO MESTO SI
Roticox 30 mg filmsko obložene tablete
HU/H/0435/001 H/17/02295/006 KRKA, D.D., NOVO MESTO SI
Roticox 30 mg filmsko obložene tablete
HU/H/0435/001 H/17/02295/007 KRKA, D.D., NOVO MESTO SI
Roticox 30 mg filmsko obložene tablete
HU/H/0435/001 H/17/02295/008 KRKA, D.D., NOVO MESTO SI
Roticox 30 mg filmsko obložene tablete
HU/H/0435/001 H/17/02295/009 KRKA, D.D., NOVO MESTO SI
Roticox 30 mg filmtabletta HU/H/0435/001 OGYI-T-23097/01 KRKA, D.D., NOVO MESTO HU Roticox 30 mg filmtabletta HU/H/0435/001 OGYI-T-23097/02 KRKA, D.D., NOVO MESTO HU Roticox 30 mg filmtabletta HU/H/0435/001 OGYI-T-23097/03 KRKA, D.D., NOVO MESTO HU Roticox 30 mg filmtabletta HU/H/0435/001 OGYI-T-23097/04 KRKA, D.D., NOVO MESTO HU Roticox 30 mg filmtabletta HU/H/0435/001 OGYI-T-23097/05 KRKA, D.D., NOVO MESTO HU Roticox 30 mg filmtabletta HU/H/0435/001 OGYI-T-23097/06 KRKA, D.D., NOVO MESTO HU Roticox 30 mg filmtabletta HU/H/0435/001 OGYI-T-23097/07 KRKA, D.D., NOVO MESTO HU Roticox 30 mg filmtabletta HU/H/0435/001 OGYI-T-23097/08 KRKA, D.D., NOVO MESTO HU Roticox 30 mg filmtabletta HU/H/0435/001 OGYI-T-23097/09 KRKA, D.D., NOVO MESTO HU Roticox 30 mg potahované tablet HU/H/0435/001 29/473/16-C KRKA, D.D., NOVO MESTO CZ Roticox 60 mg comprimate filmate HU/H/0435/002 9482/2016/01 KRKA, D.D., NOVO MESTO RO Roticox 60 mg comprimate filmate HU/H/0435/002 9482/2016/02 KRKA, D.D., NOVO MESTO RO
List of nationally authorised medicinal products EMA/812634/2017 Page 215/231
Product Name (in authorisation country)
MRP/DCP Authorisation Number
National Authorisation Number
MAH of product in the Member State
Member State where product is authorised
Roticox 60 mg comprimate filmate HU/H/0435/002 9482/2016/03 KRKA, D.D., NOVO MESTO RO Roticox 60 mg comprimate filmate HU/H/0435/002 9482/2016/04 KRKA, D.D., NOVO MESTO RO Roticox 60 mg comprimate filmate HU/H/0435/002 9482/2016/05 KRKA, D.D., NOVO MESTO RO Roticox 60 mg comprimate filmate HU/H/0435/002 9482/2016/06 KRKA, D.D., NOVO MESTO RO Roticox 60 mg comprimate filmate HU/H/0435/002 9482/2016/07 KRKA, D.D., NOVO MESTO RO Roticox 60 mg comprimate filmate HU/H/0435/002 9482/2016/08 KRKA, D.D., NOVO MESTO RO Roticox 60 mg comprimate filmate HU/H/0435/002 9482/2016/09 KRKA, D.D., NOVO MESTO RO Roticox 60 mg comprimate filmate HU/H/0435/002 9482/2016/10 KRKA, D.D., NOVO MESTO RO Roticox 60 mg comprimate filmate HU/H/0435/002 9482/2016/11 KRKA, D.D., NOVO MESTO RO Roticox 60 mg filmom obalené tablety
HU/H/0435/002 29/0457/16-S KRKA, D.D., NOVO MESTO SK
Roticox 60 mg filmsko obložene tablete
HU/H/0435/002 H/17/02295/010 KRKA, D.D., NOVO MESTO SI
Roticox 60 mg filmsko obložene tablete
HU/H/0435/002 H/17/02295/011 KRKA, D.D., NOVO MESTO SI
Roticox 60 mg filmsko obložene tablete
HU/H/0435/002 H/17/02295/012 KRKA, D.D., NOVO MESTO SI
Roticox 60 mg filmsko obložene tablete
HU/H/0435/002 H/17/02295/013 KRKA, D.D., NOVO MESTO SI
Roticox 60 mg filmsko obložene tablete
HU/H/0435/002 H/17/02295/014 KRKA, D.D., NOVO MESTO SI
Roticox 60 mg filmsko obložene tablete
HU/H/0435/002 H/17/02295/015 KRKA, D.D., NOVO MESTO SI
Roticox 60 mg filmsko obložene tablete
HU/H/0435/002 H/17/02295/016 KRKA, D.D., NOVO MESTO SI
Roticox 60 mg filmsko obložene tablete
HU/H/0435/002 H/17/02295/017 KRKA, D.D., NOVO MESTO SI
List of nationally authorised medicinal products EMA/812634/2017 Page 216/231
Product Name (in authorisation country)
MRP/DCP Authorisation Number
National Authorisation Number
MAH of product in the Member State
Member State where product is authorised
Roticox 60 mg filmsko obložene tablete
HU/H/0435/002 H/17/02295/018 KRKA, D.D., NOVO MESTO SI
Roticox 60 mg filmsko obložene tablete
HU/H/0435/002 H/17/02295/019 KRKA, D.D., NOVO MESTO SI
Roticox 60 mg filmsko obložene tablete
HU/H/0435/002 H/17/02295/020 KRKA, D.D., NOVO MESTO SI
Roticox 60 mg filmtabletta HU/H/0435/002 OGYI-T-23097/10 KRKA, D.D., NOVO MESTO HU Roticox 60 mg filmtabletta HU/H/0435/002 OGYI-T-23097/11 KRKA, D.D., NOVO MESTO HU Roticox 60 mg filmtabletta HU/H/0435/002 OGYI-T-23097/12 KRKA, D.D., NOVO MESTO HU Roticox 60 mg filmtabletta HU/H/0435/002 OGYI-T-23097/13 KRKA, D.D., NOVO MESTO HU Roticox 60 mg filmtabletta HU/H/0435/002 OGYI-T-23097/14 KRKA, D.D., NOVO MESTO HU Roticox 60 mg filmtabletta HU/H/0435/002 OGYI-T-23097/15 KRKA, D.D., NOVO MESTO HU Roticox 60 mg filmtabletta HU/H/0435/002 OGYI-T-23097/16 KRKA, D.D., NOVO MESTO HU Roticox 60 mg filmtabletta HU/H/0435/002 OGYI-T-23097/17 KRKA, D.D., NOVO MESTO HU Roticox 60 mg filmtabletta HU/H/0435/002 OGYI-T-23097/18 KRKA, D.D., NOVO MESTO HU Roticox 60 mg filmtabletta HU/H/0435/002 OGYI-T-23097/19 KRKA, D.D., NOVO MESTO HU Roticox 60 mg filmtabletta HU/H/0435/002 OGYI-T-23097/20 KRKA, D.D., NOVO MESTO HU Roticox 60 mg potahované tablet HU/H/0435/002 29/474/16-C KRKA, D.D., NOVO MESTO CZ Roticox 90 mg comprimate filmate HU/H/0435/003 9483/2016/01 KRKA, D.D., NOVO MESTO RO Roticox 90 mg comprimate filmate HU/H/0435/003 9483/2016/02 KRKA, D.D., NOVO MESTO RO Roticox 90 mg comprimate filmate HU/H/0435/003 9483/2016/03 KRKA, D.D., NOVO MESTO RO Roticox 90 mg comprimate filmate HU/H/0435/003 9483/2016/04 KRKA, D.D., NOVO MESTO RO Roticox 90 mg comprimate filmate HU/H/0435/003 9483/2016/05 KRKA, D.D., NOVO MESTO RO Roticox 90 mg comprimate filmate HU/H/0435/003 9483/2016/06 KRKA, D.D., NOVO MESTO RO Roticox 90 mg comprimate filmate HU/H/0435/003 9483/2016/07 KRKA, D.D., NOVO MESTO RO Roticox 90 mg comprimate filmate HU/H/0435/003 9483/2016/08 KRKA, D.D., NOVO MESTO RO Roticox 90 mg comprimate filmate HU/H/0435/003 9483/2016/09 KRKA, D.D., NOVO MESTO RO Roticox 90 mg comprimate filmate HU/H/0435/003 9483/2016/10 KRKA, D.D., NOVO MESTO RO
List of nationally authorised medicinal products EMA/812634/2017 Page 217/231
Product Name (in authorisation country)
MRP/DCP Authorisation Number
National Authorisation Number
MAH of product in the Member State
Member State where product is authorised
Roticox 90 mg comprimate filmate HU/H/0435/003 9483/2016/11 KRKA, D.D., NOVO MESTO RO Roticox 90 mg comprimate filmate HU/H/0435/003 9483/2016/12 KRKA, D.D., NOVO MESTO RO Roticox 90 mg filmom obalené tablety
HU/H/0435/003 29/0458/16-S KRKA, D.D., NOVO MESTO SK
Roticox 90 mg filmsko obložene tablete
HU/H/0435/003 H/17/02295/021 KRKA, D.D., NOVO MESTO SI
Roticox 90 mg filmsko obložene tablete
HU/H/0435/003 H/17/02295/022 KRKA, D.D., NOVO MESTO SI
Roticox 90 mg filmsko obložene tablete
HU/H/0435/003 H/17/02295/023 KRKA, D.D., NOVO MESTO SI
Roticox 90 mg filmsko obložene tablete
HU/H/0435/003 H/17/02295/024 KRKA, D.D., NOVO MESTO SI
Roticox 90 mg filmsko obložene tablete
HU/H/0435/003 H/17/02295/025 KRKA, D.D., NOVO MESTO SI
Roticox 90 mg filmsko obložene tablete
HU/H/0435/003 H/17/02295/026 KRKA, D.D., NOVO MESTO SI
Roticox 90 mg filmsko obložene tablete
HU/H/0435/003 H/17/02295/027 KRKA, D.D., NOVO MESTO SI
Roticox 90 mg filmsko obložene tablete
HU/H/0435/003 H/17/02295/028 KRKA, D.D., NOVO MESTO SI
Roticox 90 mg filmsko obložene tablete
HU/H/0435/003 H/17/02295/029 KRKA, D.D., NOVO MESTO SI
Roticox 90 mg filmsko obložene tablete
HU/H/0435/003 H/17/02295/030 KRKA, D.D., NOVO MESTO SI
Roticox 90 mg filmsko obložene tablete
HU/H/0435/003 H/17/02295/031 KRKA, D.D., NOVO MESTO SI
Roticox 90 mg filmsko obložene tablete
HU/H/0435/003 H/17/02295/032 KRKA, D.D., NOVO MESTO SI
Roticox 90 mg filmtabletta HU/H/0435/003 OGYI-T-23097/21 KRKA, D.D., NOVO MESTO HU
List of nationally authorised medicinal products EMA/812634/2017 Page 218/231
Product Name (in authorisation country)
MRP/DCP Authorisation Number
National Authorisation Number
MAH of product in the Member State
Member State where product is authorised
Roticox 90 mg filmtabletta HU/H/0435/003 OGYI-T-23097/22 KRKA, D.D., NOVO MESTO HU Roticox 90 mg filmtabletta HU/H/0435/003 OGYI-T-23097/23 KRKA, D.D., NOVO MESTO HU Roticox 90 mg filmtabletta HU/H/0435/003 OGYI-T-23097/24 KRKA, D.D., NOVO MESTO HU Roticox 90 mg filmtabletta HU/H/0435/003 OGYI-T-23097/25 KRKA, D.D., NOVO MESTO HU Roticox 90 mg filmtabletta HU/H/0435/003 OGYI-T-23097/26 KRKA, D.D., NOVO MESTO HU Roticox 90 mg filmtabletta HU/H/0435/003 OGYI-T-23097/27 KRKA, D.D., NOVO MESTO HU Roticox 90 mg filmtabletta HU/H/0435/003 OGYI-T-23097/28 KRKA, D.D., NOVO MESTO HU Roticox 90 mg filmtabletta HU/H/0435/003 OGYI-T-23097/29 KRKA, D.D., NOVO MESTO HU Roticox 90 mg filmtabletta HU/H/0435/003 OGYI-T-23097/30 KRKA, D.D., NOVO MESTO HU Roticox 90 mg filmtabletta HU/H/0435/003 OGYI-T-23097/31 KRKA, D.D., NOVO MESTO HU Roticox 90 mg filmtabletta HU/H/0435/003 OGYI-T-23097/32 KRKA, D.D., NOVO MESTO HU Roticox 90 mg potahované tablet HU/H/0435/003 29/475/16-C KRKA, D.D., NOVO MESTO CZ Roticox, 120 mg, tabletki powlekane
HU/H/0435/004 23768 KRKA, D.D., NOVO MESTO PL
Roticox, 30 mg, tabletki powlekane
HU/H/0435/001 23765 KRKA, D.D., NOVO MESTO PL
Roticox, 60 mg, tabletki powlekane
HU/H/0435/002 23766 KRKA, D.D., NOVO MESTO PL
Roticox, 90 mg, tabletki powlekane
HU/H/0435/003 23767 KRKA, D.D., NOVO MESTO PL
TAUXIB 120 mg compresse rivestite con film
UK/H/0535/01-3 035890298 ADDENDA PHARMA S.R.L. IT
TAUXIB 120 mg compresse rivestite con film
UK/H/0535/01-3 035890425 ADDENDA PHARMA S.R.L. IT
TAUXIB 120 mg compresse rivestite con film
UK/H/0535/01-3 035890300 ADDENDA PHARMA S.R.L. IT
TAUXIB 120 mg compresse rivestite con film
UK/H/0535/01-3 035890312 ADDENDA PHARMA S.R.L. IT
List of nationally authorised medicinal products EMA/812634/2017 Page 219/231
Product Name (in authorisation country)
MRP/DCP Authorisation Number
National Authorisation Number
MAH of product in the Member State
Member State where product is authorised
TAUXIB 120 mg compresse rivestite con film
UK/H/0535/01-3 035890324 ADDENDA PHARMA S.R.L. IT
TAUXIB 120 mg compresse rivestite con film
UK/H/0535/01-3 035890336 ADDENDA PHARMA S.R.L. IT
TAUXIB 120 mg compresse rivestite con film
UK/H/0535/01-3 035890348 ADDENDA PHARMA S.R.L. IT
TAUXIB 120 mg compresse rivestite con film
UK/H/0535/001-003 035890351 ADDENDA PHARMA S.R.L. IT
TAUXIB 120 mg compresse rivestite con film
UK/H/0535/001-003 035890363 ADDENDA PHARMA S.R.L. IT
TAUXIB 120 mg compresse rivestite con film
UK/H/0535/001-003 035890375 ADDENDA PHARMA S.R.L. IT
TAUXIB 120 mg compresse rivestite con film
UK/H/0535/001-003 035890387 ADDENDA PHARMA S.R.L. IT
TAUXIB 120 mg compresse rivestite con film
UK/H/0535/001-003 035890399 ADDENDA PHARMA S.R.L. IT
TAUXIB 120 mg compresse rivestite con film
UK/H/0535/001-003 035890401 ADDENDA PHARMA S.R.L. IT
TAUXIB 120 mg compresse rivestite con film
UK/H/0535/001-003 035890413 ADDENDA PHARMA S.R.L. IT
TAUXIB 30 mg compresse rivestite con film
UK/H/0535/001-003 035890449 ADDENDA PHARMA S.R.L. IT
TAUXIB 30 mg compresse rivestite con film
UK/H/0535/001-003 035890437 ADDENDA PHARMA S.R.L. IT
TAUXIB 30 mg compresse rivestite con film
UK/H/0535/001-003 035890452 ADDENDA PHARMA S.R.L. IT
TAUXIB 60 mg compresse rivestite con film
UK/H/0535/001-003 035890019 ADDENDA PHARMA S.R.L. IT
List of nationally authorised medicinal products EMA/812634/2017 Page 220/231
Product Name (in authorisation country)
MRP/DCP Authorisation Number
National Authorisation Number
MAH of product in the Member State
Member State where product is authorised
TAUXIB 60 mg compresse rivestite con film
UK/H/0535/001-003 035890021 ADDENDA PHARMA S.R.L. IT
TAUXIB 60 mg compresse rivestite con film
UK/H/0535/001-003 035890033 ADDENDA PHARMA S.R.L. IT
TAUXIB 60 mg compresse rivestite con film
UK/H/0535/001-003 035890045 ADDENDA PHARMA S.R.L. IT
TAUXIB 60 mg compresse rivestite con film
UK/H/0535/001-003 035890058 ADDENDA PHARMA S.R.L. IT
TAUXIB 60 mg compresse rivestite con film
UK/H/0535/001-003 035890060 ADDENDA PHARMA S.R.L. IT
TAUXIB 60 mg compresse rivestite con film
UK/H/0535/001-003 035890072 ADDENDA PHARMA S.R.L. IT
TAUXIB 60 mg compresse rivestite con film
UK/H/0535/001-003 035890084 ADDENDA PHARMA S.R.L. IT
TAUXIB 60 mg compresse rivestite con film
UK/H/0535/001-003 035890096 ADDENDA PHARMA S.R.L. IT
TAUXIB 60 mg compresse rivestite con film
UK/H/0535/001-003 035890108 ADDENDA PHARMA S.R.L. IT
TAUXIB 60 mg compresse rivestite con film
UK/H/0535/001-003 035890110 ADDENDA PHARMA S.R.L. IT
TAUXIB 60 mg compresse rivestite con film
UK/H/0535/001-003 035890122 ADDENDA PHARMA S.R.L. IT
TAUXIB 60 mg compresse rivestite con film
UK/H/0535/001-003 035890134 ADDENDA PHARMA S.R.L. IT
TAUXIB 60 mg compresse rivestite con film
UK/H/0535/001-003 035890146 ADDENDA PHARMA S.R.L. IT
TAUXIB 60 mg compresse rivestite con film
UK/H/0535/001-003 35890464 ADDENDA PHARMA S.R.L. IT
List of nationally authorised medicinal products EMA/812634/2017 Page 221/231
Product Name (in authorisation country)
MRP/DCP Authorisation Number
National Authorisation Number
MAH of product in the Member State
Member State where product is authorised
TAUXIB 90 mg compresse rivestite con film
UK/H/0535/001-003 035890159 ADDENDA PHARMA S.R.L. IT
TAUXIB 90 mg compresse rivestite con film
UK/H/0535/001-003 035890161 ADDENDA PHARMA S.R.L. IT
TAUXIB 90 mg compresse rivestite con film
UK/H/0535/001-003 035890173 ADDENDA PHARMA S.R.L. IT
TAUXIB 90 mg compresse rivestite con film
UK/H/0535/001-003 035890185 ADDENDA PHARMA S.R.L. IT
TAUXIB 90 mg compresse rivestite con film
UK/H/0535/001-003 035890197 ADDENDA PHARMA S.R.L. IT
TAUXIB 90 mg compresse rivestite con film
UK/H/0535/001-003 035890209 ADDENDA PHARMA S.R.L. IT
TAUXIB 90 mg compresse rivestite con film
UK/H/0535/001-003 035890211 ADDENDA PHARMA S.R.L. IT
TAUXIB 90 mg compresse rivestite con film
UK/H/0535/001-003 035890223 ADDENDA PHARMA S.R.L. IT
TAUXIB 90 mg compresse rivestite con film
UK/H/0535/001-003 035890235 ADDENDA PHARMA S.R.L. IT
TAUXIB 90 mg compresse rivestite con film
UK/H/0535/001-003 035890247 ADDENDA PHARMA S.R.L. IT
TAUXIB 90 mg compresse rivestite con film
UK/H/0535/001-003 035890250 ADDENDA PHARMA S.R.L. IT
TAUXIB 90 mg compresse rivestite con film
UK/H/0535/01-3 035890262 ADDENDA PHARMA S.R.L. IT
TAUXIB 90 mg compresse rivestite con film
UK/H/0535/01-3 035890274 ADDENDA PHARMA S.R.L. IT
TAUXIB 90 mg compresse rivestite con film
UK/H/0535/01-3 035890286 ADDENDA PHARMA S.R.L. IT
List of nationally authorised medicinal products EMA/812634/2017 Page 222/231
Product Name (in authorisation country)
MRP/DCP Authorisation Number
National Authorisation Number
MAH of product in the Member State
Member State where product is authorised
Turox 120 mg comprimidos revestidos por película
UK/H/0535/003 4115481 MERCK SHARP & DOHME, LDA.
PT
Turox 120 mg comprimidos revestidos por película
UK/H/0535/003 4114880 MERCK SHARP & DOHME, LDA.
PT
Turox 120 mg comprimidos revestidos por película
UK/H/0535/003 4241584 MERCK SHARP & DOHME, LDA.
PT
Turox 120 mg comprimidos revestidos por película
UK/H/0535/003 4115580 MERCK SHARP & DOHME, LDA.
PT
Turox 120 mg comprimidos revestidos por película
UK/H/0535/003 4115382 MERCK SHARP & DOHME, LDA.
PT
Turox 120 mg comprimidos revestidos por película
UK/H/0535/003 4115283 MERCK SHARP & DOHME, LDA.
PT
Turox 120 mg comprimidos revestidos por película
UK/H/0535/003 4115689 MERCK SHARP & DOHME, LDA.
PT
Turox 120 mg comprimidos revestidos por película
UK/H/0535/003 4114484 MERCK SHARP & DOHME, LDA.
PT
Turox 120 mg comprimidos revestidos por película
UK/H/0535/003 4115085 MERCK SHARP & DOHME, LDA.
PT
Turox 120 mg comprimidos revestidos por película
UK/H/0535/003 4114989 MERCK SHARP & DOHME, LDA.
PT
Turox 120 mg comprimidos revestidos por película
UK/H/0535/003 4114682 MERCK SHARP & DOHME, LDA.
PT
Turox 120 mg comprimidos revestidos por película
UK/H/0535/003 4114385 MERCK SHARP & DOHME, LDA.
PT
Turox 120 mg comprimidos revestidos por película
UK/H/0535/003 4115184 MERCK SHARP & DOHME, LDA.
PT
Turox 120 mg comprimidos revestidos por película
UK/H/0535/003 4114583 MERCK SHARP & DOHME, LDA.
PT
List of nationally authorised medicinal products EMA/812634/2017 Page 223/231
Product Name (in authorisation country)
MRP/DCP Authorisation Number
National Authorisation Number
MAH of product in the Member State
Member State where product is authorised
Turox 120 mg comprimidos revestidos por película
UK/H/0535/003 4114781 MERCK SHARP & DOHME, LDA.
PT
Turox 120 mg comprimidos revestidos por película
UK/H/0535/003 4241683 MERCK SHARP & DOHME, LDA.
PT
Turox 30 mg comprimidos revestidos por película
UK/H/0535/004 5063052 MERCK SHARP & DOHME, LDA.
PT
Turox 30 mg comprimidos revestidos por película
UK/H/0535/004 5118617 MERCK SHARP & DOHME, LDA.
PT
Turox 30 mg comprimidos revestidos por película
UK/H/0535/004 5715040 MERCK SHARP & DOHME, LDA.
PT
Turox 60 mg comprimidos revestidos por película
UK/H/0535/001 4117081 MERCK SHARP & DOHME, LDA.
PT
Turox 60 mg comprimidos revestidos por película
UK/H/0535/001 4116489 MERCK SHARP & DOHME, LDA.
PT
Turox 60 mg comprimidos revestidos por película
UK/H/0535/001 4116083 MERCK SHARP & DOHME, LDA.
PT
Turox 60 mg comprimidos revestidos por película
UK/H/0535/001 4116984 MERCK SHARP & DOHME, LDA.
PT
Turox 60 mg comprimidos revestidos por película
UK/H/0535/001 4241287 MERCK SHARP & DOHME, LDA.
PT
Turox 60 mg comprimidos revestidos por película
UK/H/0535/001 4116786 MERCK SHARP & DOHME, LDA.
PT
Turox 60 mg comprimidos revestidos por película
UK/H/0535/001 4116588 MERCK SHARP & DOHME, LDA.
PT
Turox 60 mg comprimidos revestidos por película
UK/H/0535/001 4116687 MERCK SHARP & DOHME, LDA.
PT
Turox 60 mg comprimidos revestidos por película
UK/H/0535/001 4116281 MERCK SHARP & DOHME, LDA.
PT
List of nationally authorised medicinal products EMA/812634/2017 Page 224/231
Product Name (in authorisation country)
MRP/DCP Authorisation Number
National Authorisation Number
MAH of product in the Member State
Member State where product is authorised
Turox 60 mg comprimidos revestidos por película
UK/H/0535/001 4115788 MERCK SHARP & DOHME, LDA.
PT
Turox 60 mg comprimidos revestidos por película
UK/H/0535/001 4115986 MERCK SHARP & DOHME, LDA.
PT
Turox 60 mg comprimidos revestidos por película
UK/H/0535/001 4116182 MERCK SHARP & DOHME, LDA.
PT
Turox 60 mg comprimidos revestidos por película
UK/H/0535/001 4116380 MERCK SHARP & DOHME, LDA.
PT
Turox 60 mg comprimidos revestidos por película
UK/H/0535/001 4115887 MERCK SHARP & DOHME, LDA.
PT
Turox 60 mg comprimidos revestidos por película
UK/H/0535/001 4241188 MERCK SHARP & DOHME, LDA.
PT
Turox 60 mg comprimidos revestidos por película
UK/H/0535/001 4116885 MERCK SHARP & DOHME, LDA.
PT
Turox 90 mg comprimidos revestidos por película
UK/H/0535/002 4117388 MERCK SHARP & DOHME, LDA.
PT
Turox 90 mg comprimidos revestidos por película
UK/H/0535/002 4117289 MERCK SHARP & DOHME, LDA.
PT
Turox 90 mg comprimidos revestidos por película
UK/H/0535/002 4117180 MERCK SHARP & DOHME, LDA.
PT
Turox 90 mg comprimidos revestidos por película
UK/H/0535/002 4118188 MERCK SHARP & DOHME, LDA.
PT
Turox 90 mg comprimidos revestidos por película
UK/H/0535/002 4117982 MERCK SHARP & DOHME, LDA.
PT
Turox 90 mg comprimidos revestidos por película
UK/H/0535/002 4241485 MERCK SHARP & DOHME, LDA.
PT
Turox 90 mg comprimidos revestidos por película
UK/H/0535/002 4117685 MERCK SHARP & DOHME, LDA.
PT
List of nationally authorised medicinal products EMA/812634/2017 Page 225/231
Product Name (in authorisation country)
MRP/DCP Authorisation Number
National Authorisation Number
MAH of product in the Member State
Member State where product is authorised
Turox 90 mg comprimidos revestidos por película
UK/H/0535/002 4117784 MERCK SHARP & DOHME, LDA.
PT
Turox 90 mg comprimidos revestidos por película
UK/H/0535/002 4241386 MERCK SHARP & DOHME, LDA.
PT
Turox 90 mg comprimidos revestidos por película
UK/H/0535/002 4118386 MERCK SHARP & DOHME, LDA.
PT
Turox 90 mg comprimidos revestidos por película
UK/H/0535/002 4117883 MERCK SHARP & DOHME, LDA.
PT
Turox 90 mg comprimidos revestidos por película
UK/H/0535/002 4118287 MERCK SHARP & DOHME, LDA.
PT
Turox 90 mg comprimidos revestidos por película
UK/H/0535/002 4118485 MERCK SHARP & DOHME, LDA.
PT
Turox 90 mg comprimidos revestidos por película
UK/H/0535/002 4117586 MERCK SHARP & DOHME, LDA.
PT
Turox 90 mg comprimidos revestidos por película
UK/H/0535/002 4118089 MERCK SHARP & DOHME, LDA.
PT
Turox 90 mg comprimidos revestidos por película
UK/H/0535/002 4117487 MERCK SHARP & DOHME, LDA.
PT
TUROX® 120 mg film-coated tablets
UK/H/0535/003 PL 0025/0433 MERCK SHARP & DOHME LTD.
UK
TUROX® 30 mg film-coated tablets
UK/H/0535/004 PL 0025/0481 MERCK SHARP & DOHME LTD.
UK
TUROX® 60 mg film-coated tablets
UK/H/0535/001 PL 0025/0431 MERCK SHARP & DOHME LTD.
UK
TUROX® 90 mg film-coated tablets
UK/H/0535/002 PL 0025/0432 MERCK SHARP & DOHME LTD.
UK
АРКОКСИЯ 120 mg филмирани таблетки
not available 20030176 MERCK SHARP & DOHME BULGARIA EOOD
BG
List of nationally authorised medicinal products EMA/812634/2017 Page 226/231
Product Name (in authorisation country)
MRP/DCP Authorisation Number
National Authorisation Number
MAH of product in the Member State
Member State where product is authorised
АРКОКСИЯ 30 mg филмирани таблетки
not available 20100552 MERCK SHARP & DOHME BULGARIA EOOD
BG
АРКОКСИЯ 60 mg филмирани таблетки
not available 20030174 MERCK SHARP & DOHME BULGARIA EOOD
BG
АРКОКСИЯ 90 mg филмирани таблетки
not available 20030175 MERCK SHARP & DOHME BULGARIA EOOD
BG
Долоксиб 120 mg филмирани таблетки еторикоксиб
EE/H/0211/004 20160197 ZENTIVA, K.S. BG
Долоксиб 120 mg филмирани таблетки еторикоксиб
EE/H/0211/004 20160197 ZENTIVA, K.S. BG
Долоксиб 120 mg филмирани таблетки еторикоксиб
EE/H/0211/004 20160197 ZENTIVA, K.S. BG
Долоксиб 120 mg филмирани таблетки еторикоксиб
EE/H/0211/004 20160197 ZENTIVA, K.S. BG
Долоксиб 120 mg филмирани таблетки еторикоксиб
EE/H/0211/004 20160197 ZENTIVA, K.S. BG
Долоксиб 120 mg филмирани таблетки еторикоксиб
EE/H/0211/004 20160197 ZENTIVA, K.S. BG
Долоксиб 120 mg филмирани таблетки еторикоксиб
EE/H/0211/004 20160197 ZENTIVA, K.S. BG
Долоксиб 120 mg филмирани таблетки еторикоксиб
EE/H/0211/004 20160197 ZENTIVA, K.S. BG
Долоксиб 120 mg филмирани таблетки еторикоксиб
EE/H/0211/004 20160197 ZENTIVA, K.S. BG
Долоксиб 120 mg филмирани таблетки еторикоксиб
EE/H/0211/004 20160197 ZENTIVA, K.S. BG
Долоксиб 30 mg филмирани таблетки еторикоксиб
EE/H/0211/001 20160194 ZENTIVA, K.S. BG
List of nationally authorised medicinal products EMA/812634/2017 Page 227/231
Product Name (in authorisation country)
MRP/DCP Authorisation Number
National Authorisation Number
MAH of product in the Member State
Member State where product is authorised
Долоксиб 30 mg филмирани таблетки еторикоксиб
EE/H/0211/001 20160194 ZENTIVA, K.S. BG
Долоксиб 30 mg филмирани таблетки еторикоксиб
EE/H/0211/001 20160194 ZENTIVA, K.S. BG
Долоксиб 30 mg филмирани таблетки еторикоксиб
EE/H/0211/001 20160194 ZENTIVA, K.S. BG
Долоксиб 30 mg филмирани таблетки еторикоксиб
EE/H/0211/001 20160194 ZENTIVA, K.S. BG
Долоксиб 30 mg филмирани таблетки еторикоксиб
EE/H/0211/001 20160194 ZENTIVA, K.S. BG
Долоксиб 60 mg филмирани таблетки еторикоксиб
EE/H/0211/002 20160195 ZENTIVA, K.S. BG
Долоксиб 60 mg филмирани таблетки еторикоксиб
EE/H/0211/002 20160195 ZENTIVA, K.S. BG
Долоксиб 60 mg филмирани таблетки еторикоксиб
EE/H/0211/002 20160195 ZENTIVA, K.S. BG
Долоксиб 60 mg филмирани таблетки еторикоксиб
EE/H/0211/002 20160195 ZENTIVA, K.S. BG
Долоксиб 60 mg филмирани таблетки еторикоксиб
EE/H/0211/002 20160195 ZENTIVA, K.S. BG
Долоксиб 60 mg филмирани таблетки еторикоксиб
EE/H/0211/002 20160195 ZENTIVA, K.S. BG
Долоксиб 60 mg филмирани таблетки еторикоксиб
EE/H/0211/002 20160195 ZENTIVA, K.S. BG
Долоксиб 60 mg филмирани таблетки еторикоксиб
EE/H/0211/002 20160195 ZENTIVA, K.S. BG
Долоксиб 60 mg филмирани таблетки еторикоксиб
EE/H/0211/002 20160195 ZENTIVA, K.S. BG
List of nationally authorised medicinal products EMA/812634/2017 Page 228/231
Product Name (in authorisation country)
MRP/DCP Authorisation Number
National Authorisation Number
MAH of product in the Member State
Member State where product is authorised
Долоксиб 60 mg филмирани таблетки еторикоксиб
EE/H/0211/002 20160195 ZENTIVA, K.S. BG
Долоксиб 60 mg филмирани таблетки еторикоксиб
EE/H/0211/002 20160195 ZENTIVA, K.S. BG
Долоксиб 60 mg филмирани таблетки еторикоксиб
EE/H/0211/002 20160195 ZENTIVA, K.S. BG
Долоксиб 90 mg филмирани таблетки еторикоксиб
EE/H/0211/003 20160196 ZENTIVA, K.S. BG
Долоксиб 90 mg филмирани таблетки еторикоксиб
EE/H/0211/003 20160196 ZENTIVA, K.S. BG
Долоксиб 90 mg филмирани таблетки еторикоксиб
EE/H/0211/003 20160196 ZENTIVA, K.S. BG
Долоксиб 90 mg филмирани таблетки еторикоксиб
EE/H/0211/003 20160196 ZENTIVA, K.S. BG
Долоксиб 90 mg филмирани таблетки еторикоксиб
EE/H/0211/003 20160196 ZENTIVA, K.S. BG
Долоксиб 90 mg филмирани таблетки еторикоксиб
EE/H/0211/003 20160196 ZENTIVA, K.S. BG
Долоксиб 90 mg филмирани таблетки еторикоксиб
EE/H/0211/003 20160196 ZENTIVA, K.S. BG
Долоксиб 90 mg филмирани таблетки еторикоксиб
EE/H/0211/003 20160196 ZENTIVA, K.S. BG
Долоксиб 90 mg филмирани таблетки еторикоксиб
EE/H/0211/003 20160196 ZENTIVA, K.S. BG
Долоксиб 90 mg филмирани таблетки еторикоксиб
EE/H/0211/003 20160196 ZENTIVA, K.S. BG
Долоксиб 90 mg филмирани таблетки еторикоксиб
EE/H/0211/003 20160196 ZENTIVA, K.S. BG
List of nationally authorised medicinal products EMA/812634/2017 Page 229/231
Product Name (in authorisation country)
MRP/DCP Authorisation Number
National Authorisation Number
MAH of product in the Member State
Member State where product is authorised
Долоксиб 90 mg филмирани таблетки еторикоксиб
EE/H/0211/003 20160196 ZENTIVA, K.S. BG
Еторикоксиб Тева 120 mg филмирани таблетки
DE/H/5031/004 20160114 TEVA PHARMACEUTICAL BULGARIA EOOD
BG
Еторикоксиб Тева 120 mg филмирани таблетки
DE/H/5031/004 20160114 TEVA PHARMACEUTICALS BULGARIA EOOD
BG
Еторикоксиб Тева 30 mg филмирани таблетки
DE/H/5031/001 20160111 TEVA PHARMACEUTICALS BULGARIA EOOD
BG
Еторикоксиб Тева 30 mg филмирани таблетки
DE/H/5031/001 20160111 TEVA PHARMACEUTICALS BULGARIA EOOD
BG
Еторикоксиб Тева 60 mg филмирани таблетки
DE/H/5031/002 20160112 TEVA PHARMACEUTICALS BULGARIA EOOD
BG
Еторикоксиб Тева 90 mg филмирани таблетки
DE/H/5031/003 20160113 TEVA PHARMACEUTICALS BULGARIA EOOD
BG
КОКСИЕНТ 120 mg филмирани таблетки
IS/H/0244/004 II-35187 ALVOGEN MALTA OPERATIONS (ROW) LTD
BG
КОКСИЕНТ 120 mg филмирани таблетки
IS/H/0244/004 II-35187 ALVOGEN MALTA OPERATIONS (ROW) LTD
BG
КОКСИЕНТ 120 mg филмирани таблетки
IS/H/0244/004 II-35187 ALVOGEN MALTA OPERATIONS (ROW) LTD
BG
КОКСИЕНТ 120 mg филмирани таблетки
IS/H/0244/004 II-35187 ALVOGEN MALTA OPERATIONS (ROW) LTD
BG
КОКСИЕНТ 120 mg филмирани таблетки
IS/H/0244/004 II-35187 ALVOGEN MALTA OPERATIONS (ROW) LTD
BG
КОКСИЕНТ 60 mg филмирани таблетки
IS/H/0244/002 II-35185 ALVOGEN MALTA OPERATIONS (ROW) LTD
BG
КОКСИЕНТ 60 mg филмирани таблетки
IS/H/0244/002 II-35185 ALVOGEN MALTA OPERATIONS (ROW) LTD
BG
List of nationally authorised medicinal products EMA/812634/2017 Page 230/231
Product Name (in authorisation country)
MRP/DCP Authorisation Number
National Authorisation Number
MAH of product in the Member State
Member State where product is authorised
КОКСИЕНТ 60 mg филмирани таблетки
IS/H/0244/002 II-35185 ALVOGEN MALTA OPERATIONS (ROW) LTD
BG
КОКСИЕНТ 60 mg филмирани таблетки
IS/H/0244/002 II-35185 ALVOGEN MALTA OPERATIONS (ROW) LTD
BG
КОКСИЕНТ 60 mg филмирани таблетки
IS/H/0244/002 II-35185 ALVOGEN MALTA OPERATIONS (ROW) LTD
BG
КОКСИЕНТ 90 mg филмирани таблетки
IS/H/0244/003 II-35186 ALVOGEN MALTA OPERATIONS (ROW) LTD
BG
КОКСИЕНТ 90 mg филмирани таблетки
IS/H/0244/003 II-35186 ALVOGEN MALTA OPERATIONS (ROW) LTD
BG
КОКСИЕНТ 90 mg филмирани таблетки
IS/H/0244/003 II-35186 ALVOGEN MALTA OPERATIONS (ROW) LTD
BG
КОКСИЕНТ 90 mg филмирани таблетки
IS/H/0244/003 II-35186 ALVOGEN MALTA OPERATIONS (ROW) LTD
BG
КОКСИЕНТ 90 mg филмирани таблетки
IS/H/0244/003 II-35186 ALVOGEN MALTA OPERATIONS (ROW) LTD
BG
КОСТАРОКС 120 MG ФИЛМИРАНИ ТАБЛЕТКИ
DE/H/3908/004 20160272 SANDOZ PHARMACEUTICALS D.D.
BG
КОСТАРОКС 30 MG ФИЛМИРАНИ ТАБЛЕТКИ
DE/H/3908/001 20160269 SANDOZ PHARMACEUTICALS D.D.
BG
КОСТАРОКС 60 MG ФИЛМИРАНИ ТАБЛЕТКИ
DE/H/3908/002 20160270 SANDOZ PHARMACEUTICALS D.D.
BG
КОСТАРОКС 90 MG ФИЛМИРАНИ ТАБЛЕТКИ
DE/H/3908/003 20160271 SANDOZ PHARMACEUTICALS D.D.
BG
Ротикокс 120 mg филмирани таблетки
HU/H/0435/004 20170069 KRKA, D.D., NOVO MESTO BG
Ротикокс 30 mg филмирани таблетки
HU/H/0435/001 20170066 KRKA, D.D., NOVO MESTO BG
List of nationally authorised medicinal products EMA/812634/2017 Page 231/231
Product Name (in authorisation country)
MRP/DCP Authorisation Number
National Authorisation Number
MAH of product in the Member State
Member State where product is authorised
Ротикокс 60 mg филмирани таблетки
HU/H/0435/002 20170067 KRKA, D.D., NOVO MESTO BG
Ротикокс 90 mg филмирани таблетки
HU/H/0435/003 20170068 KRKA, D.D., NOVO MESTO BG
