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© European Medicines Agency, 2018. Reproduction is authorised provided the source is acknowledged.
11 January 2018 EMA/24903/2018 Human Medicines Evaluation Division
List of nationally authorised medicinal products
Active substance: venlafaxine
Procedure no.: PSUSA/00003104/201705
List of nationally authorised medicinal products EMA/24903/2018 Page 2/117
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
Apclaven XL 150 mg Prolonged release capsule
not available PL 40378/0190 TORRENT PHARMA LTD. UK
Apclaven XL 37.5 mg Prolonged release capsule
not available PL 40378/0188 TORRENT PHARMA LTD. UK
Apclaven XL 75 mg Prolonged release capsule
not available PL 40378/0189 TORRENT PHARMA LTD. UK
Dobupal 37,5 mg comprimidos
ES/H/0154/001 60.666 ALMIRALL, S.A. ES
Dobupal 50 mg comprimidos
ES/H/0154/002 60.667 ALMIRALL, S.A. ES
Dobupal 75 mg comprimidos
ES/H/0154/003 60.668 ALMIRALL, S.A. ES
Dobupal Retard 150 mg cápsulas duras de liberación prolongada
ES/H/0154/005 62.421 ALMIRALL, S.A. ES
Dobupal Retard 75 mg cápsulas duras de liberación prolongada
ES/H/0154/004 62.420 ALMIRALL, S.A. ES
Duofaxin SE/H/0564/004 IS/1/14/052/01 MEDILINK A/S IS
Duofaxin SE/H/0564/003 IS/1/14/052/02 MEDILINK A/S IS
List of nationally authorised medicinal products EMA/24903/2018 Page 3/117
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
Duofaxin SE/H/0564/004 IS/1/14/052/03 MEDILINK A/S IS
Duofaxin SE/H/0564/004 IS/1/14/052/01 MEDILINK A/S IS
Duofaxin SE/H/0564/003 IS/1/14/052/02 MEDILINK A/S IS
Duofaxin SE/H/0564/004 IS/1/14/052/03 MEDILINK A/S IS
Duofaxin, depottabletter SE/H/0564/002 39249 MEDILINK A/S DK
Duofaxin, depottabletter SE/H/0564/003 39250 MEDILINK A/S DK
Duofaxin, depottabletter SE/H/0564/004 39251 MEDILINK A/S DK
Duofaxin, depottabletter SE/H/0564/002 39249 MEDILINK A/S DK
Duofaxin, depottabletter SE/H/0564/003 39250 MEDILINK A/S DK
List of nationally authorised medicinal products EMA/24903/2018 Page 4/117
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
Duofaxin, depottabletter SE/H/0564/004 39251 MEDILINK A/S DK
EFECTIN EP 150 mg capsule cu eliberare prelungită
SE/H/0936/003 7977/2015/19 PFIZER EUROPE MA EEIG RO
EFECTIN EP 150 mg capsule cu eliberare prelungită
SE/H/0936/003 7977/2015/18 PFIZER EUROPE MA EEIG RO
EFECTIN EP 150 mg capsule cu eliberare prelungită
SE/H/0936/003 7977/2015/21 PFIZER EUROPE MA EEIG RO
EFECTIN EP 150 mg capsule cu eliberare prelungită
SE/H/0936/003 7977/2015/20 PFIZER EUROPE MA EEIG RO
EFECTIN EP 150 mg capsule cu eliberare prelungită
SE/H/0936/003 7977/2015/07 PFIZER EUROPE MA EEIG RO
EFECTIN EP 150 mg capsule cu eliberare prelungită
SE/H/0936/003 7977/2015/08 PFIZER EUROPE MA EEIG RO
EFECTIN EP 150 mg capsule cu eliberare prelungită
SE/H/0936/003 7977/2015/23 PFIZER EUROPE MA EEIG RO
EFECTIN EP 150 mg capsule cu eliberare prelungită
SE/H/0936/003 7977/2015/22 PFIZER EUROPE MA EEIG RO
List of nationally authorised medicinal products EMA/24903/2018 Page 5/117
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
EFECTIN EP 150 mg capsule cu eliberare prelungită
SE/H/0936/003 7977/2015/09 PFIZER EUROPE MA EEIG RO
EFECTIN EP 150 mg capsule cu eliberare prelungită
SE/H/0936/003 7977/2015/24 PFIZER EUROPE MA EEIG RO
EFECTIN EP 150 mg capsule cu eliberare prelungită
SE/H/0936/003 7977/2015/10 PFIZER EUROPE MA EEIG RO
EFECTIN EP 150 mg capsule cu eliberare prelungită
SE/H/0936/003 7977/2015/11 PFIZER EUROPE MA EEIG RO
EFECTIN EP 150 mg capsule cu eliberare prelungită
SE/H/0936/003 7977/2015/02 PFIZER EUROPE MA EEIG RO
EFECTIN EP 150 mg capsule cu eliberare prelungită
SE/H/0936/003 7977/2015/12 PFIZER EUROPE MA EEIG RO
EFECTIN EP 150 mg capsule cu eliberare prelungită
SE/H/0936/003 7977/2015/04 PFIZER EUROPE MA EEIG RO
EFECTIN EP 150 mg capsule cu eliberare prelungită
SE/H/0936/003 7977/2015/05 PFIZER EUROPE MA EEIG RO
EFECTIN EP 150 mg capsule cu eliberare prelungită
SE/H/0936/003 7977/2015/13 PFIZER EUROPE MA EEIG RO
List of nationally authorised medicinal products EMA/24903/2018 Page 6/117
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
EFECTIN EP 150 mg capsule cu eliberare prelungită
SE/H/0936/003 7977/2015/03 PFIZER EUROPE MA EEIG RO
EFECTIN EP 150 mg capsule cu eliberare prelungită
SE/H/0936/003 7977/2015/01 PFIZER EUROPE MA EEIG RO
EFECTIN EP 150 mg capsule cu eliberare prelungită
SE/H/0936/003 7977/2015/16 PFIZER EUROPE MA EEIG RO
EFECTIN EP 150 mg capsule cu eliberare prelungită
SE/H/0936/003 7977/2015/14 PFIZER EUROPE MA EEIG RO
EFECTIN EP 150 mg capsule cu eliberare prelungită
SE/H/0936/003 7977/2015/15 PFIZER EUROPE MA EEIG RO
EFECTIN EP 150 mg capsule cu eliberare prelungită
SE/H/0936/003 7977/2015/06 PFIZER EUROPE MA EEIG RO
EFECTIN EP 150 mg capsule cu eliberare prelungită
SE/H/0936/003 7977/2015/17 PFIZER EUROPE MA EEIG RO
EFECTIN EP 37,5 mg capsule cu eliberare prelungită
SE/H/0936/001 7975/2015/12 PFIZER EUROPE MA EEIG RO
EFECTIN EP 37,5 mg capsule cu eliberare prelungită
SE/H/0936/001 7975/2015/13 PFIZER EUROPE MA EEIG RO
List of nationally authorised medicinal products EMA/24903/2018 Page 7/117
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
EFECTIN EP 37,5 mg capsule cu eliberare prelungită
SE/H/0936/001 7975/2015/10 PFIZER EUROPE MA EEIG RO
EFECTIN EP 37,5 mg capsule cu eliberare prelungită
SE/H/0936/001 7975/2015/16 PFIZER EUROPE MA EEIG RO
EFECTIN EP 37,5 mg capsule cu eliberare prelungită
SE/H/0936/001 7975/2015/15 PFIZER EUROPE MA EEIG RO
EFECTIN EP 37,5 mg capsule cu eliberare prelungită
SE/H/0936/001 7975/2015/14 PFIZER EUROPE MA EEIG RO
EFECTIN EP 37,5 mg capsule cu eliberare prelungită
SE/H/0936/001 7975/2015/17 PFIZER EUROPE MA EEIG RO
EFECTIN EP 37,5 mg capsule cu eliberare prelungită
SE/H/0936/001 7975/2015/19 PFIZER EUROPE MA EEIG RO
EFECTIN EP 37,5 mg capsule cu eliberare prelungită
SE/H/0936/001 7975/2015/02 PFIZER EUROPE MA EEIG RO
EFECTIN EP 37,5 mg capsule cu eliberare prelungită
SE/H/0936/001 7975/2015/01 PFIZER EUROPE MA EEIG RO
EFECTIN EP 37,5 mg capsule cu eliberare prelungită
SE/H/0936/001 7975/2015/18 PFIZER EUROPE MA EEIG RO
List of nationally authorised medicinal products EMA/24903/2018 Page 8/117
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
EFECTIN EP 37,5 mg capsule cu eliberare prelungită
SE/H/0936/001 7975/2015/20 PFIZER EUROPE MA EEIG RO
EFECTIN EP 37,5 mg capsule cu eliberare prelungită
SE/H/0936/001 7975/2015/03 PFIZER EUROPE MA EEIG RO
EFECTIN EP 37,5 mg capsule cu eliberare prelungită
SE/H/0936/001 7975/2015/22 PFIZER EUROPE MA EEIG RO
EFECTIN EP 37,5 mg capsule cu eliberare prelungită
SE/H/0936/001 7975/2015/07 PFIZER EUROPE MA EEIG RO
EFECTIN EP 37,5 mg capsule cu eliberare prelungită
SE/H/0936/001 7975/2015/05 PFIZER EUROPE MA EEIG RO
EFECTIN EP 37,5 mg capsule cu eliberare prelungită
SE/H/0936/001 7975/2015/24 PFIZER EUROPE MA EEIG RO
EFECTIN EP 37,5 mg capsule cu eliberare prelungită
SE/H/0936/001 7975/2015/21 PFIZER EUROPE MA EEIG RO
EFECTIN EP 37,5 mg capsule cu eliberare prelungită
SE/H/0936/001 7975/2015/04 PFIZER EUROPE MA EEIG RO
EFECTIN EP 37,5 mg capsule cu eliberare prelungită
SE/H/0936/001 7975/2015/09 PFIZER EUROPE MA EEIG RO
List of nationally authorised medicinal products EMA/24903/2018 Page 9/117
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
EFECTIN EP 37,5 mg capsule cu eliberare prelungită
SE/H/0936/001 7975/2015/23 PFIZER EUROPE MA EEIG RO
EFECTIN EP 37,5 mg capsule cu eliberare prelungită
SE/H/0936/001 7975/2015/11 PFIZER EUROPE MA EEIG RO
EFECTIN EP 37,5 mg capsule cu eliberare prelungită
SE/H/0936/001 7975/2015/06 PFIZER EUROPE MA EEIG RO
EFECTIN EP 37,5 mg capsule cu eliberare prelungită
SE/H/0936/001 7975/2015/25 PFIZER EUROPE MA EEIG RO
EFECTIN EP 37,5 mg capsule cu eliberare prelungită
SE/H/0936/001 7975/2015/08 PFIZER EUROPE MA EEIG RO
EFECTIN EP 75 mg capsule cu eliberare prelungită
SE/H/0936/002 7976/2015/16 PFIZER EUROPE MA EEIG RO
EFECTIN EP 75 mg capsule cu eliberare prelungită
SE/H/0936/002 7976/2015/02 PFIZER EUROPE MA EEIG RO
EFECTIN EP 75 mg capsule cu eliberare prelungită
SE/H/0936/002 7976/2015/16 PFIZER EUROPE MA EEIG RO
EFECTIN EP 75 mg capsule cu eliberare prelungită
SE/H/0936/002 7976/2015/17 PFIZER EUROPE MA EEIG RO
List of nationally authorised medicinal products EMA/24903/2018 Page 10/117
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
EFECTIN EP 75 mg capsule cu eliberare prelungită
SE/H/0936/002 7976/2015/01 PFIZER EUROPE MA EEIG RO
EFECTIN EP 75 mg capsule cu eliberare prelungită
SE/H/0936/002 7976/2015/18 PFIZER EUROPE MA EEIG RO
EFECTIN EP 75 mg capsule cu eliberare prelungită
SE/H/0936/002 7976/2015/03 PFIZER EUROPE MA EEIG RO
EFECTIN EP 75 mg capsule cu eliberare prelungită
SE/H/0936/002 7976/2015/19 PFIZER EUROPE MA EEIG RO
EFECTIN EP 75 mg capsule cu eliberare prelungită
SE/H/0936/002 7976/2015/04 PFIZER EUROPE MA EEIG RO
EFECTIN EP 75 mg capsule cu eliberare prelungită
SE/H/0936/002 7976/2015/05 PFIZER EUROPE MA EEIG RO
EFECTIN EP 75 mg capsule cu eliberare prelungită
SE/H/0936/002 7976/2015/21 PFIZER EUROPE MA EEIG RO
EFECTIN EP 75 mg capsule cu eliberare prelungită
SE/H/0936/002 7976/2015/06 PFIZER EUROPE MA EEIG RO
EFECTIN EP 75 mg capsule cu eliberare prelungită
SE/H/0936/002 7976/2015/23 PFIZER EUROPE MA EEIG RO
List of nationally authorised medicinal products EMA/24903/2018 Page 11/117
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
EFECTIN EP 75 mg capsule cu eliberare prelungită
SE/H/0936/002 7976/2015/08 PFIZER EUROPE MA EEIG RO
EFECTIN EP 75 mg capsule cu eliberare prelungită
SE/H/0936/002 7976/2015/20 PFIZER EUROPE MA EEIG RO
EFECTIN EP 75 mg capsule cu eliberare prelungită
SE/H/0936/002 7976/2015/09 PFIZER EUROPE MA EEIG RO
EFECTIN EP 75 mg capsule cu eliberare prelungită
SE/H/0936/002 7976/2015/07 PFIZER EUROPE MA EEIG RO
EFECTIN EP 75 mg capsule cu eliberare prelungită
SE/H/0936/002 7976/2015/22 PFIZER EUROPE MA EEIG RO
EFECTIN EP 75 mg capsule cu eliberare prelungită
SE/H/0936/002 7976/2015/24 PFIZER EUROPE MA EEIG RO
EFECTIN EP 75 mg capsule cu eliberare prelungită
SE/H/0936/002 7976/2015/11 PFIZER EUROPE MA EEIG RO
EFECTIN EP 75 mg capsule cu eliberare prelungită
SE/H/0936/002 7976/2015/10 PFIZER EUROPE MA EEIG RO
EFECTIN EP 75 mg capsule cu eliberare prelungită
SE/H/0936/002 7976/2015/13 PFIZER EUROPE MA EEIG RO
List of nationally authorised medicinal products EMA/24903/2018 Page 12/117
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
EFECTIN EP 75 mg capsule cu eliberare prelungită
SE/H/0936/002 7976/2015/12 PFIZER EUROPE MA EEIG RO
EFECTIN EP 75 mg capsule cu eliberare prelungită
SE/H/0936/002 7976/2015/14 PFIZER EUROPE MA EEIG RO
Efectin ER 150 mg Hartkapseln, retardiert
SE/H/0936/003 1-23043 PFIZER CORPORATION AUSTRIA GESELLSCHAFT M.B.H.
AT
EFECTIN ER 150 mg trde kapsule s podaljšanim sproščanjem
SE/H/0936/003 H/00/00529/097 PFIZER EUROPE MA EEIG SI
EFECTIN ER 150 mg trde kapsule s podaljšanim sproščanjem
SE/H/0936/003 H/00/00529/087 PFIZER EUROPE MA EEIG SI
EFECTIN ER 150 mg trde kapsule s podaljšanim sproščanjem
SE/H/0936/003 H/00/00529/095 PFIZER EUROPE MA EEIG SI
EFECTIN ER 150 mg trde kapsule s podaljšanim sproščanjem
SE/H/0936/003 H/00/00529/100 PFIZER EUROPE MA EEIG SI
EFECTIN ER 150 mg trde kapsule s podaljšanim sproščanjem
SE/H/0936/003 H/00/00529/101 PFIZER EUROPE MA EEIG SI
EFECTIN ER 150 mg trde kapsule s podaljšanim sproščanjem
SE/H/0936/003 H/00/00529/098 PFIZER EUROPE MA EEIG SI
List of nationally authorised medicinal products EMA/24903/2018 Page 13/117
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
EFECTIN ER 150 mg trde kapsule s podaljšanim sproščanjem
SE/H/0936/003 H/00/00529/107 PFIZER EUROPE MA EEIG SI
EFECTIN ER 150 mg trde kapsule s podaljšanim sproščanjem
SE/H/0936/003 H/00/00529/108 PFIZER EUROPE MA EEIG SI
EFECTIN ER 150 mg trde kapsule s podaljšanim sproščanjem
SE/H/0936/003 H/00/00529/094 PFIZER EUROPE MA EEIG SI
EFECTIN ER 150 mg trde kapsule s podaljšanim sproščanjem
SE/H/0936/003 H/00/00529/103 PFIZER EUROPE MA EEIG SI
EFECTIN ER 150 mg trde kapsule s podaljšanim sproščanjem
SE/H/0936/003 H/00/00529/086 PFIZER EUROPE MA EEIG SI
EFECTIN ER 150 mg trde kapsule s podaljšanim sproščanjem
SE/H/0936/003 H/00/00529/096 PFIZER EUROPE MA EEIG SI
EFECTIN ER 150 mg trde kapsule s podaljšanim sproščanjem
SE/H/0936/003 H/00/00529/106 PFIZER EUROPE MA EEIG SI
EFECTIN ER 150 mg trde kapsule s podaljšanim sproščanjem
SE/H/0936/003 H/00/00529/081 PFIZER EUROPE MA EEIG SI
EFECTIN ER 150 mg trde kapsule s podaljšanim sproščanjem
SE/H/0936/003 H/00/00529/093 PFIZER EUROPE MA EEIG SI
List of nationally authorised medicinal products EMA/24903/2018 Page 14/117
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
EFECTIN ER 150 mg trde kapsule s podaljšanim sproščanjem
SE/H/0936/003 H/00/00529/085 PFIZER EUROPE MA EEIG SI
EFECTIN ER 150 mg trde kapsule s podaljšanim sproščanjem
SE/H/0936/003 H/00/00529/105 PFIZER EUROPE MA EEIG SI
EFECTIN ER 150 mg trde kapsule s podaljšanim sproščanjem
SE/H/0936/003 H/00/00529/082 PFIZER EUROPE MA EEIG SI
EFECTIN ER 150 mg trde kapsule s podaljšanim sproščanjem
SE/H/0936/003 H/00/00529/080 PFIZER EUROPE MA EEIG SI
EFECTIN ER 150 mg trde kapsule s podaljšanim sproščanjem
SE/H/0936/003 H/00/00529/104 PFIZER EUROPE MA EEIG SI
EFECTIN ER 150 mg trde kapsule s podaljšanim sproščanjem
SE/H/0936/003 H/00/00529/077 PFIZER EUROPE MA EEIG SI
EFECTIN ER 150 mg trde kapsule s podaljšanim sproščanjem
SE/H/0936/003 H/00/00529/102 PFIZER EUROPE MA EEIG SI
EFECTIN ER 150 mg trde kapsule s podaljšanim sproščanjem
SE/H/0936/003 H/00/00529/078 PFIZER EUROPE MA EEIG SI
EFECTIN ER 150 mg trde kapsule s podaljšanim sproščanjem
SE/H/0936/003 H/00/00529/076 PFIZER EUROPE MA EEIG SI
List of nationally authorised medicinal products EMA/24903/2018 Page 15/117
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
EFECTIN ER 150 mg trde kapsule s podaljšanim sproščanjem
SE/H/0936/003 H/00/00529/099 PFIZER EUROPE MA EEIG SI
EFECTIN ER 150 mg trde kapsule s podaljšanim sproščanjem
SE/H/0936/003 H/00/00529/089 PFIZER EUROPE MA EEIG SI
EFECTIN ER 150 mg trde kapsule s podaljšanim sproščanjem
SE/H/0936/003 H/00/00529/088 PFIZER EUROPE MA EEIG SI
EFECTIN ER 150 mg trde kapsule s podaljšanim sproščanjem
SE/H/0936/003 H/00/00529/083 PFIZER EUROPE MA EEIG SI
EFECTIN ER 150 mg trde kapsule s podaljšanim sproščanjem
SE/H/0936/003 H/00/00529/092 PFIZER EUROPE MA EEIG SI
EFECTIN ER 150 mg trde kapsule s podaljšanim sproščanjem
SE/H/0936/003 H/00/00529/074 PFIZER EUROPE MA EEIG SI
EFECTIN ER 150 mg trde kapsule s podaljšanim sproščanjem
SE/H/0936/003 H/00/00529/084 PFIZER EUROPE MA EEIG SI
EFECTIN ER 150 mg trde kapsule s podaljšanim sproščanjem
SE/H/0936/003 H/00/00529/090 PFIZER EUROPE MA EEIG SI
EFECTIN ER 150 mg trde kapsule s podaljšanim sproščanjem
SE/H/0936/003 H/00/00529/079 PFIZER EUROPE MA EEIG SI
List of nationally authorised medicinal products EMA/24903/2018 Page 16/117
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
EFECTIN ER 150 mg trde kapsule s podaljšanim sproščanjem
SE/H/0936/003 H/00/00529/073 PFIZER EUROPE MA EEIG SI
EFECTIN ER 150 mg trde kapsule s podaljšanim sproščanjem
SE/H/0936/003 H/00/00529/091 PFIZER EUROPE MA EEIG SI
EFECTIN ER 150 mg trde kapsule s podaljšanim sproščanjem
SE/H/0936/003 H/00/00529/075 PFIZER EUROPE MA EEIG SI
EFECTIN ER 150 mg tvrdé tobolky s prodlouženým uvolňováním
SE/H/0936/003 30/687/99-C PFIZER, SPOL. S R.O. CZ
Efectin ER 150, 150 mg, kapsułki o przedłużonym uwalnianiu, twarde
SE/H/0936/003 4940 PFIZER EUROPE MA EEIG PL
Efectin ER 37,5 mg Hartkapseln, retardiert
SE/H/0936/001 1-24637 PFIZER CORPORATION AUSTRIA GESELLSCHAFT M.B.H.
AT
EFECTIN ER 37,5 mg trde kapsule s podaljšanim sproščanjem
SE/H/0936/001 H/00/00529/025 PFIZER EUROPE MA EEIG SI
EFECTIN ER 37,5 mg trde kapsule s podaljšanim sproščanjem
SE/H/0936/001 H/00/00529/031 PFIZER EUROPE MA EEIG SI
EFECTIN ER 37,5 mg trde kapsule s podaljšanim sproščanjem
SE/H/0936/001 H/00/00529/021 PFIZER EUROPE MA EEIG SI
List of nationally authorised medicinal products EMA/24903/2018 Page 17/117
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
EFECTIN ER 37,5 mg trde kapsule s podaljšanim sproščanjem
SE/H/0936/001 H/00/00529/028 PFIZER EUROPE MA EEIG SI
EFECTIN ER 37,5 mg trde kapsule s podaljšanim sproščanjem
SE/H/0936/001 H/00/00529/026 PFIZER EUROPE MA EEIG SI
EFECTIN ER 37,5 mg trde kapsule s podaljšanim sproščanjem
SE/H/0936/001 H/00/00529/023 PFIZER EUROPE MA EEIG SI
EFECTIN ER 37,5 mg trde kapsule s podaljšanim sproščanjem
SE/H/0936/001 H/00/00529/024 PFIZER EUROPE MA EEIG SI
EFECTIN ER 37,5 mg trde kapsule s podaljšanim sproščanjem
SE/H/0936/001 H/00/00529/015 PFIZER EUROPE MA EEIG SI
EFECTIN ER 37,5 mg trde kapsule s podaljšanim sproščanjem
SE/H/0936/001 H/00/00529/030 PFIZER EUROPE MA EEIG SI
EFECTIN ER 37,5 mg trde kapsule s podaljšanim sproščanjem
SE/H/0936/001 H/00/00529/027 PFIZER EUROPE MA EEIG SI
EFECTIN ER 37,5 mg trde kapsule s podaljšanim sproščanjem
SE/H/0936/001 H/00/00529/018 PFIZER EUROPE MA EEIG SI
EFECTIN ER 37,5 mg trde kapsule s podaljšanim sproščanjem
SE/H/0936/001 H/00/00529/034 PFIZER EUROPE MA EEIG SI
List of nationally authorised medicinal products EMA/24903/2018 Page 18/117
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
EFECTIN ER 37,5 mg trde kapsule s podaljšanim sproščanjem
SE/H/0936/001 H/00/00529/019 PFIZER EUROPE MA EEIG SI
EFECTIN ER 37,5 mg trde kapsule s podaljšanim sproščanjem
SE/H/0936/001 H/00/00529/035 PFIZER EUROPE MA EEIG SI
EFECTIN ER 37,5 mg trde kapsule s podaljšanim sproščanjem
SE/H/0936/001 H/00/00529/016 PFIZER EUROPE MA EEIG SI
EFECTIN ER 37,5 mg trde kapsule s podaljšanim sproščanjem
SE/H/0936/001 H/00/00529/020 PFIZER EUROPE MA EEIG SI
EFECTIN ER 37,5 mg trde kapsule s podaljšanim sproščanjem
SE/H/0936/001 H/00/00529/036 PFIZER EUROPE MA EEIG SI
EFECTIN ER 37,5 mg trde kapsule s podaljšanim sproščanjem
SE/H/0936/001 H/00/00529/012 PFIZER EUROPE MA EEIG SI
EFECTIN ER 37,5 mg trde kapsule s podaljšanim sproščanjem
SE/H/0936/001 H/00/00529/022 PFIZER EUROPE MA EEIG SI
EFECTIN ER 37,5 mg trde kapsule s podaljšanim sproščanjem
SE/H/0936/001 H/00/00529/010 PFIZER EUROPE MA EEIG SI
EFECTIN ER 37,5 mg trde kapsule s podaljšanim sproščanjem
SE/H/0936/001 H/00/00529/017 PFIZER EUROPE MA EEIG 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
EFECTIN ER 37,5 mg trde kapsule s podaljšanim sproščanjem
SE/H/0936/001 H/00/00529/011 PFIZER EUROPE MA EEIG SI
EFECTIN ER 37,5 mg trde kapsule s podaljšanim sproščanjem
SE/H/0936/001 H/00/00529/014 PFIZER EUROPE MA EEIG SI
EFECTIN ER 37,5 mg trde kapsule s podaljšanim sproščanjem
SE/H/0936/001 H/00/00529/032 PFIZER EUROPE MA EEIG SI
EFECTIN ER 37,5 mg trde kapsule s podaljšanim sproščanjem
SE/H/0936/001 H/00/00529/033 PFIZER EUROPE MA EEIG SI
EFECTIN ER 37,5 mg trde kapsule s podaljšanim sproščanjem
SE/H/0936/001 H/00/00529/013 PFIZER EUROPE MA EEIG SI
EFECTIN ER 37,5 mg trde kapsule s podaljšanim sproščanjem
SE/H/0936/001 H/00/00529/029 PFIZER EUROPE MA EEIG SI
EFECTIN ER 37,5 mg trde kapsule s podaljšanim sproščanjem
SE/H/0936/001 H/00/00529/006 PFIZER EUROPE MA EEIG SI
EFECTIN ER 37,5 mg trde kapsule s podaljšanim sproščanjem
SE/H/0936/001 H/00/00529/008 PFIZER EUROPE MA EEIG SI
EFECTIN ER 37,5 mg trde kapsule s podaljšanim sproščanjem
SE/H/0936/001 H/00/00529/007 PFIZER EUROPE MA EEIG 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
EFECTIN ER 37,5 mg trde kapsule s podaljšanim sproščanjem
SE/H/0936/001 H/00/00529/009 PFIZER EUROPE MA EEIG SI
EFECTIN ER 37,5 mg trde kapsule s podaljšanim sproščanjem
SE/H/0936/001 H/00/00529/001 PFIZER EUROPE MA EEIG SI
EFECTIN ER 37,5 mg trde kapsule s podaljšanim sproščanjem
SE/H/0936/001 H/00/00529/002 PFIZER EUROPE MA EEIG SI
EFECTIN ER 37,5 mg trde kapsule s podaljšanim sproščanjem
SE/H/0936/001 H/00/00529/005 PFIZER EUROPE MA EEIG SI
EFECTIN ER 37,5 mg trde kapsule s podaljšanim sproščanjem
SE/H/0936/001 H/00/00529/004 PFIZER EUROPE MA EEIG SI
EFECTIN ER 37,5 mg trde kapsule s podaljšanim sproščanjem
SE/H/0936/001 H/00/00529/003 PFIZER EUROPE MA EEIG SI
Efectin ER 37,5, 37,5 mg, kapsułki o przedłużonym uwalnianiu, twarde
SE/H/0936/001 10523 PFIZER EUROPE MA EEIG PL
Efectin ER 75 mg Hartkapseln, retardiert
SE/H/0936/002 1-23042 PFIZER CORPORATION AUSTRIA GESELLSCHAFT M.B.H.
AT
EFECTIN ER 75 mg trde kapsule s podaljšanim sproščanjem
SE/H/0936/002 H/00/00529/066 PFIZER EUROPE MA EEIG 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
EFECTIN ER 75 mg trde kapsule s podaljšanim sproščanjem
SE/H/0936/002 H/00/00529/064 PFIZER EUROPE MA EEIG SI
EFECTIN ER 75 mg trde kapsule s podaljšanim sproščanjem
SE/H/0936/002 H/00/00529/061 PFIZER EUROPE MA EEIG SI
EFECTIN ER 75 mg trde kapsule s podaljšanim sproščanjem
SE/H/0936/002 H/00/00529/065 PFIZER EUROPE MA EEIG SI
EFECTIN ER 75 mg trde kapsule s podaljšanim sproščanjem
SE/H/0936/002 H/00/00529/054 PFIZER EUROPE MA EEIG SI
EFECTIN ER 75 mg trde kapsule s podaljšanim sproščanjem
SE/H/0936/002 H/00/00529/056 PFIZER EUROPE MA EEIG SI
EFECTIN ER 75 mg trde kapsule s podaljšanim sproščanjem
SE/H/0936/002 H/00/00529/057 PFIZER EUROPE MA EEIG SI
EFECTIN ER 75 mg trde kapsule s podaljšanim sproščanjem
SE/H/0936/002 H/00/00529/053 PFIZER EUROPE MA EEIG SI
EFECTIN ER 75 mg trde kapsule s podaljšanim sproščanjem
SE/H/0936/002 H/00/00529/048 PFIZER EUROPE MA EEIG SI
EFECTIN ER 75 mg trde kapsule s podaljšanim sproščanjem
SE/H/0936/002 H/00/00529/063 PFIZER EUROPE MA EEIG 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
EFECTIN ER 75 mg trde kapsule s podaljšanim sproščanjem
SE/H/0936/002 H/00/00529/071 PFIZER EUROPE MA EEIG SI
EFECTIN ER 75 mg trde kapsule s podaljšanim sproščanjem
SE/H/0936/002 H/00/00529/043 PFIZER EUROPE MA EEIG SI
EFECTIN ER 75 mg trde kapsule s podaljšanim sproščanjem
SE/H/0936/002 H/00/00529/072 PFIZER EUROPE MA EEIG SI
EFECTIN ER 75 mg trde kapsule s podaljšanim sproščanjem
SE/H/0936/002 H/00/00529/055 PFIZER EUROPE MA EEIG SI
EFECTIN ER 75 mg trde kapsule s podaljšanim sproščanjem
SE/H/0936/002 H/00/00529/068 PFIZER EUROPE MA EEIG SI
EFECTIN ER 75 mg trde kapsule s podaljšanim sproščanjem
SE/H/0936/002 H/00/00529/052 PFIZER EUROPE MA EEIG SI
EFECTIN ER 75 mg trde kapsule s podaljšanim sproščanjem
SE/H/0936/002 H/00/00529/058 PFIZER EUROPE MA EEIG SI
EFECTIN ER 75 mg trde kapsule s podaljšanim sproščanjem
SE/H/0936/002 H/00/00529/051 PFIZER EUROPE MA EEIG SI
EFECTIN ER 75 mg trde kapsule s podaljšanim sproščanjem
SE/H/0936/002 H/00/00529/042 PFIZER EUROPE MA EEIG 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
EFECTIN ER 75 mg trde kapsule s podaljšanim sproščanjem
SE/H/0936/002 H/00/00529/069 PFIZER EUROPE MA EEIG SI
EFECTIN ER 75 mg trde kapsule s podaljšanim sproščanjem
SE/H/0936/002 H/00/00529/037 PFIZER EUROPE MA EEIG SI
EFECTIN ER 75 mg trde kapsule s podaljšanim sproščanjem
SE/H/0936/002 H/00/00529/044 PFIZER EUROPE MA EEIG SI
EFECTIN ER 75 mg trde kapsule s podaljšanim sproščanjem
SE/H/0936/002 H/00/00529/049 PFIZER EUROPE MA EEIG SI
EFECTIN ER 75 mg trde kapsule s podaljšanim sproščanjem
SE/H/0936/002 H/00/00529/039 PFIZER EUROPE MA EEIG SI
EFECTIN ER 75 mg trde kapsule s podaljšanim sproščanjem
SE/H/0936/002 H/00/00529/045 PFIZER EUROPE MA EEIG SI
EFECTIN ER 75 mg trde kapsule s podaljšanim sproščanjem
SE/H/0936/002 H/00/00529/050 PFIZER EUROPE MA EEIG SI
EFECTIN ER 75 mg trde kapsule s podaljšanim sproščanjem
SE/H/0936/002 H/00/00529/046 PFIZER EUROPE MA EEIG SI
EFECTIN ER 75 mg trde kapsule s podaljšanim sproščanjem
SE/H/0936/002 H/00/00529/070 PFIZER EUROPE MA EEIG 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
EFECTIN ER 75 mg trde kapsule s podaljšanim sproščanjem
SE/H/0936/002 H/00/00529/040 PFIZER EUROPE MA EEIG SI
EFECTIN ER 75 mg trde kapsule s podaljšanim sproščanjem
SE/H/0936/002 H/00/00529/038 PFIZER EUROPE MA EEIG SI
EFECTIN ER 75 mg trde kapsule s podaljšanim sproščanjem
SE/H/0936/002 H/00/00529/067 PFIZER EUROPE MA EEIG SI
EFECTIN ER 75 mg trde kapsule s podaljšanim sproščanjem
SE/H/0936/002 H/00/00529/041 PFIZER EUROPE MA EEIG SI
EFECTIN ER 75 mg trde kapsule s podaljšanim sproščanjem
SE/H/0936/002 H/00/00529/062 PFIZER EUROPE MA EEIG SI
EFECTIN ER 75 mg trde kapsule s podaljšanim sproščanjem
SE/H/0936/002 H/00/00529/060 PFIZER EUROPE MA EEIG SI
EFECTIN ER 75 mg trde kapsule s podaljšanim sproščanjem
SE/H/0936/002 H/00/00529/059 PFIZER EUROPE MA EEIG SI
EFECTIN ER 75 mg trde kapsule s podaljšanim sproščanjem
SE/H/0936/002 H/00/00529/047 PFIZER EUROPE MA EEIG SI
EFECTIN ER 75 mg tvrdé tobolky s prodlouženým uvolňováním
SE/H/0936/002 30/686/99-C PFIZER, SPOL. S R.O. CZ
List of nationally authorised medicinal products EMA/24903/2018 Page 25/117
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
Efectin ER 75, 75 mg, kapsułki o przedłużonym uwalnianiu, twarde
SE/H/0936/002 4939 PFIZER EUROPE MA EEIG PL
Efexor 150 mg capsule rigide a rilascio prolungato
SE/H/0936/003 028831105 PFIZER ITALIA S.R.L. IT
Efexor 150 mg capsule rigide a rilascio prolungato
SE/H/0936/003 028831067 PFIZER ITALIA S.R.L. IT
Efexor 37,5 mg capsule rigide a rilascio prolungato
SE/H/0936/001 028831129 PFIZER ITALIA S.R.L. IT
Efexor 37,5 mg capsule rigide a rilascio prolungato
SE/H/0936/001 028831117 PFIZER ITALIA S.R.L. IT
Efexor 37,5 mg capsule rigide a rilascio prolungato
SE/H/0936/001 028831131 PFIZER ITALIA S.R.L. IT
Efexor 75 mg capsule rigide a rilascio prolungato
SE/H/0936/002 028831093 PFIZER ITALIA S.R.L. IT
Efexor 75 mg capsule rigide a rilascio prolungato
SE/H/0936/002 028831055 PFIZER ITALIA S.R.L. IT
Efexor Depot 150 mg depotkapsel, hard
SE/H/0936/003 97-4783 PFIZER AS NO
List of nationally authorised medicinal products EMA/24903/2018 Page 26/117
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
Efexor Depot 150 mg depotkapsel, hård
SE/H/0936/003 12607 PFIZER OY FI
Efexor Depot 150 mg depotkapsel, hård
SE/H/0936/003 13321 PFIZER AB SE
Efexor Depot 150 mg depotkapseli, kova
SE/H/0936/003 12607 PFIZER OY FI
Efexor Depot 150 mg forðahylki, hart
SE/H/0936/003 970068 PFIZER APS IS
Efexor Depot 225 mg depotkapsel, hård
SE/H/0936/004 49965 PFIZER AB SE
Efexor Depot 37,5 mg depotkapsel, hard
SE/H/0936/001 04-3083 PFIZER AS NO
Efexor Depot 37,5 mg depotkapsel, hård
SE/H/0936/001 20185 PFIZER OY FI
Efexor Depot 37,5 mg depotkapsel, hård
SE/H/0936/001 21800 PFIZER AB SE
Efexor Depot 37,5 mg depotkapseli, kova
SE/H/0936/001 20185 PFIZER OY FI
List of nationally authorised medicinal products EMA/24903/2018 Page 27/117
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
Efexor Depot 37,5 mg forðahylki, hart
SE/H/0936/001 IS/1/06/101/01 PFIZER APS IS
Efexor Depot 75 mg depotkapsel, hard
SE/H/0936/002 97-4782 PFIZER AS NO
Efexor Depot 75 mg depotkapsel, hård
SE/H/0936/002 12606 PFIZER OY FI
Efexor Depot 75 mg depotkapsel, hård
SE/H/0936/002 13320 PFIZER AB SE
Efexor Depot 75 mg depotkapseli, kova
SE/H/0936/002 12606 PFIZER OY FI
Efexor Depot 75 mg forðahylki, hart
SE/H/0936/002 970067 PFIZER APS IS
Efexor Depot, hårde depotkapsler
SE/H/0936/001 37361 PFIZER APS DK
Efexor Depot, hårde depotkapsler
SE/H/0936/003 18578 PFIZER APS DK
Efexor Depot, hårde depotkapsler
SE/H/0936/002 18577 PFIZER APS DK
List of nationally authorised medicinal products EMA/24903/2018 Page 28/117
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
Efexor XL 150 mg prolonged-release capsules, hard
SE/H/0936/003 PA 822/72/3 PFIZER HEALTHCARE IRELAND
IE
Efexor XL 150 mg prolonged-release capsules, hard
SE/H/0936/003 MA505/06202 PFIZER HELLAS, A.E. MT
Efexor XL 150 mg prolonged-release capsules, hard
SE/H/0936/003 PL 00057/1281 PFIZER LIMITED UK
Efexor XL 225 mg prolonged-release capsules, hard
SE/H/0936/004 PL 00057/1512 PFIZER LIMITED UK
Efexor XL 37.5 mg prolonged-release capsules, hard
SE/H/0936/001 PA 822/72/1 PFIZER HEALTHCARE IRELAND
IE
Efexor XL 75 mg prolonged-release capsules, hard
SE/H/0936/002 PA 822/72/2 PFIZER HEALTHCARE IRELAND
IE
Efexor XL 75 mg prolonged-release capsules, hard
SE/H/0936/002 MA505/06201 PFIZER HELLAS, A.E. MT
Efexor XL 75 mg prolonged-release capsules, hard
SE/H/0936/002 PL 00057/1280 PFIZER LIMITED UK
Efexor XR 150 mg cápsulas de libertação prolongada
SE/H/0936/003 5417183 LABORATÓRIOS PFIZER, LDA.
PT
List of nationally authorised medicinal products EMA/24903/2018 Page 29/117
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
Efexor XR 150 mg cápsulas de libertação prolongada
SE/H/0936/003 5770698 LABORATÓRIOS PFIZER, LDA.
PT
Efexor XR 150 mg cápsulas de libertação prolongada
SE/H/0936/003 4273181 LABORATÓRIOS PFIZER, LDA.
PT
Efexor XR 150 mg pailginto atpalaidavimo kietosios kapsulės
SE/H/0936/003 LT/1/2000/1045/055 PFIZER EUROPE MA EEIG LT
Efexor XR 150 mg pailginto atpalaidavimo kietosios kapsulės
SE/H/0936/003 LT/1/2000/1045/071 PFIZER EUROPE MA EEIG LT
Efexor XR 150 mg pailginto atpalaidavimo kietosios kapsulės
SE/H/0936/003 LT/1/2000/1045/057 PFIZER EUROPE MA EEIG LT
Efexor XR 150 mg pailginto atpalaidavimo kietosios kapsulės
SE/H/0936/003 LT/1/2000/1045/061 PFIZER EUROPE MA EEIG LT
Efexor XR 150 mg pailginto atpalaidavimo kietosios kapsulės
SE/H/0936/003 LT/1/2000/1045/052 PFIZER EUROPE MA EEIG LT
Efexor XR 150 mg pailginto atpalaidavimo kietosios kapsulės
SE/H/0936/003 LT/1/2000/1045/063 PFIZER EUROPE MA EEIG LT
Efexor XR 150 mg pailginto atpalaidavimo kietosios kapsulės
SE/H/0936/003 LT/1/2000/1045/064 PFIZER EUROPE MA EEIG LT
List of nationally authorised medicinal products EMA/24903/2018 Page 30/117
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
Efexor XR 150 mg pailginto atpalaidavimo kietosios kapsulės
SE/H/0936/003 LT/1/2000/1045/062 PFIZER EUROPE MA EEIG LT
Efexor XR 150 mg pailginto atpalaidavimo kietosios kapsulės
SE/H/0936/003 LT/1/2000/1045/008 PFIZER EUROPE MA EEIG LT
Efexor XR 150 mg pailginto atpalaidavimo kietosios kapsulės
SE/H/0936/003 LT/1/2000/1045/059 PFIZER EUROPE MA EEIG LT
Efexor XR 150 mg pailginto atpalaidavimo kietosios kapsulės
SE/H/0936/003 LT/1/2000/1045/068 PFIZER EUROPE MA EEIG LT
Efexor XR 150 mg pailginto atpalaidavimo kietosios kapsulės
SE/H/0936/003 LT/1/2000/1045/007 PFIZER EUROPE MA EEIG LT
Efexor XR 150 mg pailginto atpalaidavimo kietosios kapsulės
SE/H/0936/003 LT/1/2000/1045/070 PFIZER EUROPE MA EEIG LT
Efexor XR 150 mg pailginto atpalaidavimo kietosios kapsulės
SE/H/0936/003 LT/1/2000/1045/056 PFIZER EUROPE MA EEIG LT
Efexor XR 150 mg pailginto atpalaidavimo kietosios kapsulės
SE/H/0936/003 LT/1/2000/1045/060 PFIZER EUROPE MA EEIG LT
Efexor XR 150 mg pailginto atpalaidavimo kietosios kapsulės
SE/H/0936/003 LT/1/2000/1045/067 PFIZER EUROPE MA EEIG LT
List of nationally authorised medicinal products EMA/24903/2018 Page 31/117
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
Efexor XR 150 mg pailginto atpalaidavimo kietosios kapsulės
SE/H/0936/003 LT/1/2000/1045/066 PFIZER EUROPE MA EEIG LT
Efexor XR 150 mg pailginto atpalaidavimo kietosios kapsulės
SE/H/0936/003 LT/1/2000/1045/065 PFIZER EUROPE MA EEIG LT
Efexor XR 150 mg pailginto atpalaidavimo kietosios kapsulės
SE/H/0936/003 LT/1/2000/1045/009 PFIZER EUROPE MA EEIG LT
Efexor XR 150 mg pailginto atpalaidavimo kietosios kapsulės
SE/H/0936/003 LT/1/2000/1045/053 PFIZER EUROPE MA EEIG LT
Efexor XR 150 mg pailginto atpalaidavimo kietosios kapsulės
SE/H/0936/003 LT/1/2000/1045/069 PFIZER EUROPE MA EEIG LT
Efexor XR 150 mg pailginto atpalaidavimo kietosios kapsulės
SE/H/0936/003 LT/1/2000/1045/058 PFIZER EUROPE MA EEIG LT
Efexor XR 150 mg pailginto atpalaidavimo kietosios kapsulės
SE/H/0936/003 LT/1/2000/1045/054 PFIZER EUROPE MA EEIG LT
Efexor XR 150, capsules met verlengde afgifte, hard, 150 mg
SE/H/0936/003 RVG 20863 PFIZER B.V. NL
Efexor XR 225 mg cápsulas de libertação prolongada
SE/H/0936/004 SE/H/0936/004 LABORATÓRIOS PFIZER, LDA.
PT
List of nationally authorised medicinal products EMA/24903/2018 Page 32/117
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
Efexor XR 37,5 mg cápsulas de libertação prolongada
SE/H/0936/001 4895181 LABORATÓRIOS PFIZER, LDA.
PT
Efexor XR 37,5 mg cápsulas de libertação prolongada
SE/H/0936/001 4895280 LABORATÓRIOS PFIZER, LDA.
PT
Efexor XR 37,5 mg pailginto atpalaidavimo kietosios kapsulės
SE/H/0936/001 LT/1/2000/1045/001 PFIZER EUROPE MA EEIG LT
Efexor XR 37,5 mg pailginto atpalaidavimo kietosios kapsulės
SE/H/0936/001 LT/1/2000/1045/027 PFIZER EUROPE MA EEIG LT
Efexor XR 37,5 mg pailginto atpalaidavimo kietosios kapsulės
SE/H/0936/001 LT/1/2000/1045/012 PFIZER EUROPE MA EEIG LT
Efexor XR 37,5 mg pailginto atpalaidavimo kietosios kapsulės
SE/H/0936/001 LT/1/2000/1045/015 PFIZER EUROPE MA EEIG LT
Efexor XR 37,5 mg pailginto atpalaidavimo kietosios kapsulės
SE/H/0936/001 LT/1/2000/1045/024 PFIZER EUROPE MA EEIG LT
Efexor XR 37,5 mg pailginto atpalaidavimo kietosios kapsulės
SE/H/0936/001 LT/1/2000/1045/013 PFIZER EUROPE MA EEIG LT
Efexor XR 37,5 mg pailginto atpalaidavimo kietosios kapsulės
SE/H/0936/001 LT/1/2000/1045/031 PFIZER EUROPE MA EEIG LT
List of nationally authorised medicinal products EMA/24903/2018 Page 33/117
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
Efexor XR 37,5 mg pailginto atpalaidavimo kietosios kapsulės
SE/H/0936/001 LT/1/2000/1045/022 PFIZER EUROPE MA EEIG LT
Efexor XR 37,5 mg pailginto atpalaidavimo kietosios kapsulės
SE/H/0936/001 LT/1/2000/1045/029 PFIZER EUROPE MA EEIG LT
Efexor XR 37,5 mg pailginto atpalaidavimo kietosios kapsulės
SE/H/0936/001 LT/1/2000/1045/028 PFIZER EUROPE MA EEIG LT
Efexor XR 37,5 mg pailginto atpalaidavimo kietosios kapsulės
SE/H/0936/001 LT/1/2000/1045/030 PFIZER EUROPE MA EEIG LT
Efexor XR 37,5 mg pailginto atpalaidavimo kietosios kapsulės
SE/H/0936/001 LT/1/2000/1045/003 PFIZER EUROPE MA EEIG LT
Efexor XR 37,5 mg pailginto atpalaidavimo kietosios kapsulės
SE/H/0936/001 LT/1/2000/1045/017 PFIZER EUROPE MA EEIG LT
Efexor XR 37,5 mg pailginto atpalaidavimo kietosios kapsulės
SE/H/0936/001 LT/1/2000/1045/010 PFIZER EUROPE MA EEIG LT
Efexor XR 37,5 mg pailginto atpalaidavimo kietosios kapsulės
SE/H/0936/001 LT/1/2000/1045/018 PFIZER EUROPE MA EEIG LT
Efexor XR 37,5 mg pailginto atpalaidavimo kietosios kapsulės
SE/H/0936/001 LT/1/2000/1045/019 PFIZER EUROPE MA EEIG LT
List of nationally authorised medicinal products EMA/24903/2018 Page 34/117
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
Efexor XR 37,5 mg pailginto atpalaidavimo kietosios kapsulės
SE/H/0936/001 LT/1/2000/1045/021 PFIZER EUROPE MA EEIG LT
Efexor XR 37,5 mg pailginto atpalaidavimo kietosios kapsulės
SE/H/0936/001 LT/1/2000/1045/016 PFIZER EUROPE MA EEIG LT
Efexor XR 37,5 mg pailginto atpalaidavimo kietosios kapsulės
SE/H/0936/001 LT/1/2000/1045/011 PFIZER EUROPE MA EEIG LT
Efexor XR 37,5 mg pailginto atpalaidavimo kietosios kapsulės
SE/H/0936/001 LT/1/2000/1045/002 PFIZER EUROPE MA EEIG LT
Efexor XR 37,5 mg pailginto atpalaidavimo kietosios kapsulės
SE/H/0936/001 LT/1/2000/1045/020 PFIZER EUROPE MA EEIG LT
Efexor XR 37,5 mg pailginto atpalaidavimo kietosios kapsulės
SE/H/0936/001 LT/1/2000/1045/023 PFIZER EUROPE MA EEIG LT
Efexor XR 37,5 mg pailginto atpalaidavimo kietosios kapsulės
SE/H/0936/001 LT/1/2000/1045/026 PFIZER EUROPE MA EEIG LT
Efexor XR 37,5 mg pailginto atpalaidavimo kietosios kapsulės
SE/H/0936/001 LT/1/2000/1045/014 PFIZER EUROPE MA EEIG LT
Efexor XR 37,5 mg pailginto atpalaidavimo kietosios kapsulės
SE/H/0936/001 LT/1/2000/1045/025 PFIZER EUROPE MA EEIG LT
List of nationally authorised medicinal products EMA/24903/2018 Page 35/117
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
Efexor XR 37,5, capsules met verlengde afgifte, hard, 37,5 mg
SE/H/0936/001 RVG 26661 PFIZER B.V. NL
Efexor XR 75 mg cápsulas de libertação prolongada
SE/H/0936/002 4499885 LABORATÓRIOS PFIZER, LDA.
PT
Efexor XR 75 mg cápsulas de libertação prolongada
SE/H/0936/002 4273082 LABORATÓRIOS PFIZER, LDA.
PT
Efexor XR 75 mg pailginto atpalaidavimo kietosios kapsulės
SE/H/0936/002 LT/1/2000/1045/044 PFIZER EUROPE MA EEIG LT
Efexor XR 75 mg pailginto atpalaidavimo kietosios kapsulės
SE/H/0936/002 LT/1/2000/1045/038 PFIZER EUROPE MA EEIG LT
Efexor XR 75 mg pailginto atpalaidavimo kietosios kapsulės
SE/H/0936/002 LT/1/2000/1045/005 PFIZER EUROPE MA EEIG LT
Efexor XR 75 mg pailginto atpalaidavimo kietosios kapsulės
SE/H/0936/002 LT/1/2000/1045/047 PFIZER EUROPE MA EEIG LT
Efexor XR 75 mg pailginto atpalaidavimo kietosios kapsulės
SE/H/0936/002 LT/1/2000/1045/006 PFIZER EUROPE MA EEIG LT
Efexor XR 75 mg pailginto atpalaidavimo kietosios kapsulės
SE/H/0936/002 LT/1/2000/1045/032 PFIZER EUROPE MA EEIG LT
List of nationally authorised medicinal products EMA/24903/2018 Page 36/117
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
Efexor XR 75 mg pailginto atpalaidavimo kietosios kapsulės
SE/H/0936/002 LT/1/2000/1045/051 PFIZER EUROPE MA EEIG LT
Efexor XR 75 mg pailginto atpalaidavimo kietosios kapsulės
SE/H/0936/002 LT/1/2000/1045/049 PFIZER EUROPE MA EEIG LT
Efexor XR 75 mg pailginto atpalaidavimo kietosios kapsulės
SE/H/0936/002 LT/1/2000/1045/037 PFIZER EUROPE MA EEIG LT
Efexor XR 75 mg pailginto atpalaidavimo kietosios kapsulės
SE/H/0936/002 LT/1/2000/1045/042 PFIZER EUROPE MA EEIG LT
Efexor XR 75 mg pailginto atpalaidavimo kietosios kapsulės
SE/H/0936/002 LT/1/2000/1045/046 PFIZER EUROPE MA EEIG LT
Efexor XR 75 mg pailginto atpalaidavimo kietosios kapsulės
SE/H/0936/002 LT/1/2000/1045/050 PFIZER EUROPE MA EEIG LT
Efexor XR 75 mg pailginto atpalaidavimo kietosios kapsulės
SE/H/0936/002 LT/1/2000/1045/033 PFIZER EUROPE MA EEIG LT
Efexor XR 75 mg pailginto atpalaidavimo kietosios kapsulės
SE/H/0936/002 LT/1/2000/1045/043 PFIZER EUROPE MA EEIG LT
Efexor XR 75 mg pailginto atpalaidavimo kietosios kapsulės
SE/H/0936/002 LT/1/2000/1045/041 PFIZER EUROPE MA EEIG LT
List of nationally authorised medicinal products EMA/24903/2018 Page 37/117
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
Efexor XR 75 mg pailginto atpalaidavimo kietosios kapsulės
SE/H/0936/002 LT/1/2000/1045/034 PFIZER EUROPE MA EEIG LT
Efexor XR 75 mg pailginto atpalaidavimo kietosios kapsulės
SE/H/0936/002 LT/1/2000/1045/048 PFIZER EUROPE MA EEIG LT
Efexor XR 75 mg pailginto atpalaidavimo kietosios kapsulės
SE/H/0936/002 LT/1/2000/1045/045 PFIZER EUROPE MA EEIG LT
Efexor XR 75 mg pailginto atpalaidavimo kietosios kapsulės
SE/H/0936/002 LT/1/2000/1045/040 PFIZER EUROPE MA EEIG LT
Efexor XR 75 mg pailginto atpalaidavimo kietosios kapsulės
SE/H/0936/002 LT/1/2000/1045/004 PFIZER EUROPE MA EEIG LT
Efexor XR 75 mg pailginto atpalaidavimo kietosios kapsulės
SE/H/0936/002 LT/1/2000/1045/039 PFIZER EUROPE MA EEIG LT
Efexor XR 75 mg pailginto atpalaidavimo kietosios kapsulės
SE/H/0936/002 LT/1/2000/1045/035 PFIZER EUROPE MA EEIG LT
Efexor XR 75 mg pailginto atpalaidavimo kietosios kapsulės
SE/H/0936/002 LT/1/2000/1045/036 PFIZER EUROPE MA EEIG LT
Efexor XR 75, capsules met verlengde afgifte, hard, 75 mg
SE/H/0936/002 RVG 20862 PFIZER B.V. NL
List of nationally authorised medicinal products EMA/24903/2018 Page 38/117
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
Efexor XR, 150 mg toimeainet prolongeeritult vabastavad kõvakapslid
SE/H/0936/003 317700 PFIZER EUROPE MA EEIG EE
Efexor XR, 37,5 mg toimeainet prolongeeritult vabastavad kõvakapslid
SE/H/0936/001 352801 PFIZER EUROPE MA EEIG EE
Efexor XR, 75 mg toimeainet prolongeeritult vabastavad kõvakapslid
SE/H/0936/002 317800 PFIZER EUROPE MA EEIG EE
Efexor® XR 150 mg καψάκια παρατεταμένης αποδέσμευσης, σκληρά
SE/H/0936/003 018334 PFIZER HELLAS, A.E. CY
Efexor® XR 150 mg καψάκια παρατεταμένης αποδέσμευσης, σκληρά
SE/H/0936/003 PRD495475 PFIZER HELLAS, A.E. GR
Efexor® XR 37,5 mg καψάκια παρατεταμένης αποδέσμευσης, σκληρά
SE/H/0936/001 20345 PFIZER HELLAS, A.E. CY
Efexor® XR 37,5 mg καψάκια παρατεταμένης αποδέσμευσης, σκληρά
SE/H/0936/001 30731/6-4-2016 PFIZER HELLAS, A.E. GR
Efexor® XR 75 mg καψάκια παρατεταμένης αποδέσμευσης, σκληρά
SE/H/0936/002 018335 PFIZER HELLAS, A.E. CY
Efexor® XR 75 mg καψάκια παρατεταμένης αποδέσμευσης, σκληρά
SE/H/0936/002 30729/6-4-2016 PFIZER HELLAS, A.E. GR
List of nationally authorised medicinal products EMA/24903/2018 Page 39/117
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
Efexor-Exel 150 mg gélules à libération prolongée
SE/H/0936/003 BE196533 PFIZER S.A. (BELGIUM) BE
Efexor-Exel 150 mg gélules à libération prolongée
SE/H/0936/003 BE421994 PFIZER S.A. (BELGIUM) BE
Efexor-Exel 150 mg gélules à libération prolongée
SE/H/0936/003 2011030970 PFIZER S.A. (BELGIUM) LU
Efexor-Exel 150 mg harde capsules met verlengde afgifte
SE/H/0936/003 BE421994 PFIZER S.A. (BELGIUM) BE
Efexor-Exel 150 mg harde capsules met verlengde afgifte
SE/H/0936/003 BE196533 PFIZER S.A. (BELGIUM) BE
Efexor-Exel 150 mg retardierte Hartkapseln
SE/H/0936/003 BE196533 PFIZER S.A. (BELGIUM) BE
Efexor-Exel 150 mg retardierte Hartkapseln
SE/H/0936/003 BE421994 PFIZER S.A. (BELGIUM) BE
Efexor-Exel 150 mg retardierte Hartkapseln
SE/H/0936/003 2011030970 PFIZER S.A. (BELGIUM) LU
Efexor-Exel 225 mg gélules à libération prolongée
SE/H/0936/004 BE467333 PFIZER S.A. (BELGIUM) BE
List of nationally authorised medicinal products EMA/24903/2018 Page 40/117
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
Efexor-Exel 225 mg gélules à libération prolongée
SE/H/0936/004 2015040065 PFIZER S.A. (BELGIUM) LU
Efexor-Exel 225 mg harde capsules met verlengde afgifte
SE/H/0936/004 BE467333 PFIZER S.A. (BELGIUM) BE
Efexor-Exel 225 mg retardierte Hartkapseln
SE/H/0936/004 BE467333 PFIZER S.A. (BELGIUM) BE
Efexor-Exel 225 mg retardierte Hartkapseln
SE/H/0936/004 2015040065 PFIZER S.A. (BELGIUM) LU
Efexor-Exel 37,5 mg gélules à libération prolongée
SE/H/0936/001 BE239337 PFIZER S.A. (BELGIUM) BE
Efexor-Exel 37,5 mg gélules à libération prolongée
SE/H/0936/001 BE422003 PFIZER S.A. (BELGIUM) BE
Efexor-Exel 37,5 mg gélules à libération prolongée
SE/H/0936/001 2011010961 PFIZER S.A. (BELGIUM) LU
Efexor-Exel 37,5 mg harde capsules met verlengde afgifte
SE/H/0936/001 BE239337 PFIZER S.A. (BELGIUM) BE
Efexor-Exel 37,5 mg harde capsules met verlengde afgifte
SE/H/0936/001 BE422003 PFIZER S.A. (BELGIUM) BE
List of nationally authorised medicinal products EMA/24903/2018 Page 41/117
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
Efexor-Exel 37,5 mg retardierte Hartkapseln
SE/H/0936/001 BE422003 PFIZER S.A. (BELGIUM) BE
Efexor-Exel 37,5 mg retardierte Hartkapseln
SE/H/0936/001 BE239337 PFIZER S.A. (BELGIUM) BE
Efexor-Exel 37,5 mg retardierte Hartkapseln
SE/H/0936/001 2011010961 PFIZER S.A. (BELGIUM) LU
Efexor-Exel 75 mg gélules à libération prolongée
SE/H/0936/002 BE422012 PFIZER S.A. (BELGIUM) BE
Efexor-Exel 75 mg gélules à libération prolongée
SE/H/0936/002 BE196524 PFIZER S.A. (BELGIUM) BE
Efexor-Exel 75 mg gélules à libération prolongée
SE/H/0936/002 2011010962 PFIZER S.A. (BELGIUM) LU
Efexor-Exel 75 mg harde capsules met verlengde afgifte
SE/H/0936/002 BE196524 PFIZER S.A. (BELGIUM) BE
Efexor-Exel 75 mg harde capsules met verlengde afgifte
SE/H/0936/002 BE422012 PFIZER S.A. (BELGIUM) BE
Efexor-Exel 75 mg retardierte Hartkapseln
SE/H/0936/002 BE422012 PFIZER S.A. (BELGIUM) BE
List of nationally authorised medicinal products EMA/24903/2018 Page 42/117
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
Efexor-Exel 75 mg retardierte Hartkapseln
SE/H/0936/002 BE196524 PFIZER S.A. (BELGIUM) BE
Efexor-Exel 75 mg retardierte Hartkapseln
SE/H/0936/002 2011010962 PFIZER S.A. (BELGIUM) LU
EFFEXOR L.P. 37,5 mg, gélule à libération prolongée
SE/H/0936/001 34009 346 562 7 9 PFIZER HOLDING FRANCE (S.C.A.)
FR
EFFEXOR L.P. 37,5 mg, gélule à libération prolongée
SE/H/0936/001 34009 346 565 6 9 PFIZER HOLDING FRANCE (S.C.A.)
FR
EFFEXOR L.P. 37,5 mg, gélule à libération prolongée
SE/H/0936/001 34009 346 563 3 0 PFIZER HOLDING FRANCE (S.C.A.)
FR
EFFEXOR L.P. 75 mg, gélule à libération prolongée
SE/H/0936/002 34009 346 557 3 9 PFIZER HOLDING FRANCE (S.C.A.)
FR
EFFEXOR L.P. 75 mg, gélule à libération prolongée
SE/H/0936/002 34009 346 556 7 8 PFIZER HOLDING FRANCE (S.C.A.)
FR
EFFEXOR L.P. 75 mg, gélule à libération prolongée
SE/H/0936/002 34009 376 270 4 7 PFIZER HOLDING FRANCE (S.C.A.)
FR
EFFEXOR L.P. 75 mg, gélule à libération prolongée
SE/H/0936/002 34009 346 555 0 0 PFIZER HOLDING FRANCE (S.C.A.)
FR
List of nationally authorised medicinal products EMA/24903/2018 Page 43/117
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
ELIFY XR 37.5 mg κάψουλες παρατεταμένης αποδέσμευσης, σκληρές
NL/H/0927/001 20208 MEDOCHEMIE LTD. CY
EФЕКТИН ER 150 mg капсули с удължено освобождаване, твърди
SE/H/0936/003 9800389 PFIZER EUROPE MA EEIG BG
EФЕКТИН ER 75 mg капсули с удължено освобождаване, твърди
SE/H/0936/002 9800390 PFIZER EUROPE MA EEIG BG
Faxiprol 150 mg retard tabletta
SE/564/01-04/DC OGYI-T-20519/21-30 MEDICO UNO PHARMACEUTICALS SE
HU
Faxiprol 150 mg retard tabletta
SE/564/01-04/DC OGYI-T-20519/21-30 MEDICO UNO PHARMACEUTICALS SE
HU
Faxiprol 75 mg retard tabletta
SE/564/01-04/DC OGYI-T-20519/11-20 MEDICO UNO PHARMACEUTICALS SE
HU
Faxiprol 75 mg retard tabletta
SE/564/01-04/DC OGYI-T-20519/11-20 MEDICO UNO PHARMACEUTICALS SE
HU
Genexin 150 mg comprimidos de liberta ﾃｧ
ﾃ｣o prolongada
not available 5099528 GENEDEC - MEDICAMENTOS GENÉRICOS, LDA.
PT
Genexin 150 mg comprimidos de liberta ﾃｧ
ﾃ｣o prolongada
not available 5099536 GENEDEC - MEDICAMENTOS GENÉRICOS, LDA.
PT
List of nationally authorised medicinal products EMA/24903/2018 Page 44/117
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
Genexin 150 mg comprimidos de liberta ﾃｧ
ﾃ｣o prolongada
not available 5099544 GENEDEC - MEDICAMENTOS GENÉRICOS, LDA.
PT
Genexin 150 mg comprimidos de liberta ﾃｧ
ﾃ｣o prolongada
not available 5099551 GENEDEC - MEDICAMENTOS GENÉRICOS, LDA.
PT
Genexin 150 mg comprimidos de liberta ﾃｧ
ﾃ｣o prolongada
not available 5099569 GENEDEC - MEDICAMENTOS GENÉRICOS, LDA.
PT
Genexin 150 mg comprimidos de liberta ﾃｧ
ﾃ｣o prolongada
not available 5099510 GENEDEC - MEDICAMENTOS GENÉRICOS, LDA.
PT
Genexin 37,5 mg comprimidos de liberta ﾃｧ
ﾃ｣o prolongada
not available 5974399 GENEDEC - MEDICAMENTOS GENÉRICOS, LDA.
PT
Genexin 37,5 mg comprimidos de liberta ﾃｧ
ﾃ｣o prolongada
not available 5974498 GENEDEC - MEDICAMENTOS GENÉRICOS, LDA.
PT
Genexin 37,5 mg comprimidos de liberta ﾃｧ
ﾃ｣o prolongada
not available 5974597 GENEDEC - MEDICAMENTOS GENÉRICOS, LDA.
PT
Genexin 37,5 mg comprimidos de liberta ﾃｧ
ﾃ｣o prolongada
not available 5974290 GENEDEC - MEDICAMENTOS GENÉRICOS, LDA.
PT
Genexin 75 mg comprimidos de liberta ﾃｧ
ﾃ｣o prolongada
not available 5975198 GENEDEC - MEDICAMENTOS GENÉRICOS, LDA.
PT
List of nationally authorised medicinal products EMA/24903/2018 Page 45/117
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
Genexin 75 mg comprimidos de liberta ﾃｧ
ﾃ｣o prolongada
not available 5975297 GENEDEC - MEDICAMENTOS GENÉRICOS, LDA.
PT
Genexin 75 mg comprimidos de liberta ﾃｧ
ﾃ｣o prolongada
not available 5975396 GENEDEC - MEDICAMENTOS GENÉRICOS, LDA.
PT
Genexin 75 mg comprimidos de liberta ﾃｧ
ﾃ｣o prolongada
not available 5975099 GENEDEC - MEDICAMENTOS GENÉRICOS, LDA.
PT
Pracet 150 mg comprimidos de libertação prolongada
not available 5180922 UCB PHARMA (PRODUTOS FARMACÊUTICOS), LDA. (PACO PT)
PT
Pracet 150 mg comprimidos de libertação prolongada
not available 5180930 UCB PHARMA (PRODUTOS FARMACÊUTICOS), LDA. (PACO PT)
PT
Pracet 150 mg comprimidos de libertação prolongada
not available 5180948 UCB PHARMA (PRODUTOS FARMACÊUTICOS), LDA. (PACO PT)
PT
Pracet 150 mg comprimidos de libertação prolongada
not available 5180963 UCB PHARMA (PRODUTOS FARMACÊUTICOS), LDA. (PACO PT)
PT
Pracet 150 mg comprimidos de libertação prolongada
not available 5180955 UCB PHARMA (PRODUTOS FARMACÊUTICOS), LDA. (PACO PT)
PT
Pracet 150 mg comprimidos de libertação prolongada
not available 5180971 UCB PHARMA (PRODUTOS FARMACÊUTICOS), LDA. (PACO PT)
PT
List of nationally authorised medicinal products EMA/24903/2018 Page 46/117
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
Pracet 150 mg comprimidos de libertação prolongada
not available 5181003 UCB PHARMA (PRODUTOS FARMACÊUTICOS), LDA. (PACO PT)
PT
Pracet 150 mg comprimidos de libertação prolongada
not available 5181029 UCB PHARMA (PRODUTOS FARMACÊUTICOS), LDA. (PACO PT)
PT
Pracet 150 mg comprimidos de libertação prolongada
not available 5181011 UCB PHARMA (PRODUTOS FARMACÊUTICOS), LDA. (PACO PT)
PT
Pracet 150 mg comprimidos de libertação prolongada
not available 5181045 UCB PHARMA (PRODUTOS FARMACÊUTICOS), LDA. (PACO PT)
PT
Pracet 150 mg comprimidos de libertação prolongada
not available 5181078 UCB PHARMA (PRODUTOS FARMACÊUTICOS), LDA. (PACO PT)
PT
Pracet 150 mg comprimidos de libertação prolongada
not available 5181110 UCB PHARMA (PRODUTOS FARMACÊUTICOS), LDA. (PACO PT)
PT
Pracet 150 mg comprimidos de libertação prolongada
not available 5181128 UCB PHARMA (PRODUTOS FARMACÊUTICOS), LDA. (PACO PT)
PT
Pracet 150 mg comprimidos de libertação prolongada
not available 5181136 UCB PHARMA (PRODUTOS FARMACÊUTICOS), LDA. (PACO PT)
PT
Pracet 150 mg comprimidos de libertação prolongada
not available 5181144 UCB PHARMA (PRODUTOS FARMACÊUTICOS), LDA. (PACO PT)
PT
List of nationally authorised medicinal products EMA/24903/2018 Page 47/117
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
Pracet 150 mg comprimidos de libertação prolongada
not available 5181151 UCB PHARMA (PRODUTOS FARMACÊUTICOS), LDA. (PACO PT)
PT
Pracet 150 mg comprimidos de libertação prolongada
not available 5181037 UCB PHARMA (PRODUTOS FARMACÊUTICOS), LDA. (PACO PT)
PT
Pracet 150 mg comprimidos de libertação prolongada
not available 5181052 UCB PHARMA (PRODUTOS FARMACÊUTICOS), LDA. (PACO PT)
PT
Pracet 150 mg comprimidos de libertação prolongada
not available 5181060 UCB PHARMA (PRODUTOS FARMACÊUTICOS), LDA. (PACO PT)
PT
Pracet 150 mg comprimidos de libertação prolongada
not available 5181102 UCB PHARMA (PRODUTOS FARMACÊUTICOS), LDA. (PACO PT)
PT
Pracet 225 mg comprimidos de libertação prolongada
not available 5181169 UCB PHARMA (PRODUTOS FARMACÊUTICOS), LDA. (PACO PT)
PT
Pracet 225 mg comprimidos de libertação prolongada
not available 5181177 UCB PHARMA (PRODUTOS FARMACÊUTICOS), LDA. (PACO PT)
PT
Pracet 225 mg comprimidos de libertação prolongada
not available 5181201 UCB PHARMA (PRODUTOS FARMACÊUTICOS), LDA. (PACO PT)
PT
Pracet 225 mg comprimidos de libertação prolongada
not available 5181219 UCB PHARMA (PRODUTOS FARMACÊUTICOS), LDA. (PACO PT)
PT
List of nationally authorised medicinal products EMA/24903/2018 Page 48/117
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
Pracet 225 mg comprimidos de libertação prolongada
not available 5181227 UCB PHARMA (PRODUTOS FARMACÊUTICOS), LDA. (PACO PT)
PT
Pracet 225 mg comprimidos de libertação prolongada
not available 5181235 UCB PHARMA (PRODUTOS FARMACÊUTICOS), LDA. (PACO PT)
PT
Pracet 225 mg comprimidos de libertação prolongada
not available 5181243 UCB PHARMA (PRODUTOS FARMACÊUTICOS), LDA. (PACO PT)
PT
Pracet 225 mg comprimidos de libertação prolongada
not available 5181250 UCB PHARMA (PRODUTOS FARMACÊUTICOS), LDA. (PACO PT)
PT
Pracet 225 mg comprimidos de libertação prolongada
not available 5181268 UCB PHARMA (PRODUTOS FARMACÊUTICOS), LDA. (PACO PT)
PT
Pracet 225 mg comprimidos de libertação prolongada
not available 5181276 UCB PHARMA (PRODUTOS FARMACÊUTICOS), LDA. (PACO PT)
PT
Pracet 225 mg comprimidos de libertação prolongada
not available 5181300 UCB PHARMA (PRODUTOS FARMACÊUTICOS), LDA. (PACO PT)
PT
Pracet 225 mg comprimidos de libertação prolongada
not available 5181318 UCB PHARMA (PRODUTOS FARMACÊUTICOS), LDA. (PACO PT)
PT
Pracet 225 mg comprimidos de libertação prolongada
not available 5181326 UCB PHARMA (PRODUTOS FARMACÊUTICOS), LDA. (PACO PT)
PT
List of nationally authorised medicinal products EMA/24903/2018 Page 49/117
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
Pracet 225 mg comprimidos de libertação prolongada
not available 5181334 UCB PHARMA (PRODUTOS FARMACÊUTICOS), LDA. (PACO PT)
PT
Pracet 225 mg comprimidos de libertação prolongada
not available 5181342 UCB PHARMA (PRODUTOS FARMACÊUTICOS), LDA. (PACO PT)
PT
Pracet 225 mg comprimidos de libertação prolongada
not available 5181359 UCB PHARMA (PRODUTOS FARMACÊUTICOS), LDA. (PACO PT)
PT
Pracet 225 mg comprimidos de libertação prolongada
not available 5181367 UCB PHARMA (PRODUTOS FARMACÊUTICOS), LDA. (PACO PT)
PT
Pracet 225 mg comprimidos de libertação prolongada
not available 5181375 UCB PHARMA (PRODUTOS FARMACÊUTICOS), LDA. (PACO PT)
PT
Pracet 225 mg comprimidos de libertação prolongada
not available 5181409 UCB PHARMA (PRODUTOS FARMACÊUTICOS), LDA. (PACO PT)
PT
Pracet 225 mg comprimidos de libertação prolongada
not available 5181417 UCB PHARMA (PRODUTOS FARMACÊUTICOS), LDA. (PACO PT)
PT
Pracet 37,5 mg comprimidos de libertação prolongada
not available 5180443 UCB PHARMA (PRODUTOS FARMACÊUTICOS), LDA. (PACO PT)
PT
Pracet 37,5 mg comprimidos de libertação prolongada
not available 5180435 UCB PHARMA (PRODUTOS FARMACÊUTICOS), LDA. (PACO PT)
PT
List of nationally authorised medicinal products EMA/24903/2018 Page 50/117
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
Pracet 37,5 mg comprimidos de libertação prolongada
not available 5180450 UCB PHARMA (PRODUTOS FARMACÊUTICOS), LDA. (PACO PT)
PT
Pracet 37,5 mg comprimidos de libertação prolongada
not available 5180427 UCB PHARMA (PRODUTOS FARMACÊUTICOS), LDA. (PACO PT)
PT
Pracet 37,5 mg comprimidos de libertação prolongada
not available 5180476 UCB PHARMA (PRODUTOS FARMACÊUTICOS), LDA. (PACO PT)
PT
Pracet 37,5 mg comprimidos de libertação prolongada
not available 5180468 UCB PHARMA (PRODUTOS FARMACÊUTICOS), LDA. (PACO PT)
PT
Pracet 37,5 mg comprimidos de libertação prolongada
not available 5180500 UCB PHARMA (PRODUTOS FARMACÊUTICOS), LDA. (PACO PT)
PT
Pracet 37,5 mg comprimidos de libertação prolongada
not available 5180518 UCB PHARMA (PRODUTOS FARMACÊUTICOS), LDA. (PACO PT)
PT
Pracet 37,5 mg comprimidos de libertação prolongada
not available 5180526 UCB PHARMA (PRODUTOS FARMACÊUTICOS), LDA. (PACO PT)
PT
Pracet 37,5 mg comprimidos de libertação prolongada
not available 5180534 UCB PHARMA (PRODUTOS FARMACÊUTICOS), LDA. (PACO PT)
PT
Pracet 37,5 mg comprimidos de libertação prolongada
not available 5180542 UCB PHARMA (PRODUTOS FARMACÊUTICOS), LDA. (PACO PT)
PT
List of nationally authorised medicinal products EMA/24903/2018 Page 51/117
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
Pracet 37,5 mg comprimidos de libertação prolongada
not available 5180559 UCB PHARMA (PRODUTOS FARMACÊUTICOS), LDA. (PACO PT)
PT
Pracet 37,5 mg comprimidos de libertação prolongada
not available 5180567 UCB PHARMA (PRODUTOS FARMACÊUTICOS), LDA. (PACO PT)
PT
Pracet 37,5 mg comprimidos de libertação prolongada
not available 5180575 UCB PHARMA (PRODUTOS FARMACÊUTICOS), LDA. (PACO PT)
PT
Pracet 37,5 mg comprimidos de libertação prolongada
not available 5180609 UCB PHARMA (PRODUTOS FARMACÊUTICOS), LDA. (PACO PT)
PT
Pracet 37,5 mg comprimidos de libertação prolongada
not available 5180617 UCB PHARMA (PRODUTOS FARMACÊUTICOS), LDA. (PACO PT)
PT
Pracet 37,5 mg comprimidos de libertação prolongada
not available 5180625 UCB PHARMA (PRODUTOS FARMACÊUTICOS), LDA. (PACO PT)
PT
Pracet 37,5 mg comprimidos de libertação prolongada
not available 5180633 UCB PHARMA (PRODUTOS FARMACÊUTICOS), LDA. (PACO PT)
PT
Pracet 37,5 mg comprimidos de libertação prolongada
not available 5180641 UCB PHARMA (PRODUTOS FARMACÊUTICOS), LDA. (PACO PT)
PT
Pracet 37,5 mg comprimidos de libertação prolongada
not available 5180658 UCB PHARMA (PRODUTOS FARMACÊUTICOS), LDA. (PACO PT)
PT
List of nationally authorised medicinal products EMA/24903/2018 Page 52/117
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
Pracet 75 mg comprimidos de libertação prolongada
not available 5180674 UCB PHARMA (PRODUTOS FARMACÊUTICOS), LDA. (PACO PT)
PT
Pracet 75 mg comprimidos de libertação prolongada
not available 5180708 UCB PHARMA (PRODUTOS FARMACÊUTICOS), LDA. (PACO PT)
PT
Pracet 75 mg comprimidos de libertação prolongada
not available 5180716 UCB PHARMA (PRODUTOS FARMACÊUTICOS), LDA. (PACO PT)
PT
Pracet 75 mg comprimidos de libertação prolongada
not available 5180724 UCB PHARMA (PRODUTOS FARMACÊUTICOS), LDA. (PACO PT)
PT
Pracet 75 mg comprimidos de libertação prolongada
not available 5180732 UCB PHARMA (PRODUTOS FARMACÊUTICOS), LDA. (PACO PT)
PT
Pracet 75 mg comprimidos de libertação prolongada
not available 5180740 UCB PHARMA (PRODUTOS FARMACÊUTICOS), LDA. (PACO PT)
PT
Pracet 75 mg comprimidos de libertação prolongada
not available 5180757 UCB PHARMA (PRODUTOS FARMACÊUTICOS), LDA. (PACO PT)
PT
Pracet 75 mg comprimidos de libertação prolongada
not available 5180765 UCB PHARMA (PRODUTOS FARMACÊUTICOS), LDA. (PACO PT)
PT
Pracet 75 mg comprimidos de libertação prolongada
not available 5180773 UCB PHARMA (PRODUTOS FARMACÊUTICOS), LDA. (PACO PT)
PT
List of nationally authorised medicinal products EMA/24903/2018 Page 53/117
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
Pracet 75 mg comprimidos de libertação prolongada
not available 5180807 UCB PHARMA (PRODUTOS FARMACÊUTICOS), LDA. (PACO PT)
PT
Pracet 75 mg comprimidos de libertação prolongada
not available 5180815 UCB PHARMA (PRODUTOS FARMACÊUTICOS), LDA. (PACO PT)
PT
Pracet 75 mg comprimidos de libertação prolongada
not available 5180823 UCB PHARMA (PRODUTOS FARMACÊUTICOS), LDA. (PACO PT)
PT
Pracet 75 mg comprimidos de libertação prolongada
not available 5180831 UCB PHARMA (PRODUTOS FARMACÊUTICOS), LDA. (PACO PT)
PT
Pracet 75 mg comprimidos de libertação prolongada
not available 5180666 UCB PHARMA (PRODUTOS FARMACÊUTICOS), LDA. (PACO PT)
PT
Pracet 75 mg comprimidos de libertação prolongada
not available 5180849 UCB PHARMA (PRODUTOS FARMACÊUTICOS), LDA. (PACO PT)
PT
Pracet 75 mg comprimidos de libertação prolongada
not available 5180856 UCB PHARMA (PRODUTOS FARMACÊUTICOS), LDA. (PACO PT)
PT
Pracet 75 mg comprimidos de libertação prolongada
not available 5180864 UCB PHARMA (PRODUTOS FARMACÊUTICOS), LDA. (PACO PT)
PT
Pracet 75 mg comprimidos de libertação prolongada
not available 5180872 UCB PHARMA (PRODUTOS FARMACÊUTICOS), LDA. (PACO PT)
PT
List of nationally authorised medicinal products EMA/24903/2018 Page 54/117
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
Pracet 75 mg comprimidos de libertação prolongada
not available 5180914 UCB PHARMA (PRODUTOS FARMACÊUTICOS), LDA. (PACO PT)
PT
Pracet 75 mg comprimidos de libertação prolongada
not available 5180906 UCB PHARMA (PRODUTOS FARMACÊUTICOS), LDA. (PACO PT)
PT
Serosmine 150 mg δισκία παρατεταμένης αποδέσμευσης
SE/H/0581/003 68910 ITF HELLAS AE GR
Serosmine 150 mg δισκία παρατεταμένης αποδέσμευσης
SE/H/0581/003 68910 ITF HELLAS AE GR
Serosmine 225 mg δισκία παρατεταμένης αποδέσμευσης
SE/H/0581/004 68911 ITF HELLAS AE GR
Serosmine 225 mg δισκία παρατεταμένης αποδέσμευσης
SE/H/0581/004 68911 ITF HELLAS AE GR
Serosmine 37,5 mg δισκία παρατεταμένης αποδέσμευσης
SE/H/0581/001 68912 ITF HELLAS AE GR
Serosmine 37,5 mg δισκία παρατεταμένης αποδέσμευσης
SE/H/0581/001 68912 ITF HELLAS AE GR
Serosmine 75 mg δισκία παρατεταμένης αποδέσμευσης
SE/H/0581/002 68909 ITF HELLAS AE GR
List of nationally authorised medicinal products EMA/24903/2018 Page 55/117
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
Serosmine 75 mg δισκία παρατεταμένης αποδέσμευσης
SE/H/0581/002 68909 ITF HELLAS AE GR
Sunveniz XL 150 mg prolonged-release tablets
NL/H/3948/003 PL31750/0027 SUN PHARMACEUTICAL INDUSTRIES EUROPE B.V.
UK
Sunveniz XL 37.5 mg prolonged-release tablets
NL/H/3948/001 PL31750/0025 SUN PHARMACEUTICAL INDUSTRIES EUROPE B.V.
UK
Sunveniz XL 75 mg prolonged-release tablets
NL/H/3948/002 PL31750/0026 SUN PHARMACEUTICAL INDUSTRIES EUROPE B.V.
UK
Trevilor 150 mg hard prolonged-release capsules
SE/H/0938/003 42827 PFIZER AB SE
Trevilor 37.5 mg hard prolonged-release capsules
SE/H/0938/001 42825 PFIZER AB SE
Trevilor 75 mg hard prolonged-release capsules
SE/H/0938/002 42826 PFIZER AB SE
Trevilor® retard 150 mg Hartkapseln, retardiert
SE/H/0936/003 45300.01.00 PFIZER PHARMA PFE GMBH DE
Trevilor® retard 37,5 mg Hartkapseln, retardiert
SE/H/0936/001 62104.00.00 PFIZER PHARMA PFE GMBH DE
List of nationally authorised medicinal products EMA/24903/2018 Page 56/117
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
Trevilor® retard 75 mg Hartkapseln, retardiert
SE/H/0936/002 45300.00.00 PFIZER PHARMA PFE GMBH DE
Vandral Retard 150 mg cápsulas duras de liberación prolongada
SE/H/0936/003 62.402 WYETH FARMA, S.A ES
Vandral Retard 225 mg cápsulas duras de liberación prolongada
SE/H/0936/004 79.960 WYETH FARMA, S.A ES
Vandral Retard 75 mg cápsulas duras de liberación prolongada
SE/H/0936/002 62.401 WYETH FARMA, S.A ES
VENLABRAIN retard 150 mg comprimidos de liberación prolongada
SE/H/0582/002 69.751 FERRER INTERNACIONAL, S.A.
ES
VENLABRAIN retard 150 mg comprimidos de liberación prolongada
SE/H/0582/002 69.751 FERRER INTERNACIONAL, S.A.
ES
VENLABRAIN retard 225 mg comprimidos de liberación prolongada
SE/H/0582/003 69.750 FERRER INTERNACIONAL, S.A.
ES
VENLABRAIN retard 225 mg comprimidos de liberación prolongada
SE/H/0582/003 69.750 FERRER INTERNACIONAL, S.A.
ES
VENLABRAIN retard 75 mg comprimidos de liberación prolongada
SE/H/0582/001 69.752 FERRER INTERNACIONAL, S.A.
ES
List of nationally authorised medicinal products EMA/24903/2018 Page 57/117
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
VENLABRAIN retard 75 mg comprimidos de liberación prolongada
SE/H/0582/001 69.752 FERRER INTERNACIONAL, S.A.
ES
Venlafaxin "Hexal" NL/H/1307/001 42725 HEXAL A/S DK
Venlafaxin "Medical Valley", depottabletter
SE/H/0582/001 58739 MEDICAL VALLEY INVEST AB DK
Venlafaxin "Medical Valley", depottabletter
SE/H/0582/002 58740 MEDICAL VALLEY INVEST AB DK
Venlafaxin "Medical Valley", depottabletter
SE/H/0582/003 58741 MEDICAL VALLEY INVEST AB DK
Venlafaxin "Medical Valley", depottabletter
SE/H/0582/001 58739 MEDICAL VALLEY INVEST AB DK
Venlafaxin "Medical Valley", depottabletter
SE/H/0582/002 58740 MEDICAL VALLEY INVEST AB DK
Venlafaxin "Medical Valley", depottabletter
SE/H/0582/003 58741 MEDICAL VALLEY INVEST AB DK
Venlafaxin AbZ 150 mg Retardtabletten
DE/H/3592/003 74546.00.00 ABZ-PHARMA GMBH DE
List of nationally authorised medicinal products EMA/24903/2018 Page 58/117
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
Venlafaxin AbZ 225 mg Retardtabletten
DE/H/3592/004 74547.00.00 ABZ-PHARMA GMBH DE
Venlafaxin AbZ 37,5 mg Retardtabletten
DE/H/3592/001 74544.00.00 ABZ-PHARMA GMBH DE
Venlafaxin AbZ 75 mg Retardtabletten
DE/H/3592/002 74545.00.00 ABZ-PHARMA GMBH DE
Venlafaxin AGP 150 mg depotabletter
SE/H/0564/003 23683 LABORATORIOS LICONSA, S.A.
SE
Venlafaxin AGP 150 mg depotabletter
SE/H/0564/003 23683 LABORATORIOS LICONSA, S.A.
SE
Venlafaxin AGP 150 mg depottabletter
SE/H/0564/003 23683 LABORATORIOS LICONSA, S.A.
SE
Venlafaxin AGP 150 mg depottabletter
SE/H/0564/003 23683 LABORATORIOS LICONSA, S.A.
SE
Venlafaxin AGP 150 mg depottabletter
SE/H/0564/003 23683 LABORATORIOS LICONSA, S.A.
SE
Venlafaxin AGP 150 mg depottabletter
SE/H/0564/003 23683 LABORATORIOS LICONSA, S.A.
SE
List of nationally authorised medicinal products EMA/24903/2018 Page 59/117
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
Venlafaxin AGP 150 mg depottabletter
SE/H/0564/003 23683 LABORATORIOS LICONSA, S.A.
SE
Venlafaxin AGP 225 mg depotabletter
SE/H/0564/004 23684 LABORATORIOS LICONSA, S.A.
SE
Venlafaxin AGP 225 mg depotabletter
SE/H/0564/004 23684 LABORATORIOS LICONSA, S.A.
SE
Venlafaxin AGP 225 mg depotabletter
SE/H/0564/004 23684 LABORATORIOS LICONSA, S.A.
SE
Venlafaxin AGP 225 mg depottabletter
SE/H/0564/004 23684 LABORATORIOS LICONSA, S.A.
SE
Venlafaxin AGP 225 mg depottabletter
SE/H/0564/004 23684 LABORATORIOS LICONSA, S.A.
SE
Venlafaxin AGP 225 mg depottabletter
SE/H/0564/004 23684 LABORATORIOS LICONSA, S.A.
SE
Venlafaxin AGP 225 mg depottabletter
SE/H/0564/004 23684 LABORATORIOS LICONSA, S.A.
SE
Venlafaxin AGP 37,5 mg depottabletter
SE/H/0564/001 23681 LABORATORIOS LICONSA, S.A.
SE
List of nationally authorised medicinal products EMA/24903/2018 Page 60/117
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
Venlafaxin AGP 37,5 mg depottabletter
SE/H/0564/001 23681 LABORATORIOS LICONSA, S.A.
SE
Venlafaxin AGP 37,5 mg depottabletter
SE/H/0564/001 23681 LABORATORIOS LICONSA, S.A.
SE
Venlafaxin AGP 37,5 mg depottabletter
SE/H/0564/001 23681 LABORATORIOS LICONSA, S.A.
SE
Venlafaxin AGP 37.5 mg depottabletter
SE/H/0564/001 23681 LABORATORIOS LICONSA, S.A.
SE
Venlafaxin AGP 37.5 mg depottabletter
SE/H/0564/001 23681 LABORATORIOS LICONSA, S.A.
SE
Venlafaxin AGP 37.5 mg depottabletter
SE/H/0564/001 23681 LABORATORIOS LICONSA, S.A.
SE
Venlafaxin AGP 75 mg depotabletter
SE/H/0564/002 23682 LABORATORIOS LICONSA, S.A.
SE
Venlafaxin AGP 75 mg depotabletter
SE/H/0564/002 23682 LABORATORIOS LICONSA, S.A.
SE
Venlafaxin AGP 75 mg depottabletter
SE/H/0564/002 23682 LABORATORIOS LICONSA, S.A.
SE
List of nationally authorised medicinal products EMA/24903/2018 Page 61/117
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
Venlafaxin AGP 75 mg depottabletter
SE/H/0564/002 23682 LABORATORIOS LICONSA, S.A.
SE
Venlafaxin AGP 75 mg depottabletter
SE/H/0564/002 23682 LABORATORIOS LICONSA, S.A.
SE
Venlafaxin AGP 75 mg depottabletter
SE/H/0564/002 23682 LABORATORIOS LICONSA, S.A.
SE
Venlafaxin AGP 75 mg depottabletter
SE/H/0564/002 23682 LABORATORIOS LICONSA, S.A.
SE
Venlafaxin Heumann 225 mg Hartkapseln, retardiert
DE/H/4271/001 93933.00.00 HEUMANN PHARMA GMBH & CO. GENERICA KG
DE
Venlafaxin Hexal 50 mg tablett
SE/H/0880/003 25910 HEXAL AG SE
Venlafaxin Medical Valley 150 mg depottabletter
SE/H/0582/002 23690 MEDICAL VALLEY INVEST AB SE
Venlafaxin Medical Valley 150 mg depottabletter
SE/H/0582/002 23690 MEDICAL VALLEY INVEST AB SE
Venlafaxin Medical Valley 150 mg forðatöflur
SE/H/0582/002 IS/1/17/021/02 MEDICAL VALLEY INVEST AB IS
List of nationally authorised medicinal products EMA/24903/2018 Page 62/117
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
Venlafaxin Medical Valley 150 mg forðatöflur
SE/H/0582/002 IS/1/17/021/02 MEDICAL VALLEY INVEST AB IS
Venlafaxin Medical Valley 225 mg depottabletter
SE/H/0582/003 23691 MEDICAL VALLEY INVEST AB SE
Venlafaxin Medical Valley 225 mg depottabletter
SE/H/0582/003 23691 MEDICAL VALLEY INVEST AB SE
Venlafaxin Medical Valley 225 mg forðatöflur
SE/H/0582/003 IS/1/17/021/03 MEDICAL VALLEY INVEST AB IS
Venlafaxin Medical Valley 225 mg forðatöflur
SE/H/0582/003 IS/1/17/021/03 MEDICAL VALLEY INVEST AB IS
Venlafaxin Medical Valley 37,5 mg depottabletter
SE/H/0582/004 42949 MEDICAL VALLEY INVEST AB SE
Venlafaxin Medical Valley 37,5 mg depottabletter
SE/H/0582/004 42949 MEDICAL VALLEY INVEST AB SE
Venlafaxin Medical Valley 75 mg depottabletter
SE/H/0582/001 23689 MEDICAL VALLEY INVEST AB SE
Venlafaxin Medical Valley 75 mg depottabletter
SE/H/0582/001 23689 MEDICAL VALLEY INVEST AB SE
List of nationally authorised medicinal products EMA/24903/2018 Page 63/117
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
Venlafaxin Medical Valley 75 mg forðatöflur
SE/H/0582/001 IS/1/17/021/01 MEDICAL VALLEY INVEST AB IS
Venlafaxin Medical Valley 75 mg forðatöflur
SE/H/0582/001 IS/1/17/021/01 MEDICAL VALLEY INVEST AB IS
VENLAFAXIN WINTHROP® OSMO 150 MG RETARDTABLETTEN
SE/H/0582/002 66084.00.00 WINTHROP ARZNEIMITTEL GMBH
DE
VENLAFAXIN WINTHROP® OSMO 150 MG RETARDTABLETTEN
SE/H/0582/002 66084.00.00 WINTHROP ARZNEIMITTEL GMBH
DE
VENLAFAXIN WINTHROP® OSMO 150 MG RETARDTABLETTEN
SE/H/0582/002 66084.00.00 WINTHROP ARZNEIMITTEL GMBH
DE
VENLAFAXIN WINTHROP® OSMO 150 MG RETARDTABLETTEN
SE/H/0582/002 66084.00.00 WINTHROP ARZNEIMITTEL GMBH
DE
VENLAFAXIN WINTHROP® OSMO 150 MG RETARDTABLETTEN
SE/H/0582/002 66084.00.00 WINTHROP ARZNEIMITTEL GMBH
DE
VENLAFAXIN WINTHROP® OSMO 150 MG RETARDTABLETTEN
SE/H/0582/002 66084.00.00 WINTHROP ARZNEIMITTEL GMBH
DE
VENLAFAXIN WINTHROP® OSMO 150 MG RETARDTABLETTEN
SE/H/0582/002 66084.00.00 WINTHROP ARZNEIMITTEL GMBH
DE
List of nationally authorised medicinal products EMA/24903/2018 Page 64/117
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
VENLAFAXIN WINTHROP® OSMO 150 MG RETARDTABLETTEN
SE/H/0582/002 66084.00.00 WINTHROP ARZNEIMITTEL GMBH
DE
VENLAFAXIN WINTHROP® OSMO 150 MG RETARDTABLETTEN
SE/H/0582/002 66084.00.00 WINTHROP ARZNEIMITTEL GMBH
DE
VENLAFAXIN WINTHROP® OSMO 150 MG RETARDTABLETTEN
SE/H/0582/002 66084.00.00 WINTHROP ARZNEIMITTEL GMBH
DE
VENLAFAXIN WINTHROP® OSMO 150 MG RETARDTABLETTEN
SE/H/0582/002 66084.00.00 WINTHROP ARZNEIMITTEL GMBH
DE
VENLAFAXIN WINTHROP® OSMO 150 MG RETARDTABLETTEN
SE/H/0582/002 66084.00.00 WINTHROP ARZNEIMITTEL GMBH
DE
VENLAFAXIN WINTHROP® OSMO 150 MG RETARDTABLETTEN
SE/H/0582/002 66084.00.00 WINTHROP ARZNEIMITTEL GMBH
DE
VENLAFAXIN WINTHROP® OSMO 150 MG RETARDTABLETTEN
SE/H/0582/002 66084.00.00 WINTHROP ARZNEIMITTEL GMBH
DE
VENLAFAXIN WINTHROP® OSMO 150 MG RETARDTABLETTEN
SE/H/0582/002 66084.00.00 WINTHROP ARZNEIMITTEL GMBH
DE
VENLAFAXIN WINTHROP® OSMO 150 MG RETARDTABLETTEN
SE/H/0582/002 66084.00.00 WINTHROP ARZNEIMITTEL GMBH
DE
List of nationally authorised medicinal products EMA/24903/2018 Page 65/117
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
VENLAFAXIN WINTHROP® OSMO 150 MG RETARDTABLETTEN
SE/H/0582/002 66084.00.00 WINTHROP ARZNEIMITTEL GMBH
DE
VENLAFAXIN WINTHROP® OSMO 150 MG RETARDTABLETTEN
SE/H/0582/002 66084.00.00 WINTHROP ARZNEIMITTEL GMBH
DE
VENLAFAXIN WINTHROP® OSMO 225 MG RETARDTABLETTEN
SE/H/0582/003 66085.00.00 WINTHROP ARZNEIMITTEL GMBH
DE
VENLAFAXIN WINTHROP® OSMO 225 MG RETARDTABLETTEN
SE/H/0582/003 66085.00.00 WINTHROP ARZNEIMITTEL GMBH
DE
VENLAFAXIN WINTHROP® OSMO 225 MG RETARDTABLETTEN
SE/H/0582/003 66085.00.00 WINTHROP ARZNEIMITTEL GMBH
DE
VENLAFAXIN WINTHROP® OSMO 225 MG RETARDTABLETTEN
SE/H/0582/003 66085.00.00 WINTHROP ARZNEIMITTEL GMBH
DE
VENLAFAXIN WINTHROP® OSMO 225 MG RETARDTABLETTEN
SE/H/0582/003 66085.00.00 WINTHROP ARZNEIMITTEL GMBH
DE
VENLAFAXIN WINTHROP® OSMO 225 MG RETARDTABLETTEN
SE/H/0582/003 66085.00.00 WINTHROP ARZNEIMITTEL GMBH
DE
VENLAFAXIN WINTHROP® OSMO 225 MG RETARDTABLETTEN
SE/H/0582/003 66085.00.00 WINTHROP ARZNEIMITTEL GMBH
DE
List of nationally authorised medicinal products EMA/24903/2018 Page 66/117
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
VENLAFAXIN WINTHROP® OSMO 225 MG RETARDTABLETTEN
SE/H/0582/003 66085.00.00 WINTHROP ARZNEIMITTEL GMBH
DE
VENLAFAXIN WINTHROP® OSMO 225 MG RETARDTABLETTEN
SE/H/0582/003 66085.00.00 WINTHROP ARZNEIMITTEL GMBH
DE
VENLAFAXIN WINTHROP® OSMO 225 MG RETARDTABLETTEN
SE/H/0582/003 66085.00.00 WINTHROP ARZNEIMITTEL GMBH
DE
VENLAFAXIN WINTHROP® OSMO 225 MG RETARDTABLETTEN
SE/H/0582/003 66085.00.00 WINTHROP ARZNEIMITTEL GMBH
DE
VENLAFAXIN WINTHROP® OSMO 225 MG RETARDTABLETTEN
SE/H/0582/003 66085.00.00 WINTHROP ARZNEIMITTEL GMBH
DE
VENLAFAXIN WINTHROP® OSMO 225 MG RETARDTABLETTEN
SE/H/0582/003 66085.00.00 WINTHROP ARZNEIMITTEL GMBH
DE
VENLAFAXIN WINTHROP® OSMO 225 MG RETARDTABLETTEN
SE/H/0582/003 66085.00.00 WINTHROP ARZNEIMITTEL GMBH
DE
VENLAFAXIN WINTHROP® OSMO 225 MG RETARDTABLETTEN
SE/H/0582/003 66085.00.00 WINTHROP ARZNEIMITTEL GMBH
DE
VENLAFAXIN WINTHROP® OSMO 225 MG RETARDTABLETTEN
SE/H/0582/003 66085.00.00 WINTHROP ARZNEIMITTEL GMBH
DE
List of nationally authorised medicinal products EMA/24903/2018 Page 67/117
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
VENLAFAXIN WINTHROP® OSMO 225 MG RETARDTABLETTEN
SE/H/0582/003 66085.00.00 WINTHROP ARZNEIMITTEL GMBH
DE
VENLAFAXIN WINTHROP® OSMO 225 MG RETARDTABLETTEN
SE/H/0582/003 66085.00.00 WINTHROP ARZNEIMITTEL GMBH
DE
Venlafaxin Winthrop® osmo 37,5 mg Retardtabletten
SE/H/0582/004 79446.00.00 WINTHROP ARZNEIMITTEL GMBH
DE
Venlafaxin Winthrop® osmo 37,5 mg Retardtabletten
SE/H/0582/004 79446.00.00 WINTHROP ARZNEIMITTEL GMBH
DE
Venlafaxin Winthrop® osmo 37,5 mg Retardtabletten
SE/H/0582/004 79446.00.00 WINTHROP ARZNEIMITTEL GMBH
DE
Venlafaxin Winthrop® osmo 37,5 mg Retardtabletten
SE/H/0582/004 79446.00.00 WINTHROP ARZNEIMITTEL GMBH
DE
Venlafaxin Winthrop® osmo 37,5 mg Retardtabletten
SE/H/0582/004 79446.00.00 WINTHROP ARZNEIMITTEL GMBH
DE
Venlafaxin Winthrop® osmo 37,5 mg Retardtabletten
SE/H/0582/004 79446.00.00 WINTHROP ARZNEIMITTEL GMBH
DE
Venlafaxin Winthrop® osmo 37,5 mg Retardtabletten
SE/H/0582/004 79446.00.00 WINTHROP ARZNEIMITTEL GMBH
DE
List of nationally authorised medicinal products EMA/24903/2018 Page 68/117
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
Venlafaxin Winthrop® osmo 37,5 mg Retardtabletten
SE/H/0582/004 79446.00.00 WINTHROP ARZNEIMITTEL GMBH
DE
VENLAFAXIN WINTHROP® OSMO 75 MG RETARDTABLETTEN
SE/H/0582/001 66083.00.00 WINTHROP ARZNEIMITTEL GMBH
DE
VENLAFAXIN WINTHROP® OSMO 75 MG RETARDTABLETTEN
SE/H/0582/001 66083.00.00 WINTHROP ARZNEIMITTEL GMBH
DE
VENLAFAXIN WINTHROP® OSMO 75 MG RETARDTABLETTEN
SE/H/0582/001 66083.00.00 WINTHROP ARZNEIMITTEL GMBH
DE
VENLAFAXIN WINTHROP® OSMO 75 MG RETARDTABLETTEN
SE/H/0582/001 66083.00.00 WINTHROP ARZNEIMITTEL GMBH
DE
VENLAFAXIN WINTHROP® OSMO 75 MG RETARDTABLETTEN
SE/H/0582/001 66083.00.00 WINTHROP ARZNEIMITTEL GMBH
DE
VENLAFAXIN WINTHROP® OSMO 75 MG RETARDTABLETTEN
SE/H/0582/001 66083.00.00 WINTHROP ARZNEIMITTEL GMBH
DE
VENLAFAXIN WINTHROP® OSMO 75 MG RETARDTABLETTEN
SE/H/0582/001 66083.00.00 WINTHROP ARZNEIMITTEL GMBH
DE
VENLAFAXIN WINTHROP® OSMO 75 MG RETARDTABLETTEN
SE/H/0582/001 66083.00.00 WINTHROP ARZNEIMITTEL GMBH
DE
List of nationally authorised medicinal products EMA/24903/2018 Page 69/117
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
VENLAFAXIN WINTHROP® OSMO 75 MG RETARDTABLETTEN
SE/H/0582/001 66083.00.00 WINTHROP ARZNEIMITTEL GMBH
DE
VENLAFAXIN WINTHROP® OSMO 75 MG RETARDTABLETTEN
SE/H/0582/001 66083.00.00 WINTHROP ARZNEIMITTEL GMBH
DE
VENLAFAXIN WINTHROP® OSMO 75 MG RETARDTABLETTEN
SE/H/0582/001 66083.00.00 WINTHROP ARZNEIMITTEL GMBH
DE
VENLAFAXIN WINTHROP® OSMO 75 MG RETARDTABLETTEN
SE/H/0582/001 66083.00.00 WINTHROP ARZNEIMITTEL GMBH
DE
VENLAFAXIN WINTHROP® OSMO 75 MG RETARDTABLETTEN
SE/H/0582/001 66083.00.00 WINTHROP ARZNEIMITTEL GMBH
DE
VENLAFAXIN WINTHROP® OSMO 75 MG RETARDTABLETTEN
SE/H/0582/001 66083.00.00 WINTHROP ARZNEIMITTEL GMBH
DE
VENLAFAXIN WINTHROP® OSMO 75 MG RETARDTABLETTEN
SE/H/0582/001 66083.00.00 WINTHROP ARZNEIMITTEL GMBH
DE
VENLAFAXIN WINTHROP® OSMO 75 MG RETARDTABLETTEN
SE/H/0582/001 66083.00.00 WINTHROP ARZNEIMITTEL GMBH
DE
VENLAFAXIN WINTHROP® OSMO 75 MG RETARDTABLETTEN
SE/H/0582/001 66083.00.00 WINTHROP ARZNEIMITTEL GMBH
DE
List of nationally authorised medicinal products EMA/24903/2018 Page 70/117
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
VENLAFAXIN WINTHROP® OSMO 75 MG RETARDTABLETTEN
SE/H/0582/001 66083.00.00 WINTHROP ARZNEIMITTEL GMBH
DE
Venlafaxina Aurobindo 37,5 mg cápsulas duras de liberación prolongada
PT/H/0703/001 79.387 LABORATORIOS AUROBINDO S.L.U.
ES
Venlafaxina Aurobindo 37,5 mg capsule rigide a rilascio prolungato
PT/H/0703/001 041691015 AUROBINDO PHARMA (ITALIA) S.R.L.
IT
Venlafaxina Aurobindo 37,5 mg capsule rigide a rilascio prolungato
PT/H/0703/001 041691027 AUROBINDO PHARMA (ITALIA) S.R.L.
IT
Venlafaxina Aurobindo 37,5 mg capsule rigide a rilascio prolungato
PT/H/0703/001 041691039 AUROBINDO PHARMA (ITALIA) S.R.L.
IT
Venlafaxina Aurobindo 37,5 mg capsule rigide a rilascio prolungato
PT/H/0703/001 041691041 AUROBINDO PHARMA (ITALIA) S.R.L.
IT
Venlafaxina Aurobindo 37,5 mg capsule rigide a rilascio prolungato
PT/H/0703/001 041691054 AUROBINDO PHARMA (ITALIA) S.R.L.
IT
Venlafaxina Aurobindo 37,5 mg capsule rigide a rilascio prolungato
PT/H/0703/001 041691066 AUROBINDO PHARMA (ITALIA) S.R.L.
IT
Venlafaxina Aurobindo 37,5 mg capsule rigide a rilascio prolungato
PT/H/0703/001 041691078 AUROBINDO PHARMA (ITALIA) S.R.L.
IT
List of nationally authorised medicinal products EMA/24903/2018 Page 71/117
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
Venlafaxina Aurobindo 37,5 mg capsule rigide a rilascio prolungato
PT/H/0703/001 041691080 AUROBINDO PHARMA (ITALIA) S.R.L.
IT
Venlafaxina Aurobindo 37,5 mg capsule rigide a rilascio prolungato
PT/H/0703/001 041691092 AUROBINDO PHARMA (ITALIA) S.R.L.
IT
Venlafaxina Aurobindo 37,5 mg capsule rigide a rilascio prolungato
PT/H/0703/001 041691104 AUROBINDO PHARMA (ITALIA) S.R.L.
IT
Venlafaxina Aurobindo 37,5 mg capsule rigide a rilascio prolungato
PT/H/0703/001 041691116 AUROBINDO PHARMA (ITALIA) S.R.L.
IT
Venlafaxina Aurobindo 37,5 mg capsule rigide a rilascio prolungato
PT/H/0703/001 041691128 AUROBINDO PHARMA (ITALIA) S.R.L.
IT
Venlafaxina Aurobindo 37,5 mg capsule rigide a rilascio prolungato
PT/H/0703/001 041691130 AUROBINDO PHARMA (ITALIA) S.R.L.
IT
Venlafaxina Aurobindo 37,5 mg capsule rigide a rilascio prolungato
PT/H/0703/001 041691142 AUROBINDO PHARMA (ITALIA) S.R.L.
IT
Venlafaxina Aurobindo 37,5 mg capsule rigide a rilascio prolungato
PT/H/0703/001 041691155 AUROBINDO PHARMA (ITALIA) S.R.L.
IT
Venlafaxina Pfizer 150 mg capsule rigide a rilascio prolungato
SE/H/0938/003 028834101 PFIZER ITALIA S.R.L. IT
List of nationally authorised medicinal products EMA/24903/2018 Page 72/117
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
Venlafaxina Pfizer 150 mg capsule rigide a rilascio prolungato
SE/H/0938/003 028834063 PFIZER ITALIA S.R.L. IT
Venlafaxina Pfizer 37,5 mg capsule rigide a rilascio prolungato
SE/H/0938/001 028834125 PFIZER ITALIA S.R.L. IT
Venlafaxina Pfizer 37,5 mg capsule rigide a rilascio prolungato
SE/H/0938/001 028834137 PFIZER ITALIA S.R.L. IT
Venlafaxina Pfizer 37,5 mg capsule rigide a rilascio prolungato
SE/H/0938/001 028834113 PFIZER ITALIA S.R.L. IT
Venlafaxina Pfizer 75 mg capsule rigide a rilascio prolungato
SE/H/0938/002 028834099 PFIZER ITALIA S.R.L. IT
Venlafaxina Pfizer 75 mg capsule rigide a rilascio prolungato
SE/H/0938/002 028834051 PFIZER ITALIA S.R.L. IT
Venlafaxina SUN 150 mg comprimidos de liberación prolongada
NL/H/3948/003 76603 SUN PHARMACEUTICAL INDUSTRIES EUROPE B.V.
ES
Venlafaxina SUN 37,5 mg comprimidos de liberación prolongada
NL/H/3948/001 76602 SUN PHARMACEUTICAL INDUSTRIES EUROPE B.V.
ES
Venlafaxina SUN 75 mg comprimidos de liberación prolongada
NL/H/3948/002 76604 SUN PHARMACEUTICAL INDUSTRIES EUROPE B.V.
ES
List of nationally authorised medicinal products EMA/24903/2018 Page 73/117
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
Venlafaxina toLife 150 mg comprimidos de libertação prolongada
not available 5073226 TOLIFE - PRODUTOS FARMACÊUTICOS, S.A.
PT
Venlafaxina toLife 150 mg comprimidos de libertação prolongada
not available 5073234 TOLIFE - PRODUTOS FARMACÊUTICOS, S.A.
PT
Venlafaxina toLife 150 mg comprimidos de libertação prolongada
not available 5073242 TOLIFE - PRODUTOS FARMACÊUTICOS, S.A.
PT
Venlafaxina toLife 37,5 mg comprimidos de libertação prolongada
not available 5708995 TOLIFE - PRODUTOS FARMACÊUTICOS, S.A.
PT
Venlafaxina toLife 37,5 mg comprimidos de libertação prolongada
not available 5709092 TOLIFE - PRODUTOS FARMACÊUTICOS, S.A.
PT
Venlafaxina toLife 75 mg comprimidos de libertação prolongada
not available 5709191 TOLIFE - PRODUTOS FARMACÊUTICOS, S.A.
PT
Venlafaxina toLife 75 mg comprimidos de libertação prolongada
not available 5709290 TOLIFE - PRODUTOS FARMACÊUTICOS, S.A.
PT
Venlafaxin-CT 150 mg Retardtabletten
DE/H/3593/003 74550.00.00 ABZ-PHARMA GMBH DE
Venlafaxin-CT 225 mg Retardtabletten
DE/H/3593/004 74551.00.00 ABZ-PHARMA GMBH DE
List of nationally authorised medicinal products EMA/24903/2018 Page 74/117
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
Venlafaxin-CT 37,5 mg Retardtabletten
DE/H/3593/001 74548.00.00 ABZ-PHARMA GMBH DE
Venlafaxin-CT 75 mg Retardtabletten
DE/H/3593/002 74549.00.00 ABZ-PHARMA GMBH DE
Venlafaxine 150 mg Focus, tabletten met verlengde afgifte
not available RVG 108591 FOCUS CARE PHARMACEUTICALS B.V.
NL
Venlafaxine 225 mg Focus, tabletten met verlengde afgifte
not available RVG 108592 FOCUS CARE PHARMACEUTICALS B.V.
NL
Venlafaxine 37,5 mg Focus, tabletten met verlengde afgifte
not available RVG 108589 FOCUS CARE PHARMACEUTICALS B.V.
NL
Venlafaxine 75 mg Focus, tabletten met verlengde afgifte
not available RVG 108590 FOCUS CARE PHARMACEUTICALS B.V.
NL
Venlafaxine Aurobindo 225 mg tabletten met verlengde afgifte
SE/H/0581/004 RVG 33889 AUROBINDO PHARMA B.V. NL
VENLAFAXINE BIPHAR 150 mg, comprimé à libération prolongée
SE/H/0581/003 34009 384 482 7 6 MYLAN MEDICAL SAS FR
VENLAFAXINE BIPHAR 150 mg, comprimé à libération prolongée
SE/H/0581/003 34009 384 483 3 7 MYLAN MEDICAL SAS FR
List of nationally authorised medicinal products EMA/24903/2018 Page 75/117
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
VENLAFAXINE BIPHAR 150 mg, comprimé à libération prolongée
SE/H/0581/003 34009 384 485 6 6 MYLAN MEDICAL SAS FR
VENLAFAXINE BIPHAR 150 mg, comprimé à libération prolongée
SE/H/0581/003 34009 384 487 9 5 MYLAN MEDICAL SAS FR
VENLAFAXINE BIPHAR 150 mg, comprimé à libération prolongée
SE/H/0581/003 34009 384 488 5 6 MYLAN MEDICAL SAS FR
VENLAFAXINE BIPHAR 150 mg, comprimé à libération prolongée
SE/H/0581/003 34009 384 489 1 7 MYLAN MEDICAL SAS FR
VENLAFAXINE BIPHAR 150 mg, comprimé à libération prolongée
SE/H/0581/003 34009 384 491 6 7 MYLAN MEDICAL SAS FR
VENLAFAXINE BIPHAR 150 mg, comprimé à libération prolongée
SE/H/0581/003 34009 384 492 2 8 MYLAN MEDICAL SAS FR
VENLAFAXINE BIPHAR 150 mg, comprimé à libération prolongée
SE/H/0581/003 34009 572 358 8 8 MYLAN MEDICAL SAS FR
VENLAFAXINE BIPHAR 150 mg, comprimé à libération prolongée
SE/H/0581/003 34009 384 494 5 7 MYLAN MEDICAL SAS FR
VENLAFAXINE BIPHAR 150 mg, comprimé à libération prolongée
SE/H/0581/003 34009 384 495 1 8 MYLAN MEDICAL SAS FR
List of nationally authorised medicinal products EMA/24903/2018 Page 76/117
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
VENLAFAXINE BIPHAR 150 mg, comprimé à libération prolongée
SE/H/0581/003 34009 384 496 8 6 MYLAN MEDICAL SAS FR
VENLAFAXINE BIPHAR 150 mg, comprimé à libération prolongée
SE/H/0581/003 34009 384 497 4 7 MYLAN MEDICAL SAS FR
VENLAFAXINE BIPHAR 150 mg, comprimé à libération prolongée
SE/H/0581/003 34009 384 498 0 8 MYLAN MEDICAL SAS FR
VENLAFAXINE BIPHAR 150 mg, comprimé à libération prolongée
SE/H/0581/003 34009 384 499 7 6 MYLAN MEDICAL SAS FR
VENLAFAXINE BIPHAR 150 mg, comprimé à libération prolongée
SE/H/0581/003 34009 384 500 5 7 MYLAN MEDICAL SAS FR
VENLAFAXINE BIPHAR 150 mg, comprimé à libération prolongée
SE/H/0581/003 34009 384 501 1 8 MYLAN MEDICAL SAS FR
VENLAFAXINE BIPHAR 150 mg, comprimé à libération prolongée
SE/H/0581/003 34009 572 359 4 9 MYLAN MEDICAL SAS FR
VENLAFAXINE BIPHAR 150 mg, comprimé à libération prolongée
SE/H/0581/003 34009 384 486 2 7 MYLAN MEDICAL SAS FR
VENLAFAXINE BIPHAR 150 mg, comprimé à libération prolongée
SE/H/0581/003 34009 384 493 9 6 MYLAN MEDICAL SAS FR
List of nationally authorised medicinal products EMA/24903/2018 Page 77/117
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
VENLAFAXINE BIPHAR 150 mg, comprimé à libération prolongée
SE/H/0581/003 34009 384 482 7 6 MYLAN MEDICAL SAS FR
VENLAFAXINE BIPHAR 150 mg, comprimé à libération prolongée
SE/H/0581/003 34009 384 483 3 7 MYLAN MEDICAL SAS FR
VENLAFAXINE BIPHAR 150 mg, comprimé à libération prolongée
SE/H/0581/003 34009 384 485 6 6 MYLAN MEDICAL SAS FR
VENLAFAXINE BIPHAR 150 mg, comprimé à libération prolongée
SE/H/0581/003 34009 384 487 9 5 MYLAN MEDICAL SAS FR
VENLAFAXINE BIPHAR 150 mg, comprimé à libération prolongée
SE/H/0581/003 34009 384 488 5 6 MYLAN MEDICAL SAS FR
VENLAFAXINE BIPHAR 150 mg, comprimé à libération prolongée
SE/H/0581/003 34009 384 489 1 7 MYLAN MEDICAL SAS FR
VENLAFAXINE BIPHAR 150 mg, comprimé à libération prolongée
SE/H/0581/003 34009 384 491 6 7 MYLAN MEDICAL SAS FR
VENLAFAXINE BIPHAR 150 mg, comprimé à libération prolongée
SE/H/0581/003 34009 384 492 2 8 MYLAN MEDICAL SAS FR
VENLAFAXINE BIPHAR 150 mg, comprimé à libération prolongée
SE/H/0581/003 34009 572 358 8 8 MYLAN MEDICAL SAS FR
List of nationally authorised medicinal products EMA/24903/2018 Page 78/117
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
VENLAFAXINE BIPHAR 150 mg, comprimé à libération prolongée
SE/H/0581/003 34009 384 494 5 7 MYLAN MEDICAL SAS FR
VENLAFAXINE BIPHAR 150 mg, comprimé à libération prolongée
SE/H/0581/003 34009 384 495 1 8 MYLAN MEDICAL SAS FR
VENLAFAXINE BIPHAR 150 mg, comprimé à libération prolongée
SE/H/0581/003 34009 384 496 8 6 MYLAN MEDICAL SAS FR
VENLAFAXINE BIPHAR 150 mg, comprimé à libération prolongée
SE/H/0581/003 34009 384 497 4 7 MYLAN MEDICAL SAS FR
VENLAFAXINE BIPHAR 150 mg, comprimé à libération prolongée
SE/H/0581/003 34009 384 498 0 8 MYLAN MEDICAL SAS FR
VENLAFAXINE BIPHAR 150 mg, comprimé à libération prolongée
SE/H/0581/003 34009 384 499 7 6 MYLAN MEDICAL SAS FR
VENLAFAXINE BIPHAR 150 mg, comprimé à libération prolongée
SE/H/0581/003 34009 384 500 5 7 MYLAN MEDICAL SAS FR
VENLAFAXINE BIPHAR 150 mg, comprimé à libération prolongée
SE/H/0581/003 34009 384 501 1 8 MYLAN MEDICAL SAS FR
VENLAFAXINE BIPHAR 150 mg, comprimé à libération prolongée
SE/H/0581/003 34009 572 359 4 9 MYLAN MEDICAL SAS FR
List of nationally authorised medicinal products EMA/24903/2018 Page 79/117
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
VENLAFAXINE BIPHAR 150 mg, comprimé à libération prolongée
SE/H/0581/003 34009 384 486 2 7 MYLAN MEDICAL SAS FR
VENLAFAXINE BIPHAR 150 mg, comprimé à libération prolongée
SE/H/0581/003 34009 384 493 9 6 MYLAN MEDICAL SAS FR
VENLAFAXINE BIPHAR 225 mg, comprimé à libération prolongée
SE/H/0581/004 34009 384 502 8 6 MYLAN MEDICAL SAS FR
VENLAFAXINE BIPHAR 225 mg, comprimé à libération prolongée
SE/H/0581/004 34009 384 503 4 7 MYLAN MEDICAL SAS FR
VENLAFAXINE BIPHAR 225 mg, comprimé à libération prolongée
SE/H/0581/004 34009 384 504 0 8 MYLAN MEDICAL SAS FR
VENLAFAXINE BIPHAR 225 mg, comprimé à libération prolongée
SE/H/0581/004 34009 384 505 7 6 MYLAN MEDICAL SAS FR
VENLAFAXINE BIPHAR 225 mg, comprimé à libération prolongée
SE/H/0581/004 34009 384 506 3 7 MYLAN MEDICAL SAS FR
VENLAFAXINE BIPHAR 225 mg, comprimé à libération prolongée
SE/H/0581/004 34009 384 508 6 6 MYLAN MEDICAL SAS FR
VENLAFAXINE BIPHAR 225 mg, comprimé à libération prolongée
SE/H/0581/004 34009 384 509 2 7 MYLAN MEDICAL SAS FR
List of nationally authorised medicinal products EMA/24903/2018 Page 80/117
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
VENLAFAXINE BIPHAR 225 mg, comprimé à libération prolongée
SE/H/0581/004 34009 384 510 0 9 MYLAN MEDICAL SAS FR
VENLAFAXINE BIPHAR 225 mg, comprimé à libération prolongée
SE/H/0581/004 34009 384 511 7 7 MYLAN MEDICAL SAS FR
VENLAFAXINE BIPHAR 225 mg, comprimé à libération prolongée
SE/H/0581/004 34009 572 360 2 1 MYLAN MEDICAL SAS FR
VENLAFAXINE BIPHAR 225 mg, comprimé à libération prolongée
SE/H/0581/004 34009 384 512 3 8 MYLAN MEDICAL SAS FR
VENLAFAXINE BIPHAR 225 mg, comprimé à libération prolongée
SE/H/0581/004 34009 384 514 6 7 MYLAN MEDICAL SAS FR
VENLAFAXINE BIPHAR 225 mg, comprimé à libération prolongée
SE/H/0581/004 34009 384 515 2 8 MYLAN MEDICAL SAS FR
VENLAFAXINE BIPHAR 225 mg, comprimé à libération prolongée
SE/H/0581/004 34009 384 516 9 6 MYLAN MEDICAL SAS FR
VENLAFAXINE BIPHAR 225 mg, comprimé à libération prolongée
SE/H/0581/004 34009 384 517 5 7 MYLAN MEDICAL SAS FR
VENLAFAXINE BIPHAR 225 mg, comprimé à libération prolongée
SE/H/0581/004 34009 384 518 1 8 MYLAN MEDICAL SAS FR
List of nationally authorised medicinal products EMA/24903/2018 Page 81/117
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
VENLAFAXINE BIPHAR 225 mg, comprimé à libération prolongée
SE/H/0581/004 34009 384 519 8 6 MYLAN MEDICAL SAS FR
VENLAFAXINE BIPHAR 225 mg, comprimé à libération prolongée
SE/H/0581/004 34009 384 520 6 8 MYLAN MEDICAL SAS FR
VENLAFAXINE BIPHAR 225 mg, comprimé à libération prolongée
SE/H/0581/004 34009 384 521 2 9 MYLAN MEDICAL SAS FR
VENLAFAXINE BIPHAR 225 mg, comprimé à libération prolongée
SE/H/0581/004 34009 572 361 9 9 MYLAN MEDICAL SAS FR
VENLAFAXINE BIPHAR 225 mg, comprimé à libération prolongée
SE/H/0581/004 34009 384 502 8 6 MYLAN MEDICAL SAS FR
VENLAFAXINE BIPHAR 225 mg, comprimé à libération prolongée
SE/H/0581/004 34009 384 503 4 7 MYLAN MEDICAL SAS FR
VENLAFAXINE BIPHAR 225 mg, comprimé à libération prolongée
SE/H/0581/004 34009 384 504 0 8 MYLAN MEDICAL SAS FR
VENLAFAXINE BIPHAR 225 mg, comprimé à libération prolongée
SE/H/0581/004 34009 384 505 7 6 MYLAN MEDICAL SAS FR
VENLAFAXINE BIPHAR 225 mg, comprimé à libération prolongée
SE/H/0581/004 34009 384 506 3 7 MYLAN MEDICAL SAS FR
List of nationally authorised medicinal products EMA/24903/2018 Page 82/117
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
VENLAFAXINE BIPHAR 225 mg, comprimé à libération prolongée
SE/H/0581/004 34009 384 508 6 6 MYLAN MEDICAL SAS FR
VENLAFAXINE BIPHAR 225 mg, comprimé à libération prolongée
SE/H/0581/004 34009 384 509 2 7 MYLAN MEDICAL SAS FR
VENLAFAXINE BIPHAR 225 mg, comprimé à libération prolongée
SE/H/0581/004 34009 384 510 0 9 MYLAN MEDICAL SAS FR
VENLAFAXINE BIPHAR 225 mg, comprimé à libération prolongée
SE/H/0581/004 34009 384 511 7 7 MYLAN MEDICAL SAS FR
VENLAFAXINE BIPHAR 225 mg, comprimé à libération prolongée
SE/H/0581/004 34009 572 360 2 1 MYLAN MEDICAL SAS FR
VENLAFAXINE BIPHAR 225 mg, comprimé à libération prolongée
SE/H/0581/004 34009 384 512 3 8 MYLAN MEDICAL SAS FR
VENLAFAXINE BIPHAR 225 mg, comprimé à libération prolongée
SE/H/0581/004 34009 384 514 6 7 MYLAN MEDICAL SAS FR
VENLAFAXINE BIPHAR 225 mg, comprimé à libération prolongée
SE/H/0581/004 34009 384 515 2 8 MYLAN MEDICAL SAS FR
VENLAFAXINE BIPHAR 225 mg, comprimé à libération prolongée
SE/H/0581/004 34009 384 516 9 6 MYLAN MEDICAL SAS FR
List of nationally authorised medicinal products EMA/24903/2018 Page 83/117
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
VENLAFAXINE BIPHAR 225 mg, comprimé à libération prolongée
SE/H/0581/004 34009 384 517 5 7 MYLAN MEDICAL SAS FR
VENLAFAXINE BIPHAR 225 mg, comprimé à libération prolongée
SE/H/0581/004 34009 384 518 1 8 MYLAN MEDICAL SAS FR
VENLAFAXINE BIPHAR 225 mg, comprimé à libération prolongée
SE/H/0581/004 34009 384 519 8 6 MYLAN MEDICAL SAS FR
VENLAFAXINE BIPHAR 225 mg, comprimé à libération prolongée
SE/H/0581/004 34009 384 520 6 8 MYLAN MEDICAL SAS FR
VENLAFAXINE BIPHAR 225 mg, comprimé à libération prolongée
SE/H/0581/004 34009 384 521 2 9 MYLAN MEDICAL SAS FR
VENLAFAXINE BIPHAR 225 mg, comprimé à libération prolongée
SE/H/0581/004 34009 572 361 9 9 MYLAN MEDICAL SAS FR
Venlafaxine Liconsa 150 mg depottabletter
SE/H/0581/003 23687 LABORATORIOS LICONSA, S.A.
SE
Venlafaxine Liconsa 150 mg depottabletter
SE/H/0581/003 23687 LABORATORIOS LICONSA, S.A.
SE
Venlafaxine Liconsa 150 mg depottabletter
SE/H/0581/003 23687 LABORATORIOS LICONSA, S.A.
SE
List of nationally authorised medicinal products EMA/24903/2018 Page 84/117
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
Venlafaxine Liconsa 150 mg depottabletter
SE/H/0581/003 23687 LABORATORIOS LICONSA, S.A.
SE
Venlafaxine Liconsa 150 mg tabletten met verlengde afgifte
SE/H/0581/003 RVG 33888 LABORATORIOS LICONSA, S.A.
NL
Venlafaxine Liconsa 150 mg tabletten met verlengde afgifte
SE/H/0581/003 RVG 33888 LABORATORIOS LICONSA, S.A.
NL
Venlafaxine Liconsa 150 mg tabletten met verlengde afgifte
SE/H/0581/003 RVG 33888 LABORATORIOS LICONSA, S.A.
NL
Venlafaxine Liconsa 150 mg tabletten met verlengde afgifte
SE/H/0581/003 RVG 33888 LABORATORIOS LICONSA, S.A.
NL
Venlafaxine Liconsa 225 mg depottabletter
SE/H/0581/004 23688 LABORATORIOS LICONSA, S.A.
SE
Venlafaxine Liconsa 225 mg depottabletter
SE/H/0581/004 23688 LABORATORIOS LICONSA, S.A.
SE
Venlafaxine Liconsa 225 mg depottabletter
SE/H/0581/004 23688 LABORATORIOS LICONSA, S.A.
SE
Venlafaxine Liconsa 225 mg depottabletter
SE/H/0581/004 23688 LABORATORIOS LICONSA, S.A.
SE
List of nationally authorised medicinal products EMA/24903/2018 Page 85/117
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
Venlafaxine Liconsa 225 mg tabletten met verlengde afgifte
SE/H/0581/004 RVG 33889 LABORATORIOS LICONSA, S.A.
NL
Venlafaxine Liconsa 225 mg tabletten met verlengde afgifte
SE/H/0581/004 RVG 33889 LABORATORIOS LICONSA, S.A.
NL
Venlafaxine Liconsa 37,5 mg depottabletter
SE/H/0581/001 23685 LABORATORIOS LICONSA, S.A.
SE
Venlafaxine Liconsa 37,5 mg depottabletter
SE/H/0581/001 23685 LABORATORIOS LICONSA, S.A.
SE
Venlafaxine Liconsa 37,5 mg depottabletter
SE/H/0581/001 23685 LABORATORIOS LICONSA, S.A.
SE
Venlafaxine Liconsa 37,5 mg depottabletter
SE/H/0581/001 23685 LABORATORIOS LICONSA, S.A.
SE
Venlafaxine Liconsa 37,5 mg tabletten met verlengde afgifte
SE/H/0581/001 RVG 33886 LABORATORIOS LICONSA, S.A.
NL
Venlafaxine Liconsa 37,5 mg tabletten met verlengde afgifte
SE/H/0581/001 RVG 33886 LABORATORIOS LICONSA, S.A.
NL
Venlafaxine Liconsa 37,5 mg tabletten met verlengde afgifte
SE/H/0581/001 RVG 33886 LABORATORIOS LICONSA, S.A.
NL
List of nationally authorised medicinal products EMA/24903/2018 Page 86/117
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
Venlafaxine Liconsa 37,5 mg tabletten met verlengde afgifte
SE/H/0581/001 RVG 33886 LABORATORIOS LICONSA, S.A.
NL
Venlafaxine Liconsa 75 mg depottabletter
SE/H/0581/002 23686 LABORATORIOS LICONSA, S.A.
SE
Venlafaxine Liconsa 75 mg depottabletter
SE/H/0581/002 23686 LABORATORIOS LICONSA, S.A.
SE
Venlafaxine Liconsa 75 mg depottabletter
SE/H/0581/002 23686 LABORATORIOS LICONSA, S.A.
SE
Venlafaxine Liconsa 75 mg depottabletter
SE/H/0581/002 23686 LABORATORIOS LICONSA, S.A.
SE
Venlafaxine Liconsa 75 mg tabletten met verlengde afgifte
SE/H/0581/002 RVG 33887 LABORATORIOS LICONSA, S.A.
NL
Venlafaxine Liconsa 75 mg tabletten met verlengde afgifte
SE/H/0581/002 RVG 33887 LABORATORIOS LICONSA, S.A.
NL
Venlafaxine Liconsa 75 mg tabletten met verlengde afgifte
SE/H/0581/002 RVG 33887 LABORATORIOS LICONSA, S.A.
NL
Venlafaxine Liconsa 75 mg tabletten met verlengde afgifte
SE/H/0581/002 RVG 33887 LABORATORIOS LICONSA, S.A.
NL
List of nationally authorised medicinal products EMA/24903/2018 Page 87/117
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
Venlafaxine Liconsa, 150 mg toimeainet prolongeeritult vabastavad tabletid
SE/H/0581/003 553307 LABORATORIOS LICONSA, S.A.
EE
Venlafaxine Liconsa, 150 mg toimeainet prolongeeritult vabastavad tabletid
SE/H/0581/003 553307 LABORATORIOS LICONSA, S.A.
EE
Venlafaxine Liconsa, 150 mg toimeainet prolongeeritult vabastavad tabletid
SE/H/0581/003 553307 LABORATORIOS LICONSA, S.A.
EE
Venlafaxine Liconsa, 150 mg toimeainet prolongeeritult vabastavad tabletid
SE/H/0581/003 553307 LABORATORIOS LICONSA, S.A.
EE
Venlafaxine Liconsa, 225 mg toimeainet prolongeeritult vabastavad tabletid
SE/H/0581/004 553207 LABORATORIOS LICONSA, S.A.
EE
Venlafaxine Liconsa, 225 mg toimeainet prolongeeritult vabastavad tabletid
SE/H/0581/004 553207 LABORATORIOS LICONSA, S.A.
EE
Venlafaxine Liconsa, 225 mg toimeainet prolongeeritult vabastavad tabletid
SE/H/0581/004 553207 LABORATORIOS LICONSA, S.A.
EE
List of nationally authorised medicinal products EMA/24903/2018 Page 88/117
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
Venlafaxine Liconsa, 225 mg toimeainet prolongeeritult vabastavad tabletid
SE/H/0581/004 553207 LABORATORIOS LICONSA, S.A.
EE
Venlafaxine Liconsa, 37,5 mg toimeainet prolongeeritult vabastavad tabletid
SE/H/0581/001 553407 LABORATORIOS LICONSA, S.A.
EE
Venlafaxine Liconsa, 37,5 mg toimeainet prolongeeritult vabastavad tabletid
SE/H/0581/001 553407 LABORATORIOS LICONSA, S.A.
EE
Venlafaxine Liconsa, 37,5 mg toimeainet prolongeeritult vabastavad tabletid
SE/H/0581/001 553407 LABORATORIOS LICONSA, S.A.
EE
Venlafaxine Liconsa, 37,5 mg toimeainet prolongeeritult vabastavad tabletid
SE/H/0581/001 553407 LABORATORIOS LICONSA, S.A.
EE
Venlafaxine Liconsa, 75 mg toimeainet prolongeeritult vabastavad tabletid
SE/H/0581/002 553507 LABORATORIOS LICONSA, S.A.
EE
Venlafaxine Liconsa, 75 mg toimeainet prolongeeritult vabastavad tabletid
SE/H/0581/002 553507 LABORATORIOS LICONSA, S.A.
EE
List of nationally authorised medicinal products EMA/24903/2018 Page 89/117
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
Venlafaxine Liconsa, 75 mg toimeainet prolongeeritult vabastavad tabletid
SE/H/0581/002 553507 LABORATORIOS LICONSA, S.A.
EE
Venlafaxine Liconsa, 75 mg toimeainet prolongeeritult vabastavad tabletid
SE/H/0581/002 553507 LABORATORIOS LICONSA, S.A.
EE
VENLAFAXINE PFIZER L.P. 37,5 mg, gélule à libération prolongée
SE/H/0938/001 34009 346 617 6 1 PFIZER HOLDING FRANCE (S.C.A.)
FR
VENLAFAXINE PFIZER L.P. 37,5 mg, gélule à libération prolongée
SE/H/0938/001 34009 346 618 2 2 PFIZER HOLDING FRANCE (S.C.A.)
FR
VENLAFAXINE PFIZER L.P. 37,5 mg, gélule à libération prolongée
SE/H/0938/001 34009 346 619 9 0 PFIZER HOLDING FRANCE (S.C.A.)
FR
VENLAFAXINE PFIZER L.P. 75 mg, gélule à libération prolongée
SE/H/0938/002 34009 346 567 9 8 PFIZER HOLDING FRANCE (S.C.A.)
FR
VENLAFAXINE PFIZER L.P. 75 mg, gélule à libération prolongée
SE/H/0938/002 34009 346 566 2 0 PFIZER HOLDING FRANCE (S.C.A.)
FR
VENLAFAXINE PFIZER L.P. 75 mg, gélule à libération prolongée
SE/H/0938/002 34 009 346 568 5 9 PFIZER HOLDING FRANCE (S.C.A.)
FR
List of nationally authorised medicinal products EMA/24903/2018 Page 90/117
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
Venlafaxine SUN 150 mg tabletten met verlengde afgifte
NL/H/3948/003 RVG 105066 SUN PHARMACEUTICAL INDUSTRIES EUROPE B.V.
NL
Venlafaxine SUN 37,5 mg tabletten met verlengde afgifte
NL/H/3948/001 RVG 105061 SUN PHARMACEUTICAL INDUSTRIES EUROPE B.V.
NL
Venlafaxine SUN 75 mg tabletten met verlengde afgifte
NL/H/3948/002 RVG 105065 SUN PHARMACEUTICAL INDUSTRIES EUROPE B.V.
NL
Venlafaxine Teva 150 mg comprimés à libération prolongée
DE/H/3591/003 BE347365 TEVA PHARMA BELGIUM N.V./S.A
BE
Venlafaxine Teva 150 mg comprimés à libération prolongée
DE/H/3591/003 BE347356 TEVA PHARMA BELGIUM N.V./S.A
BE
VENLAFAXINE TEVA 150 mg RETARDTABLETTEN
DE/H/3591/003 BE347365 TEVA PHARMA BELGIUM N.V./S.A
BE
VENLAFAXINE TEVA 150 mg RETARDTABLETTEN
DE/H/3591/003 BE347356 TEVA PHARMA BELGIUM N.V./S.A
BE
Venlafaxine Teva 150 mg tabletten met verlengde afgifte
DE/H/3591/003 BE347356 TEVA PHARMA BELGIUM N.V./S.A
BE
Venlafaxine Teva 150 mg tabletten met verlengde afgifte
DE/H/3591/003 BE347365 TEVA PHARMA BELGIUM N.V./S.A
BE
List of nationally authorised medicinal products EMA/24903/2018 Page 91/117
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
Venlafaxine Teva 225 mg comprimés à libération prolongée
DE/H/3591/004 BE347374 TEVA PHARMA BELGIUM N.V./S.A
BE
Venlafaxine Teva 225 mg comprimés à libération prolongée
DE/H/3591/004 BE347383 TEVA PHARMA BELGIUM N.V./S.A
BE
VENLAFAXINE TEVA 225 mg RETARDTABLETTEN
DE/H/3591/004 BE347374 TEVA PHARMA BELGIUM N.V./S.A
BE
VENLAFAXINE TEVA 225 mg RETARDTABLETTEN
DE/H/3591/004 BE347383 TEVA PHARMA BELGIUM N.V./S.A
BE
Venlafaxine Teva 225 mg tabletten met verlengde afgifte
DE/H/3591/004 BE347374 TEVA PHARMA BELGIUM N.V./S.A
BE
Venlafaxine Teva 225 mg tabletten met verlengde afgifte
DE/H/3591/004 BE347383 TEVA PHARMA BELGIUM N.V./S.A
BE
Venlafaxine Teva 225 mg tabletten met verlengde afgifte
DE/H/3591/001 BE347313 TEVA PHARMA BELGIUM N.V./S.A
BE
Venlafaxine Teva 37,5 mg comprimés à libération prolongée
DE/H/3591/001 BE347313 TEVA PHARMA BELGIUM N.V./S.A
BE
Venlafaxine Teva 37,5 mg comprimés à libération prolongée
DE/H/3591/001 BE347322 TEVA PHARMA BELGIUM N.V./S.A
BE
List of nationally authorised medicinal products EMA/24903/2018 Page 92/117
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
VENLAFAXINE TEVA 37,5 mg RETARDTABLETTEN
DE/H/3591/001 BE347313 TEVA PHARMA BELGIUM N.V./S.A
BE
VENLAFAXINE TEVA 37,5 mg RETARDTABLETTEN
DE/H/3591/001 BE347322 TEVA PHARMA BELGIUM N.V./S.A
BE
Venlafaxine Teva 37,5 mg tabletten met verlengde afgifte
DE/H/3591/001 BE347322 TEVA PHARMA BELGIUM N.V./S.A
BE
Venlafaxine Teva 75 mg comprimés à libération prolongée
DE/H/3591/002 BE347331 TEVA PHARMA BELGIUM N.V./S.A
BE
Venlafaxine Teva 75 mg comprimés à libération prolongée
DE/H/3591/002 BE347347 TEVA PHARMA BELGIUM N.V./S.A
BE
VENLAFAXINE TEVA 75 mg RETARDTABLETTEN
DE/H/3591/002 BE347331 TEVA PHARMA BELGIUM N.V./S.A
BE
VENLAFAXINE TEVA 75 mg RETARDTABLETTEN
DE/H/3591/002 BE347347 TEVA PHARMA BELGIUM N.V./S.A
BE
Venlafaxine Teva 75 mg tabletten met verlengde afgifte
DE/H/3591/002 BE347331 TEVA PHARMA BELGIUM N.V./S.A
BE
Venlafaxine Teva 75 mg tabletten met verlengde afgifte
DE/H/3591/002 BE347347 TEVA PHARMA BELGIUM N.V./S.A
BE
List of nationally authorised medicinal products EMA/24903/2018 Page 93/117
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
Venlafaxine XR Pfizer 150 mg, capsules met verlengde afgifte, hard, 150 mg
SE/H/0938/003 RVG 107029 PFIZER B.V. NL
Venlafaxine XR Pfizer 37,5 mg, capsules met verlengde afgifte, hard, 37,5 mg
SE/H/0938/001 RVG 107027 PFIZER B.V. NL
Venlafaxine XR Pfizer 75 mg, capsules met verlengde afgifte, hard, 75 mg
SE/H/0938/002 RVG 107028 PFIZER B.V. NL
Venlafaxin-neuraxpharm 225 mg retard Retardtabletten
not available 73279.00.00 NEURAXPHARM ARZNEIMITTEL GMBH
DE
Venlafaxin-ratiopharm® 150 mg Retardtabletten
DE/H/3591/003 74542.00.00 RATIOPHARM GMBH DE
Venlafaxin-ratiopharm® 225 mg Retardtabletten
DE/H/3591/004 74543.00.00 RATIOPHARM GMBH DE
Venlafaxin-ratiopharm® 37,5 mg Retardtabletten
DE/H/3591/001 74540.00.00 RATIOPHARM GMBH DE
Venlafaxin-ratiopharm® 75 mg Retardtabletten
DE/H/3591/002 74541.00.00 RATIOPHARM GMBH DE
List of nationally authorised medicinal products EMA/24903/2018 Page 94/117
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
Venlalic XL 150 mg prolonged-release tablets
SE/H/0581/003 PA1969/001/002 ETHYPHARM UK LTD IE
Venlalic XL 150 mg prolonged-release tablets
SE/H/0581/003 PA1969/001/002 ETHYPHARM UK LTD IE
Venlalic XL 150 mg prolonged-release tablets
SE/H/0581/003 PL 42623/0019 ETHYPHARM UK LTD UK
Venlalic XL 150 mg prolonged-release tablets
SE/H/0581/003 PL 42623/0019 ETHYPHARM UK LTD UK
Venlalic XL 225 mg prolonged-release tablets
SE/H/0581/004 PA 1969/001/003 ETHYPHARM UK LTD IE
Venlalic XL 225 mg prolonged-release tablets
SE/H/0581/004 PA 1969/001/003 ETHYPHARM UK LTD IE
Venlalic XL 225 mg prolonged-release tablets
SE/H/0581/004 PL 42623/0020 ETHYPHARM UK LTD UK
Venlalic XL 225 mg prolonged-release tablets
SE/H/0581/004 PL 42623/0020 ETHYPHARM UK LTD UK
Venlalic XL 37.5 mg prolonged-release tablets
SE/H/0581/001 PA1969/001/004 ETHYPHARM UK LTD IE
List of nationally authorised medicinal products EMA/24903/2018 Page 95/117
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
Venlalic XL 37.5 mg prolonged-release tablets
SE/H/0581/001 PA1969/001/004 ETHYPHARM UK LTD IE
Venlalic XL 37.5 mg prolonged-release tablets
SE/H/0581/001 PL 42623/0017 ETHYPHARM UK LTD UK
Venlalic XL 37.5 mg prolonged-release tablets
SE/H/0581/001 PL 42623/0017 ETHYPHARM UK LTD UK
Venlalic XL 75 mg prolonged-release tablets
SE/H/0581/002 PA1969/001/001 ETHYPHARM UK LTD IE
Venlalic XL 75 mg prolonged-release tablets
SE/H/0581/002 PA1969/001/001 ETHYPHARM UK LTD IE
Venlalic XL 75 mg prolonged-release tablets
SE/H/0581/002 PL 42623/0018 ETHYPHARM UK LTD UK
Venlalic XL 75 mg prolonged-release tablets
SE/H/0581/002 PL 42623/0018 ETHYPHARM UK LTD UK
Venlaneo XL 150 mg Prolonged Release Capsules
not available PL 20417/0085 FANNIN (UK) LIMITED UK
Venlaneo XL 75 mg Prolonged Release Capsules
not available PL 20417/0087 FANNIN (UK) LIMITED UK
List of nationally authorised medicinal products EMA/24903/2018 Page 96/117
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
VENLAXIN 150 mg δισκία παρατεταμένης αποδέσμευσης
not available 021936 IASIS PHARMA CY
VENLAXIN 150 mg δισκία παρατεταμένης αποδέσμευσης
not available 108419/14/18-05-2015 IASIS PHARMA GR
VENLAXIN 225 mg δισκία παρατεταμένης αποδέσμευσης
not available 021937 IASIS PHARMA CY
VENLAXIN 225 mg δισκία παρατεταμένης αποδέσμευσης
not available 108419/14/18-05-2015 IASIS PHARMA GR
VENLAXIN 75 mg δισκία παρατεταμένης αποδέσμευσης
not available 021935 IASIS PHARMA CY
VENLAXIN 75 mg δισκία παρατεταμένης αποδέσμευσης
not available 108419/14/18-05-2015 IASIS PHARMA GR
Venlazid 150 mg depottabletter
SE/H/0582/002 16-11408 MEDICAL VALLEY INVEST AB NO
Venlazid 150 mg depottabletter
SE/H/0582/002 16-11408 MEDICAL VALLEY INVEST AB NO
Venlazid 225 mg depottabletter
SE/H/0582/003 16-11409 MEDICAL VALLEY INVEST AB NO
List of nationally authorised medicinal products EMA/24903/2018 Page 97/117
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
Venlazid 225 mg depottabletter
SE/H/0582/003 16-11409 MEDICAL VALLEY INVEST AB NO
Venlazid 75 mg depottabletter
SE/H/0582/001 16-11407 MEDICAL VALLEY INVEST AB NO
Venlazid 75 mg depottabletter
SE/H/0582/001 16-11407 MEDICAL VALLEY INVEST AB NO
Venxin 150 mg comprimidos de liberta ﾃｧ
ﾃ｣o prolongada
not available 5099635 DECOMED FARMACÊUTICA, S.A.
PT
Venxin 150 mg comprimidos de liberta ﾃｧ
ﾃ｣o prolongada
not available 5099643 DECOMED FARMACÊUTICA, S.A.
PT
Venxin 150 mg comprimidos de liberta ﾃｧ
ﾃ｣o prolongada
not available 5099577 DECOMED FARMACÊUTICA, S.A.
PT
Venxin 150 mg comprimidos de liberta ﾃｧ
ﾃ｣o prolongada
not available 5099601 DECOMED FARMACÊUTICA, S.A.
PT
Venxin 150 mg comprimidos de liberta ﾃｧ
ﾃ｣o prolongada
not available 5099619 DECOMED FARMACÊUTICA, S.A.
PT
Venxin 150 mg comprimidos de liberta ﾃｧ
ﾃ｣o prolongada
not available 5099627 DECOMED FARMACÊUTICA, S.A.
PT
List of nationally authorised medicinal products EMA/24903/2018 Page 98/117
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
Venxin 37,5 mg comprimidos de liberta ﾃｧ
ﾃ｣o prolongada
not available 5974795 DECOMED FARMACÊUTICA, S.A.
PT
Venxin 37,5 mg comprimidos de liberta ﾃｧ
ﾃ｣o prolongada
not available 5974894 DECOMED FARMACÊUTICA, S.A.
PT
Venxin 37,5 mg comprimidos de liberta ﾃｧ
ﾃ｣o prolongada
not available 5974993 DECOMED FARMACÊUTICA, S.A.
PT
Venxin 37,5 mg comprimidos de liberta ﾃｧ
ﾃ｣o prolongada
not available 5974696 DECOMED FARMACÊUTICA, S.A.
PT
Venxin 75 mg comprimidos de liberta ﾃｧ
ﾃ｣o prolongada
not available 5975594 DECOMED FARMACÊUTICA, S.A.
PT
Venxin 75 mg comprimidos de liberta ﾃｧ
ﾃ｣o prolongada
not available 5975693 DECOMED FARMACÊUTICA, S.A.
PT
Venxin 75 mg comprimidos de liberta ﾃｧ
ﾃ｣o prolongada
not available 5975792 DECOMED FARMACÊUTICA, S.A.
PT
Venxin 75 mg comprimidos de liberta ﾃｧ
ﾃ｣o prolongada
not available 5975495 DECOMED FARMACÊUTICA, S.A.
PT
VENZIP XL 37.5 mg prolonged-release capsules, hard
PT/H/0703/001 MA807/04601 AUROBINDO PHARMA (MALTA) LIMITED
MT
List of nationally authorised medicinal products EMA/24903/2018 Page 99/117
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
Zarelis 150 mg Compressa a rilascio prolungato
SE/H/0581/02/MR 038316218 ITALFARMACO S.P.A IT
Zarelis 150 mg Compressa a rilascio prolungato
SE/H/0581/02/MR 038316220 ITALFARMACO S.P.A IT
Zarelis 150 mg Compressa a rilascio prolungato
SE/H/0581/02/MR 038316232 ITALFARMACO S.P.A IT
Zarelis 150 mg Compressa a rilascio prolungato
SE/H/0581/02/MR 038316244 ITALFARMACO S.P.A IT
Zarelis 150 mg Compressa a rilascio prolungato
SE/H/0581/02/MR 038316257 ITALFARMACO S.P.A IT
Zarelis 150 mg Compressa a rilascio prolungato
SE/H/0581/02/MR 038316269 ITALFARMACO S.P.A IT
Zarelis 150 mg Compressa a rilascio prolungato
SE/H/0581/02/MR 038316271 ITALFARMACO S.P.A IT
Zarelis 150 mg Compressa a rilascio prolungato
SE/H/0581/02/MR 038316283 ITALFARMACO S.P.A IT
Zarelis 150 mg Compressa a rilascio prolungato
SE/H/0581/02/MR 038316295 ITALFARMACO S.P.A IT
List of nationally authorised medicinal products EMA/24903/2018 Page 100/117
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
Zarelis 150 mg Compressa a rilascio prolungato
SE/H/0581/02/MR 038316307 ITALFARMACO S.P.A IT
Zarelis 150 mg Compressa a rilascio prolungato
SE/H/0581/02/MR 038316319 ITALFARMACO S.P.A IT
Zarelis 150 mg Compressa a rilascio prolungato
SE/H/0581/02/MR 038316321 ITALFARMACO S.P.A IT
Zarelis 150 mg Compressa a rilascio prolungato
SE/H/0581/02/MR 038316333 ITALFARMACO S.P.A IT
Zarelis 150 mg Compressa a rilascio prolungato
SE/H/0581/02/MR 038316345 ITALFARMACO S.P.A IT
Zarelis 150 mg Compressa a rilascio prolungato
SE/H/0581/02/MR 038316358 ITALFARMACO S.P.A IT
Zarelis 150 mg Compressa a rilascio prolungato
SE/H/0581/02/MR 038316360 ITALFARMACO S.P.A IT
Zarelis 150 mg Compressa a rilascio prolungato
SE/H/0581/02/MR 038316372 ITALFARMACO S.P.A IT
Zarelis 150 mg Compressa a rilascio prolungato
SE/H/0581/02/MR 038316384 ITALFARMACO S.P.A IT
List of nationally authorised medicinal products EMA/24903/2018 Page 101/117
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
Zarelis 150 mg Compressa a rilascio prolungato
SE/H/0581/02/MR 038316396 ITALFARMACO S.P.A IT
Zarelis 150 mg Compressa a rilascio prolungato
SE/H/0581/02/MR 038316408 ITALFARMACO S.P.A IT
Zarelis 150 mg Compressa a rilascio prolungato
SE/H/0581/02/MR 038316218 ITALFARMACO S.P.A IT
Zarelis 150 mg Compressa a rilascio prolungato
SE/H/0581/02/MR 038316220 ITALFARMACO S.P.A IT
Zarelis 150 mg Compressa a rilascio prolungato
SE/H/0581/02/MR 038316232 ITALFARMACO S.P.A IT
Zarelis 150 mg Compressa a rilascio prolungato
SE/H/0581/02/MR 038316244 ITALFARMACO S.P.A IT
Zarelis 150 mg Compressa a rilascio prolungato
SE/H/0581/02/MR 038316257 ITALFARMACO S.P.A IT
Zarelis 150 mg Compressa a rilascio prolungato
SE/H/0581/02/MR 038316269 ITALFARMACO S.P.A IT
Zarelis 150 mg Compressa a rilascio prolungato
SE/H/0581/02/MR 038316271 ITALFARMACO S.P.A IT
List of nationally authorised medicinal products EMA/24903/2018 Page 102/117
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
Zarelis 150 mg Compressa a rilascio prolungato
SE/H/0581/02/MR 038316283 ITALFARMACO S.P.A IT
Zarelis 150 mg Compressa a rilascio prolungato
SE/H/0581/02/MR 038316295 ITALFARMACO S.P.A IT
Zarelis 150 mg Compressa a rilascio prolungato
SE/H/0581/02/MR 038316307 ITALFARMACO S.P.A IT
Zarelis 150 mg Compressa a rilascio prolungato
SE/H/0581/02/MR 038316319 ITALFARMACO S.P.A IT
Zarelis 150 mg Compressa a rilascio prolungato
SE/H/0581/02/MR 038316321 ITALFARMACO S.P.A IT
Zarelis 150 mg Compressa a rilascio prolungato
SE/H/0581/02/MR 038316333 ITALFARMACO S.P.A IT
Zarelis 150 mg Compressa a rilascio prolungato
SE/H/0581/02/MR 038316345 ITALFARMACO S.P.A IT
Zarelis 150 mg Compressa a rilascio prolungato
SE/H/0581/02/MR 038316358 ITALFARMACO S.P.A IT
Zarelis 150 mg Compressa a rilascio prolungato
SE/H/0581/02/MR 038316360 ITALFARMACO S.P.A IT
List of nationally authorised medicinal products EMA/24903/2018 Page 103/117
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
Zarelis 150 mg Compressa a rilascio prolungato
SE/H/0581/02/MR 038316372 ITALFARMACO S.P.A IT
Zarelis 150 mg Compressa a rilascio prolungato
SE/H/0581/02/MR 038316384 ITALFARMACO S.P.A IT
Zarelis 150 mg Compressa a rilascio prolungato
SE/H/0581/02/MR 038316396 ITALFARMACO S.P.A IT
Zarelis 150 mg Compressa a rilascio prolungato
SE/H/0581/02/MR 038316408 ITALFARMACO S.P.A IT
Zarelis 225 mg Compressa a rilascio prolungato
SE/H/0581/03/MR 038316410 ITALFARMACO S.P.A IT
Zarelis 225 mg Compressa a rilascio prolungato
SE/H/0581/03/MR 038316422 ITALFARMACO S.P.A IT
Zarelis 225 mg Compressa a rilascio prolungato
SE/H/0581/03/MR 038316434 ITALFARMACO S.P.A IT
Zarelis 225 mg Compressa a rilascio prolungato
SE/H/0581/03/MR 038316446 ITALFARMACO S.P.A IT
Zarelis 225 mg Compressa a rilascio prolungato
SE/H/0581/03/MR 038316459 ITALFARMACO S.P.A IT
List of nationally authorised medicinal products EMA/24903/2018 Page 104/117
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
Zarelis 225 mg Compressa a rilascio prolungato
SE/H/0581/03/MR 038316461 ITALFARMACO S.P.A IT
Zarelis 225 mg Compressa a rilascio prolungato
SE/H/0581/03/MR 038316473 ITALFARMACO S.P.A IT
Zarelis 225 mg Compressa a rilascio prolungato
SE/H/0581/03/MR 038316485 ITALFARMACO S.P.A IT
Zarelis 225 mg Compressa a rilascio prolungato
SE/H/0581/03/MR 038316497 ITALFARMACO S.P.A IT
Zarelis 225 mg Compressa a rilascio prolungato
SE/H/0581/03/MR 038316509 ITALFARMACO S.P.A IT
Zarelis 225 mg Compressa a rilascio prolungato
SE/H/0581/03/MR 038316511 ITALFARMACO S.P.A IT
Zarelis 225 mg Compressa a rilascio prolungato
SE/H/0581/03/MR 038316523 ITALFARMACO S.P.A IT
Zarelis 225 mg Compressa a rilascio prolungato
SE/H/0581/03/MR 038316535 ITALFARMACO S.P.A IT
Zarelis 225 mg Compressa a rilascio prolungato
SE/H/0581/03/MR 038316547 ITALFARMACO S.P.A IT
List of nationally authorised medicinal products EMA/24903/2018 Page 105/117
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
Zarelis 225 mg Compressa a rilascio prolungato
SE/H/0581/03/MR 038316550 ITALFARMACO S.P.A IT
Zarelis 225 mg Compressa a rilascio prolungato
SE/H/0581/03/MR 038316562 ITALFARMACO S.P.A IT
Zarelis 225 mg Compressa a rilascio prolungato
SE/H/0581/03/MR 038316574 ITALFARMACO S.P.A IT
Zarelis 225 mg Compressa a rilascio prolungato
SE/H/0581/03/MR 038316586 ITALFARMACO S.P.A IT
Zarelis 225 mg Compressa a rilascio prolungato
SE/H/0581/03/MR 038316598 ITALFARMACO S.P.A IT
Zarelis 225 mg Compressa a rilascio prolungato
SE/H/0581/03/MR 038316600 ITALFARMACO S.P.A IT
Zarelis 225 mg Compressa a rilascio prolungato
SE/H/0581/03/MR 038316410 ITALFARMACO S.P.A IT
Zarelis 225 mg Compressa a rilascio prolungato
SE/H/0581/03/MR 038316422 ITALFARMACO S.P.A IT
Zarelis 225 mg Compressa a rilascio prolungato
SE/H/0581/03/MR 038316434 ITALFARMACO S.P.A IT
List of nationally authorised medicinal products EMA/24903/2018 Page 106/117
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
Zarelis 225 mg Compressa a rilascio prolungato
SE/H/0581/03/MR 038316446 ITALFARMACO S.P.A IT
Zarelis 225 mg Compressa a rilascio prolungato
SE/H/0581/03/MR 038316459 ITALFARMACO S.P.A IT
Zarelis 225 mg Compressa a rilascio prolungato
SE/H/0581/03/MR 038316461 ITALFARMACO S.P.A IT
Zarelis 225 mg Compressa a rilascio prolungato
SE/H/0581/03/MR 038316473 ITALFARMACO S.P.A IT
Zarelis 225 mg Compressa a rilascio prolungato
SE/H/0581/03/MR 038316485 ITALFARMACO S.P.A IT
Zarelis 225 mg Compressa a rilascio prolungato
SE/H/0581/03/MR 038316497 ITALFARMACO S.P.A IT
Zarelis 225 mg Compressa a rilascio prolungato
SE/H/0581/03/MR 038316509 ITALFARMACO S.P.A IT
Zarelis 225 mg Compressa a rilascio prolungato
SE/H/0581/03/MR 038316511 ITALFARMACO S.P.A IT
Zarelis 225 mg Compressa a rilascio prolungato
SE/H/0581/03/MR 038316523 ITALFARMACO S.P.A IT
List of nationally authorised medicinal products EMA/24903/2018 Page 107/117
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
Zarelis 225 mg Compressa a rilascio prolungato
SE/H/0581/03/MR 038316535 ITALFARMACO S.P.A IT
Zarelis 225 mg Compressa a rilascio prolungato
SE/H/0581/03/MR 038316547 ITALFARMACO S.P.A IT
Zarelis 225 mg Compressa a rilascio prolungato
SE/H/0581/03/MR 038316550 ITALFARMACO S.P.A IT
Zarelis 225 mg Compressa a rilascio prolungato
SE/H/0581/03/MR 038316562 ITALFARMACO S.P.A IT
Zarelis 225 mg Compressa a rilascio prolungato
SE/H/0581/03/MR 038316574 ITALFARMACO S.P.A IT
Zarelis 225 mg Compressa a rilascio prolungato
SE/H/0581/03/MR 038316586 ITALFARMACO S.P.A IT
Zarelis 225 mg Compressa a rilascio prolungato
SE/H/0581/03/MR 038316598 ITALFARMACO S.P.A IT
Zarelis 225 mg Compressa a rilascio prolungato
SE/H/0581/03/MR 038316600 ITALFARMACO S.P.A IT
Zarelis 37,5 mg Compressa a rilascio prolungato
SE/H/0581/04/MR 038316612 ITALFARMACO S.P.A IT
List of nationally authorised medicinal products EMA/24903/2018 Page 108/117
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
Zarelis 37,5 mg Compressa a rilascio prolungato
SE/H/0581/04/MR 038316624 ITALFARMACO S.P.A IT
Zarelis 37,5 mg Compressa a rilascio prolungato
SE/H/0581/04/MR 038316636 ITALFARMACO S.P.A IT
Zarelis 37,5 mg Compressa a rilascio prolungato
SE/H/0581/04/MR 038316648 ITALFARMACO S.P.A IT
Zarelis 37,5 mg Compressa a rilascio prolungato
SE/H/0581/04/MR 038316651 ITALFARMACO S.P.A IT
Zarelis 37,5 mg Compressa a rilascio prolungato
SE/H/0581/04/MR 038316663 ITALFARMACO S.P.A IT
Zarelis 37,5 mg Compressa a rilascio prolungato
SE/H/0581/04/MR 038316675 ITALFARMACO S.P.A IT
Zarelis 37,5 mg Compressa a rilascio prolungato
SE/H/0581/04/MR 038316687 ITALFARMACO S.P.A IT
Zarelis 37,5 mg Compressa a rilascio prolungato
SE/H/0581/04/MR 038316699 ITALFARMACO S.P.A IT
Zarelis 37,5 mg Compressa a rilascio prolungato
SE/H/0581/04/MR 038316701 ITALFARMACO S.P.A IT
List of nationally authorised medicinal products EMA/24903/2018 Page 109/117
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
Zarelis 37,5 mg Compressa a rilascio prolungato
SE/H/0581/04/MR 038316713 ITALFARMACO S.P.A IT
Zarelis 37,5 mg Compressa a rilascio prolungato
SE/H/0581/04/MR 038316725 ITALFARMACO S.P.A IT
Zarelis 37,5 mg Compressa a rilascio prolungato
SE/H/0581/04/MR 038316737 ITALFARMACO S.P.A IT
Zarelis 37,5 mg Compressa a rilascio prolungato
SE/H/0581/04/MR 038316749 ITALFARMACO S.P.A IT
Zarelis 37,5 mg Compressa a rilascio prolungato
SE/H/0581/04/MR 038316752 ITALFARMACO S.P.A IT
Zarelis 37,5 mg Compressa a rilascio prolungato
SE/H/0581/04/MR 038316764 ITALFARMACO S.P.A IT
Zarelis 37,5 mg Compressa a rilascio prolungato
SE/H/0581/04/MR 038316776 ITALFARMACO S.P.A IT
Zarelis 37,5 mg Compressa a rilascio prolungato
SE/H/0581/04/MR 038316788 ITALFARMACO S.P.A IT
Zarelis 37,5 mg Compressa a rilascio prolungato
SE/H/0581/04/MR 038316790 ITALFARMACO S.P.A IT
List of nationally authorised medicinal products EMA/24903/2018 Page 110/117
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
Zarelis 37,5 mg Compressa a rilascio prolungato
SE/H/0581/04/MR 038316802 ITALFARMACO S.P.A IT
Zarelis 37,5 mg Compressa a rilascio prolungato
SE/H/0581/04/MR 038316612 ITALFARMACO S.P.A IT
Zarelis 37,5 mg Compressa a rilascio prolungato
SE/H/0581/04/MR 038316624 ITALFARMACO S.P.A IT
Zarelis 37,5 mg Compressa a rilascio prolungato
SE/H/0581/04/MR 038316636 ITALFARMACO S.P.A IT
Zarelis 37,5 mg Compressa a rilascio prolungato
SE/H/0581/04/MR 038316648 ITALFARMACO S.P.A IT
Zarelis 37,5 mg Compressa a rilascio prolungato
SE/H/0581/04/MR 038316651 ITALFARMACO S.P.A IT
Zarelis 37,5 mg Compressa a rilascio prolungato
SE/H/0581/04/MR 038316663 ITALFARMACO S.P.A IT
Zarelis 37,5 mg Compressa a rilascio prolungato
SE/H/0581/04/MR 038316675 ITALFARMACO S.P.A IT
Zarelis 37,5 mg Compressa a rilascio prolungato
SE/H/0581/04/MR 038316687 ITALFARMACO S.P.A IT
List of nationally authorised medicinal products EMA/24903/2018 Page 111/117
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
Zarelis 37,5 mg Compressa a rilascio prolungato
SE/H/0581/04/MR 038316699 ITALFARMACO S.P.A IT
Zarelis 37,5 mg Compressa a rilascio prolungato
SE/H/0581/04/MR 038316701 ITALFARMACO S.P.A IT
Zarelis 37,5 mg Compressa a rilascio prolungato
SE/H/0581/04/MR 038316713 ITALFARMACO S.P.A IT
Zarelis 37,5 mg Compressa a rilascio prolungato
SE/H/0581/04/MR 038316725 ITALFARMACO S.P.A IT
Zarelis 37,5 mg Compressa a rilascio prolungato
SE/H/0581/04/MR 038316737 ITALFARMACO S.P.A IT
Zarelis 37,5 mg Compressa a rilascio prolungato
SE/H/0581/04/MR 038316749 ITALFARMACO S.P.A IT
Zarelis 37,5 mg Compressa a rilascio prolungato
SE/H/0581/04/MR 038316752 ITALFARMACO S.P.A IT
Zarelis 37,5 mg Compressa a rilascio prolungato
SE/H/0581/04/MR 038316764 ITALFARMACO S.P.A IT
Zarelis 37,5 mg Compressa a rilascio prolungato
SE/H/0581/04/MR 038316776 ITALFARMACO S.P.A IT
List of nationally authorised medicinal products EMA/24903/2018 Page 112/117
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
Zarelis 37,5 mg Compressa a rilascio prolungato
SE/H/0581/04/MR 038316788 ITALFARMACO S.P.A IT
Zarelis 37,5 mg Compressa a rilascio prolungato
SE/H/0581/04/MR 038316790 ITALFARMACO S.P.A IT
Zarelis 37,5 mg Compressa a rilascio prolungato
SE/H/0581/04/MR 038316802 ITALFARMACO S.P.A IT
Zarelis 75 mg Compressa a rilascio prolungato
SE/H/0581/01/MR 038316016 ITALFARMACO S.P.A IT
Zarelis 75 mg Compressa a rilascio prolungato
SE/H/0581/01/MR 038316028 ITALFARMACO S.P.A IT
Zarelis 75 mg Compressa a rilascio prolungato
SE/H/0581/01/MR 038316030 ITALFARMACO S.P.A IT
Zarelis 75 mg Compressa a rilascio prolungato
SE/H/0581/01/MR 038316042 ITALFARMACO S.P.A IT
Zarelis 75 mg Compressa a rilascio prolungato
SE/H/0581/01/MR 038316055 ITALFARMACO S.P.A IT
Zarelis 75 mg Compressa a rilascio prolungato
SE/H/0581/01/MR 038316067 ITALFARMACO S.P.A IT
List of nationally authorised medicinal products EMA/24903/2018 Page 113/117
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
Zarelis 75 mg Compressa a rilascio prolungato
SE/H/0581/01/MR 038316079 ITALFARMACO S.P.A IT
Zarelis 75 mg Compressa a rilascio prolungato
SE/H/0581/01/MR 038316081 ITALFARMACO S.P.A IT
Zarelis 75 mg Compressa a rilascio prolungato
SE/H/0581/01/MR 038316093 ITALFARMACO S.P.A IT
Zarelis 75 mg Compressa a rilascio prolungato
SE/H/0581/01/MR 038316105 ITALFARMACO S.P.A IT
Zarelis 75 mg Compressa a rilascio prolungato
SE/H/0581/01/MR 038316117 ITALFARMACO S.P.A IT
Zarelis 75 mg Compressa a rilascio prolungato
SE/H/0581/01/MR 038316129 ITALFARMACO S.P.A IT
Zarelis 75 mg Compressa a rilascio prolungato
SE/H/0581/01/MR 038316131 ITALFARMACO S.P.A IT
Zarelis 75 mg Compressa a rilascio prolungato
SE/H/0581/01/MR 038316143 ITALFARMACO S.P.A IT
Zarelis 75 mg Compressa a rilascio prolungato
SE/H/0581/01/MR 038316156 ITALFARMACO S.P.A IT
List of nationally authorised medicinal products EMA/24903/2018 Page 114/117
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
Zarelis 75 mg Compressa a rilascio prolungato
SE/H/0581/01/MR 038316168 ITALFARMACO S.P.A IT
Zarelis 75 mg Compressa a rilascio prolungato
SE/H/0581/01/MR 038316170 ITALFARMACO S.P.A IT
Zarelis 75 mg Compressa a rilascio prolungato
SE/H/0581/01/MR 038316182 ITALFARMACO S.P.A IT
Zarelis 75 mg Compressa a rilascio prolungato
SE/H/0581/01/MR 038316194 ITALFARMACO S.P.A IT
Zarelis 75 mg Compressa a rilascio prolungato
SE/H/0581/01/MR 038316206 ITALFARMACO S.P.A IT
Zarelis 75 mg Compressa a rilascio prolungato
SE/H/0581/01/MR 038316016 ITALFARMACO S.P.A IT
Zarelis 75 mg Compressa a rilascio prolungato
SE/H/0581/01/MR 038316028 ITALFARMACO S.P.A IT
Zarelis 75 mg Compressa a rilascio prolungato
SE/H/0581/01/MR 038316030 ITALFARMACO S.P.A IT
Zarelis 75 mg Compressa a rilascio prolungato
SE/H/0581/01/MR 038316042 ITALFARMACO S.P.A IT
List of nationally authorised medicinal products EMA/24903/2018 Page 115/117
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
Zarelis 75 mg Compressa a rilascio prolungato
SE/H/0581/01/MR 038316055 ITALFARMACO S.P.A IT
Zarelis 75 mg Compressa a rilascio prolungato
SE/H/0581/01/MR 038316067 ITALFARMACO S.P.A IT
Zarelis 75 mg Compressa a rilascio prolungato
SE/H/0581/01/MR 038316079 ITALFARMACO S.P.A IT
Zarelis 75 mg Compressa a rilascio prolungato
SE/H/0581/01/MR 038316081 ITALFARMACO S.P.A IT
Zarelis 75 mg Compressa a rilascio prolungato
SE/H/0581/01/MR 038316093 ITALFARMACO S.P.A IT
Zarelis 75 mg Compressa a rilascio prolungato
SE/H/0581/01/MR 038316105 ITALFARMACO S.P.A IT
Zarelis 75 mg Compressa a rilascio prolungato
SE/H/0581/01/MR 038316117 ITALFARMACO S.P.A IT
Zarelis 75 mg Compressa a rilascio prolungato
SE/H/0581/01/MR 038316129 ITALFARMACO S.P.A IT
Zarelis 75 mg Compressa a rilascio prolungato
SE/H/0581/01/MR 038316131 ITALFARMACO S.P.A IT
List of nationally authorised medicinal products EMA/24903/2018 Page 116/117
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
Zarelis 75 mg Compressa a rilascio prolungato
SE/H/0581/01/MR 038316143 ITALFARMACO S.P.A IT
Zarelis 75 mg Compressa a rilascio prolungato
SE/H/0581/01/MR 038316156 ITALFARMACO S.P.A IT
Zarelis 75 mg Compressa a rilascio prolungato
SE/H/0581/01/MR 038316168 ITALFARMACO S.P.A IT
Zarelis 75 mg Compressa a rilascio prolungato
SE/H/0581/01/MR 038316170 ITALFARMACO S.P.A IT
Zarelis 75 mg Compressa a rilascio prolungato
SE/H/0581/01/MR 038316182 ITALFARMACO S.P.A IT
Zarelis 75 mg Compressa a rilascio prolungato
SE/H/0581/01/MR 038316194 ITALFARMACO S.P.A IT
Zarelis 75 mg Compressa a rilascio prolungato
SE/H/0581/01/MR 038316206 ITALFARMACO S.P.A IT
Zarelis Retard 150 mg comprimidos de liberación prolongada
SE/H/0564/003 69.738 ITALFARMACO S.A. ES
Zarelis Retard 150 mg comprimidos de liberación prolongada
SE/H/0564/003 69.738 ITALFARMACO S.A. ES
List of nationally authorised medicinal products EMA/24903/2018 Page 117/117
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
Zarelis Retard 225 mg comprimidos de liberación prolongada
SE/H/0564/004 69.739 ITALFARMACO S.A. ES
Zarelis Retard 225 mg comprimidos de liberación prolongada
SE/H/0564/004 69.739 ITALFARMACO S.A. ES
Zarelis Retard 75 mg comprimidos de liberación prolongada
SE/H/0564/002 69.737 ITALFARMACO S.A. ES
Zarelis Retard 75 mg comprimidos de liberación prolongada
SE/H/0564/002 69.737 ITALFARMACO S.A. ES
