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An agency of the European Union
Telephone +44 (0)20 3660 6000 Facsimile +44 (0)20 3660 5525 Send a question via our website www.ema.europa.eu/contact
© European Medic ines A gency, 2017. Reproduc tion is authorised provided the source is acknowledged.
26 October 2017 EMA/726434/2017 Human Medicines Evaluation Division
List of nationally authorised medicinal products
Active substance: amoxicillin
Procedure no.: PSUSA/00000187/201703
L is t of nationally authorised medicinal products EMA/726434/2017 P age 2/27
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number MAH of product in the Member State
Member State where product is authorised
Ospamox 250 mg – lösbare Tabletten
8331825 137432 SANDOZ GMBH AT
Ospamox 250 mg – lösbare Tabletten
8331825 137432 SANDOZ GMBH AT
Ospamox 500 mg – Filmtabletten
922.421 17.659 SANDOZ GMBH AT
Ospamox 750 mg – Filmtabletten
922.420 17.657 SANDOZ GMBH AT
Ospamox 1000 mg – Filmtabletten
922.419 17.653 SANDOZ GMBH AT
Ospamox 125 mg/5 ml - Pulver für orale Suspension
AT/H/0116/003 17.661 SANDOZ GMBH AT
Ospamox 500 mg/5 ml - Pulver für orale Suspension
AT/H/0116/005 1-24881 SANDOZ GMBH AT
Ospamox 500 mg - lösbare Tabletten
NL/H/0455/001 1-25540 SANDOZ GMBH AT
Ospamox 750 mg - lösbare Tabletten
NL/H/0455/002 1-25541 SANDOZ GMBH AT
Amoxicillin Sandoz 750 mg – Filmtabletten
AT/H/0187/002 1-28901 SANDOZ GMBH AT
Amoxicillin Sandoz 1000 mg – Filmtabletten
AT/H/0187/003 1-28902 SANDOZ GMBH AT
Amoxicillin Hexal 500 mg – Filmtabletten
AT/H/0188/001 1-28778 HEXAL PHARMA GMBH AT
Amoxicillin Hexal 750 mg – Filmtabletten
AT/H/0188/002 1-28779 HEXAL PHARMA GMBH AT
Amoxicillin Hexal 1000 mg – Filmtabletten
AT/H/0188/003 1-28780 HEXAL PHARMA GMBH AT
Amoxicillin 1A Pharma 500 mg – Filmtabletten
AT/H/0189/001 1-28793 1A PHARMA GMBH AT
Amoxicillin Sandoz 500 mg – Filmtabletten
AT/H/0187/001 1-28900 SANDOZ GMBH AT
L is t of nationally authorised medicinal products EMA/726434/2017 P age 3/27
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number MAH of product in the Member State
Member State where product is authorised
Amoxicillin 1A Pharma 750 mg - Filmtabletten
AT/H/0189/002 1-28794 1A PHARMA GMBH AT
Amoxicillin 1A Pharma 1000 mg – Filmtabletten
AT/H/0189/003 1-28795 1A PHARMA GMBH AT
Clamoxyl I.V./I.M. 1 g poeder en oplosmiddel voor oplossing voor injectie
not available BE109417 GLAXOSMITHKLINE PHARMACEUTICALS SA
BE
CLAMOXYL I.V./I.M. 1 g Pulver und Lösungsmittel zur Herstellung einer Injektionslösung
not available BE109417 GLAXOSMITHKLINE PHARMACEUTICALS SA
BE
Clamoxyl 250 mg/5 ml, poeder voor orale suspensie
FR/H/600/03/MR BE080577 GLAXOSMITHKLINE PHARMACEUTICALS SA
BE
Clamoxyl 250 mg/5 ml, Pulver zur Herstellung einer Suspension zum Einnehmen
FR/H/600/03/MR BE080577 GLAXOSMITHKLINE PHARMACEUTICALS SA
BE
Clamoxyl 125 mg/5 ml, poeder voor orale suspensie
FR/H/600/02/MR BE080595 GLAXOSMITHKLINE PHARMACEUTICALS SA
BE
Clamoxyl 125 mg/5 ml, Pulver zur Herstellung einer Suspension zum Einnehmen
FR/H/600/02/MR BE080595 GLAXOSMITHKLINE PHARMACEUTICALS SA
BE
Clamoxyl 1 g, dispergeerbare tabletten
FR/H/600/01/MR BE164306 GLAXOSMITHKLINE PHARMACEUTICALS SA
BE
Clamoxyl 1 g, Tabletten zur Herstellung einer Suspension zum Einnehmen
FR/H/0600/001 BE164306 GLAXOSMITHKLINE PHARMACEUTICALS SA
BE
Clamoxyl 500 mg, harde capsules
UK/H/6220/02 BE191807 GLAXOSMITHKLINE PHARMACEUTICALS SA
BE
L is t of nationally authorised medicinal products EMA/726434/2017 P age 4/27
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number MAH of product in the Member State
Member State where product is authorised
CLAMOXYL 500 mg Kapseln
UK/H/6220/02 BE191807 GLAXOSMITHKLINE PHARMACEUTICALS SA
BE
Clamoxyl 250 mg/5 ml, poudre pour suspension buvable
FR/H/600/03/MR BE080577 GLAXOSMITHKLINE PHARMACEUTICALS SA
BE
Clamoxyl I.V./I.M. 1 g, poudre pour solution injectable/pour perfusion
BE/H/0259/001 BE109417 GLAXOSMITHKLINE PHARMACEUTICALS SA
BE
Clamoxyl 125 mg/5 ml, poudre pour suspension buvable
FR/H/600/02/MR BE080595 GLAXOSMITHKLINE PHARMACEUTICALS SA
BE
Clamoxyl 500 mg, gélules
UK/H/6220/002 BE191807 GLAXOSMITHKLINE PHARMACEUTICALS SA
BE
Clamoxyl 1 g, comprimés dispersibles
FR/H/600/01/MR BE164306 GLAXOSMITHKLINE PHARMACEUTICALS SA
BE
Flemoxin 250 mg/5 ml Pulver zur Herstellung einer Suspension zum Einnehmen
not available BE126987 ASTELLAS PHARMA B.V., OFFICE BE
BE
Flemoxin Solutab 500 mg lösliche Tabletten
not available BE127005 ASTELLAS PHARMA B.V., OFFICE BE
BE
Flemoxin Solutab 1 g lösliche Tabletten
not available BE171805 ASTELLAS PHARMA B.V., OFFICE BE
BE
Flemoxin 250 mg/5 ml poeder voor orale suspensie
not available BE126987 ASTELLAS PHARMA B.V., OFFICE BE
BE
Flemoxin Solutab 500 mg oplosbare tabletten
not available BE127005 ASTELLAS PHARMA B.V., OFFICE BE
BE
Flemoxin Solutab 1 g oplosbare tabletten
not available BE171805 ASTELLAS PHARMA B.V., OFFICE BE
BE
Flemoxin Solutab, comprimés solubles à 1 g
not available BE171805 ASTELLAS PHARMA B.V., OFFICE BE
BE
Flemoxin Solutab, comprimés solubles à 500 mg
not available BE127005 ASTELLAS PHARMA B.V., OFFICE BE
BE
L is t of nationally authorised medicinal products EMA/726434/2017 P age 5/27
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number MAH of product in the Member State
Member State where product is authorised
Flemoxin 250 mg/5 ml poudre pour suspension buvable
not available BE126987 ASTELLAS PHARMA B.V., OFFICE BE
BE
Clamoxyl I.V./I.M. 1 g poeder en oplosmiddel voor oplossing voor injectie
not available BE109417 GLAXOSMITHKLINE PHARMACEUTICALS SA
BE
Clamoxyl 250 mg/5 ml, poeder voor orale suspensie
FR/H/600/03/MR BE080577 GLAXOSMITHKLINE PHARMACEUTICALS SA
BE
Clamoxyl 125 mg/5 ml, poeder voor orale suspensie
FR/H/600/02/MR BE080595 GLAXOSMITHKLINE PHARMACEUTICALS SA
BE
Clamoxyl 1 g, dispergeerbare tabletten
FR/H/600/01/MR BE164306 GLAXOSMITHKLINE PHARMACEUTICALS SA
BE
Clamoxyl 500 mg, harde capsules
UK/H/6220/02 BE191807 GLAXOSMITHKLINE PHARMACEUTICALS SA
BE
CLAMOXYL 500 mg Kapseln
UK/H/6220/02 BE191807 GLAXOSMITHKLINE PHARMACEUTICALS SA
BE
Clamoxyl I.V./I.M. 1 g, poudre pour solution injectable/pour perfusion
BE/H/0259/001 BE109417 GLAXOSMITHKLINE PHARMACEUTICALS SA
BE
Clamoxyl 500 mg, gélules
UK/H/6220/002 BE191807 GLAXOSMITHKLINE PHARMACEUTICALS SA
BE
Clamoxyl 1 g, comprimés dispersibles
FR/H/600/01/MR BE164306 GLAXOSMITHKLINE PHARMACEUTICALS SA
BE
Amoxil 500 mg καψάκια, σκληρά
UK/H/6220/02 19966 SMITHKLINE BEECHAM LTD CY
Amoxil Forte 250 mg/5 ml κόνις για πόσιμο εναιώρημα
FR/H/600/003 3617 SMITHKLINE BEECHAM LTD CY
Amoxil 500 mg καψάκια, σκληρά
UK/H/6220/02 19966 SMITHKLINE BEECHAM LTD CY
L is t of nationally authorised medicinal products EMA/726434/2017 P age 6/27
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number MAH of product in the Member State
Member State where product is authorised
Amoxil Forte 250 mg/5 ml κόνις για πόσιμο εναιώρημα
FR/H/600/003 3617 SMITHKLINE BEECHAM LTD CY
Amoxicillin Micro Labs 250 mg Filmtabletten
DE/H/4385/001 94792.00.00 MICRO LABS GMBH DE
Amoxicillin Micro Labs 250 mg Filmtabletten
DE/H/4385/001 94792.00.00 MICRO LABS GMBH DE
Amoxicillin Micro Labs 250 mg Filmtabletten
DE/H/4385/001 94792.00.00 MICRO LABS GMBH DE
Amoxicillin Micro Labs 250 mg Filmtabletten
DE/H/4385/001 94792.00.00 MICRO LABS GMBH DE
Amoxicillin Micro Labs 250 mg Filmtabletten
DE/H/4385/001 94792.00.00 MICRO LABS GMBH DE
Amoxicillin Micro Labs 250 mg Filmtabletten
DE/H/4385/001 94792.00.00 MICRO LABS GMBH DE
Amoxicillin Micro Labs 250 mg Filmtabletten
DE/H/4385/001 94792.00.00 MICRO LABS GMBH DE
Amoxicillin Micro Labs 250 mg Filmtabletten
DE/H/4385/001 94792.00.00 MICRO LABS GMBH DE
Amoxicillin Micro Labs 250 mg Filmtabletten
DE/H/4385/001 94792.00.00 MICRO LABS GMBH DE
Amoxicillin Micro Labs 250 mg Filmtabletten
DE/H/4385/001 94792.00.00 MICRO LABS GMBH DE
Amoxicillin Micro Labs 250 mg Filmtabletten
DE/H/4385/001 94792.00.00 MICRO LABS GMBH DE
Amoxicillin Micro Labs 250 mg Filmtabletten
DE/H/4385/001 94792.00.00 MICRO LABS GMBH DE
Amoxicillin Micro Labs 250 mg Filmtabletten
DE/H/4385/001 94792.00.00 MICRO LABS GMBH DE
Amoxicillin Micro Labs 250 mg Filmtabletten
DE/H/4385/001 94792.00.00 MICRO LABS GMBH DE
Amoxicillin Micro Labs 250 mg Filmtabletten
DE/H/4385/001 94792.00.00 MICRO LABS GMBH DE
L is t of nationally authorised medicinal products EMA/726434/2017 P age 7/27
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number MAH of product in the Member State
Member State where product is authorised
Amoxicillin Micro Labs 250 mg Filmtabletten
DE/H/4385/001 94792.00.00 MICRO LABS GMBH DE
Amoxicillin Micro Labs 250 mg Filmtabletten
DE/H/4385/001 94792.00.00 MICRO LABS GMBH DE
Amoxicillin Micro Labs 250 mg Filmtabletten
DE/H/4385/001 94792.00.00 MICRO LABS GMBH DE
Amoxicillin Micro Labs 250 mg Filmtabletten
DE/H/4385/001 94792.00.00 MICRO LABS GMBH DE
Amoxicillin Micro Labs 500 mg Filmtabletten
DE/H/4385/002 94793.00.00 MICRO LABS GMBH DE
Amoxicillin Micro Labs 500 mg Filmtabletten
DE/H/4385/002 94793.00.00 MICRO LABS GMBH DE
Amoxicillin Micro Labs 500 mg Filmtabletten
DE/H/4385/002 94793.00.00 MICRO LABS GMBH DE
Amoxicillin Micro Labs 500 mg Filmtabletten
DE/H/4385/002 94793.00.00 MICRO LABS GMBH DE
Amoxicillin Micro Labs 500 mg Filmtabletten
DE/H/4385/002 94793.00.00 MICRO LABS GMBH DE
Amoxicillin Micro Labs 500 mg Filmtabletten
DE/H/4385/002 94793.00.00 MICRO LABS GMBH DE
Amoxicillin Micro Labs 500 mg Filmtabletten
DE/H/4385/002 94793.00.00 MICRO LABS GMBH DE
Amoxicillin Micro Labs 500 mg Filmtabletten
DE/H/4385/002 94793.00.00 MICRO LABS GMBH DE
Amoxicillin Micro Labs 500 mg Filmtabletten
DE/H/4385/002 94793.00.00 MICRO LABS GMBH DE
Amoxicillin Micro Labs 500 mg Filmtabletten
DE/H/4385/002 94793.00.00 MICRO LABS GMBH DE
Amoxicillin Micro Labs 500 mg Filmtabletten
DE/H/4385/002 94793.00.00 MICRO LABS GMBH DE
Amoxicillin Micro Labs 500 mg Filmtabletten
DE/H/4385/002 94793.00.00 MICRO LABS GMBH DE
Amoxicillin Micro Labs 500 mg Filmtabletten
DE/H/4385/002 94793.00.00 MICRO LABS GMBH DE
L is t of nationally authorised medicinal products EMA/726434/2017 P age 8/27
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number MAH of product in the Member State
Member State where product is authorised
Amoxicillin Micro Labs 500 mg Filmtabletten
DE/H/4385/002 94793.00.00 MICRO LABS GMBH DE
Amoxicillin Micro Labs 500 mg Filmtabletten
DE/H/4385/002 94793.00.00 MICRO LABS GMBH DE
Amoxicillin Micro Labs 500 mg Filmtabletten
DE/H/4385/002 94793.00.00 MICRO LABS GMBH DE
Amoxicillin Micro Labs 500 mg Filmtabletten
DE/H/4385/002 94793.00.00 MICRO LABS GMBH DE
Amoxicillin Micro Labs 500 mg Filmtabletten
DE/H/4385/002 94793.00.00 MICRO LABS GMBH DE
Amoxicillin Micro Labs 500 mg Filmtabletten
DE/H/4385/002 94793.00.00 MICRO LABS GMBH DE
Amoxicillin Micro Labs 750 mg Filmtabletten
DE/H/4385/003 94794.00.00 MICRO LABS GMBH DE
Amoxicillin Micro Labs 750 mg Filmtabletten
DE/H/4385/003 94794.00.00 MICRO LABS GMBH DE
Amoxicillin Micro Labs 750 mg Filmtabletten
DE/H/4385/003 94794.00.00 MICRO LABS GMBH DE
Amoxicillin Micro Labs 750 mg Filmtabletten
DE/H/4385/003 94794.00.00 MICRO LABS GMBH DE
Amoxicillin Micro Labs 750 mg Filmtabletten
DE/H/4385/003 94794.00.00 MICRO LABS GMBH DE
Amoxicillin Micro Labs 750 mg Filmtabletten
DE/H/4385/003 94794.00.00 MICRO LABS GMBH DE
Amoxicillin Micro Labs 750 mg Filmtabletten
DE/H/4385/003 94794.00.00 MICRO LABS GMBH DE
Amoxicillin Micro Labs 750 mg Filmtabletten
DE/H/4385/003 94794.00.00 MICRO LABS GMBH DE
Amoxicillin Micro Labs 750 mg Filmtabletten
DE/H/4385/003 94794.00.00 MICRO LABS GMBH DE
Amoxicillin Micro Labs 750 mg Filmtabletten
DE/H/4385/003 94794.00.00 MICRO LABS GMBH DE
Amoxicillin Micro Labs 750 mg Filmtabletten
DE/H/4385/003 94794.00.00 MICRO LABS GMBH DE
L is t of nationally authorised medicinal products EMA/726434/2017 P age 9/27
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number MAH of product in the Member State
Member State where product is authorised
Amoxicillin Micro Labs 750 mg Filmtabletten
DE/H/4385/003 94794.00.00 MICRO LABS GMBH DE
Amoxicillin Micro Labs 750 mg Filmtabletten
DE/H/4385/003 94794.00.00 MICRO LABS GMBH DE
Amoxicillin Micro Labs 750 mg Filmtabletten
DE/H/4385/003 94794.00.00 MICRO LABS GMBH DE
Amoxicillin Micro Labs 750 mg Filmtabletten
DE/H/4385/003 94794.00.00 MICRO LABS GMBH DE
Amoxicillin Micro Labs 750 mg Filmtabletten
DE/H/4385/003 94794.00.00 MICRO LABS GMBH DE
Amoxicillin Micro Labs 750 mg Filmtabletten
DE/H/4385/003 94794.00.00 MICRO LABS GMBH DE
Amoxicillin Micro Labs 750 mg Filmtabletten
DE/H/4385/003 94794.00.00 MICRO LABS GMBH DE
Amoxicillin Micro Labs 750 mg Filmtabletten
DE/H/4385/003 94794.00.00 MICRO LABS GMBH DE
Helicomp® Sandoz®, 20 mg/1000 mg/500 mg magensaftresistente Hartkapseln/Filmtabletten
not available 63912.00.00 HEXAL AG DE
OMEP Plus Amoxicillin + Clarithromycin
not available 65160.00.00 HEXAL AG DE
Imacillin, granulat til oral suspension
not available 11372 MEDA AS DK
Imacillin, opløselige tabletter
not available 15288 MEDA AS DK
Imacillin, opløselige tabletter
not available 15289 MEDA AS DK
Imacillin, opløselige tabletter
not available 15290 MEDA AS DK
Imacillin, opløselige tabletter
not available 15291 MEDA AS DK
Imacillin, opløselige tabletter
not available 16713 MEDA AS DK
L is t of nationally authorised medicinal products EMA/726434/2017 P age 10/27
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number MAH of product in the Member State
Member State where product is authorised
AMITRÓN® 250 mg/5 ml Suspensión extemporánea
not available 54.625 LDP LABORATORIOS TORLAN, S.A.
ES
Clamoxyl 500 mg cápsulas
not available 50.239 GLAXOSMITHKLINE S.A. ES
CLAMOXYL 1 g intramuscular
not available 55522 GLAXOSMITHKLINE, S.A. ES
Clamoxyl 250 mg polvo para suspensión oral en sobre
not available 50.944 GLAXOSMITHKLINE S.A. ES
Clamoxyl 1 g polvo para suspensión oral en sobre
not available 59.132 GLAXOSMITHKLINE S.A. ES
Clamoxyl 250 mg/5 ml polvo para suspensión oral en frasco
not available 52.015 GLAXOSMITHKLINE S.A. ES
Clamoxyl 1 g comprimidos
FR/H/600/01 59.133 GLAXOSMITHKLINE S.A. ES
Clamoxyl 750 mg comprimidos
not available 51.426 GLAXOSMITHKLINE S.A. ES
Clamoxyl 500 mg polvo para suspensión oral en sobre
not available 58.840 GLAXOSMITHKLINE S.A. ES
AMITRÓN® 500 mg Inyectable
not available 56.265 LDP LABORATORIOS TORLAN, S.A.
ES
AMITRÓN® 1g Inyectable
not available 56.266 LDP LABORATORIOS TORLAN, S.A.
ES
AMITRÓN® 250 mg Inyectable
not available 56.264 LDP LABORATORIOS TORLAN, S.A.
ES
AMITRÓN® 500 mg Cápsulas
not available 54.626 LDP LABORATORIOS TORLAN, S.A.
ES
Clamoxyl 500 mg cápsulas
not available 50.239 GLAXOSMITHKLINE S.A. ES
CLAMOXYL 1 g intramuscular
not available 55522 GLAXOSMITHKLINE, S.A. ES
L is t of nationally authorised medicinal products EMA/726434/2017 P age 11/27
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number MAH of product in the Member State
Member State where product is authorised
Clamoxyl 250 mg polvo para suspensión oral en sobre
not available 50.944 GLAXOSMITHKLINE S.A. ES
Clamoxyl 1 g polvo para suspensión oral en sobre
not available 59.132 GLAXOSMITHKLINE S.A. ES
Clamoxyl 1 g comprimidos
FR/H/600/01 59.133 GLAXOSMITHKLINE S.A. ES
Clamoxyl 750 mg comprimidos
not available 51.426 GLAXOSMITHKLINE S.A. ES
AMOXICILLINE SANDOZ 500 mg, gélule
NL 21558 34009 367 960 1 0 SANDOZ FR
HICONCIL 500 mg, gélule
not available 316 122-9 BRISTOL-MYERS SQUIBB FR
HICONCIL 500 mg, gélule
not available 316 121-2 BRISTOL-MYERS SQUIBB FR
HICONCIL 500 mg, gélule
not available 316 123-5 BRISTOL-MYERS SQUIBB FR
HICONCIL 500 mg, gélule
not available 553 445-6 BRISTOL-MYERS SQUIBB FR
HICONCIL 500 mg, gélule
not available 554 346-1 BRISTOL-MYERS SQUIBB FR
HICONCIL 500 mg, gélule
not available 342 243-4 BRISTOL-MYERS SQUIBB FR
HICONCIL 125 mg /5 ml, pour poudre suspension buvable
not available 3400931703464 BRISTOL-MYERS SQUIBB FR
HICONCIL 250 mg /5 ml, pour poudre suspension buvable
not available 3400931761594 BRISTOL-MYERS SQUIBB FR
HICONCIL 500 mg /5 ml, pour poudre suspension buvable
not available 3400932026616 BRISTOL-MYERS SQUIBB FR
CLAMOXYL 1 g, poudre et solvant pour solution injectable (IM)
not available VNL11851 LABORATOIRE GLAXOSMITHKLINE
FR
L is t of nationally authorised medicinal products EMA/726434/2017 P age 12/27
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number MAH of product in the Member State
Member State where product is authorised
CLAMOXYL 2 g, poudre pour solution injectable (IV)
not available VNL11492 LABORATOIRE GLAXOSMITHKLINE
FR
CLAMOXYL 500 mg, poudre pour solution injectable (IM, IV)
not available VNL11494-1 LABORATOIRE GLAXOSMITHKLINE
FR
CLAMOXYL 1 g, poudre pour solution injectable (IM - IV)
not available VNL11491-1 LABORATOIRE GLAXOSMITHKLINE
FR
CLAMOXYL 125 mg/5 ml, poudre pour suspension buvable
not available VNL11074 LABORATOIRE GLAXOSMITHKLINE
FR
CLAMOXYL 250 mg/5 ml, poudre pour suspension buvable
not available VNL11075 LABORATOIRE GLAXOSMITHKLINE
FR
CLAMOXYL 1 g, comprimé dispersible
not available NL15119 LABORATOIRE GLAXOSMITHKLINE
FR
CLAMOXYL 1 g, poudre pour suspension buvable en sachet-dose
not available NL15559 LABORATOIRE GLAXOSMITHKLINE
FR
CLAMOXYL 500 mg/5 ml, poudre pour suspension buvable
not available VNL11666 LABORATOIRE GLAXOSMITHKLINE
FR
CLAMOXYL 500 mg, gélule
not available VNL9721 LABORATOIRE GLAXOSMITHKLINE
FR
CLAMOXYL 1 g, poudre et solvant pour solution injectable (IM)
not available VNL11851 LABORATOIRE GLAXOSMITHKLINE
FR
CLAMOXYL 2 g, poudre pour solution injectable (IV)
not available VNL11492 LABORATOIRE GLAXOSMITHKLINE
FR
CLAMOXYL 500 mg, poudre pour solution injectable (IM, IV)
not available VNL11494-1 LABORATOIRE GLAXOSMITHKLINE
FR
L is t of nationally authorised medicinal products EMA/726434/2017 P age 13/27
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number MAH of product in the Member State
Member State where product is authorised
CLAMOXYL 1 g, poudre pour solution injectable (IM - IV)
not available VNL11491-1 LABORATOIRE GLAXOSMITHKLINE
FR
CLAMOXYL 125 mg/5 ml, poudre pour suspension buvable
not available VNL11074 LABORATOIRE GLAXOSMITHKLINE
FR
CLAMOXYL 250 mg/5 ml, poudre pour suspension buvable
not available VNL11075 LABORATOIRE GLAXOSMITHKLINE
FR
CLAMOXYL 1 g, comprimé dispersible
not available NL15119 LABORATOIRE GLAXOSMITHKLINE
FR
CLAMOXYL 1 g, poudre pour suspension buvable en sachet-dose
not available NL15559 LABORATOIRE GLAXOSMITHKLINE
FR
CLAMOXYL 500 mg/5 ml, poudre pour suspension buvable
not available VNL11666 LABORATOIRE GLAXOSMITHKLINE
FR
CLAMOXYL 500 mg, gélule
not available VNL9721 LABORATOIRE GLAXOSMITHKLINE
FR
AMOXICILLINE BIOGARAN 500 mg, gélule
not available 3400933856731 BIOGARAN FR
AMOXICILLINE BIOGARAN 500 mg, gélule
not available 3400933857042 BIOGARAN FR
AMOXICILLINE BIOGARAN 500 mg, gélule
not available 3400933856960 BIOGARAN FR
AMOXICILLINE BIOGARAN 500 mg, gélule
not available 3400933857103 BIOGARAN FR
AMOXICILLINE BIOGARAN 500 mg, gélule
not available 3400933857271 BIOGARAN FR
L is t of nationally authorised medicinal products EMA/726434/2017 P age 14/27
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number MAH of product in the Member State
Member State where product is authorised
AMOXICILLINE SANDOZ 125 mg/5 ml, poudre pour suspension buvable
NL 21556 368 829-6 SANDOZ FR
AMOXICILLINE SANDOZ 250 mg/5 ml, poudre pour suspension buvable
NL 21557 365 824-3 SANDOZ FR
AMOXICILLINE SANDOZ 500 mg, gélule
NL 21558 34009 367 960 1 0 SANDOZ FR
AMOXICILLINE RPG 250 mg/5 ml, poudre pour suspension buvable en flacon
not available NL 21 383 RANBAXY PHARMACIE GENERIQUES
FR
AMOXICILLINE RPG 500 mg/5 ml, poudre pour suspension buvable en flacon
not available NL 21 384 RANBAXY PHARMACIE GENERIQUES
FR
Amoxil 500 mg/5 ml κόνις για πόσιμο εναιώρημα
FR/H/600/04/MR 0933603 GLAXOSMITHKLINE AEBE GR
AMOXIL FR/H/0600/001 85885/11/16-02-2012 GLAXOSMITHKLINE AEBE GR AMOXIL UK/H/6220/02 49566/23-06-2014 GLAXOSMITHKLINE AEBE GR Amoxil 250 mg/5 ml κόνις για πόσιμο εναιώρημα
FR/H/600/03/MR 0933602 GLAXOSMITHKLINE AEBE GR
Amoxil 1 g κόνις για ενέσιμο διάλυμα ή διάλυμα προς έγχυση
BE/H/0259/001 0933607 GLAXOSMITHKLINE AEBE GR
AMOXIL FR/H/0600/001 85885/11/16-02-2012 GLAXOSMITHKLINE AEBE GR AMOXIL UK/H/6220/02 49566/23-06-2014 GLAXOSMITHKLINE AEBE GR Amoxil 250 mg/5 ml κόνις για πόσιμο εναιώρημα
FR/H/600/03/MR 0933602 GLAXOSMITHKLINE AEBE GR
Duomox 1000 mg tabletta
not available OGYI-T-5460/05 ASTELLAS PHARMA KFT HU
Duomox 250 mg tabletta not available OGYI-T-5460/01 ASTELLAS PHARMA KFT HU
L is t of nationally authorised medicinal products EMA/726434/2017 P age 15/27
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number MAH of product in the Member State
Member State where product is authorised
Duomox 500 mg tabletta not available OGYI-T-5460/03 ASTELLAS PHARMA KFT HU Duomox 750 mg tabletta not available OGYI-T-5460/04 ASTELLAS PHARMA KFT HU Oramox (Amoxicillin Oral Suspension BP) 125mg / 5ml
not available PA0298/019/001 ATHLONE LABORATORIES LIMITED
IE
Oramox (Amoxicillin Oral Suspension BP) 250mg/5ml
not available PA0298/019/002 ATHLONE LABORATORIES LIMITED
IE
Oramox 250mg Hard Capsules
not available PA0298/019/003 ATHLONE LABORATORIES LIMITED
IE
Oramox 500mg Hard Capsules
not available PA0298/019/004 ATHLONE LABORATORIES LIMITED
IE
Amoxil 3g Powder for Oral Suspension Sachets
UK/H/6220/07 PA 1077/33/6 GLAXOSMITHKLINE (IRELAND) LIMITED
IE
Amoxil Vials 500mg, powder for solution for injection or infusion
UK/H/6220/05 PA 1077/33/4 GLAXOSMITHKLINE (IRELAND) LIMITED
IE
Amoxil Paediatric 125mg/1.25ml Powder for Oral Suspension
UK/H/6220/03 PA 1077/33/5 GLAXOSMITHKLINE (IRELAND) LIMITED
IE
Amoxil 3g Powder for Oral Suspension Sachets
UK/H/6220/07 PA 1077/33/6 GLAXOSMITHKLINE (IRELAND) LIMITED
IE
Amoxil Vials 500mg, powder for solution for injection or infusion
UK/H/6220/05 PA 1077/33/4 GLAXOSMITHKLINE (IRELAND) LIMITED
IE
Amoxil Paediatric 125mg/1.25ml Powder for Oral Suspension
UK/H/6220/03 PA 1077/33/5 GLAXOSMITHKLINE (IRELAND) LIMITED
IE
Amoxicillin 250 mg/5 ml powder for oral suspension
not available PA0126/282/004 CLONMEL HEALTHCARE LTD. IE
Amoxicillin 250 mg hard capsules
not available PA0126/282/001 CLONMEL HEALTHCARE LTD. IE
L is t of nationally authorised medicinal products EMA/726434/2017 P age 16/27
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number MAH of product in the Member State
Member State where product is authorised
Amoxicillin 125mg / 5ml powder for oral suspension
not available PA0126/282/003 CLONMEL HEALTHCARE LTD. IE
Amoxicillin 125mg / 5ml powder for oral suspension
not available PA0126/282/003 CLONMEL HEALTHCARE LTD. IE
Amoxicillin 250 mg/5 ml powder for oral suspension
not available PA0126/282/004 CLONMEL HEALTHCARE LTD. IE
Amoxicillin 500 mg hard capsules
not available PA0126/282/002 CLONMEL HEALTHCARE LTD. IE
Amoxicillin 250 mg hard capsules
not available PA0126/282/001 CLONMEL HEALTHCARE LTD. IE
Amoxicillin 500 mg hard capsules
not available PA0126/282/002 CLONMEL HEALTHCARE LTD. IE
Amoxicillin Sandoz 100 mg/ml mixtúruduft, dreifa
AT/H/0116/005 IS/1/15/062/01 SANDOZ A/S IS
SINTOPEN “ 250 MG/5 ML GRANULATO PER SOSPENSIONE ORALE”
not available 023053135 MAGIS FARMACEUTICI SRL IT
SINTOPEN " 1 G COMPRESSE"
not available 023053123 MAGIS FARMACEUTICI SRL IT
ZIMOX 1 g compresse solubili e masticabili
not available 023086174 PFIZER ITALIA S.R.L. IT
ZIMOX 500 mg capsule rigide
not available 023086061 PFIZER ITALIA S.R.L. IT
ZIMOX 500 mg compresse solubili e masticabili
not available 023086162 PFIZER ITALIA S.R.L. IT
ZIMOX 1 g compresse not available 023086150 PFIZER ITALIA S.R.L. IT ZIMOX 250 mg/5 ml polvere per sospensione orale
not available 023086097 PFIZER ITALIA S.R.L. IT
L is t of nationally authorised medicinal products EMA/726434/2017 P age 17/27
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number MAH of product in the Member State
Member State where product is authorised
ZIMOX 100 mg/ml gocce orali, sospensione
not available 023086186 PFIZER ITALIA S.R.L. IT
Amoxina 1 g compresse dispersibili
not available 023966094 AESCULAPIUS FARMACEUTICI S.R.L.
IT
Amoxina 1 g compresse dispersibili
not available 023966118 AESCULAPIUS FARMACEUTICI S.R.L.
IT
Amoxina 250mg/5ml granulato per sospensione orale
not available 023966106 AESCULAPIUS FARMACEUTICI S.R.L.
IT
Amoxina 250mg/5ml granulato per sospensione orale
not available 023966082 AESCULAPIUS FARMACEUTICI S.R.L.
IT
VELAMOX 1 g compresse dispersibili
not available 023097102 MEDIOLANUM FARMACEUTICI SPA
IT
VELAMOX 250 mg/7 ml polvere per sospensione orale
not available 023097037 MEDIOLANUM FARMACEUTICI SPA
IT
VELAMOX 500 mg capsule rigide
not available 023097013 MEDIOLANUM FARMACEUTICI SPA
IT
Amoxil 1 g disperguojamosios tabletės
FR/H/0600/001 LT/1/04/0031/006 BEECHAM GROUP PLC LT
Amoxil 250 mg/5 ml milteliai geriamajai suspensijai
FR/H/600/003 LT/1/04/0031/001 BEECHAM GROUP PLC LT
Amoxil 1 g disperguojamosios tabletės
FR/H/0600/001 LT/1/04/0031/004 BEECHAM GROUP PLC LT
Amoxil 1 g disperguojamosios tabletės
FR/H/0600/001 LT/1/04/0031/005 BEECHAM GROUP PLC LT
Amoxil 500 mg kietos kapsulės
UK/H/6220/02 LT/1/04/0031/002 BEECHAM GROUP PLC LT
Amoxil 500 mg kietos kapsules
UK/H/6220/02 LT/1/04/0031/003 BEECHAM GROUP PLC LT
L is t of nationally authorised medicinal products EMA/726434/2017 P age 18/27
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number MAH of product in the Member State
Member State where product is authorised
Amoxil 1 g disperguojamosios tabletės
FR/H/0600/001 LT/1/04/0031/006 BEECHAM GROUP PLC LT
Amoxil 250 mg/5 ml milteliai geriamajai suspensijai
FR/H/600/003 LT/1/04/0031/001 BEECHAM GROUP PLC LT
Amoxil 1 g disperguojamosios tabletės
FR/H/0600/001 LT/1/04/0031/004 BEECHAM GROUP PLC LT
Amoxil 1 g disperguojamosios tabletės
FR/H/0600/001 LT/1/04/0031/005 BEECHAM GROUP PLC LT
Amoxil 500 mg kietos kapsulės
UK/H/6220/02 LT/1/04/0031/002 BEECHAM GROUP PLC LT
Amoxil 500 mg kietos kapsules
UK/H/6220/02 LT/1/04/0031/003 BEECHAM GROUP PLC LT
Clamoxyl I.V./I.M. 1 g poeder en oplosmiddel voor oplossing voor injectie
not available 260/08 10 0038 GLAXOSMITHKLINE PHARMACEUTICALS SA
LU
CLAMOXYL I.V./I.M. 1 g Pulver und Lösungsmittel zur Herstellung einer Injektionslösung
not available 260/08 10 0038 GLAXOSMITHKLINE PHARMACEUTICALS SA
LU
Clamoxyl 1 g, dispergeerbare tabletten
FR/H/600/01 2008 10 0030 GLAXOSMITHKLINE PHARMACEUTICALS SA
LU
Clamoxyl 1 g, Tabletten zur Herstellung einer Suspension zum Einnehmen
FR/H/0600/001 2008 10 0030 GLAXOSMITHKLINE PHARMACEUTICALS SA
LU
Clamoxyl 500 mg capsules
not available 260/08 10 0031 GLAXOSMITHKLINE PHARMACEUTICALS SA
LU
CLAMOXYL 500 mg Kapseln
not available 260/08 10 0031 GLAXOSMITHKLINE PHARMACEUTICALS SA
LU
L is t of nationally authorised medicinal products EMA/726434/2017 P age 19/27
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number MAH of product in the Member State
Member State where product is authorised
Clamoxyl 125 mg/5 ml, Pulver zur Herstellung einer Suspension zum Einnehmen
FR/H/600/02/MR 0260/08100032 GLAXOSMITHKLINE PHARMACEUTICALS SA
LU
Clamoxyl 250 mg/5 ml, Pulver zur Herstellung einer Suspension zum Einnehmen
FR/H/600/03/MR 0260/08100033 GLAXOSMITHKLINE PHARMACEUTICALS SA
LU
Clamoxyl 125 mg/5 ml, poudre pour suspension buvable
FR/H/600/02/MR 0260/08100032 GLAXOSMITHKLINE PHARMACEUTICALS SA
LU
Clamoxyl 250 mg/5 ml, poudre pour suspension buvable
FR/H/600/03/MR 0260/08100033 GLAXOSMITHKLINE PHARMACEUTICALS SA
LU
Clamoxyl I.V./I.M. 1 g, poudre pour solution injectable/pour perfusion
BE/H/0259/001 260/08 10 0038 GLAXOSMITHKLINE PHARMACEUTICALS SA
LU
Clamoxyl 500 mg, gélules
not available 260/08 10 0031 GLAXOSMITHKLINE PHARMACEUTICALS SA
LU
Clamoxyl 1 g, comprimés dispersibles
FR/H/600/01/MR 2008 10 0030 GLAXOSMITHKLINE PHARMACEUTICALS SA
LU
CLAMOXYL I.V./I.M. 1 g Pulver und Lösungsmittel zur Herstellung einer Injektionslösung
not available 260/08 10 0038 GLAXOSMITHKLINE PHARMACEUTICALS SA
LU
Clamoxyl 500 mg capsules
not available 260/08 10 0031 GLAXOSMITHKLINE PHARMACEUTICALS SA
LU
CLAMOXYL 500 mg Kapseln
not available 260/08 10 0031 GLAXOSMITHKLINE PHARMACEUTICALS SA
LU
Clamoxyl 125 mg/5 ml, Pulver zur Herstellung einer Suspension zum Einnehmen
FR/H/600/02/MR 0260/08100032 GLAXOSMITHKLINE PHARMACEUTICALS SA
LU
L is t of nationally authorised medicinal products EMA/726434/2017 P age 20/27
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number MAH of product in the Member State
Member State where product is authorised
Clamoxyl 250 mg/5 ml, poudre pour suspension buvable
FR/H/600/03/MR 0260/08100033 GLAXOSMITHKLINE PHARMACEUTICALS SA
LU
Clamoxyl I.V./I.M. 1 g, poudre pour solution injectable/pour perfusion
BE/H/0259/001 260/08 10 0038 GLAXOSMITHKLINE PHARMACEUTICALS SA
LU
Clamoxyl 1 g, comprimés dispersibles
FR/H/600/01/MR 2008 10 0030 GLAXOSMITHKLINE PHARMACEUTICALS SA
LU
Flemoxin Solutab, comprimés solubles à 500 mg
not available BE127005 ASTELLAS PHARMA B.V., OFFICE BE
LU
Flemoxin Solutab, comprimés solubles à 1 g
not available 1996060293 ASTELLAS PHARMA B.V., OFFICE BE
LU
Amoxil 500 mg cietās kapsulas
UK/H/6220/02 04-0196 GLAXOSMITHKLINE LATVIA SIA
LV
Ospamox 1000 mg apvalkotās tabletes
AT/H/0187/003 10-0081 SANDOZ PHARMACEUTICALS D.D.
LV
Amoxil 250 mg/5 ml powder for oral suspension
FR/H/600/03/MR MA447/00105 BEECHAM GROUP PLC MT
Amoxil and associated names 500 mg capsules, hard
UK/H/6220/02 MA447/00103 BEECHAM GROUP PLC MT
Amoxil 250 mg/5 ml powder for oral suspension
FR/H/600/03/MR MA447/00105 BEECHAM GROUP PLC MT
Amoxil and associated names 500 mg capsules, hard
UK/H/6220/02 MA447/00103 BEECHAM GROUP PLC MT
IMACILLIN® not available 94-1502 MEDA AS NO IMACILLIN® not available 8005 MEDA AS NO IMACILLIN® not available 6187 MEDA AS NO IMACILLIN® not available 7886 MEDA AS NO IMACILLIN® not available 7887 MEDA AS NO
L is t of nationally authorised medicinal products EMA/726434/2017 P age 21/27
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number MAH of product in the Member State
Member State where product is authorised
IMACILLIN® not available 7888 MEDA AS NO IMACILLIN® not available 7889 MEDA AS NO IMACILLIN® not available 7890 MEDA AS NO Ospamox 500 mg, tabletki powlekane
AT/H/0188/001 16801 SANDOZ GMBH PL
Ospamox 750 mg, tabletki powlekane
AT/H/0188/002 16802 SANDOZ GMBH PL
OSPAMOX 1000 MG, 1000 MG, TABLETKI POWLEKANE
AT/H/0188/003 16687 SANDOZ GMBH PL
Clamoxyl 500 mg cápsulas
UK/H/6220/02 4667481 BEECHAM PORTUGUESA, PRODUTOS FARMACÊUTICOS E QUÍMICOS, LDA
PT
Clamoxyl 500 mg cápsulas
UK/H/6220/02 8352112 BEECHAM PORTUGUESA, PRODUTOS FARMACÊUTICOS E QUÍMICOS, LDA
PT
Clamoxyl 250 mg/5 ml pó para suspensão oral
FR/H/0600/003 8352203 SMITH KLINE & FRENCH PORTUGUESA-PRODUTOS FARMACEUTICOS LDA
PT
Clamoxyl 1 g comprimidos dispersíveis
FR/H/600/01/MR 8436816 SMITH KLINE & FRENCH PORTUGUESA-PRODUTOS FARMACEUTICOS LDA
PT
Clamoxyl 500 mg/5 ml pó para suspensão oral
FR/H/0600/004 8352211 SMITH KLINE & FRENCH PORTUGUESA-PRODUTOS FARMACEUTICOS LDA
PT
Clamoxyl 1 g comprimidos dispersíveis
FR/H/0600/001 4667580 SMITH KLINE & FRENCH PORTUGUESA-PRODUTOS FARMACEUTICOS LDA
PT
Flemoxin Solutab® not available 2234284 ASTELLAS FARMA LDA. PT Flemoxin Solutab® not available 4695383 ASTELLAS FARMA LDA. PT Flemoxin Solutab® not available 2234482 ASTELLAS FARMA LDA. PT Flemoxin Solutab® not available 4695581 ASTELLAS FARMA LDA. PT
L is t of nationally authorised medicinal products EMA/726434/2017 P age 22/27
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number MAH of product in the Member State
Member State where product is authorised
Clamoxyl 500 mg cápsulas
UK/H/6220/02 4667481 BEECHAM PORTUGUESA, PRODUTOS FARMACÊUTICOS E QUÍMICOS, LDA
PT
Clamoxyl 500 mg cápsulas
UK/H/6220/02 8352112 BEECHAM PORTUGUESA, PRODUTOS FARMACÊUTICOS E QUÍMICOS, LDA
PT
Clamoxyl 250 mg/5 ml pó para suspensão oral
FR/H/0600/003 8352203 SMITH KLINE & FRENCH PORTUGUESA-PRODUTOS FARMACEUTICOS LDA
PT
Clamoxyl 1 g comprimidos dispersíveis
FR/H/600/01/MR 8436816 SMITH KLINE & FRENCH PORTUGUESA-PRODUTOS FARMACEUTICOS LDA
PT
Clamoxyl 500 mg/5 ml pó para suspensão oral
FR/H/0600/004 8352211 SMITH KLINE & FRENCH PORTUGUESA-PRODUTOS FARMACEUTICOS LDA
PT
Clamoxyl 1 g comprimidos dispersíveis
FR/H/0600/001 4667580 SMITH KLINE & FRENCH PORTUGUESA-PRODUTOS FARMACEUTICOS LDA
PT
OSPAMOX 125 MG/5 ML AT/H/0116/003 5022082 SANDOZ FARMACÊUTICA LDA.
PT
AMOXICILINA SANDOZ 1000 mg comprimate filmate
AT/H/0187/003 5475/2013/08 S.C. SANDOZ S.R.L. RO
AMOXICILINA SANDOZ 500 mg comprimate filmate
AT/H/0187/001 5474/2013/01 S.C. SANDOZ S.R.L. RO
AMOXICILINA SANDOZ 500 mg comprimate filmate
AT/H/0187/001 5474/2013/02 S.C. SANDOZ S.R.L. RO
AMOXICILINA SANDOZ 500 mg comprimate filmate
AT/H/0187/001 5474/2013/04 S.C. SANDOZ S.R.L. RO
L is t of nationally authorised medicinal products EMA/726434/2017 P age 23/27
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number MAH of product in the Member State
Member State where product is authorised
AMOXICILINA SANDOZ 500 mg comprimate filmate
AT/H/0187/001 5474/2013/03 S.C. SANDOZ S.R.L. RO
AMOXICILINA SANDOZ 500 mg comprimate filmate
AT/H/0187/001 5474/2013/05 S.C. SANDOZ S.R.L. RO
AMOXICILINA SANDOZ 500 mg comprimate filmate
AT/H/0187/001 5474/2013/06 S.C. SANDOZ S.R.L. RO
AMOXICILINA SANDOZ 500 mg comprimate filmate
AT/H/0187/001 5474/2013/07 S.C. SANDOZ S.R.L. RO
AMOXICILINA SANDOZ 500 mg comprimate filmate
AT/H/0187/001 5474/2013/09 S.C. SANDOZ S.R.L. RO
AMOXICILINA SANDOZ 500 mg comprimate filmate
AT/H/0187/001 5474/2013/08 S.C. SANDOZ S.R.L. RO
AMOXICILINA SANDOZ 500 mg comprimate filmate
AT/H/0187/001 5474/2013/10 S.C. SANDOZ S.R.L. RO
AMOXICILINA SANDOZ 1000 mg comprimate filmate
AT/H/0187/003 5475/2013/01 S.C. SANDOZ S.R.L. RO
AMOXICILINA SANDOZ 1000 mg comprimate filmate
AT/H/0187/003 5475/2013/02 S.C. SANDOZ S.R.L. RO
AMOXICILINA SANDOZ 1000 mg comprimate filmate
AT/H/0187/003 5475/2013/04 S.C. SANDOZ S.R.L. RO
AMOXICILINA SANDOZ 1000 mg comprimate filmate
AT/H/0187/003 5475/2013/03 S.C. SANDOZ S.R.L. RO
L is t of nationally authorised medicinal products EMA/726434/2017 P age 24/27
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number MAH of product in the Member State
Member State where product is authorised
AMOXICILINA SANDOZ 1000 mg comprimate filmate
AT/H/0187/003 5475/2013/05 S.C. SANDOZ S.R.L. RO
AMOXICILINA SANDOZ 1000 mg comprimate filmate
AT/H/0187/003 5475/2013/06 S.C. SANDOZ S.R.L. RO
AMOXICILINA SANDOZ 1000 mg comprimate filmate
AT/H/0187/003 5475/2013/07 S.C. SANDOZ S.R.L. RO
AMOXICILINA SANDOZ 1000 mg comprimate filmate
AT/H/0187/003 5475/2013/10 S.C. SANDOZ S.R.L. RO
AMOXICILINA SANDOZ 1000 mg comprimate filmate
AT/H/0187/003 5475/2013/09 S.C. SANDOZ S.R.L. RO
Amimox 375 mg filmdragerade tabletter
not available 11538 MEDA AB SE
Amimox 500 mg filmdragerade tabletter
not available 11647 MEDA AB SE
Imacillin 750 mg tabletter
not available 11801 MEDA AB SE
Amimox 750 mg filmdragerade tabletter
not available 11539 MEDA AB SE
Amimox 50 mg/ml granulat till oral suspension
not available 11541 MEDA AB SE
Imacillin 1 g tabletter not available 11802 MEDA AB SE Amimox 100 mg/ml granulat till oral suspension
not available 11837 MEDA AB SE
Amimox 125 mg granulat till oral suspension, dospåse
not available 11540 MEDA AB SE
Duomox 1 000 not available 15/0383/95-S ASTELLAS PHARMA S.R.O. SK Duomox 125 not available 15/0383/95-S ASTELLAS PHARMA S.R.O. SK
L is t of nationally authorised medicinal products EMA/726434/2017 P age 25/27
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number MAH of product in the Member State
Member State where product is authorised
Duomox 250 not available 15/0383/95-S ASTELLAS PHARMA S.R.O. SK Duomox 375 not available 15/0383/95-S ASTELLAS PHARMA S.R.O. SK Duomox 750 not available 15/0383/95-S ASTELLAS PHARMA S.R.O. SK Duomox 500 not available 15/0383/95-S ASTELLAS PHARMA S.R.O. SK Amoxicillin 125mg/5ml Oral Suspension Sugar Free
not available PL 30464/0088 ATHLONE PHARMACEUTICALS LIMITED
UK
Amoxicillin 250mg/5ml Oral Suspension Sugar Free
not available PL 30464/0089 ATHLONE PHARMACEUTICALS LIMITED
UK
Amoxicillin 125mg/5ml Oral Suspension Sugar Free
not available PL 30464/0090 ATHLONE PHARMACEUTICALS LIMITED
UK
Amoxicillin 250mg/5ml Oral Suspension Sugar Free
not available PL 30464/0091 ATHLONE PHARMACEUTICALS LIMITED
UK
Amoxicillin 500 mg Capsules
not available PL 30464/0106 ATHLONE PHARMACEUTICALS LIMITED
UK
Amoxicillin Oral Suspension BP 250 mg/5 ml
not available PL 30464/0010 ATHLONE PHARMACEUTICALS LIMITED
UK
Amoxicillin 250 mg Capsules
not available PL 30464/0105 ATHLONE PHARMACEUTICALS LIMITED
UK
Amoxicillin Sugar Free Suspension BP 125mg/5ml
not available PL 21880/0123 MEDREICH PLC UK
Amoxicillin Sugar Free Suspension BP 250mg/5ml
not available PL 21880/0124 MEDREICH PLC UK
Amoxil Capsules 250 mg UK/H/6220/01 PL 00038/0103 BEECHAM GROUP PLC UK Amoxil Capsules 500 mg UK/H/6220/02 PL 00038/0105 BEECHAM GROUP PLC UK Amoxil Vials for Injection 1 g
UK/H/6220/06 PL 00038/0225 BEECHAM GROUP PLC UK
L is t of nationally authorised medicinal products EMA/726434/2017 P age 26/27
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number MAH of product in the Member State
Member State where product is authorised
Amoxil Sachets 3 G Sucrose-Free
UK/H/6220/07 PL 00038/0334 BEECHAM GROUP PLC UK
Amoxil Paediatric Suspension
UK/H/6220/03 PL 00038/0107 BEECHAM GROUP PLC UK
Amoxil Vials for Injection 250 mg
UK/H/6220/04 0038/0221 BEECHAM GROUP PLC UK
Amoxil Vials for Injection 500 mg
UK/H/6220/05 PL 00038/0222 BEECHAM GROUP PLC UK
Amoxil Capsules 250 mg UK/H/6220/01 PL 00038/0103 BEECHAM GROUP PLC UK Amoxil Capsules 500 mg UK/H/6220/02 PL 00038/0105 BEECHAM GROUP PLC UK Amoxil Vials for Injection 1 g
UK/H/6220/06 PL 00038/0225 BEECHAM GROUP PLC UK
Amoxil Sachets 3 G Sucrose-Free
UK/H/6220/07 PL 00038/0334 BEECHAM GROUP PLC UK
Amoxil Paediatric Suspension
UK/H/6220/03 PL 00038/0107 BEECHAM GROUP PLC UK
Amoxil Vials for Injection 250 mg
UK/H/6220/04 0038/0221 BEECHAM GROUP PLC UK
Amoxil Vials for Injection 500 mg
UK/H/6220/05 PL 00038/0222 BEECHAM GROUP PLC UK
Amoxicillin 250mg Capsules
not available PL 36722/0019 SPECIAL CONCEPT DEVELOPMENT (UK) LTD
UK
Amoxicillin 500mg Capsules
not available PL 36722/0020 SPECIAL CONCEPT DEVELOPMENT (UK) LTD
UK
Amoxicillin 250 mg/5 ml powder for oral suspension
AT/H/0116/004 PL 04416/0485 SANDOZ LTD UK
Amoxicillin 500 mg hard capsules
AT/H/0116/002 PL 04416/0577 SANDOZ LTD UK
Amoxicillin 250 mg hard capsules
AT/H/0116/001 PL 04416/0576 SANDOZ LTD UK
Amoxicillin 125mg/5ml Suspension
AT/H/0116/003 PL 04416/0484 SANDOZ LTD UK
L is t of nationally authorised medicinal products EMA/726434/2017 P age 27/27
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number MAH of product in the Member State
Member State where product is authorised
Amoxicillin Mixture BP 125mg/5ml
not available PL 06464/1420 WAYMADE PLC UK
Amoxicillin Mixture BP 250mg/5ml
not available PL 06464/1421 WAYMADE PLC UK
Amoxicillin 250mg Capsules
not available PL 06464/1418 WAYMADE PLC UK
Amoxicillin 500mg Capsules
not available PL 06464/1419 WAYMADE PLC UK
Amoxicillin 500 mg Capsules
not available PL 44041/0002 NOUMED LIFE SCIENCES UK
Amoxicillin 250 mg Capsules
not available PL 40496/0041 BRILL PHARMA LIMITED UK
Amoxicillin 500 mg Capsules
not available PL 40496/0042 BRILL PHARMA LIMITED UK
