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