Official Journal
of the European Union
EN
C series
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Official Journal |
EN C series |
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C/2024/5668 |
30.9.2024 |
Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 August 2024 to 31 August 2024
(Decisions taken pursuant to Article 34 of Directive 2001/83/EC (1) , Article 38 of Directive 2001/82/EC (2) or Article 5 of Regulation (EU) 2019/6 of the European Parliament and of the Council (3) )
(C/2024/5668)
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— |
Issuing, maintenance or modification of a national marketing authorisation
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(1) OJ L 311, 28.11.2001, p. 67, ELI: https://data.europa.eu/eli/dir/2001/83/oj.
(2) OJ L 311, 28.11.2001, p. 1, ELI: https://data.europa.eu/eli/dir/2001/82/oj.
(3) OJ L 4, 7.1.2019, p. 43, ELI: https://data.europa.eu/eli/reg/2019/6/oj.
ANNEX I
List of medicinal products and presentations
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Member State EU/EEA |
Marketing authorisation holder |
Invented name |
Strength |
Pharmaceutical form |
Route of administration |
Content (concentration) |
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Austria |
|
HAVRIX 1440 |
One dose (1,0 ml) contains: Hepatitis A virus (inactivated) 1440 ELISA Units Produced on human diploid (MRC-5) cells Adsorbed on aluminium hydroxide, hydrated Total: 0,50 milligrams Al3+ |
Suspension for injection |
Intramuscular use |
1 ml |
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Austria |
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HAVRIX JUNIOR 720 |
One dose (0,5 ml) contains: Hepatitis A virus (inactivated) 720 ELISA Units Produced on human diploid (MRC-5) cells Adsorbed on aluminium hydroxide, hydrated Total: 0,25 milligrams Al3+ |
Suspension for injection |
Intramuscular use |
0,5 ml |
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Belgium |
|
HAVRIX 1440 |
One dose (1,0 ml) contains: Hepatitis A virus (inactivated) 1440 ELISA Units Produced on human diploid (MRC-5) cells Adsorbed on aluminium hydroxide, hydrated Total: 0,50 milligrams Al3+ |
Suspension for injection |
Intramuscular use |
1 ml |
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Belgium |
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HAVRIX JUNIOR 720 |
One dose (0,5 ml) contains: Hepatitis A virus (inactivated) 720 ELISA Units Produced on human diploid (MRC-5) cells Adsorbed on aluminium hydroxide, hydrated Total: 0,25 milligrams Al3+ |
Suspension for injection |
Intramuscular use |
0,5 ml |
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|
Bulgaria |
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ХАВРИКС 1440 инжекционна суспензия (доза за възрастни) |
One dose (1,0 ml) contains: Hepatitis A virus (inactivated) 1440 ELISA Units Produced on human diploid (MRC-5) cells Adsorbed on aluminium hydroxide, hydrated Total: 0,50 milligrams Al3+ |
Suspension for injection |
Intramuscular use |
1 ml |
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|
Bulgaria |
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ХАВРИКС 720 инжекционна суспензия (доза за деца) |
One dose (0,5 ml) contains: Hepatitis A virus (inactivated) 720 ELISA Units Produced on human diploid (MRC-5) cells Adsorbed on aluminium hydroxide, hydrated Total: 0,25 milligrams Al3+ |
Suspension for injection |
Intramuscular use |
0,5 ml |
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Cyprus |
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HAVRIX 1440 IU |
One dose (1,0 ml) contains: Hepatitis A virus (inactivated) 1440 ELISA Units Produced on human diploid (MRC-5) cells Adsorbed on aluminium hydroxide, hydrated Total: 0,50 milligrams Al3+ |
Suspension for injection |
Intramuscular use |
1 ml |
||||||
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Cyprus |
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HAVRIX JUNIOR |
One dose (0,5 ml) contains: Hepatitis A virus (inactivated) 720 ELISA Units Produced on human diploid (MRC-5) cells Adsorbed on aluminium hydroxide, hydrated Total: 0,25 milligrams Al3+ |
Suspension for injection |
Intramuscular use |
0,5 ml |
||||||
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Czech Republic |
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HAVRIX |
One dose (1,0 ml) of Havrix 1440 Adult contains: Hepatitis A virus (inactivated) 1440 ELISA Units Produced on human diploid (MRC-5) cells Adsorbed on aluminium hydroxide, hydrated Total: 0,50 milligrams Al3+ |
Suspension for injection |
Intramuscular use |
1 ml |
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|
Czech Republic |
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HAVRIX JUNIOR MONODOSE |
One dose (0,5 ml) contains: Hepatitis A virus (inactivated) 720 ELISA Units Produced on human diploid (MRC-5) cells Adsorbed on aluminium hydroxide, hydrated Total: 0,25 milligrams Al3+ |
Suspension for injection |
Intramuscular use |
0,5 ml |
||||||
|
Denmark |
|
HAVRIX |
One dose (1,0 ml) of Havrix 1440 Adult contains: Hepatitis A virus (inactivated) 1440 ELISA Units Produced on human diploid (MRC-5) cells Adsorbed on aluminium hydroxide, hydrated Total: 0,50 milligrams Al3+ |
Suspension for injection |
Intramuscular use |
1 ml |
||||||
|
Denmark |
|
HAVRIX |
One dose (0,5 ml) of Havrix for Children contains: Hepatitis A virus (inactivated) 720 ELISA Units Produced on human diploid (MRC-5) cells Adsorbed on aluminium hydroxide, hydrated Total: 0,25 milligrams Al3+ |
Suspension for injection |
Intramuscular use |
0,5 ml |
||||||
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Estonia |
|
HAVRIX |
One dose (1,0 ml) of Havrix 1440 Adult contains: Hepatitis A virus (inactivated) 1440 ELISA Units Produced on human diploid (MRC-5) cells Adsorbed on aluminium hydroxide, hydrated Total: 0,50 milligrams Al3+ |
Suspension for injection |
Intramuscular use |
1 ml |
||||||
|
Estonia |
|
HAVRIX |
One dose (0,5 ml) of Havrix 720 Junior contains: Hepatitis A virus (inactivated) 720 ELISA Units Produced on human diploid (MRC-5) cells Adsorbed on aluminium hydroxide, hydrated Total: 0,25 milligrams Al3+ |
Suspension for injection |
Intramuscular use |
0,5 ml |
||||||
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Finland |
|
HAVRIX |
One dose (1,0 ml) of Havrix 1440 Adult contains: Hepatitis A virus (inactivated) 1440 ELISA Units Produced on human diploid (MRC-5) cells Adsorbed on aluminium hydroxide, hydrated Total: 0,50 milligrams Al3+ |
Suspension for injection |
Intramuscular use |
1 ml |
||||||
|
Finland |
|
HAVRIX |
One dose (0,5 ml) of Havrix 720 Junior contains: Hepatitis A virus (inactivated) 720 ELISA Units Produced on human diploid (MRC-5) cells Adsorbed on aluminium hydroxide, hydrated Total: 0,25 milligrams Al3+ |
Suspension for injection |
Intramuscular use |
0,5 ml |
||||||
|
France |
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HAVRIX 1440 U/1ml ADULTES |
One dose (1,0 ml) contains: Hepatitis A virus (inactivated) 1440 ELISA Units Produced on human diploid (MRC-5) cells Adsorbed on aluminium hydroxide, hydrated Total: 0,50 milligrams Al3+ |
Suspension for injection |
Intramuscular use |
1 ml |
||||||
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France |
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HAVRIX NOURRISSONS ET ENFANTS 720 U/0,5 ml |
One dose (0,5 ml) contains: Hepatitis A virus (inactivated) 720 ELISA Units Produced on human diploid (MRC-5) cells Adsorbed on aluminium hydroxide, hydrated Total: 0,25 milligrams Al3+ |
Suspension for injection |
Intramuscular use |
0,5 ml |
||||||
|
Germany |
|
Havrix 1440 |
One dose (1,0 ml) contains: Hepatitis A virus (inactivated) 1440 ELISA Units Produced on human diploid (MRC-5) cells Adsorbed on aluminium hydroxide, hydrated Total: 0,50 milligrams Al3+ |
Suspension for injection |
Intramuscular use |
1 ml |
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Germany |
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Havrix 720 Kinder |
One dose (0,5 ml) contains: Hepatitis A virus (inactivated) 720 ELISA Units Produced on human diploid (MRC-5) cells Adsorbed on aluminium hydroxide, hydrated Total: 0,25 milligrams Al3+ |
Suspension for injection |
Intramuscular use |
0,5 ml |
||||||
|
Greece |
|
HAVRIX |
One dose (1,0 ml) of Havrix 1440 Adult contains: Hepatitis A virus (inactivated) 1440 ELISA Units Produced on human diploid (MRC-5) cells Adsorbed on aluminium hydroxide, hydrated Total: 0,50 milligrams Al3+ |
Suspension for injection |
Intramuscular use |
1 ml |
||||||
|
Greece |
|
HAVRIX |
One dose (0,5 ml) of Havrix 720 Junior contains: Hepatitis A virus (inactivated) 720 ELISA Units Produced on human diploid (MRC-5) cells Adsorbed on aluminium hydroxide, hydrated Total: 0,25 milligrams Al3+ |
Suspension for injection |
Intramuscular use |
0,5 ml |
||||||
|
Hungary |
GlaxoSmithKline Biologicals SA Rue de l’Institut 89, B-1330 Rixensart, Belgium |
HAVRIX 1440 |
One dose (1,0 ml) contains: Hepatitis A virus (inactivated) 1440 ELISA Units Produced on human diploid (MRC-5) cells Adsorbed on aluminium hydroxide, hydrated Total: 0,50 milligrams Al3+ |
Suspension for injection |
Intramuscular use |
1 ml |
||||||
|
Hungary |
GlaxoSmithKline Biologicals SA Rue de l’Institut 89, B-1330 Rixensart, Belgium |
HAVRIX 720 JUNIOR |
One dose (0,5 ml) contains: Hepatitis A virus (inactivated) 720 ELISA Units Produced on human diploid (MRC-5) cells Adsorbed on aluminium hydroxide, hydrated Total: 0,25 milligrams Al3+ |
Suspension for injection |
Intramuscular use |
0,5 ml |
||||||
|
Iceland |
|
HAVRIX |
One dose (1,0 ml) of Havrix 1440 Adult contains: Hepatitis A virus (inactivated) ≥ 1440 ELISA Units Produced on human diploid (MRC-5) cells Adsorbed on aluminium hydroxide, hydrated Total: 0,50 milligrams Al3+ |
Suspension for injection |
Intramuscular use |
1 ml |
||||||
|
Iceland |
|
HAVRIX |
One dose (0,5 ml) of Havrix 720 Junior contains: Hepatitis A virus (inactivated) ≥ 720 ELISA Units Produced on human diploid (MRC-5) cells Adsorbed on aluminium hydroxide, hydrated Total: 0,25 milligrams Al3+ |
Suspension for injection |
Intramuscular use |
0,5 ml |
||||||
|
Ireland |
|
HAVRIX MONODOSE |
One dose (1,0 ml) contains: Hepatitis A virus (inactivated) 1440 ELISA Units Produced on human diploid (MRC-5) cells Adsorbed on aluminium hydroxide, hydrated Total: 0,50 milligrams Al3+ |
Suspension for injection |
Intramuscular use |
1 ml |
||||||
|
Ireland |
|
HAVRIX JUNIOR MONODOSE |
One dose (0,5 ml) contains: Hepatitis A virus (inactivated) 720 ELISA Units Produced on human diploid (MRC-5) cells Adsorbed on aluminium hydroxide, hydrated Total: 0,25 milligrams Al3+ |
Suspension for injection |
Intramuscular use |
0,5 ml |
||||||
|
Italy |
|
HAVRIX |
One dose (1,0 ml) contains: Hepatitis A virus (inactivated) 1440 ELISA Units Produced on human diploid (MRC-5) cells Adsorbed on aluminium hydroxide, hydrated Total: 0,50 milligrams Al3+ |
Suspension for injection |
Intramuscular use |
1 ml |
||||||
|
Italy |
|
HAVRIX |
One dose (0,5 ml) contains: Hepatitis A virus (inactivated) 720 ELISA Units Produced on human diploid (MRC-5) cells Adsorbed on aluminium hydroxide, hydrated Total: 0,25 milligrams Al3+ |
Suspension for injection |
Intramuscular use |
0,5 ml |
||||||
|
Latvia |
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HAVRIX 1440 ELISA units/ml vienības/ml suspensija injekcijām |
One dose (1,0 ml) contains: Hepatitis A virus (inactivated) 1440 ELISA Units Produced on human diploid (MRC-5) cells Adsorbed on aluminium hydroxide, hydrated Total: 0,50 milligrams Al3+ |
Suspension for injection |
Intramuscular use |
1 ml |
||||||
|
Latvia |
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HAVRIX 720 ELISA units/0,5 ml vienības/0,5 ml suspensija injekcijām |
One dose (0,5 ml) contains: Hepatitis A virus (inactivated) 720 ELISA Units Produced on human diploid (MRC-5) cells Adsorbed on aluminium hydroxide, hydrated Total: 0,25 milligrams Al3+ |
Suspension for injection |
Intramuscular use |
0,5 ml |
||||||
|
Lithuania |
|
Havrix 1440 ELISA vienetų/ml injekcinė suspensija |
One dose (1,0 ml) contains: Hepatitis A virus (inactivated) 1440 ELISA Units Produced on human diploid (MRC-5) cells Adsorbed on aluminium hydroxide, hydrated Total: 0m50 milligrams Al3+ |
Suspension for injection |
Intramuscular use |
1 ml |
||||||
|
Lithuania |
|
Havrix 720 ELISA vienetų/0,5 ml injekcinė suspensija |
One dose (0m5 ml) contains: Hepatitis A virus (inactivated) 720 ELISA Units Produced on human diploid (MRC-5) cells Adsorbed on aluminium hydroxide, hydrated Total: 0m25 milligrams Al3+ |
Suspension for injection |
Intramuscular use |
0,5 ml |
||||||
|
Luxembourg |
|
HAVRIX 1440 |
One dose (1,0 ml) contains: Hepatitis A virus (inactivated) 1440 ELISA Units Produced on human diploid (MRC-5) cells Adsorbed on aluminium hydroxide, hydrated Total: 0,50 milligrams Al3+ |
Suspension for injection |
Intramuscular use |
1 ml |
||||||
|
Luxembourg |
|
HAVRIX JUNIOR 720 |
One dose (0,5 ml) contains: Hepatitis A virus (inactivated) 720 ELISA Units Produced on human diploid (MRC-5) cells Adsorbed on aluminium hydroxide, hydrated Total: 0,25 milligrams Al3+ |
Suspension for injection |
Intramuscular use |
0,5 ml |
||||||
|
Malta |
|
HAVRIX MONODOSE |
One dose (1,0 ml) contains: Hepatitis A virus (inactivated) 1440 ELISA Units Produced on human diploid (MRC-5) cells Adsorbed on aluminium hydroxide, hydrated Total: 0,50 milligrams Al3+ |
Suspension for injection |
Intramuscular use |
1 ml |
||||||
|
Malta |
|
HAVRIX JUNIOR |
One dose (0,5 ml) contains: Hepatitis A virus (inactivated) 720 ELISA Units Produced on human diploid (MRC-5) cells Adsorbed on aluminium hydroxide, hydrated Total : 0,25 milligrams Al3+ |
Suspension for injection |
Intramuscular use |
0,5 ml |
||||||
|
Netherlands |
|
HAVRIX 1440 |
One dose (1,0 ml) contains: Hepatitis A virus (inactivated) 1440 ELISA Units Produced on human diploid (MRC-5) cells Adsorbed on aluminium hydroxide, hydrated Total: 0,50 milligrams Al3+ |
Suspension for injection |
Intramuscular use |
1 ml |
||||||
|
Netherlands |
|
HAVRIX JUNIOR |
One dose (0,5 ml) contains: Hepatitis A virus (inactivated) 720 ELISA Units Produced on human diploid (MRC-5) cells Adsorbed on aluminium hydroxide, hydrated Total: 0,25 milligrams Al3+ |
Suspension for injection |
Intramuscular use |
0,5 ml |
||||||
|
Norway |
|
Havrix |
1,0 ml of Havrix 1440 contains: Hepatitis A virus (inactivated) 1440 ELISA Units Produced on human diploid (MRC-5) cells Adsorbed on aluminium hydroxide, hydrated Total: 0,50 milligrams Al3+ |
Suspension for injection |
Intramuscular use |
1 ml |
||||||
|
Norway |
|
Havrix |
1,0 ml of Havrix 1440 contains: Hepatitis A virus (inactivated) 1440 ELISA Units Produced on human diploid (MRC-5) cells Adsorbed on aluminium hydroxide, hydrated Total: 0,50 milligrams Al3+ |
Suspension for injection |
Intramuscular use |
0,5 ml |
||||||
|
Poland |
|
HAVRIX ADULT |
One dose (1,0 ml) contains: Hepatitis A virus (inactivated) 1440 ELISA Units Produced on human diploid (MRC-5) cells Adsorbed on aluminium hydroxide, hydrated Total: 0,50 milligrams Al3+ |
Suspension for injection |
Intramuscular use |
1 ml |
||||||
|
Poland |
|
HAVRIX 720 JUNIOR |
One dose (0,5 ml) contains: Hepatitis A virus (inactivated) 720 ELISA Units Produced on human diploid (MRC-5) cells Adsorbed on aluminium hydroxide, hydrated Total: 0,25 milligrams Al3+ |
Suspension for injection |
Intramuscular use |
0,5 ml |
||||||
|
Portugal |
|
HAVRIX 1440 ADULTO |
One dose (1,0 ml) contains: Hepatitis A virus (inactivated) 1440 ELISA Units Produced on human diploid (MRC-5) cells Adsorbed on aluminium hydroxide, hydrated Total: 0,50 milligrams Al3+ |
Suspension for injection |
Intramuscular use |
1 ml |
||||||
|
Portugal |
|
HAVRIX 720 Júnior |
One dose (0,5 ml) contains: Hepatitis A virus (inactivated) 720 ELISA Units Produced on human diploid (MRC-5) cells Adsorbed on aluminium hydroxide, hydrated Total: 0,25 milligrams Al3+ |
Suspension for injection |
Intramuscular use |
0,5 ml |
||||||
|
Romania |
|
HAVRIX ADULT 1440 suspensie injectabilă |
One dose (1,0 ml) contains: Hepatitis A virus (inactivated) 1440 ELISA Units Produced on human diploid (MRC-5) cells Adsorbed on aluminium hydroxide, hydrated Total: 0,50 milligrams Al3+ |
Suspension for injection |
Intramuscular use |
1 ml |
||||||
|
Romania |
|
HAVRIX JUNIOR 720 suspensie injectabilă |
One dose (0,5 ml) contains: Hepatitis A virus (inactivated) 720 ELISA Units Produced on human diploid (MRC-5) cells Adsorbed on aluminium hydroxide, hydrated Total: 0,25 milligrams Al3+ |
Suspension for injection |
Intramuscular use |
0,5 ml |
||||||
|
Slovak Republic |
|
HAVRIX 1440 Dosis adulta |
One dose (1,0 ml) contains: Hepatitis A virus (inactivated) 1440 ELISA Units Produced on human diploid (MRC-5) cells Adsorbed on aluminium hydroxide, hydrated Total: 0,50 milligrams Al3+ |
Suspension for injection |
Intramuscular use |
1 ml |
||||||
|
Slovak Republic |
|
HAVRIX 720 Junior monodose |
One dose (0,5 ml) contains: Hepatitis A virus (inactivated) 720 ELISA Units Produced on human diploid (MRC-5) cells Adsorbed on aluminium hydroxide, hydrated Total: 0,25 milligrams Al3+ |
Suspension for injection |
Intramuscular use |
0,5 ml |
||||||
|
Slovenia |
|
HAVRIX 1440 ELISA enot suspenzija za injiciranje za odrasle |
One dose (1,0 ml) contains: Hepatitis A virus (inactivated) 1440 ELISA Units Produced on human diploid (MRC-5) cells Adsorbed on aluminium hydroxide, hydrated Total: 0,50 milligrams Al3+ |
Suspension for injection |
Intramuscular use |
1 ml |
||||||
|
Slovenia |
|
HAVRIX 720 ELISA enot suspenzija za injiciranje za otroke |
One dose (0,5 ml) contains: Hepatitis A virus (inactivated) 720 ELISA Units Produced on human diploid (MRC-5) cells Adsorbed on aluminium hydroxide, hydrated Total: 0,25 milligrams Al3+ |
Suspension for injection |
Intramuscular use |
0,5 ml |
||||||
|
Spain |
|
HAVRIX 1440 suspensión inyectable en jeringa precargada |
One dose (1,0 ml) contains: Hepatitis A virus (inactivated) 1440 ELISA Units Produced on human diploid (MRC-5) cells Adsorbed on aluminium hydroxide, hydrated Total: 0,50 milligrams Al3+ |
Suspension for injection |
Intramuscular use |
1 ml |
||||||
|
Spain |
|
HAVRIX 720 suspensión inyectable en jeringa precargada |
One dose (0,5 ml) contains: Hepatitis A virus (inactivated) 720 ELISA Units Produced on human diploid (MRC-5) cells Adsorbed on aluminium hydroxide, hydrated Total: 0,25 milligrams Al3+ |
Suspension for injection |
Intramuscular use |
0,5 ml |
||||||
|
Sweden |
|
Havrix |
One dose (1,0 ml) of Havrix contains: Hepatitis A virus (inactivated) 1440 ELISA Units Produced on human diploid (MRC-5) cells Adsorbed on aluminium hydroxide, hydrated Total: 0,50 milligrams Al3+ |
Suspension for injection |
Intramuscular use |
1 ml |
||||||
|
Sweden |
|
Havrix |
One dose (0,5 ml) of Havrix contains: Hepatitis A virus (inactivated) 720 ELISA Units Produced on human diploid (MRC-5) cells Adsorbed on aluminium hydroxide, hydrated Total: 0,25 milligrams Al3+ |
Suspension for injection |
Intramuscular use |
0,5 ml |
ANNEX II
List of medicinal products and presentations
|
Member State EU/EEA |
Marketing authorisation holder company name, address |
(Invented) Name |
Strength |
Pharmaceutical form |
Route of administration |
Content (concentration) |
|
Austria |
Macure Pharma ApS, Hejrevej 39, 2400 Copenhagen NV, Denmark |
Lorazepam Macure 4 mg/ml Injektionslösung |
4 mg/ml |
Solution for injection |
Intravenous use, Intramuscular use |
4 mg |
|
Belgium |
Macure Pharma ApS, Hejrevej 39, 2400 Copenhagen NV, Denmark |
Lorazepam Macure 4 mg/ml solution injectable / oplossing voor injectie |
4 mg/ml |
Solution for injection |
Intravenous use, Intramuscular use |
4 mg |
|
Denmark |
Macure Pharma ApS, Hejrevej 39, 2400 Copenhagen NV, Denmark |
Lorazepam Macure |
4 mg/ml |
Solution for injection |
Intravenous use, Intramuscular use |
4 mg |
|
Finland |
Macure Pharma ApS, Hejrevej 39, 2400 Copenhagen NV, Denmark |
Lorazepam Macure 4 mg/ml injektioneste, liuos / injektionsvätska, lösning |
4 mg/ml |
Solution for injection |
Intravenous use, Intramuscular use |
4 mg |
|
Germany |
Macure Pharma ApS, Hejrevej 39, 2400 Copenhagen NV, Denmark |
Lorazepam Macure |
4 mg/ml |
Solution for injection |
Intravenous use, Intramuscular use |
4 mg |
|
Ireland |
Macure Pharma ApS, Hejrevej 39, 2400 Copenhagen NV, Denmark |
Lorazepam Macure 4 mg/ml solution for injection |
4 mg/ml |
Solution for injection |
Intravenous use, Intramuscular use |
4 mg |
|
Italy |
Macure Pharma ApS, Hejrevej 39, 2400 Copenhagen NV, Denmark |
Lorazepam Macure |
4 mg/ml |
Solution for injection |
Intravenous use, Intramuscular use |
4 mg |
|
The Netherlands |
Macure Pharma ApS, Hejrevej 39, 2400 Copenhagen NV, Denmark |
Lorazepam Macure 4 mg/ml oplossing voor injectie |
4 mg/ml |
Solution for injection |
Intravenous use, Intramuscular use |
4 mg |
|
Norway |
Macure Pharma ApS, Hejrevej 39, 2400 Copenhagen NV, Denmark |
Lorazepam Macure |
4 mg/ml |
Solution for injection |
Intravenous use, Intramuscular use |
4 mg |
|
Slovenia |
Macure Pharma ApS, Hejrevej 39, 2400 Copenhagen NV, Denmark |
Lorazepam Macure 4 mg/ml raztopina za injiciranje |
4 mg/ml |
Solution for injection |
Intravenous use, Intramuscular use |
4 mg |
|
Sweden |
Macure Pharma ApS, Hejrevej 39, 2400 Copenhagen NV, Denmark |
Lorazepam Macure |
4 mg/ml |
Solution for injection |
Intravenous use, Intramuscular use |
4 mg |
ELI: http://data.europa.eu/eli/C/2024/5668/oj
ISSN 1977-091X (electronic edition)