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, Article 38 of Directive 2001/82/EC or Article 5 of Regulation (EU) 2019/6 of the European Parliament and of the Council)
Date: 2024-09-30
Institutions: Directorate-General for Health and Food Safety, European Commission
Subjects: EU Member State, drug surveillance, market approval, marketing standard, medicinal product








C_202405668EN.000101.fmx.xml












Official Journal of the European Union


EN
C series













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)







—



Issuing, maintenance or modification of a national marketing authorisation











Date of the decision


Name(s) of the medicinal product


INN (International Non-Proprietary Name)


Holder(s) of the marketing authorisation


Member State concerned


Date of notification




26.8.2024


Havrix and associated names


inactivated hepatitis A virus


See Annex I


See Annex I


26.8.2024




29.8.2024


Lorazepam Macure


lorazepam


See Annex II


See Annex II


29.8.2024










(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











Member State EU/EEA


Marketing authorisation holder


Invented name


Strength


Pharmaceutical form


Route of administration


Content (concentration)




Austria







GlaxoSmithKline Pharma GmbH




Wienerbergstraße 7, 5. Stock




1100 Vienna




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




Austria







GlaxoSmithKline Pharma GmbH




Wienerbergstraße 7, 5. Stock




1100 Vienna




Austria






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




Belgium







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




Belgium







GlaxoSmithKline Biologicals SA




Rue de l’Institut 89




B-1330 Rixensart




Belgium






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




Bulgaria







GlaxoSmithKline Biologicals SA




Rue de l’Institut 89




1330 Rixensart




Belgium






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




Bulgaria







GlaxoSmithKline Biologicals SA




Rue de l’Institut 89




1330 Rixensart




Belgium






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




Cyprus







GlaxoSmithKline Biologicals SA




Rue de l’Institut 89




B-1330 Rixensart




Belgium






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




Cyprus







GlaxoSmithKline Biologicals SA




Rue de l’Institut 89




B-1330 Rixensart




Belgium






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




Czech Republic







GlaxoSmithKline Biologicals SA




Rue de l’Institut 89




B-1330 Rixensart




Belgium






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




Czech Republic







GlaxoSmithKline Biologicals SA




Rue de l’Institut 89




B-1330 Rixensart




Belgium






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







GlaxoSmithKline Pharma A/S




Delta Park 37




2665 Vallensbæk Strand




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







GlaxoSmithKline Pharma A/S




Delta Park 37




2665 Vallensbæk Strand




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




Estonia







GlaxoSmithKline Biologicals SA




Rue de l’Institut 89




B-1330 Rixensart




Belgium






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







GlaxoSmithKline Biologicals SA




Rue de l’Institut 89




B-1330 Rixensart




Belgium






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




Finland







GlaxoSmithKline Biologicals SA




Rue de l’Institut 89




B-1330 Rixensart




Belgium






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







GlaxoSmithKline Biologicals SA




Rue de l’Institut 89




B-1330 Rixensart




Belgium






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







LABORATOIRE GLAXOSMITHKLINE




23, RUE FRANCOIS JACOB




92500 RUEIL MALMAISON




France






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




France







LABORATOIRE GLAXOSMITHKLINE




23, RUE FRANCOIS JACOB




92500 RUEIL MALMAISON




France






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







GlaxoSmithKline GmbH & Co. KG




Prinzregentenplatz 9




Bogenhausen




Bayern




81675 München




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




Germany







GlaxoSmithKline GmbH & Co. KG




Prinzregentenplatz 9




Bogenhausen




Bayern




81675 München




Germany






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







GlaxoSmithKline Single Member A.E.B.E.




Kifissias avenue 266




152 32 Halandri, Athens




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







GlaxoSmithKline Single Member A.E.B.E.




Kifissias avenue 266




152 32 Halandri, Athens




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







GlaxoSmithKline Pharma A/S




Delta Park 37




2665 Vallensbæk Strand




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




Iceland







GlaxoSmithKline Pharma A/S




Delta Park 37




2665 Vallensbæk Strand




Denmark






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







GLAXOSMITHKLINE (IRELAND) LIMITED




12 Riverwalk, Citywest Business Campus,




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







GLAXOSMITHKLINE (IRELAND) LIMITED




12 Riverwalk, Citywest Business Campus,




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







GlaxoSmithKline S.p.A.




Viale dell'Agricoltura, 7




37135 Verona VR




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







GlaxoSmithKline S.p.A.




Viale dell'Agricoltura, 7




37135 Verona VR




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







GlaxoSmithKline Biologicals SA




Rue de l’Institut 89




B-1330 Rixensart




Belgium






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







GlaxoSmithKline Biologicals SA




Rue de l’Institut 89




B-1330 Rixensart




Belgium






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







GlaxoSmithKline Biologicals SA




Rue de l’Institut 89




B-1330 Rixensart




Belgium






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







GlaxoSmithKline Biologicals SA




Rue de l'Institut 89




B-1330 Rixensart




Belgium






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







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




Luxembourg







GlaxoSmithKline Biologicals SA




Rue de l'Institut 89




B-1330 Rixensart




Belgium






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







GlaxoSmithKline (Ireland) Limited 12 Riverwalk,




Citywest Business Campus, Dublin 24




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




Malta







GlaxoSmithKline (Ireland) Limited 12 Riverwalk,




Citywest Business Campus, Dublin 24




Ireland






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







GlaxoSmithKline BV




Van Asch van Wijckstraat 55H




3811 LP Amersfoort




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







GlaxoSmithKline BV




Van Asch van Wijckstraat 55H




3811 LP Amersfoort




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







GlaxoSmithKline AS




Postboks 180, Vinderen




0319 Oslo




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







GlaxoSmithKline AS




Postboks 180, Vinderen




0319 Oslo




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







GlaxoSmithKline Biologicals SA




Rue de l’Institut 89




B-1330 Rixensart




Belgium






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







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




Portugal







Smith Kline & French Portuguesa-Produtos Farmaceuticos LDA




Rua Dr. António Loureiro Borges, 3 Arquiparque, Miraflores Algés




1495-131 Algés




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







Smith Kline & French Portuguesa-Produtos Farmaceuticos LDA




Rua Dr. António Loureiro Borges, 3 Arquiparque, Miraflores Algés




1495-131 Algés




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







GlaxoSmithKline Biologicals SA




Rue de l’Institut 89




B-1330 Rixensart




Belgium






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







GlaxoSmithKline Biologicals SA




Rue de l’Institut 89




B-1330 Rixensart




Belgium






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







GlaxoSmithKline Biologicals SA




Rue de l’Institut 89




B-1330 Rixensart




Belgium






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







GlaxoSmithKline Biologicals SA




Rue de l’Institut 89




B-1330 Rixensart




Belgium






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







GlaxoSmithKline Biologicals SA




Rue de l’Institut 89




B-1330 Rixensart




Belgium






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







GlaxoSmithKline Biologicals SA




Rue de l’Institut 89




B-1330 Rixensart




Belgium






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







GlaxoSmithKline S.A.




Severo Ochoa, 2 Parque Tecnologico de Madrid Tres Cantos




28760 Madrid




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







GlaxoSmithKline S.A.




Severo Ochoa, 2 Parque Tecnologico de Madrid Tres Cantos




28760 Madrid




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







GlaxoSmithKline AB




P.O. Box 516




169 29 Solna




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







GlaxoSmithKline AB




P.O. Box 516




169 29 Solna




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)