Member State

(in EEA)

Marketing Authorisation Holder

Invented name

Strength

Pharmaceutical Form

Route of administration

France

PLETAL 100 mg, comprimé

100 mg

tablet

oral use

France

PLETAL 50 mg, comprimé

50 mg

tablet

oral use

Germany

Pletal 50 mg, Tabletten

50 mg

tablet

oral use

Germany

Pletal 100 mg, Tabletten

100 mg

tablet

oral use

Italy

PLETAL

50 MG

tablet

oral use

Italy

PLETAL

100 MG

tablet

oral use

Spain

PLETAL 50 mg comprimidos

50 mg

tablet

oral use

Spain

PLETAL 100 mg comprimidos

100 mg

tablet

oral use

Spain

EKISTOL 50 mg comprimidos

50 mg

tablet

oral use

Spain

EKISTOL 100 mg comprimidos

100 mg

tablet

oral use

Sweden

PLETAL

50 mg

tablet

oral use

Sweden

PLETAL

100 mg

tablet

oral use

United Kingdom

Pletal 50 mg Tablets

50 mg

tablet

oral use

United Kingdom

Pletal 100 mg Tablets

100 mg

tablet

oral use

Member State

(in EEA)

Marketing authorisaton holder

Product name

Strength

Pharmaceutical form

Route of administration

Austria

Alisma 2 mg/35 μg Filmtablette

2,00 mg

0,035 mg

Film-coated tablet

Oral use

Austria

Bellgyn ‘ratiopharm’ 2 mg/0,035 mg - überzogene Tabletten

2,00 mg

0,035 mg

Coated tablet

Oral use

Austria

Cyprotomin 2 mg/0,035 mg Filmtabletten

2,00 mg

0,035 mg

film-coated tablet

Oral use

Austria

Diane mite - Dragees

2,00 mg

0,035 mg

Coated tablet

Oral use

Austria

Femogyn 2 mg/0,035 mg überzogene Tabletten

2,00 mg

0,035 mg

Coated tablet

Oral use

Austria

Midane - Dragees

2,00 mg

0,035 mg

Coated tablet

Oral use

Austria

Minerva - Dragees

2,00 mg

0,035 mg

Coated tablet

Oral use

Austria

Xylia - Dragées

2,00 mg

0,035 mg

Coated tablet

Oral use

Belgium

Chloe

2,00 mg

0,035 mg

Film-coated tablet

Oral use

Belgium

Claudia-35

2,00 mg

0,035 mg

Coated tablet

Oral use

Belgium

Daphne

2,00 mg

0,035 mg

Coated tablet

Oral use

Belgium

Diane-35

2,00 mg

0,035 mg

Coated tablet

Oral use

Belgium

Elisamylan

2,00 mg

0,035 mg

Coated tablet

Oral use

Belgium

Gratiella 35

2,00 mg

0,035 mg

Coated tablet

Oral use

Bulgaria

Diane 35

0,035 mg

2,00 mg

Coated tablet

Oral use

Bulgaria

Melleva

0,035 mg

2,00 mg

Film-coated tablet

Oral use

Bulgaria

Chloe

0,035 mg

2,00 mg

Film-coated tablet

Oral use

Czech Republic

CHLOE

2,00 mg

0,035 mg

Film-coated tablet

Oral use

Czech Republic

VREYA

2,00 mg

0,035 mg

Film-coated tablet

Oral use

Czech Republic

MINERVA

2,00 mg

0,035 mg

Coated tablet

Oral use

Czech Republic

DIANE-35

2,00 mg

0,035 mg

Coated tablet

Oral use

Denmark

Chloe

2,00 mg

0,035 mg

Film-coated tablet

Oral use

Denmark

Cypretyl

2,00 mg

0,035 mg

Film-coated tablet

Oral use

Denmark

Diane Mite

2,00 mg

0,035 mg

Film-coated tablet

Oral use

Denmark

Dianova Mite

2,00 mg

0,035 mg

Film-coated tablet

Oral use

Denmark

Feminil mite

2,00 mg

0,035 mg

Film-coated tablet

Oral use

Denmark

Vreya

2,00 mg

0,035 mg

Film-coated tablet

Oral use

Denmark

Zyrona

2,00 mg

0,035 mg

Film-coated tablet

Oral use

Estonia

Diane

2,00 mg

0,035 mg

Coated tablet

Oral use

Estonia

Femina

2,00 mg

0,035 mg

Coated tablet

Oral use

Estonia

Cypretil

2,00 mg

0,035 mg

Coated tablet

Oral use

Finland

DIANE NOVA

2,00 mg

0,035 mg

Tablet

Oral use

Finland

CYPRETYL

2,00 mg

0,035 mg

Tablet

Oral use

Finland

FEMINIL

2,00 mg

0,035 mg

Tablet

Oral use

Finland

VREYA

2,00 mg

0,035 mg

Tablet

Oral use

France

DIANE 35 μg, coated tablet

2,00 mg

0,035 mg

Coated tablet

Oral use

France

MINERVA 35 μg

2,00 mg

0,035 mg

Coated tablet

Oral use

France

CYPROTERONE/ETHINYLESTRADIOL BAYER 35 μg

2,00 mg

0,035 mg

Coated tablet

Oral use

France

CYPROPHARM 2 mg/0,035 mg

2,00 mg

0,035 mg

Coated tablet

Oral use

France

CYPROTERONE/ETHINYLESTRADIOL DCI PHARMA 2 mg/0,035 mg

2,00 mg

0,035 mg

Coated tablet

Oral use

France

CYPROTERONE/ETHINYLESTRADIOL EG 2 mg/0,035 mg

2,00 mg

0,035 mg

Coated tablet

Oral use

France

CYPROTERONE/ETHINYLESTRADIOL RANBAXY 2 mg/0,035 mg

2,00 mg

0,035 mg

Coated tablet

Oral use

France

CYPROTERONE/ETHINYLESTRADIOL RATIOPHARM 2 mg/0,035 mg

2,00 mg

0,035 mg

Coated tablet

Oral use

France

CYPROTERONE/ETHINYLESTRADIOL SANDOZ 2 mg/0,035 mg

2,00 mg

0,035 mg

Coated tablet

Oral use

France

CYPROTERONE/ETHINYLESTRADIOL TEVA 2 mg/0,035 mg

2,00 mg

0,035 mg

Coated tablet

Oral use

France

CYPROTERONE/ETHINYLESTRADIOL ZENTIVA 2 mg/0,035 mg

2,00 mg

0,035 mg

Coated tablet

Oral use

France

CYPROTERONE/ETHINYLESTRADIOL ZYDUS 2 mg/0,035 mg

2,00 mg

0,035 mg

Coated tablet

Oral use

France

ELLEACNELLE 2 mg/0,035 mg

2,00 mg

0,035 mg

Coated tablet

Oral use

France

EVEPAR 2 mg/0,035 mg

2,00 mg

0,035 mg

Coated tablet

Oral use

France

HOLGYEME 2 mg/0,035 mg

2,00 mg

0,035 mg

Coated tablet

Oral use

France

LUMALIA 2 mg/0,035 mg

2,00 mg

0,035 mg

Coated tablet

Oral use

Germany

Cyproethinyl acis

0,035 mg

2,00 mg

Film-coated tablet

Oral use

Germany

Jennifer 35 2 mg/0,035 mg Filmtabletten

0,035 mg

2,00 mg

Film-coated tablet

Oral use

Germany

Diane-35 0,035 mg/2 mg überzogene Tablette

0,035 mg

2,00 mg

Coated tablet

Oral use

Germany

Cyproteronacetat/Ethinylestradiol Dermapharm 2 mg/0,035 mg überzogene Tablette

0,035 mg

2,00 mg

Coated tablet

Oral use

Germany

Bella HEXAL 35 2 mg/0,035 mg überzogene Tablette

0,035 mg

2,00 mg

Coated tablet

Oral use

Germany

Juliette

0,035 mg

2,00 mg

Coated tablet

Oral use

Germany

Attempta-ratiopharm 35 2 mg/0,035 mg überzogene Tablette

0,035 mg

2,00 mg

Coated tablet

Oral use

Germany

Ergalea 2,00/0,035 mg Filmtabletten

0,035 mg

2,00 mg

Film-coated tablet

Oral use

Germany

Moea Sanol 2 mg/0,035 mg überzogene Tabletten

0,035 mg

2,00 mg

Coated tablet

Oral use

Greece

GYNOFEN 35

2,00 mg

0,035 mg

Coated tablet

Oral use

Hungary

Bellune Pliva

2,00 mg

0,035 mg

Coated tablet

Oral use

Hungary

Diane

2,00 mg

0,035 mg

Coated tablet

Oral use

Hungary

Minerva

2,00 mg

0,035 mg

Coated tablet

Oral use

Iceland

Diane mite

2,00 mg

0,035 mg

Tablet

Oral use

Iceland

Cypretyl

2,00 mg

0,035 mg

Coated tablet

Oral use

Ireland

Cyproterone Acetate/Ethinylestradiol Tablets 2 mg/0,035 mg

2,00 mg

0,035 mg

Tablet

Oral use

Ireland

Dianette 2 mg/35 microgram coated tablets.

2,00 mg

0,035 mg

Coated tablet

Oral use

Italy

DIANE

2,00 mg

0,035 mg

Coated tablet

Oral use

Italy

VISOFID

2,00 mg

0,035 mg

Coated tablet

Oral use

Latvia

Chloe 35 micrograms/2 mg film-coated tablets

0,035 mg

2,00 mg

Film-coated tablet

Oral use

Latvia

Femina 2 mg/35 micrograms coated tablets

2,00 mg

0,035 mg

Coated tablet

Oral use

Latvia

Diane 2 000 micrograms/35 micrograms film-coated tablets

2,00 mg

0,035 mg

Film-coated tablet

Oral use

Lithuania

Diane

2,00 mg

0,035 mg

Coated tablet

Oral use

Lithuania

Femina

2,00 mg

0,035 mg

Coated tablet

Oral use

Lithuania

CHLOE

2,00 mg

0,035 mg

Film-coated tablet

Oral use

Lithuania

Cypretil

2,00 mg

0,035 mg

Coated tablet

Oral use

Luxembourg

Diane-35

2,00 mg

0,035 mg

Coated tablet

Oral use

Luxembourg

Chloe

2,00 mg

0,035 mg

Coated tablet

Oral use

Luxembourg

Daphne

2,00 mg

0,035 mg

Coated tablet

Oral use

Luxembourg

Lumalia

2,00 mg

0,035 mg

Coated tablet

Oral use

Malta

Clairette 2000/35 Tablets

2,00 mg

0,035 mg

Coated tablet

Oral use

Malta

Acnocin 2000/35 Tablets

2,00 mg

0,035 mg

Coated tablet

Oral use

Norway

Diane

2,00 mg

0,035 mg

Coated tablet

Oral use

Norway

Feminil

2,00 mg

0,035 mg

Coated tablet

Oral use

Norway

Zyrona

2,00 mg

0,035 mg

Coated tablet

Oral use

Poland

Acnemine

2,00 mg

0,035 mg

Film-coated tablet

Oral use

Poland

Diane-35

2,00 mg

0,035 mg

Film-coated tablet

Oral use

Poland

Chloe

2,00 mg

0,035 mg

Film-coated tablet

Oral use

Poland

Cyprest

0,035 mg

2,00 mg

Coated tablet

Oral use

Poland

OC-35

0,035 mg

2,00 mg

Film-coated tablet

Oral use

Poland

Syndi-35

2,00 mg

0,035 mg

Coated tablet

Oral use

Poland

Cyprodiol

2,00 mg

0,035 mg

Coated tablet

Oral use

Portugal

Diane 35

2,00 mg

0,035 mg

Coated tablet

Oral use

Portugal

Acetato Ciproterona/Etinilestradiol 2 mg/0,035 mg Comprimidos

2,00 mg

0,035 mg

Coated tablet

Oral use

Portugal

Ciproterona + Etinilestradiol Generis

2,00 mg

0,035 mg

Coated tablet

Oral use

Portugal

Ciproterona + Etinilestradiol Inventis

2,00 mg

0,035 mg

Coated tablet

Oral use

Romania

DIANE- 35

2,00 mg

0,035 mg

Coated tablet

Oral use

Romania

MELLEVA 2 mg/0,035 mg

2,00 mg

0,035 mg

Film-coated tablet

Oral use

Slovak Republic

Vreya

2,00 mg

0,035 mg

Coated tablet

Oral use

Slovak Republic

Minerva

2,00 mg

0,035 mg

Coated tablet

Oral use

Slovak Republic

CHLOE

2,00 mg

0,035 mg

Coated tablet

Oral use

Slovak Republic

Diane-35

2,00 mg

0,035 mg

Coated tablet

Oral use

Slovenia

Diane 0,035 mg/2 mg obložene tablete

0,035 mg

2,00 mg

Coated tablet

Oral use

Spain

DIANE 35

2,00 mg

0,035 mg

Coated tablet

Oral use

Spain

DIANE 35 DIARIO

2,00 mg

0,035 mg

Coated tablet

Oral use

Spain

ETINILESTRADIOL/CIPROTERONA GINESERVICE 0,035 mg/2 mg comprimidos EFG

2,00 mg

0,035 mg

Coated tablet

Oral use

Spain

ACETATO DE CIPROTERONA/ETINILESTRADIOL SANDOZ 2 mg/0,035 mg comprimidos recubiertos EFG

2,00 mg

0,035 mg

Film-coated tablet

Oral use

Spain

GYNEPLEN 0,035 mg/2 mg comprimidos recubiertos

2,00 mg

0,035 mg

Coated tablet

Oral use

Spain

DIALIDER 2/0,035 mg comprimidos recubiertos con película

2,00 mg

0,035 mg

Film-coated tablet

Oral use

Spain

CYPRINETTE DIARIO 0,035 mg/2 mg comprimidos recubiertos EFG

2,00 mg

0,035 mg

Coated tablet

Oral use

Sweden

Diane®

2,00 mg

0,035 mg

Tablet

Oral use

Sweden

Zyrona

2,00 mg

0,035 mg

Coated tablet

Oral use

The Netherlands

Cyproteronacetaat/ethinylestradiol Actavis 2/0,035 mg, filmomhulde tabletten 2 mg/0,035 mg

2,00 mg

0,035 mg

Film-coated tablet

Oral use

The Netherlands

Cyproteronacetaat/ethinylestradiol Apotex 2/0,035 mg, omhulde tabletten

2,00 mg

0,035 mg

Film-coated tablet

Oral use

The Netherlands

Cyproteronacetaat/Ethinylestradiol CF 2/0,035 mg, omhulde tablet

2,00 mg

0,035 mg

Film-coated tablet

Oral use

The Netherlands

Cyproteronacetaat/Ethinylestradiol Mylan 2 mg/0,035 mg, omhulde tabletten

2,00 mg

0,035 mg

Film-coated tablet

Oral use

The Netherlands

Cyproteronacetaat/Ethinylestradiol Mylan 2 mg/0,035 mg, omhulde tabletten

2,00 mg

0,035 mg

Film-coated tablet

Oral use

The Netherlands

Cyproteronacetaat/ethinylestradiol ratiopharm 2 mg/0,035 mg, omhulde tabletten

2,00 mg

0,035 mg

Film-coated tablet

Oral use

The Netherlands

Cyproteronacetaat/Ethinylestradiol Sandoz 2/0,035, omhulde tabletten

2,00 mg

0,035 mg

Film-coated tablet

Oral use

The Netherlands

Cyproteronacetaat/Ethinylestradiol 2 mg/0,035 mg, omhulde tabletten

2,00 mg

0,035 mg

Film-coated tablet

Oral use

The Netherlands

Cyproteronacetaat/Ethinylestradiol 2/0,035 PCH, omhulde tabletten 2 mg/0,035 mg

2,00 mg

0,035 mg

Film-coated tablet

Oral use

The Netherlands

Ethinylestradiol 0,035 mg/Cyproteronacetaat 2 mg, omhulde tabletten

2,00 mg

0,035 mg

Film-coated tablet

Oral use

The Netherlands

Diane-35, omhulde tabletten

2,00 mg

0,035 mg

Film-coated tablet

Oral use

United Kingdom

Dianette Tablets

0,035 mg

2,00 mg

Coated tablet

Oral use

United Kingdom

Co-Cyprindiol Tablets 2000/35

0,035 mg

2,00 mg

Coated tablet

Oral use

United Kingdom

Clairette Tablets 2000/35

0,035 mg

2,00 mg

Coated tablet

Oral use

United Kingdom

Camilette Co-Cyprindiol 2000/35 Tablets

0,035 mg

2,00 mg

Tablet

Oral use

United Kingdom

Acnocin 2000/35 Tablets

0,035 mg

2,00 mg

Coated tablet

Oral use

United Kingdom

Cyproterone Acetate 2,0 mg Ethinylestradiol 0,035 mg Tablets

0,035 mg

2,00 mg

Coated tablet

Oral use

United Kingdom

Co-Cyprindiol Tablets 2 mg/0,035 mg

0,035 mg

2,00 mg

Coated tablet

Oral use

United Kingdom

Generics UK Cyproterone Acetate and Ethinylestradiol Tablets

0,035 mg

2,00 mg

Coated tablet

Oral use

United Kingdom

Strandhaven Co-Cyprindiol 2000/35 Tablets

0,035 mg

2,00 mg

Coated tablet

Oral use

United Kingdom

Fannin UK Co-Cyprindiol 2000/35 Tablets

0,035 mg

2,00 mg

Film-coated tablet

Oral use

United Kingdom

Dialider Tablets

0,035 mg

2,00 mg

Film-coated tablet

Oral use

United Kingdom

Co-Cyprindiol 2000/35 Tablets

0,035 mg

2,00 mg

Film-coated tablet

Oral use

Member State

(EU/EEA)

Marketing authorisaton holder

Invented name

Strength

Pharmaceutical form

Route of administration

France

ROUVAX, poudre et solvant pour suspension injectable en flacon multidose, vaccin vivant hyperatténué contre la rougeole

one dose (0,5 ml) contains:

Measles virus Schwartz strain (live, attenuated) - not less than 103,0 CCID50

Powder and solvent for solution for injection

Intramuscular use, subcutaneous use

France

ROUVAX, poudre et solvant pour suspension injectable, vaccin vivant hyperatténué contre la rougeole

one dose (0,5 ml) contains:

Measles virus Schwartz strain (live, attenuated) - not less than 103,0 CCID50

Powder and solvent for solution for injection

Intramuscular use, subcutaneous use

Germany

Masern-Impfstoff Merieux

one dose (0,5 ml) contains:

Measles virus Schwartz strain (live, attenuated) - not less than 103,0 CCID50

Powder and solvent for solution for injection

Intramuscular use, subcutaneous use

Germany

Masern-Impfstoff Merieux

one dose (0,5 ml) contains:

Measles virus Schwartz strain (live, attenuated) - not less than 103,0 CCID50

Powder and solvent for solution for injection

Intramuscular use, subcutaneous use

Spain

AMUNOVAX VIAL

one dose (0,5 ml) contains:

Measles virus (live, attenuated) - not less than 103,0 TCID50

Powder and solvent for solution for injection

Subcutaneous use

Member State

(EU/EEA)

Marketing authorisation holder

Invented name

Strength

Pharmaceutical form

Route of administration

France

VACCIN OREILLONS AVENTIS PASTEUR MSD, poudre et solvant pour suspension injectable en seringue préremplie vaccin des oreillons, atténué

one dose (0,5 ml) contains:

Mumps virus Jeryl Lynn strain (live, attenuated) – 5 × 103,0 CCID50

Powder and solvent for solution for injection

Subcutaneous use

France

IMOVAX OREILLONS, poudre et solvant pour préparation injectable. vaccin à virus vivants atténués contre les oreillons

one dose (0,5 ml) contains:

Mumps virus URABE AM-9 strain (live, attenuated) - not less than 5 × 103,0 CCID50

Powder and solvent for solution for injection

Intramuscular use, subcutaneous use

Spain

VACUNA MSD ANTI-PAROTIDITIS

one dose (0,5 ml) contains:

Mumps virus (Strain Jeryl Lynn - B level) - not less than 20 × 103,0 TCID50

Powder and solvent for solution for injection

Subcutaneous use

Member State

(EU/EEA)

Marketing authorisation holder

Invented name

Strength

Pharmaceutical form

Route of administration

Bulgaria

Rudixax

one dose (0,5 ml) contains:

live, attenuated rubella virus (strain Wistar RA 27/3) - at least 103,0 CCID50

Powder and solvent for suspension for injection

Intramuscular use, subcutaneous use

France

RUDIVAX, poudre et solvant pour suspension injectable. Vaccin rubéoleux atténué.

one dose (0,5 ml) contains:

Rubella virus Wistar RA 27/3 strain (live, attenuated) - 103,0 CCID50

Powder and solvent for solution for injection

Intramuscular use, subcutaneous use

Germany

Röteln-Impfstoff HDC Merieux

one dose (0,5 ml) contains:

Rubella virus Wistar RA 27/3 strain (live, attenuated) - 103,0 CCID50

Powder and solvent for solution for injection

Intramuscular use, subcutaneous use

Germany

Röteln-Impfstoff HDC Merieux

one dose (0,5 ml) contains:

Rubella virus Wistar RA 27/3 strain (live, attenuated) - 103,0 CCID50

Powder and solvent for solution for injection

Intramuscular use, subcutaneous use

Spain

VACUNA ANTIRRUBEOLA MERIEUX

one dose (0,5 ml) contains:

Rubella virus live attenuated (Strain Wistar RA 27/3M) - not less than 103,0 TCID50

Powder and solvent for solution for injection

Subcutaneous use

Spain

VACUNA ANTIRRUBEOLA GSK

one dose (0,5 ml) contains:

Live attenuated rubella virus (Strain RA 27/3) - not less than 103,0 TCID50

Powder and solvent for solution for injection

Subcutaneous use

Spain

RUBEATEN BERNA

Rubella virus live (Strain Wistar RA 27/3) - not less than 103,0 TCID50

Powder and solvent for solution for injection

Subcutaneous use

Member State

(EU/EEA)

Marketing authorisation holder

Invented name

Strength

Pharmaceutical form

Route of administration

Austria

Varilrix Pulver und Lösungsmittel zur Herstellung einer Injektionssuspension

one dose (0,5 ml) contains:

Live attenuated varicella-zoster virus (Oka strain) - not less than 103,3 PFU (1)

Powder and solvent for suspension for injection

Subcutaneous use

Austria

VARIVAX Pulver und Lösungsmittel zur Herstellung einer Injektionssuspension

one dose (0,5 ml) contains:

Varicella virus strain Oka/Merck (live, attenuated) ≥ 1 350 PFU (1)

Powder and solvent for suspension for injection

Intramuscular use,

subcutaneous use

Belgium

Varilrix

one dose (0,5 ml) contains:

Live attenuated varicella-zoster virus (Oka strain) - not less than 103,3 PFU (1)

Powder and solvent for solution for injection

Subcutaneous use

Belgium

Provarivax

one dose (0,5 ml) contains:

Varicella virus Oka/Merck strain (live, attenuated) ≥ 1 350 PFU (1)

Powder and solvent for solution for injection

Subcutaneous use

Cyprus

Varivax powder and solvent for suspension for injection 1 350 PFU

one dose (0,5 ml) contains:

Varicella virus Oka/Merck strain (live, attenuated) 1 350 PFU (1)

Powder and solvent for suspension for injection

Subcutaneous use

Cyprus

VARILRIX powder and solvent for solution for injection

one dose (0,5 ml) contains:

Live attenuated varicella-zoster virus (Oka strain) 103,3 PFU (1)

Powder and solvent for solution for injection

Subcutaneous use

Czech Republic

VARILRIX

one dose (0,5 ml) contains:

Live attenuated varicella-zoster virus (Oka strain) - not less than 103,3 PFU (1)

Powder and solvent for solution for injection

Subcutaneous use

Estonia

VARILRIX

one dose (0,5 ml) contains:

Live attenuated varicella-zoster virus (Oka strain) - not less than 103,3 PFU (1)

Powder and solvent for solution for injection

Subcutaneous use

Denmark

Varilrix

one dose (0,5 ml) contains:

Live attenuated varicella-zoster virus (Oka strain) – not less than 103,3 PFU (1)

Powder and solvent for solution for injection

Subcutaneous use

Denmark

Provarivax

one dose (0,5 ml) contains:

Varicella virus Oka/Merck strain (live, attenuated) ≥ 1 350 PFU (1)

Powder and solvent for solution for injection, suspension

Subcutaneous use

Estonia

VARIVAX

one dose (0,5 ml) contains:

Varicella virus Oka/Merck strain (live, attenuated) ≥ 1 350 PFU (1)

Powder and solvent for suspension for injection

Subcutaneous use

Finland

VARIVAX

one dose (0,5 ml) contains:

Varicella virus (Oka/Merck): not less than 1 350 PFU (1)

Powder and solvent for solution for injection

Intramuscular use, subcutaneous use

Finland

VARILRIX

one dose (0,5 ml) contains:

Live attenuated varicella-zoster virus (OKa strain) - not less than 103,3 PFU (1)

Powder and solvent for solution for injection

Intramuscular use, subcutaneous use

France

VARILRIX, poudre et solvant pour solution injectable en seringue préremplie. Vaccin varicelleux vivant

one dose (0,5 ml) contains:

Live attenuated varicella-zoster virus (Oka strain) – not less than 103,7 PFU (1)

Powder and solvent for solution for injection

Subcutaneous use

France

VARIVAX, poudre et solvant pour suspension injectable. Vaccin varicelleux vivant

one dose (0,5 ml) contains:

Varicella virus Oka/Merck strain (live, attenuated) ≥ 1 350 PFU (1)

Powder and solvent for solution for injection

Intramuscular use, subcutaneous use

Germany

Varivax

one dose (0,5 ml) contains:

Varicella virus Oka/Merck strain (live, attenuated) ≥ 1 350 PFU (1)

Powder and solvent for solution for injection

Subcutaneous use

Germany

Varilrix

one dose (0,5 ml) contains:

Live attenuated varicella-zoster virus (Oka strain) – not less than 103,3 PFU (1)

Powder and solvent for solution for injection

Intramuscular use, subcutaneous use

Germany

Varivax

one dose (0,5 ml) contains:

Varicella virus Oka/Merck strain (live, attenuated) ≥ 1 350 PFU (1)

Powder and solvent for solution for injection

Subcutaneous use

Greece

VARILRIX

one dose (0,5 ml) contains:

Live attenuated varicella-zoster virus (Oka strain) - not less than 103,3 PFU (1)

Powder and solvent for solution for injection

Subcutaneous use

Greece

VARIVAX

one dose (0,5 ml) contains:

Varicella Virus OKA/Merck Strain - not less than 1 350 PFU (1)

Powder and solution for injection

Intramuscular use, subcutaneous use

Hungary

Varilrix

one dose (0,5 ml) contains:

Live attenuated varicella-zoster virus (Oka strain) - not less than 103,3 PFU (1)

Powder and solvent for solution for injection

Subcutaneous use

Hungary

Varivax

one dose (0,5 ml) contains:

Varicella virus OKA/Merck strain (live, attenuated) not less than 1 350 PFU (1)

Powder and solution for injection

Intramuscular use, subcutaneous use

Iceland

Varilrix

one dose (0,5 ml) contains:

Live attenuated varicella-zoster virus (Oka strain) - not less than 103,3 PFU (1)

Powder and solvent for solution for injection

Subcutaneous use

Ireland

VARIVAX powder and solvent for suspension for injection.

one dose (0,5 ml) contains:

Live attenuated varicella virus (Oka/Merck strain) not less than 1 350 PFU (1)

Powder and solvent for suspension for injection

Subcutaneous use

Italy

VARILRIX

one dose (0,5 ml) contains:

Live attenuated varicella-zoster virus (Oka strain) - not less than 103,3 PFU (1)

Powder and solvent for solution for injection

Subcutaneous use

Italy

VARIVAX

one dose (0,5 ml) contains:

Live, attenuated Varicella virus (OKA/Merck strain) not less than 1 350 PFU (1)

Powder and solvent for suspension for injection

Intramuscular use, subcutaneous use

Latvia

Varivax powder and solvent for suspension for injection

one dose (0,5 ml) contains:

Varicella virus Oka/Merck strain (live, attenuated) ≥ 1 350 PFU (1)

Powder and solvent for suspension for injection

Intramuscular use, subcutaneous use

Latvia

Varilrix powder and solvent for solution for injection

one dose (0,5 ml) contains:

Live attenuated varicella-zoster virus (Oka strain) – not less than 103,3 PFU (1)

Powder and solvent for solution for injection

Subcutaneous use

Lithuania

Varilrix

one dose (0,5 ml) contains:

Live attenuated varicella-zoster virus (Oka strain) - not less than 103,3 PFU (1)

Powder and solvent for solution for injection

Subcutaneous use

Lithuania

VARIVAX

one dose (0,5 ml) contains:

Varicella, live attenuated (Oka/Merck strain) - 1 350 PFU (1)

Powder and solvent for suspension for injection

Intramuscular use, subcutaneous use

Luxembourg

VARILRIX

one dose (0,5 ml) contains:

Live attenuated varicella-zoster virus (Oka strain) - not less than 103,3 PFU (1)

Powder and solvent for solution for injection

Subcutaneous use

Luxembourg

PROVARIVAX

one dose (0,5 ml) contains:

Varicella virus Oka/Merck strain (live, attenuated) ≥ 1 350 PFU (1)

Powder for suspension for injection

Subcutaneous use

Malta

Varilrix

one dose (0,5 ml) contains:

Live attenuated varicella-zoster virus (Oka strain) - not less than 103,3 PFU (1)

Powder and solvent for solution for injection

Subcutaneous use

Malta

Varivax

one dose (0,5 ml) contains:

not less than 1 350 PFU (1) of the live attenuated varicella virus (OKA.Merck strain)

Powder and solvent for suspension for injection

Intramuscular use, subcutaneous use

Norway

Varilrix

one dose (0,5 ml) contains:

Live attenuated varicella-zoster virus (Oka strain) - not less than 103,3 PFU (1)

Powder and solvent for solution for injection

Subcutaneous use

Norway

Varivax

one dose (0,5 ml) contains:

Varicella virus, live attenuated, Oka/Merck strain ≥ 1 350 PFU (1)

Powder and solvent for suspension for injection

Intramuscular use, subcutaneous use

Poland

Varilrix

one dose (0,5 ml) contains:

Live attenuated varicella-zoster virus (Oka strain) - not less than 103,3 PFU (1)

Powder and solvent for solution for injection

Subcutaneous use

Portugal

Varilrix

one dose (0,5 ml) contains:

Live attenuated varicella-zoster virus (Oka strain) - not less than 103,3 PFU (1)

Powder and solvent for solution for injection

Subcutaneous use

Portugal

Varivax

one dose (0,5 ml) contains:

varicella virus (zoster vivo) – 1 350 PFU (1)

Powder and solvent for suspension for injection

Subcutaneous use

Romania

VARILRIX

one dose (0,5 ml) contains:

Live attenuated varicella-zoster virus (Oka strain) - not less than 103,3 PFU (1)

Powder and solvent for solution for injection

Subcutaneous use

Slovak Republic

Varivax

one dose (0,5 ml) contains:

Varicella virus (Oka/Merck strain) ≥ 1 350 PFU (1)

Powder and solvent for suspension for injection

Intramuscular use, subcutaneous use

Slovenia

Varivax prasek in vehikel za suspenzijo za injiciranje

one dose (0,5 ml) contains:

Varicella virus (strain Oka/Merck) (live, attenuated) - not less than 1 350,00 PFU (1)

Powder and solvent for suspension for injection

Intramuscular use, subcutaneous use

Spain

VARILRIX

one dose (0,5 ml) contains:

Live attenuated varicella-zoster virus (Oka strain) - not less than 103,3 PFU (1)

Powder and solvent for solution for injection

Subcutaneous use

Spain

VARIVAX POLVO Y DISOLVENTE PARA SUSPENSIÓN INYECTABLE

one dose (0,5 ml) contains:

Live atenuated varicella virus (Strain OKA/Merk) - ≥ 1 350 PFU (1)

Powder and solvent for suspension for injection

Intramuscular use, subcutaneous use

Sweden

Varilrix®

one dose (0,5 ml) contains:

Live attenuated varicella-zoster virus (Oka strain) - not less than 103,3 PFU (1)

Powder and solvent for solution for injection

Subcutaneous use

Sweden

Varivax®

one dose (0,5 ml) contains:

Varicella virus, strain Oka/Merck live attenuated - 1 350 PFU (1)

Powder and solvent for solution for injection

Intramuscular use, subcutaneous use

The Netherlands

Provarivax, poeder en oplosmiddel voor suspensie voor injectie

one dose (0,5 ml) contains:

Varicella virus Oka/Merck strain (live, attenuated) > 1 350 PFU (1)

Powder and solvent for solution for injection

Parenteral use

United Kingdom

VARILRIX

one dose (0,5 ml) contains:

Live attenuated varicella-zoster virus (Oka strain) - not less than 103,3 PFU (1)

Powder and solvent for solution for injection

Subcutaneous use

United Kingdom

VARIVAX Powder for Suspension

one dose (0,5 ml) contains:

Varicella Virus OKA/Merck Strain - 1 350 PFU (1)

Powder for suspension for injection

Subcutaneous use

Member State

(EU/EEA)

Marketing Authorisation Holder

Invented name

Strength

Pharmaceutical form

Route of administration

France

RUDI ROUVAX, poudre et solvant pour solution injectable. vaccin à virus vivants atténués contre la rougeole et la rubéole

one dose (0,5 ml) contains:

Powder and solvent for solution for injection

Intramuscular use,

subcutaneous use

Member State

(EU/EEA)

Marketing authorisation holder

Invented name

Strength

Pharmaceutical form

Route of administration

Austria

Priorix Pulver in Durchstechflaschen und Lösungsmittel in Fertigspritzen zur Herstellung einer Injektionslösung

one dose (0,5 ml) contains:

Live attenuated measles virus (Schwarz strain) - not less than 103,0 CCID50

Live attenuated mumps virus (RIT 4385, derived from Jeryl Lynn strain) - not less than 103,7 CCID50

Live attenuated rubella virus (Wistar RA 27/3 strain) - not less than 103,0 CCID50

Powder and solvent for solution for injection

Intramuscular use, subcutaneous use

Austria

Priorix Pulver und Lösungsmittel zur Herstellung einer Injektionslösung

one dose (0,5 ml) contains:

Live attenuated measles virus (Schwarz strain) - not less than 103,0 CCID50

Live attenuated mumps virus (RIT 4385, derived from Jeryl Lynn strain) - not less than 103,7 CCID50

Live attenuated rubella virus (Wistar RA 27/3 strain) - not less than 103,0 CCID50

Powder and solvent for solution for injection

Intramuscular use, subcutaneous use

Belgium

Priorix

one dose (0,5 ml) contains:

Live attenuated measles virus (Schwarz strain) - not less than 103,0 CCID50

Live attenuated mumps virus (RIT 4385, derived from Jeryl Lynn strain) - not less than 103,7 CCID50

Live attenuated rubella virus (Wistar RA 27/3 strain) - not less than 103,0 CCID50

Powder and solvent for solution for injection

Subcutaneous use

Intramuscular use, subcutaneous use

Bulgaria

Priorix

one dose (0,5 ml) contains:

Live attenuated measles virus (Schwarz strain) - not less than 103,0 CCID50

Live attenuated mumps virus (RIT 4385, derived from Jeryl Lynn strain) - not less than 103,7 CCID50

Live attenuated rubella virus (Wistar RA 27/3 strain) - not less than 103,0 CCID50

Powder and solvent for suspension for injection

Intramuscular use, subcutaneous use

Cyprus

Priorix injection

one dose (0,5 ml) contains:

Live attenuated measles virus (Schwarz strain) - not less than 103,0 CCID50

Live attenuated mumps virus (RIT 4385, derived from Jeryl Lynn strain) - not less than 103,7 CCID50

Live attenuated rubella virus (Wistar RA 27/3 strain) - not less than 103,0 CCID50

Powder and solvent for solution for injection

Intramuscular use, subcutaneous use

Czech Republic

PRIORIX

one dose (0,5 ml) contains:

Live attenuated measles virus (Schwarz strain) - not less than 103,0 CCID50

Live attenuated mumps virus (RIT 4385, derived from Jeryl Lynn strain) - not less than 103,7 CCID50

Live attenuated rubella virus (Wistar RA 27/3 strain) - not less than 103,0 CCID50

Powder and solvent for solution for injection

Intramuscular use, subcutaneous use

Denmark

Priorix

one dose (0,5 ml) contains:

Live attenuated measles virus (Schwarz strain) - not less than 103,0 CCID50

Live attenuated mumps virus (RIT 4385, derived from Jeryl Lynn strain) - not less than 103,7 CCID50

Live attenuated rubella virus (Wistar RA 27/3 strain) - not less than 103,0 CCID50

Powder and solvent for solution for injection

Intramuscular use, subcutaneous use

Estonia

PRIORIX

one dose (0,5 ml) contains:

Live attenuated measles virus (Schwarz strain) - not less than 103,0 CCID50

Live attenuated mumps virus (RIT 4385, derived from Jeryl Lynn strain) - not less than 103,7 CCID50

Live attenuated rubella virus (Wistar RA 27/3 strain) - not less than 103,0 CCID50

Powder and solvent for solution for injection

Subcutaneous use

Finland

PRIORIX

one dose (0,5 ml) contains:

Live attenuated measles virus (Schwarz strain) - not less than 103,0 CCID50

Live attenuated mumps virus (RIT 4385, derived from Jeryl Lynn strain) - not less than 103,7 CCID50

Live attenuated rubella virus (Wistar RA 27/3 strain) - not less than 103,0 CCID50

Powder and solvent for solution for injection

Intramuscular use, subcutaneous use

France

PRIORIX, poudre et solvant pour solution injectable en seringue préremplie. vaccin rougeoleux, des oreillons et rubéoleux vivant

one dose (0,5 ml) contains:

Live attenuated measles virus (Schwarz strain) - not less than 103,0 CCID50

Live attenuated mumps virus (RIT 4385 strain, derived from Jeryl Lynn strain) - not less than 103,7 CCID50

Live attenuated rubella virus (Wistar RA 27/3 strain) - not less than 103,0 CCID50

Powder and solvent for solution for injection

Intramuscular use, subcutaneous use

France

R.O.R., poudre et solvant pour solution injectable. vaccin à virus vivants atténués contre la rougeole, les oreillons et la rubéole

one dose (0,5 ml) contains:

Measles virus Schwartz strain (live, attenuated) not less than 103,0 CCID50

Mumps virus URABE AM-9 strain (live, attenuated) not less than 5 × 103,0 CCID50

Rubella virus Wistar RA 27/3 strain (live, attenuated) not less than 103,0 CCID50