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Document 52013XC0830(09)
Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 February 2013 to 28 February 2013 (Decisions taken pursuant to Article 34 of Directive 2001/83/EC or Article 38 of Directive 2001/82/EC)
Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 February 2013 to 28 February 2013 (Decisions taken pursuant to Article 34 of Directive 2001/83/EC or Article 38 of Directive 2001/82/EC)
Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 February 2013 to 28 February 2013 (Decisions taken pursuant to Article 34 of Directive 2001/83/EC or Article 38 of Directive 2001/82/EC)
OJ C 250, 30.8.2013, p. 1–29
(BG, ES, CS, DA, DE, ET, EL, EN, FR, HR, IT, LV, LT, HU, MT, NL, PL, PT, RO, SK, SL, FI, SV)
- Date of document:
- 30/08/2013; Date of publication
- Author:
- European Commission
- Form:
- Notice
- Legal basis:
-
- 32001L0082 - A38
- 32001L0083 - A34
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- Select all documents mentioning this document
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- EUROVOC descriptor:
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|
30.8.2013 |
EN |
Official Journal of the European Union |
C 250/1 |
Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 February 2013 to 28 February 2013
(Decisions taken pursuant to Article 34 of Directive 2001/83/EC (1) or Article 38 of Directive 2001/82/EC (2) )
2013/C 250/01
— Issuing, maintenance or modification of a national marketing authorization
|
Date of the decision |
Name(s) of the medicinal product |
Holder(s) of the marketing authorization |
Member State concerned |
Date of notification |
|
28.2.2013 |
Monovalent and multivalent measles, mumps, rubella and varicella vaccines (live) |
See Annex I |
See Annex I |
1.3.2013 |
(1) OJ L 311, 28.11.2001, p. 67.
(2) OJ L 311, 28.11.2001, p. 1.
ANNEX I
LIST OF THE NAMES, PHARMACEUTICAL FORMS, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTES OF ADMINISTRATION, MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES
Measles vaccines (live) with Marketing Authorisation in the European Union
|
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 1 000 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 1 000 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 1 000 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 1 000 CCID50 |
Powder and solvent for solution for injection |
Intramuscular use, subcutaneous use |
||||
|
Spain |
|
AMUNOVAX VIAL |
Measles virus (live, attenuated) - not less than 1 000 TCID50 |
Powder and solvent for solution for injection |
Subcutaneous use |
Mumps vaccines (live) with Marketing Authorisation in the European Union
|
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) - 5 000 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 5 000 CCID50 |
Powder and solvent for solution for injection |
Intramuscular use, subcutaneous use |
||||
|
Spain |
|
VACUNA MSD ANTI-PAROTIDITIS |
Mumps virus (Strain Jeryl Lynn - B level) - not less than 20 000 TCID50 |
Powder and solvent for solution for injection |
Subcutaneous use |
Rubella vaccines (live) with Marketing Authorisation in the European Union
|
Member State (EU/EEA) |
Marketing authorisation holder |
Invented name |
Strength |
Pharmaceutical form |
Route of administration |
|||||
|
Bulgaria |
|
Rudixax |
live, attenuated rubella virus (strain Wistar RA 27/3) - at least 1 000 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) - 1 000 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) - 1 000 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) - 1 000 CCID50 |
Powder and solvent for solution for injection |
Intramuscular use, subcutaneous use |
|||||
|
Spain |
|
VACUNA ANTIRRUBEOLA MERIEUX |
Rubella virus live attenuated (Strain Wistar RA 27/3M) - not less than 1 000 TCID50 |
Powder and solvent for solution for injection |
Subcutaneous use |
|||||
|
Spain |
|
VACUNA ANTIRRUBEOLA GSK |
Rubella virus live attenuated (Strain RA 27/3) - not less than 1 000 TCID50 |
Powder and solvent for solution for injection |
Subcutaneous use |
|||||
|
Spain |
|
RUBEATEN BERNA |
Rubella virus live (Strain Wistar RA 27/3) - not less than 1 000 TCID50 |
Powder and solvent for solution for injection |
Subcutaneous use |
Varicella vaccines (live) with Marketing Authorisation in the European Union
|
Member State (EU/EEA) |
Marketing authorisation holder |
Invented name |
Strength |
Pharmaceutical form |
Route of administration |
||||||
|
Austria |
|
Varilrix Pulver und Lösungsmittel zur Herstellung einer Injektionssuspension |
After resuspension, one dose (0,5 ml) contains attenuated varicella zoster virus (OKA strain) - not less than 103,3 PFU (Plaque forming units) |
Powder and solvent for suspension for injection |
Subcutaneous use |
||||||
|
Austria |
|
VARIVAX Pulver und Lösungsmittel zur Herstellung einer Injektionssuspension |
After reconstitution, one dose (0,5 ml) contains: Varicella virus** strain Oka/Merck (live, attenuated) ≥ 1,350 PFU*** ** produced in MRC-5 human diploid cells. *** PFU = Plaque forming units |
Powder and solvent for suspension for injection |
Intramuscular use, subcutaneous use |
||||||
|
Belgium |
|
Varilrix |
Each 0,5 ml dose of the reconstituted vaccine contains: Varicella virus - not less than 103,3 UFP |
Powder and solvent for solution for injection |
Subcutaneous use |
||||||
|
Belgium |
|
Provarivax |
After reconstitution, one dose (0,5 mL) contains: Varicella virus** Oka/Merck strain (live, attenuated) 31 350 PFU*** * Produced in human diploid cells (MRC-5) *** PFU = Plaque-forming units |
Powder and solvent for solution for injection |
Subcutaneous use |
||||||
|
Cyprus |
|
Varivax powder and solvent for suspension for injection 1350 PFU |
After reconstitution, one dose (0,5 ml) contains: Varicella virus** Oka/Merck strain (live, attenuated) 1 350 PFU*** |
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 (Oka strain) virus* 103,3 plaque forming units (PFU) |
Powder and solvent for solution for injection |
Subcutaneous use |
||||||
|
Czech Republic |
|
VARILRIX |
One dose (0,5 ml) contains: Live, attenuated varicella virus - not less than 103,3 PFU |
Powder and solvent for solution for injection |
Subcutaneous use |
||||||
|
Estonia |
|
VARILRIX |
After reconstitution, one dose (0,5 ml) contains: minimum 103,3 PFU Varicella zoster-virus |
Powder and solvent for solution for injection |
Subcutaneous use |
||||||
|
Estonia |
|
VARIVAX |
After reconstitution, one dose (0,5 ml) contains: Varicella virus Oka/Merck strain (live, attenuated) ≥ 1 350 PFU |
Powder and solvent for suspension for injection |
Subcutaneous use |
||||||
|
Finland |
|
VARIVAX |
per 0,5 ml: Varicella virus (Oka/Merck): not less than: 1 350 PFU |
Powder and solvent for solution for injection |
Intramuscular use, subcutaneous use |
||||||
|
Finland |
|
VARILRIX |
per 0,5 ml: Varicella virus (Oka): not less than: 103,3 PFU |
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: Varicella virus** Oka/Merck strain (live, attenuated) 103,7 PFU*** ** Produced in human diploid cells (MRC-5) ***PFU = Plaque-forming units |
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*** ** Produced in human diploid cells (MRC-5) ***PFU = Plaque-forming units |
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*** ** Produced in human diploid cells (MRC-5) ***PFU = Plaque-forming units |
Powder and solvent for solution for injection |
Subcutaneous use |
||||||
|
Germany |
|
Varilrix |
one dose (0,5 mL) contains: Varicella virus**OKA strain (live, attenuated) 103,7 PFU** ***Produced in human diploid cells (MRC-5) ***PFU = Plaque-forming units |
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*** ** Produced in human diploid cells (MRC-5) ***PFU = Plaque-forming units |
Powder and solvent for solution for injection |
Subcutaneous use |
||||||
|
Germany |
|
Varilrix |
one dose (0,5 ml) contains: Varicella virus** OKA strain (live, attenuated) 103,7 PFU*** ** Produced in human diploid cells (MRC-5) ***PFU = Plaque-forming units |
Powder and solvent for solution for injection |
Intramuscular use, subcutaneous use |
||||||
|
Greece |
|
VARILRIX |
per 0,5 ml dose: Live Attenuated Varicella Virus OKA Strain not less than 103,3 PFU |
Powder and solvent for solution for injection |
Subcutaneous use |
||||||
|
Greece |
|
VARIVAX |
per 0,5 ml dose: Varicella Virus OKA/Merck Strain - not less than 1 350 PFU |
Powder and solution for injection |
Intramuscular use, subcutaneous use |
||||||
|
Hungary |
|
Varilrix |
After reconstitution, 1 dose (0,5 ml) contains: Varicella virus OKA strain (live, attenuated) not less than 103,3 PFU |
Powder and solvent for solution for injection |
Subcutaneous use |
||||||
|
Hungary |
|
Varivax |
After reconstitution, 1 dose (0,5 ml) contains: Varicella virus OKA/Merck strain (live, attenuated) not less than 1 350 PFU |
Powder and solution for injection |
Intramuscular use, subcutaneous use |
||||||
|
Iceland |
|
Varilrix |
1 dose (0,5 ml) contains: ≥ 103,3 PFU (Plaque forming units) of Varicella-Zoster Virus OKA strain |
Powder and solvent for solution for injection |
Subcutaneous use |
||||||
|
Ireland |
|
VARIVAX powder and solvent for suspension for injection. |
Each 0,5 ml dose of reconstituted vaccine contains: Live attenuated varicella virus (Oka/Merck strain) not less than 1 350 PFU |
Powder and solvent for suspension for injection |
Subcutaneous use |
||||||
|
Italy |
|
VARILRIX |
After reconstitution, 1 dose (0,5 ml) contains: Live, attenuated Varicella virus (OKA strain) not less than 2 000 PFU |
Powder and solvent for solution for injection |
Subcutaneous use |
||||||
|
Italy |
|
VARIVAX |
After reconstitution, 1 dose (0,5 ml) contains: Live, attenuated Varicella virus (OKA/Merck strain) not less than 1 350 PFU |
Powder and solvent for suspension for injection |
Intramuscular use, subcutaneous use |
||||||
|
Latvia |
|
Varivax powder and solvent for suspension for injection |
After reconstitution, one dose (0,5 ml) contains: Varicella virus Oka/Merck strain (live, attenuated) ≥ 1 350 PFU |
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 (Oka strain) virus 103,3 plaque forming units (PFU) |
Powder and solvent for solution for injection |
Subcutaneous use |
||||||
|
Lithuania |
|
Varilrix |
After reconstitution, 1 dose (0,5 ml) contains: Live attenuated varicella zoster virus (Oka strain) - not less than 103,3 PFU |
Powder and solvent for solution for injection |
Subcutaneous use |
||||||
|
Lithuania |
|
VARIVAX |
per dose (0,5 ml): Varicella, live attenuated (Oka/Merck strain) - 1 350 PFU |
Powder and solvent for suspension for injection |
Intramuscular use, subcutaneous use |
||||||
|
Luxembourg |
|
VARILRIX |
1 dose (0,5 ml) contains: Live attenuated Varicella virus - not less than 103,3 PFU |
Powder and solvent for solution for injection |
Subcutaneous use |
||||||
|
Luxembourg |
|
PROVARIVAX |
1 dose (0,5 ml) contains: Live attenuated varicella-zoster (Oka/Merck strain) virus not less than 1 350 PFU |
Powder for suspension for injection |
Subcutaneous use |
||||||
|
Malta |
|
Varilrix |
Each 0,5 ml dose of the reconstituted vaccine contains: NLT 103,3 PFU of the live attenuated varicella-zoster virus (OKA strain) |
Powder and solvent for solution for injection |
Subcutaneous use |
||||||
|
Malta |
Merck Sharp & Dohme Ltd. Hertford Road Hoddesdon Hertfordshire EN 11 9BU United Kingdom |
Varivax |
Each 0,5 ml dose of the reconstituted vaccine contains: NLT 1 350 PFU of the live attenuated varicella virus (produced in human diploid (MRC-5) cells (OKA.Merck strain) |
Powder and solvent for suspension for injection |
Intramuscular use, subcutaneous use |
||||||
|
Norway |
|
Varilrix |
After reconstitution, 1 dose (0,5 ml) contains: Live attenuated varicella zoster virus (Oka strain) - not less than 103,3 PFU |
Powder and solvent for solution for injection |
Subcutaneous use |
||||||
|
Norway |
|
Varivax |
After reconstitution, one dose (0,5 ml) contains: Varicella virus, live attenuated, Oka/Merck strain ≥ 1 350 PFU |
Powder and solvent for suspension for injection |
Intramuscular use, subcutaneous use |
||||||
|
Poland |
|
Varilrix |
per 0,5 ml of reconstituted vaccine: Not less than 2 000 PFU of the varicella-zoster virus (oka strain) |
Powder and solvent for solution for injection |
Subcutaneous use |
||||||
|
Portugal |
|
Varilrix |
varicella virus (zoster vivo) - 3,3 log10 PFU/0,5 ml |
Powder and solvent for solution for injection |
Subcutaneous use |
||||||
|
Portugal |
|
Varivax |
varicella virus (zoster vivo) - 1 350 FPU/0,5 ml |
Powder and solvent for suspension for injection |
Subcutaneous use |
||||||
|
Romania |
|
VARILRIX |
Varicella virus (Oka strain): ≥ 103,3 PFU |
Powder and solvent for solution for injection |
Subcutaneous use |
||||||
|
Slovak Republic |
|
Varivax |
Varicella virus** (Oka/Merck strain) 31 350 PFU*** ** Produced on human diploid cells (MRC-5) ***PFU = Plaque-forming units |
Powder and solvent for suspension for injection |
Intramuscular use, subcutaneous use |
||||||
|
Slovenia |
|
Varivax prasek in vehikel za suspenzijo za injiciranje |
per dose (0,5 ml): Varicella virus (strain Oka/Merck) (live, attenuated) - not less than 1 350,00 PFU |
Powder and solvent for suspension for injection |
Intramuscular use, subcutaneous use |
||||||
|
Spain |
|
VARILRIX |
Live atenuated varicella-zoster virus (Strain OKA) - not less than 103,3 UFP |
Powder and solvent for solution for injection |
Subcutaneous use |
||||||
|
Spain |
|
VARIVAX POLVO Y DISOLVENTE PARA SUSPENSIÓN INYECTABLE |
Live atenuated varicella virus (Strain OKA/Merk) - 31 350 UFP |
Powder and solvent for suspension for injection |
Intramuscular use, subcutaneous use |
||||||
|
Sweden |
|
Varilrix® |
Varicella virus, strain Oka/Merck live attenuated - 103,3 pfu |
Powder and solvent for solution for injection |
Subcutaneous use |
||||||
|
Sweden |
|
Varivax® |
Varicella virus, strain Oka/Merck live attenuated - 1 350 pfu |
Powder and solvent for solution for injection |
Intramuscular use, subcutaneous use |
||||||
|
The Netherlands |
|
Provarivax, poeder en oplosmiddel voor suspensie voor injectie |
per 0,5 ml Varicella virus Oka/Merck strain (live, attenuated) > 1 350 PFU |
Powder and solvent for solution for injection |
Parenteral use |
||||||
|
United Kingdom |
|
VARILRIX |
Live Attenuated Varicella Virus OKA Strain - 10 000 PFU/0,5 ml |
Powder and solvent for solution for injection |
Subcutaneous use |
||||||
|
United Kingdom |
|
VARIVAX Powder for Suspension |
Varicella Virus OKA/Merck Strain - 1 350 PFU |
Powder for suspension for injection |
Subcutaneous use |
Measles and rubella vaccines (live) with Marketing Authorisation in the European Union
|
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 |
Measles, mumps and rubella vaccines (live) with Marketing Authorisation in the European Union
|
Member State (EU/EEA) |
Marketing authorisation holder |
Invented name |
Strength |
Pharmaceutical form |
Route administration |
||||||||||||||||
|
Austria |
|
Priorix Pulver in Durchstechflaschen und Lösungsmittel in Fertigspritzen zur Herstellung einer Injektionslösung |
After reconstitution, one dose (0,5 ml) contains:
|
Powder and solvent for solution for injection |
Intramuscular use, subcutaneous use |
||||||||||||||||
|
Austria |
|
Priorix Pulver und Lösungsmittel zur Herstellung einer Injektionslösung |
After reconstitution, one dose (0,5 ml) contains: Measles virus, strain Schwarz1 (live, attenuated) not less than 103,0 CCID503 Mumps virus, strain RIT 43851, derived from strain Jeryl Lynn (live, attenuated) not less than 103,7 CCID503 Rubella virus, strain Wistar RA 27/32 (live, attenuated) not less than 103,0 CCID503
|
Powder and solvent for solution for injection |
Intramuscular use, subcutaneous use |
||||||||||||||||
|
Belgium |
|
Priorix |
Each 0,5 ml dose of the reconstituted vaccine contains:
*CCID 50 – Cell Culture Infective Dose 50
|
Powder and solvent for solution for injection |
Subcutaneous use Intramuscular use, subcutaneous use |
||||||||||||||||
|
Bulgaria |
|
Priorix |
live attenuated measles virus (Schwarz strain) ≥ 103,0 CCID50 live attenuated mumps virus (RIT 4385 strain) ≥ 103,7 CCID50 live attenuated rubella virus (strain Wistar RA 27/3) ≥ 103,0 CCID50 |
Powder and solvent for suspension for injection |
Intramuscular use, subcutaneous use |
||||||||||||||||
|
Cyprus |
|
Priorix injection |
Each 0,5 ml dose of the reconstituted vaccine contains: not less than 103,0 CCID50* of the Schwarz measles1 not less than 103,7 CCID50 of the RIT 4385 mumps1 not less than 103,0 CCID50 of the Wistar RA 27/3 rubella2 virus strains. |
Powder and solvent for solution for injection |
Intramuscular use, subcutaneous use |
||||||||||||||||
|
Czech Republic |
|
PRIORIX |
per 0,5 ml/dose: Live, attenuated measles virus (Schwarz strain) - not less than 103,0 CCID503 Live, attenuated mumps virus (RIT 4385 strain, derived from Jeryl Lynn strain) - not less than 103,7 CCID503 Live, attenuated rubella virus (Wistar RA 27/3 strain) - not less than 103,0 CCID503 |
Powder and solvent for solution for injection |
Intramuscular use, subcutaneous use |
||||||||||||||||
|
Denmark |
|
Priorix |
per 0,5 mL dose: Not less than: 103,0 CCID50 of the Schwarz measles; Not less than: 103,7 CCID50 of the RIT 4385 mumps; Not less than: 103,0 CCID50 of the Wistar RA 27/3 rubella |
Powder and solvent for solution for injection |
Intramuscular use, subcutaneous use |
||||||||||||||||
|
Denmark |
|
Varilrix |
One dose (0,5 ml) contains: Live attenuated varicella-zoster (Oka strain) virus* 103,3 plaque forming units (PFU) |
Powder and solvent for solution for injection |
Subcutaneous use |
||||||||||||||||
|
Denmark |
|
Provarivax |
One dose (0,5 ml) contains: Live attenuated varicella-zoster (Oka strain) virus* 103,3 plaque forming units (PFU) |
Powder and solvent for solution for injection, suspension |
Subcutaneous use |
||||||||||||||||
|
Estonia |
|
PRIORIX |
Measles virus (live, attenuated) NLT 103,0 CCID50; Mumps virus (live, attenuated) NLT 103,7 CCID50; Rubella virus (live, attenuated) NLT 103,0 CCID50 |
Powder and solvent for solution for injection |
Subcutaneous use |
||||||||||||||||
|
Finland |
|
PRIORIX |
per 0,5 ml: Measles virus (Schwarz) - not less than 103,0 CCID50 Mumps virus (RIT 4385) - not less than 103,7 CCID50 Rubella virus (Wistar RA27/3) - 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 |
1 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 1 000 CCID50 Mumps virus URABE AM-9 strain (live, attenuated) not less than 5 000 CCID50 Rubella virus Wistar RA 27/3 strain (live, attenuated) not less than 1 000 CCID50 |
Powder and solvent for solution for injection |
Intramuscular use, subcutaneous use |
||||||||||||||||
|
France |
|
R.O.R. VAX, poudre et solvant pour suspension injectable. Vaccin rougeoleux, des oreillons et rubéoleux atténué. |
one dose (0,5 ml) contains: Measles virus Edmonston 749D strain (live, attenuated) - 1 000 CCID50 Mumps virus Jeryl Lynn strain (live, attenuated) - 5 000 CCID50 Rubella virus Wistar RA 27/3 strain (live, attenuated) - 1 000 CCID50 |
Powder and solvent for solution for injection |
Intramuscular use, subcutaneous use |
||||||||||||||||
|
Germany |
|
Priorix |
per 0,5 ml dose: Measles virus - not less than 3,0 log10 CCID50 mumps virus - not less than 3,7 log10 CCID50 rubella virus - not less than 3,0 log10 CCID50 |
Powder and solvent for solution for injection |
Intramuscular use, subcutaneous use |
||||||||||||||||
|
Germany |
|
Priorix |
per 0,5 ml dose: Measles virus - not less than 3,0 log10 CCID50 mumps virus - not less than 3,7 log10 CCID50 rubella virus - not less than 3,0 log10 CCID50 |
Powder and solvent for solution for injection |
Intramuscular use, subcutaneous use |
||||||||||||||||
|
Greece |
|
PRIORIX |
Live attenuated measles virus (Schwarz strain) - 1 000,000 CC Live attenuated mumps virus (RIT 4385 strain) - 1 000,000 CC Live attenuated rubella virus (Wistar RA 27/3 strain) - 1 000,000 CC |
Powder and solvent for solution for injection |
Intramuscular use, subcutaneous use |
||||||||||||||||
|
Hungary |
|
Priorix por ésoldószer oldatos injekcióhoz |
After reconstitution, 1 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 0 CCID50 |
Powder and solvent for solution for injection |
Intramuscular use, subcutaneous use |
||||||||||||||||
|
Iceland |
|
Priorix |
per 0,5 ml Rubella virus >= 103 CCID50 Measles virus >= 103 CCID50 Mumps virus >= 103,7 CCID50 |
Powder and solvent for solution for injection |
Intramuscular use, subcutaneous use |
||||||||||||||||
|
Italy |
|
PRIORIX |
Live attenuated measles virus1 (Schwarz strain) - not less than 103,0 CCID503 Live attenuated mumps virus1 (RIT 4385 strain, derived from Jeryl Lynn strain) - not less than 7 CCID503 Live attenuated rubella virus2 (Wistar RA 27/3 strain) - not less than 103,0 CCID503 |
Powder and solvent for solution for injection |
Intramuscular use, subcutaneous use |
||||||||||||||||
|
Latvia |
|
Priorix powder and solvent for solution for injection |
After reconstitution, 1 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 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 |
||||||||||||||||
|
Latvia |
|
Priorix powder and solvent for solution for injection in pre-filled syringe |
After reconstitution, 1 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 |
||||||||||||||||
|
Lithuania |
|
Priorix |
After reconstitution, 1 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 |
||||||||||||||||
|
Luxembourg |
|
PRIORIX |
1 dose (0,5 ml) contains: Live attenuated measles virus (Schwarz strain) - not less than 103 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 CCID50 |
Powder and solvent for solution for injection |
Intramuscular use, subcutaneous use |
||||||||||||||||
|
Malta |
|
Priorix |
Each 0,5 ml dose of the reconstituted vaccine contains; NLT 103,0 CCID50 of the Schwarz measles (produced in chick embryo cells) NLT 103,7 CCID50 of the RIT 4385 mumps (produced in chick embryo cells) NTL 103,0 CCID50 of the Wistar RA 27/3 rubella (produced in human diploid MRC-5 cells) virus strains |
Powder and solvent for solution for injection |
Subcutaneous use, Intramascular use |
||||||||||||||||
|
Norway |
|
Priorix |
Each 0,5 ml dose of the reconstitured vaccine contains: Live attenuated Schwarz measles virus strain: not less than 103 CCID50 Live attenuated RIT 4385 mumps virus strain: not less than 103,7 CCID50 Live attenuated Wistar RA 27/3 rubella virus strain: not less than 103 CCID50. |
Powder and solvent for solution for injection |
Intramuscular use, subcutaneous use |
||||||||||||||||
|
Poland |
|
M-M-R II |
per 0,5 ml dose: not less than 1 000 CCID50 of the measlec virus Enders-Edmonston strain, not less than 12 500 CCID50 of the mumps virus (Jeryl Lynn strain); and not less than 1 000 CCID50 of the Wistar RA 27/3 rubella virus strains |
Powder and solvent for solution for injection |
Subcutaneous use |
||||||||||||||||
|
Poland |
|
Priorix |
per 0,5 ml dose: Not less than: 103,0 CCID50 of the Schwarz measles virus; Not less than:103,7 CCID50 of the RIT 4385 mumps virus; Not less than:103,0 CCID50 of the Wistar RA 27/3 rubella virus strains |
Powder and solvent for solution for injection |
Intramuscular use, subcutaneous use |
||||||||||||||||
|
Portugal |
|
Priorix |
per 0,5 ml dose: Measles virus (Schwarz strain) - not less than 3,0 log10 CCID50 mumps virus (RIT 4385 strain) - not less than 3,7 log10 CCID50 rubella virus (Wistar RA 27/3 starin) - not less than 3,0 log10 CCID50 |
Powder and solvent for solution for injection |
Intramuscular use, subcutaneous use |
||||||||||||||||
|
Portugal |
|
Priorix |
per 0,5 ml dose: Measles virus (Schwarz strain) - not less than 3,0 log10 CCID50 mumps virus (RIT 4385 strain) - not less than 3,7 log10 CCID50 rubella virus (Wistar RA 27/3 starin) - not less than 3,0 log10 CCID50 |
Powder and solvent for solution for injection in pre-filled syringe |
Intramuscular use, subcutaneous use |
||||||||||||||||
|
Romania |
|
PRIORIX |
Measles virus (Schwarz strain): ≥ 103,0 CCID50 Mumps virus (RIT 4385 strain): ≥ 103,7 CCID50 Rubella virus (Wistar RA 27/3 strain): ≥ 103,0 CCID50 |
Powder and solvent for solution for injection |
Intramuscular use, subcutaneous use |
||||||||||||||||
|
Slovak Republic |
|
Proirix |
Measles virus Schwarz strain (live, attenuated) not less than 103,0 CCID503 Mumps virus RIT 4385 strain, derived from Jeryl Lynn strain (live, attenuated) not less than 103,7 CCID503 Rubella virus (Wistar RA 27/3 strain) (live, attenuated) - not less than 103,0 CCID503 |
Powder and solvent for solution for injection |
Intramuscular use, subcutaneous use |
||||||||||||||||
|
Slovenia |
|
Priorix prašek in vehikel za raztopino za injiciranje |
per dose (0,5 ml): Measles virus (strain Schwarz) (live, atenuated) - not less than 103,0 CCID50 Mumps virus (strain RIT 4385 - derived from strain Jeryl Lynn) (live, atenuated) - not less than 103,7 CCID50 Rubella virus (strain Wistar RA 27/3) (live, atenuated) - not less than 103,0 CCID50 |
Powder and solvent for solution for injection |
Intramuscular use, subcutaneous use |
||||||||||||||||
|
Spain |
|
PRIORIX, POLVO Y DISOLVENTE EN JERINGA PRECARGADA PARA SOLUCIÓN INYECTABLE |
Live atenuated rubella (Strain Wistar RA 27/3) - not less than 103,0 CCID50, measles (Cepa Schwarz) - 103,0 CCID50 mumps (Cepa RIT 4385, derivated from Cepa Jeryl Lynn) - 103,7 CCID50 |
Powder and solvent for solution for injection |
Intramuscular use, subcutaneous use |
||||||||||||||||
|
Sweden |
|
Priorix® |
After reconstitution, 1 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 |
||||||||||||||||
|
The Netherlands |
|
Priorix, poeder en oplosmiddel voor suspensie voor injectie |
per 0,5 ml: Measles virus Schwarz strain (live, attenuated) not less than 10 CCID50 Mumps virus RIT 4385 strain, derived from Jeryl Lynn strain (live, attenuated) not less than 10 CCID50 Rubella virus Wistar RA 27/3 strain (live, attenuated) not less than 100 CCID50 |
Powder and solvent for solution for injection |
Parenteral use |
||||||||||||||||
|
United Kingdom |
SmithKline Beecham plc 980 Great West Road Brentford Middlesex TW8 9GS United Kingdom |
PRIORIX powder and solvent for solution for injection |
Mumps (RIT 4385 Derived from Jeryl Lynn): 5 011 CID50 Measles (Schwarz Strain): 1 000 CID50 Rubella (Wistar RA 27/3 Strain): 1 000 CID50 |
Powder and solvent for solution for injection |
Intramuscular use, subcutaneous use |
Measles, mumps, rubella and varicella vaccines (live) with Marketing Authorisation in the European Union
|
Member State (EU/EEA) |
Marketing authorisation holder |
Invented name |
Strength |
Pharmaceutical form |
Route of administration |
||||||||||||
|
Austria |
|
Priorix - Tetra Pulver in Durchstechflaschen und Lösungsmittel in Fertigspritzen zur Herstellung einer Injektionslösung |
One dose (0,5 ml) of the solved vaccine contains: Measles virus, strain Schwarz1 (live, attenuated) - not less than 103,0 CCID503 Mumps virus, strain RIT 43851, derived from strain Jeryl Lynn (live, attenuated) - not less than 104,4 CCID503 Rubella virus, strain Wistar RA 27/32 (live, attenuated) - not less than 103,0 CCID503 Varicella Virus, strain OKA2 (live, attenuated) - not less than 103,3 PFU4
|
Powder and solvent for solution for injection |
Subcutaneous use |
||||||||||||
|
Austria |
|
Priorix - Tetra Pulver und Lösungsmittel zur Herstellung einer Injektionslösung |
One dose (0,5 ml) of the solved vaccine contains: Measles virus, strain Schwarz1 (live, attenuated) - not less than 103,0 CCID503 Mumps virus, strain RIT 43851, derived from strain Jeryl Lynn (live, attenuated) - not less than 104,4 CCID503 Rubella virus, strain Wistar RA 27/32 (live, attenuated) - not less than 103,0 CCID503 Varicella virus, strain OKA2 (live, attenuated) - not less than 103,3 PFU4
|
Powder and solvent for solution for injection |
Subcutaneous use |
||||||||||||
|
Belgium |
|
Priorix-Tetra |
After reconstitution, 1 dose (0,5 ml) contains: Measles virus Schwarz strain (live, attenuated) not less than 103,0 CCID50 Mumps virus RIT 4385 strain, derived from Jeryl Lynn strain (live, attenuated) not less than 104,4 CCID50 Rubella virus (Wistar RA 27/3 strain) (live, attenuated) not less than 103,0 CCID50 Varicella virus OKA strain (live, attenuated) not less than 103,3 PFU |
Powder and solvent for solution for injection |
Subcutaneous use |
||||||||||||
|
Cyprus |
|
Priorix Tetra powder and solvent for solution for injection |
Each 0,5 ml dose of the reconstituted vaccine contains: - not less than 103,0 CCID50* of the Schwarz measles1 - not less than 104,4 CCID50 of the RIT 4385 mumps1, - not less than 103,0 CCID50 of the Wistar RA 27/3 rubella2 virus strains and - not less than 103,3 plaque forming units (PFU) of live attenuated varicella-zoster (Oka strain) virus |
Powder and solvent for solution for injection |
Subcutaneous use |
||||||||||||
|
Cyprus |
|
PRIORIX TETRA POWDER IN VIAL + SOLVENT IN AMPOULE |
Each 0,5 ml dose of the reconstituted vaccine contains: - not less than 103,0 CCID50* of the Schwarz measles1 - not less than 104,4 CCID50 of the RIT 4385 mumps1, - not less than 103,0 CCID50 of the Wistar RA 27/3 rubella2 virus strains and - not less than 103,3 plaque forming units (PFU) of live attenuated varicella-zoster (Oka strain) virus |
Powder and solvent for solution for injection |
Subcutaneous use |
||||||||||||
|
Czech Republic |
|
PRIORIX-TETRA INJ. STŘÍKAČKA |
per 0,5 ml/dose: 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 104,4 CCID50 Live, attenuated rubella virus (Wistar RA 27/3 strain) - not less than 103,0 CCID50 Live, attenuated varicella virus (Oka strain) - not less than 103,3 PFU |
Powder and solvent for solution for injection |
Subcutaneous use |
||||||||||||
|
Czech Republic |
|
PRIORIX-TETRA LAHVIČKA/AMPULE |
per 0,5 ml/dose: 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 104,4 CCID50 Live, attenuated rubella virus (Wistar RA 27/3 strain) - not less than 103,0 CCID50 Live, attenuated varicella virus (Oka strain) - not less than 103,3 PFU |
Powder and solvent for solution for injection |
Subcutaneous use |
||||||||||||
|
Denmark |
|
Priorix-Tetra |
Live, attenuated measles virus (Schwarz strain) - not less than 103,0 CCID50 Live, attenuated mumps virus (RIT 4385 strain, derived from Jeyl Lynn strain) - not less than 104,0 CCID50 Live attenuated rubella virus (Wistar RA 27/3 strain) - not less than 103,0 CCID50. Live, attenuated varicella virus (Oka strain) - not less than 103,3 PFU |
Powder and solvent for solution for injection |
Subcutaneous use |
||||||||||||
|
Denmark |
|
Priorix-T,etra |
Live, attenuated measles virus (Schwarz strain) - not less than 103,0 CCID50 Live, attenuated mumps virus (RIT 4385 strain, derived from Jeyl Lynn strain) - not less than 104,4 CCID50 Live attenuated rubella virus (Wistar RA 27/3 strain) - not less than 103,0 CCID50. Live, attenuated varicella virus (Oka strain) - not less than 103,3 PFU |
Powder and solvent for solution for injection |
Subcutaneous use |
||||||||||||
|
Estonia |
|
PRIORIX-TETRA |
Measles virus (live, attenuated) NLT 103,0 CCID50; Mumps virus (live, attenuated) NLT 104,4 CCID50; Rubella virus (live, attenuated) NLT 103,0 CCID50; Varicella virus (live, attenuated) NLT 103,3 PFU |
Powder and solvent for solution for injection |
Subcutaneous use |
||||||||||||
|
Estonia |
|
PRIORIX-TETRA |
Measles virus (live, attenuated) NLT 103,0 CCID50; Mumps virus (live, attenuated) NLT 104,4 CCID50; Rubella virus (live, attenuated) NLT 103,0 CCID50; Varicella virus (live, attenuated) NLT 103,3 PFU |
Powder and solvent for solution for injection |
Subcutaneous use |
||||||||||||
|
Finland |
|
PRIORIX TETRA |
per 0,5 ml: Measles virus (Schwarz) - not less than 103,0 CCID50 Mumps virus (RIT 4385) - not less than 104,4 CCID50 Rubella virus (Wistar RA27/3) - not less than: 103,0 CCID50 Varicella virus (Oka) - not less than: 103,3 PFU |
Powder and solvent for solution for injection |
Intramuscular use, subcutaneous use |
||||||||||||
|
France |
|
PRIORIX-TETRA, poudre et solvant pour solution injectable en seringue préremplie. Vaccin rougeoleux, des oreillons, rubéoleux et varicelleux (vivant) |
1 dose (0,5 ml) contains: Measles virus1 Schwarz strain (live, attenuated) not less than 103,0 CCID503 Mumps virus1 RIT 4385 strain, derived from Jeryl Lynn strain (live, attenuated) not less than 104,4 CCID503 Rubella virus2 Wistar RA 27/3 strain (live, attenuated) not less than 103,0 CCID503 Varicella virus2 OKA strain (live, attenuated) not less than 103,3 PFU4 |
Powder and solvent for solution for injection |
Subcutaneous use |
||||||||||||
|
France |
|
PRIORIX-TETRA, poudre et solvant pour solution injectable. Vaccin rougeoleux, des oreillons, rubéoleux et varicelleux (vivant) |
1 dose (0,5 ml) contains: Measles virus1 Schwarz strain (live, attenuated) - not less than 103,0 CCID503 Mumps virus1 RIT 4385 strain, derived from Jeryl Lynn strain (live, attenuated) - not less than 104,4 CCID503 Rubella virus2 Wistar RA 27/3 strain (live, attenuated) - not less than 103,0 CCID503 Varicella virus2 OKA strain (live, attenuated) - not less than 103,3 PFU4 |
Powder and solvent for solution for injection |
Subcutaneous use |
||||||||||||
|
Germany |
|
Priorix-Tetra |
per 0,5 ml dose: Measles virus - not less than 3,0 log10 CCID50 mumps virus - not less than 4,4 log10 CCID50; rubella virus - not less than 3,0 log10 CCID50; varicella virus - not less than 3,3 log10 PFU |
Powder and solvent for solution for injection |
Subcutaneous use |
||||||||||||
|
Germany |
|
Priorix-Tetra |
per 0,5 ml dose: Measles virus - not less than 3,0 log10 CCID50; mumps virus - not less than 4,4 log10 CCID50; rubella virus - not less than 3,0 log10 CCID50; varicella virus - not less than 3,3 log10 PFU |
Powder and solvent for solution for injection |
Subcutaneous use |
||||||||||||
|
Greece |
|
PRIORIX-TETRA |
Measles virus live attenuated (Schwarz strain) - 1 000,000 CC Mumps virus live attenuated (RIT 4385 strain) - 1 000,000 CC Rubella virus live attenuated (WISTAR RA 27/3 strain) - 1 000,000 CC |
Powder and solvent for solution for injection |
Intramuscular use, subcutaneous use |
||||||||||||
|
Greece |
|
R.O.R.VAX, |
per 0,5 ml dose: not less than 1 000 CCID50 of the measles virus Enders-Edmonston strain not less than 5 000 CCID50 of the mumps virus (Jeryl Lynn strain) not less than 1 000 CCID50 of the rubella virus strain |
Powder and solvent for solution for injection |
Intramuscular use |
||||||||||||
|
Hungary |
|
Priorix Tetra por és oldószer oldatos injekcióhoz |
After reconstitution, 1 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 103,7 104,4 CCID50 Live attenuated rubella virus (Wistar RA 27/3 strain) not less than 103,0 CCID50 Varicella virus OKA strain (live, attenuated) not less than 103,3 PFU |
Powder and solvent for solution for injection |
Subcutaneous use |
||||||||||||
|
Hungary |
|
Priorix Tetra por és oldószer oldatos injekcióhoz előretöltött fecskendőben |
After reconstitution, 1 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 104,4 CCID50 Live attenuated rubella virus (Wistar RA 27/3 strain) not less than 103,0 CCID50 Varicella virus OKA strain (live, attenuated) not less than 103,3 PFU |
Powder and solvent for solution for injection in pre-filled syringe |
Subcutaneous use |
||||||||||||
|
Iceland |
|
Priorix Tetra |
per 0,5 ml Live attenuated measles virus >= 103 CCID50 - Live attenuated mumps virus >= 104,4 CCID50 - Live attenuated rubella virus >= 103 CCID50 - Live attenuated varicella virus >= 103,3 CCID50 |
Powder and solvent for solution for injection |
Subcutaneous use |
||||||||||||
|
Iceland |
|
Priorix Tetra |
per 0,5 ml Live attenuated measles virus >= 103 CCID50 - Live attenuated mumps virus >= 104,4 CCID50 - Live attenuated rubella virus >= 103 CCID50 - Live attenuated varicella virus >= 103,3 CCID50 |
Powder and solvent for solution for injection |
Subcutaneous use |
||||||||||||
|
Ireland |
|
Priorix-Tetra – powder and solvent for solution for injection in a pre-filled syringe Measles, mumps, rubella and varicella vaccine (live) |
per 0,5 mg: Live attenuated measles virus (Schwarz strain) not less than 103,0 CCID50 Live attenuated mumps virus (RIT 4385 strain) not less than 104,4 CCID50 Live attenuated rubella virus (Wistar RA 27/3 strain) not less than 103,0 CCID50 Live attenuated varicella virus (OKA strain) not less than 103,3 PFU |
Powder and solvent for solution for injection |
Subcutaneous use |
||||||||||||
|
Ireland |
|
Priorix-Tetra – powder and solvent for solution for injection Measles, mumps, rubella and varicella vaccine (live) |
per 0,5 ml: Live attenuated measles virus (Schwarz strain) - not less than 103,0 CCID50 Live attenuated mumps virus (RIT 4385 strain) - not less than 104,4 CCID50 Live attenuated rubella virus (Wistar RA 27/3 strain) - not less than 103,0 CCID50 Live attenuated varicella virus (OKA strain) - not less than 103,3 PFU |
Powder and solvent for solution for injection |
Subcutaneous use |
||||||||||||
|
Ireland |
|
Priorix-Tetra – powder and solvent for solution for injection Measles, mumps, rubella and varicella vaccine (live) |
per 0,5 ml: Live attenuated measles virus (Schwarz strain) - not less than 103,0 CCID50 Live attenuated mumps virus (RIT 4385 in) - not less than 104,4 CCID50 Live attenuated rubella virus (Wistar RA 27/3 strain) - not less than 103,0 CCID50 Live attenuated varicella virus (OKA strain) - not less than 103,3 PFU |
Powder and solvent for solution for injection |
Subcutaneous use |
||||||||||||
|
Italy |
|
PRIRIX TETRA |
Measles virus1 Schwarz strain (live, attenuated) - not less than 103,0 CCID503 Mumps virus1 RIT 4385 strain, derived from Jeryl Lynn strain (live, attenuated) - not less than 104,4CCID503 Rubella virus2 Wistar RA 27/3 strain (live, attenuated) - not less than 103,0 CCID503 Varicella virus2 OKA strain (live, attenuated) - not less than 103,3 PFU4 |
Powder and solvent for solution for injection |
Subcutaneous use |
||||||||||||
|
Latvia |
|
Priorix-Tetra powder and solvent for solution for injection |
After reconstitution, 1 dose (0,5 ml) contains: Measles virus1 Schwarz strain (live, attenuated) not less than 103,0 CCID503 Mumps virus1 RIT 4385 strain, derived from Jeryl Lynn strain (live, attenuated) not less than 104,4 CCID503 Rubella virus2 Wistar RA 27/3 strain (live, attenuated) not less than 103,0 CCID503 Varicella virus2 OKA strain (live, attenuated) not less than 103,3 PFU4 |
Powder and solvent for solution for injection |
Subcutaneous use |
||||||||||||
|
Latvia |
|
Priorix-Tetra powder and solvent for solution for injection in pre-filled syringe |
After reconstitution, 1 dose (0,5 ml) contains: Measles virus1 Schwarz strain (live, attenuated) not less than 103,0 CCID503 Mumps virus1 RIT 4385 strain, derived from Jeryl Lynn strain (live, attenuated) - not less than 104,4 CCID503 Rubella virus2 Wistar RA 27/3 strain (live, attenuated) - not less than 103,0 CCID503 Varicella virus2 OKA strain (live, attenuated) - not less than 103,3 PFU4 |
Powder and solvent for solution for injection |
Subcutaneous use |
||||||||||||
|
Lithuania |
|
Priorix-Tetra |
After reconstitution, 1 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 104,4 CCID50 Live attenuated rubella virus (Wistar RA 27/3 strain) - not less than 103,0 CCID50 Live, attenuated varicella virus - not less than 103,3 PFU 4 |
Powder and solvent for solution for injection |
Subcutaneous use |
||||||||||||
|
Luxembourg |
|
PRIORIX TETRA |
1 dose (0,5 ml) contains: Live attenuated Measles virus (Schwarz strain) - not less than 103 CCID503 Live attenuated Mumps virus (RIT 4385 strain derived from Jeryl Lynn strain) - not less than 104,4 CCID503 Live attenuated Rubella virus (Wistar RA 27/3 strain) - not less than 103 CCID503 Live attenuated Varicella virus (OKA strain) - not less than 103,3 PFU |
Powder and solvent for solution for injection |
Subcutaneous use |
||||||||||||
|
Poland |
|
Priorix-Tetra |
per 0,5 ml dose: Not less than 103,0 CCID50 of the live, attenuated measles virus (Schwarz strain), not less than 104,4 CCID50 of the live, attenuated mumps virus (RIT 4385 strain, derived from Jeryl Lynn strain), not less than 103,0 CCID50 of the live, attenuated rubella virus (Wistar RA 27/3 strain), not less than 103,3 PFU of the live, attenuated varicella virus (Oka strain) |
Powder and solvent for solution for injection |
Subcutaneous use |
||||||||||||
|
Poland |
|
Priorix-Tetra |
Not less than 103,0 CCID50 of the live, attenuated measles virus (Schwarz strain) not less than 104,4 CCID50 of the live, attenuated mumps virus (RIT 4385 strain, derived from Jeryl Lynn strain) not less than 103,0 CCID50 of the live, attenuated rubella virus (Wistar RA 27/3 strain) not less than 103,3 PFU of the live, attenuated varicella virus (Oka strain) per 0,5 ml dose |
Powder and solvent for solution for injection |
Subcutaneous use |
||||||||||||
|
Portugal |
|
Priorix-Tetra |
per 0,5 ml dose: Measles virus (Schwarz strain) - not less than 3,0 log10 CCID50 mumps virus (RIT 4385 strain) - not less than 3,7 log10 CCID50 rubella virus (Wistar RA 27/3 starin) - not less than 3,0 log10 CCID50 varicella virus (zoster vivo - OKA strain) - not less than 3,3 log10 PFU |
Powder and solvent for solution for injection |
Subcutaneous use |
||||||||||||
|
Portugal |
|
Priorix-Tetra |
per 0,5 ml dose: Measles virus (Schwarz strain) - not less than 3,0 log10 CCID50 mumps virus (RIT 4385 strain) - not less than 3,7 log10 CCID50 rubella virus (Wistar RA 27/3 starin) - not less than 3,0 log10 CCID50 varicella virus (zoster vivo - OKA strain) - not less than 3,3 log10 PFU |
Powder and solvent for solution for injection in pre-filled syringe |
Subcutaneous use |
||||||||||||
|
Romania |
|
PRIORIX-TETRA |
Measles virus (Schwarz strain): ≥ 103,0 CCID50 Mumps virus (RIT 4385 strain): ≥ 104,4 CCID50 Rubella virus (Wistar RA 27/3 strain): ≥ 103,0 CCID50 Varicella virus (Oka strain): ≥ 103,3 PFU |
Powder and solvent for solution for injection |
Subcutaneous use |
||||||||||||
|
Romania |
|
PRIORIX-TETRA |
Measles virus (Schwarz strain): ≥ 103,0 CCID50 Mumps virus (RIT4385 strain): ≥ 104,4 CCID50 Rubella virus (Wistar RA 27/3 strain): ≥ 103,0 CCID50 Varicella virus (Oka strain): ≥ 103,3 PFU |
Powder and solvent for solution for injection |
Subcutaneous use |
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Slovak Republic |
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Priorix Tetra |
Measles virus Schwarz strain (live, attenuated) not less than 103,0 CCID503 Mumps virus RIT 4385 strain, derived from Jeryl Lynn strain (live, attenuated) not less than 104,4 CCID503 Varicella virus OKA strain (live, attenuated) not less than 103,3 PFU4 |
Powder and solvent for solution for injection |
Subcutaneous use |
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Slovak Republic |
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Priorix-Tetra lag |
Measles virus Schwarz strain (live, attenuated) not less than 103,0 CCID503 Mumps virus RIT 4385 strain, derived from Jeryl Lynn strain (live, attenuated) not less than 104,4 CCID503 Rubella virus (Wistar RA 27/3 strain) (live, attenuated) not less than 103,0 CCID503 Varicella virus OKA strain (live, attenuated) not less than 103,3 PFU4 |
Powder and solvent for solution for injection |
Subcutaneous use |
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Slovenia |
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Priorix-Tetra prašek in vehikel za raztopino za injiciranje v napolnjeni injekcijski brizgi |
per dose (0,5 ml): Measles virus (strain Schwarz) (live, atenuated) - not less than 103,0 CCID50 Mumps virus (strain RIT 4385 - derived from strain Jeryl Lynn) (live, atenuated) - not less than 104,4 CCID50 Rubella virus (strain Wistar RA 27/3) (live, atenuated) - not less than 103,0 CCID50 Varicella virus (strain OKA) (live, atenuated) - not less than 103,3 PFU |
Powder and solvent for solution for injection |
Subcutaneous use |
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Sweden |
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Priorix Tetra |
Measles virus, live attenuated strain Schwarz 103,0 CCID50; Mumps virus, live attenuated strain RIT 4385104,4 CCID50 Rubella virus, live attenuated strain Wistar RA 27/3 - 103,0 CCID50 Varicella virus, strain OKA, live attenuated 103,3 pfu |
Powder and solvent for solution for injection |
Subcutaneous use |
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Sweden |
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Priorix Tetra |
Measles virus, live attenuated strain Schwarz 103,0 CCID50; Mumps virus, live attenuated strain RIT 4385104,4 CCID50 Rubella virus, live attenuated strain Wistar RA 27/3 103,0 CCID50 Varicella virus, strain OKA, live attenuated 103,3 pfu |
Powder and solvent for solution for injection |
Subcutaneous use |
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The Netherlands |
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Priorix-Tetra injectieflacon/ampul, poeder en oplosmiddel voor oplossing voor injectie |
per 0,5 ml: Measles virus Schwarz strain (live, attenuated) not less than 10 CCID50 Mumps virus RIT 4385 strain, derived from Jeryl Lynn strain (live, attenuated) not less than 10 CCID50 Rubella virus Wistar RA 27/3 strain (live, attenuated) not less than 100 CCID50 Varicella virus OKA strain (live, attenuated) not less than 10 PFU |
Powder and solvent for solution for injection |
Parenteral use |
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The Netherlands |
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Priorix-Tetra, poeder en oplosmiddel in voorgevulde spuit voor oplossing voor injectie |
per 0,5 ml: Measles virus Schwarz strain (live, attenuated) not less than 10 CCID50 Mumps virus RIT 4385 strain, derived from Jeryl Lynn strain (live, attenuated) not less than 10 CCID50 Rubella virus Wistar RA 27/3 strain (live, attenuated) not less than 100 CCID50 Varicella virus OKA strain (live, attenuated) not less than 10 PFU |
Powder and solvent for solution for injection |
Parenteral use |
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United Kingdom |
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PRIORIX-TETRA powder for solution for injection |
Live Attenuated Mumps Virus RT 4385: 4,4 CID50 Live Attenuated Measles Virus (Schwarz Strain): 3 CID50 Live Attenuated Rubella (Wistar RA 27/3 Strain): 3 CID50 Varicella Virus OKA Strain: 3,3 CID50 |
Powder and solution for injection |
Subcutaneous use |
