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)
Date: 2013-08-30
Institutions: European Commission
Subjects: drug surveillance, market approval, marketing standard, medicinal product








C_2013250EN.01000101.xml










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







Sanofi Pasteur S.A.




2 avenue Pont Pasteur




69007 Lyon




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







Sanofi Pasteur S.A.




2 avenue Pont Pasteur




69007 Lyon




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







Sanofi Pasteur MSD GmbH




Paul-Ehrlich-Str. 1




69181 Leimen




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







Sanofi Pasteur MSD GmbH




Paul-Ehrlich-Str. 1




69181 Leimen




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







Aventis Pasteur MSD S.A. Po Castellana, 141




28046 Madrid




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







Sanofi Pasteur MSD S.N.C., 8, Rue Jonas Salk




FR-69007 Lyon




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







Sanofi Pasteur S.A.




2 avenue Pont Pasteur




69007 Lyon




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







Aventis Pasteur MSD S.A.




Po Castellana, 141




28046 Madrid




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







Sanofi Pasteur S.A.




2 avenue Pont Pasteur




69007 Lyon




France






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







Sanofi Pasteur S.A.




2 avenue Pont Pasteur




69007 Lyon




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







Sanofi Pasteur MSD GmbH




Paul-Ehrlich-Str. 1




69181 Leimen




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







Sanofi Pasteur MSD GmbH




Paul-Ehrlich-Str. 1




69181 Leimen




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







Aventis Pasteur MSD S.A. Po Castellana, 141




28046 Madrid




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







GLAXOSMITHKLINE, S.A.




C/Severo Ochoa, 2




Tres Cantos




28760 Madrid




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







INSTITUTO BERNA DE ESPAÑA, S.A.




Po de la Castellana, 163




28046 MADRID




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







GlaxoSmithKline Pharma GmbH




Albert-Schweitzer-Gasse 6




AT-1140 Vienna




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







Sanofi Pasteur MSD S.N.C., 8, Rue Jonas Salk




FR-69007 Lyon




France






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







GlaxoSmithKline Biologicals S.A.




Rue de l'Institut 89




B-1330 Rixensart




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







Sanofi Pasteur MSD




Avenue Jules Bordetlaan 13




B-1140 Brussels




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







Merck Sharp & Dohme B.V.




Waardeweg 39,




2031 BN Haarlem




The Netherlands






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







GlaxoSmithKline Biologicals S.A.




Rue de l'Institut 89




B-1330 Rixensart




Belgium






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







GlaxoSmithKline Biologicals S.A.




Rue de l'Institut 89




B-1330 Rixensart




Belgium






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







GlaxoSmithKline Biologicals S.A.




Rue de l'Institut 89




B-1330 Rixensart




Belgium






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







Merck Sharp & Dohme OÜ




A.H. Tammsaare tee 47




Tallinn 11316




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







Sanofi Pasteur MSD




Avenue Jules Bordetlaan 13




B-1140 Brussels




Belgium






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







GlaxoSmithKline Biologicals S.A.




Rue de l'Institut 89




B-1330 Rixensart




Belgium






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







Laboratoire GlaxoSmithKline




100 route de Versailles




78163 Marly-le-Roi Cedex




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







Sanofi Pasteur MSD S.N.C., 8, Rue Jonas Salk




FR-69007 Lyon




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







Sanofi Pasteur MSD GmbH




Paul-Ehrlich-Str. 1




69181 Leimen




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







GlaxoSmithKline GmbH & Co. KG




Theresienhöhe 11




80339 München




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







Sanofi Pasteur MSD GmbH




Paul-Ehrlich-Str. 1




69181 Leimen




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







GlaxoSmithKline GmbH & Co. KG




Theresienhöhe 11




80339 München




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







GlaxoSmithKline A.E.B.E




Kifissias Avenue 266




Halandri 15232, Athens




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







VIANEX S.A




Tatoiou Str.




18th km National Road Athens-Lamia




New Erythraia P.C. 14671




Athens




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







GlaxoSmithKline Kft.




1124 Budapest




Csörsz u 43




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







MSD Pharma Hungary Ltd.




1095 Budapest




Lechner Odon fasor 8




Millennium Tower III, 3. em.




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







GlaxoSmithkline ehf.




Þverholti 14




105 Reykjavík




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







Sanofi Pasteur MSD Limited




Block A, Second Floor




Cookstown Court




Old Belgard Road, Tallaght




Dublin 24




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







GlaxoSmithKline Biologicals S.A.




Rue de l'Institut 89




B-1330 Rixensart




Belgium






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







Sanofi Pasteur MSD S.p.A.




Via degli Aldobrandeschi, 15




00163 Rome




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







SIA ‘Merck Sharp & Dohme Latvija’, Skanstes iela 50A




LV - 1013 Riga




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







GlaxoSmithKline Biologicals S.A.




Rue de l'Institut 89




B-1330 Rixensart




Belgium






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







UAB ‘GlaxoSmithKline Lietuva’




Goštauto 40A




LT-01112 Vilnius




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







Merck Sharp & Dohme UAB




Kestucio str. 59/27




LT-08124 Vilnius




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







GlaxoSmithKline Biologicals S.A.




Rue de l'Institut 89




B-1330 Rixensart




Belgium






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







Sanofi Pasteur MSD




Avenue Jules Bordetlaan 13




B-1140 Brussels




Belgium






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







GlaxoSmithKline Biologicals S.A.




Rue de l'Institut 89




B-1330 Rixensart




Belgium






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







GlaxoSmithKline AS




Forskningsveien 2a




Postboks 180 Vinderen




0319 Oslo




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







Sanofi Pasteur MSD




Avenue Jules




Bordetlaan 13




B-1140 Brussels




Belgium






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







GlaxoSmithKline Biologicals S.A.




Rue de l'Institut 89




B-1330 Rixensart




Belgium






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







SmithKline & French Portuguesa - Produtos Farmacêuticos, Lda.




Rua Dr. António Loureiro Borges, 3




Arquiparque - Miraflores




1495-131 Algés




Portugal






Varilrix


varicella virus (zoster vivo) - 3,3 log10 PFU/0,5 ml


Powder and solvent for solution for injection


Subcutaneous use




Portugal







Sanofi Pasteur MSD, S.A.




Alfrapark - Estrada de Alfragide, 67




Lote F Sul, Piso 2




2610-008 Amadora




Portugal






Varivax


varicella virus (zoster vivo) - 1 350 FPU/0,5 ml


Powder and solvent for suspension for injection


Subcutaneous use




Romania







GlaxoSmithKline Biologicals S.A.




Rue de l'Institut 89




B-1330 Rixensart




Belgium






VARILRIX


Varicella virus (Oka strain): ≥ 103,3 PFU


Powder and solvent for solution for injection


Subcutaneous use




Slovak Republic







Merck Sharp & Dohme B.V




Waarderweg 39




2031 BN Haarlem




The Netherlands






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







Merck Sharp & Dohme inovativna zdravila d.o.o.,




Smartinska cesta 140




1000 Ljubljana




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







GLAXOSMITHKLINE, S.A.




C/Severo Ochoa, 2




Tres Cantos




28760 Madrid




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







Aventis Pasteur MSD, S.A.




Po Castellana, 141




28046 Madrid




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







GlaxoSmithKline AB




Box 516




169 29 Solna




Sweden






Varilrix®


Varicella virus, strain Oka/Merck live attenuated - 103,3 pfu


Powder and solvent for solution for injection


Subcutaneous use




Sweden







Sanofi Pasteur MSD




Avenue Jules Bordetlaan 13




B-1140 Brussels




Belgium






Varivax®


Varicella virus, strain Oka/Merck live attenuated - 1 350 pfu


Powder and solvent for solution for injection


Intramuscular use, subcutaneous use




The Netherlands







Sanofi Pasteur MSD




Avenue Jules Bordetlaan 13




B-1140 Brussels




Belgium






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







SmithKline Beecham plc




980 Great West Road




Brentford




Middlesex TW8 9GS




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







Sanofi Pasteur MSD Limited




Mallards Reach




Bridge Avenue




Maidenhead




Berkshire SL6 1QP




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







Sanofi Pasteur S.A.




2 avenue Pont Pasteur




69007 Lyon




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:






 


Measles virus Schwartz strain (live, attenuated) - not less than 1 000 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








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







GlaxoSmithKline Pharma GmbH




Albert - Schweitzer - Gasse 6




AT-1140 Vienna




Austria






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


After reconstitution, one dose (0,5 ml) contains:






 


Measles virus, strain Schwarz1 (live, attenuated) not less than 103,7 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










1


produced in chick embryo cells.










2


produced in MRC-5 human diploid cells.










3


CCID50 = 50 % cell culture infectious dose.






Powder and solvent for solution for injection


Intramuscular use, subcutaneous use




Austria







GlaxoSmithKline Pharma GmbH




Albert - Schweitzer - Gasse 6




AT-1140 Vienna




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






1


produced in chick embryo cells.










2


produced in MRC-5 human diploid cells.










3


CCID50 = 50 % cell culture infectious dose.






Powder and solvent for solution for injection


Intramuscular use, subcutaneous use




Belgium







GlaxoSmithKline Biologicals S.A.




Rue de l'Institut 89




B-1330 Rixensart




Belgium






Priorix


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, and










—


not less than 103,0 CCID50 of the Wistar RA 27/3 rubella2 virus strains.




*CCID 50 – Cell Culture Infective Dose 50






1


produced in chick embryo cells










2


produced in human diploid (MRC-5) cells






Powder and solvent for solution for injection


Subcutaneous use Intramuscular use, subcutaneous use




Bulgaria







GlaxoSmithKline Biologicals S.A.




Rue de l'Institut 89




B-1330 Rixensart




Belgium






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







GlaxoSmithKline Biologicals S.A.




Rue de l'Institut 89




B-1330 Rixensart




Belgium






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







GlaxoSmithKline Biologicals S.A.




Rue de l'Institut 89




B-1330 Rixensart




Belgium






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







GlaxoSmithKline Pharma A/S




Nykær 68




DK-2605 Brøndby




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







GlaxoSmithKline Pharma A/S




Nykær 68




DK-2605 Brøndby




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







Sanofi Pasteur MSD




Avenue Jules Bordetlaan 13




B-1140 Brussels




Belgium






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







GlaxoSmithKline Biologicals S.A.




Rue de l'Institut 89




B-1330 Rixensart




Belgium






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







GlaxoSmithKline Biologicals S.A.




Rue de l'Institut 89




B-1330 Rixensart




Belgium






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







Laboratoire GlaxoSmithKline




100 route de Versailles




78163 Marly-le-Roi Cedex




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







Sanofi Pasteur S.A.




2 avenue Pont Pasteur




69007 Lyon




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







Sanofi Pasteur MSD S.N.C., 8, Rue Jonas Salk




FR-69007 Lyon




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







GlaxoSmithKline GmbH & Co. KG




Theresienhöhe 11




80339 München




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







GlaxoSmithKline GmbH & Co. KG




Theresienhöhe 11




80339 München




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







GlaxoSmithKline A.E.B.E




Kifissias Avenue 266




Halandri 15232, Athens




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







GlaxoSmithKline Kft.




1124 Budapest




Csörsz u 43




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







GlaxoSmithkline ehf.




Þverholti 14




105 Reykjavík




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







GlaxoSmithKline S.p.A.




Via A. Fleming, 2




37135 Verona




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







GlaxoSmithKline Biologicals S.A.




Rue de l'Institut 89




B-1330 Rixensart




Belgium






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







GlaxoSmithKline Biologicals S.A.




Rue de l'Institut 89




B-1330 Rixensart




Belgium






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







UAB ‘GlaxoSmithKline Lietuva’




Goštauto 40A




LT-01112 Vilnius




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







GlaxoSmithKline Biologicals S.A.




Rue de l'Institut 89




B-1330 Rixensart




Belgium






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







SmithKline Beecham plc




980 Great West Road




Brentford




Middlesex TW8 9GS




United Kingdom






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







GlaxoSmithKline AS




Forskningsveien 2a




Postboks 180 Vinderen




0319 Oslo




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







MSD Polska Sp. z o.o.




Chlodna st., 51




00-867, Warsaw




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







GlaxoSmithKline Biologicals S.A.




Rue de l'Institut 89




B-1330 Rixensart




Belgium






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







SmithKline & French Portuguesa - Produtos Farmacêuticos, Lda.




Rua Dr. António Loureiro Borges, 3




Arquiparque - Miraflores




1495-131 Algés




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







SmithKline & French Portuguesa - Produtos Farmacêuticos, Lda.




Rua Dr. António Loureiro Borges, 3




Arquiparque - Miraflores




1495-131 Algés




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







GlaxoSmithKline Biologicals S.A.




Rue de l'Institut 89




B-1330 Rixensart




Belgium






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







GlaxoSmithKline Biologicals S.A.




Rue de l'Institut 89




B-1330 Rixensart




Belgium






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







GSK d.o.o




Cvetkova ulica 29




1000 Ljubljana




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







GLAXOSMITHKLINE S.A.




C/Severo Ochoa, 2




Tres Cantos




28760 Madrid




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







GlaxoSmithKline AB




Box 516




169 29 Solna




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







GlaxoSmithKline B.V




Huis ter Heideweg 62




3705 LZ ZEIST




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







GlaxoSmithKline Pharma GmbH




Albert - Schweitzer - Gasse 6




AT-1140 Vienna




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






1


produced in chick embryo cells.










2


produced in MRC-5 human diploid cells.










3


CCID50 = 50 % cell culture infectious dose.










4


PFU = Plaque forming units.






Powder and solvent for solution for injection


Subcutaneous use




Austria







GlaxoSmithKline Pharma GmbH




Albert - Schweitzer - Gasse 6




AT-1140 Vienna




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






1


produced in chick embryo cells.










2


produced in MRC-5 human diploid cells.










3


CCID50 = 50 % cell culture infectious dose.










4


PFU = Plaque forming units.






Powder and solvent for solution for injection


Subcutaneous use




Belgium







GlaxoSmithKline Biologicals S.A.




Rue de l'Institut 89




B-1330 Rixensart




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







GlaxoSmithKline (Cyprus) Ltd




12-14 Kennedy Avenue




Kennedy Business Centre




4th Floor




1087 Lefkosia




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







GlaxoSmithKline (Cyprus) Ltd




12-14 Kennedy Avenue




Kennedy Business Centre




4th Floor




1087 Lefkosia




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







GlaxoSmithKline, s.r.o.




Na Pankráci 17/1685




140 21 Prague 4




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







GlaxoSmithKline, s.r.o.




Na Pankráci 17/1685




140 21 Prague 4




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







GlaxoSmithKline Pharma A/S




Nykær 68




DK-2605 Brøndby




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







GlaxoSmithKline Pharma A/S




Nykær 68




DK-2605 Brøndby




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







GlaxoSmithKline Eesti OÜ




Lõõtsa 2




11415 Tallinn




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







GlaxoSmithKline Eesti OÜ




Lõõtsa 2




11415 Tallinn




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







GlaxoSmithKline Biologicals S.A.




Rue de l'Institut 89




B-1330 Rixensart




Belgium






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







Laboratoire GlaxoSmithKline




100 route de Versailles




78163 Marly-le-Roi Cedex




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







Laboratoire GlaxoSmithKline




100 route de Versailles




78163 Marly-le-Roi Cedex




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







GlaxoSmithKline GmbH & Co. KG




Theresienhöhe 11




80339 München




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







GlaxoSmithKline GmbH & Co. KG




Theresienhöhe 11




80339 München




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







GlaxoSmithKline A.E.B.E




Kifissias Avenue 266




Halandri 15232, Athens




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







VIANEX S.A




Tatoiou Str.




18th km National Road Athens-Lamia




New Erythraia P.C. 14671




Athens




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







GlaxoSmithKline Kft.




1124 Budapest




Csörsz u 43




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







GlaxoSmithKline Kft.




1124 Budapest




Csörsz u 43




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







GlaxoSmithkline ehf.




Þverholti 14




105 Reykjavík




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







GlaxoSmithkline ehf.




Þverholti 14




105 Reykjavík




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







GlaxoSmithKline (Ireland) Ltd.




Stonemasons Way




Rathfarnham




Dublin 16




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







GlaxoSmithKline (Ireland) Ltd.




Stonemasons Way




Rathfarnham




Dublin 16




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







GlaxoSmithKline (Ireland) Ltd.




Stonemasons Way




Rathfarnham




Dublin 16




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







GlaxoSmithKline S.p.A.




Via A. Fleming, 2




37135 Verona




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







GlaxoSmithKline Latvia SIA




Bruņinieku iela 5




Rīga LV-1001




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







GlaxoSmithKline Latvia SIA




Bruņinieku iela 5




Rīga LV-1001




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







UAB ‘GlaxoSmithKline Lietuva’




Goštauto 40A




LT-01112 Vilnius




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







GlaxoSmithKline Biologicals S.A.




Rue de l'Institut 89




B-1330 Rixensart




Belgium






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







GlaxoSmithKline Biologicals S.A.




Rue de l'Institut 89




B-1330 Rixensart




Belgium






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







GlaxoSmithKline Biologicals S.A.




Rue de l'Institut 89




B-1330 Rixensart




Belgium






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







SmithKline & French Portuguesa - Produtos Farmacêuticos, Lda.




Rua Dr. António Loureiro Borges, 3




Arquiparque - Miraflores




1495-131 Algés




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







SmithKline & French Portuguesa - Produtos Farmacêuticos, Lda.




Rua Dr. António Loureiro Borges, 3




Arquiparque - Miraflores




1495-131 Algés




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







GLAXOSMITHKLINE (GSK) SRL - ROMANIA




Costache Negri Street, No. 1-5




Opera Center 1




Etaj 3, sector 5




050552 Bucharest




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







GLAXOSMITHKLINE (GSK) SRL - ROMANIA




Costache Negri Street, No. 1-5




Opera Center 1




Etaj 3, sector 5




050552 Bucharest




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




Slovak Republic







GlaxoSmithKline Slovakia s.r.o.,




Galvaniho 7/A




Bratislava 2, 821 04




Slovak Republic






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




Slovak Republic







GlaxoSmithKline Slovakia s.r.o.,




Galvaniho 7/A




Bratislava 2, 821 04




Slovak Republic






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




Slovenia







GSK d.o.o




Cvetkova ulica 29




1000 Ljubljana




Slovenia






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




Sweden







GlaxoSmithKline AB




Box 516




169 29 Solna




Sweden






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




Sweden







GlaxoSmithKline AB




Box 516




169 29 Solna




Sweden






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




The Netherlands







GlaxoSmithKline B.V.




Huis ter Heideweg 62




3705 LZ ZEIST




The Netherlands






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




The Netherlands







GlaxoSmithKline B.V.




Huis ter Heideweg 62




3705 LZ ZEIST




The Netherlands






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




United Kingdom







SmithKline Beecham plc




980 Great West Road




Brentford




Middlesex TW8 9GS




United Kingdom






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