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-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 104.4 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 3,3log10 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 3,3log10 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