# C_2013250EN.01000101.xml

| 30.8.2013 | EN | Official Journal of the European Union | C 250/1 |
| --- | --- | --- | --- |

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)
  )

(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

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 |

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.

1

(2)  OJ L 311, 28.11.2001, p. 1.

2

---

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |
| --- | --- |

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 |
| --- | --- |

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 |

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 |
| --- | --- |

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 |
| --- | --- |

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 |
| --- | --- |

Rubella virus, strain Wistar RA 27/32

(live, attenuated) not less than 103,0 CCID503

| 1 | produced in chick embryo cells. |
| --- | --- |

1

produced in chick embryo cells.

| 2 | produced in MRC-5 human diploid cells. |
| --- | --- |

2

produced in MRC-5 human diploid cells.

| 3 | CCID50 = 50 % cell culture infectious dose. |
| --- | --- |

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 |

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. |
| --- | --- |

1

produced in chick embryo cells.

| 2 | produced in MRC-5 human diploid cells. |
| --- | --- |

2

produced in MRC-5 human diploid cells.

| 3 | CCID50 = 50 % cell culture infectious dose. |
| --- | --- |

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 |

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 103,0 CCID50* of the Schwarz measles1

| — | not less than 103,7 CCID50 of the RIT 4385 mumps1, and |
| --- | --- |

—

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. |
| --- | --- |

—

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 |
| --- | --- |

1

produced in chick embryo cells

| 2 | produced in human diploid (MRC-5) 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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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. |
| --- | --- |

1

produced in chick embryo cells.

| 2 | produced in MRC-5 human diploid cells. |
| --- | --- |

2

produced in MRC-5 human diploid cells.

| 3 | CCID50 = 50 % cell culture infectious dose. |
| --- | --- |

3

CCID50 = 50 % cell culture infectious dose.

| 4 | PFU = Plaque forming units. |
| --- | --- |

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 |

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. |
| --- | --- |

1

produced in chick embryo cells.

| 2 | produced in MRC-5 human diploid cells. |
| --- | --- |

2

produced in MRC-5 human diploid cells.

| 3 | CCID50 = 50 % cell culture infectious dose. |
| --- | --- |

3

CCID50 = 50 % cell culture infectious dose.

| 4 | PFU = Plaque forming units. |
| --- | --- |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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

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