# Official Journal C 250/2013

| | ISSN 1977-091X
  doi:10.3000/1977091X.C_2013.250.eng |
| --- | --- |
| Official Journal
  of the European Union | C 250 |
| | |
| English edition | Information and Notices | Volume 5630 August 2013 |

ISSN 1977-091X

doi:10.3000/1977091X.C_2013.250.eng

Official Journal

of the European Union

C 250

English edition

Information and Notices

Volume 5630 August 2013

---

| Notice No | Contents | page |
| --- | --- | --- |
| | IV   Notices |
| | NOTICES FROM EUROPEAN UNION INSTITUTIONS, BODIES, OFFICES AND AGENCIES |
| | European Commission |
| 2013/C 250/01 | Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 February 2013 to 28 February 2013(Decisions taken pursuant to Article 34 of Directive 2001/83/EC or Article 38 of Directive 2001/82/EC) | 1 |
| 2013/C 250/02 | Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 June 2013 to 31 July 2013(Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council) | 30 |
| 2013/C 250/03 | Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 June 2013 to 31 July 2013(Decisions taken pursuant to Article 34 of Directive 2001/83/EC or Article 38 of Directive 2001/82/EC) | 44 |

Notice No

Contents

page

IV   Notices

NOTICES FROM EUROPEAN UNION INSTITUTIONS, BODIES, OFFICES AND AGENCIES

European Commission

2013/C 250/01

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 February 2013 to 28 February 2013(Decisions taken pursuant to Article 34 of Directive 2001/83/EC or Article 38 of Directive 2001/82/EC)

(Decisions taken pursuant to Article 34 of Directive 2001/83/EC or Article 38 of Directive 2001/82/EC)

1

2013/C 250/02

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 June 2013 to 31 July 2013(Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council)

(Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council)

30

2013/C 250/03

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 June 2013 to 31 July 2013(Decisions taken pursuant to Article 34 of Directive 2001/83/EC or Article 38 of Directive 2001/82/EC)

(Decisions taken pursuant to Article 34 of Directive 2001/83/EC or Article 38 of Directive 2001/82/EC)

44

| EN | |
| --- | --- |

EN

---

IV Notices

NOTICES FROM EUROPEAN UNION INSTITUTIONS, BODIES, OFFICES AND AGENCIES

European Commission

| 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)
  )

2013/C 250/01

—   Issuing, maintenance or modification of a national marketing authorization

| Date of the decision | Name(s) of the medicinal product | Holder(s) of the marketing authorization | Member State concerned | Date of notification |
| --- | --- | --- | --- | --- |
| 28.2.2013 | Monovalent and multivalent measles, mumps, rubella and varicella vaccines (live) | See Annex I | See Annex I | 1.3.2013 |

Date of the decision

Name(s) of the medicinal product

Holder(s) of the marketing authorization

Member State concerned

Date of notification

28.2.2013

Monovalent and multivalent measles, mumps, rubella and varicella vaccines (live)

See Annex I

See Annex I

1.3.2013

---

(1)  OJ L 311, 28.11.2001, p. 67.

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

---

ANNEX I

LIST OF THE NAMES, PHARMACEUTICAL FORMS, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTES OF ADMINISTRATION, MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES

Measles vaccines (live) with Marketing Authorisation in the European Union

| Member State
  (EU/EEA) | Marketing authorisaton holder | Invented name | Strength | Pharmaceutical form | Route of administration |
| --- | --- | --- | --- | --- | --- |
| France | Sanofi Pasteur S.A. |
| 2 avenue Pont Pasteur |
| 69007 Lyon |
| France |

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

---

| 30.8.2013 | EN | Official Journal of the European Union | C 250/30 |
| --- | --- | --- | --- |

30.8.2013

EN

Official Journal of the European Union

C 250/30

---

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 June 2013 to 31 July 2013

(Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council
   (1)
  )

2013/C 250/02

—   Issuing of a marketing authorization (Article 13 of Regulation (EC) No 726/2004 of the European Parliament and of the Council): Accepted

| Date of the decision | Name of the medicinal product | INN (International Non-Proprietary Name) | Holder of the marketing authorization | Number of the entry in the Community Register | Pharmaceutical form | ATC code (Anatomical Therapeutic Chemical Code) | Date of notification |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 13.6.2013 | Memantine ratiopharm | memantine | ratiopharm GmbH |
| Graf-Arco-Straße 3, D-89079 Ulm, Deutschland |

Date of the decision

Name of the medicinal product

INN (International Non-Proprietary Name)

Holder of the marketing authorization

Number of the entry in the Community Register

Pharmaceutical form

ATC code (Anatomical Therapeutic Chemical Code)

Date of notification

13.6.2013

Memantine ratiopharm

memantine

ratiopharm GmbH

Graf-Arco-Straße 3, D-89079 Ulm, Deutschland

EU/1/13/836

Film-coated tablet

N06DX01

17.6.2013

14.6.2013

Votrient

Pazopanib hydrochloride

| Glaxo Group Limited |
| --- |
| 980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom |

Glaxo Group Limited

980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom

EU/1/10/628

Film-coated tablet

L01XE11

18.6.2013

21.6.2013

Capecitabine SUN

Capecitabine

| Sun Pharmaceutical Industries Europe BV |
| --- |
| Polarisavenue 87, NL-2132 JH Hoofddorp, Nederland |

Sun Pharmaceutical Industries Europe BV

Polarisavenue 87, NL-2132 JH Hoofddorp, Nederland

EU/1/13/831

Film-coated tablet

L01BC06

25.6.2013

21.6.2013

Spedra

avanafil

| VIVUS B.V. |
| --- |
| Prins Bernhardplein 200, NL-1097 JB Amsterdam, Nederland |

VIVUS B.V.

Prins Bernhardplein 200, NL-1097 JB Amsterdam, Nederland

EU/1/13/841

Tablet

G04BE

25.6.2013

21.6.2013

Xtandi

enzalutamide

| Astellas Pharma Europe B.V. |
| --- |
| Sylviusweg 62, NL-2333 BE Leiden, Nederland |

Astellas Pharma Europe B.V.

Sylviusweg 62, NL-2333 BE Leiden, Nederland

EU/1/13/846

Capsule, soft

Pending

25.6.2013

24.6.2013

Nuedexta

Dextromethorphan/quinidine

| Jenson Pharmaceutical Services Ltd |
| --- |
| Carradine House 237 Regents Park Road, London N3 3LF, United Kingdom |

Jenson Pharmaceutical Services Ltd

Carradine House 237 Regents Park Road, London N3 3LF, United Kingdom

EU/1/13/833

Capsule, hard

N07XX

26.6.2013

24.6.2013

Stayveer

bosentan

| Marklas Nederland B.V. |
| --- |
| Beneluxlaan 2b, NL-3446 GR Woerden, Nederland |

Marklas Nederland B.V.

Beneluxlaan 2b, NL-3446 GR Woerden, Nederland

EU/1/13/832

Film-coated tablet

C02KX01

25.6.2013

27.6.2013

MACI

Matrix applied characterised autologous cultured chondrocytes

| Genzyme Europe B.V. |
| --- |
| Gooimeer 10, NL-1411 DD Naarden, Nederland |

Genzyme Europe B.V.

Gooimeer 10, NL-1411 DD Naarden, Nederland

EU/1/13/847

Implantation matrix

M09AX02

1.7.2013

1.7.2013

Iclusig

ponatinib

| ARIAD Pharma Ltd |
| --- |
| 2 Temple Back East, Temple Quay, Bristol, BS1 6EG, United Kingdom |

ARIAD Pharma Ltd

2 Temple Back East, Temple Quay, Bristol, BS1 6EG, United Kingdom

EU/1/13/839

Film-coated tablet

L01XE24

3.7.2013

1.7.2013

Imatinib Accord

Imatinib

| Accord Healthcare Limited |
| --- |
| Sage house, 319 Pinner road, North Harrow, Middlesex HA1 4HF, United Kingdom |

Accord Healthcare Limited

Sage house, 319 Pinner road, North Harrow, Middlesex HA1 4HF, United Kingdom

EU/1/13/845

Film-coated tablet

L01XE01

3.7.2013

12.7.2013

Erivedge

vismodegib

| Roche Registration Limited |
| --- |
| 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom |

Roche Registration Limited

6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom

EU/1/13/848

Capsule, hard

L01XX43

17.7.2013

25.7.2013

Lonquex

lipegfilgrastim

| Teva Pharma B.V. |
| --- |
| Computerweg 10, NL-3542 DR Utrecht, Nederland |

Teva Pharma B.V.

Computerweg 10, NL-3542 DR Utrecht, Nederland

EU/1/13/856

Solution for injection

L03AA14

29.7.2013

31.7.2013

Atosiban SUN

atosiban

| Sun Pharmaceutical Industries Europe BV |
| --- |
| Polarisavenue 87, NL-2132 JH Hoofddorp, Nederland |

Sun Pharmaceutical Industries Europe BV

Polarisavenue 87, NL-2132 JH Hoofddorp, Nederland

EU/1/13/852

Concentrate for solution for infusion

Solution for injection

G02CX01

2.8.2013

31.7.2013

Imvanex

modified vaccinia ankara virus

| Bavarian Nordic A/S |
| --- |
| Hejreskovvej 10a, DK-3490 Kvistgaard, Danmark |

Bavarian Nordic A/S

Hejreskovvej 10a, DK-3490 Kvistgaard, Danmark

EU/1/13/855

Suspension for injection

J07BX

5.8.2013

31.7.2013

Lojuxta

Lomitapide

| Aegerion Pharmaceuticals |
| --- |
| 37/39 avenue Ledru Rollin, F-75012 Paris, France |

Aegerion Pharmaceuticals

37/39 avenue Ledru Rollin, F-75012 Paris, France

EU/1/13/851

Capsule, hard

C10AX12

5.8.2013

31.7.2013

PHEBURANE

Sodium Phenylbutyrate

| Lucane Pharma |
| --- |
| 172 rue de Charonne, 75011 Paris, France |

Lucane Pharma

172 rue de Charonne, 75011 Paris, France

EU/1/13/822/

Granules

A16AX03

5.8.2013

—   Modification of a marketing authorization (Article 13 of Regulation (EC) No 726/2004 of the European Parliament and of the Council): Accepted

| Date of the decision | Name of the medicinal product | Holder of the marketing authorization | Number of the entry in the Community Register | Date of notification |
| --- | --- | --- | --- | --- |
| 11.6.2013 | IOA | Organon N.V. |
| Kloosterstraat 6, NL-5349 AB Oss, Nederland |

Date of the decision

Name of the medicinal product

Holder of the marketing authorization

Number of the entry in the Community Register

Date of notification

11.6.2013

IOA

Organon N.V.

Kloosterstraat 6, NL-5349 AB Oss, Nederland

EU/1/11/689

13.6.2013

11.6.2013

Rienso

| Takeda Pharma A/S |
| --- |
| PO Box 88, Langebjerg 1, DK-4000 Roskilde, Danmark |

Takeda Pharma A/S

PO Box 88, Langebjerg 1, DK-4000 Roskilde, Danmark

EU/1/12/774

13.6.2013

11.6.2013

Zoely

| Theramex S.r.l. |
| --- |
| Via Messina 38, 20154 Milano, Italia |

Theramex S.r.l.

Via Messina 38, 20154 Milano, Italia

EU/1/11/690

18.6.2013

13.6.2013

Abilify

| Otsuka Pharmaceutical Europe Ltd |
| --- |
| Hunton House, Highbridge Estate, Oxford Road, Uxbridge, Middlesex UB8 1LX, United Kingdom. |

Otsuka Pharmaceutical Europe Ltd

Hunton House, Highbridge Estate, Oxford Road, Uxbridge, Middlesex UB8 1LX, United Kingdom.

EU/1/04/276

17.6.2013

13.6.2013

Atripla

| Bristol-Myers Squibb and Gilead Sciences Limited |
| --- |
| IDA Business & Technology Park, Carrigtohill, Co. Cork, Ireland |

Bristol-Myers Squibb and Gilead Sciences Limited

IDA Business & Technology Park, Carrigtohill, Co. Cork, Ireland

EU/1/07/430

17.6.2013

13.6.2013

Revlimid

| Celgene Europe Limited |
| --- |
| 1 Longwalk Road, Stockley Park, Uxbridge, Middlesex UB11 1DB, United Kingdom |

Celgene Europe Limited

1 Longwalk Road, Stockley Park, Uxbridge, Middlesex UB11 1DB, United Kingdom

EU/1/07/391

17.6.2013

13.6.2013

Tysabri

| Biogen Idec Limited |
| --- |
| Innovation House, 70 Norden Road, Maidenhead, Berkshire SL6 4AY, United Kingdom |

Biogen Idec Limited

Innovation House, 70 Norden Road, Maidenhead, Berkshire SL6 4AY, United Kingdom

EU/1/06/346

17.6.2013

21.6.2013

Bridion

| Organon N.V. |
| --- |
| Kloosterstraat 6, NL-5349 AB Oss, Nederland |

Organon N.V.

Kloosterstraat 6, NL-5349 AB Oss, Nederland

EU/1/08/466

25.6.2013

21.6.2013

Brinavess

| Cardiome UK Limited |
| --- |
| Sherborne House, 119-121 Cannon Street, 3rd Floor, London EC4N 5AT, United Kingdom |

Cardiome UK Limited

Sherborne House, 119-121 Cannon Street, 3rd Floor, London EC4N 5AT, United Kingdom

EU/1/10/645

25.6.2013

21.6.2013

EDURANT

| Janssen-Cilag International NV |
| --- |
| Turnhoutseweg 30, B-2340 Beerse, België |

Janssen-Cilag International NV

Turnhoutseweg 30, B-2340 Beerse, België

EU/1/11/736

25.6.2013

21.6.2013

Eviplera

| Gilead Sciences International Limited |
| --- |
| Cambridge CB21 6GT, United Kingdom |

Gilead Sciences International Limited

Cambridge CB21 6GT, United Kingdom

EU/1/11/737

25.6.2013

21.6.2013

Intelence

| Janssen-Cilag International NV |
| --- |
| Turnhoutseweg 30, B-2340 Beerse, België |

Janssen-Cilag International NV

Turnhoutseweg 30, B-2340 Beerse, België

EU/1/08/468

25.6.2013

21.6.2013

Javlor

| Pierre Fabre Médicament |
| --- |
| 45, place Abel Gance, F-92100 Boulogne, France |

Pierre Fabre Médicament

45, place Abel Gance, F-92100 Boulogne, France

EU/1/09/550

25.6.2013

21.6.2013

Osseor

| Les Laboratoires Servier |
| --- |
| 50 rue Carnot, F-92284 Suresnes CEDEX, France |

Les Laboratoires Servier

50 rue Carnot, F-92284 Suresnes CEDEX, France

EU/1/04/287

25.6.2013

21.6.2013

Protelos

| Les Laboratoires Servier |
| --- |
| 50 rue Carnot, F-92284 Suresnes CEDEX, France |

Les Laboratoires Servier

50 rue Carnot, F-92284 Suresnes CEDEX, France

EU/1/04/288

25.6.2013

21.6.2013

Reyataz

| Bristol-Myers Squibb Pharma EEIG |
| --- |
| Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom |

Bristol-Myers Squibb Pharma EEIG

Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom

EU/1/03/267

25.6.2013

21.6.2013

Xenical

| Roche Registration Limited |
| --- |
| 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom |

Roche Registration Limited

6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom

EU/1/98/071

25.6.2013

21.6.2013

Zerit

| Bristol-Myers Squibb Pharma EEIG |
| --- |
| Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom |

Bristol-Myers Squibb Pharma EEIG

Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom

EU/1/96/009

25.6.2013

27.6.2013

Glivec

| Novartis Europharm Limited |
| --- |
| Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom |

Novartis Europharm Limited

Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom

EU/1/01/198

1.7.2013

27.6.2013

Levodopa/Carbidopa/Entacapone Orion

| Orion Corporation |
| --- |
| Orionintie 1, FI-02200 Espoo, Suomi |

Orion Corporation

Orionintie 1, FI-02200 Espoo, Suomi

EU/1/11/706

1.7.2013

27.6.2013

Rasilamlo

| Novartis Europharm Limited |
| --- |
| Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom |

Novartis Europharm Limited

Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom

EU/1/11/686

1.7.2013

27.6.2013

Rasilez

| Novartis Europharm Limited |
| --- |
| Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom |

Novartis Europharm Limited

Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom

EU/1/07/405

1.7.2013

27.6.2013

Vivanza

| Bayer Pharma AG |
| --- |
| D-13342 Berlin, Deutschland |

Bayer Pharma AG

D-13342 Berlin, Deutschland

EU/1/03/249

1.7.2013

1.7.2013

Ariclaim

| Eli Lilly Nederland B.V. |
| --- |
| Grootslag 1-5, NL-3991 RA Houten, Nederland |

Eli Lilly Nederland B.V.

Grootslag 1-5, NL-3991 RA Houten, Nederland

EU/1/04/283

3.7.2013

1.7.2013

Emtriva

| Gilead Sciences International Limited |
| --- |
| Cambridge CB21 6GT, United Kingdom |

Gilead Sciences International Limited

Cambridge CB21 6GT, United Kingdom

EU/1/03/261

3.7.2013

1.7.2013

Fampyra

| Biogen Idec Limited |
| --- |
| Innovation House, 70 Norden Road, Maidenhead, Berkshire SL6 4AY, United Kingdom |

Biogen Idec Limited

Innovation House, 70 Norden Road, Maidenhead, Berkshire SL6 4AY, United Kingdom

EU/1/11/699

3.7.2013

1.7.2013

Intelence

| Janssen-Cilag International NV |
| --- |
| Turnhoutseweg 30, B-2340 Beerse, België |

Janssen-Cilag International NV

Turnhoutseweg 30, B-2340 Beerse, België

EU/1/08/468

3.7.2013

1.7.2013

PREZISTA

| Janssen-Cilag International NV |
| --- |
| Turnhoutseweg 30, B-2340 Beerse, België |

Janssen-Cilag International NV

Turnhoutseweg 30, B-2340 Beerse, België

EU/1/06/380

3.7.2013

1.7.2013

Rasilez HCT

| Novartis Europharm Limited |
| --- |
| Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom |

Novartis Europharm Limited

Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom

EU/1/08/491

3.7.2013

1.7.2013

Replagal

| Shire Human Genetic Therapies AB |
| --- |
| Svärdvägen 11D, SE-182 33 Danderyd, Sverige |

Shire Human Genetic Therapies AB

Svärdvägen 11D, SE-182 33 Danderyd, Sverige

EU/1/01/189

3.7.2013

1.7.2013

Stocrin

| Merck Sharp & Dohme Limited |
| --- |
| Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom |

Merck Sharp & Dohme Limited

Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom

EU/1/99/111

3.7.2013

1.7.2013

Sustiva

| Bristol-Myers Squibb Pharma EEIG |
| --- |
| Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom |

Bristol-Myers Squibb Pharma EEIG

Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom

EU/1/99/110

3.7.2013

1.7.2013

Trobalt

| Glaxo Group Limited |
| --- |
| 980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom |

Glaxo Group Limited

980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom

EU/1/11/681

3.7.2013

1.7.2013

Truvada

| Gilead Sciences International Limited |
| --- |
| Cambridge CB21 6GT, United Kingdom |

Gilead Sciences International Limited

Cambridge CB21 6GT, United Kingdom

EU/1/04/305

3.7.2013

1.7.2013

Viread

| Gilead Sciences International Limited |
| --- |
| Cambridge CB21 6GT, United Kingdom |

Gilead Sciences International Limited

Cambridge CB21 6GT, United Kingdom

EU/1/01/200

3.7.2013

1.7.2013

Votrient

| Glaxo Group Limited |
| --- |
| 980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom |

Glaxo Group Limited

980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom

EU/1/10/628

3.7.2013

1.7.2013

Yentreve

| Eli Lilly Nederland B.V. |
| --- |
| Grootslag 1-5, NL-3991 RA Houten, Nederland |

Eli Lilly Nederland B.V.

Grootslag 1-5, NL-3991 RA Houten, Nederland

EU/1/04/280

3.7.2013

4.7.2013

Cymbalta

| Eli Lilly Nederland B.V. |
| --- |
| Grootslag 1-5, NL-3991 RA Houten, Nederland |

Eli Lilly Nederland B.V.

Grootslag 1-5, NL-3991 RA Houten, Nederland

EU/1/04/296

8.7.2013

4.7.2013

Lucentis

| Novartis Europharm Limited |
| --- |
| Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom |

Novartis Europharm Limited

Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom

EU/1/06/374

8.7.2013

4.7.2013

Rasitrio

| Novartis Europharm Limited |
| --- |
| Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom |

Novartis Europharm Limited

Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom

EU/1/11/730

8.7.2013

4.7.2013

Xeristar

| Eli Lilly Nederland B.V. |
| --- |
| Grootslag 1-5, NL-3991 RA Houten, Nederland |

Eli Lilly Nederland B.V.

Grootslag 1-5, NL-3991 RA Houten, Nederland

EU/1/04/297

8.7.2013

9.7.2013

Prevenar 13

| Pfizer Limited |
| --- |
| Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom |

Pfizer Limited

Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom

EU/1/09/590

11.7.2013

9.7.2013

Tysabri

| Biogen Idec Limited |
| --- |
| Innovation House, 70 Norden Road, Maidenhead, Berkshire SL6 4AY, United Kingdom |

Biogen Idec Limited

Innovation House, 70 Norden Road, Maidenhead, Berkshire SL6 4AY, United Kingdom

EU/1/06/346

11.7.2013

15.7.2013

Benlysta

| Glaxo Group Limited |
| --- |
| Glaxo Wellcome House, Berkeley Avenue, Greenford, Middlesex UB6 0NN, United Kingdom |

Glaxo Group Limited

Glaxo Wellcome House, Berkeley Avenue, Greenford, Middlesex UB6 0NN, United Kingdom

EU/1/11/700

17.7.2013

15.7.2013

Onduarp

| Boehringer Ingelheim International GmbH |
| --- |
| Binger Straße 173, D-55216 Ingelheim am Rhein, Deutschland |

Boehringer Ingelheim International GmbH

Binger Straße 173, D-55216 Ingelheim am Rhein, Deutschland

EU/1/11/729

17.7.2013

15.7.2013

Pradaxa

| Boehringer Ingelheim International GmbH |
| --- |
| Binger Straße 173, D-55216 Ingelheim am Rhein, Deutschland |

Boehringer Ingelheim International GmbH

Binger Straße 173, D-55216 Ingelheim am Rhein, Deutschland

EU/1/08/442

17.7.2013

15.7.2013

Votubia

| Novartis Europharm Limited |
| --- |
| Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom |

Novartis Europharm Limited

Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom

EU/1/11/710

17.7.2013

17.7.2013

Iscover

| Sanofi-Aventis groupe |
| --- |
| 54 rue La Boétie, F-75008 Paris, France |

Sanofi-Aventis groupe

54 rue La Boétie, F-75008 Paris, France

EU/1/98/070

19.7.2013

17.7.2013

Plavix

| Sanofi Pharma Bristol-Myers Squibb SNC |
| --- |
| 54 rue La Boétie, F-75008 Paris, France |

Sanofi Pharma Bristol-Myers Squibb SNC

54 rue La Boétie, F-75008 Paris, France

EU/1/98/069

19.7.2013

17.7.2013

Votubia

| Novartis Europharm Limited |
| --- |
| Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom |

Novartis Europharm Limited

Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom

EU/1/11/710

19.7.2013

19.7.2013

Clopidogrel Zentiva

| Sanofi-Aventis groupe |
| --- |
| 54 rue La Boétie, F-75008 Paris, France |

Sanofi-Aventis groupe

54 rue La Boétie, F-75008 Paris, France

EU/1/08/465

23.7.2013

19.7.2013

DuoPlavin

| Sanofi Pharma Bristol-Myers Squibb SNC |
| --- |
| 54 rue La Boétie, F-75008 Paris, France |

Sanofi Pharma Bristol-Myers Squibb SNC

54 rue La Boétie, F-75008 Paris, France

EU/1/10/619

23.7.2013

19.7.2013

Ratiograstim

| ratiopharm GmbH |
| --- |
| Graf-Arco-Straße 3, D-89079 Ulm, Deutschland |

ratiopharm GmbH

Graf-Arco-Straße 3, D-89079 Ulm, Deutschland

EU/1/08/444

23.7.2013

19.7.2013

Tevagrastim

| Teva GmbH |
| --- |
| Graf-Arco-Straße 3, D-89079 Ulm, Deutschland |

Teva GmbH

Graf-Arco-Straße 3, D-89079 Ulm, Deutschland

EU/1/08/445

23.7.2013

19.7.2013

Thalidomide Celgene

| Celgene Europe Limited |
| --- |
| 1 Longwalk Road, Stockley Park, Uxbridge, Middlesex UB11 1DB, United Kingdom |

Celgene Europe Limited

1 Longwalk Road, Stockley Park, Uxbridge, Middlesex UB11 1DB, United Kingdom

EU/1/08/443

23.7.2013

25.7.2013

Aranesp

| Amgen Europe B.V. |
| --- |
| Minervum 7061, NL-4817 ZK Breda, Nederland |

Amgen Europe B.V.

Minervum 7061, NL-4817 ZK Breda, Nederland

EU/1/01/185

29.7.2013

25.7.2013

Biograstim

| CT Arzneimittel GmbH |
| --- |
| Graf-Arco-Straße 3, D-89079 Ulm, Deutschland |

CT Arzneimittel GmbH

Graf-Arco-Straße 3, D-89079 Ulm, Deutschland

EU/1/08/450

29.7.2013

25.7.2013

Leflunomide medac

| medac Gesellschaft für klinische Spezialpräparate mbH |
| --- |
| Fehlandtstraße 3, D-20354 Hamburg, Deutschland |

medac Gesellschaft für klinische Spezialpräparate mbH

Fehlandtstraße 3, D-20354 Hamburg, Deutschland

EU/1/10/637

29.7.2013

25.7.2013

Remicade

| Janssen Biologics B.V. |
| --- |
| Einsteinweg 101, NL-2333 CB Leiden, Nederland |

Janssen Biologics B.V.

Einsteinweg 101, NL-2333 CB Leiden, Nederland

EU/1/99/116

29.7.2013

25.7.2013

Tyverb

| Glaxo Group Limited |
| --- |
| 980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom |

Glaxo Group Limited

980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom

EU/1/07/440

29.7.2013

25.7.2013

Vectibix

| Amgen Europe B.V. |
| --- |
| Minervum 7061, NL-4817 ZK Breda, Nederland |

Amgen Europe B.V.

Minervum 7061, NL-4817 ZK Breda, Nederland

EU/1/07/423

29.7.2013

25.7.2013

Zytiga

| Janssen-Cilag International NV |
| --- |
| Turnhoutseweg 30, B-2340 Beerse, België |

Janssen-Cilag International NV

Turnhoutseweg 30, B-2340 Beerse, België

EU/1/11/714

29.7.2013

26.7.2013

BYDUREON

| Bristol-Myers Squibb/AstraZeneca EEIG |
| --- |
| Bristol Myers Squibb House, Uxbridge Business Park, Sanderson Road, Uxbridge, Middlesex UB8 1DH, United Kingdom |

Bristol-Myers Squibb/AstraZeneca EEIG

Bristol Myers Squibb House, Uxbridge Business Park, Sanderson Road, Uxbridge, Middlesex UB8 1DH, United Kingdom

EU/1/11/696

31.7.2013

26.7.2013

DuoCover

| Sanofi-Aventis groupe |
| --- |
| 54 rue La Boétie, F-75008 Paris, France |

Sanofi-Aventis groupe

54 rue La Boétie, F-75008 Paris, France

EU/1/10/623

31.7.2013

26.7.2013

Eucreas

| Novartis Europharm Limited |
| --- |
| Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom |

Novartis Europharm Limited

Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom

EU/1/07/425

30.7.2013

26.7.2013

Evicel

| Omrix Biopharmaceuticals N.V. |
| --- |
| Leonardo Da Vincilaan 15, B-1831 Diegem, België |

Omrix Biopharmaceuticals N.V.

Leonardo Da Vincilaan 15, B-1831 Diegem, België

EU/1/08/473

30.7.2013

26.7.2013

Iscover

| Sanofi-Aventis groupe |
| --- |
| 54 rue La Boétie, F-75008 Paris, France |

Sanofi-Aventis groupe

54 rue La Boétie, F-75008 Paris, France

EU/1/98/070

31.7.2013

26.7.2013

Onglyza

| Bristol-Myers Squibb/AstraZeneca EEIG |
| --- |
| Bristol Myers Squibb House, Uxbridge Business Park, Sanderson Road, Uxbridge, Middlesex UB8 1DH, United Kingdom |

Bristol-Myers Squibb/AstraZeneca EEIG

Bristol Myers Squibb House, Uxbridge Business Park, Sanderson Road, Uxbridge, Middlesex UB8 1DH, United Kingdom

EU/1/09/545

30.7.2013

26.7.2013

Plavix

| Sanofi Pharma Bristol-Myers Squibb SNC |
| --- |
| 54 rue La Boétie, F-75008 Paris, France |

Sanofi Pharma Bristol-Myers Squibb SNC

54 rue La Boétie, F-75008 Paris, France

EU/1/98/069

30.7.2013

26.7.2013

Rasilez

| Novartis Europharm Limited |
| --- |
| Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom |

Novartis Europharm Limited

Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom

EU/1/07/405

31.7.2013

26.7.2013

Rasitrio

| Novartis Europharm Limited |
| --- |
| Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom |

Novartis Europharm Limited

Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom

EU/1/11/730

30.7.2013

26.7.2013

Teysuno

| Nordic Group B.V. |
| --- |
| Siriusdreef 22, NL-2132 WT Hoofddorp, Nederland |

Nordic Group B.V.

Siriusdreef 22, NL-2132 WT Hoofddorp, Nederland

EU/1/11/669

31.7.2013

31.7.2013

Aprovel

| Sanofi Pharma Bristol-Myers Squibb SNC |
| --- |
| 54 rue La Boétie, F-75008 Paris, France |

Sanofi Pharma Bristol-Myers Squibb SNC

54 rue La Boétie, F-75008 Paris, France

EU/1/97/046

5.8.2013

31.7.2013

CoAprovel

| Sanofi Pharma Bristol-Myers Squibb SNC |
| --- |
| 54 rue La Boétie, F-75008 Paris, France |

Sanofi Pharma Bristol-Myers Squibb SNC

54 rue La Boétie, F-75008 Paris, France

EU/1/98/086

5.8.2013

31.7.2013

Copalia

| Novartis Europharm Limited |
| --- |
| Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom |

Novartis Europharm Limited

Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom

EU/1/06/372

2.8.2013

31.7.2013

Copalia HCT

| Novartis Europharm Limited |
| --- |
| Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom |

Novartis Europharm Limited

Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom

EU/1/09/575

5.8.2013

31.7.2013

Dafiro

| Novartis Europharm Limited |
| --- |
| Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom |

Novartis Europharm Limited

Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom

EU/1/06/371

5.8.2013

31.7.2013

Dafiro HCT

| Novartis Europharm Limited |
| --- |
| Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom |

Novartis Europharm Limited

Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom

EU/1/09/574

2.8.2013

31.7.2013

Exforge

| Novartis Europharm Limited |
| --- |
| Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom |

Novartis Europharm Limited

Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom

EU/1/06/370

5.8.2013

31.7.2013

Exforge HCT

| Novartis Europharm Limited |
| --- |
| Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom |

Novartis Europharm Limited

Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom

EU/1/09/569

2.8.2013

31.7.2013

Galvus

| Novartis Europharm Limited |
| --- |
| Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom |

Novartis Europharm Limited

Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom

EU/1/07/414

5.8.2013

31.7.2013

Icandra

| Novartis Europharm Limited |
| --- |
| Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom |

Novartis Europharm Limited

Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom

EU/1/08/484

5.8.2013

31.7.2013

Imprida

| Novartis Europharm Limited |
| --- |
| Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom |

Novartis Europharm Limited

Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom

EU/1/06/373

5.8.2013

31.7.2013

Irbesartan HCT Zentiva

| Sanofi-Aventis groupe |
| --- |
| 54 rue La Boétie, F-75008 Paris, France |

Sanofi-Aventis groupe

54 rue La Boétie, F-75008 Paris, France

EU/1/06/377

2.8.2013

31.7.2013

Irbesartan Zentiva

| Sanofi-Aventis groupe |
| --- |
| 54 rue La Boétie, F-75008 Paris, France |

Sanofi-Aventis groupe

54 rue La Boétie, F-75008 Paris, France

EU/1/06/376

5.8.2013

31.7.2013

Jalra

| Novartis Europharm Limited |
| --- |
| Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom |

Novartis Europharm Limited

Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom

EU/1/08/485

5.8.2013

31.7.2013

Karvea

| Sanofi-Aventis groupe |
| --- |
| 54 rue La Boétie, F-75008 Paris, France |

Sanofi-Aventis groupe

54 rue La Boétie, F-75008 Paris, France

EU/1/97/049

2.8.2013

31.7.2013

Karvezide

| Sanofi-Aventis groupe |
| --- |
| 54 rue La Boétie, F-75008 Paris, France |

Sanofi-Aventis groupe

54 rue La Boétie, F-75008 Paris, France

EU/1/98/085

2.8.2013

31.7.2013

Leganto

| UCB Manufacturing Ireland Ltd. |
| --- |
| Shannon Industrial Estate, Co, Clare, Ireland |

UCB Manufacturing Ireland Ltd.

Shannon Industrial Estate, Co, Clare, Ireland

EU/1/11/695

2.8.2013

31.7.2013

Neupro

| UCB Manufacturing Ireland Ltd. |
| --- |
| Shannon Industrial Estate, Co, Clare, Ireland |

UCB Manufacturing Ireland Ltd.

Shannon Industrial Estate, Co, Clare, Ireland

EU/1/05/331

2.8.2013

31.7.2013

ProQuad

| Sanofi Pasteur MSD, SNC |
| --- |
| 8 rue Jonas Salk, F-69007 Lyon, France |

Sanofi Pasteur MSD, SNC

8 rue Jonas Salk, F-69007 Lyon, France

EU/1/05/323

2.8.2013

31.7.2013

VELCADE

| Janssen-Cilag International NV |
| --- |
| Turnhoutseweg 30, B-2340 Beerse, België |

Janssen-Cilag International NV

Turnhoutseweg 30, B-2340 Beerse, België

EU/1/04/274

5.8.2013

31.7.2013

Vimpat

| UCB Pharma S.A. |
| --- |
| Allée de la Recherche 60, 1070 Bruxelles, Belgique/Researchdreef 60, 1070 Brussel, België |

UCB Pharma S.A.

Allée de la Recherche 60, 1070 Bruxelles, Belgique/Researchdreef 60, 1070 Brussel, België

EU/1/08/470

5.8.2013

31.7.2013

Xiliarx

| Novartis Europharm Limited |
| --- |
| Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom |

Novartis Europharm Limited

Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom

EU/1/08/486

5.8.2013

31.7.2013

Zomarist

| Novartis Europharm Limited |
| --- |
| Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom |

Novartis Europharm Limited

Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom

EU/1/08/483

2.8.2013

—   Withdrawal of a marketing authorization (Article 13 of Regulation (EC) No 726/2004 of the European Parliament and of the Council)

| Date of the decision | Name of the medicinal product | Holder of the marketing authorization | Number of the entry in the Community Register | Date of notification |
| --- | --- | --- | --- | --- |
| 6.6.2013 | Sepioglin | Vaia S.A. |
| 1, 28 Octovriou str., Ag. Varvara 123 51, Athens, Ελλάδα |

Date of the decision

Name of the medicinal product

Holder of the marketing authorization

Number of the entry in the Community Register

Date of notification

6.6.2013

Sepioglin

Vaia S.A.

1, 28 Octovriou str., Ag. Varvara 123 51, Athens, Ελλάδα

EU/1/12/754

10.6.2013

—   Lift of suspension of a marketing authorization (Article 20 of Regulation (EC) No 726/2004 of the European Parliament and of the Council)

| Date of the decision | Name of the medicinal product | Holder of the marketing authorization | Number of the entry in the Community Register | Date of notification |
| --- | --- | --- | --- | --- |
| 17.7.2013 | Ribavirin Teva | Teva Pharma B.V. |
| Computerweg 10, NL-3542 DR Utrecht, Nederland |

Date of the decision

Name of the medicinal product

Holder of the marketing authorization

Number of the entry in the Community Register

Date of notification

17.7.2013

Ribavirin Teva

Teva Pharma B.V.

Computerweg 10, NL-3542 DR Utrecht, Nederland

EU/1/09/509

19.7.2013

17.7.2013

Ribavirin Teva Pharma BV

| Teva Pharma B.V. |
| --- |
| Computerweg 10, NL-3542 DR Utrecht, Nederland |

Teva Pharma B.V.

Computerweg 10, NL-3542 DR Utrecht, Nederland

EU/1/09/527

19.7.2013

—   Issuing of a marketing authorization (Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council
   (2)
  ): Accepted

| Date of the decision | Name of the medicinal product | INN (International Non-Proprietary Name) | Holder of the marketing authorization | Number of the entry in the Community Register | Pharmaceutical form | ATC code (Anatomical Therapeutic Chemical Code) | Date of notification |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 6.6.2013 | Equilis West Nile | Inactivated chimeric flavivirus strain YF-WN | Intervet International B.V. |
| Wim de Körverstraat 35, NL-5831 AN Boxmeer, Nederland |

Date of the decision

Name of the medicinal product

INN (International Non-Proprietary Name)

Holder of the marketing authorization

Number of the entry in the Community Register

Pharmaceutical form

ATC code (Anatomical Therapeutic Chemical Code)

Date of notification

6.6.2013

Equilis West Nile

Inactivated chimeric flavivirus strain YF-WN

Intervet International B.V.

Wim de Körverstraat 35, NL-5831 AN Boxmeer, Nederland

EU/2/13/151

Suspension for injection

QI05AA10

10.6.2013

12.7.2013

ProZinc

Insulin human

| Boehringer Ingelheim Vetmedica GmbH |
| --- |
| Binger Straße 173, D-55216 Ingelheim am Rhein, Deutschland |

Boehringer Ingelheim Vetmedica GmbH

Binger Straße 173, D-55216 Ingelheim am Rhein, Deutschland

EU/2/13/152

Suspension for injection

QA10AC01

16.7.2013

15.7.2013

Aftovaxpur Doe

purified, inactivated foot-and-mouth disease virus strains O1 Manisa, O1 BFS, O Taiwan 3/97, A22 Iraq, A24 Cruzeiro, A Turkey 14/98, Asia 1 Shamir

| Merial |
| --- |
| 29 avenue Tony Garnier, F-69007 Lyon, France |

Merial

29 avenue Tony Garnier, F-69007 Lyon, France

EU/2/13/153

Emulsion for injection

QI02AA04

17.7.2013

—   Modification of a marketing authorization (Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council): Accepted

| Date of the decision | Name of the medicinal product | Holder of the marketing authorization | Number of the entry in the Community Register | Date of notification |
| --- | --- | --- | --- | --- |
| 6.6.2013 | Equioxx | Merial |
| 29 avenue Tony Garnier, F-69007 Lyon, France |

Date of the decision

Name of the medicinal product

Holder of the marketing authorization

Number of the entry in the Community Register

Date of notification

6.6.2013

Equioxx

Merial

29 avenue Tony Garnier, F-69007 Lyon, France

EU/2/08/083

11.6.2013

13.6.2013

Contacera

| Zoetis Belgium S.A. |
| --- |
| Rue Laid Burniat 1, 1348 Louvain-La-Neuve, Belgique |

Zoetis Belgium S.A.

Rue Laid Burniat 1, 1348 Louvain-La-Neuve, Belgique

EU/2/12/144

17.6.2013

9.7.2013

Suvaxyn Aujeszky 783 + O/W

| Zoetis Belgium S.A. |
| --- |
| Rue Laid Burniat 1, 1348 Louvain-La-Neuve, Belgique |

Zoetis Belgium S.A.

Rue Laid Burniat 1, 1348 Louvain-La-Neuve, Belgique

EU/2/98/009

11.7.2013

15.7.2013

Reconcile

| Eli Lilly and Company Ltd |
| --- |
| Priestley Road, Basingstoke, Hampshire RG24 9NL, United Kingdom |

Eli Lilly and Company Ltd

Priestley Road, Basingstoke, Hampshire RG24 9NL, United Kingdom

EU/2/08/080

19.7.2013

15.7.2013

Zactran

| Merial |
| --- |
| 29 avenue Tony Garnier, F-69007 Lyon, France |

Merial

29 avenue Tony Garnier, F-69007 Lyon, France

EU/2/08/082

17.7.2013

26.7.2013

Zulvac 1+8 Ovis

| Zoetis Belgium S.A. |
| --- |
| Rue Laid Burniat 1, 1348 Louvain-La-Neuve, Belgique |

Zoetis Belgium S.A.

Rue Laid Burniat 1, 1348 Louvain-La-Neuve, Belgique

EU/2/11/120

30.7.2013

—   Withdrawal of a marketing authorization (Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council)

| Date of the decision | Name of the medicinal product | Holder of the marketing authorization | Number of the entry in the Community Register | Date of notification |
| --- | --- | --- | --- | --- |
| 21.6.2013 | Ibaflin | Intervet International B.V. |
| Wim de Körverstraat 35, NL-5831 AN Boxmeer, Nederland |

Date of the decision

Name of the medicinal product

Holder of the marketing authorization

Number of the entry in the Community Register

Date of notification

21.6.2013

Ibaflin

Intervet International B.V.

Wim de Körverstraat 35, NL-5831 AN Boxmeer, Nederland

EU/2/00/022

25.6.2013

Anyone wishing to consult the public assessment report on the medicinal products in question and the decisions relating thereto is invited to contact:

| The European Medicines Agency |
| --- |
| 7, Westferry Circus, Canary Wharf |
| UK-LONDON E14 4H |

The European Medicines Agency

7, Westferry Circus, Canary Wharf

UK-LONDON E14 4H

---

(1)  OJ L 136, 30.4.2004, p. 1.

(2)  OJ L 136, 30.4.2004, p. 1.

---

| 30.8.2013 | EN | Official Journal of the European Union | C 250/44 |
| --- | --- | --- | --- |

30.8.2013

EN

Official Journal of the European Union

C 250/44

---

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 June 2013 to 31 July 2013

(Decisions taken pursuant to Article 34 of Directive 2001/83/EC
   (1)
  or Article 38 of Directive 2001/82/EC
   (2)
  )

2013/C 250/03

—   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 |
| --- | --- | --- | --- | --- |
| 24.6.2013 | Cilostazol | See Annex I | See Annex I | 25.6.2013 |
| 25.7.2013 | Cyproterone acetate/ethinylestradiol | See Annex II | See Annex II | 29.7.2013 |
| 27.6.2013 | Monovalent and multivalent measles, mumps, rubella and varicella vaccines | See Annex III | See Annex III | 1.7.2013 |

Date of the decision

Name(s) of the medicinal product

Holder(s) of the marketing authorization

Member State concerned

Date of notification

24.6.2013

Cilostazol

See Annex I

See Annex I

25.6.2013

25.7.2013

Cyproterone acetate/ethinylestradiol

See Annex II

See Annex II

29.7.2013

27.6.2013

Monovalent and multivalent measles, mumps, rubella and varicella vaccines

See Annex III

See Annex III

1.7.2013

---

(1)  OJ L 311, 28.11.2001, p. 67.

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

---

ANNEX I

LIST OF THE NAMES, PHARMACEUTICAL FORMS, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTES OF ADMINISTRATION AND MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES

| Member State
  (in EEA) | Marketing Authorisation Holder | Invented name | Strength | Pharmaceutical Form | Route of administration |
| --- | --- | --- | --- | --- | --- |
| France | Otsuka Pharmaceutical Europe Ltd. |
| Hunton House Highbridge Business Park |
| Oxford Road |
| GB-UB8 1HU MIDDLESEX |
| United Kingdom |

Member State

(in EEA)

Marketing Authorisation Holder

Invented name

Strength

Pharmaceutical Form

Route of administration

France

Otsuka Pharmaceutical Europe Ltd.

Hunton House Highbridge Business Park

Oxford Road

GB-UB8 1HU MIDDLESEX

United Kingdom

PLETAL 100 mg, comprimé

100 mg

tablet

oral use

France

| Otsuka Pharmaceutical Europe Ltd. |
| --- |
| Hunton House Highbridge Business Park |
| Oxford Road |
| GB-UB8 1HU MIDDLESEX |
| United Kingdom |

Otsuka Pharmaceutical Europe Ltd.

Hunton House Highbridge Business Park

Oxford Road

GB-UB8 1HU MIDDLESEX

United Kingdom

PLETAL 50 mg, comprimé

50 mg

tablet

oral use

Germany

| Otsuka Pharmaceutical Europe Ltd. |
| --- |
| Hunton House Highbridge Business Park |
| Oxford Road Uxbridge |
| GB-UB8 1HU MIDDLESEX |
| United Kingdom |

Otsuka Pharmaceutical Europe Ltd.

Hunton House Highbridge Business Park

Oxford Road Uxbridge

GB-UB8 1HU MIDDLESEX

United Kingdom

Pletal 50 mg, Tabletten

50 mg

tablet

oral use

Germany

| Otsuka Pharmaceutical Europe Ltd. |
| --- |
| Hunton House Highbridge Business Park |
| Oxford Road Uxbridge |
| GB-UB8 1HU MIDDLESEX |
| United Kingdom |

Otsuka Pharmaceutical Europe Ltd.

Hunton House Highbridge Business Park

Oxford Road Uxbridge

GB-UB8 1HU MIDDLESEX

United Kingdom

Pletal 100 mg, Tabletten

100 mg

tablet

oral use

Italy

| Otsuka Pharmaceutical Europe Ltd. |
| --- |
| Hunton House, Highbridge Business Park, Oxford Road, Uxbridge,Middlesex, |
| UB8 1LX |
| United Kingdom |

Otsuka Pharmaceutical Europe Ltd.

Hunton House, Highbridge Business Park, Oxford Road, Uxbridge,Middlesex,

UB8 1LX

United Kingdom

PLETAL

50 MG

tablet

oral use

Italy

| Otsuka Pharmaceutical Europe Ltd. |
| --- |
| Hunton House, Highbridge Business Park, |
| Oxford Road, Uxbridge, |
| Middlesex, |
| UB8 1LX |
| United Kingdom |

Otsuka Pharmaceutical Europe Ltd.

Hunton House, Highbridge Business Park,

Oxford Road, Uxbridge,

Middlesex,

UB8 1LX

United Kingdom

PLETAL

100 MG

tablet

oral use

Spain

| Otsuka Pharmaceutical Europe Ltd. |
| --- |
| Hunton House, Highbridge Business Park, |
| Oxford Road |
| Middlesex, |
| UB8 1LX |
| United Kingdom |

Otsuka Pharmaceutical Europe Ltd.

Hunton House, Highbridge Business Park,

Oxford Road

Middlesex,

UB8 1LX

United Kingdom

PLETAL 50 mg comprimidos

50 mg

tablet

oral use

Spain

| Otsuka Pharmaceutical Europe Ltd. |
| --- |
| Huton House Highbridge Busines Park, |
| Oxford Road Uxbridge, |
| Middlesex, |
| UB8 1LX |
| United Kingdom |

Otsuka Pharmaceutical Europe Ltd.

Huton House Highbridge Busines Park,

Oxford Road Uxbridge,

Middlesex,

UB8 1LX

United Kingdom

PLETAL 100 mg comprimidos

100 mg

tablet

oral use

Spain

| LACER S.A. |
| --- |
| Sardenya, 350 |
| 08025 Barcelona |

LACER S.A.

Sardenya, 350

08025 Barcelona

EKISTOL 50 mg comprimidos

50 mg

tablet

oral use

Spain

| LACER S.A. |
| --- |
| Sardenya, 350 |
| 08025 Barcelona |

LACER S.A.

Sardenya, 350

08025 Barcelona

EKISTOL 100 mg comprimidos

100 mg

tablet

oral use

Sweden

| Otsuka Pharmaceutical Europe Limited |
| --- |
| Hunton House Highbridge Business Park |
| Oxford Road |
| Uxbridge Middlesex UB8 1HU |
| GB |

Otsuka Pharmaceutical Europe Limited

Hunton House Highbridge Business Park

Oxford Road

Uxbridge Middlesex UB8 1HU

GB

PLETAL

50 mg

tablet

oral use

Sweden

| Otsuka Pharmaceutical Europe Limited |
| --- |
| Hunton House Highbridge Business Park |
| Oxford Road |
| Uxbridge Middlesex UB8 1HU |
| GB |

Otsuka Pharmaceutical Europe Limited

Hunton House Highbridge Business Park

Oxford Road

Uxbridge Middlesex UB8 1HU

GB

PLETAL

100 mg

tablet

oral use

United Kingdom

| Otsuka Pharmaceutical Europe Limited, |
| --- |
| Hunton House, Highbridge Business Park, |
| Oxford Road, Uxbridge, |
| Middlesex UB8 1HU, |
| UK |

Otsuka Pharmaceutical Europe Limited,

Hunton House, Highbridge Business Park,

Oxford Road, Uxbridge,

Middlesex UB8 1HU,

UK

Pletal 50 mg Tablets

50 mg

tablet

oral use

United Kingdom

| Otsuka Pharmaceutical Europe Limited, |
| --- |
| Hunton House, Highbridge Business Park, |
| Oxford Road, Uxbridge, |
| Middlesex UB8 1HU, |
| UK |

Otsuka Pharmaceutical Europe Limited,

Hunton House, Highbridge Business Park,

Oxford Road, Uxbridge,

Middlesex UB8 1HU,

UK

Pletal 100 mg Tablets

100 mg

tablet

oral use

---

ANNEX II

LIST OF THE NAMES, PHARMACEUTICAL FORMS, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTE OF ADMINISTRATION, MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES

| Member State
  (in EEA) | Marketing authorisaton holder | Product name | Strength | Pharmaceutical form | Route of administration |
| --- | --- | --- | --- | --- | --- |
| Austria | Gynial GmbH |
| Gablenzgasse 11/III |
| 1150 Wien |
| Austria |

Member State

(in EEA)

Marketing authorisaton holder

Product name

Strength

Pharmaceutical form

Route of administration

Austria

Gynial GmbH

Gablenzgasse 11/III

1150 Wien

Austria

Alisma 2 mg/35 μg Filmtablette

2,00 mg

0,035 mg

Film-coated tablet

Oral use

Austria

| Ratiopharm Arzneimittel Vertriebs-GmbH |
| --- |
| Albert-Schweitzer-Gasse 3 |
| 1140 Wien |
| Austria |

Ratiopharm Arzneimittel Vertriebs-GmbH

Albert-Schweitzer-Gasse 3

1140 Wien

Austria

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

2,00 mg

0,035 mg

Coated tablet

Oral use

Austria

| Dermapharma GmbH, Türkenstraße 25/12 |
| --- |
| A-1090 Wien, |
| Austria |

Dermapharma GmbH, Türkenstraße 25/12

A-1090 Wien,

Austria

Cyprotomin 2 mg/0,035 mg Filmtabletten

2,00 mg

0,035 mg

film-coated tablet

Oral use

Austria

| Bayer Austria GmbH |
| --- |
| Herbststrasse 6-10 |
| 1160 Wien |
| Austria |

Bayer Austria GmbH

Herbststrasse 6-10

1160 Wien

Austria

Diane mite - Dragees

2,00 mg

0,035 mg

Coated tablet

Oral use

Austria

| Dermapharm AG |
| --- |
| Lil-Dagover-Ring 7 |
| 82031 Grünwald |
| Germany |

Dermapharm AG

Lil-Dagover-Ring 7

82031 Grünwald

Germany

Femogyn 2 mg/0,035 mg überzogene Tabletten

2,00 mg

0,035 mg

Coated tablet

Oral use

Austria

| Pelpharma Handels GmbH |
| --- |
| Stammhausstraße 31 |
| 1140 Wien |
| Austria |

Pelpharma Handels GmbH

Stammhausstraße 31

1140 Wien

Austria

Midane - Dragees

2,00 mg

0,035 mg

Coated tablet

Oral use

Austria

| Bayer Austria GmbH |
| --- |
| Herbststrasse 6-10 |
| 1160 Wien |
| Austria |

Bayer Austria GmbH

Herbststrasse 6-10

1160 Wien

Austria

Minerva - Dragees

2,00 mg

0,035 mg

Coated tablet

Oral use

Austria

| Sandoz GmbH |
| --- |
| Biochemiestrase 10 |
| 6250 Kundl |
| Austria |

Sandoz GmbH

Biochemiestrase 10

6250 Kundl

Austria

Xylia - Dragées

2,00 mg

0,035 mg

Coated tablet

Oral use

Belgium

| Mithra Pharmaceuticals S.A. |
| --- |
| Rue Saint Georges 5 |
| 4000 Liège |
| Belgium |

Mithra Pharmaceuticals S.A.

Rue Saint Georges 5

4000 Liège

Belgium

Chloe

2,00 mg

0,035 mg

Film-coated tablet

Oral use

Belgium

| Sandoz N.V. |
| --- |
| Telecom Gardens |
| Medialaan 40 |
| 1800 Vilvoorde |
| Belgium |

Sandoz N.V.

Telecom Gardens

Medialaan 40

1800 Vilvoorde

Belgium

Claudia-35

2,00 mg

0,035 mg

Coated tablet

Oral use

Belgium

| Mithra Pharmaceuticals S.A. |
| --- |
| Rue Saint Georges 5 |
| 4000 Liège |
| Belgium |

Mithra Pharmaceuticals S.A.

Rue Saint Georges 5

4000 Liège

Belgium

Daphne

2,00 mg

0,035 mg

Coated tablet

Oral use

Belgium

| Bayer N.V. |
| --- |
| Jan Emiel Mommaertslaan 14 |
| 1831 Machelen |
| Belgium |

Bayer N.V.

Jan Emiel Mommaertslaan 14

1831 Machelen

Belgium

Diane-35

2,00 mg

0,035 mg

Coated tablet

Oral use

Belgium

| Mylan BVBA/SPRL |
| --- |
| Terhulpsesteenweg 6A |
| 1560 Hoeilaart |
| Belgium |

Mylan BVBA/SPRL

Terhulpsesteenweg 6A

1560 Hoeilaart

Belgium

Elisamylan

2,00 mg

0,035 mg

Coated tablet

Oral use

Belgium

| 3 DDD Pharma N.V. |
| --- |
| Diestersteenweg 349 |
| 3510 Hasselt |
| Belgium |

3 DDD Pharma N.V.

Diestersteenweg 349

3510 Hasselt

Belgium

Gratiella 35

2,00 mg

0,035 mg

Coated tablet

Oral use

Bulgaria

| Bayer Pharma AG |
| --- |
| Muellerstrasse 178 |
| D-13353 Berlin |
| Germany |

Bayer Pharma AG

Muellerstrasse 178

D-13353 Berlin

Germany

Diane 35

0,035 mg

2,00 mg

Coated tablet

Oral use

Bulgaria

| Medico Uno Worldwide Ltd. |
| --- |
| 2 Grigori Afxentiou Street |
| Larnaca 6023 |
| Cyprus |

Medico Uno Worldwide Ltd.

2 Grigori Afxentiou Street

Larnaca 6023

Cyprus

Melleva

0,035 mg

2,00 mg

Film-coated tablet

Oral use

Bulgaria

| Zentiva, k.s. |
| --- |
| U kabelovny 130 |
| 102 37 Praha 10 |
| Dolní Měcholupy |
| Czech Republic |

Zentiva, k.s.

U kabelovny 130

102 37 Praha 10

Dolní Měcholupy

Czech Republic

Chloe

0,035 mg

2,00 mg

Film-coated tablet

Oral use

Czech Republic

| Zentiva, k.s. |
| --- |
| U kabelovny 130 |
| 102 37 Praha 10 |
| Dolní Měcholupy |
| Czech Republic |

Zentiva, k.s.

U kabelovny 130

102 37 Praha 10

Dolní Měcholupy

Czech Republic

CHLOE

2,00 mg

0,035 mg

Film-coated tablet

Oral use

Czech Republic

| Heaton k.s. |
| --- |
| Na Pankráci 332/14 |
| 14000 Praha 4Czech Republic |

Heaton k.s.

Na Pankráci 332/14

14000 Praha 4Czech Republic

VREYA

2,00 mg

0,035 mg

Film-coated tablet

Oral use

Czech Republic

| Bayer Pharma AG |
| --- |
| Muellerstrasse 178 |
| D-13353 Berlin |
| Germany |

Bayer Pharma AG

Muellerstrasse 178

D-13353 Berlin

Germany

MINERVA

2,00 mg

0,035 mg

Coated tablet

Oral use

Czech Republic

| Bayer Pharma AG |
| --- |
| Muellerstrasse 178 |
| D-13353 Berlin |
| Germany |

Bayer Pharma AG

Muellerstrasse 178

D-13353 Berlin

Germany

DIANE-35

2,00 mg

0,035 mg

Coated tablet

Oral use

Denmark

| Mithra Pharmaceuticals S.A. |
| --- |
| Rue Saint Georges 5 |
| 4000 Liège |
| Belgium |

Mithra Pharmaceuticals S.A.

Rue Saint Georges 5

4000 Liège

Belgium

Chloe

2,00 mg

0,035 mg

Film-coated tablet

Oral use

Denmark

| Teva Denmark A/S |
| --- |
| Parallelvej 10-12 |
| DK-2800 Kongens Lyngby |
| Denmark |

Teva Denmark A/S

Parallelvej 10-12

DK-2800 Kongens Lyngby

Denmark

Cypretyl

2,00 mg

0,035 mg

Film-coated tablet

Oral use

Denmark

| Bayer Pharma AG |
| --- |
| Muellerstrasse 178 |
| D-13353 Berlin |
| Germany |

Bayer Pharma AG

Muellerstrasse 178

D-13353 Berlin

Germany

Diane Mite

2,00 mg

0,035 mg

Film-coated tablet

Oral use

Denmark

| Alternova A/S |
| --- |
| Lodshusvej 11 |
| DK-4230 Skælskør |
| Denmark |

Alternova A/S

Lodshusvej 11

DK-4230 Skælskør

Denmark

Dianova Mite

2,00 mg

0,035 mg

Film-coated tablet

Oral use

Denmark

| Sandoz A/S |
| --- |
| Edvard Thomsens Vej 14 |
| DK-2300 København S |
| Denmark |

Sandoz A/S

Edvard Thomsens Vej 14

DK-2300 København S

Denmark

Feminil mite

2,00 mg

0,035 mg

Film-coated tablet

Oral use

Denmark

| Stragen Nordic A/S |
| --- |
| Helsingørsgade 8C |
| DK-3400 Hillerød |
| Denmark |

Stragen Nordic A/S

Helsingørsgade 8C

DK-3400 Hillerød

Denmark

Vreya

2,00 mg

0,035 mg

Film-coated tablet

Oral use

Denmark

| Orifarm Generics A/S |
| --- |
| Postbox 69 |
| Energivej 15 |
| DK-5260 Odense S. |
| Denmark |

Orifarm Generics A/S

Postbox 69

Energivej 15

DK-5260 Odense S.

Denmark

Zyrona

2,00 mg

0,035 mg

Film-coated tablet

Oral use

Estonia

| Bayer Pharma AG |
| --- |
| D-13342 Berlin |
| Germany |

Bayer Pharma AG

D-13342 Berlin

Germany

Diane

2,00 mg

0,035 mg

Coated tablet

Oral use

Estonia

| Nycomed Sefa AS |
| --- |
| Jaama 55B |
| 63308 Põlva |
| Estonia |

Nycomed Sefa AS

Jaama 55B

63308 Põlva

Estonia

Femina

2,00 mg

0,035 mg

Coated tablet

Oral use

Estonia

| Ratiopharm GmbH |
| --- |
| Graf-Arco-Strasse 3 |
| DE-89079 Ulm |
| Germany |

Ratiopharm GmbH

Graf-Arco-Strasse 3

DE-89079 Ulm

Germany

Cypretil

2,00 mg

0,035 mg

Coated tablet

Oral use

Finland

| Bayer Oy |
| --- |
| Pansiontie 47 |
| FI-20210 Turku |
| Finland |

Bayer Oy

Pansiontie 47

FI-20210 Turku

Finland

DIANE NOVA

2,00 mg

0,035 mg

Tablet

Oral use

Finland

| Ratiopharm GmbH |
| --- |
| Graf-Arco-Strasse 3 |
| DE-89079 Ulm |
| Germany |

Ratiopharm GmbH

Graf-Arco-Strasse 3

DE-89079 Ulm

Germany

CYPRETYL

2,00 mg

0,035 mg

Tablet

Oral use

Finland

| Sandoz A/S |
| --- |
| Edvard Thomsens Vej 14 |
| DK-2300 København S |
| Denmark |

Sandoz A/S

Edvard Thomsens Vej 14

DK-2300 København S

Denmark

FEMINIL

2,00 mg

0,035 mg

Tablet

Oral use

Finland

| Stragen Nordic A/S |
| --- |
| Helsingørsgade 8C |
| DK-3400 Hillerød |
| Denmark |

Stragen Nordic A/S

Helsingørsgade 8C

DK-3400 Hillerød

Denmark

VREYA

2,00 mg

0,035 mg

Tablet

Oral use

France

| Bayer Santé |
| --- |
| 220, avenue de la Recherche |
| 59120 Loos |
| France |

Bayer Santé

220, avenue de la Recherche

59120 Loos

France

DIANE 35 μg, coated tablet

2,00 mg

0,035 mg

Coated tablet

Oral use

France

| Bayer Santé |
| --- |
| 220, avenue de la Recherche |
| 59120 Loos |
| France |

Bayer Santé

220, avenue de la Recherche

59120 Loos

France

MINERVA 35 μg

2,00 mg

0,035 mg

Coated tablet

Oral use

France

| Bayer Santé |
| --- |
| 220, avenue de la Recherche |
| 59120 Loos |
| France |

Bayer Santé

220, avenue de la Recherche

59120 Loos

France

CYPROTERONE/ETHINYLESTRADIOL BAYER 35 μg

2,00 mg

0,035 mg

Coated tablet

Oral use

France

| Laboratoires Majorelle |
| --- |
| 80-82 rue Gallieni |
| 92100 Boulogne Billancourt |
| France |

Laboratoires Majorelle

80-82 rue Gallieni

92100 Boulogne Billancourt

France

CYPROPHARM 2 mg/0,035 mg

2,00 mg

0,035 mg

Coated tablet

Oral use

France

| DCI Pharma |
| --- |
| 180 Rue Eugene Avinee |
| 59120 Loos |
| France |

DCI Pharma

180 Rue Eugene Avinee

59120 Loos

France

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

2,00 mg

0,035 mg

Coated tablet

Oral use

France

| EG LABO - LABORATOIRES EUROGENERICS |
| --- |
| 12 rue Danjou |
| le Quintet bâtiment A |
| 92517 Boulogne |
| Billancourt Cedex |
| France |

EG LABO - LABORATOIRES EUROGENERICS

12 rue Danjou

le Quintet bâtiment A

92517 Boulogne

Billancourt Cedex

France

CYPROTERONE/ETHINYLESTRADIOL EG 2 mg/0,035 mg

2,00 mg

0,035 mg

Coated tablet

Oral use

France

| Ranbaxy Pharmacie Generiques |
| --- |
| 11-15 quai de Dion Bouton |
| 92800 Puteaux |
| France |

Ranbaxy Pharmacie Generiques

11-15 quai de Dion Bouton

92800 Puteaux

France

CYPROTERONE/ETHINYLESTRADIOL RANBAXY 2 mg/0,035 mg

2,00 mg

0,035 mg

Coated tablet

Oral use

France

| Teva Sante |
| --- |
| 110 Esplanade du Général de Gaulle |
| 92931 Paris la Defence |
| France |

Teva Sante

110 Esplanade du Général de Gaulle

92931 Paris la Defence

France

CYPROTERONE/ETHINYLESTRADIOL RATIOPHARM 2 mg/0,035 mg

2,00 mg

0,035 mg

Coated tablet

Oral use

France

| SANDOZ |
| --- |
| 49 avenue Georges Pompidou |
| 92593 Levallois Perret Cedex |
| France |

SANDOZ

49 avenue Georges Pompidou

92593 Levallois Perret Cedex

France

CYPROTERONE/ETHINYLESTRADIOL SANDOZ 2 mg/0,035 mg

2,00 mg

0,035 mg

Coated tablet

Oral use

France

| Teva Sante |
| --- |
| 110 Esplanade du Général de Gaulle |
| 92931 Paris la Defence |
| France |

Teva Sante

110 Esplanade du Général de Gaulle

92931 Paris la Defence

France

CYPROTERONE/ETHINYLESTRADIOL TEVA 2 mg/0,035 mg

2,00 mg

0,035 mg

Coated tablet

Oral use

France

| Sanofi Aventis France |
| --- |
| 1-13 Boulevard Romain Rolland |
| 75014 Paris |
| France |

Sanofi Aventis France

1-13 Boulevard Romain Rolland

75014 Paris

France

CYPROTERONE/ETHINYLESTRADIOL ZENTIVA 2 mg/0,035 mg

2,00 mg

0,035 mg

Coated tablet

Oral use

France

| ZYDUS France |
| --- |
| Parc d'Activités des Peupliers |
| 25 rue des Peupliers |
| 92000 Nanterre |
| France |

ZYDUS France

Parc d'Activités des Peupliers

25 rue des Peupliers

92000 Nanterre

France

CYPROTERONE/ETHINYLESTRADIOL ZYDUS 2 mg/0,035 mg

2,00 mg

0,035 mg

Coated tablet

Oral use

France

| CHEMICAL FARMA |
| --- |
| 19-23 rue d'Hautpoul |
| 75019 Paris |
| France |

CHEMICAL FARMA

19-23 rue d'Hautpoul

75019 Paris

France

ELLEACNELLE 2 mg/0,035 mg

2,00 mg

0,035 mg

Coated tablet

Oral use

France

| MYLAN SAS |
| --- |
| 117 allée des Parcs |
| 69800 Saint Priest |
| France |

MYLAN SAS

117 allée des Parcs

69800 Saint Priest

France

EVEPAR 2 mg/0,035 mg

2,00 mg

0,035 mg

Coated tablet

Oral use

France

| EFFIK |
| --- |
| bâtiment ‘le Newton’ |
| 9-11 rue Jeanne Braconnier |
| 92366 Meudon la Foret |
| France |

EFFIK

bâtiment ‘le Newton’

9-11 rue Jeanne Braconnier

92366 Meudon la Foret

France

HOLGYEME 2 mg/0,035 mg

2,00 mg

0,035 mg

Coated tablet

Oral use

France

| Pierre Fabre Dermatologie |
| --- |
| 45, place Abel Gance |
| F-92100 Boulogne |
| France |

Pierre Fabre Dermatologie

45, place Abel Gance

F-92100 Boulogne

France

LUMALIA 2 mg/0,035 mg

2,00 mg

0,035 mg

Coated tablet

Oral use

Germany

| Dermapharm AG |
| --- |
| Lil-Dagover-Ring 7 |
| 82031 Grünwald |
| Germany |

Dermapharm AG

Lil-Dagover-Ring 7

82031 Grünwald

Germany

Cyproethinyl acis

0,035 mg

2,00 mg

Film-coated tablet

Oral use

Germany

| Aristo Pharma GmbH |
| --- |
| Wallenroder Str. 8-10 |
| 13435 Berlin |
| Germany |

Aristo Pharma GmbH

Wallenroder Str. 8-10

13435 Berlin

Germany

Jennifer 35 2 mg/0,035 mg Filmtabletten

0,035 mg

2,00 mg

Film-coated tablet

Oral use

Germany

| Bayer Vital GmbH |
| --- |
| Kaiser-Wilhelm-Allee |
| 51373 Leverkusen |
| Germany |

Bayer Vital GmbH

Kaiser-Wilhelm-Allee

51373 Leverkusen

Germany

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

0,035 mg

2,00 mg

Coated tablet

Oral use

Germany

| Dermapharm AG |
| --- |
| Lil-Dagover-Ring 7 |
| 82031 Grünwald |
| Germany |

Dermapharm AG

Lil-Dagover-Ring 7

82031 Grünwald

Germany

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

0,035 mg

2,00 mg

Coated tablet

Oral use

Germany

| Hexal Aktiengesellschaft |
| --- |
| Industriestr. 25 |
| 83607 Holzkirchen |
| Germany |

Hexal Aktiengesellschaft

Industriestr. 25

83607 Holzkirchen

Germany

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

0,035 mg

2,00 mg

Coated tablet

Oral use

Germany

| Mylan dura GmbH |
| --- |
| Wittichstr. 6 |
| 64295 Darmstadt |
| Germany |

Mylan dura GmbH

Wittichstr. 6

64295 Darmstadt

Germany

Juliette

0,035 mg

2,00 mg

Coated tablet

Oral use

Germany

| Ratiopharm GmbH |
| --- |
| Graf-Arco-Strasse 3 |
| DE-89079 Ulm |
| Germany |

Ratiopharm GmbH

Graf-Arco-Strasse 3

DE-89079 Ulm

Germany

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

0,035 mg

2,00 mg

Coated tablet

Oral use

Germany

| Taurus Pharma GmbH |
| --- |
| Benzstr. 11 |
| 61352 Bad Homburg |
| Germany |

Taurus Pharma GmbH

Benzstr. 11

61352 Bad Homburg

Germany

Ergalea 2,00/0,035 mg Filmtabletten

0,035 mg

2,00 mg

Film-coated tablet

Oral use

Germany

| UCB Pharma GmbH |
| --- |
| Alfred-Nobel-Str. 10 |
| 40789 Monheim |
| Germany |

UCB Pharma GmbH

Alfred-Nobel-Str. 10

40789 Monheim

Germany

Moea Sanol 2 mg/0,035 mg überzogene Tabletten

0,035 mg

2,00 mg

Coated tablet

Oral use

Greece

| Bayer Hellas ABEE |
| --- |
| Sorou 18-20 |
| Maroussi |
| Athens GR-15125 |
| Greece |

Bayer Hellas ABEE

Sorou 18-20

Maroussi

Athens GR-15125

Greece

GYNOFEN 35

2,00 mg

0,035 mg

Coated tablet

Oral use

Hungary

| Pliva Hungária Kereskedelmi és Szolgáltató Kft. |
| --- |
| Rákóczi út 70-72 |
| Budapest 1074 |
| Hungary |

Pliva Hungária Kereskedelmi és Szolgáltató Kft.

Rákóczi út 70-72

Budapest 1074

Hungary

Bellune Pliva

2,00 mg

0,035 mg

Coated tablet

Oral use

Hungary

| Bayer Pharma AG |
| --- |
| Muellerstrasse 178 |
| D-13353 Berlin |
| Germany |

Bayer Pharma AG

Muellerstrasse 178

D-13353 Berlin

Germany

Diane

2,00 mg

0,035 mg

Coated tablet

Oral use

Hungary

| Bayer Pharma AG |
| --- |
| Muellerstrasse 178 |
| D-13353 Berlin |
| Germany |

Bayer Pharma AG

Muellerstrasse 178

D-13353 Berlin

Germany

Minerva

2,00 mg

0,035 mg

Coated tablet

Oral use

Iceland

| Bayer Pharma AG |
| --- |
| D-13342 Berlin |
| Germany |

Bayer Pharma AG

D-13342 Berlin

Germany

Diane mite

2,00 mg

0,035 mg

Tablet

Oral use

Iceland

| Ratiopharm GmbH |
| --- |
| Graf-Arco-Strasse 3 |
| DE-89079 Ulm |
| Germany |

Ratiopharm GmbH

Graf-Arco-Strasse 3

DE-89079 Ulm

Germany

Cypretyl

2,00 mg

0,035 mg

Coated tablet

Oral use

Ireland

| Generics (UK) Limited |
| --- |
| Station Close |
| Potters Bar |
| Hertfordshire EN6 1TL |
| United Kingdom |

Generics (UK) Limited

Station Close

Potters Bar

Hertfordshire EN6 1TL

United Kingdom

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

2,00 mg

0,035 mg

Tablet

Oral use

Ireland

| Bayer Limited |
| --- |
| The Atrium |
| Blackthorn Road |
| Sandyford |
| Dublin 18 |
| Ireland |

Bayer Limited

The Atrium

Blackthorn Road

Sandyford

Dublin 18

Ireland

Dianette 2 mg/35 microgram coated tablets.

2,00 mg

0,035 mg

Coated tablet

Oral use

Italy

| Bayer S.p.A. |
| --- |
| Viale Certosa, 130 |
| 20156 Milano (MI) |
| Italy |

Bayer S.p.A.

Viale Certosa, 130

20156 Milano (MI)

Italy

DIANE

2,00 mg

0,035 mg

Coated tablet

Oral use

Italy

| FIDIA Farmaceutici S.p.A. |
| --- |
| Via Ponte della Fabbrica 3/A |
| 35031 Abano Terme (PD) |
| Italy |

FIDIA Farmaceutici S.p.A.

Via Ponte della Fabbrica 3/A

35031 Abano Terme (PD)

Italy

VISOFID

2,00 mg

0,035 mg

Coated tablet

Oral use

Latvia

| Zentiva, k.s. |
| --- |
| U kabelovny 130 |
| 102 37 Praha 10 |
| Dolní Měcholupy |
| Czech Republic |

Zentiva, k.s.

U kabelovny 130

102 37 Praha 10

Dolní Měcholupy

Czech Republic

Chloe 35 micrograms/2 mg film-coated tablets

0,035 mg

2,00 mg

Film-coated tablet

Oral use

Latvia

| Takeda Pharma AS |
| --- |
| Jaama 55B |
| 63308 Põlva |
| Estonia |

Takeda Pharma AS

Jaama 55B

63308 Põlva

Estonia

Femina 2 mg/35 micrograms coated tablets

2,00 mg

0,035 mg

Coated tablet

Oral use

Latvia

| Bayer Pharma AG |
| --- |
| Muellerstrasse 178 |
| D-13353 Berlin |
| Germany |

Bayer Pharma AG

Muellerstrasse 178

D-13353 Berlin

Germany

Diane 2 000 micrograms/35 micrograms film-coated tablets

2,00 mg

0,035 mg

Film-coated tablet

Oral use

Lithuania

| Bayer Pharma AG |
| --- |
| Muellerstrasse 178 |
| D-13353 Berlin |
| Germany |

Bayer Pharma AG

Muellerstrasse 178

D-13353 Berlin

Germany

Diane

2,00 mg

0,035 mg

Coated tablet

Oral use

Lithuania

| Nycomed Sefa AS |
| --- |
| Jaama 55B |
| 63308 Põlva |
| Estonia |

Nycomed Sefa AS

Jaama 55B

63308 Põlva

Estonia

Femina

2,00 mg

0,035 mg

Coated tablet

Oral use

Lithuania

| Zentiva, k.s. |
| --- |
| U kabelovny 130 |
| 102 37 Praha 10 |
| Dolní Měcholupy |
| Czech Republic |

Zentiva, k.s.

U kabelovny 130

102 37 Praha 10

Dolní Měcholupy

Czech Republic

CHLOE

2,00 mg

0,035 mg

Film-coated tablet

Oral use

Lithuania

| Ratiopharm GmbH |
| --- |
| Graf-Arco-Strasse 3 |
| DE-89079 Ulm |
| Germany |

Ratiopharm GmbH

Graf-Arco-Strasse 3

DE-89079 Ulm

Germany

Cypretil

2,00 mg

0,035 mg

Coated tablet

Oral use

Luxembourg

| Bayer SA/NV |
| --- |
| 14 J.E. Mommaertslaan |
| B-1831 Diegem |
| Belgium |

Bayer SA/NV

14 J.E. Mommaertslaan

B-1831 Diegem

Belgium

Diane-35

2,00 mg

0,035 mg

Coated tablet

Oral use

Luxembourg

| Mithra Pharmaceuticals S.A. |
| --- |
| Rue Saint Georges 5 |
| 4000 Liège |
| Belgium |

Mithra Pharmaceuticals S.A.

Rue Saint Georges 5

4000 Liège

Belgium

Chloe

2,00 mg

0,035 mg

Coated tablet

Oral use

Luxembourg

| Mithra Pharmaceuticals S.A. |
| --- |
| Rue Saint Georges 5 |
| 4000 Liège |
| Belgium |

Mithra Pharmaceuticals S.A.

Rue Saint Georges 5

4000 Liège

Belgium

Daphne

2,00 mg

0,035 mg

Coated tablet

Oral use

Luxembourg

| Pierre Fabre Dermatologie |
| --- |
| 45, place Abel Gance |
| F-92100 Boulogne |
| France |

Pierre Fabre Dermatologie

45, place Abel Gance

F-92100 Boulogne

France

Lumalia

2,00 mg

0,035 mg

Coated tablet

Oral use

Malta

| Stragen UK Limited |
| --- |
| Castle Court 41 |
| London Road |
| Reigate, Surrey RH2 PRJ |
| United Kingdom |

Stragen UK Limited

Castle Court 41

London Road

Reigate, Surrey RH2 PRJ

United Kingdom

Clairette 2000/35 Tablets

2,00 mg

0,035 mg

Coated tablet

Oral use

Malta

| Sandoz d.d |
| --- |
| Verovskova 57 |
| 1000 Ljubljana |
| Slovenia |

Sandoz d.d

Verovskova 57

1000 Ljubljana

Slovenia

Acnocin 2000/35 Tablets

2,00 mg

0,035 mg

Coated tablet

Oral use

Norway

| Bayer Pharma AG |
| --- |
| Muellerstrasse 178 |
| D-13353 Berlin |
| Germany |

Bayer Pharma AG

Muellerstrasse 178

D-13353 Berlin

Germany

Diane

2,00 mg

0,035 mg

Coated tablet

Oral use

Norway

| Sandoz |
| --- |
| Edvard Thomsens Vej 14 |
| 2300 KØBENHAVN S |
| Denmark |

Sandoz

Edvard Thomsens Vej 14

2300 KØBENHAVN S

Denmark

Feminil

2,00 mg

0,035 mg

Coated tablet

Oral use

Norway

| Orifarm Generics A/S |
| --- |
| Postbox 69 |
| Energivej 15 |
| DK-5260 Odense S. |
| Denmark |

Orifarm Generics A/S

Postbox 69

Energivej 15

DK-5260 Odense S.

Denmark

Zyrona

2,00 mg

0,035 mg

Coated tablet

Oral use

Poland

| Acis Arzneimittel GmbH |
| --- |
| Lil-Dagover-Ring 7 |
| 82031 Grünwald |
| Germany |

Acis Arzneimittel GmbH

Lil-Dagover-Ring 7

82031 Grünwald

Germany

Acnemine

2,00 mg

0,035 mg

Film-coated tablet

Oral use

Poland

| Bayer Pharma AG |
| --- |
| Muellerstrasse 178 |
| D-13353 Berlin |
| Germany |

Bayer Pharma AG

Muellerstrasse 178

D-13353 Berlin

Germany

Diane-35

2,00 mg

0,035 mg

Film-coated tablet

Oral use

Poland

| Zentiva, k.s. |
| --- |
| U kabelovny 130 |
| 102 37 Praha 10 |
| Dolní Měcholupy |
| Czech Republic |

Zentiva, k.s.

U kabelovny 130

102 37 Praha 10

Dolní Měcholupy

Czech Republic

Chloe

2,00 mg

0,035 mg

Film-coated tablet

Oral use

Poland

| Pabianickie Zakłady Farmaceutyczne Polfa S.A. |
| --- |
| ul. Marszałka J. Piłsudskiego 5 |
| 95-200 Pabianice |
| Poland |

Pabianickie Zakłady Farmaceutyczne Polfa S.A.

ul. Marszałka J. Piłsudskiego 5

95-200 Pabianice

Poland

Cyprest

0,035 mg

2,00 mg

Coated tablet

Oral use

Poland

| Polfarmex S.A. |
| --- |
| Józefów 9 |
| 99-300 Kutno |
| Poland |

Polfarmex S.A.

Józefów 9

99-300 Kutno

Poland

OC-35

0,035 mg

2,00 mg

Film-coated tablet

Oral use

Poland

| SymPhar Sp. z o.o. |
| --- |
| ul. Włoska 1 |
| 00-777 Warszawa |
| Poland |

SymPhar Sp. z o.o.

ul. Włoska 1

00-777 Warszawa

Poland

Syndi-35

2,00 mg

0,035 mg

Coated tablet

Oral use

Poland

| Sun-Farm Sp. z o.o. |
| --- |
| Człekówka 75 |
| 05-340 Kołbiel |
| Poland |

Sun-Farm Sp. z o.o.

Człekówka 75

05-340 Kołbiel

Poland

Cyprodiol

2,00 mg

0,035 mg

Coated tablet

Oral use

Portugal

| Berlifarma - Especialidades Farmaceuticas, Lda. |
| --- |
| Rua Quinta Pinheiro, 5, Outurela |
| 2794-003 Carnaxide |
| Portugal |

Berlifarma - Especialidades Farmaceuticas, Lda.

Rua Quinta Pinheiro, 5, Outurela

2794-003 Carnaxide

Portugal

Diane 35

2,00 mg

0,035 mg

Coated tablet

Oral use

Portugal

| Mylan, Lda. |
| --- |
| Rua Alfredo da Silva, 3 C-4o 1300-040 Lisboa |
| Portugal |

Mylan, Lda.

Rua Alfredo da Silva, 3 C-4o 1300-040 Lisboa

Portugal

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

2,00 mg

0,035 mg

Coated tablet

Oral use

Portugal

| Generis Farmaceutica, S.A. |
| --- |
| Rua Joao de Deus, 19 |
| 2700-487 Amadora |
| Portugal |

Generis Farmaceutica, S.A.

Rua Joao de Deus, 19

2700-487 Amadora

Portugal

Ciproterona + Etinilestradiol Generis

2,00 mg

0,035 mg

Coated tablet

Oral use

Portugal

| Generis Farmaceutica, S.A. |
| --- |
| Rua Joao de Deus, 19 |
| 2700-487 Amadora |
| Portugal |

Generis Farmaceutica, S.A.

Rua Joao de Deus, 19

2700-487 Amadora

Portugal

Ciproterona + Etinilestradiol Inventis

2,00 mg

0,035 mg

Coated tablet

Oral use

Romania

| Bayer Pharma AG |
| --- |
| Muellerstrasse 178 |
| D-13353 Berlin |
| Germany |

Bayer Pharma AG

Muellerstrasse 178

D-13353 Berlin

Germany

DIANE- 35

2,00 mg

0,035 mg

Coated tablet

Oral use

Romania

| Ladeepharma Pharmaceutical Limited |
| --- |
| Lajos u. 48-66 |
| E ép. 5. em. |
| H-1036 Budapest |
| Hungary |

Ladeepharma Pharmaceutical Limited

Lajos u. 48-66

E ép. 5. em.

H-1036 Budapest

Hungary

MELLEVA 2 mg/0,035 mg

2,00 mg

0,035 mg

Film-coated tablet

Oral use

Slovak Republic

| Heaton a.s. |
| --- |
| Na Pankráci 14 |
| 14000 Praha 4 |
| Czech Republic |

Heaton a.s.

Na Pankráci 14

14000 Praha 4

Czech Republic

Vreya

2,00 mg

0,035 mg

Coated tablet

Oral use

Slovak Republic

| Bayer Pharma AG |
| --- |
| Muellerstrasse 178 |
| D-13353 Berlin |
| Germany |

Bayer Pharma AG

Muellerstrasse 178

D-13353 Berlin

Germany

Minerva

2,00 mg

0,035 mg

Coated tablet

Oral use

Slovak Republic

| Zentiva, k.s. |
| --- |
| U kabelovny 130 |
| 102 37 Praha 10 |
| Dolní Měcholupy |
| Czech Republic |

Zentiva, k.s.

U kabelovny 130

102 37 Praha 10

Dolní Měcholupy

Czech Republic

CHLOE

2,00 mg

0,035 mg

Coated tablet

Oral use

Slovak Republic

| Bayer Pharma AG |
| --- |
| Muellerstrasse 178 |
| D-13353 Berlin |
| Germany |

Bayer Pharma AG

Muellerstrasse 178

D-13353 Berlin

Germany

Diane-35

2,00 mg

0,035 mg

Coated tablet

Oral use

Slovenia

| Bayer Pharma AG |
| --- |
| Muellerstrasse 178 |
| D-13353 Berlin |
| Germany |

Bayer Pharma AG

Muellerstrasse 178

D-13353 Berlin

Germany

Diane 0,035 mg/2 mg obložene tablete

0,035 mg

2,00 mg

Coated tablet

Oral use

Spain

| BAYER HISPANIA, S.L. |
| --- |
| Avda. Baix Llobregat 3 y 5 |
| 08970 Sant Joan Despi |
| Barcelona |
| Spain |

BAYER HISPANIA, S.L.

Avda. Baix Llobregat 3 y 5

08970 Sant Joan Despi

Barcelona

Spain

DIANE 35

2,00 mg

0,035 mg

Coated tablet

Oral use

Spain

| BAYER HISPANIA, S.L. |
| --- |
| Avda. Baix Llobregat 3 y 5 |
| 08970 Sant Joan Despi |
| Barcelona |
| Spain |

BAYER HISPANIA, S.L.

Avda. Baix Llobregat 3 y 5

08970 Sant Joan Despi

Barcelona

Spain

DIANE 35 DIARIO

2,00 mg

0,035 mg

Coated tablet

Oral use

Spain

| Laboratorios EFFIK, S.A. |
| --- |
| San Rafael, 3 |
| 28108 Alcobendas |
| Madrid |
| Spain |

Laboratorios EFFIK, S.A.

San Rafael, 3

28108 Alcobendas

Madrid

Spain

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

2,00 mg

0,035 mg

Coated tablet

Oral use

Spain

| Sandoz Farmaceutica, S.A. |
| --- |
| Avda. Osa Mayor, 4 |
| 28023 Aravaca |
| Madrid |
| Spain |

Sandoz Farmaceutica, S.A.

Avda. Osa Mayor, 4

28023 Aravaca

Madrid

Spain

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

2,00 mg

0,035 mg

Film-coated tablet

Oral use

Spain

| Laboratorios EFFIK, S.A. |
| --- |
| San Rafael, 3 |
| 28108 Alcobendas |
| Madrid |
| Spain |

Laboratorios EFFIK, S.A.

San Rafael, 3

28108 Alcobendas

Madrid

Spain

GYNEPLEN 0,035 mg/2 mg comprimidos recubiertos

2,00 mg

0,035 mg

Coated tablet

Oral use

Spain

| Farmalider S.A. |
| --- |
| Calle Aragoneses, 15 |
| 28108 Alcobendas |
| Madrid |
| Spain |

Farmalider S.A.

Calle Aragoneses, 15

28108 Alcobendas

Madrid

Spain

DIALIDER 2/0,035 mg comprimidos recubiertos con película

2,00 mg

0,035 mg

Film-coated tablet

Oral use

Spain

| Teva Pharma, SLU |
| --- |
| Anabel Segura 11 |
| Edificio Albatros B |
| 1a planta |
| 28108 Alcobendas |
| Madrid |
| Spain |

Teva Pharma, SLU

Anabel Segura 11

Edificio Albatros B

1a planta

28108 Alcobendas

Madrid

Spain

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

2,00 mg

0,035 mg

Coated tablet

Oral use

Sweden

| Bayer Pharma AG |
| --- |
| Muellerstrasse 178 |
| D-13353 Berlin |
| Germany |

Bayer Pharma AG

Muellerstrasse 178

D-13353 Berlin

Germany

Diane®

2,00 mg

0,035 mg

Tablet

Oral use

Sweden

| Orifarm Generics A/S |
| --- |
| Postbox 69 |
| Energivej 15 |
| DK-5260 Odense S. |
| Denmark |

Orifarm Generics A/S

Postbox 69

Energivej 15

DK-5260 Odense S.

Denmark

Zyrona

2,00 mg

0,035 mg

Coated tablet

Oral use

The Netherlands

| Actavis B.V. |
| --- |
| Baarnsche Dijk 1 |
| 3741 LN Baarn |
| The Netherlands |

Actavis B.V.

Baarnsche Dijk 1

3741 LN Baarn

The Netherlands

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

2,00 mg

0,035 mg

Film-coated tablet

Oral use

The Netherlands

| Apotex Europe B.V. |
| --- |
| Darwinweg 20 |
| 2333 CR Leiden |
| The Netherlands |

Apotex Europe B.V.

Darwinweg 20

2333 CR Leiden

The Netherlands

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

2,00 mg

0,035 mg

Film-coated tablet

Oral use

The Netherlands

| Centrafarm B.V. |
| --- |
| Nieuwe Donk 3 |
| 4879 AC Etten-Leur |
| The Netherlands |

Centrafarm B.V.

Nieuwe Donk 3

4879 AC Etten-Leur

The Netherlands

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

2,00 mg

0,035 mg

Film-coated tablet

Oral use

The Netherlands

| Mylan B.V. |
| --- |
| Dieselweg 25 |
| 3752 LB Bunschoten |
| The Netherlands |

Mylan B.V.

Dieselweg 25

3752 LB Bunschoten

The Netherlands

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

2,00 mg

0,035 mg

Film-coated tablet

Oral use

The Netherlands

| Mylan B.V. |
| --- |
| Dieselweg 25 |
| 3752 LB Bunschoten |
| The Netherlands |

Mylan B.V.

Dieselweg 25

3752 LB Bunschoten

The Netherlands

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

2,00 mg

0,035 mg

Film-coated tablet

Oral use

The Netherlands

| ratiopharm Nederland B.V. |
| --- |
| Swensweg 5 |
| 2031 GA Haarlem |
| The Netherlands |

ratiopharm Nederland B.V.

Swensweg 5

2031 GA Haarlem

The Netherlands

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

2,00 mg

0,035 mg

Film-coated tablet

Oral use

The Netherlands

| Sandoz B.V. |
| --- |
| Veluwezoom 22 |
| 1327 AH Almere |
| The Netherlands |

Sandoz B.V.

Veluwezoom 22

1327 AH Almere

The Netherlands

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

2,00 mg

0,035 mg

Film-coated tablet

Oral use

The Netherlands

| Mylan B.V. |
| --- |
| Dieselweg 25 |
| 3752 LB Bunschoten |
| The Netherlands |

Mylan B.V.

Dieselweg 25

3752 LB Bunschoten

The Netherlands

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

2,00 mg

0,035 mg

Film-coated tablet

Oral use

The Netherlands

| Pharmachemie B.V. |
| --- |
| Swensweg 5 |
| 2031 GA Haarlem |
| The Netherlands |

Pharmachemie B.V.

Swensweg 5

2031 GA Haarlem

The Netherlands

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

2,00 mg

0,035 mg

Film-coated tablet

Oral use

The Netherlands

| Stragen Nordic A/S |
| --- |
| Helsingørsgade 8C |
| DK-3400 Hillerød |
| Denmark |

Stragen Nordic A/S

Helsingørsgade 8C

DK-3400 Hillerød

Denmark

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

2,00 mg

0,035 mg

Film-coated tablet

Oral use

The Netherlands

| Bayer B.V. |
| --- |
| Energieweg 1 |
| 3641 RT Mijdrecht |
| The Netherlands |

Bayer B.V.

Energieweg 1

3641 RT Mijdrecht

The Netherlands

Diane-35, omhulde tabletten

2,00 mg

0,035 mg

Film-coated tablet

Oral use

United Kingdom

| Bayer plc |
| --- |
| Bayer House |
| Strawberry Hill |
| Newbury, Berkshire |
| RG14 1JA, |
| United Kingdom |

Bayer plc

Bayer House

Strawberry Hill

Newbury, Berkshire

RG14 1JA,

United Kingdom

Dianette Tablets

0,035 mg

2,00 mg

Coated tablet

Oral use

United Kingdom

| Teva UK Limited |
| --- |
| Brampton Road |
| Hampden Park |
| Eastbourne |
| East Sussex BN22 9AG |
| United Kingdom |

Teva UK Limited

Brampton Road

Hampden Park

Eastbourne

East Sussex BN22 9AG

United Kingdom

Co-Cyprindiol Tablets 2000/35

0,035 mg

2,00 mg

Coated tablet

Oral use

United Kingdom

| Stragen UK Limited |
| --- |
| Castle Court 41 |
| London Road |
| Reigate, Surrey RH2 PRJ |
| United Kingdom |

Stragen UK Limited

Castle Court 41

London Road

Reigate, Surrey RH2 PRJ

United Kingdom

Clairette Tablets 2000/35

0,035 mg

2,00 mg

Coated tablet

Oral use

United Kingdom

| Chatfield Pharmaceuticals Limited |
| --- |
| Kramer Mews |
| London SW5 9JL |
| United Kingdom |

Chatfield Pharmaceuticals Limited

Kramer Mews

London SW5 9JL

United Kingdom

Camilette Co-Cyprindiol 2000/35 Tablets

0,035 mg

2,00 mg

Tablet

Oral use

United Kingdom

| Sandoz Limited |
| --- |
| Frimley Business Park |
| Frimley, Camberley |
| Surrey GU16 7SR |
| United Kingdom |

Sandoz Limited

Frimley Business Park

Frimley, Camberley

Surrey GU16 7SR

United Kingdom

Acnocin 2000/35 Tablets

0,035 mg

2,00 mg

Coated tablet

Oral use

United Kingdom

| Sandoz Limited |
| --- |
| Frimley Business Park |
| Frimley, Camberley |
| Surrey GU16 7SR |
| United Kingdom |

Sandoz Limited

Frimley Business Park

Frimley, Camberley

Surrey GU16 7SR

United Kingdom

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

0,035 mg

2,00 mg

Coated tablet

Oral use

United Kingdom

| Generics (UK) Limited |
| --- |
| Station Close |
| Potters Bar |
| Hertfordshire EN6 1TL |
| United Kingdom |

Generics (UK) Limited

Station Close

Potters Bar

Hertfordshire EN6 1TL

United Kingdom

Co-Cyprindiol Tablets 2 mg/0,035 mg

0,035 mg

2,00 mg

Coated tablet

Oral use

United Kingdom

| Generics (UK) Limited |
| --- |
| Station Close |
| Potters Bar |
| Hertfordshire EN6 1TL |
| United Kingdom |

Generics (UK) Limited

Station Close

Potters Bar

Hertfordshire EN6 1TL

United Kingdom

Generics UK Cyproterone Acetate and Ethinylestradiol Tablets

0,035 mg

2,00 mg

Coated tablet

Oral use

United Kingdom

| Strandhaven Limited |
| --- |
| 600 High Road |
| Seven Kings, Ilford |
| Essex IG3 8BS |
| United Kingdom |

Strandhaven Limited

600 High Road

Seven Kings, Ilford

Essex IG3 8BS

United Kingdom

Strandhaven Co-Cyprindiol 2000/35 Tablets

0,035 mg

2,00 mg

Coated tablet

Oral use

United Kingdom

| Fannin (UK) Limited |
| --- |
| 42-46 Booth Drive |
| Park Farm South |
| Wellingborough |
| Kent NN8 6GT |
| United Kingdom |

Fannin (UK) Limited

42-46 Booth Drive

Park Farm South

Wellingborough

Kent NN8 6GT

United Kingdom

Fannin UK Co-Cyprindiol 2000/35 Tablets

0,035 mg

2,00 mg

Film-coated tablet

Oral use

United Kingdom

| Farmalider SA |
| --- |
| Calle Aragoneses 15 |
| Alcobendas |
| Madrid E-28108 |
| Spain |

Farmalider SA

Calle Aragoneses 15

Alcobendas

Madrid E-28108

Spain

Dialider Tablets

0,035 mg

2,00 mg

Film-coated tablet

Oral use

United Kingdom

| Cipla (EU) Limited |
| --- |
| Hillbrow House |
| Hillbrow Road |
| Esher |
| Surrey KT10 9NW |
| United Kingdom |

Cipla (EU) Limited

Hillbrow House

Hillbrow Road

Esher

Surrey KT10 9NW

United Kingdom

Co-Cyprindiol 2000/35 Tablets

0,035 mg

2,00 mg

Film-coated tablet

Oral use

---

ANNEX III

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 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

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

one dose (0,5 ml) contains:

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

Powder and solvent for solution for injection

Intramuscular use, subcutaneous use

Germany

| 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 103,0 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 103,0 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

one dose (0,5 ml) contains:

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

Powder and solvent for solution for injection

Subcutaneous use

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 × 103,0 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 × 103,0 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

one dose (0,5 ml) contains:

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

Powder and solvent for solution for injection

Subcutaneous use

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

one dose (0,5 ml) contains:

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

Powder and solvent for suspension for injection

Intramuscular use, subcutaneous use

France

| 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) - 103,0 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) - 103,0 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) - 103,0 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

one dose (0,5 ml) contains:

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

Powder and solvent for solution for injection

Subcutaneous use

Spain

| 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

one dose (0,5 ml) contains:

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

Powder and solvent for solution for injection

Subcutaneous use

Spain

| 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 103,0 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

one dose (0,5 ml) contains:

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

Powder and solvent for suspension for injection

Subcutaneous use

Austria

| 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

one dose (0,5 ml) contains:

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

Powder and solvent for suspension for injection

Intramuscular use,

subcutaneous use

Belgium

| 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-zoster virus (Oka strain) - not less than 103,3 PFU (1)

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

one dose (0,5 ml) contains:

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

Powder and solvent for solution for injection

Subcutaneous use

Cyprus

| 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 1 350 PFU

one dose (0,5 ml) contains:

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

Powder and solvent for suspension for injection

Subcutaneous use

Cyprus

| 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 virus (Oka strain) 103,3 PFU (1)

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

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

one dose (0,5 ml) contains:

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

Powder and solvent for solution for injection

Subcutaneous use

Denmark

| 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 virus (Oka strain) – not less than 103,3 PFU (1)

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:

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

Powder and solvent for solution for injection, suspension

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

one dose (0,5 ml) contains:

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

Powder and solvent for suspension for injection

Subcutaneous use

Finland

| Sanofi Pasteur MSD |
| --- |
| Avenue Jules Bordetlaan 13 |
| B-1140 Brussels |
| Belgium |

Sanofi Pasteur MSD

Avenue Jules Bordetlaan 13

B-1140 Brussels

Belgium

VARIVAX

one dose (0,5 ml) contains:

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

Powder and solvent for solution for injection

Intramuscular use, subcutaneous use

Finland

| 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-zoster virus (OKa strain) - not less than 103,3 PFU (1)

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:

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

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 (1)

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 (1)

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:

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

Powder and solvent for solution for injection

Intramuscular use, subcutaneous use

Germany

| 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 (1)

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

VARILRIX

one dose (0,5 ml) contains:

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

Powder and solvent for solution for injection

Subcutaneous use

Greece

| 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

one dose (0,5 ml) contains:

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

Powder and solution for injection

Intramuscular use, subcutaneous use

Hungary

| GlaxoSmithKline Kft. |
| --- |
| 1124 Budapest |
| Csörsz u 43 |
| Hungary |

GlaxoSmithKline Kft.

1124 Budapest

Csörsz u 43

Hungary

Varilrix

one dose (0,5 ml) contains:

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

Powder and solvent for solution for injection

Subcutaneous use

Hungary

| 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

one dose (0,5 ml) contains:

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

Powder and solution for injection

Intramuscular use, subcutaneous use

Iceland

| GlaxoSmithkline ehf. |
| --- |
| Þverholti 14 |
| 105 Reykjavík |
| Iceland |

GlaxoSmithkline ehf.

Þverholti 14

105 Reykjavík

Iceland

Varilrix

one dose (0,5 ml) contains:

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

Powder and solvent for solution for injection

Subcutaneous use

Ireland

| 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.

one dose (0,5 ml) contains:

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

Powder and solvent for suspension for injection

Subcutaneous use

Italy

| 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-zoster virus (Oka strain) - not less than 103,3 PFU (1)

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

one dose (0,5 ml) contains:

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

Powder and solvent for suspension for injection

Intramuscular use, subcutaneous use

Latvia

| 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

one dose (0,5 ml) contains:

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

Powder and solvent for suspension for injection

Intramuscular use, subcutaneous use

Latvia

| 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 virus (Oka strain) – not less than 103,3 PFU (1)

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

one dose (0,5 ml) contains:

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

Powder and solvent for solution for injection

Subcutaneous use

Lithuania

| 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

one dose (0,5 ml) contains:

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

Powder and solvent for suspension for injection

Intramuscular use, subcutaneous use

Luxembourg

| 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-zoster virus (Oka strain) - not less than 103,3 PFU (1)

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

one dose (0,5 ml) contains:

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

Powder for suspension for injection

Subcutaneous use

Malta

| 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-zoster virus (Oka strain) - not less than 103,3 PFU (1)

Powder and solvent for solution for injection

Subcutaneous use

Malta

| Merck Sharp & Dohme Ltd. |
| --- |
| Hertford Road |
| Hoddesdon |
| Hertfordshire EN 11 9BU |
| United Kingdom |

Merck Sharp & Dohme Ltd.

Hertford Road

Hoddesdon

Hertfordshire EN 11 9BU

United Kingdom

Varivax

one dose (0,5 ml) contains:

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

Powder and solvent for suspension for injection

Intramuscular use, subcutaneous use

Norway

| GlaxoSmithKline AS |
| --- |
| Forskningsveien 2a |
| Postboks 180 Vinderen |
| 0319 Oslo |
| Norway |

GlaxoSmithKline AS

Forskningsveien 2a

Postboks 180 Vinderen

0319 Oslo

Norway

Varilrix

one dose (0,5 ml) contains:

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

Powder and solvent for solution for injection

Subcutaneous use

Norway

| Sanofi Pasteur MSD |
| --- |
| Avenue Jules |
| Bordetlaan 13 |
| B-1140 Brussels |
| Belgium |

Sanofi Pasteur MSD

Avenue Jules

Bordetlaan 13

B-1140 Brussels

Belgium

Varivax

one dose (0,5 ml) contains:

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

Powder and solvent for suspension for injection

Intramuscular use, subcutaneous use

Poland

| 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-zoster virus (Oka strain) - not less than 103,3 PFU (1)

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

one dose (0,5 ml) contains:

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

Powder and solvent for solution for injection

Subcutaneous use

Portugal

| 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

one dose (0,5 ml) contains:

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

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

one dose (0,5 ml) contains:

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

Powder and solvent for solution for injection

Subcutaneous use

Slovak Republic

| 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

one dose (0,5 ml) contains:

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

Powder and solvent for suspension for injection

Intramuscular use, subcutaneous use

Slovenia

| 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

one dose (0,5 ml) contains:

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

Powder and solvent for suspension for injection

Intramuscular use, subcutaneous use

Spain

| 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

one dose (0,5 ml) contains:

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

Powder and solvent for solution for injection

Subcutaneous use

Spain

| 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

one dose (0,5 ml) contains:

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

Powder and solvent for suspension for injection

Intramuscular use, subcutaneous use

Sweden

| GlaxoSmithKline AB |
| --- |
| Box 516 |
| 169 29 Solna |
| Sweden |

GlaxoSmithKline AB

Box 516

169 29 Solna

Sweden

Varilrix®

one dose (0,5 ml) contains:

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

Powder and solvent for solution for injection

Subcutaneous use

Sweden

| Sanofi Pasteur MSD |
| --- |
| Avenue Jules Bordetlaan 13 |
| B-1140 Brussels |
| Belgium |

Sanofi Pasteur MSD

Avenue Jules Bordetlaan 13

B-1140 Brussels

Belgium

Varivax®

one dose (0,5 ml) contains:

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

Powder and solvent for solution for injection

Intramuscular use, subcutaneous use

The Netherlands

| 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

one dose (0,5 ml) contains:

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

Powder and solvent for solution for injection

Parenteral use

United Kingdom

| 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

one dose (0,5 ml) contains:

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

Powder and solvent for solution for injection

Subcutaneous use

United Kingdom

| 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

one dose (0,5 ml) contains:

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

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 103,0 CCID50 |
| --- | --- |

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

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

Rubella virus Wistar RA 27/3 strain (live, attenuated) - not less than 103,0 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 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 Pulver in Durchstechflaschen und Lösungsmittel in Fertigspritzen zur Herstellung einer Injektionslösung

one dose (0,5 ml) contains:

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

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

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

Powder and solvent for solution for injection

Intramuscular use, subcutaneous use

Austria

| 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

one dose (0,5 ml) contains:

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

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

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

Powder and solvent for solution for injection

Intramuscular use, subcutaneous use

Belgium

| 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

one dose (0,5 ml) contains:

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

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

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

Powder and solvent for solution for injection

Subcutaneous use

Intramuscular use, subcutaneous use

Bulgaria

| 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

one dose (0,5 ml) contains:

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

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

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

Powder and solvent for suspension for injection

Intramuscular use, subcutaneous use

Cyprus

| 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

one dose (0,5 ml) contains:

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

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

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

Powder and solvent for solution for injection

Intramuscular use, subcutaneous use

Czech Republic

| 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

one dose (0,5 ml) contains:

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

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

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

Powder and solvent for solution for injection

Intramuscular use, subcutaneous use

Denmark

| GlaxoSmithKline Pharma A/S |
| --- |
| Nykær 68 |
| DK-2605 Brøndby |
| Denmark |

GlaxoSmithKline Pharma A/S

Nykær 68

DK-2605 Brøndby

Denmark

Priorix

one dose (0,5 ml) contains:

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

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

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

Powder and solvent for solution for injection

Intramuscular use, subcutaneous use

Estonia

| 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

one dose (0,5 ml) contains:

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

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

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

Powder and solvent for solution for injection

Subcutaneous use

Finland

| 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

one dose (0,5 ml) contains:

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

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

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

Powder and solvent for solution for injection

Intramuscular use, subcutaneous use

France

| 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

one dose (0,5 ml) contains:

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

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

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

Powder and solvent for solution for injection

Intramuscular use, subcutaneous use

France

| 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 103,0 CCID50

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

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

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) - 103,0 CCID50

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

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

one dose (0,5 ml) contains:

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

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

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

Powder and solvent for solution for injection

Intramuscular use, subcutaneous use

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

one dose (0,5 ml) contains:

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

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

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

Powder and solvent for solution for injection

Intramuscular use, subcutaneous use

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

one dose (0,5 ml) contains:

not less than 103,0 CCID50 of the measles virus Enders-Edmonston strain not less than 5 × 103,0 CCID50 of the mumps virus (Jeryl Lynn strain) not less than 103,0 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 por ésoldószer oldatos injekcióhoz

one dose (0,5 ml) contains:

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

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

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

Powder and solvent for solution for injection

Intramuscular use, subcutaneous use

Iceland

| GlaxoSmithkline ehf. |
| --- |
| Þverholti 14 |
| 105 Reykjavík |
| Iceland |

GlaxoSmithkline ehf.

Þverholti 14

105 Reykjavík

Iceland

Priorix

one dose (0,5 ml) contains:

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

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

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

Powder and solvent for solution for injection

Intramuscular use, subcutaneous use

Italy

| GlaxoSmithKline S.p.A. |
| --- |
| Via A. Fleming, 2 |
| 37135 Verona |
| Italy |

GlaxoSmithKline S.p.A.

Via A. Fleming, 2

37135 Verona

Italy

PRIORIX

one dose (0,5 ml) contains:

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

Live attenuated mumps virus (RIT 4385 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

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

one dose (0,5 ml) contains:

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

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

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

Powder and solvent for solution for injection

Intramuscular use, subcutaneous use

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

one dose (0,5 ml) contains:

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

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

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

Powder and solvent for solution for injection

Intramuscular use, subcutaneous use

Lithuania

| UAB ‘GlaxoSmithKline Lietuva’ |
| --- |
| Goštauto 40A |
| LT-01112 Vilnius |
| Lithuania |

UAB ‘GlaxoSmithKline Lietuva’

Goštauto 40A

LT-01112 Vilnius

Lithuania

Priorix

one dose (0,5 ml) contains:

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

Live attenuated mumps virus (RIT 4385 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

one dose (0,5 ml) contains:

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

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

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

Powder and solvent for solution for injection

Intramuscular use, subcutaneous use

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

one dose (0,5 ml) contains:

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

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

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

Powder and solvent for solution for injection

Subcutaneous use, Intramascular use

Norway

| GlaxoSmithKline AS |
| --- |
| Forskningsveien 2a |
| Postboks 180 Vinderen |
| 0319 Oslo |
| Norway |

GlaxoSmithKline AS

Forskningsveien 2a

Postboks 180 Vinderen

0319 Oslo

Norway

Priorix

one dose (0,5 ml) contains:

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

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

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

Powder and solvent for solution for injection

Intramuscular use, subcutaneous use

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

one dose (0,5 ml) contains:

not less than 103,0 CCID50 of the measles virus Enders-Edmonston strain, not less than 12 500 CCID50 of the mumps virus (Jeryl Lynn strain); and not less than 103,0 CCID50of 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

one dose (0,5 ml) contains:

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

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

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

Powder and solvent for solution for injection

Intramuscular use, subcutaneous use

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

one dose (0,5 ml) contains:

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

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

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

Powder and solvent for solution for injection

Intramuscular use, subcutaneous use

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

one dose (0,5 ml) contains:

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

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

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

Powder and solvent for solution for injection 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

one dose (0,5 ml) contains:

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

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

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

Powder and solvent for solution for injection

Intramuscular use, subcutaneous use

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

Priorix

one dose (0,5 ml) contains:

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

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

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

Powder and solvent for solution for injection

Intramuscular use, subcutaneous use

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

one dose (0,5 ml) contains:

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

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

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

Powder and solvent for solution for injection

Intramuscular use, subcutaneous use

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

one dose (0,5 ml) contains:

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

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

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

Powder and solvent for solution for injection

Intramuscular use, subcutaneous use

Sweden

| GlaxoSmithKline AB |
| --- |
| Box 516 |
| 169 29 Solna |
| Sweden |

GlaxoSmithKline AB

Box 516

169 29 Solna

Sweden

Priorix

one dose (0,5 ml) contains:

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

Live attenuated mumps virus (RIT 4385 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

one dose (0,5 ml) contains:

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

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

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

Powder and solvent for solution for injection

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 powder and solvent for solution for injection

one dose (0,5 ml) contains:

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

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

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

Powder and solvent for solution for injection

Intramuscular use, subcutaneous use

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) contains:

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

Live attenuated mumps virus (RIT 4385, derived from Jeryl Lynn strain) - not less than 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 (2)

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) contains:

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

Live attenuated mumps virus (RIT 4385, derived from Jeryl Lynn strain) - not less than 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 (2)

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

one dose (0,5 ml) contains:

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

Live attenuated mumps virus (RIT 4385, derived from Jeryl Lynn strain) - not less than 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 (2)

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

one dose (0,5 ml) contains:

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

Live attenuated mumps virus (RIT 4385, derived from Jeryl Lynn strain) - not less than 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 (2)

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

one dose (0,5 ml) contains:

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

Live attenuated mumps virus (RIT 4385, derived from Jeryl Lynn strain) - not less than 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 (2)

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

one dose (0,5 ml) contains:

Live attenuated measles virus (Schwarz strain) - not less than 103,0 CCID50Live attenuated mumps virus (RIT 4385 strain, derived from Jeryl Lynn strain) - not less than 104,4CCID50

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 (2)

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

one dose (0,5 ml) contains:

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

Live attenuated mumps virus (RIT 4385 strain, derived from Jeryl Lynn strain) - not less than 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 (2)

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

one dose (0,5 ml) contains:

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

Live attenuated mumps virus (RIT 4385 strain, derived from Jeryl Lynn strain) - not less than 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 (2)

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

one dose (0,5 ml) contains:

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

Live attenuated mumps virus (RIT 4385 strain, derived from Jeryl Lynn strain) - not less than 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 (2)

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

one dose (0,5 ml) contains:

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

Live attenuated mumps virus (RIT 4385, derived from Jeryl Lynn strain) - not less than 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 (2)

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

one dose (0,5 ml) contains:

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

Live attenuated mumps virus (RIT 4385, derived from Jeryl Lynn strain) - not less than 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 (2)

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

one dose (0,5 ml) contains:

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

Live attenuated mumps virus (RIT 4385, derived from Jeryl Lynn strain) - not less than 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 (2)

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)

one dose (0,5 ml) contains:

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

Live attenuated mumps virus (RIT 4385, derived from Jeryl Lynn strain) - not less than 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 (2)

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)

one dose (0,5 ml) contains:

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

Live attenuated mumps virus (RIT 4385, derived from Jeryl Lynn strain) - not less than 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 (2)

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

one dose (0,5 ml) contains:

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

Live attenuated mumps virus (RIT 4385, derived from Jeryl Lynn strain) - not less than 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 (2)

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

one dose (0,5 ml) contains:

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

Live attenuated mumps virus (RIT 4385, derived from Jeryl Lynn strain) - not less than 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 (2)

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

one dose (0,5 ml) contains:

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

Live attenuated mumps virus (RIT 4385, derived from Jeryl Lynn strain) - not less than 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 (2)

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 Tetra por és oldószer oldatos injekcióhoz

one dose (0,5 ml) contains:

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

Live attenuated mumps virus (RIT 4385 strain, derived from Jeryl Lynn strain) - not less than 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 (2)

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

one dose (0,5 ml) contains:

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

Live attenuated mumps virus (RIT 4385 strain, derived from Jeryl Lynn strain) - not less than 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 (2)

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

one dose (0,5 ml) contains:

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

Live attenuated mumps virus (RIT 4385, derived from Jeryl Lynn strain) - not less than 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 (2)

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

one dose (0,5 ml) contains:

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

Live attenuated mumps virus (RIT 4385, derived from Jeryl Lynn strain) - not less than 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 (2)

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)

one dose (0,5 ml) contains:

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

Live attenuated mumps virus (RIT 4385, derived from Jeryl Lynn strain) - not less than 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 (2)

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)

one dose (0,5 ml) contains:

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

Live attenuated mumps virus (RIT 4385, derived from Jeryl Lynn strain) - not less than 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 (2)

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)

one dose (0,5 ml) contains:

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

Live attenuated mumps virus (RIT 4385, derived from Jeryl Lynn strain) - not less than 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 (2)

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

one dose (0,5 ml) contains:

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

Live attenuated mumps virus (RIT 4385, derived from Jeryl Lynn strain) - not less than 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 (2)

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

one dose (0,5 ml) contains:

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

Live attenuated mumps virus (RIT 4385, derived from Jeryl Lynn strain) - not less than 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 (2)

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

one dose (0,5 ml) contains:

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

Live attenuated mumps virus (RIT 4385, derived from Jeryl Lynn strain) - not less than 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 (2)

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

one dose (0,5 ml) contains:

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

Live attenuated mumps virus (RIT 4385, derived from Jeryl Lynn strain) - not less than 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 (2)

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

one dose (0,5 ml) contains:

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

Live attenuated mumps virus (RIT 4385 strain derived from Jeryl Lynn strain) - not less than 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 (2)

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

one dose (0,5 ml) contains dose:

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

Live attenuated mumps virus (RIT 4385, derived from Jeryl Lynn strain) - not less than 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 (2)

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

one dose (0,5 ml) contains:

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

Live attenuated mumps virus (RIT 4385, derived from Jeryl Lynn strain) - not less than 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 (2)

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

one dose (0,5 ml) contains:

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

Live attenuated mumps virus (RIT 4385, derived from Jeryl Lynn strain) - not less than 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 (2)

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

one dose (0,5 ml) contains:

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

Live attenuated mumps virus (RIT 4385, derived from Jeryl Lynn strain) - not less than 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 (2)

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

one dose (0,5 ml) contains:

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

Live attenuated mumps virus (RIT 4385, derived from Jeryl Lynn strain) - not less than 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 (2)

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

one dose (0,5 ml) contains:

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

Live attenuated mumps virus (RIT 4385, derived from Jeryl Lynn strain) - not less than 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 (2)

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

one dose (0,5 ml) contains:

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

Live attenuated mumps virus (RIT 4385, derived from Jeryl Lynn strain) - not less than 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 (2)

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

one dose (0,5 ml) contains:

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

Live attenuated mumps virus (RIT 4385, derived from Jeryl Lynn strain) - not less than 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 (2)

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

one dose (0,5 ml) contains:

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

Live attenuated mumps virus (RIT 4385, derived from Jeryl Lynn strain) - not less than 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 (2)

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

one dose (0,5 ml) contains:

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

Live attenuated mumps virus (RIT 4385, derived from Jeryl Lynn strain) - not less than 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 (2)

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

one dose (0,5 ml) contains:

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

Live attenuated mumps virus (RIT 4385, derived from Jeryl Lynn strain) - not less than 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 (2)

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

one dose (0,5 ml) contains:

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

Live attenuated mumps virus (RIT 4385, derived from Jeryl Lynn strain) - not less than 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 (2)

Powder and solution for injection

Subcutaneous use

---

(1)  PFU: plaque forming units.

(2)  PFU: plaque forming units

---