# C_2021204EN.01001001.xml

| 28.5.2021 | EN | Official Journal of the European Union | C 204/10 |
| --- | --- | --- | --- |

28.5.2021

EN

Official Journal of the European Union

C 204/10

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Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 April 2021 to 30 April 2021

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

(2021/C 204/02)

—   Issuing, maintenance or modification of a national marketing authorisation

| Date of the decision | Name(s) of the medicinal product | INN (International Non-Proprietary Name) | Holder(s) of the marketing authorisation | Member State concerned | Date of notification |
| --- | --- | --- | --- | --- | --- |
| 21.4.2021 | Varilrix and associated names | Live attenuated varicella virus (OKA strain) | See Annex | See Annex | 22.4.2021 |

Date of the decision

Name(s) of the medicinal product

INN (International Non-Proprietary Name)

Holder(s) of the marketing authorisation

Member State concerned

Date of notification

21.4.2021

Varilrix and associated names

Live attenuated varicella virus (OKA strain)

See Annex

See Annex

22.4.2021

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

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

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ANNEX

List of medicinal products and presentations

| Member State EU/EEA | Marketing authorisation holder company name, address
  (Invented) | Name | Strength | Pharmaceutical form | Route of administration |
| --- | --- | --- | --- | --- | --- |
| Austria | GlaxoSmithKline Pharma GmbH |
| Euro Plaza, Gebäude I, 4. Stock Wagenseilgasse 3 |
| 1120 Vienna |
| Austria |

Member State EU/EEA

Marketing authorisation holder company name, address

(Invented)

Name

Strength

Pharmaceutical form

Route of administration

Austria

GlaxoSmithKline Pharma GmbH

Euro Plaza, Gebäude I, 4. Stock Wagenseilgasse 3

1120 Vienna

Austria

VARILRIX

Varicella virus (OKA strain):

≥ 103.3 plaque forming unit(s)

Powder and solvent for solution for injection

Subcutaneous use

Belgium

| GlaxoSmithKline Biologicals SA |
| --- |
| Rue de l’Institut 89 |
| B-1330 Rixensart |
| Belgium |

GlaxoSmithKline Biologicals SA

Rue de l’Institut 89

B-1330 Rixensart

Belgium

VARILRIX

Live attenuated Varicella virus (OKA strain):

≥ 103.3 plaque forming unit(s)

Powder and solvent for solution for injection

Subcutaneous use

Cyprus

| GlaxoSmithKline Biologicals SA |
| --- |
| Rue de l’Institut 89 |
| B-1330 Rixensart |
| Belgium |

GlaxoSmithKline Biologicals SA

Rue de l’Institut 89

B-1330 Rixensart

Belgium

VARILRIX

Varicella virus (OKA strain):

≥ 103.3 plaque forming unit(s)

Powder and solvent for solution for injection

Subcutaneous use

Czech Republic

| GlaxoSmithKline Biologicals SA |
| --- |
| Rue de l’Institut 89 |
| B-1330 Rixensart |
| Belgium |

GlaxoSmithKline Biologicals SA

Rue de l’Institut 89

B-1330 Rixensart

Belgium

VARILRIX

Varicella virus (OKA strain):

≥ 103.3 plaque forming unit(s)

Powder and solvent for solution for injection

Subcutaneous use

Denmark

| GlaxoSmithKline Pharma A/S |
| --- |
| Nykaer 68 |
| DK-2605 Broendby |
| Denmark |

GlaxoSmithKline Pharma A/S

Nykaer 68

DK-2605 Broendby

Denmark

VARILRIX

Varicella zoster-virus ≥2 000 plaque forming unit(s) per dose

Powder and solvent for solution for injection

Subcutaneous use

Estonia

| GlaxoSmithKline Biologicals SA |
| --- |
| Rue de l’Institut 89 |
| B-1330 Rixensart |
| Belgium |

GlaxoSmithKline Biologicals SA

Rue de l’Institut 89

B-1330 Rixensart

Belgium

VARILRIX

Varicella virus (OKA strain):

≥ 103.3 plaque forming unit(s)

Powder and solvent for solution for injection

Subcutaneous use

Finland

| GlaxoSmithKline Biologicals SA |
| --- |
| Rue de l’Institut 89 |
| B-1330 Rixensart |
| Belgium |

GlaxoSmithKline Biologicals SA

Rue de l’Institut 89

B-1330 Rixensart

Belgium

VARILRIX

Varicella virus (OKA strain):

≥ 103.3 plaque forming unit(s)

Powder and solvent for solution for injection

Subcutaneous use

France

| LABORATOIRE GLAXOSMITHKLINE |
| --- |
| 23, RUE FRANCOIS JACOB |
| 92500 RUEIL MALMAISON |
| France |

LABORATOIRE GLAXOSMITHKLINE

23, RUE FRANCOIS JACOB

92500 RUEIL MALMAISON

France

VARILRIX

Live attenuated Varicella virus (OKA strain):

not less than 103.3 plaque forming unit(s)

Powder and solvent for solution for injection

Subcutaneous use

Germany

| GlaxoSmithKline GmbH & Co. KG |
| --- |
| Prinzregentenplatz 9 |
| Bogenhausen |
| Bayern |
| 81675 München |
| Germany |

GlaxoSmithKline GmbH & Co. KG

Prinzregentenplatz 9

Bogenhausen

Bayern

81675 München

Germany

VARILRIX

Varicella virus (OKA strain):

≥ 103.3 plaque forming unit(s)

Powder and solvent for solution for injection

Subcutaneous use

Intramuscular use

Greece

| GlaxoSmithKline Single Member A.E.B.E. |
| --- |
| Kifissias avenue 266 |
| 152 32 Halandri, Athens |
| Greece |

GlaxoSmithKline Single Member A.E.B.E.

Kifissias avenue 266

152 32 Halandri, Athens

Greece

VARILRIX

Varicella virus (OKA strain):

≥ 103.3 plaque forming unit(s)

Powder and solvent for solution for injection

Subcutaneous use

Hungary

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

GlaxoSmithKline Kft.

43. Csörsz Street

1124 Budapest

Hungary

VARILRIX

Varicella virus (OKA strain):

≥ 103.3 plaque forming unit(s)

Powder and solvent for solution for injection

Subcutaneous use

Iceland

| GlaxoSmithKline Pharma A/S |
| --- |
| Nykaer 68 |
| DK-2605 Broendby |
| Denmark |

GlaxoSmithKline Pharma A/S

Nykaer 68

DK-2605 Broendby

Denmark

VARILRIX

Varicella virus (OKA strain):

≥ 103.3 plaque forming unit(s)

Powder and solvent for solution for injection

Subcutaneous use

Italy

| GlaxoSmithKline Biologicals SA |
| --- |
| Rue de l’Institut 89 |
| B-1330 Rixensart |
| Belgium |

GlaxoSmithKline Biologicals SA

Rue de l’Institut 89

B-1330 Rixensart

Belgium

VARILRIX

Varicella virus (OKA strain):

not less than 2 000 plaque forming unit(s)

Powder and solvent for solution for injection

Subcutaneous use

Latvia

| GlaxoSmithKline Biologicals SA |
| --- |
| Rue de l’Institut 89 |
| B-1330 Rixensart |
| Belgium |

GlaxoSmithKline Biologicals SA

Rue de l’Institut 89

B-1330 Rixensart

Belgium

VARILRIX pulveris un šķīdinātājs injekciju šķīduma pagatavošanai

Varicella virus (OKA strain):

≥ 103.3 plaque forming unit(s)

Powder and solvent for solution for injection

Subcutaneous use

Lithuania

| GlaxoSmithKline Lietuva UAB |
| --- |
| Ukmergės st. 120 |
| LT-08105 Vilnius |
| Lithuania |

GlaxoSmithKline Lietuva UAB

Ukmergės st. 120

LT-08105 Vilnius

Lithuania

Varilrix milteliai ir tirpiklis injekciniam tirpalui

Varicella virus (OKA strain):

≥ 103.3 plaque forming unit(s)

Powder and solvent for solution for injection

Subcutaneous use

Luxembourg

| GlaxoSmithKline Biologicals SA |
| --- |
| Rue de l’Institut 89 |
| B-1330 Rixensart |
| Belgium |

GlaxoSmithKline Biologicals SA

Rue de l’Institut 89

B-1330 Rixensart

Belgium

VARILRIX

Live attenuated Varicella virus (OKA strain):

≥ 103.3 plaque forming unit(s)

Powder and solvent for solution for injection

Subcutaneous use

Malta

| GlaxoSmithKline Biologicals SA |
| --- |
| Rue de l’Institut 89 |
| B-1330 Rixensart |
| Belgium |

GlaxoSmithKline Biologicals SA

Rue de l’Institut 89

B-1330 Rixensart

Belgium

VARILRIX

Varicella virus (OKA strain):

≥ 103.3 plaque forming unit(s)

Powder and solvent for solution for injection

Subcutaneous use

Norway

| GlaxoSmithKline AS |
| --- |
| Postboks 180, Vinderen |
| 0319 Oslo |
| Norway |

GlaxoSmithKline AS

Postboks 180, Vinderen

0319 Oslo

Norway

VARILRIX

Varicella virus (OKA strain):

≥ 103.3 plaque forming unit(s)

Powder and solvent for solution for injection

Subcutaneous use

Poland

| GlaxoSmithKline Biologicals SA |
| --- |
| Rue de l’Institut 89 |
| B-1330 Rixensart |
| Belgium |

GlaxoSmithKline Biologicals SA

Rue de l’Institut 89

B-1330 Rixensart

Belgium

VARILRIX

Not less than 2 000 plaque forming unit(s) of Varicella zoster virus, OKA strain/0,5 ml

Powder and solvent for solution for injection

Subcutaneous use

Portugal

| Smith Kline & French Portuguesa-Produtos Farmaceuticos LDA |
| --- |
| Rua Dr. António Loureiro Borges, 3 Arquiparque, Miraflores Algés |
| 1495-131 Algés |
| Portugal |

Smith Kline & French Portuguesa-Produtos Farmaceuticos LDA

Rua Dr. António Loureiro Borges, 3 Arquiparque, Miraflores Algés

1495-131 Algés

Portugal

VARILRIX

Varicella virus (OKA strain):

≥ 103.3 plaque forming unit(s)

Powder and solvent for solution for injection

Subcutaneous use

Romania

| GlaxoSmithKline Biologicals SA |
| --- |
| Rue de l’Institut 89 |
| B-1330 Rixensart |
| Belgium |

GlaxoSmithKline Biologicals SA

Rue de l’Institut 89

B-1330 Rixensart

Belgium

Varilrix vaccin varicelic viu atenuat, pulbere şi solvent pentru soluţie injectabilă

Varicella virus (OKA strain):

≥ 103.3 plaque forming unit(s)/0,5 ml

Powder and solvent for solution for injection

Subcutaneous use

Spain

| GlaxoSmithKline S.A. |
| --- |
| Severo Ochoa, 2 Parque Tecnologico de Madrid Tres Cantos |
| 28760 Madrid |
| Spain |

GlaxoSmithKline S.A.

Severo Ochoa, 2 Parque Tecnologico de Madrid Tres Cantos

28760 Madrid

Spain

VARILRIX 103,3 UFP/0,5 ml polvo y disolvente para solución inyectable

Varicella virus (OKA strain):

≥ 103.3 plaque forming unit(s)

Powder and solvent for solution for injection

Subcutaneous use

Sweden

| GlaxoSmithKline AB |
| --- |
| P.O. Box 516 |
| 169 29 Solna |
| Sweden |

GlaxoSmithKline AB

P.O. Box 516

169 29 Solna

Sweden

Varilrix

Varicella virus (OKA strain):

≥ 103.3 plaque forming unit(s)

Powder and solvent for solution for injection

Subcutaneous use

United Kingdom (Northern Ireland)

| SmithKline Beecham Ltd trading as GlaxoSmithKline UK |
| --- |
| 980, Great West Road |
| Brentford |
| Middlesex TW8 9GS |
| United Kingdom |

SmithKline Beecham Ltd trading as GlaxoSmithKline UK

980, Great West Road

Brentford

Middlesex TW8 9GS

United Kingdom

Varilrix 103.3 PFU/0,5 ml, powder and solvent for solution for injection

One dose (0,5 ml) contains: Live attenuated varicella-zoster (Oka strain) virus (*1) 103.3 plaque forming units (PFU)

Powder and solvent for solution for injection

Subcutaneous use

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(*1)  propagated in MRC5 human diploid cells

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