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 or Article 38 of Directive 2001/82/EC)
Date: 2021-05-28
Institutions: Directorate-General for Health and Food Safety, European Commission
Subjects: EU Member State, drug surveillance, market approval, marketing standard, medicinal product




C_2021204EN.01001001.xml










28.5.2021   


EN


Official Journal of the European Union


C 204/10






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






(1)  OJ L 311, 28.11.2001, p. 67.

(2)  OJ L 311, 28.11.2001, p. 1.




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






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






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






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






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






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






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






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






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






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






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






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






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






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






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






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






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






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






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






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






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






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






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






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






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






(*1)  propagated in MRC5 human diploid cells