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)
Date: 2013-08-30
Institutions: European Commission
Subjects: drug surveillance, market approval, marketing standard, medicinal product








C_2013250EN.01004401.xml










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






(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






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






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






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






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






PLETAL


50 MG


tablet


oral use




Italy







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






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






PLETAL 100 mg comprimidos


100 mg


tablet


oral use




Spain







LACER S.A.




Sardenya, 350




08025 Barcelona






EKISTOL 50 mg comprimidos


50 mg


tablet


oral use




Spain







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






PLETAL


50 mg


tablet


oral use




Sweden







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






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






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






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






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






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






Diane mite - Dragees


2,00 mg
0,035 mg


Coated tablet


Oral use




Austria







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






Midane - Dragees


2,00 mg
0,035 mg


Coated tablet


Oral use




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






Xylia - Dragées


2,00 mg
0,035 mg


Coated tablet


Oral use




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






Claudia-35


2,00 mg
0,035 mg


Coated tablet


Oral use




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






Diane-35


2,00 mg
0,035 mg


Coated tablet


Oral use




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






Gratiella 35


2,00 mg
0,035 mg


Coated tablet


Oral use




Bulgaria







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






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






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






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






VREYA


2,00 mg
0,035 mg


Film-coated tablet


Oral use




Czech Republic







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






DIANE-35


2,00 mg
0,035 mg


Coated tablet


Oral use




Denmark







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






Cypretyl


2,00 mg
0,035 mg


Film-coated tablet


Oral use




Denmark







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






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






Feminil mite


2,00 mg
0,035 mg


Film-coated tablet


Oral use




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






Zyrona


2,00 mg
0,035 mg


Film-coated tablet


Oral use




Estonia







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






Femina


2,00 mg
0,035 mg


Coated tablet


Oral use




Estonia







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






DIANE NOVA


2,00 mg
0,035 mg


Tablet


Oral use




Finland







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






FEMINIL


2,00 mg
0,035 mg


Tablet


Oral use




Finland







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






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






MINERVA 35 μg


2,00 mg
0,035 mg


Coated tablet


Oral use




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






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






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






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






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






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






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






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






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






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






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






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






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






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






Cyproethinyl acis


0,035 mg
2,00 mg


Film-coated tablet


Oral use




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






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






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






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






Juliette


0,035 mg
2,00 mg


Coated tablet


Oral use




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






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






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






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






Bellune Pliva


2,00 mg
0,035 mg


Coated tablet


Oral use




Hungary







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






Minerva


2,00 mg
0,035 mg


Coated tablet


Oral use




Iceland







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






Cypretyl


2,00 mg
0,035 mg


Coated tablet


Oral use




Ireland







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






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






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






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






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






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






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






Diane


2,00 mg
0,035 mg


Coated tablet


Oral use




Lithuania







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






CHLOE


2,00 mg
0,035 mg


Film-coated tablet


Oral use




Lithuania







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






Diane-35


2,00 mg
0,035 mg


Coated tablet


Oral use




Luxembourg







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






Daphne


2,00 mg
0,035 mg


Coated tablet


Oral use




Luxembourg







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






Clairette 2000/35 Tablets


2,00 mg
0,035 mg


Coated tablet


Oral use




Malta







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






Diane


2,00 mg
0,035 mg


Coated tablet


Oral use




Norway







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






Zyrona


2,00 mg
0,035 mg


Coated tablet


Oral use




Poland







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






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






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






Cyprest


0,035 mg
2,00 mg


Coated tablet


Oral use




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






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






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






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






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






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






Ciproterona + Etinilestradiol Inventis


2,00 mg
0,035 mg


Coated tablet


Oral use




Romania







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






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






Vreya


2,00 mg
0,035 mg


Coated tablet


Oral use




Slovak Republic







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






CHLOE


2,00 mg
0,035 mg


Coated tablet


Oral use




Slovak Republic







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






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






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






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






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






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






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






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






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






Diane®


2,00 mg
0,035 mg


Tablet


Oral use




Sweden







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






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






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






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






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






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






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






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






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






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






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






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






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






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






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






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






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






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






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 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 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 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






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






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






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






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






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






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






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






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






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






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






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






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






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






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






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






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






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






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






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






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






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






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






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






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






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






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






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






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






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






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






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






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






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






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






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






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






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






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






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






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






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






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






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






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






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






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






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






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






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






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






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






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






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






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






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






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






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






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






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






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






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






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






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






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






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






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






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











 


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






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






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






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






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






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






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






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






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






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






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






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






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






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






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






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






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






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






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






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






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






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






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






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






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






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






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






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






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






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






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






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






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






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






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






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






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






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






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






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






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






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






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






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






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






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






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






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






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






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






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






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






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






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






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






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






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






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






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






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






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






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






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






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






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






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






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






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






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






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






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






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






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






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






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






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






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