Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 July 2012 to 31 July 2012 (Decisions taken pursuant to Article 34 of Directive 2001/83/EC or Article 38 of Directive 2001/82/EC)
Date: 2012-08-31
Institutions: European Commission
Subjects: drug surveillance, market approval, marketing standard, medicinal product








C_2012264EN.01000901.xml










31.8.2012   


EN


Official Journal of the European Union


C 264/9





Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 July 2012 to 31 July 2012

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

2012/C 264/02
—   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




31.7.2012


Tavanic and associated names


See Annex I


See Annex I


2.8.2012







—   Refusal of 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




6.7.2012


Ethinylestradiol-Drospirenone 24 + 4 and associated names


See Annex II


See Annex II


10.7.2012






(1)  OJ L 311, 28.11.2001, p. 67.

(2)  OJ L 311, 28.11.2001, p. 1.


ANNEX I

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











Member State EU/EEA


Marketing Authorisation Holder


Invented name


Strength


Pharmaceutical form


Route of administration




Austria







Sanofi-aventis GmbH




Leonard-Bernstein-Straße 10, A-1220 Vienna






Tavanic 250 mg Filmtabletten


250 mg


Film-coated tablets


Oral use




Austria







Sanofi-aventis GmbH




Leonard-Bernstein-Straße 10, A-1220 Vienna






Tavanic 500 mg Filmtabletten


500 mg


Film-coated tablets


Oral use




Austria







Sanofi-aventis GmbH




Leonard-Bernstein-Straße 10, A-1220 Vienna






Tavanic Infusionsflasche


5 mg/ml


Solution for infusion


Intravenous use




Belgium







Sanofi-aventis Belgium




Culliganlaan, 1C




1831 Diegem - Belgium






Tavanic 250 mg filmomhulde tabletten


250 mg


Film-coated tablets


Oral use




Belgium







Sanofi-aventis Belgium




Culliganlaan, 1C




1831 Diegem - Belgium






Tavanic 500 mg filmomhulde tabletten


500 mg


Film-coated tablets


Oral use




Belgium







Sanofi-aventis Belgium




Culliganlaan, 1C




1831 Diegem - Belgium






Tavanic 5 mg/ml oplossing voor infusie


5 mg/ml


Solution for infusion


Intravenous use




Bulgaria







Sanofi-Avenstis Bulgaria EOOD,




Bulgaria, 1303 Sofia, 103 Alexander Stamboliiski Blvd, fl.8






Tavanic


250 mg


Film-coated tablets


Oral use




Bulgaria







Sanofi-Avenstis Bulgaria EOOD,




Bulgaria, 1303 Sofia, 103 Alexander Stamboliiski Blvd, fl.8






Tavanic


500 mg


Film-coated tablets


Oral use




Bulgaria







Sanofi-Avenstis Bulgaria EOOD,




Bulgaria, 1303 Sofia, 103 Alexander Stamboliiski Blvd, fl.8






Tavanic


5 mg/ml


Solution for infusion


Intravenous use




Cyprus







Sanofi-aventis Cyprus Ltd,




14 Charalambou Mouskou street, 2015 – Nicosia, Cyprus






Tavanic


250 mg


Film-coated tablets


Oral use




Cyprus







Sanofi-aventis Cyprus Ltd,




14 Charalambou Mouskou street, 2015 – Nicosia, Cyprus






Tavanic


500 mg


Film-coated tablets


Oral use




Cyprus







Sanofi-aventis Cyprus Ltd,




14 Charalambou Mouskou street, 2015 – Nicosia, Cyprus






Tavanic


5 mg/ml


Solution for infusion


Intravenous use




Czech Republic







sanofi-aventis, s.r.o.




Evropská 846/176a




160 00 Praha 6




Czech Republic






Tavanic i.v.


5 mg/ml


Solution for infusion


Intravenous use




Estonia







sanofi-aventis Estonia OÜ,




Pärnu mnt 139 E/2, 11317 Tallinn, Estonia






Tavanic


250 mg


Film-coated tablets


Oral use




Estonia







sanofi-aventis Estonia OÜ,




Pärnu mnt 139 E/2, 11317 Tallinn, Estonia






Tavanic


500 mg


Film-coated tablets


Oral use




Estonia







sanofi-aventis Estonia OÜ,




Pärnu mnt 139 E/2, 11317 Tallinn, Estonia






Tavanic


5 mg/ml


Solution for infusion


Intravenous use




Finland







sanofi-aventis Oy




Huopalahdentie 24




00350 Helsinki, Finland






Tavanic


250 mg


Film-coated tablets


Oral use




Finland







sanofi-aventis Oy




Huopalahdentie 24




00350 Helsinki, Finland






Tavanic


500 mg


Film-coated tablets


Oral use




Finland







sanofi-aventis Oy




Huopalahdentie 24




00350 Helsinki, Finland






Tavanic


5 mg/ml


Solution for infusion


Intravenous use




France







Sanofi-aventis France




1-13 Boulevard Romain Rolland




75014 Paris




FRANCE






TAVANIC 250 mg comprimé pelliculé sécable


250 mg


Film-coated tablets


Oral use




France







Sanofi-aventis France




1-13 Boulevard Romain Rolland




75014 Paris




FRANCE






TAVANIC 500 mg comprimé pelliculé sécable


500 mg


Film-coated tablets


Oral use




France







Sanofi-aventis France




1-13 Boulevard Romain Rolland




75014 Paris




FRANCE






TAVANIC 5 mg/ml solution pour perfusion


5 mg/ml


Solution for infusion


Intravenous use




Germany







Sanofi-Aventis Deutschland GmbH,




Industriepark Höchst,




Gebäude K703




65926 Frankfurt am Main, Deutschland






Tavanic 250 mg Filmtabletten


250 mg


Film-coated tablets


Oral use




Germany







Sanofi-Aventis Deutschland GmbH,




Industriepark Höchst,




Gebäude K703




65926 Frankfurt am Main, Deutschland






Tavanic 500 mg Filmtabletten


500 mg


Film-coated tablets


Oral use




Germany







Sanofi-Aventis Deutschland GmbH,




Industriepark Höchst,




Gebäude K703




65926 Frankfurt am Main, Deutschland






Tavanic 5 mg/ml Infusionslösung


5 mg/ml


Solution for infusion


Intravenous use




Greece







sanofi-aventis AEBE




348 Syngrou avenue-Building A




176 74 Kalithea – Athens




GR-Greece






Tavanic


250 mg


Film-coated tablets


Oral use




Greece







sanofi-aventis AEBE




348 Syngrou avenue-Building A




176 74 Kalithea – Athens




GR-Greece






Tavanic


500 mg


Film-coated tablets


Oral use




Greece







sanofi-aventis AEBE




348 Syngrou avenue-Building A




176 74 Kalithea – Athens




GR-Greece






Tavanic


5 mg/1 ml


Solution for infusion


Intravenous use




Hungary







sanofi-aventis Zrt.




To u. 1-5.




1045 Budapest,




Hungary






Tavanic


250 mg


Film-coated tablets


Oral use




Hungary







sanofi-aventis Zrt.




To u. 1-5.




1045 Budapest,




Hungary






Tavanic


500 mg


Film-coated tablets


Oral use




Hungary







sanofi-aventis Zrt.




To u. 1-5.




1045 Budapest,




Hungary






Tavanic


5 mg/ml


Solution for infusion


Intravenous use




Ireland







sanofi-aventis Ireland Ltd.,




Citywest Business Campus, Dublin 24, Ireland






Tavanic 250 mg film-coated tablets


250 mg


Film-coated tablets


Oral use




Ireland







sanofi-aventis Ireland Ltd.,




Citywest Business Campus, Dublin 24, Ireland






Tavanic 500 mg film-coated tablets


500 mg


Film-coated tablets


Oral use




Ireland







sanofi-aventis Ireland Ltd.,




Citywest Business Campus, Dublin 24, Ireland






Tavanic 5 mg/ml solution for infusion


5 mg/ml


Solution for infusion


Intravenous use




Italy







sanofi-aventis S.p.A.




Viale Luigi Bodio 37/B




20158 Milan




Italy






TAVANIC


250 mg


Film-coated tablets


Oral use




Italy







sanofi-aventis S.p.A.




Viale Luigi Bodio 37/B




20158 Milan




Italy






TAVANIC


500 mg


Film-coated tablets


Oral use




Italy







sanofi-aventis S.p.A.




Viale Luigi Bodio 37/B




20158 Milan




Italy






TAVANIC


5 mg/ml


Solution for infusion


Intravenous use




Lithuania







UAB ‘SANOFI-AVENTIS LIETUVA’,




A.Juozapavičiaus g. 6/2, LT-09310 Vilnius, Lithuania






Tavanic


250 mg


Film-coated tablets


Oral use




Lithuania







UAB ‘SANOFI-AVENTIS LIETUVA’,




A.Juozapavičiaus g. 6/2, LT-09310 Vilnius, Lithuania






Tavanic


500 mg


Film-coated tablets


Oral use




Lithuania







UAB ‘SANOFI-AVENTIS LIETUVA’,




A.Juozapavičiaus g. 6/2, LT-09310 Vilnius, Lithuania






Tavanic


5 mg/ml


Solution for infusion


Intravenous use




Luxembourg







Sanofi-aventis Belgium




Culliganlaan, 1C




1831 Diegem - Belgium






Tavanic 250 mg comprimés pelliculés


250 mg


Film-coated tablets


Oral use




Luxembourg







Sanofi-aventis Belgium




Culliganlaan, 1C




1831 Diegem - Belgium






Tavanic 500 mg comprimés pelliculés


500 mg


Film-coated tablets


Oral use




Luxembourg







Sanofi-aventis Belgium




Culliganlaan, 1C




1831 Diegem - Belgium






Tavanic 5 mg/ml solution pour perfusion


5 mg/ml


Solution for infusion


Intravenous use




Malta







Sanofi-Aventis Malta Ltd,




Triq Kan. K. Pirotta, Birkirkara. BKR 1114. Malta






Tavanic 250 mg film coated tablets


250 mg


Film-coated tablets


Oral use




Malta







Sanofi-Aventis Malta Ltd,




Triq Kan. K. Pirotta, Birkirkara. BKR 1114. Malta






Tavanic 500 mg film coated tablets


500 mg


Film-coated tablets


Oral use




Malta







Sanofi-Aventis Malta Ltd,




Triq Kan. K. Pirotta, Birkirkara. BKR 1114. Malta






Tavanic 5 mg/ml solution for infusion


5 mg/ml


Solution for infusion


Intravenous use




Netherlands







sanofi-aventis Netherlands B.V.,




Kampenringweg 45 D-E, 2803 PE Gouda, The Netherlands






Tavanic 250


250 mg


Film-coated tablets


Oral use




Netherlands







sanofi-aventis Netherlands B.V.,




Kampenringweg 45 D-E, 2803 PE Gouda, The Netherlands






Tavanic 500


500 mg


Film-coated tablet


Oral use




Netherlands







sanofi-aventis Netherlands B.V.,




Kampenringweg 45 D-E, 2803 PE Gouda, The Netherlands






Tavanic IV


5 mg/ml


Solution for infusion


Intravenous use




Poland







Sanofi-Aventis Deutschland GmbH




Brüningstrasse 50




D-65926 Frankfurt am Main, Germany






Tavanic 250


250 mg


Film-coated tablets


Oral use




Poland







Sanofi-Aventis Deutschland GmbH




Brüningstrasse 50




D-65926 Frankfurt am Main, Germany






Tavanic 500


500 mg


Film-coated tablets


Oral use




Poland







Sanofi-Aventis Deutschland GmbH




Brüningstrasse 50




D-65926 Frankfurt am Main, Germany






Tavanic


5 mg/ml


Solution for infusion


Intravenous use




Portugal







SANOFI-AVENTIS – Produtos Farmacêuticos, Lda.




Empreendimento Lagoas Park




Edifício 7 – 3o Piso




2740-244 Porto Salvo






TAVANIC


250 mg


Film-coated tablets


Oral use




Portugal







SANOFI-AVENTIS – Produtos Farmacêuticos, Lda.




Empreendimento Lagoas Park




Edifício 7 – 3o Piso




2740-244 Porto Salvo






TAVANIC


500 mg


Film-coated tablets


Oral use




Portugal







SANOFI-AVENTIS – Produtos Farmacêuticos, Lda.




Empreendimento Lagoas Park




Edifício 7 – 3o Piso




2740-244 Porto Salvo






TAVANIC


5 mg/ml


Solution for infusion


Intravenous use




Slovak Republic







sanofi-aventis Slovakia s.r.o.,




Einsteinova 24, 85101 Bratislava, Slovak Republic






Tavanic 500 mg


500 mg


Film-coated tablets


Oral use




Slovak Republic







sanofi-aventis Slovakia s.r.o.,




Einsteinova 24, 85101 Bratislava, Slovak Republic






Tavanic i.v. 500 mg


5 mg/ml


Solution for infusion


Intravenous use




Slovenia







sanofi-aventis d.o.o,




Dunajska 151, 1000 Ljubljana, Slovenia






Tavanic 250 mg filmsko obložene tablete


250 mg


Film-coated tablets


Oral use




Slovenia







sanofi-aventis d.o.o,




Dunajska 151, 1000 Ljubljana, Slovenia






Tavanic 500 mg filmsko obložene tablete


500 mg


Film-coated tablets


Oral use




Slovenia







sanofi-aventis d.o.o,




Dunajska 151, 1000 Ljubljana, Slovenia






Tavanic 5 mg/ml raztopina za infundiranje


5 mg/ml


Solution for infusion


Intravenous use




Spain







Sanofi-aventis, S.A.




Josep Pla, 2




08019 – Barcelona




Spain






Tavanic 500 mg comprimidos recubiertos con película


500 mg


Film-coated tablets


Oral use




Spain







Sanofi-aventis, S.A.




Josep Pla, 2




08019 – Barcelona




Spain






Tavanic 5 mg/ml solución para perfusión


5 mg/ml


Solution for infusion


Intravenous use




Sweden







sanofi-aventis AB




Box 141 42




167 14 Bromma




Sweden






Tavanic


250 mg


Film-coated tablets


Oral use




Sweden







sanofi-aventis AB




Box 141 42




167 14 Bromma




Sweden






Tavanic


500 mg


Film-coated tablets


Oral use




Sweden







sanofi-aventis AB




Box 141 42




167 14 Bromma




Sweden






Tavanic


5 mg/ml


Solution for infusion


Intravenous use




United Kingdom







Aventis Pharma Limited,




50 Kings Hill Avenue




Kings Hill




West Malling




Kent




ME19 4AH




United Kingdom




(Trading as:





Sanofi-aventis




One Onslow Street, Guildford, Surrey,




GU1 4YS, United Kingdom)






Tavanic 250 mg film-coated tablets


250 mg


Film-coated tablets


Oral use




United Kingdom







Aventis Pharma Limited,




50 Kings Hill Avenue




Kings Hill




West Malling




Kent




ME19 4AH




United Kingdom




(Trading as:





Sanofi-aventis




One Onslow Street, Guildford, Surrey,




GU1 4YS, United Kingdom)






Tavanic 500 mg film-coated tablets


500 mg


Film-coated tablets


Oral use




United Kingdom







Aventis Pharma Limited,




50 Kings Hill Avenue




Kings Hill




West Malling




Kent




ME19 4AH




United Kingdom




(Trading as:





Sanofi-aventis




One Onslow Street, Guildford, Surrey,




GU1 4YS, United Kingdom)






Tavanic 5 mg/ml solution for infusion


5 mg/ml


Solution for infusion


Intravenous use







ANNEX II

LIST OF THE NAMES, PHARMACEUTICAL FORM, STRENGTH OF THE MEDICINAL PRODUCT(S), ROUTE OF ADMINISTRATION, MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES











Member State
EU/EEA


Marketing authorisaton holder


Product name


Strength


Pharmaceutical form


Route of administration




Austria







Bayer Austria GmbH




Herbststrasse 6-10




1160 Wien




Austria






Eloine 0,02 mg/3 mg Filmtabletten


0,02 mg/3 mg


Film-coated tablet


Oral use




Bulgaria







Bayer Pharma AG,




Mullerstrasse 170-178




Berlin




13342




Germany






ELOINE


0,02 mg/3 mg


Film-coated tablet


Oral use




Cyprus







Bayer Hellas ABEE




Sorou 18-20




151 25 Marousi




Greece






LINATERA FC TABLETS


0,02 mg/3 mg


Film-coated tablet


Oral use




Czech Republic







Bayer Pharma AG Müllerstrasse




178 D-13342 Berlin




Germany






ELOINE 0,02 MG/3 MG POTAHOVANÉ TABLETY


0,02 mg/3 mg


Film-coated tablet


Oral use




Denmark







Bayer AB




Gustav III:s Boulevard 56




Postbox 606




SE-16926 Solna




Sweden






Eloine


0,02 mg/3 mg


Film-coated tablet


Oral use




Finland







Bayer Oy




Pansiontie 47




PO Box 415




20101 Turku




Finland






Linatera


0,02 mg/3 mg


Film-coated tablet


Oral use




France







BAYER SANTE




220 avenue de la Recherche




59120 Loos




France






RIMENDIA 0,02 mg/3 mg comprimé pelliculé


0,02 mg/3 mg


Film-coated tablet


Oral use




Germany







Jenapharm GmbH & Co. KG




Otto-Schott-Str. 15




D-07745 Jena




Germany






Eloine 0,02 mg/3 mg Filmtabletten


0,02 mg/3 mg


Film-coated tablet


Oral use




Greece







BAYER HELLAS ABEE




Sorou 18-20




Maroussi 15127




Greece






LINATERA


0,02 mg/3 mg


Film-coated tablet


Oral use




Iceland







Bayer AB




Gustav III:s Boulevard 56




169 26 Solna




Sweden






Eloine


0,02 mg/3 mg


Film-coated tablet


Oral use




Italy







Bayer S.p.A.




Viale Certosa 130




Milano 20156




Italy






ELOINE


0,02 mg/3 mg


Film-coated tablet


Oral use




Malta







Bayer plc




Bayer House




Strawberry Hill, Newbury




Berkshire, RG14 1JA




United Kingdom






ELOINE 0.02 mg/3 mg film coated tablets


0,02 mg/3 mg


Film-coated tablet


Oral use




Norway







Bayer AB




Gustav III's Boulevard 56




169 26 Solna




Sweden






Eloine


0,02 mg/3 mg


Film-coated tablet


Oral use




Poland







Bayer Pharma AG




Müllerstr. 178, Berlin




D-13342




Germany






Linatera


0,02 mg/3 mg


Film-coated tablet


Oral use




Portugal







Berlifarma - Especialidades Farmacêuticas, Lda.




Rua Quinta Pinheiro, 5, Outurela




2794-003 Carnaxide




Portugal






Linatera


0,02 mg/3 mg


Film-coated tablet


Oral use




Slovak Republic







Bayer spol. s r.o.




Einsteinova 25




851 01 Bratislava




Slovak Republic






Linatera


0,02 mg/3 mg


Film-coated tablet


Oral use




Slovenia







Bayer d.o.o.




Bravničarjeva 13




SI-1000 Ljubljana




Slovenia






Linatera 0,02 mg/3 mg filmsko obložene tablete


0,02 mg/3 mg


Film-coated tablet


Oral use




Spain







BAYHEALTH S.L.




Avda. Baix Llobregat 3 y 5




08970 Sant Joan Despi




Barcelona




Spain






ELOINE 0,02 mg/3 mg comprimidos recubiertos con película


0,02 mg/3 mg


Film-coated tablet


Oral use




Sweden







Bayer AB




Box 606




SE-16929 Solna




Sweden






Eloine


0,02 mg/3 mg


Film-coated tablet


Oral use




The Netherlands







Berlipharm BV.




Energieweg 1




3641 RT Mijdrecht




The Netherlands






Ethinylestradiol/Drospirenon 24 + 4 0,02 mg/3 mg Berlipharm, filmomhulde tabletten


0,02 mg/3 mg


Film-coated tablet


Oral use




United Kingdom







Bayer PLC




Bayer House




Strawberry Hill, Newbury Berkshire RG14 1JA




United Kingdom






ELOINE Film-Coated Tablets 0.02 mg/3 mg


0,02 mg/3 mg


Film-coated tablet


Oral use