Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 June 2014 to 30 June 2014 (Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council)
Date: 2014-07-25
Institutions: European Commission
Subjects: drug surveillance, market approval, marketing standard, medicinal product








C_2014243EN.01000101.xml










25.7.2014   


EN


Official Journal of the European Union


C 243/1





Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 June 2014 to 30 June 2014
(Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council (1))
2014/C 243/01
—   Issuing of a marketing authorisation (Article 13 of Regulation (EC) No 726/2004 of the European Parliament and of the Council): Accepted













Date of the decision


Name of the medicinal product


INN (International Non-Proprietary Name)


Holder of the marketing authorisation


Number of the entry in the Community Register


Pharmaceutical form


ATC code (Anatomical Therapeutic Chemical Code)


Date of notification




30.6.2014


Mekinist


trametinib







Glaxo Group Ltd




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






EU/1/14/931


Film-coated tablet


L01XE25


2.7.2014




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










Date of the decision


Name of the medicinal product


Holder of the marketing authorisation


Number of the entry in the Community Register


Date of notification




3.6.2014


Adasuve







Alexza UK Ltd.




10 Station Road, Henley-on-Thames, Oxfordshire RG9 1AY, United Kingdom






EU/1/13/823


5.6.2014




3.6.2014


Clopidogrel Krka d.d.







Krka, d. d., Novo Mesto




Šmarješka cesta 6, 8501 Novo mesto, Slovenija






EU/1/09/562


5.6.2014




3.6.2014


Docetaxel Mylan







Mylan S.A.S




117 allée des Parcs, F-69800 Saint Priest, France






EU/1/11/748


5.6.2014




3.6.2014


Docetaxel Teva







Teva Pharma B.V.




Computerweg 10, NL-3542 DR Utrecht, Nederland






EU/1/09/611


6.6.2014




3.6.2014


Efficib







Merck Sharp & Dohme Limited




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






EU/1/08/457


5.6.2014




3.6.2014


Ibandronic acid Sandoz







Sandoz Pharmaceuticals GmbH




Raiffeisenstraße 11, D-83607 Holzkirchen, Deutschland






EU/1/11/685


5.6.2014




3.6.2014


Janumet







Merck Sharp & Dohme Limited




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






EU/1/08/455


5.6.2014




3.6.2014


Kepivance







Swedish Orphan Biovitrum AB (publ)




SE-112 76, Stockholm, Sverige






EU/1/05/314


5.6.2014




3.6.2014


Kiovig







Baxter AG




Industriestraße 67, A-1221 Wien, Österreich






EU/1/05/329


5.6.2014




3.6.2014


Lysodren







Laboratoire HRA Pharma




15 rue Béranger, F-75003 Paris, France






EU/1/04/273


5.6.2014




3.6.2014


Macugen







Pfizer Limited




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






EU/1/05/325


5.6.2014




3.6.2014


Memantine LEK







Pharmathen S.A.




6 Dervenakion, 15351 Pallini Attiki, Ελλάδα






EU/1/13/826


5.6.2014




3.6.2014


Nevanac







Alcon Laboratories (UK) Ltd.




Frimley Business Park, Frimley, Camberley, Surrey, GU16 7SR, United Kingdom






EU/1/07/433


5.6.2014




3.6.2014


Pradaxa







Boehringer Ingelheim International GmbH




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






EU/1/08/442


5.6.2014




3.6.2014


Prolia







Amgen Europe B.V.




Minervum 7061, NL-4817 ZK Breda, Nederland






EU/1/10/618


5.6.2014




3.6.2014


Ristfor







Merck Sharp & Dohme Limited




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






EU/1/10/620


5.6.2014




3.6.2014


Velmetia







Merck Sharp & Dohme Limited




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






EU/1/08/456


5.6.2014




3.6.2014


Yondelis







Pharma Mar S.A.




Avda de los Reyes 1, Polígono Industrial La Mina, E-28770 Colmenar Viejo, Madrid, España






EU/1/07/417


5.6.2014




6.6.2014


Champix







Pfizer Limited




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






EU/1/06/360


11.6.2014




6.6.2014


Edarbi







Takeda Pharma A/S




Dybendal Alle 10, 2630 Taastrup, Danmark






EU/1/11/734


11.6.2014




6.6.2014


Gardasil







Sanofi Pasteur MSD, SNC




162 avenue Jean Jaurès, 69007 Lyon, France






EU/1/06/357


12.6.2014




6.6.2014


Resolor







Shire Pharmaceuticals Ireland Limited




5 River Walk, Citywest Business Campus, Dublin 24, Ireland






EU/1/09/581


11.6.2014




6.6.2014


Silgard







Merck Sharp & Dohme Limited




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






EU/1/06/358


13.6.2014




6.6.2014


Telmisartan Teva Pharma







Teva Pharma B.V.




Computerweg 10, NL-3542 DR Utrecht, Nederland






EU/1/11/719


12.6.2014




6.6.2014


Topotecan Actavis







Actavis Group PTC ehf.




Reykjavíkurvegur 76-78, 220 Hafnarfjörður, Iceland






EU/1/09/536


11.6.2014




6.6.2014


Zutectra







Biotest Pharma GmbH




Landsteinerstrasse 5, D-63303 Dreieich, Deutschland






EU/1/09/600


11.6.2014




12.6.2014


Imatinib Actavis







Actavis Group PTC ehf.




Reykjavíkurvegur 76-78, 220 Hafnarfjörður, Iceland






EU/1/13/825


16.6.2014




19.6.2014


Celvapan







Baxter AG




Industriestraße 67, A-1221 Wien, Österreich






EU/1/08/506


23.6.2014




19.6.2014


Enurev Breezhaler







Novartis Europharm Limited




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






EU/1/12/789


23.6.2014




19.6.2014


Erivedge







Roche Registration Limited




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






EU/1/13/848


23.6.2014




19.6.2014


GILENYA







Novartis Europharm Limited




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






EU/1/11/677


23.6.2014




19.6.2014


Ilaris







Novartis Europharm Limited




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






EU/1/09/564


23.6.2014




19.6.2014


Incivo







Janssen-Cilag International NV




Turnhoutseweg 30, B-2340 Beerse, België






EU/1/11/720


23.6.2014




19.6.2014


Javlor







Pierre Fabre Médicament




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






EU/1/09/550


23.6.2014




19.6.2014


Osseor







Les Laboratoires Servier




50 rue Carnot, F-92284 Suresnes CEDEX, France






EU/1/04/287


23.6.2014




19.6.2014


Ozurdex







Allergan Pharmaceuticals Ireland




Castlebar Road, Westport, County Mayo, Ireland






EU/1/10/638


23.6.2014




19.6.2014


Protelos







Les Laboratoires Servier




50 rue Carnot, F-92284 Suresnes CEDEX, France






EU/1/04/288


23.6.2014




19.6.2014


Remicade







Janssen Biologics B.V.




Einsteinweg 101, NL-2333 CB Leiden, Nederland






EU/1/99/116


23.6.2014




19.6.2014


Repaglinide Teva







Teva Pharma B.V.




Computerweg 10, NL-3542 DR Utrecht, Nederland






EU/1/09/530


23.6.2014




19.6.2014


Samsca







Otsuka Pharmaceutical Europe Ltd.




Gallions, Wexham Springs, Framewood Road, Wexham, SL3 6PJ, United Kingdom






EU/1/09/539


23.6.2014




19.6.2014


Seebri Breezhaler







Novartis Europharm Limited




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






EU/1/12/788


23.6.2014




19.6.2014


Simponi







Janssen Biologics B.V.




Einsteinweg 101, NL-2333 CB Leiden, Nederland






EU/1/09/546


23.6.2014




19.6.2014


Topotecan Teva







Teva Pharma B.V.




Computerweg 10, NL-3542 DR Utrecht, Nederland






EU/1/09/552


23.6.2014




19.6.2014


Tovanor Breezhaler







Novartis Europharm Limited




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






EU/1/12/790


23.6.2014




19.6.2014


Valdoxan







Les Laboratoires Servier




50 rue Carnot, F-92284 Suresnes CEDEX, France






EU/1/08/499


23.6.2014




19.6.2014


Votubia







Novartis Europharm Limited




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






EU/1/11/710


23.6.2014




23.6.2014


Angiox







The Medicines Company UK Ltd




115 L Milton Park, Abingdon, Oxfordshire OX14 4SA, United Kingdom






EU/1/04/289


25.6.2014




23.6.2014


Bosulif







Pfizer Limited




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






EU/1/13/818


25.6.2014




23.6.2014


Brilique







AstraZeneca AB




SE-151 85 Södertälje, Sverige






EU/1/10/655


25.6.2014




23.6.2014


Diacomit







Biocodex




7 avenue Gallieni, F-94250 Gentilly, France






EU/1/06/367


25.6.2014




23.6.2014


Prevenar 13







Pfizer Limited




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






EU/1/09/590


25.6.2014




23.6.2014


Thymanax







Servier (Ireland) Industries Limited




Gorey Road, Arklow, Co. Wicklow, Ireland






EU/1/08/498


25.6.2014




23.6.2014


Vfend







Pfizer Limited




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






EU/1/02/212


25.6.2014




23.6.2014


Yondelis







Pharma Mar S.A.




Avda de los Reyes 1, Polígono Industrial La Mina, E-28770 Colmenar Viejo, Madrid, España






EU/1/07/417


25.6.2014




23.6.2014


Zeffix







Glaxo Group Ltd




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






EU/1/99/114


25.6.2014




27.6.2014


Amyvid







Eli Lilly Nederland B.V.




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






EU/1/12/805


1.7.2014




27.6.2014


Cayston







Gilead Sciences International Limited




Granta Park, Abington, Cambridge CB21 6GT, United Kingdom






EU/1/09/543


1.7.2014




27.6.2014


Circadin







RAD Neurim Pharmaceuticals EEC Limited




One Forbury Square, The Forbury, Reading, Berkshire RG1 3EB, United Kingdom






EU/1/07/392


1.7.2014




27.6.2014


Esbriet







InterMune UK Limited




Grove House, 2nd Floor, 248A Marylebone Road, London NW1 6JZ, United Kingdom






EU/1/11/667


1.7.2014




27.6.2014


Foclivia







Novartis Vaccines and Diagnostics S.r.l.




Via Fiorentina, 1, 53100 Siena, Italia






EU/1/09/577


1.7.2014




27.6.2014


HALAVEN







Eisai Europe Limited




European Knowledge Centre, Mosquito Way, Hatfield, Herts AL10 9SN, United Kingdom






EU/1/11/678


1.7.2014




27.6.2014


Ibandronic Acid Teva







Teva Pharma B.V.




Computerweg 10, NL-3542 DR Utrecht, Nederland






EU/1/10/642


2.7.2014




27.6.2014


Kineret







Swedish Orphan Biovitrum AB (publ)




SE-112 76, Stockholm, Sverige






EU/1/02/203


1.7.2014




27.6.2014


Orfadin







Swedish Orphan Biovitrum International AB




SE-112 76, Stockholm, Sverige






EU/1/04/303


1.7.2014




27.6.2014


Rasilamlo







Novartis Europharm Limited




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






EU/1/11/686


9.7.2014




27.6.2014


Rasilez







Novartis Europharm Limited




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






EU/1/07/405


9.7.2014




27.6.2014


Rasilez HCT







Novartis Europharm Limited




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






EU/1/08/491


9.7.2014




27.6.2014


Topotecan Hospira







Hospira UK Limited




Queensway, Royal Leamington Spa, Warwickshire CV31 3RW, United Kingdom






EU/1/10/633


1.7.2014




27.6.2014


Xyrem







UCB Pharma Ltd.




208 Bath Road, Slough, Berkshire SL1 3WE, United Kingdom






EU/1/05/312


1.7.2014




27.6.2014


ZALTRAP







Sanofi-Aventis groupe




54 rue La Boétie, F-75008 Paris, France






EU/1/12/814


1.7.2014




27.6.2014


Zoledronic acid Teva







Teva Pharma B.V.




Computerweg 10, NL-3542 DR Utrecht, Nederland






EU/1/12/771


2.7.2014




30.6.2014


Arzerra







Glaxo Group Ltd




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






EU/1/10/625


2.7.2014




30.6.2014


Avastin







Roche Registration Limited




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






EU/1/04/300


2.7.2014




30.6.2014


Exforge HCT







Novartis Europharm Limited




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






EU/1/09/569


9.7.2014




30.6.2014


Perjeta







Roche Registration Limited




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






EU/1/13/813


2.7.2014




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













Date of the decision


Name of the medicinal product


INN (International Non-Proprietary Name)


Holder of the marketing authorisation


Number of the entry in the Community Register


Pharmaceutical form


ATC code (Anatomical Therapeutic Chemical Code)


Date of notification




6.6.2014


Vectra Felis


dinotefuran, pyriproxyfen







CEVA SANTE ANIMALE




10 avenue de la Ballastière, F-33500 Libourne, France






EU/2/14/165


Spot-on solution


QP53AX73


11.6.2014




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










Date of the decision


Name of the medicinal product


Holder of the marketing authorisation


Number of the entry in the Community Register


Date of notification




3.6.2014


Activyl







Intervet International B.V.




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






EU/2/10/118


5.6.2014




6.6.2014


Cerenia







Zoetis Belgium S.A.




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






EU/2/06/062


11.6.2014




6.6.2014


Leucofeligen FeLV/RCP







Virbac




1ère Avenue — 2065 m — L.I.D., F-06516 Carros CEDEX, France






EU/2/09/097


11.6.2014




6.6.2014


Melovem







Dopharma Research B.V.




Zalmweg 24, NL-4941 VX Raamsdonksveer, Nederland






EU/2/09/098


11.6.2014




6.6.2014


Metacam







Boehringer Ingelheim Vetmedica GmbH




D-55216 Ingelheim am Rhein, Deutschland






EU/2/97/004


11.6.2014




6.6.2014


Suvaxyn PCV







Zoetis Belgium S.A.




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






EU/2/09/099


11.6.2014




12.6.2014


Leucogen







Virbac




1ère Avenue — 2065 m — L.I.D., F-06516 Carros CEDEX, France






EU/2/09/096


16.6.2014




19.6.2014


Locatim







Biokema Anstalt




Pflugstrasse 12, 9490 Vaduz, Fürstentum Liechtenstein






EU/2/99/011


23.6.2014




19.6.2014


Previcox







Merial




29 avenue Tony Garnier, F-69007 Lyon, France






EU/2/04/045


23.6.2014




23.6.2014


Econor







Novartis Tiergesundheit GmbH




Zielstattstrasse 40, D-81379 München, Deutschland






EU/2/98/010


25.6.2014




27.6.2014


Hiprabovis IBR Marker Live







Laboratorios Hipra, S.A.




Avda. La Selva, 135, E-17170- Amer (Girona), España






EU/2/10/114


1.7.2014




27.6.2014


Zulvac 8 Bovis







Zoetis Belgium S.A.




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






EU/2/09/105


1.7.2014




27.6.2014


Zulvac 8 Ovis







Zoetis Belgium S.A.




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






EU/2/09/104


1.7.2014




30.6.2014


TruScient







Zoetis Belgium S.A.




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






EU/2/11/136


2.7.2014




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





The European Medicines Agency




7, Westferry Circus, Canary Wharf




UK — LONDON E14 4H






(1)  OJ L 136, 30.4.04, p. 1.

(2)  OJ L 136, 30.4.04, p. 1.