Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 October 2015 to 31 October 2015 (Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council)
Date: 2015-11-27
Institutions: European Commission
Subjects: drug surveillance, market approval, marketing standard, medicinal product, withdrawal from the market








C_2015396EN.01000101.xml










27.11.2015   


EN


Official Journal of the European Union


C 396/1





Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 October 2015 to 31 October 2015
(Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council (1))
(2015/C 396/01)
—   Issuing of a marketing authorization (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 authorization


Number of the entry in the Community Register


Pharmaceutical form


ATC code (Anatomical Therapeutic Chemical Code)


Date of notification




15.10.2015


Cresemba


isavuconazole


Basilea Medical Ltd
c/o Cox Costello & Horne Limited, Langwood House, 63-81
High Street, Rickmansworth, Hertfordshire
WD3 1EQ, United Kingdom


EU/1/15/1036


Powder for concentrate for solution for infusion


J02AC05


19.10.2015




—   Modification of a marketing authorization (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 authorization


Number of the entry in the Community Register


Date of notification




5.10.2015


Kanuma


Synageva BioPharma Ltd
1A Local Board Road, Watford, Hertfordshire WD 17 2JP, United Kingdom


EU/1/15/1033


7.10.2015




5.10.2015


Potactasol


Actavis Group PTC ehf.
Reykjavíkurvegur 76-78, 220 Hafnarfjörður, Iceland


EU/1/10/660


7.10.2015




8.10.2015


Cimzia


UCB Pharma S.A.
Allée de la Recherche 60, 1070 Bruxelles, Belgique/Researchdreef 60, 1070 Brussel, België


EU/1/09/544


12.10.2015




8.10.2015


Invanz


Merck Sharp & Dohme Limited
Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom


EU/1/02/216


12.10.2015




8.10.2015


Mirapexin


Boehringer Ingelheim International GmbH
Binger Straße 173, D-55216 Ingelheim am Rhein, Deutschland


EU/1/97/051


12.10.2015




8.10.2015


Orencia


Bristol-Myers Squibb Pharma EEIG
Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom


EU/1/07/389


12.10.2015




15.10.2015


Adempas


Bayer Pharma AG
D-13342 Berlin, Deutschland


EU/1/13/907


19.10.2015




15.10.2015


Betaferon


Bayer Pharma AG
D-13342 Berlin, Deutschland


EU/1/95/003


19.10.2015




15.10.2015


ChondroCelect


TiGenix NV
Romeinse straat 12/2, B-3001 Leuven, België


EU/1/09/563


19.10.2015




15.10.2015


Dynastat


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


EU/1/02/209


19.10.2015




15.10.2015


Fortacin


Plethora Solutions Limited
Hampden House, Monument Business Park, Chalgrove, OX44 7RW United Kingdom


EU/1/13/881


19.10.2015




15.10.2015


Iressa


AstraZeneca AB
SE-151 85 Södertälje, Sverige


EU/1/09/526


19.10.2015




15.10.2015


Kadcyla


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


EU/1/13/885


19.10.2015




15.10.2015


Lyxumia


Sanofi-Aventis groupe
54 rue La Boétie, F-75008 Paris, France


EU/1/12/811


19.10.2015




15.10.2015


Mabthera


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


EU/1/98/067


19.10.2015




15.10.2015


Onbrez Breezhaler


Novartis Europharm Limited
Frimley Business Park, Camberley GU16 7SR, United Kingdom


EU/1/09/593


19.10.2015




15.10.2015


Pegasys


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


EU/1/02/221


19.10.2015




15.10.2015


Torisel


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


EU/1/07/424


19.10.2015




16.10.2015


Corbilta


Orion Corporation
Orionintie 1, FI-02200 Espoo, Suomi


EU/1/13/859


20.10.2015




16.10.2015


Silapo


STADA Arzneimittel AG
Stadastrasse 2-18, D-61118 Bad Vilbel, Deutschland


EU/1/07/432


20.10.2015




22.10.2015


Procysbi


Raptor Pharmaceuticals Europe BV
Naritaweg 165, NL-1043 BW Amsterdam, Nederland


EU/1/13/861


26.10.2015




22.10.2015


Zalasta


Krka, d. d., Novo Mesto
Šmarješka cesta 6, 8501 Novo mesto, Slovenija


EU/1/07/415


26.10.2015




28.10.2015


Cerezyme


Genzyme Europe B.V.
Gooimeer 10, NL-1411 DD Naarden, Nederland


EU/1/97/053


30.10.2015




28.10.2015


Daliresp


Takeda GmbH, (HRB 701016)
Byk-Gulden-Str. 2, D-78467 Konstanz, Deutschland


EU/1/11/668


30.10.2015




28.10.2015


Daxas


Takeda GmbH, (HRB 701016)
Byk-Gulden-Str. 2, D-78467 Konstanz, Deutschland


EU/1/10/636


30.10.2015




28.10.2015


Eylea


Bayer Pharma AG
D-13342 Berlin, Deutschland


EU/1/12/797


30.10.2015




28.10.2015


GILENYA


Novartis Europharm Limited
Frimley Business Park, Camberley GU16 7SR, United Kingdom


EU/1/11/677


30.10.2015




28.10.2015


Harvoni


Gilead Sciences International Limited
Cambridge CB21 6GT, United Kingdom


EU/1/14/958


30.10.2015




28.10.2015


Infanrix hexa


GlaxoSmithKline Biologicals S.A.
rue de l'Institut 89, 1330 Rixensart, Belgique


EU/1/00/152


30.10.2015




28.10.2015


Libertek


Takeda GmbH, (HRB 701016)
Byk-Gulden-Str. 2, D-78467 Konstanz, Deutschland


EU/1/11/666


30.10.2015




28.10.2015


Opdivo


Bristol-Myers Squibb Pharma EEIG
Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom


EU/1/15/1014


30.10.2015




28.10.2015


Rebetol


Merck Sharp & Dohme Limited
Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom


EU/1/99/107


30.10.2015




28.10.2015


Reyataz


Bristol-Myers Squibb Pharma EEIG
Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom


EU/1/03/267


30.10.2015




28.10.2015


Sycrest


Organon N.V.
Kloosterstraat 6, NL-5349 AB Oss, Nederland


EU/1/10/640


30.10.2015




28.10.2015


Vidaza


Celgene Europe Limited
1 Longwalk Road, Stockley Park, Uxbridge UB11 1DB, United Kingdom


EU/1/08/488


30.10.2015




28.10.2015


Zelboraf


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


EU/1/12/751


30.10.2015




—   Modification of a marketing authorization (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 authorization


Number of the entry in the Community Register


Date of notification




5.10.2015


RevitaCAM


Zoetis Belgium S.A.
Rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique


EU/2/12/138


7.10.2015




8.10.2015


NexGard


Merial
29 avenue Tony Garnier, F-69007 Lyon, France


EU/2/13/159


12.10.2015




8.10.2015


SevoFlo


Zoetis Belgium S.A.
Rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique


EU/2/02/035


12.10.2015




15.10.2015


Aivlosin


ECO Animal Health Ltd
78 Coombe Road, New Malden, Surrey KT3 4QS United Kingdom


EU/2/04/044


19.10.2015




15.10.2015


Zulvac SBV


Zoetis Belgium S.A.
Rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique


EU/2/14/178


19.10.2015




22.10.2015


MS-H vaccine


Pharmsure Ltd
Bewell House, Bewell St, Hereford HR4 0BA, United Kingdom


EU/2/11/126


26.10.2015




—   Withdrawal of a marketing authorization (Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council)









Date of the decision


Name of the medicinal product


Holder of the marketing authorization


Number of the entry in the Community Register


Date of notification




28.10.2015


Dicural


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


EU/2/97/003


30.10.2015




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.