Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 December 2014 to 31 December 2014 (Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council)
Date: 2015-01-30
Institutions: European Commission
Subjects: drug surveillance, market approval, marketing standard, medicinal product








C_2015032EN.01000101.xml










30.1.2015   


EN


Official Journal of the European Union


C 32/1





Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 December 2014 to 31 December 2014
(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 032/01)
—   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




5.12.2014


Paliperidone Janssen


Paliperidone


Janssen-Cilag International NV
Turnhoutseweg 30, B-2340 Beerse, België


EU/1/14/971


Prolonged release suspension for injection


N05AX13


9.12.2014




8.12.2014


Duloxetine Lilly


Duloxetine


Eli Lilly Nederland B.V.
Grootslag 1-5, NL-3991 RA Houten, Nederland


EU/1/14/972


Gastro-resistant capsule, hard


N06AX21


10.12.2014




8.12.2014


Moventig


Naloxegol


AstraZeneca AB
SE-151 85 Södertälje, Sverige


EU/1/14/962


Film-coated tablet


A06AH03


10.12.2014




16.12.2014


DUAVIVE


Oestrogens conjugated/bazedoxifene


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


EU/1/14/960


Modified-release tablet


G03CX


18.12.2014




16.12.2014


Lynparza


Olaparib


AstraZeneca AB
SE-151 85 Södertälje, Sverige


EU/1/14/959


Capsule, hard


L01


18.12.2014




19.12.2014


Cyramza


Ramucirumab


Eli Lilly Nederland B.V.
Grootslag 1-5, NL-3991 RA Houten, Nederland


EU/1/14/957


Concentrate for solution for infusion


L01XC


23.12.2014




19.12.2014


Rixubis


Nonacog gamma


Baxter Innovations GmbH
Industriestraße 67, A-1221 Wien, Österreich


EU/1/14/970


Powder and solvent for solution for injection


B02BD04


23.12.2014




22.12.2014


Scenesse


Afamelanotide


Clinuvel UK Limited
c/o — Reed Smith, Broadgate Tower, Third Floor, 20 Primrose Street, London, EC2A 2RS, United Kingdom


EU/1/14/969


Implant


D02BB02


29.12.2014




—   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




1.12.2014


Desloratadine Teva


Teva Pharma B.V.
Computerweg 10, NL-3542 DR Utrecht, Nederland


EU/1/11/732


3.12.2014




1.12.2014


Ibandronic Acid Teva


Teva Pharma B.V.
Computerweg 10, NL-3542 DR Utrecht, Nederland


EU/1/10/642


3.12.2014




1.12.2014


Irbesartan Teva


Teva Pharma B.V.
Computerweg 10, NL-3542 DR Utrecht, Nederland


EU/1/09/576


3.12.2014




1.12.2014


Optimark


Mallinckrodt Deutschland GmbH
Josef-Dietzgen-Strasse 1, D-53773 Hennef, Deutschland


EU/1/07/398


3.12.2014




4.12.2014


Menveo


Novartis Vaccines and Diagnostics S.r.l.
Via Fiorentina, 1, 53100 Siena, Italia


EU/1/10/614


9.12.2014




4.12.2014


Ratiograstim


Ratiopharm GmbH
Graf-Arco-Straße 3, D-89079 Ulm, Deutschland


EU/1/08/444


8.12.2014




4.12.2014


Tevagrastim


Teva GmbH
Graf-Arco-Straße 3, D-89079 Ulm, Deutschland


EU/1/08/445


8.12.2014




5.12.2014


Cystagon


Orphan Europe S.A.R.L.
Immeuble Le Wilson, 70 avenue du Général de Gaulle, F-92 800 Puteaux, France


EU/1/97/039


9.12.2014




5.12.2014


Erbitux


Merck KGaA
64271 Darmstadt, Deutschland


EU/1/04/281


9.12.2014




5.12.2014


Vectibix


Amgen Europe B.V.
Minervum 7061, NL-4817 ZK Breda, Nederland


EU/1/07/423


9.12.2014




11.12.2014


Bronchitol


Pharmaxis Pharmaceuticals Limited
The Priory, Stomp Road, Burnham, Buckinghamshire SL1 7LW, United Kingdom


EU/1/12/760


15.12.2014




11.12.2014


Efavirenz Teva


Teva B.V.
Swensweg 5, 2031 GA Haarlem, Nederland


EU/1/11/742


15.12.2014




11.12.2014


Eviplera


Gilead Sciences International Limited
Cambridge CB21 6GT, United Kingdom


EU/1/11/737


15.12.2014




11.12.2014


Levetiracetam Ratiopharm


Ratiopharm GmbH
Graf-Arco-Straße 3, D-89079 Ulm, Deutschland


EU/1/11/702


15.12.2014




11.12.2014


Removab


Neovii Biotech GmbH
Am Haag 6-7, 82166 Graefelfing, Deutschland


EU/1/09/512


15.12.2014




15.12.2014


Lantus


Sanofi-Aventis Deutschland GmbH
D-65926 Frankfurt am Main, Deutschland


EU/1/00/134


18.12.2014




15.12.2014


Lemtrada


Genzyme Therapeutics Ltd
4620 Kingsgate, Cascade Way, Oxford Business Park South, Oxford OX4 2SU, United Kingdom


EU/1/13/869


17.12.2014




15.12.2014


Levetiracetam Actavis Group


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


EU/1/11/738


18.12.2014




15.12.2014


Mircera


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


EU/1/07/400


18.12.2014




15.12.2014


Naglazyme


BioMarin Europe Ltd
164 Shaftesbury Avenue, London WC2H 8HL, United Kingdom


EU/1/05/324


17.12.2014




15.12.2014


Optisulin


Sanofi-Aventis Deutschland GmbH
D-65926 Frankfurt am Main, Deutschland


EU/1/00/133


18.12.2014




15.12.2014


Revestive


NPS Pharma Holdings Limited
Grand Canal House, 1 Grand Canal Street Upper, Dublin 4, Ireland


EU/1/12/787


17.12.2014




15.12.2014


Somatropin Biopartners


BioPartners GmbH
Kaiserpassage 11, D-72764 Reutlingen, Deutschland


EU/1/13/849


17.12.2014




15.12.2014


Tasigna


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


EU/1/07/422


18.12.2014




15.12.2014


Xeloda


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


EU/1/00/163


18.12.2014




16.12.2014


Afinitor


Novartis Europharm Limited
Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom


EU/1/09/538


18.12.2014




16.12.2014


Brintellix


H. Lundbeck A/S
Ottiliavej 9, DK-2500 Valby, Danmark


EU/1/13/891


18.12.2014




16.12.2014


Cimzia


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


EU/1/09/544


17.12.2014




16.12.2014


Fasturtec


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


EU/1/00/170


18.12.2014




16.12.2014


Hizentra


CSL Behring GmbH
Emil-von-Behring-Straße 76, D-35041 Marburg, Deutschland


EU/1/11/687


18.12.2014




16.12.2014


HyQvia


Baxter Innovations GmbH
Industriestraße 67, A-1221 Wien, Österreich


EU/1/13/840


18.12.2014




16.12.2014


Incivo


Janssen-Cilag International NV
Turnhoutseweg 30, B-2340 Beerse, België


EU/1/11/720


18.12.2014




16.12.2014


Lamivudine Teva


Teva B.V.
Swensweg 5, 2031 GA Haarlem, Nederland


EU/1/09/566


18.12.2014




16.12.2014


Levetiracetam Actavis


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


EU/1/11/713


18.12.2014




16.12.2014


Methylthioninium chloride Proveblue


Provepharm S.A.S.
22 Rue Marc Donadille, 13013 Marseille, France


EU/1/11/682


18.12.2014




16.12.2014


NULOJIX


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


EU/1/11/694


18.12.2014




16.12.2014


Orphacol


Laboratoires CTRS
63 rue de l'Est, F-92100 Boulogne-Billancourt, France


EU/1/13/870


18.12.2014




16.12.2014


Paglitaz


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


EU/1/11/721


18.12.2014




16.12.2014


Pioglitazone Teva


Teva Pharma B.V.
Computerweg 10, NL-3542 DR Utrecht, Nederland


EU/1/12/757


18.12.2014




16.12.2014


Pioglitazone Teva Pharma


Teva Pharma B.V.
Computerweg 10, NL-3542 DR Utrecht, Nederland


EU/1/12/758


18.12.2014




16.12.2014


Remsima


Celltrion Healthcare Hungary Kft.
Árpád Fejedelem útja 26-28, H-1023 Budapest, Magyarország


EU/1/13/853


18.12.2014




16.12.2014


Ristaben


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


EU/1/10/621


19.12.2014




16.12.2014


Ristfor


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


EU/1/10/620


17.12.2014




16.12.2014


Stivarga


Bayer Pharma AG
D-13342 Berlin, Deutschland


EU/1/13/858


18.12.2014




16.12.2014


Ultibro Breezhaler


Novartis Europharm Limited
Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom


EU/1/13/862


18.12.2014




16.12.2014


Ulunar Breezhaler


Novartis Europharm Limited
Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom


EU/1/14/917


19.12.2014




16.12.2014


Votubia


Novartis Europharm Limited
Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom


EU/1/11/710


18.12.2014




16.12.2014


Xoterna Breezhaler


Novartis Europharm Limited
Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom


EU/1/13/863


18.12.2014




16.12.2014


Zelboraf


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


EU/1/12/751


19.12.2014




19.12.2014


CellCept


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


EU/1/96/005


23.12.2014




19.12.2014


InductOs


Medtronic BioPharma B.V.
Earl Bakkenstraat 10, NL-6422 PJ Heerlen, Nederland


EU/1/02/226


23.12.2014




19.12.2014


Puregon


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


EU/1/96/008


23.12.2014




19.12.2014


Rilutek


Aventis Pharma S.A.
20 avenue Raymond Aron, F-92165 Antony CEDEX, France


EU/1/96/010


23.12.2014




19.12.2014


Stayveer


Marklas Nederland B.V.
Beneluxlaan 2b, NL-3446 GR Woerden, Nederland


EU/1/13/832


5.1.2015




19.12.2014


Telmisartan Teva


Teva Pharma B.V.
Computerweg 10, NL-3542 DR Utrecht, Nederland


EU/1/09/610


24.12.2014




19.12.2014


Travatan


Alcon Laboratories (UK) Ltd
Frimley Business Park, Frimley, Camberley, Surrey, GU16 7SR, United Kingdom


EU/1/01/199


23.12.2014




19.12.2014


Victoza


Novo Nordisk A/S
Novo Allé, DK-2880 Bagsvaerd, Danmark


EU/1/09/529


23.12.2014




19.12.2014


Zoledronic acid Teva


Teva B.V.
Swensweg 5, 2031 GA Haarlem, Nederland


EU/1/12/771


24.12.2014




19.12.2014


Zoledronic acid Teva Pharma


Teva B.V.
Swensweg 5, 2031 GA Haarlem, Nederland


EU/1/12/772


24.12.2014




—   Issuing 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


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




22.12.2014


Bovela


Modified live BVDV-1, non-cytopathic parent strain KE-9, Modified live BVDV-2, non-cytopathic parent strain NY-93


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


EU/2/14/176


Lyophilisate and solvent for suspension for injection


QI02AD02


29.12.2014




—   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




4.12.2014


Gripovac 3


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


EU/2/09/102


8.12.2014




4.12.2014


Porcilis AR-T DF


Intervet International B.V.
Wim de Körverstraat 35, NL-5831 AN Boxmeer, Nederland


EU/2/00/026


8.12.2014




4.12.2014


Respiporc Flu3


IDT Biologika GmbH
Am Pharmapark, D-06861 Dessau-Rosslau, Deutschland


EU/2/09/103


8.12.2014




11.12.2014


Comfortis


Eli Lilly and Company Ltd, Elanco Animal Health
Lilly House Priestley Road, Basingstoke, Hampshire, RG24 9NL, United Kingdom


EU/2/10/115


15.12.2014




11.12.2014


Trifexis


Eli Lilly and Company Ltd, Elanco Animal Health
Lilly House Priestley Road, Basingstoke, Hampshire, RG24 9NL, United Kingdom


EU/2/13/155


15.12.2014




16.12.2014


Pexion


Boehringer Ingelheim Vetmedica GmbH
D-55216 Ingelheim am Rhein, Deutschland


EU/2/12/147


18.12.2014




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




30, Churchill Place, Canary Wharf




UK — LONDON E14 5EU






(1)  OJ L 136, 30.4.2004, p. 1.