Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 November 2014 to 30 November 2014 (Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council)
Date: 2014-12-30
Institutions: European Commission
Subjects: drug surveillance, market approval, marketing standard, medicinal product








C_2014467EN.01000101.xml










30.12.2014   


EN


Official Journal of the European Union


C 467/1





Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 November 2014 to 30 November 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 467/01)
—   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 authorization


Number of the entry in the Community Register


Pharmaceutical form


ATC code (Anatomical Therapeutic Chemical Code)


Date of notification




17.11.2014


Harvoni


ledipasvir/sofosbuvir


Gilead Sciences International Limited
Cambridge CB21 6GT, United Kingdom


EU/1/14/958


Film-coated tablet


Pending


18.11.2014




19.11.2014


Brimica Genuair


aclidinium bromide/formoterol fumarate dihydrate


Almirall, S.A.
Ronda General Mitre, 151, E-08022 Barcelona, España


EU/1/14/963


Inhalation powder


R03AL05


21.11.2014




19.11.2014


Budesonide/Formoterol Teva


budesonide/formoterol


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


EU/1/14/948


Inhalation powder


R03AK07


24.11.2014




19.11.2014


Budesonide/Formoterol Teva Pharma B.V.


budesonide/formoterol


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


EU/1/14/950


Inhalation powder


R03AK07


21.11.2014




19.11.2014


Duaklir Genuair


aclidinium bromide/formoterol fumarate dihydrate


Almirall, S.A.
Ronda General Mitre, 151, E-08022 Barcelona, España


EU/1/14/964


Inhalation powder


R03AL05


21.11.2014




19.11.2014


Ketoconazole HRA


ketoconazole


Laboratoire HRA Pharma
15 rue Béranger, F-75003 Paris, France


EU/1/14/965


Tablet


Pending


21.11.2014




19.11.2014


Lymphoseek


tilmanocept


Navidea Biopharmaceuticals Limited
30 Upper High Street Thame, OX9 3EZ United Kingdom


EU/1/14/955


Kit for radiopharmaceutical preparation


V09IA09


21.11.2014




19.11.2014


REZOLSTA


DARUNAVIR/COBICISTAT


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


EU/1/14/967


Film-coated tablet


J05AR14


21.11.2014




19.11.2014


Vylaer Spiromax


budesonide/formoterol


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


EU/1/14/949


Inhalation powder


R03AK07


24.11.2014




21.11.2014


Tadalafil Mylan


tadalafil


Generics [UK] Limited
Station Close, Potters Bar, Hertfordshire, EN6 1TL, United Kingdom


EU/1/14/961


Film-coated tablet


G04BE08


25.11.2014




21.11.2014


Trulicity


dulaglutide


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


EU/1/14/956


Solution for injection


Pending


25.11.2014




21.11.2014


Vargatef


nintedanib


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


EU/1/14/954


Capsule, soft


Pending


25.11.2014




—   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 authorization


Number of the entry in the Community Register


Date of notification




7.11.2014


Arava


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


EU/1/99/118


11.11.2014




7.11.2014


Biograstim


AbZ-Pharma GmbH
Graf-Arco-Straße 3, D-89079 Ulm, Deutschland


EU/1/08/450


11.11.2014




7.11.2014


Inlyta


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


EU/1/12/777


11.11.2014




7.11.2014


Pioglitazone Accord


Accord Healthcare Limited
Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF, United Kingdom


EU/1/11/722


11.11.2014




7.11.2014


Prometax


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


EU/1/98/092


11.11.2014




7.11.2014


Repso


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


EU/1/11/674


12.11.2014




7.11.2014


Xagrid


Shire Pharmaceutical Contracts Ltd
Hampshire International Business Park, Chineham, Basingstoke, Hampshire RG24 8EP, United Kingdom


EU/1/04/295


11.11.2014




11.11.2014


Glidipion


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


EU/1/12/756


13.11.2014




11.11.2014


Imatinib Teva


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


EU/1/12/808


13.11.2014




11.11.2014


Irbesartan/Hydrochlorothiazide Teva


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


EU/1/09/583


14.11.2014




11.11.2014


Lamivudine/Zidovudine Teva


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


EU/1/10/663


13.11.2014




11.11.2014


Nemdatine


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


EU/1/13/824


13.11.2014




11.11.2014


Pioglitazone Actavis


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


EU/1/12/755


13.11.2014




13.11.2014


Neulasta


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


EU/1/02/227


17.11.2014




13.11.2014


NovoMix


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


EU/1/00/142


17.11.2014




13.11.2014


Ribavirin Teva


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


EU/1/09/509


17.11.2014




13.11.2014


Ribavirin Teva Pharma BV


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


EU/1/09/527


17.11.2014




13.11.2014


Trisenox


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


EU/1/02/204


17.11.2014




13.11.2014


Tysabri


Biogen Idec Limited
Innovation House, 70 Norden Road, Maidenhead, Berkshire SL6 4AY, United Kingdom


EU/1/06/346


17.11.2014




17.11.2014


Avastin


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


EU/1/04/300


19.11.2014




17.11.2014


Fendrix


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


EU/1/04/299


19.11.2014




17.11.2014


Kivexa


ViiV Healthcare UK Limited
980 Great West Road, Brentford, Middlesex TW8 9GS, United Kingdom


EU/1/04/298


19.11.2014




17.11.2014


Lamivudine Teva Pharma B.V.


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


EU/1/09/596


20.11.2014




17.11.2014


Revatio


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


EU/1/05/318


19.11.2014




17.11.2014


Tepadina


ADIENNE S.r.l.
Via Galileo Galilei 19, 20867 Caponago (MB), Italia


EU/1/10/622


19.11.2014




17.11.2014


Tygacil


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


EU/1/06/336


19.11.2014




17.11.2014


Zometa


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


EU/1/01/176


19.11.2014




19.11.2014


Aldurazyme


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


EU/1/03/253


20.11.2014




19.11.2014


AUBAGIO


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


EU/1/13/838


21.11.2014




19.11.2014


Betmiga


Astellas Pharma Europe B.V.
Sylviusweg 62, NL-2333 BE Leiden, Nederland


EU/1/12/809


21.11.2014




19.11.2014


Bretaris Genuair


Almirall, S.A.
Ronda General Mitre, 151, E-08022 Barcelona, España


EU/1/12/781


21.11.2014




19.11.2014


DuoCover


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


EU/1/10/623


21.11.2014




19.11.2014


DuoPlavin


Sanofi Clir SNC
54 rue La Boétie, F-75008 Paris, France


EU/1/10/619


21.11.2014




19.11.2014


Eklira Genuair


Almirall, S.A.
Ronda General Mitre, 151, E-08022 Barcelona, España


EU/1/12/778


21.11.2014




19.11.2014


Evoltra


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


EU/1/06/334


21.11.2014




19.11.2014


Humira


AbbVie Ltd
Maidenhead, SL6 4XE, United Kingdom


EU/1/03/256


21.11.2014




19.11.2014


Imnovid


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


EU/1/13/850


21.11.2014




19.11.2014


Kalydeco


Vertex Pharmaceuticals (U.K.) Limited
Cardinal Point, Park Road, Rickmansworth, Herts WD3 1RE, United Kingdom


EU/1/12/782


21.11.2014




19.11.2014


Leflunomide Winthrop


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


EU/1/09/604


21.11.2014




19.11.2014


Lojuxta


Aegerion Pharmaceuticals Limited
Lakeside House, 1 Furzeground Way, Stockley Park East, Uxbridge UB11 1BD, United Kingdom


EU/1/13/851


21.11.2014




19.11.2014


Neupro


UCB Manufacturing Ireland Ltd
Shannon Industrial Estate, Co, Clare, Ireland


EU/1/05/331


21.11.2014




19.11.2014


Renagel


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


EU/1/99/123


21.11.2014




19.11.2014


Signifor


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


EU/1/12/753


21.11.2014




19.11.2014


Temozolomide HEXAL


Hexal AG
Industriestrasse 25, D-83607 Holzkirchen, Deutschland


EU/1/10/616


21.11.2014




19.11.2014


Temozolomide Sandoz


Sandoz Pharmaceuticals GmbH
Raiffeisenstraße 11, D-83607 Holzkirchen, Deutschland


EU/1/10/617


21.11.2014




19.11.2014


Thymanax


Servier (Ireland) Industries Limited
Gorey Road, Arklow, Co. Wicklow, Ireland


EU/1/08/498


21.11.2014




19.11.2014


Valdoxan


Les Laboratoires Servier
50 rue Carnot, F-92284 Suresnes CEDEX, France


EU/1/08/499


21.11.2014




19.11.2014


Xaluprine


Nova Laboratories Limited
Martin House, Gloucester Crescent, Wigston Leicester, LE18 4YL, United Kingdom


EU/1/11/727


21.11.2014




19.11.2014


ZALTRAP


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


EU/1/12/814


21.11.2014




21.11.2014


Capecitabine Teva


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


EU/1/12/761


25.11.2014




21.11.2014


Cervarix


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


EU/1/07/419


25.11.2014




21.11.2014


Docetaxel Teva


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


EU/1/09/611


25.11.2014




21.11.2014


Firmagon


Ferring Pharmaceuticals A/S
Kay Fiskers Plads 11, DK-2300 København S, Danmark


EU/1/08/504


25.11.2014




21.11.2014


Leganto


UCB Manufacturing Ireland Ltd
Shannon Industrial Estate, Co, Clare, Ireland


EU/1/11/695


25.11.2014




21.11.2014


Nexavar


Bayer Pharma AG
D-13342 Berlin, Deutschland


EU/1/06/342


25.11.2014




21.11.2014


Repaglinide Teva


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


EU/1/09/530


25.11.2014




21.11.2014


Stelara


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


EU/1/08/494


25.11.2014




21.11.2014


Tafinlar


GlaxoSmithKline Trading Services Limited
Currabinny, Carrigaline, County Cork, Ireland


EU/1/13/865


25.11.2014




28.11.2014


Brinavess


Cardiome UK Limited
Lakeside House, 1 Furzeground Way, Stockley Park, Uxbridge, Middlesex, UB11 1BD, United Kingdom


EU/1/10/645


2.12.2014




28.11.2014


Cetrotide


Merck Serono Europe Limited
56, Marsh Wall, London E14 9TP, United Kingdom


EU/1/99/100


2.12.2014




28.11.2014


Firdapse


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


EU/1/09/601


2.12.2014




28.11.2014


Topotecan Teva


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


EU/1/09/552


2.12.2014




28.11.2014


Xtandi


Astellas Pharma Europe B.V.
Sylviusweg 62, NL-2333 BE Leiden, Nederland


EU/1/13/846


2.12.2014




—   Suspension of a marketing authorisation (Article 20 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




19.11.2014


MACI


Aastrom Biosciences DK ApS
Oliefabriksvej 45, 2770 Kastrup, Danmark


EU/1/13/847


24.11.2014




—   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 authorization


Number of the entry in the Community Register


Pharmaceutical form


ATC code (Anatomical Therapeutic Chemical Code)


Date of notification




7.11.2014


Porcilis PCV M Hyo


Porcine circovirus and Mycoplasma hyopneumoniae vaccine (inactivated)


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


EU/2/14/175


Emulsion for injection


QI09AL


11.11.2014




—   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 authorization


Number of the entry in the Community Register


Date of notification




7.11.2014


Zolvix


Novartis Healthcare A/S
Edvard Thomsens Vej 14, DK-2300 København S, Danmark


EU/2/09/101


11.11.2014




7.11.2014


Zulvac 8 Bovis


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


EU/2/09/105


12.11.2014




7.11.2014


Zulvac 8 Ovis


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


EU/2/09/104


12.11.2014




28.11.2014


ProZinc


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


EU/2/13/152


2.12.2014




28.11.2014


Semintra


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


EU/2/12/146


2.12.2014




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.

(2)  OJ L 136, 30.4.2004, p. 1.