Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 September 2014 to 30 September 2014 (Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council)
Date: 2014-10-31
Institutions: European Commission
Subjects: drug surveillance, market approval, marketing standard, medicinal product








C_2014386EN.01000301.xml










31.10.2014   


EN


Official Journal of the European Union


C 386/3





Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 September 2014 to 30 September 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 386/02
—   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




1.9.2014


Clopidogrel/Acetylsalicylic acid Teva


clopidogrel/acetylsalicylic acid


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


EU/1/14/942


Film-coated tablet


B01AC30


3.9.2014




1.9.2014


Triumeq


dolutegravir/abacavir/lamivudine


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


EU/1/14/940


Film-coated tablet


J05AR13


3.9.2014




9.9.2014


ABASRIA


Insulin glargine


Eli Lilly Regional Operations GmbH.
Kölblgasse 8-10, 1030 Wien, Österreich


EU/1/14/944


Solution for injection


A10AE04


11.9.2014




18.9.2014


Accofil


Filgrastim


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


EU/1/14/946


Solution for injection or infusion


L03AA02


22.9.2014




18.9.2014


Xultophy


insulin degludec/liraglutide


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


EU/1/14/947


Solution for injection in pre-filled pen


Pending


22.9.2014




18.9.2014


Zydelig


idelalisib


Gilead Sciences International Limited
Cambridge CB21 6GT, United Kingdom


EU/1/14/938


Film-coated tablet


L01XX47


19.9.2014




22.9.2014


Busulfan Fresenius Kabi


busulfan


Fresenius Kabi Oncology Plc.
Lion Court, Farnham Road, Bordon, Hampshire GU35 0NF, United Kingdom


EU/1/14/951


Concentrate for solution for infusion


L01AB01


24.9.2014




—   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




1.9.2014


Daliresp


Takeda GmbH
Byk-Gulden-Straße 2, D-78467 Konstanz, Deutschland


EU/1/11/668


3.9.2014




1.9.2014


Daxas


Takeda GmbH
Byk-Gulden-Straße 2, D-78467 Konstanz, Deutschland


EU/1/10/636


3.9.2014




1.9.2014


Desloratadine ratiopharm


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


EU/1/11/746


4.9.2014




1.9.2014


DuoCover


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


EU/1/10/623


3.9.2014




1.9.2014


EDURANT


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


EU/1/11/736


3.9.2014




1.9.2014


Humira


AbbVie Ltd
Maidenhead, SL6 4XE, United Kingdom


EU/1/03/256


3.9.2014




1.9.2014


Imatinib Accord


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


EU/1/13/845


3.9.2014




1.9.2014


Libertek


Takeda GmbH
Byk-Gulden-Straße 2, D-78467 Konstanz, Deutschland


EU/1/11/666


3.9.2014




1.9.2014


Macugen


PharmaSwiss Česká republika s.r.o.
Jankovcova 1569/2c 17000 Praha 7 Czech Republic


EU/1/05/325


3.9.2014




1.9.2014


PHEBURANE


Lucane Pharma
172 rue de Charonne, 75011 Paris, France


EU/1/13/822


3.9.2014




1.9.2014


Pixuvri


CTI Life Sciences Ltd
Highlands House, Basingstoke Road, Spencers Wood, Reading, Berkshire RG7 1NT, United Kingdom


EU/1/12/764


3.9.2014




1.9.2014


RoActemra


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


EU/1/08/492


3.9.2014




1.9.2014


Xgeva


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


EU/1/11/703


3.9.2014




1.9.2014


Zoely


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


EU/1/11/690


4.9.2014




4.9.2014


Actelsar HCT


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


EU/1/13/817


8.9.2014




4.9.2014


Aprovel


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


EU/1/97/046


8.9.2014




4.9.2014


CoAprovel


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


EU/1/98/086


8.9.2014




4.9.2014


Copalia


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


EU/1/06/372


8.9.2014




4.9.2014


Copalia HCT


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


EU/1/09/575


8.9.2014




4.9.2014


Dafiro


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


EU/1/06/371


8.9.2014




4.9.2014


Dafiro HCT


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


EU/1/09/574


8.9.2014




4.9.2014


Exforge


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


EU/1/06/370


8.9.2014




4.9.2014


Exforge HCT


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


EU/1/09/569


8.9.2014




4.9.2014


Exjade


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


EU/1/06/356


8.9.2014




4.9.2014


Extavia


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


EU/1/08/454


8.9.2014




4.9.2014


Ifirmacombi


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


EU/1/11/673


8.9.2014




4.9.2014


Ifirmasta


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


EU/1/08/480


8.9.2014




4.9.2014


Imprida


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


EU/1/06/373


8.9.2014




4.9.2014


Irbesartan HCT Zentiva


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


EU/1/06/377


8.9.2014




4.9.2014


Irbesartan/Hydrochlorothiazide Teva


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


EU/1/09/583


8.9.2014




4.9.2014


Irbesartan Teva


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


EU/1/09/576


8.9.2014




4.9.2014


Irbesartan Zentiva


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


EU/1/06/376


8.9.2014




4.9.2014


Karvea


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


EU/1/97/049


8.9.2014




4.9.2014


Karvezide


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


EU/1/98/085


8.9.2014




4.9.2014


Kinzalkomb


Bayer Pharma AG
D-13342 Berlin, Deutschland


EU/1/02/214


8.9.2014




4.9.2014


Kinzalmono


Bayer Pharma AG
D-13342 Berlin, Deutschland


EU/1/98/091


8.9.2014




4.9.2014


Lucentis


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


EU/1/06/374


8.9.2014




4.9.2014


Micardis


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


EU/1/98/090


8.9.2014




4.9.2014


MicardisPlus


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


EU/1/02/213


8.9.2014




4.9.2014


Pritor


Bayer Pharma AG
D-13342 Berlin, Deutschland


EU/1/98/089


8.9.2014




4.9.2014


PritorPlus


Bayer Pharma AG
D-13342 Berlin, Deutschland


EU/1/02/215


8.9.2014




4.9.2014


Rasilez


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


EU/1/07/405


8.9.2014




4.9.2014


Rasilez HCT


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


EU/1/08/491


8.9.2014




4.9.2014


Sabervel


Pharmathen S.A.
6 Dervenakion, 15351 Pallini Attiki, Ελλάδα


EU/1/12/765


8.9.2014




4.9.2014


Sildenafil Actavis


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


EU/1/09/595


8.9.2014




4.9.2014


Simulect


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


EU/1/98/084


8.9.2014




4.9.2014


Telmisartan Actavis


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


EU/1/10/639


8.9.2014




4.9.2014


Telmisartan Teva


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


EU/1/09/610


8.9.2014




4.9.2014


Telmisartan Teva Pharma


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


EU/1/11/719


8.9.2014




4.9.2014


Tolucombi


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


EU/1/13/821


8.9.2014




4.9.2014


Tolura


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


EU/1/10/632


8.9.2014




4.9.2014


Twynsta


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


EU/1/10/648


8.9.2014




9.9.2014


Edarbi


Takeda Pharma A/S
Dybendal Alle 10, 2630 Taastrup, Danmark


EU/1/11/734


11.9.2014




9.9.2014


Ipreziv


Takeda Pharma A/S
Dybendal Alle 10, 2630 Taastrup, Danmark


EU/1/11/735


11.9.2014




9.9.2014


Lamivudine Teva


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


EU/1/09/566


12.9.2014




9.9.2014


Rasilamlo


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


EU/1/11/686


11.9.2014




9.9.2014


Sildenafil ratiopharm


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


EU/1/09/603


11.9.2014




9.9.2014


Sildenafil Teva


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


EU/1/09/584


12.9.2014




9.9.2014


Stribild


Gilead Sciences International Limited
Cambridge CB21 6GT, United Kingdom


EU/1/13/830


10.9.2014




11.9.2014


Caelyx


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


EU/1/96/011


15.9.2014




11.9.2014


Eporatio


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


EU/1/09/573


15.9.2014




11.9.2014


Insulin Human Winthrop


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


EU/1/06/368


16.9.2014




11.9.2014


Kolbam


ASK Pharmaceuticals GmbH
Heimeranstraße 35, D-80339 München, Deutschland


EU/1/13/895


15.9.2014




11.9.2014


Lamivudine Teva Pharma B.V.


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


EU/1/09/596


15.9.2014




11.9.2014


Relistor


TMC Pharma Services Ltd
Lodge Farm Barn, Elvetham Park Estate, Fleet Road, Hartley Wintney, Hampshire RG27 8AS, United Kingdom


EU/1/08/463


15.9.2014




16.9.2014


Aranesp


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


EU/1/01/185


19.9.2014




16.9.2014


Ovaleap


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


EU/1/13/871


18.9.2014




16.9.2014


Zutectra


Biotest Pharma GmbH
Landsteinerstrasse 5, D-63303 Dreieich, Deutschland


EU/1/09/600


18.9.2014




18.9.2014


Clopidogrel Apotex


Apotex Europe B.V.
Darwinweg 20, NL-2333 CR Leiden, Nederland


EU/1/09/568


22.9.2014




18.9.2014


Clopidogrel Zentiva


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


EU/1/08/465


22.9.2014




18.9.2014


DuoPlavin


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


EU/1/10/619


22.9.2014




18.9.2014


Hirobriz Breezhaler


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


EU/1/09/594


22.9.2014




18.9.2014


Iclusig


ARIAD Pharma Ltd
Riverbridge House, Guildford Road, Leatherhead, Surrey KT22 9AD, United Kingdom


EU/1/13/839


22.9.2014




18.9.2014


Ilaris


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


EU/1/09/564


22.9.2014




18.9.2014


JEVTANA


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


EU/1/11/676


22.9.2014




18.9.2014


Noxafil


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


EU/1/05/320


22.9.2014




18.9.2014


Onbrez Breezhaler


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


EU/1/09/593


22.9.2014




18.9.2014


Oslif Breezhaler


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


EU/1/09/586


22.9.2014




18.9.2014


Prevenar 13


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


EU/1/09/590


22.9.2014




18.9.2014


Prialt


Eisai Limited
European Knowledge Centre, Mosquito Way, Hatfield, Hertfordshire AL10 9SN, United Kingdom


EU/1/04/302


22.9.2014




18.9.2014


Rienso


Takeda Pharma A/S
PO Box 88, Langebjerg 1, DK-4000 Roskilde, Danmark


EU/1/12/774


22.9.2014




18.9.2014


Silodyx


Recordati Ireland Ltd
Raheens East, Ringaskiddy Co. Cork, Ireland


EU/1/09/607


22.9.2014




18.9.2014


Trajenta


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


EU/1/11/707


22.9.2014




18.9.2014


Urorec


Recordati Ireland Ltd
Raheens East, Ringaskiddy Co. Cork, Ireland


EU/1/09/608


22.9.2014




18.9.2014


Vantavo


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


EU/1/09/572


22.9.2014




22.9.2014


Mozobil


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


EU/1/09/537


24.9.2014




22.9.2014


Multaq


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


EU/1/09/591


24.9.2014




30.9.2014


Cinryze


ViroPharma SPRL-BVBA
rue Montoyer 47, 1000 Bruxelles, Belgique/Montoyerstraat 47, 1000 Brussel, België


EU/1/11/688


2.10.2014




30.9.2014


Humalog


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


EU/1/96/007


2.10.2014




30.9.2014


Infanrix hexa


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


EU/1/00/152


6.10.2014




30.9.2014


Inflectra


Hospira UK Limited
Queensway, Royal Leamington Spa, Warwickshire CV31 3RW, United Kingdom


EU/1/13/854


2.10.2014




30.9.2014


Januvia


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


EU/1/07/383


2.10.2014




30.9.2014


Revlimid


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


EU/1/07/391


2.10.2014




—   Withdrawal of a marketing authorization (Article 13 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




1.9.2014


Clopidogrel Qualimed


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


EU/1/09/557


3.9.2014




16.9.2014


Pioglitazone Krka


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


EU/1/11/723


18.9.2014




—   Issuing of a marketing authorization (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




4.9.2014


Nobilis IB Primo QX


Live avian infectious bronchitis virus, strain D388


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


EU/2/14/174


Lyophilisate and solvent for oculonasal suspension
Lyophilisate for suspension for spray


QI01AD07


8.9.2014




—   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




1.9.2014


Inflacam


Chanelle Pharmaceuticals Manufacturing Limited
Loughrea, Co. Galway, Ireland


EU/2/11/134


3.9.2014




1.9.2014


Suvaxyn Aujeszky 783 + O/W


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


EU/2/98/009


3.9.2014




9.9.2014


Aivlosin


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


EU/2/04/044


11.9.2014




9.9.2014


Fevaxyn Pentofel


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


EU/2/96/002


11.9.2014




9.9.2014


Pirsue


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


EU/2/00/027


11.9.2014




9.9.2014


Zulvac 1 Bovis


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


EU/2/11/130


11.9.2014




9.9.2014


Zulvac 1 Ovis


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


EU/2/11/131


11.9.2014




16.9.2014


Zulvac 1+8 Ovis


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


EU/2/11/120


18.9.2014




30.9.2014


Ingelvac CircoFLEX


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


EU/2/07/079


2.10.2014




30.9.2014


Meloxoral


Le Vet B.V.
Wilgenweg 7, NL-3421 TV Oudewater, Nederland


EU/2/10/111


2.10.2014




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, 30.4.04, p. 1.


(2)  OJ L 136, 30.4.04, p. 1.