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Document 52014XC1230(02)
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)
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)
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)
OJ C 467, 30.12.2014, p. 1–10
(BG, ES, CS, DA, DE, ET, EL, EN, FR, HR, IT, LV, LT, HU, MT, NL, PL, PT, RO, SK, SL, FI, SV)
|
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:
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The European Medicines Agency |
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30, Churchill Place, Canary Wharf |
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UK — LONDON E14 5EU |
(1) OJ L 136, 30.4.2004, p. 1.
(2) OJ L 136, 30.4.2004, p. 1.