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29.12.2017 |
EN |
Official Journal of the European Union |
C 447/1 |
Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 November 2017 to 30 November 2017
(Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council (1))
(2017/C 447/01)
— 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 |
|
10.11.2017 |
Cyltezo |
adalimumab |
Boehringer Ingelheim International GmbH Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland |
EU/1/17/1240 |
Solution for injection |
L04AB04 |
14.11.2017 |
|
10.11.2017 |
Miglustat Gen.Orph |
Miglustat |
Gen.Orph 100 rue Louis Blanc, TSA/Bâtiment Copenhague, 60160 Montataire, France |
EU/1/17/1232 |
Capsule, hard |
A16AX06 |
14.11.2017 |
|
10.11.2017 |
Nyxoid |
naloxone |
Mundipharma Corporation Limited Cambridge Science Park, Milton Road, Cambridge CB4 0AB, United Kingdom |
EU/1/17/1238 |
Nasal spray, solution |
V03AB15 |
14.11.2017 |
|
10.11.2017 |
Ritonavir Mylan |
ritonavir |
Mylan S.A.S. 117 allée des Parcs, 69800 Saint Priest, France |
EU/1/17/1242 |
Film-coated tablet |
J05AE03 |
14.11.2017 |
|
10.11.2017 |
TOOKAD |
padeliporfin |
Steba Biotech S.A 7 Place du Théâtre, 2613 Luxembourg, Luxembourg |
EU/1/17/1228 |
Powder for solution for injection |
L01XD07 |
14.11.2017 |
|
10.11.2017 |
Tremfya |
Guselkumab |
Janssen-Cilag International NV Turnhoutseweg 30, 2340 Beerse, België |
EU/1/17/1234 |
Solution for injection |
L04AC |
14.11.2017 |
|
10.11.2017 |
VeraSeal |
human fibrinogen / human thrombin |
Instituto Grifols, S.A. Can Guasch 2, Parets del Vallès, 08150 Barcelona, Espaňa |
EU/1/17/1239 |
Solutions for sealant |
B02BC |
14.11.2017 |
|
10.11.2017 |
Zubsolv |
buprenorphine / naloxone |
Mundipharma Corporation Limited Cambridge Science Park, Milton Road, Cambridge CB4 0AB, United Kingdom |
EU/1/17/1233 |
Sublingual tablet |
N07BC51 |
14.11.2017 |
|
15.11.2017 |
Elebrato Ellipta |
fluticasone furoate/umeclidinium/vilanterol |
GlaxoSmithKline Trading Services Limited Currabinny, Carrigaline, County Cork, Ireland |
EU/1/17/1237 |
Inhalation powder, pre-dispensed |
Pending |
17.11.2017 |
|
15.11.2017 |
Imatinib Teva B.V. |
imatinib |
Teva B.V. Swensweg 5, 2031 GA Haarlem, Nederland |
EU/1/17/1243 |
Capsule, hard Film-coated tablet |
L01XE01 |
17.11.2017 |
|
15.11.2017 |
Ontruzant |
trastuzumab |
Samsung Bioepis UK Limited 5th floor, Profile West, 950 Great West Road, Brentford, Middlesex TW8 9ES, United Kingdom |
EU/1/17/1241 |
Powder for concentrate for solution for infusion |
L01XC03 |
17.11.2017 |
|
15.11.2017 |
Trelegy Ellipta |
fluticasone furoate/umeclidinium/vilanterol |
GlaxoSmithKline Trading Services Limited Currabinny, Carrigaline, County Cork, Ireland |
EU/1/17/1236 |
Inhalation powder, pre-dispensed |
Pending |
17.11.2017 |
|
16.11.2017 |
Zejula |
niraparib |
TESARO UK LIMITED 55 Baker Street, London W1U 7EU, United Kingdom |
EU/1/17/1235 |
Capsule, hard |
L01XX54 |
20.11.2017 |
— Issuing of a marketing authorisation (Article 13 of Regulation (EC) No 726/2004 of the European Parliament and of the Council): Rejected
|
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 |
|
16.11.2017 |
Adlumiz |
Helsinn Birex Pharmaceuticals Ltd Damastown, Mulhuddart, Dublin 15, Ireland |
— |
20.11.2017 |
— 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 |
|
10.11.2017 |
ADCETRIS |
Takeda Pharma A/S Dybendal Alle 10, 2630 Taastrup, Danmark |
EU/1/12/794 |
14.11.2017 |
|
10.11.2017 |
APTIVUS |
Boehringer Ingelheim International GmbH Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland |
EU/1/05/315 |
14.11.2017 |
|
10.11.2017 |
Benlysta |
Glaxo Group Ltd 980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom |
EU/1/11/700 |
16.11.2017 |
|
10.11.2017 |
BYDUREON |
AstraZeneca AB 151 85 Södertälje, Sverige |
EU/1/11/696 |
14.11.2017 |
|
10.11.2017 |
ellaOne |
Laboratoire HRA Pharma 15 rue Béranger, 75003 Paris, France |
EU/1/09/522 |
14.11.2017 |
|
10.11.2017 |
Emtricitabine /Tenofovir disoproxil Krka d.d. |
Krka d. d., Novo Mesto Šmarješka cesta 6, 8501 Novo mesto, Slovenija |
EU/1/17/1182 |
14.11.2017 |
|
10.11.2017 |
Exjade |
Novartis Europharm Limited Frimley Business Park, Camberley GU16 7SR, United Kingdom |
EU/1/06/356 |
14.11.2017 |
|
10.11.2017 |
Exviera |
AbbVie Ltd Abbvie House, Vanwall Business Park, Vanwall Road, Maidenhead, Berkshire SL6 4UB, United Kingdom |
EU/1/14/983 |
14.11.2017 |
|
10.11.2017 |
Faslodex |
AstraZeneca UK Limited Charter Way, Macclesfield, Cheshire, SK10 2NA, United Kingdom |
EU/1/03/269 |
14.11.2017 |
|
10.11.2017 |
Glubrava |
Takeda Pharma A/S Dybendal Alle 10, 2630 Taastrup, Danmark |
EU/1/07/421 |
14.11.2017 |
|
10.11.2017 |
Humira |
AbbVie Ltd Abbvie House, Vanwall Business Park, Vanwall Road, Maidenhead, Berkshire SL6 4UB, United Kingdom |
EU/1/03/256 |
14.11.2017 |
|
10.11.2017 |
Iblias |
Bayer AG D-51368 Leverkusen, Deutschland |
EU/1/15/1077 |
14.11.2017 |
|
10.11.2017 |
Kolbam |
Retrophin Europe Limited Palmerstown House, Fenian Street, Dublin 2, Ireland |
EU/1/13/895 |
14.11.2017 |
|
10.11.2017 |
Kovaltry |
Bayer AG D-51368 Leverkusen, Deutschland |
EU/1/15/1076 |
14.11.2017 |
|
10.11.2017 |
Mepact |
Takeda France SAS Immeuble Pacific, 11-13 cours Valmy, 92800 Puteaux, France |
EU/1/08/502 |
14.11.2017 |
|
10.11.2017 |
NexoBrid |
MediWound Germany GmbH Eisenstraße 5, 65428 Ruesselsheim, Deutschland |
EU/1/12/803 |
14.11.2017 |
|
10.11.2017 |
Ovitrelle |
Merck Serono Europe Limited 56, Marsh Wall, London E14 9TP, United Kingdom |
EU/1/00/165 |
15.11.2017 |
|
10.11.2017 |
Pegasys |
Roche Registration Limited 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom |
EU/1/02/221 |
14.11.2017 |
|
10.11.2017 |
Plegridy |
Biogen Idec Limited Innovation House, 70 Norden Road, Maidenhead, Berkshire SL6 4AY, United Kingdom |
EU/1/14/934 |
14.11.2017 |
|
10.11.2017 |
Revatio |
Pfizer Limited Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom |
EU/1/05/318 |
14.11.2017 |
|
10.11.2017 |
Selincro |
H. Lundbeck A/S Ottiliavej 9, 2500 Valby, Danmark |
EU/1/12/815 |
14.11.2017 |
|
10.11.2017 |
Tandemact |
Takeda Pharma A/S Dybendal Alle 10, 2630 Taastrup, Danmark |
EU/1/06/366 |
14.11.2017 |
|
10.11.2017 |
Teysuno |
Nordic Group B.V. Siriusdreef 22, 2132 WT Hoofddorp, Nederland |
EU/1/11/669 |
14.11.2017 |
|
10.11.2017 |
Valdoxan |
Les Laboratoires Servier 50 rue Carnot, 92284 Suresnes CEDEX, France |
EU/1/08/499 |
14.11.2017 |
|
15.11.2017 |
Aripiprazole Accord |
Accord Healthcare Limited Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF, United Kingdom |
EU/1/15/1045 |
17.11.2017 |
|
15.11.2017 |
Bortezomib SUN |
Sun Pharmaceutical Industries Europe BV Polarisavenue 87, 2132 JH Hoofddorp, Nederland |
EU/1/16/1102 |
17.11.2017 |
|
15.11.2017 |
Emtricitabine/Tenofovir disoproxil Krka |
Krka d. d., Novo Mesto Šmarješka cesta 6, 8501 Novo mesto, Slovenija |
EU/1/16/1151 |
17.11.2017 |
|
15.11.2017 |
Imvanex |
Bavarian Nordic A/S Hejreskovvej 10a, 3490 Kvistgaard, Danmark |
EU/1/13/855 |
17.11.2017 |
|
15.11.2017 |
Kyprolis |
Amgen Europe B.V. Minervum 7061, 4817 ZK Breda, Nederland |
EU/1/15/1060 |
17.11.2017 |
|
15.11.2017 |
Lemtrada |
Genzyme Therapeutics Ltd 4620 Kingsgate, Cascade Way, Oxford Business Park South, Oxford OX4 2SU, United Kingdom |
EU/1/13/869 |
17.11.2017 |
|
15.11.2017 |
NovoEight |
Novo Nordisk A/S Novo Allé, 2880 Bagsvaerd, Danmark |
EU/1/13/888 |
17.11.2017 |
|
15.11.2017 |
Ozurdex |
Allergan Pharmaceuticals Ireland Castlebar Road, Westport, County Mayo, Ireland |
EU/1/10/638 |
20.11.2017 |
|
15.11.2017 |
ReFacto AF |
Pfizer Limited Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom |
EU/1/99/103 |
17.11.2017 |
|
15.11.2017 |
Savene |
Clinigen Healthcare Limited Pitcairn House, Crown Square, First Avenue, Burton-on-Trent, Staffordshire DE14 2WW, United Kingdom |
EU/1/06/350 |
17.11.2017 |
|
15.11.2017 |
Saxenda |
Novo Nordisk A/S Novo Allé, 2880 Bagsvaerd, Danmark |
EU/1/15/992 |
17.11.2017 |
|
15.11.2017 |
Tasigna |
Novartis Europharm Limited Frimley Business Park, Camberley GU16 7SR, United Kingdom |
EU/1/07/422 |
17.11.2017 |
|
15.11.2017 |
Viekirax |
AbbVie Ltd Abbvie House, Vanwall Business Park, Vanwall Road, Maidenhead, Berkshire SL6 4UB, United Kingdom |
EU/1/14/982 |
17.11.2017 |
|
15.11.2017 |
Voncento |
CSL Behring GmbH Emil-von-Behring-Straße 76, 35041 Marburg, Deutschland |
EU/1/13/857 |
17.11.2017 |
|
15.11.2017 |
Zytiga |
Janssen-Cilag International NV Turnhoutseweg 30, 2340 Beerse, België |
EU/1/11/714 |
17.11.2017 |
|
16.11.2017 |
ATryn |
Laboratoire français du Fractionnement et des Biotechnologies 3 Avenue des Tropiques, ZA de Courtaboeuf, 91940 Les Ulis, France |
EU/1/06/355 |
20.11.2017 |
|
16.11.2017 |
Cubicin |
Merck Sharp & Dohme Limited Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom |
EU/1/05/328 |
20.11.2017 |
|
16.11.2017 |
Docetaxel Winthrop |
Aventis Pharma S.A. 20 avenue Raymond Aron, 92165 Antony CEDEX, France |
EU/1/07/384 |
20.11.2017 |
|
16.11.2017 |
Elocta |
Swedish Orphan Biovitrum AB (publ) 112 76 Stockholm, Sverige |
EU/1/15/1046 |
20.11.2017 |
|
16.11.2017 |
Helixate NexGen |
Bayer AG D-51368 Leverkusen, Deutschland |
EU/1/00/144 |
20.11.2017 |
|
16.11.2017 |
KOGENATE Bayer |
Bayer AG D-51368 Leverkusen, Deutschland |
EU/1/00/143 |
20.11.2017 |
|
16.11.2017 |
Levemir |
Novo Nordisk A/S Novo Allé, 2880 Bagsvaerd, Danmark |
EU/1/04/278 |
20.11.2017 |
|
16.11.2017 |
Levetiracetam Accord |
Accord Healthcare Limited Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF, United Kingdom |
EU/1/11/712 |
20.11.2017 |
|
16.11.2017 |
Taxotere |
Aventis Pharma S.A. 20 avenue Raymond Aron, 92165 Antony CEDEX, France |
EU/1/95/002 |
20.11.2017 |
|
16.11.2017 |
Zydelig |
Gilead Sciences International Limited Cambridge CB21 6GT, United Kingdom |
EU/1/14/938 |
20.11.2017 |
|
24.11.2017 |
Advate |
Baxter AG Industriestraße 67, 1221 Wien, Österreich |
EU/1/03/271 |
28.11.2017 |
|
24.11.2017 |
Nuwiq |
Octapharma AB Lars Forssells gata 23, 112 75 Stockholm, Sverige |
EU/1/14/936 |
28.11.2017 |
|
28.11.2017 |
Entacapone Orion |
Orion Corporation Orionintie 1, 02200 Espoo, Suomi |
EU/1/11/708 |
30.11.2017 |
|
28.11.2017 |
Prepandrix |
GlaxoSmithKline Biologicals S.A. rue de l'Institut 89, 1330 Rixensart, Belgique |
EU/1/08/453 |
30.11.2017 |
|
28.11.2017 |
Privigen |
CSL Behring GmbH Emil-von-Behring-Straße 76, 35041 Marburg, Deutschland |
EU/1/08/446 |
30.11.2017 |
|
30.11.2017 |
Zepatier |
Merck Sharp & Dohme Limited Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom |
EU/1/16/1119 |
4.12.2017 |
— Withdrawal of a marketing authorisation (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 authorisation |
Number of the entry in the Community Register |
Date of notification |
|
10.11.2017 |
Prevenar |
Pfizer Limited Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom |
EU/1/00/167 |
14.11.2017 |
|
15.11.2017 |
EVARREST |
Omrix Biopharmaceuticals N.V. Leonardo Da Vincilaan 15, 1831 Diegem, België |
EU/1/13/868 |
17.11.2017 |
— 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 authorisation |
Number of the entry in the Community Register |
Date of notification |
|
23.11.2017 |
Optimark |
Guerbet 15 rue des Vanesses, 93420, Villepinte, France |
EU/1/07/398 |
27.12.2017 |
— 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 |
|
6.11.2017 |
Nobivac LeuFel |
Feline leukaemia vaccine (inactivated) |
Virbac 1ère Avenue — 2065 m — L.I.D., 06516 Carros CEDEX, France |
EU/2/17/217 |
Suspension for injection |
QI06AA01 |
8.11.2017 |
|
21.11.2017 |
Bovilis Blue-8 |
Bluetongue virus vaccine (inactivated) serotype 8 |
Intervet International B.V. Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland |
EU/2/17/218 |
Suspension for injection |
QI02AA08 QI04AA02 |
23.11.2017 |
— 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 |
|
14.11.2017 |
SevoFlo |
Zoetis Belgium S.A. rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique |
EU/2/02/035 |
16.11.2017 |
|
15.11.2017 |
Contacera |
Zoetis Belgium S.A. rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique |
EU/2/12/144 |
16.11.2017 |
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21.11.2017 |
Circovac |
Ceva-Phylaxia Zrt. Szállás u. 5, 1107 Budapest, Magyarország |
EU/2/07/075 |
23.11.2017 |
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21.11.2017 |
Pexion |
Boehringer Ingelheim Vetmedica GmbH D-55216 Ingelheim am Rhein, Deutschland |
EU/2/12/147 |
23.11.2017 |
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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European Medicines Agency |
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30 Churchill Place |
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Canary Wharf |
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London E14 5EU |
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United Kingdom |
(1) OJ L 136, 30.4.2004, p. 1.