ISSN 1977-091X
Official Journal
of the European Union
C 266
English edition
Information and Notices
Volume 61
27 July 2018
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ISSN 1977-091X |
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Official Journal of the European Union |
C 266 |
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English edition |
Information and Notices |
Volume 61 |
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Contents |
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IV Notices |
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NOTICES FROM EUROPEAN UNION INSTITUTIONS, BODIES, OFFICES AND AGENCIES |
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European Commission |
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2018/C 266/01 |
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EN |
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IV Notices
NOTICES FROM EUROPEAN UNION INSTITUTIONS, BODIES, OFFICES AND AGENCIES
European Commission
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27.7.2018 |
EN |
Official Journal of the European Union |
C 266/1 |
Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 June 2018 to 30 June 2018
(Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council (1))
(2018/C 266/01)
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— |
Issuing of a marketing authorisation (Article 13 of Regulation (EC) No 726/2004 of the European Parliament and of the Council): Accepted |
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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 |
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18.6.2018 |
Blincyto |
blinatumomab |
Amgen Europe B.V. Minervum 7061, 4817 ZK Breda, Nederland |
EU/1/15/1047 |
Powder for concentrate for solution for infusion |
L01XC19 |
20.6.2018 |
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21.6.2018 |
Biktarvy |
bictegravir / emtricitabine / tenofovir alafenamide |
Gilead Sciences International Limited Cambridge CB21 6GT United Kingdom |
EU/1/18/1289 |
Film-coated tablet |
J05AR20 |
25.6.2018 |
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25.6.2018 |
Dzuveo |
sufentanil |
FGK Representative Service GmbH Heimeranstraße 35, 80339 München, Deutschland |
EU/1/18/1284 |
Sublingual tablet |
N01AH03 |
27.6.2018 |
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— |
Modification of a marketing authorisation (Article 13 of Regulation (EC) No 726/2004 of the European Parliament and of the Council): Accepted |
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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 |
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4.6.2018 |
Copalia |
Novartis Europharm Limited Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland |
EU/1/06/372 |
6.6.2018 |
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4.6.2018 |
Emtriva |
Gilead Sciences Ireland UC Carrigtohill, County Cork, T45 DP77, Ireland |
EU/1/03/261 |
6.6.2018 |
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4.6.2018 |
Iclusig |
Incyte Biosciences Distribution B.V. Paasheuvelweg 25, 1105 BP Amsterdam, Nederland |
EU/1/13/839 |
6.6.2018 |
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4.6.2018 |
Prolia |
Amgen Europe B.V. Minervum 7061, 4817 ZK Breda, Nederland |
EU/1/10/618 |
6.6.2018 |
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4.6.2018 |
Stocrin |
Merck Sharp & Dohme B.V. Waarderweg 39, 2031 BN Haarlem, Nederland |
EU/1/99/111 |
6.6.2018 |
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4.6.2018 |
Stribild |
Gilead Sciences Ireland UC Carrigtohill, County Cork, T45 DP77, Ireland |
EU/1/13/830 |
6.6.2018 |
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4.6.2018 |
Truvada |
Gilead Sciences Ireland UC Carrigtohill, County Cork, T45 DP77, Ireland |
EU/1/04/305 |
6.6.2018 |
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4.6.2018 |
Tybost |
Gilead Sciences Ireland UC Carrigtohill, County Cork, T45 DP77, Ireland |
EU/1/13/872 |
6.6.2018 |
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4.6.2018 |
Zinbryta |
Biogen Idec Limited Innovation House, 70 Norden Road, Maidenhead, Berkshire SL6 4AY, United Kingdom |
EU/1/16/1107 |
6.6.2018 |
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7.6.2018 |
ALPROLIX |
Swedish Orphan Biovitrum AB (publ) 112 76 Stockholm, Sverige |
EU/1/16/1098 |
11.6.2018 |
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7.6.2018 |
BeneFIX |
Pfizer Limited Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom |
EU/1/97/047 |
11.6.2018 |
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7.6.2018 |
Bexsero |
GlaxoSmithKline Vaccines S.r.l. Via Fiorentina, 1, 53100 Siena, Italia |
EU/1/12/812 |
11.6.2018 |
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7.6.2018 |
Cerdelga |
Genzyme Europe B.V. Gooimeer 10, 1411 DD Naarden, Nederland |
EU/1/14/974 |
11.6.2018 |
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7.6.2018 |
Cimzia |
UCB Pharma S.A. Allée de la Recherche 60, 1070 Bruxelles, Belgique/Researchdreef 60, 1070 Brussel, België |
EU/1/09/544 |
11.6.2018 |
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7.6.2018 |
Constella |
Allergan Pharmaceuticals International Limited Clonshaugh Business & Technology Park, Dublin 17, D17 E400, Ireland |
EU/1/12/801 |
11.6.2018 |
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7.6.2018 |
Dafiro |
Novartis Europharm Limited Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland |
EU/1/06/371 |
11.6.2018 |
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7.6.2018 |
Exforge HCT |
Novartis Europharm Limited Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland |
EU/1/09/569 |
11.6.2018 |
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7.6.2018 |
Genvoya |
Gilead Sciences Ireland UC Carrigtohill, County Cork, T45 DP77, Ireland |
EU/1/15/1061 |
11.6.2018 |
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7.6.2018 |
Harvoni |
Gilead Sciences Ireland UC Carrigtohill, County Cork, T45 DP77, Ireland |
EU/1/14/958 |
11.6.2018 |
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7.6.2018 |
Isentress |
Merck Sharp & Dohme B.V. Waarderweg 39, 2031 BN Haarlem, Nederland |
EU/1/07/436 |
11.6.2018 |
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7.6.2018 |
Pemetrexed Accord |
Accord Healthcare Limited Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF, United Kingdom |
EU/1/15/1071 |
11.6.2018 |
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7.6.2018 |
Pradaxa |
Boehringer Ingelheim International GmbH Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland |
EU/1/08/442 |
11.6.2018 |
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7.6.2018 |
Quinsair |
Chiesi Farmaceutici S.p.A. Via Palermo 26/A, 43122 Parma, Italia |
EU/1/14/973 |
11.6.2018 |
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7.6.2018 |
SomaKit TOC |
Advanced Accelerator Applications 20 rue Diesel, 01630 Saint-Genis-Pouilly, France |
EU/1/16/1141 |
11.6.2018 |
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7.6.2018 |
TAGRISSO |
AstraZeneca AB 151 85 Södertälje, Sverige |
EU/1/16/1086 |
11.6.2018 |
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7.6.2018 |
Uptravi |
Actelion Registration Ltd Chiswick Tower, 13th floor, 389 Chiswick High Road, London W4 4AL, United Kingdom |
EU/1/15/1083 |
11.6.2018 |
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7.6.2018 |
Viekirax |
AbbVie Deutschland GmbH & Co. KG Knollstrasse, 67061 Ludwigshafen, Deutschland |
EU/1/14/982 |
11.6.2018 |
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7.6.2018 |
Vosevi |
Gilead Sciences Ireland UC Carrigtohill, County Cork, T45 DP77, Ireland |
EU/1/17/1223 |
11.6.2018 |
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7.6.2018 |
Votubia |
Novartis Europharm Limited Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland |
EU/1/11/710 |
11.6.2018 |
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7.6.2018 |
Xultophy |
Novo Nordisk A/S Novo Allé, 2880 Bagsvaerd, Danmark |
EU/1/14/947 |
11.6.2018 |
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7.6.2018 |
Zydelig |
Gilead Sciences Ireland UC Carrigtohill, County Cork, T45 DP77, Ireland |
EU/1/14/938 |
11.6.2018 |
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7.6.2018 |
Zykadia |
Novartis Europharm Limited Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland |
EU/1/15/999 |
11.6.2018 |
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12.6.2018 |
Emtricitabine/Tenofovir disoproxil Mylan |
Mylan S.A.S. 117 allée des Parcs, 69800 Saint Priest, France |
EU/1/16/1133 |
14.6.2018 |
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12.6.2018 |
Fareston |
Orion Corporation Orionintie 1, 02200 Espoo, Suomi |
EU/1/96/004 |
14.6.2018 |
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12.6.2018 |
Incruse |
Glaxo Group Ltd 980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom |
EU/1/14/922 |
14.6.2018 |
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12.6.2018 |
Kuvan |
BioMarin International Limited Shanbally, Ringaskiddy, County Cork, Ireland |
EU/1/08/481 |
14.6.2018 |
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14.6.2018 |
Insuman |
Sanofi-Aventis Deutschland GmbH D-65926 Frankfurt am Main, Deutschland |
EU/1/97/030 |
19.6.2018 |
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14.6.2018 |
Iscover |
Sanofi-Aventis groupe 54 rue La Boétie, 75008 Paris, France |
EU/1/98/070 |
19.6.2018 |
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14.6.2018 |
SOLYMBIC |
Amgen Europe B.V. Minervum 7061, 4817 ZK Breda, Nederland |
EU/1/16/1163 |
19.6.2018 |
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15.6.2018 |
Aerinaze |
Merck Sharp & Dohme Limited Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom |
EU/1/07/399 |
19.6.2018 |
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15.6.2018 |
Lusduna |
Merck Sharp & Dohme B.V. Waarderweg 39, 2031 BN Haarlem, Nederland |
EU/1/16/1162 |
19.6.2018 |
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15.6.2018 |
Maviret |
AbbVie Deutschland GmbH & Co. KG Knollstrasse, 67061 Ludwigshafen, Deutschland |
EU/1/17/1213 |
19.6.2018 |
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15.6.2018 |
Neoclarityn |
Merck Sharp & Dohme Limited Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom |
EU/1/00/161 |
19.6.2018 |
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15.6.2018 |
Xyrem |
UCB Pharma S.A. Allée de la Recherche 60, 1070 Bruxelles, Belgique/Researchdreef 60, 1070 Brussel, België |
EU/1/05/312 |
19.6.2018 |
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15.6.2018 |
Zepatier |
Merck Sharp & Dohme B.V. Waarderweg 39, 2031 BN Haarlem, Nederland |
EU/1/16/1119 |
19.6.2018 |
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15.6.2018 |
Zerbaxa |
Merck Sharp & Dohme B.V. Waarderweg 39, 2031 BN Haarlem, Nederland |
EU/1/15/1032 |
19.6.2018 |
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15.6.2018 |
ZINPLAVA |
Merck Sharp & Dohme B.V. Waarderweg 39, 2031 BN Haarlem, Nederland |
EU/1/16/1156 |
19.6.2018 |
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21.6.2018 |
Inflectra |
Hospira UK Limited Horizon, Honey Lane, Hurley, Maidenhead SL6 6RJ, United Kingdom |
EU/1/13/854 |
25.6.2018 |
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21.6.2018 |
KEYTRUDA |
Merck Sharp & Dohme B.V. Waarderweg 39, 2031 BN Haarlem, Nederland |
EU/1/15/1024 |
25.6.2018 |
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21.6.2018 |
Leflunomide medac |
medac Gesellschaft für klinische Spezialpräparate mbH Theaterstraße 6, 22880 Wedel, Deutschland |
EU/1/10/637 |
25.6.2018 |
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21.6.2018 |
Panretin |
Eisai Limited European Knowledge Centre, Mosquito Way, Hatfield, Hertfordshire AL10 9SN, United Kingdom |
EU/1/00/149 |
25.6.2018 |
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21.6.2018 |
Remsima |
Celltrion Healthcare Hungary Kft. Váci út 1-3. WestEnd Office Building B torony, 1062 Budapest, Magyarország |
EU/1/13/853 |
25.6.2018 |
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21.6.2018 |
Rolufta |
GlaxoSmithKline Trading Services Limited Currabinny, Carrigaline, County Cork, Ireland |
EU/1/17/1174 |
25.6.2018 |
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21.6.2018 |
Targretin |
Eisai Limited European Knowledge Centre, Mosquito Way, Hatfield, Hertfordshire AL10 9SN, United Kingdom |
EU/1/01/178 |
25.6.2018 |
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21.6.2018 |
Xeljanz |
Pfizer Limited Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom |
EU/1/17/1178 |
25.6.2018 |
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21.6.2018 |
Xofigo |
Bayer AG D-51368 Leverkusen, Deutschland |
EU/1/13/873 |
25.6.2018 |
|
25.6.2018 |
Copalia HCT |
Novartis Europharm Limited Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland |
EU/1/09/575 |
27.6.2018 |
|
25.6.2018 |
Cubicin |
Merck Sharp & Dohme Limited Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom |
EU/1/05/328 |
27.6.2018 |
|
25.6.2018 |
Dafiro HCT |
Novartis Europharm Limited Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland |
EU/1/09/574 |
27.6.2018 |
|
25.6.2018 |
Darzalex |
Janssen-Cilag International NV Turnhoutseweg 30, 2340 Beerse, België |
EU/1/16/1101 |
27.6.2018 |
|
25.6.2018 |
Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan |
Mylan S.A.S. 117 allée des Parcs, 69800 Saint Priest, France |
EU/1/17/1222 |
27.6.2018 |
|
25.6.2018 |
Exforge |
Novartis Europharm Limited Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland |
EU/1/06/370 |
27.6.2018 |
|
25.6.2018 |
Glivec |
Novartis Europharm Limited Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland |
EU/1/01/198 |
27.6.2018 |
|
25.6.2018 |
Leflunomide Winthrop |
Sanofi-Aventis Deutschland GmbH D-65926 Frankfurt am Main, Deutschland |
EU/1/09/604 |
27.6.2018 |
|
25.6.2018 |
Nexium Control |
Pfizer Consumer Healthcare Limited Ramsgate Road, Sandwich, Kent, CT13 9NJ, United Kingdom |
EU/1/13/860 |
27.6.2018 |
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25.6.2018 |
Orbactiv |
The Medicines Company UK Ltd 115L Milton Park, Abingdon, Oxfordshire OX14 4SA, United Kingdom |
EU/1/15/989 |
27.6.2018 |
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25.6.2018 |
PANTOLOC Control |
Takeda GmbH Byk-Gulden-Straße 2, 78467 Konstanz, Deutschland |
EU/1/09/519 |
27.6.2018 |
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25.6.2018 |
pantoprazole |
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26.6.2018 |
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25.6.2018 |
Stivarga |
Bayer AG D-51368 Leverkusen, Deutschland |
EU/1/13/858 |
27.6.2018 |
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25.6.2018 |
Xeljanz |
Pfizer Limited Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom |
EU/1/17/1178 |
27.6.2018 |
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25.6.2018 |
Xgeva |
Amgen Europe B.V. Minervum 7061, 4817 ZK Breda, Nederland |
EU/1/11/703 |
27.6.2018 |
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25.6.2018 |
Yondelis |
Pharma Mar S.A. Avenida de los Reyes 1, Polígono Industrial La Mina, 28770 Colmenar Viejo, Madrid, España |
EU/1/07/417 |
27.6.2018 |
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29.6.2018 |
Aerius |
Merck Sharp & Dohme B.V. Waarderweg 39, 2031 BN Haarlem, Nederland |
EU/1/00/160 |
3.7.2018 |
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29.6.2018 |
Azomyr |
Merck Sharp & Dohme B.V. Waarderweg 39, 2031 BN Haarlem, Nederland |
EU/1/00/157 |
3.7.2018 |
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29.6.2018 |
Edistride |
AstraZeneca AB 151 85 Södertälje, Sverige |
EU/1/15/1052 |
3.7.2018 |
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29.6.2018 |
Efficib |
Merck Sharp & Dohme B.V. Waarderweg 39, 2031 BN Haarlem, Nederland |
EU/1/08/457 |
3.7.2018 |
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29.6.2018 |
Granupas |
Eurocept International B.V. Trapgans 5, 1244 RL Ankeveen, Nederland |
EU/1/13/896 |
3.7.2018 |
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29.6.2018 |
IMBRUVICA |
Janssen-Cilag International NV Turnhoutseweg 30, 2340 Beerse, België |
EU/1/14/945 |
3.7.2018 |
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29.6.2018 |
Janumet |
Merck Sharp & Dohme B.V. Waarderweg 39, 2031 BN Haarlem, Nederland |
EU/1/08/455 |
3.7.2018 |
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29.6.2018 |
Jinarc |
Otsuka Pharmaceutical Europe Ltd Gallions, Wexham Springs, Framewood Road, Wexham, SL3 6PJ, United Kingdom |
EU/1/15/1000 |
3.7.2018 |
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29.6.2018 |
Olumiant |
Eli Lilly Nederland B.V. Papendorpseweg 83, 3528 BJ Utrecht, Nederland |
EU/1/16/1170 |
3.7.2018 |
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29.6.2018 |
Orgalutran |
Merck Sharp & Dohme Limited Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom |
EU/1/00/130 |
3.7.2018 |
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29.6.2018 |
Revlimid |
Celgene Europe B.V. Winthonlaan 6N, 3526 KV Utrecht, Nederland |
EU/1/07/391 |
3.7.2018 |
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29.6.2018 |
Rezolsta |
Janssen-Cilag International NV Turnhoutseweg 30, 2340 Beerse, België |
EU/1/14/967 |
3.7.2018 |
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29.6.2018 |
Ristfor |
Merck Sharp & Dohme B.V. Waarderweg 39, 2031 BN Haarlem, Nederland |
EU/1/10/620 |
3.7.2018 |
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29.6.2018 |
Samsca |
Otsuka Pharmaceutical Europe Ltd Gallions, Wexham Springs, Framewood Road, Wexham, SL3 6PJ, United Kingdom |
EU/1/09/539 |
3.7.2018 |
|
29.6.2018 |
Spectrila |
medac Gesellschaft für klinische Spezialpräparate mbH Theaterstraße 6, 22880 Wedel, Deutschland |
EU/1/15/1072 |
3.7.2018 |
|
29.6.2018 |
Temozolomide Accord |
Accord Healthcare Limited Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF, United Kingdom |
EU/1/10/615 |
3.7.2018 |
|
29.6.2018 |
Velmetia |
Merck Sharp & Dohme B.V. Waarderweg 39, 2031 BN Haarlem, Nederland |
EU/1/08/456 |
3.7.2018 |
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— |
Withdrawal of a marketing authorisation (Article 13 of Regulation (EC) No 726/2004 of the European Parliament and of the Council) |
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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 |
|
15.6.2018 |
SOLYMBIC |
Amgen Europe B.V. Minervum 7061, 4817 ZK Breda, Nederland |
EU/1/16/1163 |
19.6.2018 |
|
21.6.2018 |
Angiox |
The Medicines Company UK Ltd 115L Milton Park, Abingdon, Oxfordshire OX14 4SA, United Kingdom |
EU/1/04/289 |
25.6.2018 |
|
29.6.2018 |
Victrelis |
Merck Sharp & Dohme Limited Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom |
EU/1/11/704 |
3.7.2018 |
|
— |
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 |
|
14.6.2018 |
Dany's BienenWohl |
oxalic acid dihydrate |
Dany Bienenwohl GmbH Geyerspergerstraße 27, 80689 München, Deutschland |
EU/2/18/225 |
Powder and solution for bee-hive dispersion |
QP53AG03 |
19.6.2018 |
|
— |
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 |
|
4.6.2018 |
Activyl |
Intervet International B.V. Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland |
EU/2/10/118 |
6.6.2018 |
|
4.6.2018 |
Cepedex |
CP-Pharma Handelsgesellschaft mbH Ostlandring 13, 31303 Burgdorf, Deutschland |
EU/2/16/200 |
6.6.2018 |
|
11.6.2018 |
Veraflox |
Bayer Animal Health GmbH D-51368 Leverkusen, Deutschland |
EU/2/10/107 |
13.6.2018 |
|
14.6.2018 |
Aftovaxpur Doe |
Merial 29 avenue Tony Garnier, 69007 Lyon, France |
EU/2/13/153 |
19.6.2018 |
|
18.6.2018 |
Rhiniseng |
Laboratorios Hipra, S.A. Avda. La Selva, 135, 17170 Amer (Girona), España |
EU/2/10/109 |
20.6.2018 |
|
27.6.2018 |
BROADLINE |
Merial 29 avenue Tony Garnier, 69007 Lyon, France |
EU/2/13/157 |
29.6.2018 |
|
27.6.2018 |
Evalon |
Laboratorios Hipra, S.A. Avda. La Selva, 135, 17170 Amer (Girona), España |
EU/2/16/194 |
29.6.2018 |
|
27.6.2018 |
Porcilis PCV M Hyo |
Intervet International B.V. Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland |
EU/2/14/175 |
29.6.2018 |
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 |