ISSN 1977-091X
Official Journal
of the European Union
C 35
English edition
Information and Notices
Volume 59
29 January 2016
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ISSN 1977-091X |
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Official Journal of the European Union |
C 35 |
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English edition |
Information and Notices |
Volume 59 |
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Notice No |
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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2016/C 035/01 |
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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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29.1.2016 |
EN |
Official Journal of the European Union |
C 35/1 |
Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 December 2015 to 31 December 2015
(Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council (1))
(2016/C 035/01)
— 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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2.12.2015 |
Ciambra |
pemetrexed |
Menarini International Operations Luxembourg S.A. 1 avenue de la Gare, L-1611 Luxembourg, Grand-Duché de Luxembourg |
EU/1/15/1055 |
Powder for concentrate for solution for infusion |
L01BA04 |
4.12.2015 |
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2.12.2015 |
Nucala |
mepolizumab |
GlaxoSmithKline Trading Services Limited Currabinny, Carrigaline, County Cork, Ireland |
EU/1/15/1043 |
Powder for solution for injection |
Pending |
7.12.2015 |
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16.12.2015 |
Imlygic |
talimogene laherparepvec |
Amgen Europe B.V. Minervum 7061, NL-4817 ZK Breda, Nederland |
EU/1/15/1064 |
Solution for injection |
Pending |
18.12.2015 |
— Issuing of a marketing authorisation (Article 13 of Regulation (EC) No 726/2004 of the European Parliament and of the Council): Rejected
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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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21.12.2015 |
Heparesc |
Cytonet GmbH & Co. KG Albert-Ludwig-Grimm Straße 20, D-69469 Weinheim, Deutschland |
— |
23.12.2015 |
— 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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2.12.2015 |
Tadalafil Mylan |
Generics [UK] Limited Station Close, Potters Bar, Hertfordshire, EN6 1TL, United Kingdom |
EU/1/14/961 |
4.12.2015 |
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2.12.2015 |
Twinrix Adult |
GlaxoSmithKline Biologicals S.A. rue de l’Institut 89, 1330 Rixensart, Belgique |
EU/1/96/020 |
4.12.2015 |
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2.12.2015 |
Twinrix Paediatric |
GlaxoSmithKline Biologicals S.A. rue de l’Institut 89, 1330 Rixensart, Belgique |
EU/1/97/029 |
4.12.2015 |
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2.12.2015 |
Zyclara |
Meda AB Pipers väg 2A, SE-170 73 Solna, Sverige |
EU/1/12/783 |
4.12.2015 |
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9.12.2015 |
Abasaglar |
Eli Lilly Regional Operations GmbH. Kölblgasse 8-10, 1030 Wien, Österreich |
EU/1/14/944 |
11.12.2015 |
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9.12.2015 |
Voriconazole Accord |
Accord Healthcare Limited Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF, United Kingdom |
EU/1/13/835 |
11.12.2015 |
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10.12.2015 |
Accofil |
Accord Healthcare Limited Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF, United Kingdom |
EU/1/14/946 |
14.12.2015 |
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10.12.2015 |
Amyvid |
Eli Lilly Nederland B.V. Grootslag 1-5, NL-3991 RA Houten, Nederland |
EU/1/12/805 |
14.12.2015 |
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10.12.2015 |
Cervarix |
GlaxoSmithKline Biologicals S.A. rue de l’Institut 89, 1330 Rixensart, Belgique |
EU/1/07/419 |
14.12.2015 |
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10.12.2015 |
Efient |
DAIICHI SANKYO EUROPE GmbH Zielstattstrasse 48, D-81379 München, Deutschland |
EU/1/08/503 |
14.12.2015 |
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10.12.2015 |
Gardasil |
Sanofi Pasteur MSD SNC 162 avenue Jean Jaurès, 69007 Lyon, France |
EU/1/06/357 |
14.12.2015 |
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10.12.2015 |
Holoclar |
Chiesi Farmaceutici S.P.A. Via Palermo 26/A, 43122 Parma, Italia |
EU/1/14/987 |
14.12.2015 |
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10.12.2015 |
Ifirmasta |
Krka, d. d., Novo Mesto Šmarješka cesta 6, 8501 Novo mesto, Slovenija |
EU/1/08/480 |
14.12.2015 |
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10.12.2015 |
Remsima |
Celltrion Healthcare Hungary Kft. Árpád Fejedelem útja 26-28, H-1023 Budapest, Magyarország |
EU/1/13/853 |
14.12.2015 |
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10.12.2015 |
Silgard |
Merck Sharp & Dohme Limited Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom |
EU/1/06/358 |
14.12.2015 |
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10.12.2015 |
Starlix |
Novartis Europharm Limited Frimley Business Park, Camberley GU16 7SR, United Kingdom |
EU/1/01/174 |
14.12.2015 |
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10.12.2015 |
Synagis |
AbbVie Ltd Maidenhead, SL6 4UB, United Kingdom |
EU/1/99/117 |
14.12.2015 |
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10.12.2015 |
Vipidia |
Takeda Pharma A/S Dybendal Alle 10, 2630 Taastrup, Danmark |
EU/1/13/844 |
14.12.2015 |
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10.12.2015 |
Votubia |
Novartis Europharm Limited Frimley Business Park, Camberley GU16 7SR, United Kingdom |
EU/1/11/710 |
14.12.2015 |
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10.12.2015 |
Zoledronic acid Actavis |
Actavis Group PTC ehf. Reykjavíkurvegur 76-78, 220 Hafnarfjörður, Ísland |
EU/1/12/759 |
14.12.2015 |
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14.12.2015 |
Atripla |
Bristol-Myers Squibb and Gilead Sciences Limited IDA Business & Technology Park, Carrigtohill, Co. Cork, Ireland |
EU/1/07/430 |
16.12.2015 |
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14.12.2015 |
Envarsus |
Chiesi Farmaceutici S.P.A. Via Palermo 26/A, 43122 Parma, Italia |
EU/1/14/935 |
16.12.2015 |
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14.12.2015 |
Incruse |
Glaxo Group Ltd 980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom |
EU/1/14/922 |
16.12.2015 |
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14.12.2015 |
Jardiance |
Boehringer Ingelheim International GmbH Binger Straße 173, D-55216 Ingelheim am Rhein, Deutschland |
EU/1/14/930 |
16.12.2015 |
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14.12.2015 |
Pandemrix |
GlaxoSmithKline Biologicals S.A. rue de l’Institut 89, 1330 Rixensart, Belgique |
EU/1/08/452 |
16.12.2015 |
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14.12.2015 |
Yervoy |
Bristol-Myers Squibb Pharma EEIG Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom |
EU/1/11/698 |
16.12.2015 |
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16.12.2015 |
Aldurazyme |
Genzyme Europe B.V. Gooimeer 10, NL-1411 DD Naarden, Nederland |
EU/1/03/253 |
18.12.2015 |
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16.12.2015 |
Angiox |
The Medicines Company UK Ltd 115L Milton Park, Abingdon, Oxfordshire OX14 4SA, United Kingdom |
EU/1/04/289 |
18.12.2015 |
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16.12.2015 |
AUBAGIO |
Sanofi-Aventis groupe 54 rue La Boétie, F-75008 Paris, France |
EU/1/13/838 |
18.12.2015 |
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16.12.2015 |
BYDUREON |
AstraZeneca AB SE-151 85 Södertälje, Sverige |
EU/1/11/696 |
18.12.2015 |
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16.12.2015 |
Byetta |
AstraZeneca AB SE-151 85 Södertälje, Sverige |
EU/1/06/362 |
18.12.2015 |
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16.12.2015 |
Caprelsa |
AstraZeneca AB SE-151 85 Södertälje, Sverige |
EU/1/11/749 |
18.12.2015 |
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16.12.2015 |
Cholestagel |
Genzyme Europe B.V. Gooimeer 10, NL-1411 DD Naarden, Nederland |
EU/1/03/268 |
18.12.2015 |
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16.12.2015 |
Cimzia |
UCB Pharma S.A. Allée de la Recherche 60, 1070 Bruxelles, Belgique/Researchdreef 60, 1070 Brussel, België |
EU/1/09/544 |
18.12.2015 |
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16.12.2015 |
Emend |
Merck Sharp & Dohme Limited Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom |
EU/1/03/262 |
18.12.2015 |
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16.12.2015 |
Eucreas |
Novartis Europharm Limited Frimley Business Park, Camberley GU16 7SR, United Kingdom |
EU/1/07/425 |
18.12.2015 |
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16.12.2015 |
Fuzeon |
Roche Registration Limited 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom |
EU/1/03/252 |
18.12.2015 |
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16.12.2015 |
Galvus |
Novartis Europharm Limited Frimley Business Park, Camberley GU16 7SR, United Kingdom |
EU/1/07/414 |
18.12.2015 |
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16.12.2015 |
Icandra |
Novartis Europharm Limited Frimley Business Park, Camberley GU16 7SR, United Kingdom |
EU/1/08/484 |
18.12.2015 |
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16.12.2015 |
Invokana |
Janssen-Cilag International NV Turnhoutseweg 30, B-2340 Beerse, België |
EU/1/13/884 |
18.12.2015 |
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16.12.2015 |
Jalra |
Novartis Europharm Limited Frimley Business Park, Camberley GU16 7SR, United Kingdom |
EU/1/08/485 |
18.12.2015 |
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16.12.2015 |
Kentera |
Nicobrand Limited 189 Castleroe Road, Coleraine, Northern Ireland BT51 3 RP, United Kindom |
EU/1/03/270 |
21.12.2015 |
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16.12.2015 |
Lyrica |
Pfizer Limited Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom |
EU/1/04/279 |
18.12.2015 |
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16.12.2015 |
Nimenrix |
Pfizer Limited Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom |
EU/1/12/767 |
18.12.2015 |
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16.12.2015 |
ProQuad |
Sanofi Pasteur MSD SNC 162 avenue Jean Jaurès, 69007 Lyon, France |
EU/1/05/323 |
18.12.2015 |
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16.12.2015 |
Protopic |
Astellas Pharma Europe B.V. Sylviusweg 62, NL-2333 BE Leiden, Nederland |
EU/1/02/201 |
18.12.2015 |
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16.12.2015 |
Stivarga |
Bayer Pharma AG D-13342 Berlin, Deutschland |
EU/1/13/858 |
18.12.2015 |
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16.12.2015 |
Tecfidera |
Biogen Idec Limited Innovation House, 70 Norden Road, Maidenhead, Berkshire SL6 4AY, United Kingdom |
EU/1/13/837 |
22.12.2015 |
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16.12.2015 |
Vfend |
Pfizer Limited Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom |
EU/1/02/212 |
18.12.2015 |
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16.12.2015 |
Vokanamet |
Janssen-Cilag International NV Turnhoutseweg 30, B-2340 Beerse, België |
EU/1/14/918 |
18.12.2015 |
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16.12.2015 |
Xeplion |
Janssen-Cilag International NV Turnhoutseweg 30, B-2340 Beerse, België |
EU/1/11/672 |
18.12.2015 |
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16.12.2015 |
Xiliarx |
Novartis Europharm Limited Frimley Business Park, Camberley GU16 7SR, United Kingdom |
EU/1/08/486 |
18.12.2015 |
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16.12.2015 |
Zomarist |
Novartis Europharm Limited Frimley Business Park, Camberley GU16 7SR, United Kingdom |
EU/1/08/483 |
18.12.2015 |
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16.12.2015 |
Zutectra |
Biotest Pharma GmbH Landsteinerstrasse 5, D-63303 Dreieich, Deutschland |
EU/1/09/600 |
18.12.2015 |
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18.12.2015 |
Harvoni |
Gilead Sciences International Limited Cambridge CB21 6GT, United Kingdom |
EU/1/14/958 |
22.12.2015 |
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18.12.2015 |
Zostavax |
Sanofi Pasteur MSD SNC 162 avenue Jean Jaurès, 69007 Lyon, France |
EU/1/06/341 |
22.12.2015 |
— 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 |
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16.12.2015 |
Osigraft |
Olympus Biotech International Limited 40 Upper Mount Street, Dublin 2, Ireland |
EU/1/01/179 |
21.12.2015 |
— Issuing of a marketing authorisation (Article 38 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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9.12.2015 |
Imrestor |
pegbovigrastim |
Eli Lilly and Company Limited Elanco Animal Health, Lilly House, Priestley Road, Basingstoke, Hampshire RG24 9NL, United Kingdom |
EU/2/15/193 |
Solution for injection |
QL03AA90 |
11.12.2015 |
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9.12.2015 |
Velactis |
Cabergoline |
Ceva Santé Animale 10 av. de La Ballastière, 33500 Libourne, France |
EU/2/15/192 |
Solution for injection |
QG02CB03 |
11.12.2015 |
— Modification of a marketing authorisation (Article 38 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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2.12.2015 |
Easotic |
VIRBAC S.A. 1ère Avenue — 2065 m — L.I.D., F-06516 Carros Cedex, France |
EU/2/08/085 |
4.12.2015 |
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2.12.2015 |
Inflacam |
Chanelle Pharmaceuticals Manufacturing Limited Loughrea, Co. Galway, Ireland |
EU/2/11/134 |
4.12.2015 |
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2.12.2015 |
Purevax Rabies |
Merial 29 avenue Tony Garnier, F-69007 Lyon, France |
EU/2/10/117 |
4.12.2015 |
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18.12.2015 |
Equip WNV |
Zoetis Belgium S.A. Rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique |
EU/2/08/086 |
21.12.2015 |
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18.12.2015 |
Novem |
Boehringer Ingelheim Vetmedica GmbH D-55216 Ingelheim am Rhein, Deutschland |
EU/2/04/042 |
22.12.2015 |
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18.12.2015 |
Purevax RC |
Merial 29 avenue Tony Garnier, F-69007 Lyon, France |
EU/2/04/051 |
22.12.2015 |
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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7, Westferry Circus, Canary Wharf |
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UK — LONDON E14 4H |
(1) OJ L 136, 30.4.2004, p. 1.