ISSN 1977-091X
Official Journal
of the European Union
C 61
English edition
Information and Notices
Volume 60
24 February 2017
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ISSN 1977-091X |
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Official Journal of the European Union |
C 61 |
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English edition |
Information and Notices |
Volume 60 |
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Notice No |
Contents |
page |
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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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2017/C 61/01 |
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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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24.2.2017 |
EN |
Official Journal of the European Union |
C 61/1 |
Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 January 2017 to 31 January 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 061/01)
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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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4.1.2017 |
AFSTYLA |
lonoctocog alfa |
CSL Behring GmbH Emil-von-Behring-Straße 76, D-35041 Marburg, Deutschland |
EU/1/16/1158 |
Powder and solvent for solution for injection |
B02BD02 |
6.1.2017 |
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4.1.2017 |
Darunavir Mylan |
darunavir |
Mylan S.A.S 117 allée des Parcs, F-69800 Saint Priest, France |
EU/1/16/1140 |
Film-coated tablet |
J05AE10 |
6.1.2017 |
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4.1.2017 |
Lusduna |
insulin glargine |
Merck Sharp & Dohme Limited Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom |
EU/1/16/1162 |
Solution for injection |
A10AE04 |
6.1.2017 |
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4.1.2017 |
Terrosa |
teriparatide |
Gedeon Richter Plc. Gyömrői út 19-21., H-1103 Budapest, Magyarország |
EU/1/16/1159 |
Solution for injection |
H05AA02 |
6.1.2017 |
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9.1.2017 |
Fiasp |
insulin aspart |
Novo Nordisk A/S Novo Allé, DK-2880 Bagsvaerd, Danmark |
EU/1/16/1160 |
Solution for injection |
A10AB05 |
11.1.2017 |
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9.1.2017 |
Tadalafil Generics |
tadalafil |
Mylan S.A.S. 117 Allée des Parcs, 69800 Saint-Priest, France |
EU/1/16/1153 |
Film-coated tablet |
G04BE08 |
11.1.2017 |
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9.1.2017 |
Vemlidy |
tenofovir alafenamide |
Gilead Sciences International Ltd. Cambridge, CB21 6GT, United Kingdom |
EU/1/16/1154 |
Film-coated tablet |
J05AF13 |
11.1.2017 |
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11.1.2017 |
Movymia |
teriparatide |
STADA Arzneimittel AG Stadastrasse 2-18, D-61118 Bad Vilbel, Deutschland |
EU/1/16/1161 |
Solution for injection |
H05AA02 |
13.1.2017 |
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11.1.2017 |
Suliqua |
insulin glargine/lixisenatide |
Sanofi-Aventis groupe 54 rue La Boétie, F-75008 Paris, France |
EU/1/16/1157 |
Solution for injection |
A10AE54 |
13.1.2017 |
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18.1.2017 |
ZINPLAVA |
bezlotoxumab |
Merck Sharp & Dohme Limited Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom |
EU/1/16/1156 |
Concentrate for solution for infusion |
J06BB21 |
20.1.2017 |
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19.1.2017 |
Cystadrops |
mercaptamine |
Orphan Europe SARL Immeuble ‘Le Wilson’, 70, Avenue du Général de Gaulle, 92800 Puteaux, France |
EU/1/15/1049 |
Eye drops, solution |
S01XA21 |
23.1.2017 |
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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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4.1.2017 |
Emadine |
Alcon Laboratories (UK) Ltd Frimley Business Park, Frimley, Camberley, Surrey, GU16 7SR, United Kingdom |
EU/1/98/095 |
6.1.2017 |
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4.1.2017 |
Imatinib Accord |
Accord Healthcare Limited Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF, United Kingdom |
EU/1/13/845 |
6.1.2017 |
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4.1.2017 |
Incruse |
Glaxo Group Ltd 980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom |
EU/1/14/922 |
6.1.2017 |
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4.1.2017 |
Kolbam |
Retrophin Europe Limited Palmerstown House, Fenian Street, Dublin 2, Ireland |
EU/1/13/895 |
6.1.2017 |
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4.1.2017 |
Vepacel |
Nanotherapeutics Bohumil, s.r.o. Bohumil 138, 28163 Jevany, Česká republika |
EU/1/12/752 |
6.1.2017 |
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4.1.2017 |
Zonegran |
Eisai Limited European Knowledge Centre, Mosquito Way, Hatfield, Hertfordshire AL10 9SN, United Kingdom |
EU/1/04/307 |
6.1.2017 |
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9.1.2017 |
Capecitabine Accord |
Accord Healthcare Limited Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF, United Kingdom |
EU/1/12/762 |
11.1.2017 |
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9.1.2017 |
Capecitabine Teva |
Teva B.V. Swensweg 5, 2031 GA Haarlem, Nederland |
EU/1/12/761 |
11.1.2017 |
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9.1.2017 |
DaTSCAN |
GE Healthcare Limited Little Chalfont, Bucks HP7 9NA, United Kingdom |
EU/1/00/135 |
11.1.2017 |
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9.1.2017 |
Foclivia |
Novartis Vaccines Influenza S.r.l. Via Fiorentina, 1, 53100 Siena, Italia |
EU/1/09/577 |
11.1.2017 |
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9.1.2017 |
Naglazyme |
BioMarin Europe Ltd. 10 Bloomsbury Way, London WC1A 2SL, United Kingdom |
EU/1/05/324 |
13.1.2017 |
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9.1.2017 |
Ofev |
Boehringer Ingelheim International GmbH Binger Straße 173, D-55216 Ingelheim am Rhein, Deutschland |
EU/1/14/979 |
11.1.2017 |
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9.1.2017 |
Relistor |
PharmaSwiss Česká republika s.r.o. Jankovcova 1569/2c 17000 Praha 7 Česká republika |
EU/1/08/463 |
11.1.2017 |
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9.1.2017 |
Riluzole Zentiva |
Aventis Pharma S.A. 20 avenue Raymond Aron, F-92165 Antony CEDEX, France |
EU/1/12/768 |
11.1.2017 |
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9.1.2017 |
SANCUSO |
Kyowa Kirin Limited Galabank Business Park, Galashiels, TD1 1QH, United Kingdom |
EU/1/12/766 |
11.1.2017 |
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9.1.2017 |
Translarna |
PTC Therapeutics International Limited 77 Sir John Rogerson’s Quay, Dublin 2, Ireland |
EU/1/13/902 |
11.1.2017 |
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9.1.2017 |
Viagra |
Pfizer Limited Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom |
EU/1/98/077 |
11.1.2017 |
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9.1.2017 |
Viramune |
Boehringer Ingelheim International GmbH Binger Straße 173, D-55216 Ingelheim am Rhein, Deutschland |
EU/1/97/055 |
11.1.2017 |
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9.1.2017 |
Xultophy |
Novo Nordisk A/S Novo Allé, DK-2880 Bagsvaerd, Danmark |
EU/1/14/947 |
11.1.2017 |
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11.1.2017 |
Adenuric |
Menarini International Operations Luxembourg S.A. 1 avenue de la Gare, L-1611 Luxembourg, Grand-Duché de Luxembourg |
EU/1/08/447 |
13.1.2017 |
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11.1.2017 |
Brintellix |
H. Lundbeck A/S Ottiliavej 9, DK-2500 Valby, Danmark |
EU/1/13/891 |
13.1.2017 |
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11.1.2017 |
Bronchitol |
Pharmaxis Pharmaceuticals Limited 25 Moorgate, London, EC2R 6AY, United Kingdom. |
EU/1/12/760 |
13.1.2017 |
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11.1.2017 |
Cometriq |
Ipsen Pharma 65 quai Georges Gorse, F-92100 Boulogne-Billancourt, France |
EU/1/13/890 |
13.1.2017 |
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11.1.2017 |
Defitelio |
Gentium S.r.l Piazza XX Settembre, 2, I-22079 Villa Guardia (CO), Italia |
EU/1/13/878 |
16.1.2017 |
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11.1.2017 |
Entresto |
Novartis Europharm Limited Frimley Business Park, Camberley GU16 7SR, United Kingdom |
EU/1/15/1058 |
13.1.2017 |
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11.1.2017 |
Herceptin |
Roche Registration Limited 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom |
EU/1/00/145 |
13.1.2017 |
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11.1.2017 |
Imatinib Accord |
Accord Healthcare Limited Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF, United Kingdom |
EU/1/13/845 |
13.1.2017 |
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11.1.2017 |
Inovelon |
Eisai Limited European Knowledge Centre, Mosquito Way, Hatfield, Hertfordshire AL10 9SN, United Kingdom |
EU/1/06/378 |
13.1.2017 |
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11.1.2017 |
Invanz |
Merck Sharp & Dohme Limited Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom |
EU/1/02/216 |
13.1.2017 |
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11.1.2017 |
Ivemend |
Merck Sharp & Dohme Limited Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom |
EU/1/07/437 |
13.1.2017 |
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11.1.2017 |
Kuvan |
BioMarin International Limited Shanbally, Ringaskiddy, County Cork, Ireland |
EU/1/08/481 |
13.1.2017 |
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11.1.2017 |
Pregabalin Mylan |
Generics [UK] Limited Station Close, Potters Bar, Hertfordshire, EN6 1TL, United Kingdom |
EU/1/15/997 |
13.1.2017 |
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11.1.2017 |
Pregabalin Mylan Pharma |
Generics [UK] Limited Station Close, Potters Bar, Hertfordshire, EN6 1TL, United Kingdom |
EU/1/15/998 |
13.1.2017 |
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11.1.2017 |
Ruconest |
Pharming Group N.V. Darwinweg 24, NL-2333 CR Leiden, Nederland |
EU/1/10/641 |
13.1.2017 |
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11.1.2017 |
Vimizim |
BioMarin Europe Ltd. 10 Bloomsbury Way, London WC1A 2SL, United Kingdom |
EU/1/14/914 |
13.1.2017 |
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11.1.2017 |
Xadago |
Zambon S.p.A. Via Lillo del Duca 10, 20 091 Bresso (MI), Italia |
EU/1/14/984 |
13.1.2017 |
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19.1.2017 |
Jardiance |
Boehringer Ingelheim International GmbH Binger Straße 173, D-55216 Ingelheim am Rhein, Deutschland |
EU/1/14/930 |
23.1.2017 |
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23.1.2017 |
Lymphoseek |
Norgine B.V. Hogehilweg 7, 1101CA Amsterdam, Nederland |
EU/1/14/955 |
25.1.2017 |
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23.1.2017 |
Remsima |
Celltrion Healthcare Hungary Kft. Árpád Fejedelem útja 26-28, H-1023 Budapest, Magyarország |
EU/1/13/853 |
25.1.2017 |
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26.1.2017 |
Cinryze |
Shire Services BVBA rue Montoyer 47, 1000 Bruxelles, Belgique/Montoyerstraat 47, 1000 Brussel, België |
EU/1/11/688 |
30.1.2017 |
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26.1.2017 |
Iclusig |
Incyte Biosciences UK Ltd Riverbridge House, Guildford Road, Leatherhead, Surrey KT22 9AD, United Kingdom |
EU/1/13/839 |
30.1.2017 |
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26.1.2017 |
NovoSeven |
Novo Nordisk A/S Novo Allé, DK-2880 Bagsvaerd, Danmark |
EU/1/96/006 |
30.1.2017 |
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26.1.2017 |
Orfadin |
Swedish Orphan Biovitrum International AB SE-112 76 Stockholm, Sverige |
EU/1/04/303 |
30.1.2017 |
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26.1.2017 |
Picato |
LEO Laboratories Ltd. 285 Cashel Road, Crumlin, Dublin 12, Ireland |
EU/1/12/796 |
30.1.2017 |
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26.1.2017 |
Rezolsta |
Janssen-Cilag International NV Turnhoutseweg 30, B-2340 Beerse, België |
EU/1/14/967 |
30.1.2017 |
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26.1.2017 |
Voriconazole Hikma |
Hikma Farmacêutica (Portugal), S.A. Estrada do Rio da Mó n.o 8, 8A e 8B, Fervença, 2705-906 Terrugem SNT, Portugal |
EU/1/15/1004 |
30.1.2017 |
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27.1.2017 |
Ameluz |
Biofrontera Bioscience GmbH Hemmelrather Weg 201, D-51377 Leverkusen, Deutschland |
EU/1/11/740 |
31.1.2017 |
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27.1.2017 |
Benepali |
Samsung Bioepis UK Limited 3000 Hillswood Drive, Chertsey, Surrey KT16 0RS, United Kingdom |
EU/1/15/1074 |
31.1.2017 |
|
27.1.2017 |
Docetaxel Accord |
Accord Healthcare Limited Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF, United Kingdom |
EU/1/12/769 |
31.1.2017 |
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27.1.2017 |
Jentadueto |
Boehringer Ingelheim International GmbH Binger Straße 173, D-55216 Ingelheim am Rhein, Deutschland |
EU/1/12/780 |
31.1.2017 |
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27.1.2017 |
KEYTRUDA |
Merck Sharp & Dohme Limited Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom |
EU/1/15/1024 |
31.1.2017 |
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27.1.2017 |
Opdivo |
Bristol-Myers Squibb Pharma EEIG Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom |
EU/1/15/1014 |
31.1.2017 |
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27.1.2017 |
Stivarga |
Bayer Pharma AG D-13342 Berlin, Deutschland |
EU/1/13/858 |
31.1.2017 |
|
27.1.2017 |
Trajenta |
Boehringer Ingelheim International GmbH Binger Straße 173, D-55216 Ingelheim am Rhein, Deutschland |
EU/1/11/707 |
31.1.2017 |
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27.1.2017 |
Vaxelis |
MCM Vaccine B.V. Robert Boyleweg 4, 2333 CG Leiden, Nederland |
EU/1/15/1079 |
31.1.2017 |
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27.1.2017 |
Votubia |
Novartis Europharm Limited Frimley Business Park, Camberley GU16 7SR, United Kingdom |
EU/1/11/710 |
31.1.2017 |
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27.1.2017 |
Xydalba |
Allergan Pharmaceuticals International Limited Clonshaugh Industrial Estate, Coolock, Dublin 17, Ireland |
EU/1/14/986 |
31.1.2017 |
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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 |
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9.1.2017 |
Vylaer Spiromax |
Teva Pharma B.V. Swensweg 5, 2031GA Haarlem, Nederland |
EU/1/14/949 |
11.1.2017 |
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18.1.2017 |
Clopidogrel Acino |
Acino AG Am Windfeld 35, 83714 D-Miesbach, Deutschland |
EU/1/09/532 |
20.1.2017 |
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— |
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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9.1.2017 |
Coliprotec F4/F18 |
Porcine post-weaning diarrhoea vaccine (live) |
Prevtec Microbia GmbH Geyerspergerstr 27, 80689 München, Deutschland |
EU/2/16/202 |
Lyophilisate for oral suspension |
QI09AE03 |
11.1.2017 |
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— |
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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9.1.2017 |
Novaquin |
Le Vet Beheer B.V. Wilgenweg 7, NL-3421 TV Oudewater, Nederland |
EU/2/15/186 |
11.1.2017 |
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18.1.2017 |
Nobilis IB 4-91 |
Intervet International B.V. Wim de Körverstraat 35, NL-5831 AN Boxmeer, Nederland |
EU/2/98/006 |
20.1.2017 |
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18.1.2017 |
Simparica |
Zoetis Belgium S.A. Rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique |
EU/2/15/191 |
20.1.2017 |
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.