(Notices) NOTICES FROM EUROPEAN UNION INSTITUTIONS, BODIES, OFFICES AND AGENCIES EUROPEAN COMMISSION
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1 EN Official Journal of the European Union C 70/1 IV (Notices) NOTICES FROM EUROPEAN UNION INSTITUTIONS, BODIES, OFFICES AND AGENCIES EUROPEAN COMMISSION Summary of European Union s on marketing authorisations in respect of medicinal s from 1 January 2018 to 31 January 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 070/01) ( 1 ) OJ L 136, , p. 1.
2 C 70/2 EN Official Journal of the European Union Issuing of a marketing authorisation (Article 13 of Regulation (EC) No 726/2004 of the European Parliament and of the Council): Accepted INN (International Non-Proprietary Name) Pharmaceutical form ATC code (Anatomical Therapeutic Chemical Code) ADYNOVI rurioctocog alfa pegol Baxalta Innovations GmbH Industriestraße 67, 1221 Wien, Österreich Fasenra benralizumab AstraZeneca AB Södertälje, Sverige Fulvestrant Mylan fulvestrant Mylan S.A.S. 117 allée des Parcs, Saint Priest, France Intrarosa prasterone Endoceutics Ltd. Salisbury house, London Wall, London, EC2M 5PS, Jorveza budesonide Dr Falk Pharma GmbH Leinenweberstraße 5, Freiburg im Breisgau, Ocrevus ocrelizumab Roche Registration Limited 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, PREVYMIS letermovir Merck Sharp & Dohme Limited Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, Mvasi bevacizumab Amgen Europe B.V. Minervum 7061, 4817 ZK Breda, Nederland Darunavir Krka d.d. darunavir Krka d. d., Novo Mesto Šmarješka cesta 6, 8501 Novo mesto, Slovenija Darunavir Krka darunavir Krka d. d., Novo Mesto Šmarješka cesta 6, 8501 Novo mesto, Slovenija EU/1/17/1247 Powder and solvent for solution for injection EU/1/17/1252 Solution for injection EU/1/17/1253 Solution for injection B02BD R03DX L02BA EU/1/17/1255 Pessary QM01AX EU/1/17/1254 Orodispersible tablet A07EA EU/1/17/1231 Concentrate for solution for infusion EU/1/17/1245 Concentrate for solution for infusion Film-coated tablet EU/1/17/1246 Concentrate for solution for infusion L04AA J05AX L01XC EU/1/17/1248 Film-coated tablet J05AE EU/1/17/1249 Film-coated tablet J05AE
3 EN Official Journal of the European Union C 70/3 Issuing of a marketing authorisation (Article 13 of Regulation (EC) No 726/2004 of the European Parliament and of the Council): Rejected Onzeald Nektar Therapeutics UK Limited Elizabeth House, Queen Street, Leeds LS1 2TW, Fanaptum Vanda Pharmaceuticals Limited 222 Regent Street, London W1B 5TR, United Kingdom Modification of a marketing authorisation (Article 13 of Regulation (EC) No 726/2004 of the European Parliament and of the Council): Accepted Bronchitol Pharmaxis Pharmaceuticals Limited 25 Moorgate, London, EC2R 6AY, Cimzia UCB Pharma S.A. Allée de la Recherche 60, 1070 Bruxelles, Belgique/Researchdreef 60, 1070 Brussel, België Cometriq Ipsen Pharma 65 quai Georges Gorse, Boulogne-Billancourt, France Comtess Orion Corporation Orionintie 1, Espoo, Suomi Hexacima Sanofi Pasteur SA 2 avenue Pont Pasteur, Lyon, France Hexyon Sanofi Pasteur Europe 2 avenue Pont Pasteur, Lyon, France HyQvia Baxalta Innovations GmbH Industriestraße 67, 1221 Wien, Österreich Imatinib Actavis Actavis Group PTC ehf. Reykjavíkurvegi 76-78, 220 Hafnarfjörður, Íceland Ixiaro Valneva Austria GmbH Campus Vienna Biocenter 3, 1030 Wien, Österreich Jardiance Boehringer Ingelheim International GmbH Binger Straße 173, Ingelheim am Rhein, Memantine LEK Pharmathen S.A. 6 Dervenakion, Pallini Attiki, Ελλάδα EU/1/12/ EU/1/09/ EU/1/13/ EU/1/98/ EU/1/13/ EU/1/13/ EU/1/13/ EU/1/13/ EU/1/08/ EU/1/14/ EU/1/13/
4 C 70/4 EN Official Journal of the European Union Memantine Mylan Generics [UK] Limited Station Close, Potters Bar, Hertfordshire, EN6 1TL, Nemdatine Actavis Group PTC ehf. Reykjavíkurvegi 76-78, 220 Hafnarfjörður, Íceland Orkambi Vertex Pharmaceuticals (Europe) Limited 2 Kingdom Street, London W2 6BD, United Kingdom Pradaxa Boehringer Ingelheim International GmbH Binger Straße 173, Ingelheim am Rhein, Stayveer Marklas Nederland B.V. Beneluxlaan 2b, 3446 GR Woerden, Nederland Synjardy Boehringer Ingelheim International GmbH Binger Straße 173, Ingelheim am Rhein, Tolucombi Krka d. d., Novo Mesto Šmarješka cesta 6, 8501 Novo mesto, Slovenija Votrient Novartis Europharm Limited Yervoy Bristol-Myers Squibb Pharma EEIG Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, Zinbryta Biogen Idec Limited Innovation House, 70 Norden Road, Maidenhead, Berkshire SL6 4AY, Zonegran Eisai Limited European Knowledge Centre, Mosquito Way, Hatfield, Hertfordshire AL10 9SN, Carbaglu Orphan Europe S.A.R.L. Immeuble Le Wilson, 70 avenue du Général de Gaulle, Puteaux, France Cinacalcet Mylan Mylan S.A.S. 117 allée des Parcs, Saint Priest, France Cystadrops Orphan Europe S.A.R.L. Immeuble Le Wilson, 70 avenue du Général de Gaulle, Puteaux, France Cystagon Orphan Europe S.A.R.L. Immeuble Le Wilson, 70 avenue du Général de Gaulle, Puteaux, France EU/1/13/ EU/1/13/ EU/1/15/ EU/1/08/ EU/1/13/ EU/1/15/ EU/1/13/ EU/1/10/ EU/1/11/ EU/1/16/ EU/1/04/ EU/1/02/ EU/1/15/ EU/1/15/ EU/1/97/
5 EN Official Journal of the European Union C 70/ Lartruvo Eli Lilly Nederland B.V. Papendorpseweg 83, 3528 BJ Utrecht, Nederland EU/1/16/ Laventair Glaxo Group Ltd 980 Great West Road, Brentford, Middlesex, TW8 9GS, EU/1/14/ Levetiracetam Teva Teva B.V. Swensweg 5, 2031 GA Haarlem, Nederland EU/1/11/ OLYSIO Janssen-Cilag International NV Turnhoutseweg 30, 2340 Beerse, België EU/1/14/ Adasuve Ferrer Internacional S.A. Gran Via Carlos III, Barcelona, España EU/1/13/ Ciambra Menarini International Operations Luxembourg S.A. 1 avenue de la Gare, 1611 Luxembourg, Grand- Duché de Luxembourg EU/1/15/ Prialt Eisai Limited European Knowledge Centre, Mosquito Way, Hatfield, Hertfordshire AL10 9SN, EU/1/04/ Zostavax MSD VACCINS 162 avenue Jean Jaurès, Lyon, France EU/1/06/ Bortezomib Hospira Hospira UK Limited Horizon, Honey Lane, Hurley, Maidenhead SL6 6RJ, EU/1/16/ Leganto UCB Pharma S.A. Allée de la Recherche 60, 1070 Bruxelles, Belgique/Researchdreef 60, 1070 Brussel, België EU/1/11/ Marixino Consilient Health Ltd 5th floor, Beaux Lane House, Mercer Street Lower, Dublin 2, Ireland EU/1/13/ Omidria Omeros London Limited Berkeley Square, London, W1J 6BD, United Kingdom EU/1/15/ Taltz Eli Lilly Nederland B.V. Papendorpseweg 83, 3528 BJ Utrecht, Nederland EU/1/15/ Tenofovir disoproxil Zentiva Zentiva, k.s. U Kabelovny 130, Praha 10, Česká republika EU/1/16/ XALKORI Pfizer Limited Ramsgate Road, Sandwich, Kent CT13 9NJ, EU/1/12/
6 C 70/6 EN Official Journal of the European Union Yervoy Bristol-Myers Squibb Pharma EEIG Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, EU/1/11/ Cervarix GlaxoSmithKline Biologicals S.A. rue de l'institut 89, 1330 Rixensart, Belgique EU/1/07/ DUAVIVE Pfizer Limited Ramsgate Road, Sandwich, Kent CT13 9NJ, EU/1/14/ IBRANCE Pfizer Limited Ramsgate Road, Sandwich, Kent CT13 9NJ, EU/1/16/ LeukoScan Immunomedics GmbH Paul-Ehrlich-Straße 22/D1, Rödermark, EU/1/97/ Matever Pharmathen S.A. 6 Dervenakion, Pallini Attiki, Ελλάδα EU/1/11/ Cerdelga Genzyme Europe B.V. Gooimeer 10, 1411 DD Naarden, Nederland EU/1/14/ Mysimba Orexigen Therapeutics Ireland Limited 2nd Floor, Palmerston House, Fenian Street, Dublin 2, Ireland EU/1/14/ Cialis Eli Lilly Nederland B.V. Papendorpseweg 83, 3528 BJ Utrecht, Nederland EU/1/02/ Colobreathe Teva B.V. Swensweg 5, 2031 GA Haarlem, Nederland EU/1/11/ Copalia Novartis Europharm Limited EU/1/06/ Copalia HCT Novartis Europharm Limited EU/1/09/ Cresemba Basilea Medical Ltd c/o Cox Costello & Horne Limited, Langwood House, High Street, Rickmansworth, Hertfordshire WD3 1EQ, EU/1/15/ Dafiro Novartis Europharm Limited EU/1/06/ Dafiro HCT Novartis Europharm Limited EU/1/09/
7 EN Official Journal of the European Union C 70/ Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan Mylan S.A.S. 117 allée des Parcs, Saint Priest, France Effentora Teva B.V. Swensweg 5, 2031 GA Haarlem, Nederland Exforge HCT Novartis Europharm Limited Fycompa Eisai Europe Limited European Knowledge Centre, Mosquito Way, Hatfield, Hertfordshire AL10 9SN, Granpidam Accord Healthcare Limited Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF, Hizentra CSL Behring GmbH Emil-von-Behring-Straße 76, Marburg, Ivemend Merck Sharp & Dohme Limited Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, Nplate Amgen Europe B.V. Minervum 7061, 4817 ZK Breda, Nederland Rotarix GlaxoSmithKline Biologicals S.A. rue de l'institut 89, 1330 Rixensart, Belgique Stelara Janssen-Cilag International NV Turnhoutseweg 30, 2340 Beerse, België Vectibix Amgen Europe B.V. Minervum 7061, 4817 ZK Breda, Nederland EU/1/17/ EU/1/08/ EU/1/09/ EU/1/12/ EU/1/16/ EU/1/11/ EU/1/07/ EU/1/08/ EU/1/05/ EU/1/08/ EU/1/07/ Withdrawal of a marketing authorisation (Article 13 of Regulation (EC) No 726/2004 of the European Parliament and of the Council) Daliresp AstraZeneca AB Södertälje, Sverige Insulin Human Winthrop Sanofi-Aventis GmbH D Frankfurt am Main, Libertek AstraZeneca AB Södertälje, Sverige Zoledronic acid Teva Pharma Teva B.V. Swensweg 5, 2031 GA Haarlem, Nederland LeukoScan Immunomedics GmbH Paul-Ehrlich-Straße 22/D1, Rödermark, EU/1/11/ EU/1/06/ EU/1/11/ EU/1/12/ EU/1/97/
8 C 70/8 EN Official Journal of the European Union Issuing of a marketing authorisation (Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council): Accepted INN (International Non-Proprietary Name) Pharmaceutical form ATC code (Anatomical Therapeutic Chemical Code) GALLIPRANT grapiprant Aratana Therapeutics NV Ambachtenlaan 1, 3001 Heverlee, België MiPet Easecto sarolaner Zoetis Belgium S.A. rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique EU/2/17/221 Tablet QM01AX EU/2/17/220 Chewable tablet QP53BE
9 EN Official Journal of the European Union C 70/9 Modification of a marketing authorisation (Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council): Accepted Cortavance VIRBAC S.A. 1ère Avenue 2065 m L.I.D., Carros CEDEX, France Ypozane VIRBAC S.A. 1ère Avenue 2065 m L.I.D., Carros CEDEX, France Aftovaxpur Doe Merial 29 avenue Tony Garnier, Lyon, France Leucofeligen FeLV/ RCP Virbac 1ère Avenue 2065 m L.I.D., Carros CEDEX, France Virbagen Omega VIRBAC S.A. 1ère Avenue 2065 m L.I.D., Carros CEDEX, France Zactran Merial 29 avenue Tony Garnier, Lyon, France Semintra Boehringer Ingelheim Vetmedica GmbH D Ingelheim am Rhein, Meloxoral Le Vet B.V. Wilgenweg 7, 3421 TV Oudewater, Nederland EU/2/06/ EU/2/06/ EU/2/13/ EU/2/09/ EU/2/01/ EU/2/08/ EU/2/12/ EU/2/10/ Anyone wishing to consult the public assessment report on the medicinal s in question and the s relating thereto is invited to contact: European Medicines Agency 30 Churchill Place Canary Wharf London E14 5EU
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