(Informazioni) INFORMAZIONI PROVENIENTI DALLE ISTITUZIONI, DAGLI ORGANI E DAGLI ORGANISMI DELL'UNIONE EUROPEA COMMISSIONE EUROPEA

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1 IT Gazzetta ufficiale dell Unione europea C 328/1 IV (Informazioni) INFORMAZIONI PROVENIENTI DALLE ISTITUZIONI, DAGLI ORGANI E DAGLI ORGANISMI DELL'UNIONE EUROPEA COMMISSIONE EUROPEA Sintesi delle decisioni dell'unione europea relative alle autorizzazioni all'immissione in commercio di medicinali dal 1 o luglio 2017 al 31 agosto 2017 [pubblicate a norma dell'articolo 13 o dell'articolo 38 del regolamento (CE) n. 726/2004 del Parlamento europeo e del Consiglio ( 1 )] (2017/C 328/01) ( 1 ) GU L 136 del , pag. 1.

2 C 328/2 IT Gazzetta ufficiale dell Unione europea Rilascio di un'autorizzazione all'immissione in commercio [articolo 13 del regolamento (CE) n. 726/2004 del Parlamento europeo e del Consiglio]: Accettate DCI (denominazione comune internazionale) Forma farmaceutica Codice ATC (anatomico, terapeutico e chimico) OXERVATE cenegermin Dompé farmaceutici S.p.A. Via Santa Lucia 6, Milano, Italia EU/1/17/1197 Collirio, soluzione Pending Spherox Sferoidi di condrociti umani autologhi associati alla matrice CO.DON AG Warthestraße 21, Teltow, Deutschland EU/1/17/1181 Sospensione cellulare destinata all impianto M09AX Blitzima rituximab Celltrion Healthcare Hungary Kft Budapest, Bajcsy-Zsilinszky út 12., 4. em. 410, Magyarország EU/1/17/1205 Concentrato per soluzione per infusione L01XC Reagila cariprazina Gedeon Richter Plc. Gyömrői út , H-1103 Budapest, Magyarország EU/1/17/1209 Capsula rigida N05AX Ritemvia rituximab Celltrion Healthcare Hungary Kft Budapest, Bajcsy-Zsilinszky út 12., 4. em. 410, Magyarország EU/1/17/1207 Concentrato per soluzione per infusione L01XC Tuxella rituximab Celltrion Healthcare Hungary Kft Budapest, Bajcsy-Zsilinszky út 12., 4. em. 410, Magyarország EU/1/17/1206 Concentrato per soluzione per infusione L01XC Efavirenz/Emtricitabine/Tenofovir disoproxil Zentiva efavirenz/emtricitabina/tenofovir disoproxil Zentiva, k.s. U Kabelovny 130, Praha 10, Česká republika EU/1/17/1210 Compressa rivestita con film J05AR Kyntheum brodalumab Leo Pharma A/S Industriparken 55, DK-2750 Ballerup, Danmark EU/1/16/1155 Soluzione iniettabile L04AC

3 IT Gazzetta ufficiale dell Unione europea C 328/3 DCI (denominazione comune internazionale) Trimbow beclometasone/ formoterolo/glicopirronio bromuro Chiesi Farmaceutici S.p.A. Via Palermo 26/A, Parma, Italia Insulin lispro Sanofi insulina lispro Sanofi-Aventis groupe 54 rue La Boétie, F Paris, France Veltassa patiromer Vifor Fresenius Medical Care Renal Pharma France Terrasse Boieldieu, Tour Franklin La Défense 8, Paris la Défense Cedex, France Maviret glecaprevir/pibrentasvir AbbVie Ltd Maidenhead, SL6 4UB, Vosevi sofosbuvir/velpatasvir/voxilaprevir Gilead Sciences International Limited Cambridge CB21 6GT, Zykadia ceritinib Novartis Europharm Limited United Kingdom Kisqali ribociclib Novartis Europharm Limited United Kingdom MAVENCLAD cladribina Merck Serono Europe Limited 56, Marsh Wall, London E14 9TP, Forma farmaceutica Codice ATC (anatomico, terapeutico e chimico) EU/1/17/1208 Soluzione pressurizzata per inalazione R03AL EU/1/17/1203 Soluzione iniettabile A10AB EU/1/17/1179 Polvere per sospensione orale V03AE EU/1/17/1213 Compressa rivestita con film J05AX EU/1/17/1223 Compressa rivestita con film Pending EU/1/15/999 Capsula rigida L01XE EU/1/17/1221 Compressa rivestita con film L01XE EU/1/17/1212 Compressa L01BB

4 C 328/4 IT Gazzetta ufficiale dell Unione europea DCI (denominazione comune internazionale) Fotivda tivozanib EUSA Pharma (UK) Limited Breakspear Park, Breakspear Way, HP2 4TZ, Hemel Hempstead, Imraldi adalimumab Samsung Bioepis UK Limited 5th floor, Profile West, 950 Great West Road, Brentford, Middlesex TW8 9ES, Nitisinone Mendeli- KABS nitisinone MendeliKABS Europe Limited Office 7, Gateway 1000, Whittle Way, Stevenage, Hertfordshire, SG1 2FP, Forma farmaceutica Codice ATC (anatomico, terapeutico e chimico) EU/1/17/1215 Capsula rigida L01XE EU/1/17/1216 Soluzione iniettabile L04AB EU/1/17/1217 Capsula rigida A16AX

5 IT Gazzetta ufficiale dell Unione europea C 328/5 Modifica di un'autorizzazione all'immissione in commercio [articolo 13 del regolamento (CE) n. 726/2004 del Parlamento europeo e del Consiglio]: Accettate Celsentri ViiV Healthcare UK Limited 980 Great West Road, Brentford, Middlesex TW8 9GS, EU/1/07/ Clopidogrel Krka d. d. Krka, d. d., Novo Mesto Šmarješka cesta 6, 8501 Novo mesto, Slovenija EU/1/09/ Imlygic Amgen Europe B.V. Minervum 7061, NL-4817 ZK Breda, Nederland EU/1/15/ Kivexa ViiV Healthcare UK Limited 980 Great West Road, Brentford, Middlesex TW8 9GS, EU/1/04/ Nexavar Bayer AG D Leverkusen, Deutschland EU/1/06/ Toviaz Pfizer Limited Ramsgate Road, Sandwich, Kent CT13 9NJ, EU/1/07/ Memantina Accord Accord Healthcare Limited Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF, EU/1/13/ Myozyme Genzyme Europe B.V. Gooimeer 10, NL-1411 DD Naarden, Nederland EU/1/06/ Xeloda Roche Registration Limited 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, EU/1/00/ Edistride AstraZeneca AB SE Södertälje, Sverige EU/1/15/ Enurev Breezhaler Novartis Europharm Limited EU/1/12/ Eylea Bayer AG D Leverkusen, Deutschland EU/1/12/ Incruse Glaxo Group Ltd 980 Great West Road, Brentford, Middlesex, TW8 9GS, EU/1/14/ Isentress Merck Sharp & Dohme Limited Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, EU/1/07/

6 C 328/6 IT Gazzetta ufficiale dell Unione europea Kuvan BioMarin International Limited Shanbally, Ringaskiddy, County Cork, Ireland EU/1/08/ Latuda Sunovion Pharmaceuticals Europe Ltd First Floor, Southside, Victoria Street, London SW1E 6QT, EU/1/14/ Lixiana Daiichi Sankyo Europe GmbH Zielstattstrasse 48, D München, Deutschland EU/1/15/ Memantine Merz Merz Pharmaceuticals GmbH Eckenheimer Landstraße 100 D Frankfurt am Main, Deutschland EU/1/12/ Picato LEO Laboratories Ltd. 285 Cashel Road, Crumlin, Dublin 12, Ireland EU/1/12/ Praxbind Boehringer Ingelheim International GmbH Binger Straße 173, D Ingelheim am Rhein, Deutschland EU/1/15/ Torisel Pfizer Limited Ramsgate Road, Sandwich, Kent CT13 9NJ, EU/1/07/ Xaluprine Nova Laboratories Limited Martin House, Gloucester Crescent, Wigston Leicester, LE18 4YL, EU/1/11/ Xultophy Novo Nordisk A/S Novo Allé, DK-2880 Bagsværd, Danmark EU/1/14/ Zalmoxis MolMed S.p.A. Via Olgettina 58, I Milano, Italia EU/1/16/ Zoledronic acid Accord Accord Healthcare Limited Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF, EU/1/13/ Zinbryta Biogen Idec Limited Innovation House, 70 Norden Road, Maidenhead, Berkshire SL6 4AY, EU/1/16/ Dinutuximab beta Apeiron EUSA Pharma (UK) Limited Breakspear Park, Breakspear Way, HP2 4TZ, Hemel Hempstead, EU/1/17/ Inhixa Techdow Europe AB Kåbovägen 32, Uppsala, Sverige EU/1/16/ Opsumit Actelion Registration Ltd Chiswick Tower, 13th floor, 389 Chiswick High Road, London W4 4AL, EU/1/13/

7 IT Gazzetta ufficiale dell Unione europea C 328/ Rivastigmine Sandoz Sandoz GmbH Biochemiestrasse 10, A-6250 Kundl, Österreich EU/1/09/ Thorinane Techdow Pharma Netherlands B.V. Strawinskylaan 1143, Toren C-11, 1077XX Amsterdam, Nederland Zinforo Pfizer Ireland Pharmaceuticals Operations Services Group, Ringaskiddy, County Cork, Ireland Clopidogrel BGR Laboratoires BIOGARAN 15 boulevard Charles de Gaulle, Colombes Cedex, France Clopidogrel Krka Krka, d. d., Novo Mesto Šmarješka cesta 6, 8501 Novo mesto, Slovenija Clopidogrel TAD TAD Pharma GmbH Heinz-Lohmann-Straße 5, D Cuxhaven, Deutschland Cuprymina SPARKLE S.r.l. Località Cavallino, Montecosaro (MC), Italia Forxiga AstraZeneca AB SE Södertälje, Sverige Grepid Pharmathen S.A. 6 Dervenakion, Pallini Attiki, Ελλάδα Harvoni Gilead Sciences International Limited Cambridge CB21 6GT, Jardiance Boehringer Ingelheim International GmbH Binger Straße 173, D Ingelheim am Rhein, Deutschland Ofev Boehringer Ingelheim International GmbH Binger Straße 173, D Ingelheim am Rhein, Deutschland Qtern AstraZeneca AB SE Södertälje, Sverige Raxone Santhera Pharmaceuticals (Deutschland) GmbH Marie-Curie Strasse 8, D Lörrach, Deutschland Revolade Novartis Europharm Limited Seebri Breezhaler Novartis Europharm Limited EU/1/16/ EU/1/12/ EU/1/09/ EU/1/09/ EU/1/09/ EU/1/12/ EU/1/12/ EU/1/09/ EU/1/14/ EU/1/14/ EU/1/14/ EU/1/16/ EU/1/15/ EU/1/10/ EU/1/12/

8 C 328/8 IT Gazzetta ufficiale dell Unione europea Synjardy Boehringer Ingelheim International GmbH Binger Straße 173, D Ingelheim am Rhein, Deutschland Tracleer Actelion Registration Ltd Chiswick Tower, 13th floor, 389 Chiswick High Road, London W4 4AL, Zavesca Actelion Registration Ltd Chiswick Tower, 13th floor, 389 Chiswick High Road, London W4 4AL, Zavicefta Pfizer Ireland Pharmaceuticals Operations Services Group, Ringaskiddy, County Cork, Ireland Faslodex AstraZeneca UK Limited Charter Way, Macclesfield, Cheshire, SK10 2NA, Granupas Lucane Pharma 172 rue de Charonne, Paris, France Olanzapina Mylan Generics [UK] Limited Station Close, Potters Bar, Hertfordshire, EN6 1TL, Orencia Bristol-Myers Squibb Pharma EEIG Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, EU/1/15/ EU/1/02/ EU/1/02/ EU/1/16/ EU/1/03/ EU/1/13/ EU/1/08/ EU/1/07/ Rivastigmine 1 A Pharma 1 A Pharma GmbH Keltenring 1 + 3, D Oberhaching, Deutschland EU/1/09/ Victoza Novo Nordisk A/S Novo Allé, DK-2880 Bagsværd, Danmark Voncento CSL Behring GmbH Emil-von-Behring-Straße 76, D Marburg, Deutschland EU/1/09/ EU/1/13/ Aripiprazole Mylan Pharma Mylan S.A.S 117 allée des Parcs, F Saint Priest, France EU/1/15/ Bridion Merck Sharp & Dohme Limited Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, Kaletra AbbVie Ltd Maidenhead, SL6 4UB, Oprymea Krka, d. d., Novo Mesto Šmarješka cesta 6, 8501 Novo mesto, Slovenija Tovanor Breezhaler Novartis Europharm Limited EU/1/08/ EU/1/01/ EU/1/08/ EU/1/12/

9 IT Gazzetta ufficiale dell Unione europea C 328/ Velphoro Vifor Fresenius Medical Care Renal Pharma France Terrasse Boieldieu, Tour Franklin La Défense 8, Paris la Défense Cedex, France EU/1/14/ Votubia Novartis Europharm Limited EU/1/11/ Yellox PharmaSwiss Česká republika s.r.o. Jankovcova 1569/2c Praha 7 Česká republika EU/1/11/ Stivarga Bayer AG D Leverkusen, Deutschland EU/1/13/ Zyllt Krka, d. d., Novo Mesto Šmarješka cesta 6, 8501 Novo mesto, Slovenija EU/1/09/ Abilify Otsuka Pharmaceutical Europe Ltd. Gallions, Wexham Springs, Framewood Road, Wexham, SL3 6PJ, EU/1/04/ Apidra Sanofi-Aventis Deutschland GmbH D Frankfurt am Main, Deutschland EU/1/04/ Colobreathe Teva B.V. Swensweg 5, 2031 GA Haarlem, Nederland EU/1/11/ Nordimet Nordic Group B.V. Siriusdreef 22, NL-2132 WT Hoofddorp, Nederland EU/1/16/ Stivarga Bayer AG D Leverkusen, Deutschland EU/1/13/ Exjade Novartis Europharm Limited EU/1/06/ Mekinist Novartis Europharm Limited EU/1/14/ Soliris Alexion Europe SAS 1-15 avenue Edouard Belin, Rueil- Malmaison, France EU/1/07/ Vargatef Boehringer Ingelheim International GmbH Binger Straße 173, D Ingelheim am Rhein, Deutschland EU/1/14/

10 C 328/10 IT Gazzetta ufficiale dell Unione europea Xofigo Bayer AG D Leverkusen, Deutschland EU/1/13/ CoAprovel Sanofi Clir SNC 54 rue La Boétie, F Paris, France EU/1/98/ Ketoconazole HRA Laboratoire HRA Pharma 15 rue Béranger, F Paris, France EU/1/14/ Rasilez Noden Pharma DAC D'Olier Chambers, 16A D'Olier Street, Dublin 2, Ireland EU/1/07/ SonoVue Bracco International B.V. Strawinskylaan 3051, NL-1077 ZX Amsterdam, Nederland EU/1/01/ Xarelto Bayer AG D Leverkusen, Deutschland EU/1/08/ Aranesp Amgen Europe B.V. Minervum 7061, NL-4817 ZK Breda, Nederland EU/1/01/ BYDUREON AstraZeneca AB SE Södertälje, Sverige EU/1/11/ Dacogen Janssen-Cilag International NV Turnhoutseweg 30, B-2340 Beerse, België EU/1/12/ EDURANT Janssen-Cilag International NV Turnhoutseweg 30, B-2340 Beerse, België EU/1/11/ Fluenz Tetra AstraZeneca AB SE Södertälje, Sverige EU/1/13/ IMBRUVICA Janssen-Cilag International NV Turnhoutseweg 30, B-2340 Beerse, België EU/1/14/ Invega Janssen-Cilag International NV Turnhoutseweg 30, B-2340 Beerse, België EU/1/07/ Kaletra AbbVie Ltd Maidenhead, SL6 4UB, EU/1/01/ Karvezide Sanofi-Aventis groupe 54 rue La Boétie, F Paris, France EU/1/98/ KEYTRUDA Merck Sharp & Dohme Limited Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, EU/1/15/ Norvir AbbVie Ltd Maidenhead, SL6 4UB, EU/1/96/

11 IT Gazzetta ufficiale dell Unione europea C 328/ Orkambi Vertex Pharmaceuticals (Europe) Limited 2 Kingdom Street, London W2 6BD, United Kingdom Ruconest Pharming Group N.V. Darwinweg 24, NL-2333 CR Leiden, Nederland Zoledronic acid Hospira Hospira UK Limited Horizon, Honey Lane, Hurley, Maidenhead, SL6 6RJ, Constella Allergan Pharmaceuticals International Limited Clonshaugh Industrial Estate, Coolock, Dublin 17, Ireland Ecalta Pfizer Limited Ramsgate Road, Sandwich, Kent CT13 9NJ, Forxiga AstraZeneca AB SE Södertälje, Sverige Irbesartan HCT Zentiva Sanofi-Aventis groupe 54 rue La Boétie, F Paris, France Mimpara Amgen Europe B.V. Minervum 7061, NL-4817 ZK Breda, Nederland Rasilez HCT Noden Pharma DAC D'Olier Chambers, 16A D'Olier Street, Dublin 2, Ireland EU/1/15/ EU/1/10/ EU/1/12/ EU/1/12/ EU/1/07/ EU/1/12/ EU/1/06/ EU/1/04/ EU/1/08/ Ritiro di un'autorizzazione all'immissione in commercio [articolo 13 del regolamento (CE) n. 726/2004 del Parlamento europeo e del Consiglio] Enzepi Allergan Pharmaceuticals International Limited Clonshaugh Industrial Estate, Coolock, Dublin 17, Ireland Repso Teva B.V. Swensweg 5, 2031 GA Haarlem, Nederland EU/1/16/ EU/1/11/

12 C 328/12 IT Gazzetta ufficiale dell Unione europea Rilascio di un'autorizzazione all'immissione in commercio [articolo 38 del regolamento (CE) n. 726/2004 del Parlamento europeo e del Consiglio]: Accettate DCI (denominazione comune internazionale) Forma farmaceutica Codice ATC (anatomico, terapeutico e chimico) VEPURED Vaccino per verotossina da E. coli (ricombinante inattivato) Laboratorios Hipra, S.A. Avda. La Selva, 135, Amer (Girona), España Exzolt fluralaner Intervet International B.V. Wim de Körverstraat 35, NL-5831 AN Boxmeer, Nederland Innovax-ND-IBD Vaccino (vivo ricombinante) contro la Malattia di Newcastle, la Bursite infettiva e la Malattia di Marek Suvaxyn PRRS MLV Vaccino (vivo) del virus della sindrome respiratoria e riproduttiva del suino Intervet International B.V. Wim de Körverstraat 35, NL-5831 AN Boxmeer, Nederland Zoetis Belgium S.A. Rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique EU/2/17/214 Sospensione iniettabile EU/2/17/212 Soluzione per uso in acqua da bere EU/2/17/213 Sospensione e solvente per sospensione iniettabile EU/2/17/215 Liofilizzato e solvente per sospensione iniettabile QI09AB QP53BE QI01AD QI09AD

13 IT Gazzetta ufficiale dell Unione europea C 328/13 Modifica di un'autorizzazione all'immissione in commercio [articolo 38 del regolamento (CE) n. 726/2004 del Parlamento europeo e del Consiglio]: Accettate Onsior Elanco Europe Ltd. Lilly House, Priestley Road, Basingstoke, Hampshire, RG24 9NL, Nobilis IB Primo QX Intervet International B.V. Wim de Körverstraat 35, NL-5831 AN Boxmeer, Nederland Zolvix Elanco Europe Ltd. Lilly House, Priestley Road, Basingstoke, Hampshire, RG24 9NL, Aivlosin ECO Animal Health Ltd 78 Coombe Road, New Malden, Surrey KT3 4QS Loxicom Norbrook Laboratories Ltd Station Works, Newry, Co. Down, BT35 6JP, United Kindgom Vaxxitek HVT + IBD Merial 29 avenue Tony Garnier, F Lyon, France BLUEVAC BTV8 CZ Veterinaria, S.A. La Relva s/n, Porriño, España Canigen L4 Intervet International B.V. Wim de Körverstraat 35, NL-5831 AN Boxmeer, Nederland EU/2/08/ EU/2/14/ EU/2/09/ EU/2/04/ EU/2/08/ EU/2/02/ EU/2/11/ EU/2/15/ Per consultare la relazione pubblica di valutazione sui medicinali in questione e le correlate decisioni contattare: European Medicines Agency 30 Churchill Place Canary Wharf London E14 5EU