Official Journal of the European Union

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 July 2018 to 31 July 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 309/01)

— Issuing of a marketing authorisation (Article 13 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 6.7.2018 Tegsedi inotersen IONIS USA Limited Tower 42, Level 30, International Finance Centre, 25 Old Broad Street, EC2N 1HQ London, United Kingdom EU/1/18/1296 Solution for injection Pending 10.7.2018 6.7.2018 Verkazia ciclosporin Santen Oy Niittyhaankatu 20, 33720 Tampere, Suomi EU/1/17/1219 Eye drops, emulsion S01XA18 10.7.2018 26.7.2018 Aimovig erenumab Novartis Europharm Limited Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland EU/1/18/1293 Solution for injection N02C 30.7.2018 26.7.2018 Halimatoz adalimumab Sandoz GmbH Biochemiestrasse 10, 6250 Kundl, Österreich EU/1/18/1288 Solution for injection L04AB04 30.7.2018 26.7.2018 Hefiya adalimumab Sandoz GmbH Biochemiestrasse 10, 6250 Kundl, Österreich EU/1/18/1287 Solution for injection L04AB04 30.7.2018 26.7.2018 Hyrimoz adalimumab Sandoz GmbH Biochemiestrasse 10, 6250 Kundl, Österreich EU/1/18/1286 Solution for injection L04AB04 30.7.2018 26.7.2018 Nityr nitisinone Cycle Pharmaceuticals Ltd Bailey Grundy Barrett Building, Little St Mary’s Lane, CB2 1RR, Cambridge, United Kingdom EU/1/18/1290 Tablet A16AX04 30.7.2018 26.7.2018 RXULTI brexpiprazole Otsuka Pharmaceutical Europe Ltd Gallions, Wexham Springs, Framewood Road, Wexham, SL3 6PJ, United Kingdom EU/1/18/1294 Film-coated tablet N05AX16 30.7.2018 26.7.2018 Trazimera trastuzumab Pfizer Europe MA EEIG Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom EU/1/18/1295 Powder for concentrate for solution for infusion L01XC03 30.7.2018 30.7.2018 Myalepta metreleptin Aegerion Pharmaceuticals B.V. Atrium Building, 8th Floor, Strawinskylaan 3127, 1077 ZX Amsterdam, Nederland EU/1/18/1276 Powder for solution for injection A16AA07 1.8.2018

— Issuing of a marketing authorisation (Article 13 of Regulation (EC) No 726/2004 of the European Parliament and of the Council): Rejected

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 17.7.2018 Aplidin Pharma Mar S.A. Avenida de los Reyes 1, Polígono Industrial La Mina, 28770 Colmenar Viejo, Madrid, España — 19.7.2018 26.7.2018 Alsitek AB Science 3 avenue George V, 75008 Paris, France — 30.7.2018

— Modification of a marketing authorisation (Article 13 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 2.7.2018 Bavencio Merck Europe B.V. Gustav Mahlerplein 102, 1082 MA Amsterdam, Nederland EU/1/17/1214 4.7.2018 2.7.2018 CONTROLOC Control Takeda GmbH Byk-Gulden-Straße 2, 78467 Konstanz, Deutschland EU/1/09/515 4.7.2018 2.7.2018 DepoCyte Pacira Limited Wessex House, Marlow Road, Bourne End, Buckinghamshire, SL8 5SP, United Kingdom EU/1/01/187 4.7.2018 2.7.2018 Docetaxel Accord Accord Healthcare Limited Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF, United Kingdom EU/1/12/769 4.7.2018 2.7.2018 Enurev Breezhaler Novartis Europharm Limited Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland EU/1/12/789 4.7.2018 2.7.2018 Ifirmacombi Krka d. d., Novo mesto Šmarješka cesta 6, 8501 Novo mesto, Slovenija EU/1/11/673 4.7.2018 2.7.2018 Lemtrada Genzyme Therapeutics Ltd 4620 Kingsgate, Cascade Way, Oxford Business Park South, Oxford OX4 2SU, United Kingdom EU/1/13/869 4.7.2018 2.7.2018 Mysimba Orexigen Therapeutics Ireland Limited 2nd Floor, Palmerston House, Fenian Street, Dublin 2, Ireland EU/1/14/988 4.7.2018 2.7.2018 PANTOZOL Control Takeda GmbH Byk-Gulden-Straße 2, 78467 Konstanz, Deutschland EU/1/09/517 4.7.2018 2.7.2018 Prialt RIEMSER Pharma GmbH An der Wiek 7, 17493 Greifswald-Insel Riems, Deutschland EU/1/04/302 4.7.2018 2.7.2018 Simponi Janssen Biologics B.V. Einsteinweg 101, 2333 CB Leiden, Nederland EU/1/09/546 4.7.2018 2.7.2018 SOMAC Control Takeda GmbH Byk-Gulden-Straße 2, 78467 Konstanz, Deutschland EU/1/09/516 4.7.2018 2.7.2018 Sprycel Bristol-Myers Squibb Pharma EEIG Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom EU/1/06/363 4.7.2018 2.7.2018 Tecentriq Roche Registration GmbH Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Deutschland EU/1/17/1220 4.7.2018 2.7.2018 Trulicity Eli Lilly Nederland B.V. Papendorpseweg 83, 3528 BJ Utrecht, Nederland EU/1/14/956 3.7.2018 2.7.2018 Xarelto Bayer AG D-51368 Leverkusen, Deutschland EU/1/08/472 4.7.2018 6.7.2018 Adrovance Merck Sharp & Dohme B.V. Waarderweg 39, 2031 BN Haarlem, Nederland EU/1/06/364 10.7.2018 6.7.2018 ALPROLIX Swedish Orphan Biovitrum AB (publ) 112 76 Stockholm, Sverige EU/1/16/1098 10.7.2018 6.7.2018 Ammonaps Swedish Orphan Biovitrum International AB 112 76 Stockholm, Sverige EU/1/99/120 10.7.2018 6.7.2018 Ariclaim Eli Lilly Nederland B.V. Papendorpseweg 83, 3528 BJ Utrecht, Nederland EU/1/04/283 10.7.2018 6.7.2018 Corbilta Orion Corporation Orionintie 1, 02200 Espoo, Suomi EU/1/13/859 10.7.2018 6.7.2018 Fertavid Merck Sharp & Dohme B.V. Waarderweg 39, 2031 BN Haarlem, Nederland EU/1/09/510 10.7.2018 6.7.2018 Hirobriz Breezhaler Novartis Europharm Limited Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland EU/1/09/594 10.7.2018 6.7.2018 KEYTRUDA Merck Sharp & Dohme B.V. Waarderweg 39, 2031 BN Haarlem, Nederland EU/1/15/1024 10.7.2018 6.7.2018 Ninlaro Takeda Pharma A/S Dybendal Alle 10, 2630 Taastrup, Danmark EU/1/16/1094 10.7.2018 6.7.2018 Noxafil Merck Sharp & Dohme B.V. Waarderweg 39, 2031 BN Haarlem, Nederland EU/1/05/320 10.7.2018 6.7.2018 Pemetrexed Fresenius Kabi Fresenius Kabi Deutschland GmbH Else-Kröner-Straße 1, 61352 Bad Homburg vor der Höhe, Deutschland EU/1/16/1115 10.7.2018 6.7.2018 Pemetrexed Sandoz Sandoz GmbH Biochemiestrasse 10, 6250 Kundl, Österreich EU/1/15/1037 10.7.2018 6.7.2018 Praxbind Boehringer Ingelheim International GmbH Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland EU/1/15/1056 10.7.2018 6.7.2018 PREZISTA Janssen-Cilag International NV Turnhoutseweg 30, 2340 Beerse, België EU/1/06/380 10.7.2018 6.7.2018 Puregon Merck Sharp & Dohme B.V. Waarderweg 39, 2031 BN Haarlem, Nederland EU/1/96/008 10.7.2018 6.7.2018 Revolade Novartis Europharm Limited Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland EU/1/10/612 10.7.2018 6.7.2018 Sovaldi Gilead Sciences Ireland UC Carrigtohill, County Cork, T45 DP77, Ireland EU/1/13/894 10.7.2018 6.7.2018 Symtuza Janssen-Cilag International NV Turnhoutseweg 30, 2340 Beerse, België EU/1/17/1225 10.7.2018 6.7.2018 Tafinlar Novartis Europharm Limited Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland EU/1/13/865 10.7.2018 6.7.2018 Temozolomide HEXAL Hexal AG Industriestraße 25, 83607 Holzkirchen, Deutschland EU/1/10/616 10.7.2018 6.7.2018 Temozolomide Sandoz Sandoz GmbH Biochemiestrasse 10, 6250 Kundl, Österreich EU/1/10/617 10.7.2018 6.7.2018 Visudyne Novartis Europharm Limited Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland EU/1/00/140 10.7.2018 6.7.2018 Zykadia Novartis Europharm Limited Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland EU/1/15/999 10.7.2018 9.7.2018 Betaferon Bayer AG D-51368 Leverkusen, Deutschland EU/1/95/003 11.7.2018 9.7.2018 Fosavance Merck Sharp & Dohme B.V. Waarderweg 39, 2031 BN Haarlem, Nederland EU/1/05/310 11.7.2018 9.7.2018 MAVENCLAD Merck Europe B.V. Gustav Mahlerplein 102, 1082 MA Amsterdam, Nederland EU/1/17/1212 11.7.2018 9.7.2018 Pylobactell Torbet Laboratories Limited Unit 1 Chestnut Drive, Wymondham, Norfolk, NR18 9SB, United Kingdom EU/1/98/064 11.7.2018 9.7.2018 Qutenza Grünenthal GmbH Zieglerstraße 6, 52078, Aachen, Deutschland EU/1/09/524 11.7.2018 9.7.2018 Seebri Breezhaler Novartis Europharm Limited Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland EU/1/12/788 11.7.2018 9.7.2018 Tovanor Breezhaler Novartis Europharm Limited Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland EU/1/12/790 11.7.2018 9.7.2018 Vantavo Merck Sharp & Dohme B.V. Waarderweg 39, 2031 BN Haarlem, Nederland EU/1/09/572 11.7.2018 9.7.2018 Zavesca Actelion Registration Ltd Chiswick Tower, 13th floor, 389 Chiswick High Road, London W4 4AL, United Kingdom EU/1/02/238 11.7.2018 11.7.2018 Briviact UCB Pharma S.A. Allée de la Recherche 60, 1070 Bruxelles, Belgique/Researchdreef 60, 1070 Brussel, België EU/1/15/1073 13.7.2018 11.7.2018 Byetta AstraZeneca AB 151 85 Södertälje, Sverige EU/1/06/362 13.7.2018 11.7.2018 Erelzi Sandoz GmbH Biochemiestrasse 10, 6250 Kundl, Österreich EU/1/17/1195 13.7.2018 11.7.2018 Imnovid Celgene Europe Limited 1 Longwalk Road, Stockley Park, Uxbridge, Middlesex UB11 1DB, United Kingdom EU/1/13/850 13.7.2018 11.7.2018 Vizamyl GE Healthcare Ltd Amersham Place, Little Chalfont, Buckinghamshire HP7 9NA, United Kingdom EU/1/14/941 13.7.2018 11.7.2018 Xagrid Shire Pharmaceutical Contracts Limited 1 Kingdom Street, London W2 6BD, United Kingdom EU/1/04/295 13.7.2018 13.7.2018 Firdapse BioMarin Europe Ltd 10 Bloomsbury Way, London WC1A 2SL, United Kingdom EU/1/09/601 17.7.2018 13.7.2018 Karvea Sanofi-Aventis groupe 54 rue La Boétie, 75008 Paris, France EU/1/97/049 17.7.2018 13.7.2018 Naglazyme BioMarin International Limited Shanbally, Ringaskiddy, County Cork P43 R298, Ireland EU/1/05/324 17.7.2018 13.7.2018 Rebif Merck Serono Europe Limited 56, Marsh Wall, London E14 9TP, United Kingdom EU/1/98/063 17.7.2018 19.7.2018 Dificlir Astellas Pharma Europe B.V. Sylviusweg 62, 2333 BE Leiden, Nederland EU/1/11/733 23.7.2018 19.7.2018 Irbesartan Zentiva Sanofi-Aventis groupe 54 rue La Boétie, 75008 Paris, France EU/1/06/376 23.7.2018 19.7.2018 Lopinavir/Ritonavir Mylan Mylan S.A.S. 117 allée des Parcs, 69800 Saint Priest, France EU/1/15/1067 23.7.2018 19.7.2018 Optruma Eli Lilly Nederland B.V. Papendorpseweg 83, 3528 BJ Utrecht, Nederland EU/1/98/074 23.7.2018 19.7.2018 PecFent Kyowa Kirin Holdings B.V. Bloemlaan 2, 2132 NP Hoofddorp, Nederland EU/1/10/644 23.7.2018 19.7.2018 Plegridy Biogen Netherlands B.V. Prins Mauritslaan 13, 1171 LP Badhoevedorp, Nederland EU/1/14/934 23.7.2018 19.7.2018 Qarziba EUSA Pharma (UK) Limited Breakspear Park, Breakspear Way, Hemel Hempstead HP2 4TZ, United Kingdom EU/1/17/1191 23.7.2018 19.7.2018 Rituzena Celltrion Healthcare Hungary Kft. Váci út 1-3. WestEnd Office Building B torony, 1062 Budapest, Magyarország EU/1/17/1206 23.7.2018 19.7.2018 SANCUSO Kyowa Kirin Holdings B.V. Bloemlaan 2, 2132 NP Hoofddorp, Nederland EU/1/12/766 23.7.2018 19.7.2018 Translarna PTC Therapeutics International Limited 5th Floor, 3 Grand Canal Plaza, Grand Canal Street Upper, Dublin 4, D04 EE70, Ireland EU/1/13/902 23.7.2018 23.7.2018 Bemfola Gedeon Richter Plc. Gyömrői út 19-21., 1103 Budapest, Magyarország EU/1/13/909 25.7.2018 23.7.2018 Eperzan GlaxoSmithKline Trading Services Limited Currabinny, Carrigaline, County Cork, Ireland EU/1/13/908 25.7.2018 23.7.2018 Exjade Novartis Europharm Limited Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland EU/1/06/356 25.7.2018 23.7.2018 Ivemend Merck Sharp & Dohme B.V. Waarderweg 39, 2031 BN Haarlem, Nederland EU/1/07/437 25.7.2018 23.7.2018 Moventig Kyowa Kirin Holdings B.V. Bloemlaan 2, 2132 NP Hoofddorp, Nederland EU/1/14/962 25.7.2018 23.7.2018 Parsabiv Amgen Europe B.V. Minervum 7061, 4817 ZK Breda, Nederland EU/1/16/1142 25.7.2018 23.7.2018 PREVYMIS Merck Sharp & Dohme B.V. Waarderweg 39, 2031 BN Haarlem, Nederland EU/1/17/1245 25.7.2018 23.7.2018 Translarna PTC Therapeutics International Limited 5th Floor, 3 Grand Canal Plaza, Grand Canal Street Upper, Dublin 4, D04 EE70, Ireland EU/1/13/902 25.7.2018 23.7.2018 Ultibro Breezhaler Novartis Europharm Limited Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland EU/1/13/862 25.7.2018 23.7.2018 Vargatef Boehringer Ingelheim International GmbH Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland EU/1/14/954 25.7.2018 23.7.2018 Viread Gilead Sciences Ireland UC Carrigtohill, County Cork, T45 DP77, Ireland EU/1/01/200 25.7.2018 23.7.2018 Xoterna Breezhaler Novartis Europharm Limited Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland EU/1/13/863 25.7.2018 26.7.2018 Besponsa Pfizer Europe MA EEIG Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/Pleinlaan 17, 1050 Brussel, België EU/1/17/1200 30.7.2018 26.7.2018 Ceplene Noventia Pharma Srl Via Carlo Pisacane 31, 47121 Forli, Italia EU/1/08/477 30.7.2018 26.7.2018 Esmya Gedeon Richter Plc. Gyömrői út 19-21., 1103 Budapest, Magyarország EU/1/12/750 30.7.2018 26.7.2018 Fareston Orion Corporation Orionintie 1, 02200 Espoo, Suomi EU/1/96/004 30.7.2018 26.7.2018 Genvoya Gilead Sciences Ireland UC Carrigtohill, County Cork, T45 DP77, Ireland EU/1/15/1061 30.7.2018 26.7.2018 Invokana Janssen-Cilag International NV Turnhoutseweg 30, 2340 Beerse, België EU/1/13/884 30.7.2018 26.7.2018 Jinarc Otsuka Pharmaceutical Europe Ltd Gallions, Wexham Springs, Framewood Road, Wexham, SL3 6PJ, United Kingdom EU/1/15/1000 30.7.2018 26.7.2018 Lixiana Daiichi Sankyo Europe GmbH Zielstattstraße 48, 81379 München, Deutschland EU/1/15/993 30.7.2018 26.7.2018 NovoEight Novo Nordisk A/S Novo Allé, 2880 Bagsværd, Danmark EU/1/13/888 30.7.2018 26.7.2018 Ofev Boehringer Ingelheim International GmbH Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland EU/1/14/979 30.7.2018 26.7.2018 Procysbi Chiesi Farmaceutici S.p.A. Via Palermo 26/A, 43122 Parma, Italia EU/1/13/861 30.7.2018 26.7.2018 Rasagiline ratiopharm Teva B.V. Swensweg 5, 2031 GA Haarlem, Nederland EU/1/14/977 30.7.2018 26.7.2018 Relvar Ellipta Glaxo Group Ltd 980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom EU/1/13/886 30.7.2018 26.7.2018 Revinty Ellipta Glaxo Group Ltd 980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom EU/1/14/929 30.7.2018 26.7.2018 Segluromet Merck Sharp & Dohme B.V. Waarderweg 39, 2031 BN Haarlem, Nederland EU/1/18/1265 30.7.2018 26.7.2018 Trisenox Teva B.V. Swensweg 5, 2031 GA Haarlem, Nederland EU/1/02/204 30.7.2018 26.7.2018 Tybost Gilead Sciences Ireland UC Carrigtohill, County Cork, T45 DP77, Ireland EU/1/13/872 30.7.2018 26.7.2018 Zalmoxis MolMed S.p.A. Via Olgettina 58, 20132 Milano, Italia EU/1/16/1121 30.7.2018 30.7.2018 Abraxane Celgene Europe B.V. Winthontlaan 6 N, 3526 KV Utrecht, Nederland EU/1/07/428 1.8.2018 30.7.2018 Aprovel Sanofi Clir SNC 54 rue La Boétie, 75008 Paris, France EU/1/97/046 1.8.2018 30.7.2018 Arzerra Novartis Europharm Limited Frimley Business Park, Camberley GU16 7SR, United Kingdom EU/1/10/625 1.8.2018 30.7.2018 Bridion Merck Sharp & Dohme B.V. Waarderweg 39, 2031 BN Haarlem, Nederland EU/1/08/466 1.8.2018 30.7.2018 Champix Pfizer Europe MA EEIG Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/Pleinlaan 17, 1050 Brussel, België EU/1/06/360 1.8.2018 30.7.2018 Cyanokit SERB S.A. Avenue Louise 480, 1050 Bruxelles, Belgique /Louizalaan 480, 1050 Brussel, België EU/1/07/420 1.8.2018 30.7.2018 Enbrel Pfizer Europe MA EEIG Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/Pleinlaan 17, 1050 Brussel, België EU/1/99/126 1.8.2018 30.7.2018 Eylea Bayer AG D-51368 Leverkusen, Deutschland EU/1/12/797 1.8.2018 30.7.2018 Grastofil Apotex Europe B.V. Archimedesweg 2, 2333 CN Leiden, Nederland EU/1/13/877 1.8.2018 30.7.2018 HALAVEN Eisai Europe Limited European Knowledge Centre, Mosquito Way, Hatfield, Hertfordshire AL10 9SN, United Kingdom EU/1/11/678 1.8.2018 30.7.2018 IBRANCE Pfizer Europe MA EEIG Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/Pleinlaan 17, 1050 Brussel, België EU/1/16/1147 1.8.2018 30.7.2018 Ilaris Novartis Europharm Limited Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland EU/1/09/564 1.8.2018 30.7.2018 Imlygic Amgen Europe B.V. Minervum 7061, 4817 ZK Breda, Nederland EU/1/15/1064 1.8.2018 30.7.2018 Inflectra Pfizer Europe MA EEIG Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/Pleinlaan 17, 1050 Brussel, België EU/1/13/854 1.8.2018 30.7.2018 Intelence Janssen-Cilag International NV Turnhoutseweg 30, 2340 Beerse, België EU/1/08/468 1.8.2018 30.7.2018 Lyrica Pfizer Europe MA EEIG Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/Pleinlaan 17, 1050 Brussel, België EU/1/04/279 1.8.2018 30.7.2018 Mylotarg Pfizer Europe MA EEIG Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/Pleinlaan 17, 1050 Brussel, België EU/1/18/1277 1.8.2018 30.7.2018 Nimenrix Pfizer Europe MA EEIG Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/Pleinlaan 17, 1050 Brussel, België EU/1/12/767 1.8.2018 30.7.2018 NovoEight Novo Nordisk A/S Novo Allé, 2880 Bagsværd, Danmark EU/1/13/888 1.8.2018 30.7.2018 Opdivo Bristol-Myers Squibb Pharma EEIG Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom EU/1/15/1014 1.8.2018 30.7.2018 Pregabalin Pfizer Pfizer Europe MA EEIG Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/Pleinlaan 17, 1050 Brussel, België EU/1/14/916 1.8.2018 30.7.2018 Revatio Pfizer Europe MA EEIG Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/Pleinlaan 17, 1050 Brussel, België EU/1/05/318 1.8.2018 30.7.2018 Stocrin Merck Sharp & Dohme B.V. Waarderweg 39, 2031 BN Haarlem, Nederland EU/1/99/111 1.8.2018 30.7.2018 Strimvelis GlaxoSmithKline Trading Services Limited Currabinny, Carrigaline, County Cork, Ireland EU/1/16/1097 1.8.2018 30.7.2018 Temozolomide SUN Sun Pharmaceutical Industries Europe BV Polarisavenue 87, 2132 JH Hoofddorp, Nederland EU/1/11/697 1.8.2018 30.7.2018 Temozolomide Teva Teva B.V. Swensweg 5, 2031 GA Haarlem, Nederland EU/1/09/606 1.8.2018 30.7.2018 Thalidomide Celgene Celgene Europe Limited 1 Longwalk Road, Stockley Park, Uxbridge, Middlesex UB11 1DB, United Kingdom EU/1/08/443 1.8.2018 30.7.2018 Toviaz Pfizer Europe MA EEIG Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/Pleinlaan 17, 1050 Brussel, België EU/1/07/386 1.8.2018 30.7.2018 Tygacil Pfizer Europe MA EEIG Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/Pleinlaan 17, 1050 Brussel, België EU/1/06/336 1.8.2018 30.7.2018 Tyverb Novartis Europharm Limited Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland EU/1/07/440 1.8.2018 30.7.2018 Ucedane Lucane Pharma 172 rue de Charonne, 75011 Paris, France EU/1/17/1202 1.8.2018 30.7.2018 Viagra Pfizer Europe MA EEIG Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/Pleinlaan 17, 1050 Brussel, België EU/1/98/077 1.8.2018 30.7.2018 Vidaza Celgene Europe B.V. Winthontlaan 6 N, 3526 KV Utrecht, Nederland EU/1/08/488 1.8.2018

— Withdrawal of a marketing authorisation (Article 13 of Regulation (EC) No 726/2004 of the European Parliament and of the Council)

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 6.7.2018 DepoCyte Pacira Limited Wessex House, Marlow Road, Bourne End, Buckinghamshire, SL8 5SP, United Kingdom EU/1/01/187 10.7.2018 9.7.2018 Ariclaim Eli Lilly Nederland B.V. Papendorpseweg 83, 3528 BJ Utrecht, Nederland EU/1/04/283 11.7.2018 19.7.2018 Trobalt Glaxo Group Ltd 980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom EU/1/11/681 23.7.2018

— 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 26.7.2018 UBAC Streptococcus uberis vaccine (inactivated) Laboratorios Hipra, S.A. Avda. La Selva, 135, 17170 Amer (Girona), España EU/2/18/227 Emulsion for injection QI02AB 30.7.2018

— 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 2.7.2018 ERYSENG PARVO Laboratorios Hipra, S.A. Avda. La Selva, 135, 17170 Amer (Girona), España EU/2/14/167 4.7.2018 2.7.2018 Zolvix Elanco Europe Ltd Lilly House, Priestley Road, Basingstoke, Hampshire, RG24 9NL, United Kingdom EU/2/09/101 4.7.2018 5.7.2018 Pexion Boehringer Ingelheim Vetmedica GmbH D-55216 Ingelheim am Rhein, Deutschland EU/2/12/147 9.7.2018 9.7.2018 Coliprotec F4/F18 Prevtec Microbia GmbH Geyerspergerstr 27, 80689 München, Deutschland EU/2/16/202 11.7.2018 9.7.2018 Credelio Elanco Europe Ltd Lilly House, Priestley Road, Basingstoke, Hampshire, RG24 9NL, United Kingdom EU/2/17/206 11.7.2018 9.7.2018 ERYSENG Laboratorios Hipra, S.A. Avda. La Selva, 135, 17170 Amer (Girona), España EU/2/14/166 11.7.2018 9.7.2018 Hiprabovis IBR Marker Live Laboratorios Hipra, S.A. Avda. La Selva, 135, 17170 Amer (Girona), España EU/2/10/114 11.7.2018 9.7.2018 Trocoxil Zoetis Belgium S.A. rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique EU/2/08/084 11.7.2018 10.7.2018 Econor Elanco Europe Ltd Lilly House, Priestley Road, Basingstoke, Hampshire, RG24 9NL, United Kingdom EU/2/98/010 12.7.2018 12.7.2018 Procox Bayer Animal Health GmbH D-51368 Leverkusen, Deutschland EU/2/11/123 16.7.2018 13.7.2018 Reconcile Nexcyon Pharmaceuticals Ltd First Floor Denmark House, 143 High Street, Chalfont St Peter SL9 9QL, United Kingdom EU/2/08/080 16.7.2018 23.7.2018 Nobivac L4 Intervet International B.V. Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland EU/2/12/143 25.7.2018 23.7.2018 Respiporc Flu3 IDT Biologika GmbH Am Pharmapark, 06861 Dessau-Rosslau, Deutschland EU/2/09/103 25.7.2018 26.7.2018 Apoquel Zoetis Belgium S.A. rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique EU/2/13/154 30.7.2018

Anyone wishing to consult the public assessment report on the medicinal products in question and the decisions relating thereto is invited to contact:

European Medicines Agency 30 Churchill Place Canary Wharf London E14 5EU United Kingdom

(1) OJ L 136, 30.4.2004, p. 1.