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)
Date: 2018-08-31
Institutions: European Commission
Subjects: EU Member State, drug surveillance, market approval, marketing standard, medicinal product, veterinary medicinal product, withdrawal from the market








C_2018309EN.01000101.xml










31.8.2018   


EN


Official Journal of the European Union


C 309/1






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.