Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 May 2018 to 31 May 2018 (Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council)
Date: 2018-06-29
Institutions: European Commission
Subjects: EU Member State, drug surveillance, market approval, marketing standard, medicinal product, veterinary medicinal product, withdrawal from the market








C_2018229EN.01000101.xml










29.6.2018   


EN


Official Journal of the European Union


C 229/1





Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 May 2018 to 31 May 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 229/01)






—



Issuing of a marketing authorization (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 authorization


Number of the entry in the Community Register


Pharmaceutical form


ATC code (Anatomical Therapeutic Chemical Code)


Date of notification




16.5.2018


Juluca


dolutegravir/rilpivirine


ViiV Healthcare UK Limited
980 Great West Road, Brentford, Middlesex TW8 9GS, United Kingdom


EU/1/18/1282


Film-coated tablet


J05AR21


18.5.2018




16.5.2018


KANJINTI


trastuzumab


Amgen Europe B.V.
Minervum 7061, 4817 ZK Breda, Nederland


EU/1/18/1281


Powder for concentrate for solution for infusion


L01XC03


18.5.2018




16.5.2018


Prasugrel Mylan


prasugrel


Mylan S.A.S.
117 allée des Parcs, 69800 Saint Priest, France


EU/1/18/1273


Film-coated tablet


B01AC22


18.5.2018




18.5.2018


Zessly


infliximab


Sandoz GmbH
Biochemiestrasse 10, 6250 Kundl, Österreich


EU/1/18/1280


Powder for concentrate and diluent for solution for infusion


L04AB02


23.5.2018




22.5.2018


Pemetrexed Krka


pemetrexed


KRKA, d.d., Novo mesto
Šmarješka cesta 6, 8501 Novo mesto, Slovenija


EU/1/18/1283


Powder for concentrate for solution for infusion


L01BA04


24.5.2018




24.5.2018


AMGLIDIA


glibenclamide


AMMTeK
15 rue Béranger, 75003 Paris, France


EU/1/18/1279


Oral suspension


A10BB01


28.5.2018




24.5.2018


Rubraca


rucaparib


Clovis Oncology UK Limited
Sheraton House, Castle Park, Castle Hill, Cambridge CB3 0AX, United Kingdom


EU/1/17/1250


Film-coated tablet


L01XX55


29.5.2018










—



Modification of a marketing authorization (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 authorization


Number of the entry in the Community Register


Date of notification




8.5.2018


Afinitor


Novartis Europharm Limited
Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland


EU/1/09/538


15.5.2018




8.5.2018


Aflunov


Seqirus S.r.l.
Via Fiorentina 1, Siena, Italia


EU/1/10/658


15.5.2018




8.5.2018


Alofisel


Takeda Pharma A/S
Dybendal Alle 10, 2630 Taastrup, Danmark


EU/1/17/1261


16.5.2018




8.5.2018


Busulfan Fresenius Kabi


Fresenius Kabi Deutschland GmbH
Else-Kröner-Straße 1, 61352 Bad Homburg vor der Höhe, Deutschland


EU/1/14/951


16.5.2018




8.5.2018


CABOMETYX


Ipsen Pharma
65 quai Georges Gorse, 92100 Boulogne-Billancourt, France


EU/1/16/1136


15.5.2018




8.5.2018


Docetaxel Kabi


Fresenius Kabi Deutschland GmbH
Else-Kröner-Straße 1, 61352 Bad Homburg vor der Höhe, Deutschland


EU/1/12/770


16.5.2018




8.5.2018


Effentora


Teva B.V.
Swensweg 5, 2031 GA Haarlem, Nederland


EU/1/08/441


15.5.2018




8.5.2018


Elonva


Merck Sharp & Dohme B.V.
Waarderweg 39, 2031 BN Haarlem, Nederland


EU/1/09/609


16.5.2018




8.5.2018


Flixabi


Samsung Bioepis UK Limited
5th floor, Profile West, 950 Great West Road, Brentford, Middlesex TW8 9ES, United Kingdom


EU/1/16/1106


15.5.2018




8.5.2018


Inflectra


Hospira UK Limited
Horizon, Honey Lane, Hurley, Maidenhead SL6 6RJ, United Kingdom


EU/1/13/854


16.5.2018




8.5.2018


Instanyl


Takeda Pharma A/S
Dybendal Alle 10, 2630 Taastrup, Danmark


EU/1/09/531


15.5.2018




8.5.2018


Invanz


Merck Sharp & Dohme B.V.
Waarderweg 39, 2031 BN Haarlem, Nederland


EU/1/02/216


15.5.2018




8.5.2018


Izba


Novartis Europharm Limited
Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland


EU/1/13/905


15.5.2018




8.5.2018


KEYTRUDA


Merck Sharp & Dohme B.V.
Waarderweg 39, 2031 BN Haarlem, Nederland


EU/1/15/1024


15.5.2018




8.5.2018


LIFMIOR


Pfizer Limited
Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom


EU/1/16/1165


15.5.2018




8.5.2018


Lonquex


UAB ‘Sicor Biotech’
Molėtų pl. 5, 08409 Vilnius, Lietuva


EU/1/13/856


15.5.2018




8.5.2018


Lynparza


AstraZeneca AB
151 85 Södertälje, Sverige


EU/1/14/959


15.5.2018




8.5.2018


Odomzo


Sun Pharmaceutical Industries Europe BV
Polarisavenue 87, 2132 JH Hoofddorp, Nederland


EU/1/15/1030


15.5.2018




8.5.2018


Orphacol


Laboratoires CTRS
63 rue de l’Est, 92100 Boulogne-Billancourt, France


EU/1/13/870


15.5.2018




8.5.2018


Oslif Breezhaler


Novartis Europharm Limited
Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland


EU/1/09/586


15.5.2018




8.5.2018


PecFent


Kyowa Kirin Services Ltd
Galabank Business Park, Galashiels, TD1 1QH, United Kingdom


EU/1/10/644


15.5.2018




8.5.2018


Pemetrexed Fresenius Kabi


Fresenius Kabi Oncology Plc.
Lion Court, Farnham Road, Bordon, Hampshire GU35 0NF, United Kingdom


EU/1/16/1115


15.5.2018




8.5.2018


Pemetrexed Hospira


Hospira UK Limited
Horizon, Honey Lane, Hurley, Maidenhead SL6 6RJ, United Kingdom


EU/1/15/1057


15.5.2018




8.5.2018


Pramipexole Accord


Accord Healthcare Limited
Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF, United Kingdom


EU/1/11/728


15.5.2018




8.5.2018


Prometax


Novartis Europharm Limited
Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland


EU/1/98/092


15.5.2018




8.5.2018


Rekovelle


Ferring Pharmaceuticals A/S
Kay Fiskers Plads 11, 2300 Copenhagen S, Danmark


EU/1/16/1150


15.5.2018




8.5.2018


Repatha


Amgen Europe B.V.
Minervum 7061, 4817 ZK Breda, Nederland


EU/1/15/1016


15.5.2018




8.5.2018


Riluzole Zentiva


Zentiva k.s.
U kabelovny 130, 102 37 Praha 10, Česká republika


EU/1/12/768


15.5.2018




8.5.2018


Starlix


Novartis Europharm Limited
Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland


EU/1/01/174


15.5.2018




8.5.2018


Synagis


AbbVie Deutschland GmbH & Co. KG
Knollstrasse, 67061 Ludwigshafen, Deutschland


EU/1/99/117


15.5.2018




8.5.2018


Tafinlar


Novartis Europharm Limited
Frimley Business Park, Camberley GU16 7SR, United Kingdom


EU/1/13/865


15.5.2018




8.5.2018


Tivicay


ViiV Healthcare BV
Huis ter Heideweg 62, 3705 LZ Zeist, Nederland


EU/1/13/892


16.5.2018




8.5.2018


Travatan


Novartis Europharm Limited
Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland


EU/1/01/199


15.5.2018




8.5.2018


Ulunar Breezhaler


Novartis Europharm Limited
Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland


EU/1/14/917


15.5.2018




8.5.2018


Votrient


Novartis Europharm Limited
Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland


EU/1/10/628


15.5.2018




8.5.2018


Zerbaxa


Merck Sharp & Dohme Limited
Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom


EU/1/15/1032


15.5.2018




16.5.2018


Giotrif


Boehringer Ingelheim International GmbH
Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland


EU/1/13/879


18.5.2018




16.5.2018


Januvia


Merck Sharp & Dohme Limited
Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom


EU/1/07/383


18.5.2018




16.5.2018


Nordimet


Nordic Group B.V.
Siriusdreef 22, 2132 WT Hoofddorp, Nederland


EU/1/16/1124


18.5.2018




16.5.2018


Odefsey


Gilead Sciences Ireland UC
Carrigtohill, County Cork, T45 DP77, Ireland


EU/1/16/1112


18.5.2018




16.5.2018


Ovaleap


Teva B.V.
Swensweg 5, 2031 GA Haarlem, Nederland


EU/1/13/871


18.5.2018




22.5.2018


Bosulif


Pfizer Limited
Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom


EU/1/13/818


24.5.2018




22.5.2018


Efficib


Merck Sharp & Dohme Limited
Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom


EU/1/08/457


24.5.2018




22.5.2018


Jakavi


Novartis Europharm Limited
Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland


EU/1/12/773


25.5.2018




22.5.2018


Janumet


Merck Sharp & Dohme Limited
Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom


EU/1/08/455


24.5.2018




22.5.2018


Jylamvo


Therakind Ltd
314 Regents Park Road, London N3 2JX, United Kingdom


EU/1/17/1172


24.5.2018




22.5.2018


Osseor


Les Laboratoires Servier
50 rue Carnot, 92284 Suresnes Cedex, France


EU/1/04/287


24.5.2018




22.5.2018


Pedea


Orphan Europe S.A.R.L.
Immeuble Le Wilson, 70 avenue du Général de Gaulle, 92 800 Puteaux, France


EU/1/04/284


24.5.2018




22.5.2018


Protelos


Les Laboratoires Servier
50 rue Carnot, 92284 Suresnes Cedex, France


EU/1/04/288


24.5.2018




22.5.2018


Ristaben


Merck Sharp & Dohme Limited
Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom


EU/1/10/621


24.5.2018




22.5.2018


Ristfor


Merck Sharp & Dohme Limited
Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom


EU/1/10/620


24.5.2018




22.5.2018


Stivarga


Bayer AG
D-51368 Leverkusen, Deutschland


EU/1/13/858


24.5.2018




22.5.2018


Stribild


Gilead Sciences Ireland UC
Carrigtohill, County Cork, T45 DP77, Ireland


EU/1/13/830


24.5.2018




22.5.2018


Tesavel


Merck Sharp & Dohme Limited
Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom


EU/1/07/435


24.5.2018




22.5.2018


Tybost


Gilead Sciences Ireland UC
Carrigtohill, County Cork, T45 DP77, Ireland


EU/1/13/872


24.5.2018




22.5.2018


Tyverb


Novartis Europharm Limited
Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland


EU/1/07/440


24.5.2018




22.5.2018


Ultibro Breezhaler


Novartis Europharm Limited
Frimley Business Park, Camberley GU16 7SR, United Kingdom


EU/1/13/862


24.5.2018




22.5.2018


Velmetia


Merck Sharp & Dohme Limited
Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom


EU/1/08/456


24.5.2018




22.5.2018


Xarelto


Bayer AG
D-51368 Leverkusen, Deutschland


EU/1/08/472


24.5.2018




22.5.2018


Xelevia


Merck Sharp & Dohme Limited
Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom


EU/1/07/382


24.5.2018




22.5.2018


Xoterna Breezhaler


Novartis Europharm Limited
Frimley Business Park, Camberley GU16 7SR, United Kingdom


EU/1/13/863


24.5.2018




23.5.2018


Kaletra


AbbVie Deutschland GmbH & Co. KG
Knollstrasse, 67061 Ludwigshafen, Deutschland


EU/1/01/172


25.5.2018




24.5.2018


Atazanavir Mylan


Mylan S.A.S.
117 allée des Parcs, 69800 Saint Priest, France


EU/1/16/1091


28.5.2018




24.5.2018


Cayston


Gilead Sciences Ireland UC
Carrigtohill, County Cork, T45 DP77, Ireland


EU/1/09/543


28.5.2018




24.5.2018


Darunavir Mylan


Mylan S.A.S.
117 allée des Parcs, 69800 Saint Priest, France


EU/1/16/1140


28.5.2018




24.5.2018


Emend


Merck Sharp & Dohme B.V.
Waarderweg 39, 2031 BN Haarlem, Nederland


EU/1/03/262


29.5.2018




24.5.2018


Norvir


AbbVie Deutschland GmbH & Co. KG
Knollstrasse, 67061 Ludwigshafen, Deutschland


EU/1/96/016


29.5.2018




24.5.2018


Procysbi


Chiesi Farmaceutici S.p.A.
Via Palermo 26/A, 43122 Parma, Italia


EU/1/13/861


28.5.2018




24.5.2018


Vipdomet


Takeda Pharma A/S
Dybendal Alle 10, 2630 Taastrup, Danmark


EU/1/13/843


28.5.2018




24.5.2018


Vipidia


Takeda Pharma A/S
Dybendal Alle 10, 2630 Taastrup, Danmark


EU/1/13/844


28.5.2018




25.5.2018


Armisarte


Actavis Group PTC ehf.
Reykjavíkurvegi 76-78, 220 Hafnarfjörður, Íceland


EU/1/15/1063


28.5.2018




25.5.2018


Incresync


Takeda Pharma A/S
Dybendal Alle 10, 2630 Taastrup, Danmark


EU/1/13/842


28.5.2018




28.5.2018


Atosiban SUN


Sun Pharmaceutical Industries Europe BV
Polarisavenue 87, 2132 JH Hoofddorp, Nederland


EU/1/13/852


30.5.2018




28.5.2018


AUBAGIO


Sanofi-Aventis groupe
54 rue La Boétie, 75008 Paris, France


EU/1/13/838


30.5.2018




28.5.2018


Bortezomib Accord


Accord Healthcare Limited
Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF, United Kingdom


EU/1/15/1019


30.5.2018




28.5.2018


Descovy


Gilead Sciences Ireland UC
Carrigtohill, County Cork, T45 DP77, Ireland


EU/1/16/1099


30.5.2018




28.5.2018


Epclusa


Gilead Sciences Ireland UC
Carrigtohill, County Cork, T45 DP77, Ireland


EU/1/16/1116


30.5.2018




28.5.2018


Eviplera


Gilead Sciences Ireland UC
Carrigtohill, County Cork, T45 DP77, Ireland


EU/1/11/737


30.5.2018




28.5.2018


Hepsera


Gilead Sciences Ireland UC
Carrigtohill, County Cork, T45 DP77, Ireland


EU/1/03/251


30.5.2018




28.5.2018


Ledaga


Actelion Registration Ltd
Chiswick Tower, 13th floor, 389 Chiswick High Road, London W4 4AL, United Kingdom


EU/1/16/1171


30.5.2018




28.5.2018


Lixiana


Daiichi Sankyo Europe GmbH
Zielstattstraße 48, 81379 München, Deutschland


EU/1/15/993


30.5.2018




28.5.2018


Plavix


Sanofi Clir SNC
54 rue La Boétie, 75008 Paris, France


EU/1/98/069


30.5.2018




28.5.2018


Senshio


Shionogi Limited
33 Kingsway, London WC2B 6UF, United Kingdom


EU/1/14/978


30.5.2018




28.5.2018


Tecfidera


Biogen Idec Limited
Innovation House, 70 Norden Road, Maidenhead, Berkshire SL6 4AY, United Kingdom


EU/1/13/837


30.5.2018




28.5.2018


Temodal


Merck Sharp & Dohme Limited
Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom


EU/1/98/096


30.5.2018




28.5.2018


Vemlidy


Gilead Sciences Ireland UC
Carrigtohill, County Cork, T45 DP77, Ireland


EU/1/16/1154


30.5.2018




28.5.2018


Vokanamet


Janssen-Cilag International NV
Turnhoutseweg 30, 2340 Beerse, België


EU/1/14/918


30.5.2018




31.5.2018


Alecensa


Roche Registration GmbH
Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Deutschland


EU/1/16/1169


4.6.2018




31.5.2018


Champix


Pfizer Limited
Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom


EU/1/06/360


4.6.2018




31.5.2018


Chenodeoxycholic acid Leadiant


Leadiant GmbH
Liebherrstraße 22, 80538 München, Deutschland


EU/1/16/1110


4.6.2018




31.5.2018


DuoTrav


Novartis Europharm Limited
Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland


EU/1/06/338


5.6.2018




31.5.2018


Eliquis


Bristol-Myers Squibb/Pfizer EEIG
Bristol-Myers Squibb House, Uxbridge Business Park, Sanderson Road, Uxbridge, Middlesex UB8 1DH, United Kingdom


EU/1/11/691


4.6.2018




31.5.2018


Exviera


AbbVie Deutschland GmbH & Co. KG
Knollstrasse, 67061 Ludwigshafen, Deutschland


EU/1/14/983


4.6.2018




31.5.2018


Perjeta


Roche Registration GmbH
Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Deutschland


EU/1/13/813


4.6.2018




31.5.2018


Sprycel


Bristol-Myers Squibb Pharma EEIG
Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom


EU/1/06/363


4.6.2018




31.5.2018


Tadalafil Lilly


Eli Lilly Nederland B.V.
Papendorpseweg 83, 3528 BJ Utrecht, Nederland


EU/1/17/1177


4.6.2018




31.5.2018


Twynsta


Boehringer Ingelheim International GmbH
Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland


EU/1/10/648


4.6.2018




31.5.2018


Venclyxto


AbbVie Deutschland GmbH & Co. KG
Knollstrasse, 67061 Ludwigshafen, Deutschland


EU/1/16/1138


4.6.2018




31.5.2018


Votubia


Novartis Europharm Limited
Frimley Business Park, Camberley GU16 7SR, United Kingdom


EU/1/11/710


4.6.2018




31.5.2018


Yervoy


Bristol-Myers Squibb Pharma EEIG
Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom


EU/1/11/698


4.6.2018










—



Withdrawal of a marketing authorization (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 authorization


Number of the entry in the Community Register


Date of notification




8.5.2018


Imatinib Teva B.V.


Teva B.V.
Swensweg 5, 2031 GA Haarlem, Nederland


EU/1/17/1243


15.5.2018










—



Issuing of a marketing authorization (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 authorization


Number of the entry in the Community Register


Pharmaceutical form


ATC code (Anatomical Therapeutic Chemical Code)


Date of notification




8.5.2018


Bravecto Plus


fluralaner/moxidectin


Intervet International B.V.
Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland


EU/2/18/224


Spot-on solution


QP54AB52


16.5.2018










—



Modification of a marketing authorization (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 authorization


Number of the entry in the Community Register


Date of notification




8.5.2018


Fevaxyn Pentofel


Zoetis Belgium S.A.
rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique


EU/2/96/002


15.5.2018




8.5.2018


Semintra


Boehringer Ingelheim Vetmedica GmbH
D-55216 Ingelheim am Rhein, Deutschland


EU/2/12/146


16.5.2018




8.5.2018


Suvaxyn Aujeszky 783 + O/W


Zoetis Belgium S.A.
rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique


EU/2/98/009


16.5.2018




25.5.2018


GALLIPRANT


Elanco GmbH
Heinz-Lohmann-Straße 4, 27472 Cuxhaven, Deutschland


EU/2/17/221


29.5.2018




25.5.2018


Osurnia


Elanco Europe Ltd
Lilly House, Priestley Road, Basingstoke, Hampshire, RG24 9NL, United Kingdom


EU/2/14/170


29.5.2018




25.5.2018


Profender


Bayer Animal Health GmbH
D-51368 Leverkusen, Deutschland


EU/2/05/054


29.5.2018




25.5.2018


Sevohale


Chanelle Pharmaceuticals Manufacturing Limited
Loughrea, Co. Galway, Ireland


EU/2/16/196


30.5.2018










—



Withdrawal of a marketing authorization (Article 38 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 authorization


Number of the entry in the Community Register


Date of notification




8.5.2018


BTVPUR AlSap 1


Merial
29 avenue Tony Garnier, 69007 Lyon, France


EU/2/10/112


16.5.2018




8.5.2018


BTVPUR AlSap 8


Merial
29 avenue Tony Garnier, 69007 Lyon, France


EU/2/09/094


16.5.2018




25.5.2018


Meloxivet


Eli Lilly and Company Limited
Elanco Animal Health, Lilly House, Priestley Road, Basingstoke, Hampshire RG24 9NL, United Kingdom


EU/2/07/077


29.5.2018




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.