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Dokument 52018XC0629(02)
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)
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)
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)
OJ C 229, 29.6.2018, str. 1–11
(BG, ES, CS, DA, DE, ET, EL, EN, FR, HR, IT, LV, LT, HU, MT, NL, PL, PT, RO, SK, SL, FI, SV)
|
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.