Navigation path

Pharmaceuticals - Community Register

  

Newly adopted Marketing Authorisation Decisions (last six months)

Procedures for centrally authorised medicinal products for human use
Product Marketing Authorisation Holder Decision Type Decision date EMEA Nr
Orbactiv Rempex London Ltd Centralised - Transfer Marketing Authorisation Holder 13 Aug 2018 EMEA/H/C/3785/T/20
Thalidomide Celgene Celgene Europe B.V. Centralised - Transfer Marketing Authorisation Holder 8 Aug 2018 EMEA/H/C/823/T/57
Lymphoseek Norgine B.V. Centralised - Yearly update 8 Aug 2018
Cubicin Merck Sharp & Dohme B.V. Centralised - Transfer Marketing Authorisation Holder 8 Aug 2018 EMEA/H/C/637/T/69
Brinavess Correvio Centralised - Transfer Marketing Authorisation Holder 8 Aug 2018 EMEA/H/C/1215/T/31
Sivextro Merck Sharp & Dohme B.V. Centralised - Transfer Marketing Authorisation Holder 8 Aug 2018 EMEA/H/C/2846/T/28
Tesavel Merck Sharp & Dohme B.V. Centralised - Transfer Marketing Authorisation Holder 8 Aug 2018 EMEA/H/C/910/T/65
CANCIDAS Merck Sharp & Dohme B.V. Centralised - Transfer Marketing Authorisation Holder 8 Aug 2018 EMEA/H/C/379/T/67
Torisel Pfizer Europe MA EEIG Centralised - Transfer Marketing Authorisation Holder 8 Aug 2018 EMEA/H/C/799/T/71
Januvia Merck Sharp & Dohme B.V. Centralised - Transfer Marketing Authorisation Holder 8 Aug 2018 EMEA/H/C/722/T/65
Bortezomib Hospira Pfizer Europe MA EEIG Centralised - Transfer Marketing Authorisation Holder 8 Aug 2018 EMEA/H/C/4207/T/10
GONAL-f Merck Europe B.V. Centralised - Transfer Marketing Authorisation Holder 6 Aug 2018 EMEA/H/C/71/T/140
Tadalafil Mylan Mylan S.A.S. Centralised - Transfer Marketing Authorisation Holder 3 Aug 2018 EMEA/H/C/3787/T/11
Ribavirin Mylan Mylan S.A.S. Centralised - Transfer Marketing Authorisation Holder 3 Aug 2018 EMEA/H/C/1185/T/29
Crixivan Merck Sharp & Dohme B.V. Centralised - Transfer Marketing Authorisation Holder 3 Aug 2018 EMEA/H/C/128/T/104
Duloxetine Mylan Generics [UK] Limited Centralised - Transfer Marketing Authorisation Holder 3 Aug 2018 EMEA/H/C/3981/T/14
Numient Impax Laboratories Ireland Limited Centralised - Transfer Marketing Authorisation Holder 3 Aug 2018 EMEA/H/C/2611/T/5
Vyndaqel Pfizer Europe MA EEIG Centralised - Transfer Marketing Authorisation Holder 3 Aug 2018 EMEA/H/C/2294/T/45
Inlyta Pfizer Europe MA EEIG Centralised - Transfer Marketing Authorisation Holder 3 Aug 2018 EMEA/H/C/2406/T/24
Accofil Accord Healthcare Limited Centralised - Yearly update 3 Aug 2018
Duaklir Genuair AstraZeneca AB Centralised - Yearly update 3 Aug 2018
Brimica Genuair AstraZeneca AB Centralised - Yearly update 3 Aug 2018
Intanza Sanofi Pasteur Europe Centralised - Withdrawal 3 Aug 2018
Inovelon Eisai Limited Centralised - 2-Monthly update 3 Aug 2018 EMEA/H/C/660/II/45
Memantine Accord Accord Healthcare Limited Centralised - Renewal 3 Aug 2018 EMEA/H/C/2766/R/10
Kyntheum Leo Pharma A/S Centralised - Yearly update 2 Aug 2018
Tepadina ADIENNE S.r.l. Centralised - Yearly update 2 Aug 2018
Insulin lispro Sanofi Sanofi-Aventis groupe Centralised - Yearly update 2 Aug 2018
Cetrotide Merck Europe B.V. Centralised - Transfer Marketing Authorisation Holder 2 Aug 2018 EMEA/H/C/233/T/67
DUAVIVE Pfizer Europe MA EEIG Centralised - Transfer Marketing Authorisation Holder 2 Aug 2018 EMEA/H/C/2314/T/18
Bosulif Pfizer Europe MA EEIG Centralised - Transfer Marketing Authorisation Holder 2 Aug 2018 EMEA/H/C/2373/T/32
ReFacto AF Pfizer Europe MA EEIG Centralised - Transfer Marketing Authorisation Holder 2 Aug 2018 EMEA/H/C/232/T/146
Conbriza Pfizer Europe MA EEIG Centralised - Transfer Marketing Authorisation Holder 2 Aug 2018 EMEA/H/C/913/T/47
Tysabri Biogen Netherlands B.V. Centralised - Transfer Marketing Authorisation Holder 2 Aug 2018 EMEA/H/C/603/T/110
Avonex Biogen Netherlands B.V. Centralised - Transfer Marketing Authorisation Holder 2 Aug 2018 EMEA/H/C/102/T/178
Otezla Celgene Europe B.V. Centralised - Transfer Marketing Authorisation Holder 2 Aug 2018 EMEA/H/C/3746/T/20
Siklos Addmedica Centralised - Yearly update 2 Aug 2018
Zoledronic acid Accord Accord Healthcare Limited Centralised - Yearly update 2 Aug 2018
Fampyra Biogen Netherlands B.V. Centralised - Transfer Marketing Authorisation Holder 2 Aug 2018 EMEA/H/C/2097/T/43
Onglyza AstraZeneca AB Centralised - 2-Monthly update 2 Aug 2018 EMEA/H/C/1039/WS/1289/45
Temomedac medac Gesellschaft für klinische Spezialpräparate mbH Centralised - Yearly update 2 Aug 2018
KEYTRUDA Merck Sharp & Dohme B.V. Centralised - 2-Monthly update 2 Aug 2018 EMEA/H/C/3820/II/48
Dexdor Orion Corporation Centralised - 2-Monthly update 2 Aug 2018 EMEA/H/C/2268/II/26
Rapamune Pfizer Limited Centralised - 2-Monthly update 2 Aug 2018 EMEA/H/C/273/II/164
Ucedane Lucane Pharma Centralised - Yearly update 30 Jul 2018
Inflectra Pfizer Europe MA EEIG Centralised - Transfer Marketing Authorisation Holder 30 Jul 2018 EMEA/H/C/2778/T/64
Champix Pfizer Europe MA EEIG Centralised - Transfer Marketing Authorisation Holder 30 Jul 2018 EMEA/H/C/699/T/71
HALAVEN Eisai Europe Limited Centralised - Yearly update 30 Jul 2018
Grastofil Apotex Europe B.V. Centralised - Yearly update 30 Jul 2018
Nimenrix Pfizer Europe MA EEIG Centralised - Transfer Marketing Authorisation Holder 30 Jul 2018 EMEA/H/C/2226/T/80
Arzerra Novartis Europharm Limited Centralised - Yearly update 30 Jul 2018
Lyrica Pfizer Europe MA EEIG Centralised - Transfer Marketing Authorisation Holder 30 Jul 2018 EMEA/H/C/546/T/95
Cyanokit SERB S.A. Centralised - Yearly update 30 Jul 2018
Enbrel Pfizer Europe MA EEIG Centralised - Transfer Marketing Authorisation Holder 30 Jul 2018 EMEA/H/C/262/T/222
Strimvelis GlaxoSmithKline Trading Services Limited Centralised - Yearly update 30 Jul 2018
Viagra Pfizer Europe MA EEIG Centralised - Transfer Marketing Authorisation Holder 30 Jul 2018 EMEA/H/C/202/T/98
IBRANCE Pfizer Europe MA EEIG Centralised - Transfer Marketing Authorisation Holder 30 Jul 2018 EMEA/H/C/3853/T/14
Abraxane Celgene Europe B.V. Centralised - Transfer Marketing Authorisation Holder 30 Jul 2018 EMEA/H/C/778/T/91
Vidaza Celgene Europe B.V. Centralised - Transfer Marketing Authorisation Holder 30 Jul 2018 EMEA/H/C/978/T/42
Bridion Merck Sharp & Dohme B.V. Centralised - Transfer Marketing Authorisation Holder 30 Jul 2018 EMEA/H/C/885/T/30
Aprovel Sanofi Clir SNC Centralised - Yearly update 30 Jul 2018
Tygacil Pfizer Europe MA EEIG Centralised - Transfer Marketing Authorisation Holder 30 Jul 2018 EMEA/H/C/644/T/104
Pregabalin Pfizer Pfizer Europe MA EEIG Centralised - Transfer Marketing Authorisation Holder 30 Jul 2018 EMEA/H/C/3880/T/24
Revatio Pfizer Europe MA EEIG Centralised - Transfer Marketing Authorisation Holder 30 Jul 2018 EMEA/H/C/638/T/82
Temozolomide Teva Teva B.V. Centralised - Yearly update 30 Jul 2018
Temozolomide SUN Sun Pharmaceutical Industries Europe BV Centralised - Yearly update 30 Jul 2018
Toviaz Pfizer Europe MA EEIG Centralised - Transfer Marketing Authorisation Holder 30 Jul 2018 EMEA/H/C/723/T/52
Mylotarg Pfizer Europe MA EEIG Centralised - Transfer Marketing Authorisation Holder 30 Jul 2018 EMEA/H/C/4204/T/1
Arava Sanofi-Aventis Deutschland GmbH Centralised - Yearly update 30 Jul 2018
Ilaris Novartis Europharm Limited Centralised - Transfer Marketing Authorisation Holder 30 Jul 2018 EMEA/H/C/1109/T/58
Intelence Janssen-Cilag International NV Centralised - Yearly update 30 Jul 2018
Stocrin Merck Sharp & Dohme B.V. Centralised - 2-Monthly update 30 Jul 2018 EMEA/H/C/250/II/114
Opdivo Bristol-Myers Squibb Pharma EEIG Centralised - 2-Monthly update 30 Jul 2018 EMEA/H/C/3985/II/41
Tyverb Novartis Europharm Limited Centralised - 2-Monthly update 30 Jul 2018 EMEA/H/C/795/II/51
Eylea Bayer AG Centralised - 2-Monthly update 30 Jul 2018 EMEA/H/C/2392/II/45
Imlygic Amgen Europe B.V. PSUSA - Modification 30 Jul 2018 EMEA/H/C/PSUSA/10459/201710
NovoEight Novo Nordisk A/S Centralised - Renewal 30 Jul 2018 EMEA/H/C/2719/R/25
Myalepta Aegerion Pharmaceuticals B.V. Centralised - Authorisation 30 Jul 2018 EMEA/H/C/4218
Thalidomide Celgene Celgene Europe B.V. PSUSA - Modification 30 Jul 2018 EMEA/H/C/PSUSA/2919/201710
Besponsa Pfizer Europe MA EEIG Centralised - Transfer Marketing Authorisation Holder 26 Jul 2018 EMEA/H/C/4119/T/7
Segluromet Merck Sharp & Dohme B.V. Centralised - Transfer Marketing Authorisation Holder 26 Jul 2018 EMEA/H/C/4314/T/2
Rasagiline ratiopharm Teva B.V. Centralised - Yearly update 26 Jul 2018
Jinarc Otsuka Pharmaceutical Europe Ltd Centralised - 2-Monthly update 26 Jul 2018 EMEA/H/C/2788/II/9
Ceplene Noventia Pharma Srl Centralised - Renewal 26 Jul 2018 EMEA/H/C/796/R/36
Zalmoxis MolMed S.p.A. Centralised - Renewal 26 Jul 2018 EMEA/H/C/2801/R/10
Ofev Boehringer Ingelheim International GmbH PSUSA - Modification 26 Jul 2018 EMEA/H/C/PSUSA/10319/201710
Trazimera Pfizer Europe MA EEIG Centralised - Authorisation 26 Jul 2018 EMEA/H/C/4463
Tybost Gilead Sciences Ireland UC Centralised - Renewal 26 Jul 2018 EMEA/H/C/2572/R/41
Nityr Cycle Pharmaceuticals Ltd Centralised - Authorisation 26 Jul 2018 EMEA/H/C/4582
RXULTI Otsuka Pharmaceutical Europe Ltd Centralised - Authorisation 26 Jul 2018 EMEA/H/C/3841
Lixiana Daiichi Sankyo Europe GmbH PSUSA - Modification 26 Jul 2018 EMEA/H/C/2629/PSUSA/10387/201710
Trisenox Teva B.V. PSUSA - Modification 26 Jul 2018 EMEA/H/C/PSUSA/235/201709
Fareston Orion Corporation PSUSA - Modification 26 Jul 2018 EMEA/H/C/PSUSA/2999/201709
Esmya Gedeon Richter Plc. Referral 26 Jul 2018 EMEA/H/C/2041/A-20
NovoEight Novo Nordisk A/S Centralised - 2-Monthly update 26 Jul 2018 EMEA/H/C/2719/II/23
Hefiya Sandoz GmbH Centralised - Authorisation 26 Jul 2018 EMEA/H/C/4865
Aimovig Novartis Europharm Limited Centralised - Authorisation 26 Jul 2018 EMEA/H/C/4447
Procysbi Chiesi Farmaceutici S.p.A. Centralised - Renewal 26 Jul 2018 EMEA/H/C/2465/R/19
Halimatoz Sandoz GmbH Centralised - Authorisation 26 Jul 2018 EMEA/H/C/4866
Hyrimoz Sandoz GmbH Centralised - Authorisation 26 Jul 2018 EMEA/H/C/4320
Revinty Ellipta Glaxo Group Ltd Centralised - Renewal 26 Jul 2018 EMEA/H/C/2745/R/33
Relvar Ellipta Glaxo Group Ltd Centralised - Renewal 26 Jul 2018 EMEA/H/C/2673/R/37
Genvoya Gilead Sciences Ireland UC PSUSA - Modification 26 Jul 2018 EMEA/H/C/4042/PSUSA/10449/201711
Invokana Janssen-Cilag International NV Centralised - Renewal 26 Jul 2018 EMEA/H/C/2649/R/37
Alsitek AB Science Centralised - Refusal of marketing authorisation 26 Jul 2018 EMEA/H/C/4398
Ivemend Merck Sharp & Dohme B.V. Centralised - Transfer Marketing Authorisation Holder 23 Jul 2018 EMEA/H/C/743/T/39
Eperzan GlaxoSmithKline Trading Services Limited Centralised - Yearly update 23 Jul 2018
Parsabiv Amgen Europe B.V. Centralised - Yearly update 23 Jul 2018
Xoterna Breezhaler Novartis Europharm Limited Centralised - Transfer Marketing Authorisation Holder 23 Jul 2018 EMEA/H/C/3755/T/28
Moventig Kyowa Kirin Holdings B.V. Centralised - Transfer Marketing Authorisation Holder 23 Jul 2018 EMEA/H/C/2810/T/23
Viread Gilead Sciences Ireland UC Centralised - Transfer Marketing Authorisation Holder 23 Jul 2018 EMEA/H/C/419/T/187
PREVYMIS Merck Sharp & Dohme B.V. Centralised - Transfer Marketing Authorisation Holder 23 Jul 2018 EMEA/H/C/4536/T/2
Ultibro Breezhaler Novartis Europharm Limited Centralised - Transfer Marketing Authorisation Holder 23 Jul 2018 EMEA/H/C/2679/T/25
Vargatef Boehringer Ingelheim International GmbH PSUSA - Modification 23 Jul 2018 EMEA/H/C/2569/PSUSA/10318/201710
Bemfola Gedeon Richter Plc. Centralised - Yearly update 23 Jul 2018
Exjade Novartis Europharm Limited PSUSA - Modification 23 Jul 2018 EMEA/H/C/PSUSA/939/201710
Translarna PTC Therapeutics International Limited Centralised - 2-Monthly update 23 Jul 2018 EMEA/H/C/2720/II/37
Dificlir Astellas Pharma Europe B.V. Centralised - Yearly update 19 Jul 2018
Lopinavir/Ritonavir Mylan Mylan S.A.S. Centralised - Yearly update 19 Jul 2018
Irbesartan Zentiva Sanofi-Aventis groupe Centralised - Yearly update 19 Jul 2018
Plegridy Biogen Netherlands B.V. Centralised - Transfer Marketing Authorisation Holder 19 Jul 2018 EMEA/H/C/2827/T/49
Optruma Eli Lilly Nederland B.V. Centralised - Yearly update 19 Jul 2018
PecFent Kyowa Kirin Holdings B.V. Centralised - Transfer Marketing Authorisation Holder 19 Jul 2018 EMEA/H/C/1164/T/46
SANCUSO Kyowa Kirin Holdings B.V. Centralised - Transfer Marketing Authorisation Holder 19 Jul 2018 EMEA/H/C/2296/T/52
Qarziba EUSA Pharma (UK) Limited Centralised - Yearly update 19 Jul 2018
Rituzena Celltrion Healthcare Hungary Kft. Centralised - Yearly update 19 Jul 2018
Trobalt Glaxo Group Ltd Centralised - Withdrawal 19 Jul 2018
Translarna PTC Therapeutics International Limited Centralised - Annual renewal 19 Jul 2018 EMEA/H/C/2720/R/41
Carmustine Obvius NovImmune B.V. Centralised - Authorisation 19 Jul 2018 EMEA/H/C/4326
Aplidin Pharma Mar S.A. Centralised - Refusal of marketing authorisation 17 Jul 2018 EMEA/H/C/4354
Naglazyme BioMarin International Limited Centralised - Transfer Marketing Authorisation Holder 13 Jul 2018 EMEA/H/C/640/T/72
Rebif Merck Europe B.V. Centralised - Transfer Marketing Authorisation Holder 13 Jul 2018 EMEA/H/C/136/T/135
Firdapse BioMarin International Limited Centralised - Transfer Marketing Authorisation Holder 13 Jul 2018 EMEA/H/C/1032/T/57
Karvea Sanofi-Aventis groupe Centralised - Yearly update 13 Jul 2018
Vizamyl GE Healthcare Ltd Centralised - Yearly update 11 Jul 2018
Byetta AstraZeneca AB Centralised - Yearly update 11 Jul 2018
Erelzi Sandoz GmbH Centralised - Yearly update 11 Jul 2018
Briviact UCB Pharma S.A. Centralised - 2-Monthly update 11 Jul 2018 EMEA/H/C/3898/II/10/G
Imnovid Celgene Europe Limited Centralised - Renewal 11 Jul 2018 EMEA/H/C/2682/R/28
Xagrid Shire Pharmaceutical Contracts Limited Centralised - Variation 11 Jul 2018 EMEA/H/C/480/S/81
MAVENCLAD Merck Europe B.V. Centralised - Transfer Marketing Authorisation Holder 9 Jul 2018 EMEA/H/C/4230/T/4
Betaferon Bayer AG Centralised - Yearly update 9 Jul 2018
Tovanor Breezhaler Novartis Europharm Limited Centralised - Transfer Marketing Authorisation Holder 9 Jul 2018 EMEA/H/C/2690/T/30
Fosavance Merck Sharp & Dohme B.V. Centralised - Transfer Marketing Authorisation Holder 9 Jul 2018 EMEA/H/C/619/T/42
Seebri Breezhaler Novartis Europharm Limited Centralised - Transfer Marketing Authorisation Holder 9 Jul 2018 EMEA/H/C/2430/T/27
Ariclaim Eli Lilly Nederland B.V. Centralised - Withdrawal 9 Jul 2018
Zavesca Actelion Registration Ltd Centralised - Yearly update 9 Jul 2018
Qutenza Grünenthal GmbH Centralised - Yearly update 9 Jul 2018
Pylobactell Torbet Laboratories Limited Centralised - Yearly update 9 Jul 2018
Vantavo Merck Sharp & Dohme B.V. Centralised - Transfer Marketing Authorisation Holder 9 Jul 2018 EMEA/H/C/1180/T/30
Fertavid Merck Sharp & Dohme B.V. Centralised - Transfer Marketing Authorisation Holder 6 Jul 2018 EMEA/H/C/1042/T/39
Pemetrexed Fresenius Kabi Fresenius Kabi Deutschland GmbH Centralised - Transfer Marketing Authorisation Holder 6 Jul 2018 EMEA/H/C/3895/T/7
Ariclaim Eli Lilly Nederland B.V. Centralised - Yearly update 6 Jul 2018
Praxbind Boehringer Ingelheim International GmbH Centralised - Yearly update 6 Jul 2018
Puregon Merck Sharp & Dohme B.V. Centralised - Transfer Marketing Authorisation Holder 6 Jul 2018 EMEA/H/C/86/T/97
Noxafil Merck Sharp & Dohme B.V. Centralised - Transfer Marketing Authorisation Holder 6 Jul 2018 EMEA/H/C/610/T/54
Adrovance Merck Sharp & Dohme B.V. Centralised - Transfer Marketing Authorisation Holder 6 Jul 2018 EMEA/H/C/759/T/39
DepoCyte Pacira Limited Centralised - Withdrawal 6 Jul 2018
Symtuza Janssen-Cilag International NV Centralised - 2-Monthly update 6 Jul 2018 EMEA/H/C/4391/WS/1312
PREZISTA Janssen-Cilag International NV Centralised - 2-Monthly update 6 Jul 2018 EMEA/H/C/707/WS/1312
Zykadia Novartis Europharm Limited Centralised - 2-Monthly update 6 Jul 2018 EMEA/H/C/3819/II/16
Temozolomide HEXAL Hexal AG Centralised - Yearly update 6 Jul 2018
Temozolomide Sandoz Sandoz GmbH Centralised - Yearly update 6 Jul 2018
Pemetrexed Sandoz Sandoz GmbH Centralised - Yearly update 6 Jul 2018
Ninlaro Takeda Pharma A/S Centralised - Yearly update 6 Jul 2018
KEYTRUDA Merck Sharp & Dohme B.V. Centralised - 2-Monthly update 6 Jul 2018 EMEA/H/C/3820/II/52
Hirobriz Breezhaler Novartis Europharm Limited Centralised - Transfer Marketing Authorisation Holder 6 Jul 2018 EMEA/H/C/1211/T/47
Tafinlar Novartis Europharm Limited Centralised - Transfer Marketing Authorisation Holder 6 Jul 2018 EMEA/H/C/2604/T/32
Tegsedi IONIS USA Limited Centralised - Authorisation 6 Jul 2018 EMEA/H/C/4782
Visudyne Novartis Europharm Limited Centralised - Transfer Marketing Authorisation Holder 6 Jul 2018 EMEA/H/C/305/T/96
Sovaldi Gilead Sciences Ireland UC Centralised - Transfer Marketing Authorisation Holder 6 Jul 2018 EMEA/H/C/2798/T/51
Ammonaps Swedish Orphan Biovitrum International AB Centralised - Yearly update 6 Jul 2018
Corbilta Orion Corporation Centralised - Renewal 6 Jul 2018 EMEA/H/C/2785/R/15
ALPROLIX Swedish Orphan Biovitrum AB (publ) PSUSA - Modification 6 Jul 2018 EMEA/H/C/PSUSA/10499/201709
Revolade Novartis Europharm Limited PSUSA - Modification 6 Jul 2018 EMEA/H/C/PSUSA/1205/201709
Verkazia Santen Oy Centralised - Authorisation 6 Jul 2018 EMEA/H/C/4411
Docetaxel Accord Accord Healthcare Limited Centralised - Yearly update 2 Jul 2018
Enurev Breezhaler Novartis Europharm Limited Centralised - Transfer Marketing Authorisation Holder 2 Jul 2018 EMEA/H/C/2691/T/27
Ifirmacombi Krka d. d., Novo mesto Centralised - Yearly update 2 Jul 2018
DepoCyte Pacira Limited Centralised - Yearly update 2 Jul 2018
Bavencio Merck Europe B.V. Centralised - Transfer Marketing Authorisation Holder 2 Jul 2018 EMEA/H/C/4338/T/4
Prialt RIEMSER Pharma GmbH Centralised - Transfer Marketing Authorisation Holder 2 Jul 2018 EMEA/H/C/551/T/56
Simponi Janssen Biologics B.V. Centralised - 2-Monthly update 2 Jul 2018 EMEA/H/C/992/II/79
Tecentriq Roche Registration GmbH Centralised - 2-Monthly update 2 Jul 2018 EMEA/H/C/4143/II/10
Lemtrada Genzyme Therapeutics Ltd Centralised - Renewal 2 Jul 2018 EMEA/H/C/3718/R/20
Sprycel Bristol-Myers Squibb Pharma EEIG Centralised - Variation 2 Jul 2018 EMEA/H/C/709/X/56/G
Mysimba Orexigen Therapeutics Ireland Limited PSUSA - Modification 2 Jul 2018 EMEA/H/C/3687/PSUSA/10366/201709
Xarelto Bayer AG PSUSA - Modification 2 Jul 2018 EMEA/H/C/944/PSUSA/2653/201709
PANTOZOL Control Takeda GmbH PSUSA - Modification 2 Jul 2018 EMEA/H/C/1013/PSUSA/2285/201708
CONTROLOC Control Takeda GmbH PSUSA - Modification 2 Jul 2018 EMEA/H/C/1097/PSUSA/2285/201708
SOMAC Control Takeda GmbH PSUSA - Modification 2 Jul 2018 EMEA/H/C/1098/PSUSA/2285/201708
Trulicity Eli Lilly Nederland B.V. PSUSA - Modification 2 Jul 2018 EMEA/H/C/2825/PSUSA/10311/201709
Revlimid Celgene Europe B.V. Centralised - Transfer Marketing Authorisation Holder 29 Jun 2018 EMEA/H/C/717/T/101
Spectrila medac Gesellschaft für klinische Spezialpräparate mbH Centralised - Yearly update 29 Jun 2018
Olumiant Eli Lilly Nederland B.V. Centralised - Yearly update 29 Jun 2018
Victrelis Merck Sharp & Dohme Limited Centralised - Withdrawal 29 Jun 2018
Samsca Otsuka Pharmaceutical Europe Ltd Centralised - 2-Monthly update 29 Jun 2018 EMEA/H/C/980/II/31
Edistride AstraZeneca AB Centralised - Yearly update 29 Jun 2018
Ristfor Merck Sharp & Dohme B.V. Centralised - Transfer Marketing Authorisation Holder 29 Jun 2018 EMEA/H/C/1235/T/77
Velmetia Merck Sharp & Dohme B.V. Centralised - Transfer Marketing Authorisation Holder 29 Jun 2018 EMEA/H/C/862/T/93
Janumet Merck Sharp & Dohme B.V. Centralised - Transfer Marketing Authorisation Holder 29 Jun 2018 EMEA/H/C/861/T/90
Efficib Merck Sharp & Dohme B.V. Centralised - Transfer Marketing Authorisation Holder 29 Jun 2018 EMEA/H/C/896/T/90
Aerius Merck Sharp & Dohme B.V. Centralised - Transfer Marketing Authorisation Holder 29 Jun 2018 EMEA/H/C/313/T/90
Azomyr Merck Sharp & Dohme B.V. Centralised - Transfer Marketing Authorisation Holder 29 Jun 2018 EMEA/H/C/310/T/94
Granupas Eurocept International B.V. Centralised - Transfer Marketing Authorisation Holder 29 Jun 2018 EMEA/H/C/2709/T/25
Temozolomide Accord Accord Healthcare Limited Centralised - Yearly update 29 Jun 2018
Rezolsta Janssen-Cilag International NV Centralised - 2-Monthly update 29 Jun 2018 EMEA/H/C/2819/WS/1312
Jinarc Otsuka Pharmaceutical Europe Ltd Centralised - 2-Monthly update 29 Jun 2018 EMEA/H/C/2788/II/16
IMBRUVICA Janssen-Cilag International NV Centralised - Variation 29 Jun 2018 EMEA/H/C/3791/X/37
Orgalutran Merck Sharp & Dohme Limited Centralised - Transfer Marketing Authorisation Holder 29 Jun 2018 EMEA/H/C/274/T/40
Glivec Novartis Europharm Limited Centralised - Transfer Marketing Authorisation Holder 25 Jun 2018 EMEA/H/C/406/T/110
Exforge Novartis Europharm Limited Centralised - Transfer Marketing Authorisation Holder 25 Jun 2018 EMEA/H/C/716/T/96
Copalia HCT Novartis Europharm Limited Centralised - Transfer Marketing Authorisation Holder 25 Jun 2018 EMEA/H/C/1159/T/67
Dafiro HCT Novartis Europharm Limited Centralised - Transfer Marketing Authorisation Holder 25 Jun 2018 EMEA/H/C/1160/T/68
Darzalex Janssen-Cilag International NV Centralised - Yearly update 25 Jun 2018
Leflunomide Winthrop Sanofi-Aventis Deutschland GmbH Centralised - Yearly update 25 Jun 2018
Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan Mylan S.A.S. Centralised - 2-Monthly update 25 Jun 2018 EMEA/H/C/4240/IB/1/G
Xgeva Amgen Europe B.V. PSUSA - Modification 25 Jun 2018 EMEA/H/C/2173/PSUSA/9119/201709
PANTOLOC Control Takeda GmbH PSUSA - Modification 25 Jun 2018 EMEA/H/C/1100/PSUSA/2285/201708
Stivarga Bayer AG PSUSA - Modification 25 Jun 2018 EMEA/H/C/PSUSA/10133/201709
Cubicin Merck Sharp & Dohme B.V. PSUSA - Modification 25 Jun 2018 EMEA/H/C/637/PSUSA/931/201709
Nexium Control Pfizer Consumer Healthcare Limited Centralised - Renewal 25 Jun 2018 EMEA/H/C/2618/R/21
Dzuveo FGK Representative Service GmbH Centralised - Authorisation 25 Jun 2018 EMEA/H/C/4335
Orbactiv Rempex London Ltd PSUSA - Modification 25 Jun 2018 EMEA/H/C/PSUSA/10368/201709
Yondelis Pharma Mar S.A. PSUSA - Modification 25 Jun 2018 EMEA/H/C/PSUSA/3001/201709
Xeljanz Pfizer Limited Centralised - 2-Monthly update 25 Jun 2018 EMEA/H/C/4214/II/6
Leflunomide medac medac Gesellschaft für klinische Spezialpräparate mbH Centralised - Yearly update 21 Jun 2018
Rolufta GlaxoSmithKline Trading Services Limited Centralised - Yearly update 21 Jun 2018
Angiox The Medicines Company UK Ltd Centralised - Withdrawal 21 Jun 2018
Inflectra Pfizer Europe MA EEIG Centralised - Renewal 21 Jun 2018 EMEA/H/C/2778/R/56
Remsima Celltrion Healthcare Hungary Kft. Centralised - Renewal 21 Jun 2018 EMEA/H/C/2576/R/47
KEYTRUDA Merck Sharp & Dohme B.V. PSUSA - Modification 21 Jun 2018 EMEA/H/C/3820/PSUSA/10403/201709
Xeljanz Pfizer Limited Centralised - Yearly update 21 Jun 2018
Xofigo Bayer AG Centralised - Renewal 21 Jun 2018 EMEA/H/C/2653/R/30
Biktarvy Gilead Sciences International Limited Centralised - Authorisation 21 Jun 2018 EMEA/H/C/4449
Targretin Eisai Limited Referral 21 Jun 2018 EMEA/H/A-31/1446/C/326/43
Panretin Eisai Limited Referral 21 Jun 2018 EMEA/H/A-31/1446/C/279/37
Blincyto Amgen Europe B.V. Centralised - Authorisation - Switch to non-conditional 18 Jun 2018 EMEA/H/C/3731/II/9
Xyrem UCB Pharma S.A. Centralised - Transfer Marketing Authorisation Holder 15 Jun 2018 EMEA/H/C/593/T/74
Neoclarityn Merck Sharp & Dohme Limited Centralised - Transfer Marketing Authorisation Holder 15 Jun 2018 EMEA/H/C/314/T/88
ZINPLAVA Merck Sharp & Dohme B.V. Centralised - Transfer Marketing Authorisation Holder 15 Jun 2018 EMEA/H/C/4136/T/11
Zerbaxa Merck Sharp & Dohme B.V. Centralised - Transfer Marketing Authorisation Holder 15 Jun 2018 EMEA/H/C/3772/T/17
Aerinaze Merck Sharp & Dohme B.V. Centralised - Transfer Marketing Authorisation Holder 15 Jun 2018 EMEA/H/C/772/T/37
Zepatier Merck Sharp & Dohme B.V. Centralised - Transfer Marketing Authorisation Holder 15 Jun 2018 EMEA/H/C/4126/T/15
Maviret AbbVie Deutschland GmbH & Co. KG Centralised - Transfer Marketing Authorisation Holder 15 Jun 2018 EMEA/H/C/4430/T/11
Lusduna Merck Sharp & Dohme B.V. Centralised - Transfer Marketing Authorisation Holder 15 Jun 2018 EMEA/H/C/4101/T/6
SOLYMBIC Amgen Europe B.V. Centralised - Withdrawal 15 Jun 2018
Iscover Sanofi-Aventis groupe Centralised - Yearly update 14 Jun 2018
Insuman Sanofi-Aventis Deutschland GmbH Centralised - Yearly update 14 Jun 2018
SOLYMBIC Amgen Europe B.V. Centralised - Yearly update 14 Jun 2018
Incruse Ellipta Glaxo Group Ltd Centralised - Yearly update 12 Jun 2018
Kuvan BioMarin International Limited Centralised - Yearly update 12 Jun 2018
Fareston Orion Corporation Centralised - Yearly update 12 Jun 2018
Emtricitabine/Tenofovir disoproxil Mylan Mylan S.A.S. Centralised - 2-Monthly update 12 Jun 2018 EMEA/H/C/4050/IB/3/G
Viekirax AbbVie Deutschland GmbH & Co. KG Centralised - Transfer Marketing Authorisation Holder 7 Jun 2018 EMEA/H/C/3839/T/45
Isentress Merck Sharp & Dohme B.V. Centralised - Transfer Marketing Authorisation Holder 7 Jun 2018 EMEA/H/C/860/T/75
Quinsair Chiesi Farmaceutici S.p.A. Centralised - Transfer Marketing Authorisation Holder 7 Jun 2018 EMEA/H/C/2789/T/16
Harvoni Gilead Sciences Ireland UC Centralised - Transfer Marketing Authorisation Holder 7 Jun 2018 EMEA/H/C/3850/T/67
Exforge HCT Novartis Europharm Limited Centralised - Transfer Marketing Authorisation Holder 7 Jun 2018 EMEA/H/C/1068/T/66
SomaKit TOC Advanced Accelerator Applications Centralised - Yearly update 7 Jun 2018
Zykadia Novartis Europharm Limited Centralised - Transfer Marketing Authorisation Holder 7 Jun 2018 EMEA/H/C/3819/T/24
Cimzia UCB Pharma S.A. Centralised - 2-Monthly update 7 Jun 2018 EMEA/H/C/1037/II/65
Zydelig Gilead Sciences Ireland UC Centralised - Transfer Marketing Authorisation Holder 7 Jun 2018 EMEA/H/C/3843/T/40
Uptravi Actelion Registration Ltd Centralised - Yearly update 7 Jun 2018
Dafiro Novartis Europharm Limited Centralised - Transfer Marketing Authorisation Holder 7 Jun 2018 EMEA/H/C/776/T/99
Pemetrexed Accord Accord Healthcare Limited Centralised - Yearly update 7 Jun 2018
Genvoya Gilead Sciences Ireland UC Centralised - Transfer Marketing Authorisation Holder 7 Jun 2018 EMEA/H/C/4042/T/45
Vosevi Gilead Sciences Ireland UC Centralised - Transfer Marketing Authorisation Holder 7 Jun 2018 EMEA/H/C/4350/T/15
BeneFIX Pfizer Limited Centralised - Yearly update 7 Jun 2018
Votubia Novartis Europharm Limited Centralised - Transfer Marketing Authorisation Holder 7 Jun 2018 EMEA/H/C/2311/T/52
Constella Allergan Pharmaceuticals International Limited Centralised - Yearly update 7 Jun 2018
TAGRISSO AstraZeneca AB Centralised - 2-Monthly update 7 Jun 2018 EMEA/H/C/4124/II/19
Cerdelga Genzyme Europe B.V. Centralised - 2-Monthly update 7 Jun 2018 EMEA/H/C/3724/II/15/G
Bexsero GlaxoSmithKline Vaccines S.r.l. Centralised - 2-Monthly update 7 Jun 2018 EMEA/H/C/2333/II/59
Pradaxa Boehringer Ingelheim International GmbH Centralised - 2-Monthly update 7 Jun 2018 EMEA/H/C/829/II/108
ALPROLIX Swedish Orphan Biovitrum AB (publ) Centralised - Yearly update 7 Jun 2018
Xultophy Novo Nordisk A/S Centralised - 2-Monthly update 7 Jun 2018 EMEA/H/C/2647/II/23
Prolia Amgen Europe B.V. Centralised - 2-Monthly update 4 Jun 2018 EMEA/H/C/1120/II/68
Copalia Novartis Europharm Limited Centralised - Transfer Marketing Authorisation Holder 4 Jun 2018 EMEA/H/C/774/T/97
Stocrin Merck Sharp & Dohme B.V. Centralised - Transfer Marketing Authorisation Holder 4 Jun 2018 EMEA/H/C/250/T/113
Tybost Gilead Sciences Ireland UC Centralised - Transfer Marketing Authorisation Holder 4 Jun 2018 EMEA/H/C/2572/T/43
Truvada Gilead Sciences Ireland UC Centralised - Transfer Marketing Authorisation Holder 4 Jun 2018 EMEA/H/C/594/T/148
Stribild Gilead Sciences Ireland UC Centralised - Transfer Marketing Authorisation Holder 4 Jun 2018 EMEA/H/C/2574/T/93
Emtriva Gilead Sciences Ireland UC Centralised - Transfer Marketing Authorisation Holder 4 Jun 2018 EMEA/H/C/533/T/123
Iclusig Incyte Biosciences Distribution B.V. Centralised - Transfer Marketing Authorisation Holder 4 Jun 2018 EMEA/H/C/2695/T/47
Zinbryta Biogen Idec Limited PSUSA - Modification 4 Jun 2018 EMEA/H/C/3862/PSUSA/10518/201705
Venclyxto AbbVie Deutschland GmbH & Co. KG Centralised - Transfer Marketing Authorisation Holder 31 May 2018 EMEA/H/C/4106/T/12
Suboxone Indivior Europe Limited Centralised - Transfer Marketing Authorisation Holder 31 May 2018 EMEA/H/C/697/T/38
Exviera AbbVie Deutschland GmbH & Co. KG Centralised - Transfer Marketing Authorisation Holder 31 May 2018 EMEA/H/C/3837/T/38
Twynsta Boehringer Ingelheim International GmbH Centralised - Yearly update 31 May 2018
Chenodeoxycholic acid Leadiant Leadiant GmbH Centralised - Yearly update 31 May 2018
Perjeta Roche Registration GmbH Centralised - 2-Monthly update 31 May 2018 EMEA/H/C/2547/II/34
Yervoy Bristol-Myers Squibb Pharma EEIG Centralised - 2-Monthly update 31 May 2018 EMEA/H/C/2213/II/55
Tadalafil Lilly Eli Lilly Nederland B.V. Centralised - Yearly update 31 May 2018
Eliquis Bristol-Myers Squibb/Pfizer EEIG Centralised - 2-Monthly update 31 May 2018 EMEA/H/C/2148/II/50
Champix Pfizer Europe MA EEIG Centralised - Yearly update 31 May 2018
Sprycel Bristol-Myers Squibb Pharma EEIG Centralised - Yearly update 31 May 2018
Alecensa Roche Registration GmbH Centralised - 2-Monthly update 31 May 2018 EMEA/H/C/4164/II/10
DuoTrav Novartis Europharm Limited Centralised - Transfer Marketing Authorisation Holder 31 May 2018 EMEA/H/C/665/T/53
Votubia Novartis Europharm Limited Centralised - Variation 31 May 2018 EMEA/H/C/2311/X/45
Plavix Sanofi Clir SNC Centralised - Yearly update 28 May 2018
Descovy Gilead Sciences Ireland UC Centralised - Transfer Marketing Authorisation Holder 28 May 2018 EMEA/H/C/4094/T/30
Lixiana Daiichi Sankyo Europe GmbH Centralised - Yearly update 28 May 2018
Tecfidera Biogen Idec Limited Centralised - Yearly update 28 May 2018
Ledaga Actelion Registration Ltd Centralised - Yearly update 28 May 2018
Vemlidy Gilead Sciences Ireland UC Centralised - Transfer Marketing Authorisation Holder 28 May 2018 EMEA/H/C/4169/T/13
Hepsera Gilead Sciences Ireland UC Centralised - Transfer Marketing Authorisation Holder 28 May 2018 EMEA/H/C/485/T/78
Eviplera Gilead Sciences Ireland UC Centralised - Transfer Marketing Authorisation Holder 28 May 2018 EMEA/H/C/2312/T/91
Epclusa Gilead Sciences Ireland UC Centralised - Transfer Marketing Authorisation Holder 28 May 2018 EMEA/H/C/4210/T/27
Vokanamet Janssen-Cilag International NV Centralised - Yearly update 28 May 2018
Atosiban SUN Sun Pharmaceutical Industries Europe BV Centralised - Renewal 28 May 2018 EMEA/H/C/2329/R/12
Bortezomib Accord Accord Healthcare Limited Centralised - Variation 28 May 2018 EMEA/H/C/3984/X/8
Senshio Shionogi Limited PSUSA - Modification 28 May 2018 EMEA/H/C/PSUSA/10340/201708
AUBAGIO Sanofi-Aventis groupe Centralised - Renewal 28 May 2018 EMEA/H/C/2514/R/16
Temodal Merck Sharp & Dohme Limited PSUSA - Modification 28 May 2018 EMEA/H/C/229/PSUSA/2886/201707
Armisarte Actavis Group PTC ehf. Centralised - Yearly update 25 May 2018
Cayston Gilead Sciences Ireland UC Centralised - Transfer Marketing Authorisation Holder 24 May 2018 EMEA/H/C/996/T/72
Darunavir Mylan Mylan S.A.S. Centralised - Yearly update 24 May 2018
Emend Merck Sharp & Dohme B.V. Centralised - Transfer Marketing Authorisation Holder 24 May 2018 EMEA/H/C/527/T/57
Procysbi Chiesi Farmaceutici S.p.A. Centralised - Transfer Marketing Authorisation Holder 24 May 2018 EMEA/H/C/2465/T/21
Atazanavir Mylan Mylan S.A.S. Centralised - Yearly update 24 May 2018
Norvir AbbVie Deutschland GmbH & Co. KG Centralised - Transfer Marketing Authorisation Holder 24 May 2018 EMEA/H/C/127/T/149
Rubraca Clovis Oncology UK Limited Centralised - Authorisation 24 May 2018 EMEA/H/C/4272
Vipidia Takeda Pharma A/S Centralised - Renewal 24 May 2018 EMEA/H/C/2182/R/19
Incresync Takeda Pharma A/S Centralised - Renewal 24 May 2018 EMEA/H/C/2178/R/23
Vipdomet Takeda Pharma A/S Centralised - Renewal 24 May 2018 EMEA/H/C/2654/R/24
AMGLIDIA AMMTeK Centralised - Authorisation 24 May 2018 EMEA/H/C/4379
Kaletra AbbVie Deutschland GmbH & Co. KG Centralised - Transfer Marketing Authorisation Holder 23 May 2018 EMEA/H/C/368/T/169
Tyverb Novartis Europharm Limited Centralised - Transfer Marketing Authorisation Holder 22 May 2018 EMEA/H/C/795/T/52
Jakavi Novartis Europharm Limited Centralised - Transfer Marketing Authorisation Holder 22 May 2018 EMEA/H/C/2464/T/35
Stivarga Bayer AG Centralised - Renewal 22 May 2018 EMEA/H/C/2573/R/25
Xoterna Breezhaler Novartis Europharm Limited Centralised - Renewal 22 May 2018 EMEA/H/C/3755/R/27
Velmetia Merck Sharp & Dohme B.V. PSUSA - Modification 22 May 2018 EMEA/H/C/PSUSA/2003/201708
Ristfor Merck Sharp & Dohme B.V. PSUSA - Modification 22 May 2018 EMEA/H/C/PSUSA/2003/201708
Janumet Merck Sharp & Dohme B.V. PSUSA - Modification 22 May 2018 EMEA/H/C/PSUSA/2003/201708
Efficib Merck Sharp & Dohme B.V. PSUSA - Modification 22 May 2018 EMEA/H/C/PSUSA/2003/201708
Ristaben Merck Sharp & Dohme Limited PSUSA - Modification 22 May 2018 EMEA/H/C/PSUSA/2711/201708
Xarelto Bayer AG Centralised - Renewal 22 May 2018 EMEA/H/C/944/R/60
Ultibro Breezhaler Novartis Europharm Limited Centralised - Renewal 22 May 2018 EMEA/H/C/2679/R/24
Jylamvo Therakind Ltd PSUSA - Modification 22 May 2018 EMEA/H/C/PSUSA/2014/201706
Bosulif Pfizer Europe MA EEIG Centralised - Variation 22 May 2018 EMEA/H/C/2373/X/26
Xelevia Merck Sharp & Dohme Limited PSUSA - Modification 22 May 2018 EMEA/H/C/762/PSUSA/2711/20178
Tesavel Merck Sharp & Dohme B.V. PSUSA - Modification 22 May 2018 EMEA/H/C/PSUSA/2711/201708
Pedea Orphan Europe S.A.R.L. PSUSA - Modification 22 May 2018 EMEA/H/C/PSUSA/1712/201707
Stribild Gilead Sciences Ireland UC PSUSA - Modification 22 May 2018 EMEA/H/C/2574/PSUSA/10082/201708
Tybost Gilead Sciences Ireland UC PSUSA - Modification 22 May 2018 EMEA/H/C/PSUSA/10081/201708
Osseor Les Laboratoires Servier PASS - Modification 22 May 2018 EMEA/H/C/PSR/S/13
Protelos Les Laboratoires Servier PASS - Modification 22 May 2018 EMEA/H/C/PSR/S/13
Pemetrexed Krka Krka d. d., Novo mesto Centralised - Authorisation 22 May 2018 EMEA/H/C/3958
Zessly Sandoz GmbH Centralised - Authorisation 18 May 2018 EMEA/H/C/4647
Odefsey Gilead Sciences Ireland UC Centralised - Transfer Marketing Authorisation Holder 16 May 2018 EMEA/H/C/4156/T/30
KANJINTI Amgen Europe B.V. Centralised - Authorisation 16 May 2018 EMEA/H/C/4361
Giotrif Boehringer Ingelheim International GmbH Centralised - Renewal 16 May 2018 EMEA/H/C/2280/R/26
Januvia Merck Sharp & Dohme B.V. PSUSA - Modification 16 May 2018 EMEA/H/C/PSUSA/2711/201708
Ovaleap Teva B.V. Centralised - Renewal 16 May 2018 EMEA/H/C/2608/R/23
Cholib Mylan Products Limited Centralised - Renewal 16 May 2018 EMEA/H/C/2559/R/17
Nordimet Nordic Group B.V. PSUSA - Modification 16 May 2018 EMEA/H/C/PSUSA/2014/201706
Prasugrel Mylan Mylan S.A.S. Centralised - Authorisation 16 May 2018 EMEA/H/C/4644
Juluca ViiV Healthcare UK Limited Centralised - Authorisation 16 May 2018 EMEA/H/C/4427
Orphacol Laboratoires CTRS Corrigendum 8 May 2018
Tivicay ViiV Healthcare BV Centralised - Transfer Marketing Authorisation Holder 8 May 2018 EMEA/H/C/2753/T/39
Elonva Merck Sharp & Dohme B.V. Centralised - Transfer Marketing Authorisation Holder 8 May 2018 EMEA/H/C/1106/T/40
Invanz Merck Sharp & Dohme B.V. Centralised - Transfer Marketing Authorisation Holder 8 May 2018 EMEA/H/C/389/T/58
Odomzo Sun Pharmaceutical Industries Europe BV Centralised - Yearly update 8 May 2018
Docetaxel Kabi Fresenius Kabi Deutschland GmbH Centralised - Transfer Marketing Authorisation Holder 8 May 2018 EMEA/H/C/2325/T/19
Aflunov Seqirus S.r.l. Centralised - Yearly update 8 May 2018
Imatinib Teva B.V. Teva B.V. Centralised - Withdrawal 8 May 2018
Inflectra Pfizer Europe MA EEIG Centralised - Yearly update 8 May 2018
Riluzole Zentiva Zentiva k.s. Centralised - Transfer Marketing Authorisation Holder 8 May 2018 EMEA/H/C/2622/T/23
Travatan Novartis Europharm Limited Centralised - Transfer Marketing Authorisation Holder 8 May 2018 EMEA/H/C/390/T/59
KEYTRUDA Merck Sharp & Dohme B.V. Centralised - Transfer Marketing Authorisation Holder 8 May 2018 EMEA/H/C/3820/T/45
Izba Novartis Europharm Limited Centralised - Transfer Marketing Authorisation Holder 8 May 2018 EMEA/H/C/2738/T/10
Alofisel Takeda Pharma A/S Centralised - Transfer Marketing Authorisation Holder 8 May 2018 EMEA/H/C/4258/T/1
LIFMIOR Pfizer Limited Centralised - Yearly update 8 May 2018
Busulfan Fresenius Kabi Fresenius Kabi Deutschland GmbH Centralised - Transfer Marketing Authorisation Holder 8 May 2018 EMEA/H/C/2806/T/8
Zerbaxa Merck Sharp & Dohme B.V. Centralised - Yearly update 8 May 2018
Prometax Novartis Europharm Limited Centralised - Transfer Marketing Authorisation Holder 8 May 2018 EMEA/H/C/255/T/118
CABOMETYX Ipsen Pharma Centralised - 2-Monthly update 8 May 2018 EMEA/H/C/4163/II/3
Flixabi Samsung Bioepis UK Limited Centralised - Yearly update 8 May 2018
Starlix Novartis Europharm Limited Centralised - Transfer Marketing Authorisation Holder 8 May 2018 EMEA/H/C/335/T/34
Synagis AbbVie Deutschland GmbH & Co. KG Centralised - Transfer Marketing Authorisation Holder 8 May 2018 EMEA/H/C/257/T/116
Pemetrexed Fresenius Kabi Fresenius Kabi Deutschland GmbH Centralised - Yearly update 8 May 2018
Rekovelle Ferring Pharmaceuticals A/S Centralised - Yearly update 8 May 2018
Oslif Breezhaler Novartis Europharm Limited Centralised - Transfer Marketing Authorisation Holder 8 May 2018 EMEA/H/C/1210/T/45
Afinitor Novartis Europharm Limited Centralised - Transfer Marketing Authorisation Holder 8 May 2018 EMEA/H/C/1038/T/57
Votrient Novartis Europharm Limited Centralised - Transfer Marketing Authorisation Holder 8 May 2018 EMEA/H/C/1141/T/46
Ulunar Breezhaler Novartis Europharm Limited Centralised - Transfer Marketing Authorisation Holder 8 May 2018 EMEA/H/C/3875/T/24
Orphacol Laboratoires CTRS Centralised - Yearly update 8 May 2018
Pemetrexed Hospira Hospira UK Limited Centralised - Yearly update 8 May 2018
Repatha Amgen Europe B.V. Centralised - 2-Monthly update 8 May 2018 EMEA/H/C/3766/II/17/G
Pramipexole Accord Accord Healthcare Limited Centralised - Yearly update 8 May 2018
Instanyl Takeda Pharma A/S PSUSA - Modification 8 May 2018 EMEA/H/C/959/PSUSA/1369/201704
Tafinlar Novartis Europharm Limited Centralised - Renewal 8 May 2018 EMEA/H/C/2604/R/30
Effentora Teva B.V. PSUSA - Modification 8 May 2018 EMEA/H/C/PSUSA/1369/201704
PecFent Kyowa Kirin Holdings B.V. PSUSA - Modification 8 May 2018 EMEA/H/C/1164/PSUSA/1369/201704
Lynparza AstraZeneca AB Centralised - Variation 8 May 2018 EMEA/H/C/3726/X/16/G
Lonquex UAB "Sicor Biotech" Centralised - Renewal 8 May 2018 EMEA/H/C/2556/R/39
Ivemend Merck Sharp & Dohme B.V. Corrigendum 30 Apr 2018
Pramipexole Teva Teva B.V. Centralised - Yearly update 30 Apr 2018
Avamys Glaxo Group Ltd Centralised - Yearly update 30 Apr 2018
Hemlibra Roche Registration GmbH Centralised - Transfer Marketing Authorisation Holder 30 Apr 2018 EMEA/H/C/4406/T/1
Atriance Novartis Europharm Limited Centralised - Transfer Marketing Authorisation Holder 30 Apr 2018 EMEA/H/C/752/T/41
Clopidogrel Zentiva Zentiva, k.s. Centralised - Transfer Marketing Authorisation Holder 30 Apr 2018 EMEA/H/C/975/T/60
Remsima Celltrion Healthcare Hungary Kft. Centralised - Yearly update 30 Apr 2018
Rydapt Novartis Europharm Limited Centralised - Transfer Marketing Authorisation Holder 30 Apr 2018 EMEA/H/C/4095/T/3
Ivemend Merck Sharp & Dohme B.V. Centralised - 2-Monthly update 30 Apr 2018 EMEA/H/C/743/II/37
Perjeta Roche Registration GmbH Centralised - 2-Monthly update 30 Apr 2018 EMEA/H/C/2547/II/35
Entresto Novartis Europharm Limited Centralised - Transfer Marketing Authorisation Holder 30 Apr 2018 EMEA/H/C/4062/T/18
Trisenox Teva B.V. Centralised - Yearly update 30 Apr 2018
Cosentyx Novartis Europharm Limited Centralised - Transfer Marketing Authorisation Holder 26 Apr 2018 EMEA/H/C/3729/T/36
Lucentis Novartis Europharm Limited Centralised - Transfer Marketing Authorisation Holder 26 Apr 2018 EMEA/H/C/715/t/72
Tasigna Novartis Europharm Limited Centralised - Transfer Marketing Authorisation Holder 26 Apr 2018 EMEA/H/C/798/T/94
Avonex Biogen Netherlands B.V. Centralised - Yearly update 26 Apr 2018
Xolair Novartis Europharm Limited Centralised - Transfer Marketing Authorisation Holder 26 Apr 2018 EMEA/H/C/606/T/85
Zometa Novartis Europharm Limited Centralised - Transfer Marketing Authorisation Holder 26 Apr 2018 EMEA/H/C/336/T/83
Aloxi Helsinn Birex Pharmaceuticals Ltd Centralised - 2-Monthly update 26 Apr 2018 EMEA/H/C/563/II/45/G
Truxima Celltrion Healthcare Hungary Kft. Centralised - Yearly update 26 Apr 2018
Elonva Merck Sharp & Dohme B.V. Centralised - Yearly update 26 Apr 2018
Xiliarx Novartis Europharm Limited Centralised - Transfer Marketing Authorisation Holder 26 Apr 2018 EMEA/H/C/1051/T/54
Galvus Novartis Europharm Limited Centralised - Transfer Marketing Authorisation Holder 26 Apr 2018 EMEA/H/C/771/T/55
Jalra Novartis Europharm Limited Centralised - Transfer Marketing Authorisation Holder 26 Apr 2018 EMEA/H/C/1048/T/55
Maviret AbbVie Deutschland GmbH & Co. KG Centralised - 2-Monthly update 26 Apr 2018 EMEA/H/C/4430/II/4
Firazyr Shire Orphan Therapies GmbH PSUSA - Modification 26 Apr 2018 EMEA/H/C/PSUSA/1714/201707
Trydonis Chiesi Farmaceutici S.p.A. Centralised - Authorisation 26 Apr 2018 EMEA/H/C/4702
Voncento CSL Behring GmbH Centralised - Renewal 26 Apr 2018 EMEA/H/C/2493/R/32
Onbrez Breezhaler Novartis Europharm Limited Corrigendum 23 Apr 2018
Nevanac Novartis Europharm Limited Centralised - Transfer Marketing Authorisation Holder 23 Apr 2018 EMEA/H/C/818/T/36
Pregabalin Zentiva Zentiva, k.s. Centralised - Yearly update 23 Apr 2018
Duloxetine Zentiva Zentiva, k.s. Centralised - Yearly update 23 Apr 2018
Desloratadine Actavis Actavis Group PTC ehf. Centralised - Yearly update 23 Apr 2018
GILENYA Novartis Europharm Limited Centralised - Transfer Marketing Authorisation Holder 23 Apr 2018 EMEA/H/C/2202/T/48
TOBI Podhaler Novartis Europharm Limited Centralised - Transfer Marketing Authorisation Holder 23 Apr 2018 EMEA/H/C/2155/T/36
Opdivo Bristol-Myers Squibb Pharma EEIG Centralised - 2-Monthly update 23 Apr 2018 EMEA/H/C/3985/II/36/G
Zykadia Novartis Europharm Limited Centralised - 2-Monthly update 23 Apr 2018 EMEA/H/C/3819/II/15
Aerinaze Merck Sharp & Dohme B.V. Centralised - Yearly update 23 Apr 2018
Eucreas Novartis Europharm Limited Centralised - Transfer Marketing Authorisation Holder 23 Apr 2018 EMEA/H/C/807/T/66
Emadine Novartis Europharm Limited Centralised - Transfer Marketing Authorisation Holder 23 Apr 2018 EMEA/H/C/223/T/46
Humira AbbVie Deutschland GmbH & Co. KG Centralised - 2-Monthly update 23 Apr 2018 EMEA/H/C/481/II/175
Onbrez Breezhaler Novartis Europharm Limited Centralised - Transfer Marketing Authorisation Holder 23 Apr 2018 EMEA/H/C/1114/T/45
Exelon Novartis Europharm Limited Centralised - Transfer Marketing Authorisation Holder 23 Apr 2018 EMEA/H/C/169/T/118
Imnovid Celgene Europe Limited Centralised - 2-Monthly update 23 Apr 2018 EMEA/H/C/2682/II/27
Hycamtin Novartis Europharm Limited Centralised - Transfer Marketing Authorisation Holder 23 Apr 2018 EMEA/H/C/123/T/75
Viread Gilead Sciences Ireland UC Centralised - Yearly update 23 Apr 2018
Zydelig Gilead Sciences Ireland UC PSUSA - Modification 23 Apr 2018 EMEA/H/C/3843/PSUSA/10303-201707
Spedra Menarini International Operations Luxembourg S.A. Centralised - Renewal 23 Apr 2018 EMEA/H/C/2581/R/29
Imvanex Bavarian Nordic A/S Centralised - Renewal 23 Apr 2018 EMEA/H/C/2596/R/32
Bosulif Pfizer Europe MA EEIG Centralised - 2-Monthly update 23 Apr 2018 EMEA/H/C/2373/II/25/G
Riarify Chiesi Farmaceutici S.p.A. Centralised - Authorisation 23 Apr 2018 EMEA/H/C/4836
Daxas AstraZeneca AB Centralised - Variation 23 Apr 2018 EMEA/H/C/1179/X/35
Fycompa Eisai Europe Limited PSUSA - Modification 23 Apr 2018 EMEA/H/C/2434/PSUSA/9255/201707
NeuroBloc Eisai Limited PSUSA - Modification 23 Apr 2018 EMEA/H/C/301/PSUSA/428/201706
Lojuxta Aegerion Pharmaceuticals Limited Centralised - Renewal 23 Apr 2018 EMEA/H/C/2578/R/29
Entresto Novartis Europharm Limited Centralised - Yearly update 23 Apr 2018
Volibris Glaxo Group Ltd Centralised - Yearly update 19 Apr 2018
Sutent Pfizer Limited Centralised - Yearly update 19 Apr 2018
Exjade Novartis Europharm Limited Centralised - Transfer Marketing Authorisation Holder 19 Apr 2018 EMEA/H/C/670/T/59
Opatanol Novartis Europharm Limited Centralised - Transfer Marketing Authorisation Holder 19 Apr 2018 EMEA/H/C/407/T/36
Yargesa JensonR+ Limited Centralised - Yearly update 19 Apr 2018
Movymia STADA Arzneimittel AG Centralised - Yearly update 19 Apr 2018
Repatha Amgen Europe B.V. Centralised - Yearly update 19 Apr 2018
Descovy Gilead Sciences Ireland UC Centralised - Yearly update 19 Apr 2018
Peyona Chiesi Farmaceutici S.p.A. Centralised - Yearly update 19 Apr 2018
Suliqua Sanofi-Aventis groupe Centralised - Yearly update 19 Apr 2018
Aclasta Novartis Europharm Limited Centralised - Transfer Marketing Authorisation Holder 19 Apr 2018 EMEA/H/C/595/T/70
Comtan Novartis Europharm Limited Centralised - Transfer Marketing Authorisation Holder 19 Apr 2018 EMEA/H/C/171/T/49
Azarga Novartis Europharm Limited Centralised - Transfer Marketing Authorisation Holder 19 Apr 2018 EMEA/H/C/960/T/39
Simbrinza Novartis Europharm Limited Centralised - Transfer Marketing Authorisation Holder 19 Apr 2018 EMEA/H/C/3698/T/12
Imatinib Medac medac Gesellschaft für klinische Spezialpräparate mbH Centralised - Renewal 19 Apr 2018 EMEA/H/C/2692/R/8
Imatinib Accord Accord Healthcare Limited Centralised - Renewal 19 Apr 2018 EMEA/H/C/2681/R/20
Stribild Gilead Sciences Ireland UC Centralised - Renewal 19 Apr 2018 EMEA/H/C/2574/R/86
Natpar Shire Pharmaceuticals Ireland Limited Centralised - Annual renewal 19 Apr 2018 EMEA/H/C/3861/R/7
Mylotarg Pfizer Europe MA EEIG Centralised - Authorisation 19 Apr 2018 EMEA/H/C/4204
Deltyba Otsuka Novel Products GmbH Centralised - Annual renewal 19 Apr 2018 EMEA/H/C/2552/R/27
Kyprolis Amgen Europe B.V. PSUSA - Modification 19 Apr 2018 EMEA/H/C/3790/PSUSA/10448/201707
Blincyto Amgen Europe B.V. Centralised - Annual renewal 19 Apr 2018 EMEA/H/C/3731/R/13
Xadago Zambon S.p.A. Centralised - Yearly update 19 Apr 2018
Eklira Genuair AstraZeneca AB Centralised - Yearly update 13 Apr 2018
Bretaris Genuair AstraZeneca AB Centralised - Yearly update 13 Apr 2018
PritorPlus Bayer AG Centralised - Transfer Marketing Authorisation Holder 13 Apr 2018 EMEA/H/C/414/T/115
Pritor Bayer AG Centralised - Transfer Marketing Authorisation Holder 13 Apr 2018 EMEA/H/C/210/T/124
Travatan Novartis Europharm Limited Centralised - Yearly update 13 Apr 2018
Alpivab BioCryst UK Ltd Centralised - Authorisation 13 Apr 2018 EMEA/H/C/4299
Memantine ratiopharm ratiopharm GmbH Centralised - Renewal 13 Apr 2018 EMEA/H/C/2671/R/11
Sialanar Proveca Limited Centralised - Yearly update 13 Apr 2018
Extavia Novartis Europharm Limited Centralised - Transfer Marketing Authorisation Holder 12 Apr 2018 EMEA/H/C/933/T/90
Kisqali Novartis Europharm Limited Centralised - Transfer Marketing Authorisation Holder 12 Apr 2018 EMEA/H/C/4213/T/1
Azopt Novartis Europharm Limited Centralised - Transfer Marketing Authorisation Holder 12 Apr 2018 EMEA/H/C/267/T/69
Galafold Amicus Therapeutics UK Ltd Centralised - Yearly update 12 Apr 2018
Zomarist Novartis Europharm Limited Centralised - Transfer Marketing Authorisation Holder 12 Apr 2018 EMEA/H/C/1049/T/67
Simulect Novartis Europharm Limited Centralised - Transfer Marketing Authorisation Holder 12 Apr 2018 EMEA/H/C/207/T/94
Icandra Novartis Europharm Limited Centralised - Transfer Marketing Authorisation Holder 12 Apr 2018 EMEA/H/C/1050/T/67
Sebivo Novartis Europharm Limited Centralised - Transfer Marketing Authorisation Holder 12 Apr 2018 EMEA/H/C/713/T/50
Sylvant Janssen-Cilag International NV Centralised - Yearly update 12 Apr 2018
Ferriprox Apotex Europe B.V. Centralised - Yearly update 12 Apr 2018
Vidaza Celgene Europe B.V. Centralised - Yearly update 12 Apr 2018
Lumigan Allergan Pharmaceuticals Ireland Centralised - Yearly update 12 Apr 2018
Ravicti Horizon Pharma Ireland Limited Centralised - Yearly update 12 Apr 2018
Farydak Novartis Europharm Limited Centralised - Transfer Marketing Authorisation Holder 12 Apr 2018 EMEA/H/C/3725/T/11
Fiasp Novo Nordisk A/S Centralised - 2-Monthly update 12 Apr 2018 EMEA/H/C/4046/II/3/G
Actraphane Novo Nordisk A/S Centralised - Yearly update 12 Apr 2018
Actrapid Novo Nordisk A/S Centralised - Yearly update 12 Apr 2018
Mekinist Novartis Europharm Limited Centralised - Transfer Marketing Authorisation Holder 12 Apr 2018 EMEA/H/C/2643/T/25
Neparvis Novartis Europharm Limited Centralised - Transfer Marketing Authorisation Holder 12 Apr 2018 EMEA/H/C/4343/T/17
Pemetrexed Lilly Eli Lilly Nederland B.V. Centralised - Yearly update 12 Apr 2018
Forxiga AstraZeneca AB Centralised - Yearly update 12 Apr 2018
Kinzalkomb Bayer AG Centralised - Transfer Marketing Authorisation Holder 12 Apr 2018 EMEA/H/C/415/T/105
RoActemra Roche Registration GmbH Centralised - 2-Monthly update 12 Apr 2018 EMEA/H/C/955/II/72
Signifor Novartis Europharm Limited Centralised - Transfer Marketing Authorisation Holder 12 Apr 2018 EMEA/H/C/2052/T/37
Tadalafil Mylan Mylan S.A.S. Centralised - Yearly update 12 Apr 2018
Sialanar Proveca Limited Centralised - Rectificative 12 Apr 2018 EMEA/H/C/3883
Tarceva Roche Registration GmbH Centralised - Transfer Marketing Authorisation Holder 6 Apr 2018 EMEA/H/C/618/T/57
Tamiflu Roche Registration GmbH Centralised - Transfer Marketing Authorisation Holder 6 Apr 2018 EMEA/H/C/402/T/131
Zelboraf Roche Registration GmbH Centralised - Transfer Marketing Authorisation Holder 6 Apr 2018 EMEA/H/C/2409/T/47
Gazyvaro Roche Registration GmbH Centralised - Transfer Marketing Authorisation Holder 6 Apr 2018 EMEA/H/C/2799/T/24
Revolade Novartis Europharm Limited Centralised - Transfer Marketing Authorisation Holder 6 Apr 2018 EMEA/H/C/1110/T/47
Fuzeon Roche Registration GmbH Centralised - Transfer Marketing Authorisation Holder 6 Apr 2018 EMEA/H/C/514/T/50
Herceptin Roche Registration GmbH Centralised - Transfer Marketing Authorisation Holder 6 Apr 2018 EMEA/H/C/278/T/142
RoActemra Roche Registration GmbH Centralised - Transfer Marketing Authorisation Holder 6 Apr 2018 EMEA/H/C/955/T/75
Kineret Swedish Orphan Biovitrum AB (publ) Centralised - 2-Monthly update 6 Apr 2018 EMEA/H/C/363/II/56
EnCyzix Renable Pharma Limited Centralised - Refusal of marketing authorisation 6 Apr 2018 EMEA/H/C/4198
Bonviva Atnahs Pharma UK Limited Centralised - Transfer Marketing Authorisation Holder 4 Apr 2018 EMEA/H/C/501/T/64
Marixino Krka d. d., Novo mesto Centralised - Transfer Marketing Authorisation Holder 4 Apr 2018 EMEA/H/C/2658/T/13
Kinzalmono Bayer AG Centralised - Transfer Marketing Authorisation Holder 4 Apr 2018 EMEA/H/C/211/T/111
Esbriet Roche Registration GmbH Centralised - Transfer Marketing Authorisation Holder 4 Apr 2018 EMEA/H/C/2154/T/52
Bondronat Atnahs Pharma UK Limited Centralised - Transfer Marketing Authorisation Holder 4 Apr 2018 EMEA/H/C/101/T/79
Lacosamide Accord Accord Healthcare Limited Centralised - 2-Monthly update 4 Apr 2018 EMEA/H/C/4443/IB/1
Tecentriq Roche Registration GmbH Centralised - 2-Monthly update 4 Apr 2018 EMEA/H/C/4143/II/2/G
Pandemic influenza vaccine H5N1 AstraZeneca AstraZeneca AB Centralised - Annual renewal 4 Apr 2018 EMEA/H/C/3963/R/11
Lumark IDB Holland B.V. PSUSA - Modification 4 Apr 2018 EMEA/H/C/2749/PSUSA/10391/201706
Zinbryta Biogen Idec Limited Centralised - Withdrawal 27 Mar 2018
Raplixa Mallinckrodt Pharmaceuticals Ireland Limited Centralised - Withdrawal 27 Mar 2018
Ganfort Allergan Pharmaceuticals Ireland Centralised - Yearly update 27 Mar 2018
Xgeva Amgen Europe B.V. Centralised - 2-Monthly update 27 Mar 2018 EMEA/H/C/2173/II/55
EndolucinBeta ITG Isotope Technologies Garching GmbH PSUSA - Modification 27 Mar 2018 EMEA/H/C/PSUSA/10391/201706
Invirase Roche Registration GmbH Corrigendum 23 Mar 2018
Feraccru Shield TX (UK) Limited Centralised - 2-Monthly update 23 Mar 2018 EMEA/H/C/2733/II/10
Vibativ Theravance Biopharma Ireland Limited Centralised - Withdrawal 23 Mar 2018
Perjeta Roche Registration GmbH Centralised - Transfer Marketing Authorisation Holder 23 Mar 2018 EMEA/H/C/2547/T/36
Ocrevus Roche Registration GmbH Centralised - Transfer Marketing Authorisation Holder 23 Mar 2018 EMEA/H/C/4043/T/1
Isentress Merck Sharp & Dohme B.V. Centralised - 2-Monthly update 23 Mar 2018 EMEA/H/C/860/II/64
Translarna PTC Therapeutics International Limited Centralised - 2-Monthly update 23 Mar 2018 EMEA/H/C/2720/II/39
KEYTRUDA Merck Sharp & Dohme B.V. Centralised - 2-Monthly update 23 Mar 2018 EMEA/H/C/3820/II/37/G
Torisel Pfizer Europe MA EEIG Centralised - 2-Monthly update 23 Mar 2018 EMEA/H/C/799/II/69
Invirase Roche Registration GmbH Centralised - Transfer Marketing Authorisation Holder 23 Mar 2018 EMEA/H/C/113/T/124
Lamzede Chiesi Farmaceutici S.p.A. Centralised - Authorisation 23 Mar 2018 EMEA/H/C/3922
Steglujan Merck Sharp & Dohme Limited Centralised - Authorisation 23 Mar 2018 EMEA/H/C/4313
Atripla Bristol-Myers Squibb and Gilead Sciences Limited Centralised - 2-Monthly update 23 Mar 2018 EMEA/H/C/797/II/127/G
Semglee Mylan S.A.S. Centralised - Authorisation 23 Mar 2018 EMEA/H/C/4280
Segluromet Merck Sharp & Dohme B.V. Centralised - Authorisation 23 Mar 2018 EMEA/H/C/4314
Opdivo Bristol-Myers Squibb Pharma EEIG PSUSA - Modification 23 Mar 2018 EMEA/H/C/3985/PSUSA/10379/201707
Blincyto Amgen Europe B.V. PSUSA - Modification 23 Mar 2018 EMEA/H/C/3731/PSUSA/10460/201706
Nuwiq Octapharma AB Centralised - Variation 23 Mar 2018 EMEA/H/C/2813/X/20
Pixuvri CTI Life Sciences Ltd Centralised - Annual renewal 23 Mar 2018 EMEA/H/C/2055/R/42
Alofisel Takeda Pharma A/S Centralised - Authorisation 23 Mar 2018 EMEA/H/C/4258
Lokelma AstraZeneca AB Centralised - Authorisation 22 Mar 2018 EMEA/H/C/4029
Faslodex AstraZeneca AB Corrigendum 21 Mar 2018
Aripiprazole Zentiva Zentiva, k.s. Centralised - Yearly update 21 Mar 2018
Faslodex AstraZeneca AB Centralised - Transfer Marketing Authorisation Holder 21 Mar 2018 EMEA/H/C/540/T/63
Vibativ Theravance Biopharma Ireland Limited Centralised - Yearly update 21 Mar 2018
Shingrix GlaxoSmithKline Biologicals S.A. Centralised - Authorisation 21 Mar 2018 EMEA/H/C/4336
Steglatro Merck Sharp & Dohme Limited Centralised - Authorisation 21 Mar 2018 EMEA/H/C/4315
PHEBURANE Lucane Pharma Centralised - Renewal 21 Mar 2018 EMEA/H/C/2500/R/17
OCALIVA Intercept Pharma Ltd PSUSA - Modification 21 Mar 2018 EMEA/H/C/4093/PSUSA/10555/201706
Pixuvri CTI Life Sciences Ltd PSUSA - Modification 21 Mar 2018 EMEA/H/C/PSUSA/9261/201705
Invirase Roche Registration GmbH Centralised - 2-Monthly update 20 Mar 2018 EMEA/H/C/113/II/122
Xofigo Bayer AG Corrigendum 19 Mar 2018
Xofigo Bayer AG Referral 19 Mar 2018 EMEA/H/C/2653/A-20
IDflu Sanofi Pasteur SA Centralised - Withdrawal 19 Mar 2018
Avastin Roche Registration GmbH Corrigendum 16 Mar 2018
Avastin Roche Registration GmbH Corrigendum 16 Mar 2018
Integrilin Glaxo Group Ltd Centralised - Yearly update 16 Mar 2018
Cetrotide Merck Europe B.V. Centralised - Yearly update 16 Mar 2018
Kadcyla Roche Registration GmbH Centralised - Transfer Marketing Authorisation Holder 16 Mar 2018 EMEA/H/C/2389/T/38
Cotellic Roche Registration GmbH Centralised - Transfer Marketing Authorisation Holder 16 Mar 2018 EMEA/H/C/3960/T/11
Mircera Roche Registration GmbH Centralised - Transfer Marketing Authorisation Holder 16 Mar 2018 EMEA/H/C/739/T/66
Mabthera Roche Registration GmbH Centralised - Transfer Marketing Authorisation Holder 16 Mar 2018 EMEA/H/C/165/T/148
Xeloda Roche Registration GmbH Centralised - Transfer Marketing Authorisation Holder 16 Mar 2018 EMEA/H/C/316/T/76
Kinzalkomb Bayer AG Centralised - Yearly update 16 Mar 2018
Avastin Roche Registration GmbH Centralised - Transfer Marketing Authorisation Holder 16 Mar 2018 EMEA/H/C/582/T/100
Aripiprazole Sandoz Sandoz GmbH Centralised - Yearly update 16 Mar 2018
Glyxambi Boehringer Ingelheim International GmbH Centralised - Yearly update 16 Mar 2018
Jentadueto Boehringer Ingelheim International GmbH Centralised - Yearly update 16 Mar 2018
IDflu Sanofi Pasteur SA Centralised - Yearly update 16 Mar 2018
Vaniqa Almirall, S.A. Centralised - Yearly update 16 Mar 2018
Herceptin Roche Registration GmbH Centralised - Yearly update 16 Mar 2018
Silgard Merck Sharp & Dohme Limited Centralised - Yearly update 16 Mar 2018
Zomarist Novartis Europharm Limited Centralised - Yearly update 16 Mar 2018
Alecensa Roche Registration GmbH Corrigendum 15 Mar 2018
Humira AbbVie Deutschland GmbH & Co. KG Centralised - Transfer Marketing Authorisation Holder 15 Mar 2018 EMEA/H/C/481/T/176
NeoRecormon Roche Registration GmbH Centralised - Transfer Marketing Authorisation Holder 15 Mar 2018 EMEA/H/C/116/T/98
Pegasys Roche Registration GmbH Centralised - Transfer Marketing Authorisation Holder 15 Mar 2018 EMEA/H/C/395/T/100
Vaxelis MCM Vaccine B.V. Centralised - Yearly update 15 Mar 2018
Erivedge Roche Registration GmbH Centralised - Transfer Marketing Authorisation Holder 15 Mar 2018 EMEA/H/C/2602/T/37
Alecensa Roche Registration GmbH Centralised - Transfer Marketing Authorisation Holder 15 Mar 2018 EMEA/H/C/4164/T/13
Latuda Aziende Chimiche Riunite Angelini Francesco - A.C.R.A.F. S.p.A. Corrigendum 12 Mar 2018 EMEA/H/C/2713/T/19
Latuda Aziende Chimiche Riunite Angelini Francesco - A.C.R.A.F. S.p.A. Corrigendum 12 Mar 2018
Latuda Aziende Chimiche Riunite Angelini Francesco - A.C.R.A.F. S.p.A. Centralised - Transfer Marketing Authorisation Holder 12 Mar 2018 EMEA/H/C/2713/T/19
DuoResp Spiromax Teva Pharma B.V. Centralised - Yearly update 12 Mar 2018
MicardisPlus Boehringer Ingelheim International GmbH Centralised - Yearly update 12 Mar 2018
CellCept Roche Registration Limited Centralised - Transfer Marketing Authorisation Holder 12 Mar 2018 EMEA/H/C/82/T/139
Neuraceq Piramal Imaging Limited Centralised - Transfer Marketing Authorisation Holder 12 Mar 2018 EMEA/H/C/2553/T/22
Oprymea Krka d. d., Novo mesto Centralised - 2-Monthly update 12 Mar 2018 EMEA/H/C/941/IB/28
Trajenta Boehringer Ingelheim International GmbH Centralised - Yearly update 12 Mar 2018
Zinbryta Biogen Idec Limited Referral 8 Mar 2018 EMEA/H/C/3862/A-20/1462
Tecentriq Roche Registration GmbH Centralised - Transfer Marketing Authorisation Holder 7 Mar 2018 EMEA/H/C/4143/T/6
PritorPlus Bayer AG Centralised - Yearly update 7 Mar 2018
Raplixa Mallinckrodt Pharmaceuticals Ireland Limited Centralised - Yearly update 7 Mar 2018
Lonsurf Les Laboratoires Servier Centralised - Yearly update 7 Mar 2018
Kisplyx Eisai Europe Limited Centralised - Yearly update 7 Mar 2018
Aclasta Novartis Europharm Limited Centralised - Yearly update 7 Mar 2018
Pregabalin Pfizer Pfizer Europe MA EEIG Centralised - Yearly update 7 Mar 2018
Levetiracetam Actavis Actavis Group PTC ehf. Centralised - Yearly update 7 Mar 2018
Revinty Ellipta Glaxo Group Ltd Centralised - 2-Monthly update 7 Mar 2018 EMEA/H/C/2745/WS/1208
Adempas Bayer AG Centralised - 2-Monthly update 7 Mar 2018 EMEA/H/C/2737/II/23
Litak Lipomed GmbH Centralised - 2-Monthly update 7 Mar 2018 EMEA/H/C/504/IB/13
Terrosa Gedeon Richter Plc. Centralised - Yearly update 5 Mar 2018
OLYSIO Janssen-Cilag International NV Centralised - Withdrawal 5 Mar 2018
Hizentra CSL Behring GmbH Centralised - 2-Monthly update 5 Mar 2018 EMEA/H/C/2127/II/87
Relvar Ellipta Glaxo Group Ltd Centralised - 2-Monthly update 5 Mar 2018 EMEA/H/C/2673/WS/1208
Zydelig Gilead Sciences Ireland UC Centralised - 2-Monthly update 5 Mar 2018 EMEA/H/C/3843/II/38
Viekirax AbbVie Deutschland GmbH & Co. KG Centralised - 2-Monthly update 5 Mar 2018 EMEA/H/C/3839/II/39
Sirturo Janssen-Cilag International NV Centralised - Annual renewal 5 Mar 2018 EMEA/H/C/2614/R/24
Epivir ViiV Healthcare UK Limited Centralised - 2-Monthly update 5 Mar 2018 EMEA/H/C/107/II/104
Myclausen Passauer Pharma GmbH PSUSA - Modification 5 Mar 2018 EMEA/H/C/1218/PSUSA/10550/201705
CellCept Roche Registration Limited PSUSA - Modification 5 Mar 2018 EMEA/H/C/82/PSUSA/10550/201705
Myfenax Teva B.V. PSUSA - Modification 5 Mar 2018 EMEA/H/C/PSUSA/10550/201705
Mycophenolate mofetil Teva Teva B.V. PSUSA - Modification 5 Mar 2018 EMEA/H/C/882/PSUSA/10550/201705
Adenuric Menarini International Operations Luxembourg S.A. PSUSA - Modification 5 Mar 2018 EMEA/H/C/777/PSUSA/1353/201704
IDELVION CSL Behring GmbH Centralised - Yearly update 1 Mar 2018
Mixtard Novo Nordisk A/S Centralised - Yearly update 1 Mar 2018
Insulatard Novo Nordisk A/S Centralised - Yearly update 1 Mar 2018
GONAL-f Merck Europe B.V. Centralised - Yearly update 1 Mar 2018
Protaphane Novo Nordisk A/S Centralised - Yearly update 1 Mar 2018
BiResp Spiromax Teva Pharma B.V. Centralised - Yearly update 1 Mar 2018
Neparvis Novartis Europharm Limited Centralised - Yearly update 1 Mar 2018
Xiliarx Novartis Europharm Limited Centralised - Yearly update 1 Mar 2018
Jalra Novartis Europharm Limited Centralised - Yearly update 1 Mar 2018
Ameluz Biofrontera Bioscience GmbH Centralised - 2-Monthly update 1 Mar 2018 EMEA/H/C/2204/II/27G
Xeplion Janssen-Cilag International NV Centralised - 2-Monthly update 1 Mar 2018 EMEA/H/C/2105/II/35
Galvus Novartis Europharm Limited Centralised - Yearly update 1 Mar 2018
Abasaglar Eli Lilly Nederland B.V. Centralised - Transfer Marketing Authorisation Holder 27 Feb 2018 EMEA/H/C/2835/T/18
Omnitrope Sandoz GmbH PSUSA - Modification 27 Feb 2018 EMEA/H/C/607/PSUSA/2772/201703
Hemlibra Roche Registration GmbH Corrigendum 23 Feb 2018
Hemlibra Roche Registration GmbH Corrigendum 23 Feb 2018
Hemlibra Roche Registration GmbH Centralised - Authorisation 23 Feb 2018 EMEA/H/C/4406
Eucreas Novartis Europharm Limited Centralised - Yearly update 22 Feb 2018
Zurampic Grünenthal GmbH Centralised - Yearly update 22 Feb 2018
Dynastat Pfizer Limited Centralised - Yearly update 22 Feb 2018
Trulicity Eli Lilly Nederland B.V. Centralised - 2-Monthly update 22 Feb 2018 EMEA/H/C/2825/II/22
NutropinAq Ipsen Pharma PSUSA - Modification 22 Feb 2018 EMEA/H/C/315/PSUSA/2772/201703
Lyrica Pfizer Europe MA EEIG Centralised - Yearly update 19 Feb 2018
Neulasta Amgen Europe B.V. Centralised - Yearly update 19 Feb 2018
Nucala GlaxoSmithKline Trading Services Limited Centralised - Yearly update 19 Feb 2018
Wilzin Orphan Europe S.A.R.L. Centralised - Yearly update 19 Feb 2018
Anoro Ellipta Glaxo Group Ltd Centralised - Yearly update 19 Feb 2018
Adcirca Eli Lilly Nederland B.V. Centralised - Yearly update 19 Feb 2018
Senshio Shionogi Limited Centralised - Yearly update 19 Feb 2018
Ongentys Bial - Portela & Cª, SA Centralised - Yearly update 19 Feb 2018
Tenofovir disoproxil Mylan Mylan S.A.S. Centralised - Yearly update 19 Feb 2018
Talmanco Mylan S.A.S. Centralised - Yearly update 19 Feb 2018
Gardasil 9 MSD VACCINS Centralised - Yearly update 19 Feb 2018
Aerivio Spiromax Teva B.V. Centralised - Yearly update 19 Feb 2018
Airexar Spiromax Teva B.V. Centralised - Yearly update 19 Feb 2018
Icandra Novartis Europharm Limited Centralised - Yearly update 19 Feb 2018
Zyprexa Velotab Eli Lilly Nederland B.V. Centralised - Yearly update 19 Feb 2018
PegIntron Merck Sharp & Dohme Limited Centralised - Yearly update 19 Feb 2018
Mycamine Astellas Pharma Europe B.V. Centralised - Renewal 19 Feb 2018 EMEA/H/C/734/R/34
Simulect Novartis Europharm Limited Centralised - Yearly update 19 Feb 2018
CRYSVITA Kyowa Kirin Limited Centralised - Authorisation 19 Feb 2018 EMEA/H/C/4275
Orkambi Vertex Pharmaceuticals (Europe) Limited PSUSA - Modification 19 Feb 2018 EMEA/H/C/PSUSA/10455/201705
Olanzapine Teva Teva B.V. Centralised - Yearly update 19 Feb 2018
ViraferonPeg Merck Sharp & Dohme Limited Centralised - Yearly update 19 Feb 2018
Rebetol Merck Sharp & Dohme Limited Centralised - Yearly update 19 Feb 2018
Vfend Pfizer Limited Centralised - Yearly update 19 Feb 2018
Esmya Gedeon Richter Plc. Referral 16 Feb 2018 EMEA/H/A-20/1460/C/2041/43
Vantavo Merck Sharp & Dohme B.V. Centralised - Yearly update 15 Feb 2018
Emselex Merus Labs Luxco II S.à R.L. Centralised - Transfer Marketing Authorisation Holder 15 Feb 2018 EMEA/H/C/554/T/65
Fosavance Merck Sharp & Dohme B.V. Centralised - Yearly update 15 Feb 2018
Anagrelide Mylan Mylan S.A.S. Centralised - Authorisation 15 Feb 2018 EMEA/H/C/4585
VELCADE Janssen-Cilag International NV Corrigendum 8 Feb 2018
Hexyon Sanofi Pasteur Europe Corrigendum 8 Jan 2018
Zejula TESARO U.K. Limited Corrigendum 16 Nov 2017
Kovaltry Bayer AG Corrigendum 10 Nov 2017
Iblias Bayer AG Corrigendum 10 Nov 2017
SonoVue Bracco International B.V. Corrigendum 22 Aug 2017
OXERVATE Dompé farmaceutici S.p.A. Corrigendum 6 Jul 2017
Orgalutran Merck Sharp & Dohme Limited Corrigendum 11 Apr 2017
SomaKit TOC Advanced Accelerator Applications Corrigendum 8 Dec 2016
Nevanac Novartis Europharm Limited Corrigendum 29 Jul 2016
Revinty Ellipta Glaxo Group Ltd Corrigendum 2 May 2014
Relvar Ellipta Glaxo Group Ltd Corrigendum 13 Nov 2013
Procedures for centrally authorised orphan medicinal products for human use
Product Marketing Authorisation Holder Decision Type Decision date EMEA Nr
EU/3/18/1994 Quality Regulatory Clinical Ireland Limited Transfer of orphan designation 13 Aug 2018 EMA/OD/172/17/T/01
EU/3/17/1870 Pharma Gateway AB Transfer of orphan designation 3 Aug 2018 EMA/OD/317/16/T/01
EU/3/16/1756 Kyowa Kirin Holdings B.V. Transfer of orphan designation 3 Aug 2018 EMA/OD/091/16/T/01
EU/3/16/1694 GlaxoSmithKline Trading Services Limited Transfer of orphan designation 3 Aug 2018 EMA/OD/064/16/T/01
EU/3/18/1996 Worphmed Srl Transfer of orphan designation 3 Aug 2018 EMA/OD/227/17/T/01
EU/3/16/1755 Worphmed Srl Transfer of orphan designation 3 Aug 2018 EMA/OD/127/16/T/01
EU/3/16/1683 Worphmed Srl Transfer of orphan designation 3 Aug 2018 EMA/OD/007/16/T/01
EU/3/16/1682 Worphmed Srl Transfer of orphan designation 3 Aug 2018 EMA/OD/001/16/T/01
EU/3/14/1351 Kyowa Kirin Holdings B.V. Transfer of orphan designation 31 Jul 2018 EMA/OD/133/14/T/02
EU/3/16/1660 Orchard Therapeutics Ltd Transfer of orphan designation 31 Jul 2018 EMA/OD/024/16/T/02
EU/3/07/446 Orchard Therapeutics Ltd Transfer of orphan designation 31 Jul 2018 EMA/OD/102/06/T/02
EU/3/18/2054 Mallinckrodt Specialty Pharmaceuticals Ireland Limited Orphan designation 31 Jul 2018 EMA/OD/043/18
EU/3/18/2053 Lakeside Regulatory Consulting Services Ltd Orphan designation 31 Jul 2018 EMA/OD/026/18
EU/3/18/2052 Dicerna EU Limited Orphan designation 31 Jul 2018 EMA/OD/052/18
EU/3/18/2051 Wave life Sciences Ireland Limited Orphan designation 31 Jul 2018 EMA/OD/032/18
EU/3/18/2050 AstraZeneca AB Orphan designation 31 Jul 2018 EMA/OD/045/18
EU/3/18/2049 Inozyme Pharma Ireland Ltd Orphan designation 31 Jul 2018 EMA/OD/053/18
EU/3/18/2048 Pharma Gateway AB Orphan designation 31 Jul 2018 EMA/OD/061/18
EU/3/18/2047 Glycomine SARL Orphan designation 31 Jul 2018 EMA/OD/055/18
EU/3/18/2046 Italfarmaco S.p.A. Orphan designation 31 Jul 2018 EMA/OD/062/18
EU/3/18/2045 Dystrogen Therapeutics S.A. Orphan designation 31 Jul 2018 EMA/OD/028/18
EU/3/18/2044 medac Gesellschaft für klinische Spezialpräparate mbH Orphan designation 31 Jul 2018 EMA/OD/023/18
EU/3/18/2043 Dr Ulrich Granzer Orphan designation 31 Jul 2018 EMA/OD/036/18
EU/3/18/2042 MeiraGTx UK II Limited Orphan designation 31 Jul 2018 EMA/OD/048/18
EU/3/18/2041 Ionis USA Limited Orphan designation 31 Jul 2018 EMA/OD/050/18
EU/3/12/998 Orchard Therapeutics Ltd Transfer of orphan designation 25 Jul 2018 EMA/OD/014/12/T/02
EU/3/14/1295 Celgene Europe B.V. Transfer of orphan designation 25 Jul 2018 EMA/OD/035/14/T/02
EU/3/11/890 Kowa Pharmaceutical Europe GmbH Transfer of orphan designation 25 Jul 2018 EMA/OD/003/11/T/01
EU/3/09/645 Camurus AB Transfer of orphan designation 25 Jul 2018 EMA/OD/010/09/T/03
EU/3/16/1635 Leadiant GmbH Transfer of orphan designation 25 Jul 2018 EMA/OD/228/15/T/01
EU/3/18/2013 Roche Registration GmbH Transfer of orphan designation 25 Jul 2018 EMA/OD/231/17/T/01
EU/3/13/1127 Pfizer Europe MA EEIG Transfer of orphan designation 25 Jul 2018 EMA/OD/194/12/T/01
EU/3/02/103 Chiesi Farmaceutici S.p.A. Transfer of orphan designation 25 Jul 2018 EMEA/OD/083/01/T/01
EU/3/17/1932 Millendo Therapeutics SAS Transfer of orphan designation 25 Jul 2018 EMA/OD/066/17/T/01
EU/3/14/1410 Chiesi Farmaceutici S.p.A. Transfer of orphan designation 25 Jul 2018 EMA/OD/172/14/T/01
EU/3/11/911 Chiesi Farmaceutici S.p.A. Transfer of orphan designation 25 Jul 2018 EMA/OD/042/11/T/01
EU/3/18/2019 Reata UK Limited Transfer of orphan designation 25 Jul 2018 EMA/OD/011/18/T/01
EU/3/15/1473 Celgene Europe B.V. Transfer of orphan designation 25 Jul 2018 EMA/OD/284/14/T/01
EU/3/12/1097 Celgene Europe B.V. Transfer of orphan designation 25 Jul 2018 EMA/OD/158/12/T/01
EU/3/11/924 Celgene Europe B.V. Transfer of orphan designation 25 Jul 2018 EMA/OD/078/11/T/01
EU/3/11/868 Celgene Europe B.V. Transfer of orphan designation 25 Jul 2018 EMA/OD/160/10/T/01
EU/3/09/672 Celgene Europe B.V. Transfer of orphan designation 25 Jul 2018 EMEA/OD/053/09/T/01
EU/3/07/494 Celgene Europe B.V. Transfer of orphan designation 25 Jul 2018 EMEA/OD/068/07/T/01
EU/3/04/192 Celgene Europe B.V. Transfer of orphan designation 25 Jul 2018 EMEA/OD/083/03/T/02
EU/3/14/1263 bluebird bio (Germany) GmbH Transfer of orphan designation 25 Jul 2018 EMA/OD/184/13/T/01
EU/3/12/1091 bluebird bio (Germany) GmbH Transfer of orphan designation 25 Jul 2018 EMA/OD/146/12/T/01
EU/3/12/1003 bluebird bio (Germany) GmbH Transfer of orphan designation 25 Jul 2018 EMA/OD/009/12/T/01
EU/3/06/363 Telix Pharmaceuticals Holdings Germany GmbH Transfer of orphan designation 25 Jul 2018 EMA/OD/110/05/T/02
EU/3/12/1066 Pfizer Europe MA EEIG Transfer of orphan designation 25 Jul 2018 EMA/OD/115/12/T/01
EU/3/06/420 Pfizer Europe MA EEIG Transfer of orphan designation 25 Jul 2018 EMA/OD/058/06/T/02
EU/3/06/401 Pfizer Europe MA EEIG Transfer of orphan designation 25 Jul 2018 EMA/OD/032/06/T/03
EU/3/00/005 Pfizer Europe MA EEIG Transfer of orphan designation 25 Jul 2018 EMA/OD/022/00/T/02
EU/3/12/1083 Global Regulatory Limited Transfer of orphan designation 17 Jul 2018 EMA/OD/128/12/T/02
EU/3/16/1783 Reglntel Ltd Transfer of orphan designation 16 Jul 2018 EMA/OD/138/16/T/02
EU/3/16/1686 Mereo Biopharma Ireland Ltd Transfer of orphan designation 16 Jul 2018 EMA/OD/052/16/T/02
EU/3/16/1718 Salzman Group Ltd Transfer of orphan designation 16 Jul 2018 EMA/OD/110/16/T/01
EU/3/16/1645 Salzman Group Ltd Transfer of orphan designation 16 Jul 2018 EMA/OD/248/15/T/01
EU/3/07/505 Faron Pharmaceuticals Limited Amendment of orphan designation 27 Jun 2018 EMA/OD/080/17
EU/3/18/2040 IQVIA RDS Ireland Limited Orphan designation 27 Jun 2018 EMA/OD/035/18
EU/3/18/2039 REGENXBIO EU Limited Orphan designation 27 Jun 2018 EMA/OD/027/18
EU/3/18/2038 PPD Global Ltd Orphan designation 27 Jun 2018 EMA/OD/025/18
EU/3/18/2037 Dr Stefan Blesse Orphan designation 27 Jun 2018 EMA/OD/033/18
EU/3/18/2036 PharmaKrysto Ltd Orphan designation 27 Jun 2018 EMA/OD/012/18
EU/3/18/2035 Hanmi Europe Limited Orphan designation 27 Jun 2018 EMA/OD/009/18
EU/3/18/2034 Apotex Europe B.V. Orphan designation 27 Jun 2018 EMA/OD/006/18
EU/3/18/2033 Real Regulatory Limited Orphan designation 27 Jun 2018 EMA/OD/022/18
EU/3/18/2032 ADIENNE S.r.l.S.U. Orphan designation 27 Jun 2018 EMA/OD/007/18
EU/3/18/2031 Air Liquide Santé (International) Orphan designation 27 Jun 2018 EMA/OD/031/18
EU/3/18/2030 Biophytis Orphan designation 27 Jun 2018 EMA/OD/020/18
EU/3/18/2029 Klinikum der Universität München Orphan designation 27 Jun 2018 EMA/OD/004/18
EU/3/18/2028 BioCryst UK Ltd Orphan designation 27 Jun 2018 EMA/OD/003/18
EU/3/15/1460 Eisai GmbH Transfer of orphan designation 25 Jun 2018 EMA/OD/287/14/T/01
EU/3/13/1121 Eisai GmbH Transfer of orphan designation 25 Jun 2018 EMA/OD/173/12/T/01
EU/3/13/1119 Eisai GmbH Transfer of orphan designation 25 Jun 2018 EMA/OD/019/13/T/01
EU/3/04/240 Eisai GmbH Transfer of orphan designation 25 Jun 2018 EMA/OD/047/04/T/01
EU/3/12/999 Merck Sharp & Dohme B.V. Transfer of orphan designation 25 Jun 2018 EMA/OD/008/12/T/02
EU/3/11/849 Merck Sharp & Dohme B.V. Transfer of orphan designation 25 Jun 2018 EMA/OD/090/10/T/02
EU/3/07/509 Celgene Europe B.V. Transfer of orphan designation 25 Jun 2018 EMEA/OD/085/07/T/02
EU/3/01/084 Celgene Europe B.V. Transfer of orphan designation 25 Jun 2018 EMEA/OD/059/01/T/02
EU/3/18/1995 Bayer AG Transfer of orphan designation 25 Jun 2018 EMA/OD/213/17/T/01
EU/3/15/1606 Bayer AG Transfer of orphan designation 25 Jun 2018 EMA/OD/184/15/T/02
EU/3/16/1798 Merck Europe B.V. Transfer of orphan designation 25 Jun 2018 EMA/OD/170/16/T/01
EU/3/15/1590 Merck Europe B.V. Transfer of orphan designation 25 Jun 2018 EMA/OD/150/15/T/02
EU/3/02/124 BioMarin International Limited Transfer of orphan designation 25 Jun 2018 EMA/OD/050/02/T/03
EU/3/17/1874 Sangamo Therapeutics UK LTD Transfer of orphan designation 25 Jun 2018 EMA/OD/019/17/T/01
EU/3/17/1834 Santhera Pharmaceuticals (Deutschland) GmbH Transfer of orphan designation 8 Jun 2018 EMA/OD/244/16/T/01
EU/3/13/1114 Santhera Pharmaceuticals (Deutschland) GmbH Transfer of orphan designation 8 Jun 2018 EMA/OD/166/12/T/01
EU/3/17/1922 Gilead Sciences Ireland UC Transfer of orphan designation 8 Jun 2018 EMA/OD/040/17/T/01
EU/3/11/888 Gilead Sciences Ireland UC Transfer of orphan designation 8 Jun 2018 EMA/OD/152/10/T/03
EU/3/11/887 Gilead Sciences Ireland UC Transfer of orphan designation 8 Jun 2018 EMA/OD/020/11/T/03
EU/3/11/886 Gilead Sciences Ireland UC Transfer of orphan designation 8 Jun 2018 EMA/OD/019/11/T/03
EU/3/17/1956 Sangamo Therapeutics UK LTD Transfer of orphan designation 8 Jun 2018 EMA/OD/168/17/T/01
EU/3/17/1955 Sangamo Therapeutics UK LTD Transfer of orphan designation 8 Jun 2018 EMA/OD/167/17/T/01
EU/3/10/811 Celgene Europe B.V. Transfer of orphan designation 8 Jun 2018 EMA/OD/092/10/T/03
EU/3/10/810 Celgene Europe B.V. Transfer of orphan designation 8 Jun 2018 EMA/OD/084/10/T/03
EU/3/10/794 Celgene Europe B.V. Transfer of orphan designation 8 Jun 2018 EMA/OD/069/10/T/03
EU/3/16/1802 Quality Regulatory Clinical Ireland Limited Transfer of orphan designation 8 Jun 2018 EMA/OD/197/16/T/01
EU/3/16/1615 Gilead Sciences Ireland UC Transfer of orphan designation 8 Jun 2018 EMA/OD/197/15/T/01
EU/3/14/1350 Novartis Europharm Limited Transfer of orphan designation 31 May 2018 EMA/OD/107/14/T/01
EU/3/12/1046 Novartis Europharm Limited Transfer of orphan designation 31 May 2018 EMA/OD/059/12/T/01
EU/3/10/826 Eurocept International B.V. Transfer of orphan designation 25 May 2018 EMA/OD/072/10/T/02
EU/3/09/645 Camurus AB Transfer of orphan designation 25 May 2018 EMA/OD/010/09/T/02
EU/3/18/2027 Regeneron Ireland U.C. Orphan designation 25 May 2018 EMA/OD/008/18
EU/3/18/2026 Alnylam UK Limited Orphan designation 25 May 2018 EMA/OD/019/18
EU/3/18/2025 Pharma Gateway AB Orphan designation 25 May 2018 EMA/OD/017/18
EU/3/18/2024 Galephar M/F Orphan designation 25 May 2018 EMA/OD/251/17
EU/3/18/2023 Dr Regenold GmbH Orphan designation 25 May 2018 EMA/OD/252/17
EU/3/18/2022 Hanmi Europe Limited Orphan designation 25 May 2018 EMA/OD/257/17
EU/3/18/2021 Chemo Research S.L. Orphan designation 25 May 2018 EMA/OD/248/17
EU/3/18/2020 Janssen-Cilag International NV Orphan designation 25 May 2018 EMA/OD/207/17
EU/3/18/2019 Reata UK Limited Orphan designation 25 May 2018 EMA/OD/011/18
EU/3/18/2018 Celgene Europe Limited Orphan designation 25 May 2018 EMA/OD/260/17
EU/3/18/2017 Spedding Research Solutions SAS Orphan designation 25 May 2018 EMA/OD/236/17
EU/3/18/2016 Abeona Therapeutics Europe SL Orphan designation 25 May 2018 EMA/OD/013/18
EU/3/18/2015 Baxalta Innovations GmbH Orphan designation 25 May 2018 EMA/OD/010/18
EU/3/18/2014 IQVIA RDS Ireland Limited Orphan designation 25 May 2018 EMA/OD/018/18
EU/3/14/1400 Orphan Europe S.A.R.L. Transfer of orphan designation 25 May 2018 EMA/OD/185/14/T/01
EU/3/09/699 Cambridge Regulatory Services Ltd Transfer of orphan designation 25 May 2018 EMA/OD/090/09/T/01
EU/3/11/857 Alnylam Netherlands B.V. Transfer of orphan designation 25 May 2018 EMA/OD/142/10/T/02
EU/3/14/1328 Roche Registration GmbH Transfer of orphan designation 16 May 2018 EMA/OD/100/14/T/01
EU/3/16/1745 Novartis Europharm Limited Transfer of orphan designation 16 May 2018 EMA/OD/087/16/T/01
EU/3/14/1266 Novartis Europharm Limited Transfer of orphan designation 16 May 2018 EMA/OD/187/13/T/01
EU/3/14/1421 Incyte Biosciences Distribution B.V. Transfer of orphan designation 16 May 2018 EMA/OD/212/14/T/02
EU/3/09/716 Incyte Biosciences Distribution B.V. Transfer of orphan designation 16 May 2018 EMA/OD/121/09/T/02
EU/3/09/715 Incyte Biosciences Distribution B.V. Transfer of orphan designation 16 May 2018 EMA/OD/122/09/T/02
EU/3/14/1298 Genzyme Europe B.V. Transfer of orphan designation 16 May 2018 EMA/OD/041/14/T/01
EU/3/14/1297 Genzyme Europe B.V. Transfer of orphan designation 16 May 2018 EMA/OD/039/14/T/01
EU/3/04/204 Gilead Sciences Ireland UC Transfer of orphan designation 16 May 2018 EMEA/OD/006/04/T/03
EU/3/17/1936 Pharma Gateway AB Transfer of orphan designation 16 May 2018 EMA/OD/119/17/T/01
EU/3/07/522 Best Regulatory Consulting Ltd Transfer of orphan designation 16 May 2018 EMA/OD/089/07/T/01
EU/3/16/1684 Pharma Gateway AB Transfer of orphan designation 16 May 2018 EMA/OD/047/16/T/01
EU/3/17/1945 MN Development AB Transfer of orphan designation 16 May 2018 EMA/OD/128/17/T/01
EU/3/14/1353 Lupin Europe GmbH Transfer of orphan designation 16 May 2018 EMA/OD/074/14/T/03
EU/3/14/1306 Chiesi Farmaceutici S.p.A. Transfer of orphan designation 16 May 2018 EMA/OD/070/14/T/01
EU/3/14/1252 Chiesi Farmaceutici S.p.A. Transfer of orphan designation 16 May 2018 EMA/OD/164/13/T/01
EU/3/10/778 Chiesi Farmaceutici S.p.A. Transfer of orphan designation 16 May 2018 EMA/OD/034/10/T/01
EU/3/16/1817 IQVIA RDS Ireland Limited Transfer of orphan designation 16 May 2018 EMA/OD/191/16/T/01
EU/3/15/1562 IQVIA RDS Ireland Limited Transfer of orphan designation 16 May 2018 EMA/OD/111/15/T/01
EU/3/14/1383 IQVIA RDS Ireland Limited Transfer of orphan designation 16 May 2018 EMA/OD/125/14/T/01
EU/3/13/1220 IQVIA RDS Ireland Limited Transfer of orphan designation 16 May 2018 EMA/OD/142/13/T/01
EU/3/13/1116 GlaxoSmithKline Trading Services Limited Transfer of orphan designation 8 May 2018 EMA/OD/174/12/T/01
EU/3/04/213 GlaxoSmithKline Trading Services Limited Transfer of orphan designation 8 May 2018 EMA/OD/027/04/T/02
EU/3/09/667 Takeda Pharma A/S Transfer of orphan designation 8 May 2018 EMEA/OD/054/09/T/01
EU/3/17/1919 Roche Registration GmbH Transfer of orphan designation 8 May 2018 EMA/OD/112/17/T/01
EU/3/14/1382 Novartis Europharm Limited Transfer of orphan designation 8 May 2018 EMA/OD/120/14/T/01
EU/3/14/1345 Novartis Europharm Limited Transfer of orphan designation 8 May 2018 EMA/OD/099/14/T/01
EU/3/13/1205 Novartis Europharm Limited Transfer of orphan designation 8 May 2018 EMA/OD/118/13/T/01
EU/3/12/1063 Novartis Europharm Limited Transfer of orphan designation 8 May 2018 EMA/OD/113/12/T/01
EU/3/12/1034 Novartis Europharm Limited Transfer of orphan designation 8 May 2018 EMA/OD/026/12/T/02
EU/3/10/765 Novartis Europharm Limited Transfer of orphan designation 8 May 2018 EMA/OD/016/10/T/01
EU/3/10/764 Novartis Europharm Limited Transfer of orphan designation 8 May 2018 EMA/OD/010/10/T/01
EU/3/09/671 Novartis Europharm Limited Transfer of orphan designation 8 May 2018 EMEA/OD/052/09/T/01
EU/3/09/670 Novartis Europharm Limited Transfer of orphan designation 8 May 2018 EMEA/OD/051/09/T/01
EU/3/08/605 Novartis Europharm Limited Transfer of orphan designation 8 May 2018 EMEA/OD/059/08/T/01
EU/3/06/391 Novartis Europharm Limited Transfer of orphan designation 8 May 2018 EMA/OD/027/06/T/03
EU/3/04/214 Novartis Europharm Limited Transfer of orphan designation 8 May 2018 EMEA/OD/028/04/T/01
EU/3/03/140 Novartis Europharm Limited Transfer of orphan designation 8 May 2018 EMEA/OD/072/02/T/02
EU/3/14/1305 AbbVie Deutschland GmbH & Co. KG Transfer of orphan designation 8 May 2018 EMA/OD/065/14/T/01
EU/3/17/1954 AbbVie Deutschland GmbH & Co. KG Transfer of orphan designation 8 May 2018 EMA/OD/131/17/T/01
EU/3/16/1767 AbbVie Deutschland GmbH & Co. KG Transfer of orphan designation 8 May 2018 EMA/OD/121/16/T01
EU/3/16/1766 AbbVie Deutschland GmbH & Co. KG Transfer of orphan designation 8 May 2018 EMA/OD/122/16/T/01
EU/3/16/1667 AbbVie Deutschland GmbH & Co. KG Transfer of orphan designation 8 May 2018 EMA/OD/015/16/T02
EU/3/16/1649 AbbVie Deutschland GmbH & Co. KG Transfer of orphan designation 8 May 2018 EMA/OD/239/15/T/01
EU/3/16/1617 AbbVie Deutschland GmbH & Co. KG Transfer of orphan designation 8 May 2018 EMA/OD/205/15/T/01
EU/3/10/830 AbbVie Deutschland GmbH & Co. KG Transfer of orphan designation 8 May 2018 EMA/OD/110/10/T/02
EU/3/06/375 Novartis Europharm Limited Transfer of orphan designation 8 May 2018 EMA/OD/003/06/T/01
Melatonin (haemorrhage) Therapicon Srl Refusal of orphan designation 16 Apr 2018 EMA/OD/127/17
EU/3/18/2013 Roche Registration GmbH Orphan designation 16 Apr 2018 EMA/OD/231/17
EU/3/18/2012 IDEA Innovative Drug European Associates Limited Orphan designation 16 Apr 2018 EMA/OD/244/17
EU/3/18/2011 Ultragenyx Germany GmbH Orphan designation 16 Apr 2018 EMA/OD/026/17
EU/3/18/2010 Novartis Europharm Limited Orphan designation 16 Apr 2018 EMA/OD/249/17
EU/3/18/2009 SOTIO a.s Orphan designation 16 Apr 2018 EMA/OD/246/17
EU/3/18/2008 Stolmár & Partner Patentanwälte PartG mbB Orphan designation 16 Apr 2018 EMA/OD/254/17
EU/3/18/2007 Dr Philippe Moullier Orphan designation 16 Apr 2018 EMA/OD/255/17
Autologous skeletal myoblasts expanded ex vivo Assistance Publique - Hopitaux de Paris (APHP) Refusal of orphan designation 13 Apr 2018 EMA/OD/144/17
EU/3/11/945 Mallinckrodt Pharmaceuticals Ireland Limited Transfer of orphan designation 13 Apr 2018 EMA/OD/105/11/T/03
EU/3/12/1080 AbbVie Deutschland GmbH & Co. KG Transfer of orphan designation 27 Mar 2018 EMA/OD/124/12/T/01
EU/3/13/1177 Astellas Pharma Europe B.V. Transfer of orphan designation 26 Mar 2018 EMA/OD/071/13/T/01
EU/3/12/1092 Astellas Pharma Europe B.V. Transfer of orphan designation 26 Mar 2018 EMA/OD/147/12/T/01
EU/3/10/803 Astellas Pharma Europe B.V. Transfer of orphan designation 26 Mar 2018 EMA/OD/083/10/T/01
EU/3/12/1072 Le4D Limited Transfer of orphan designation 26 Mar 2018 EMA/OD/160/11/T/01
EU/3/17/1876 FGK Representative Service GmbH Transfer of orphan designation 26 Mar 2018 EMA/OD/010/17/T/01
EU/3/04/241 Roche Registration GmbH Transfer of orphan designation 26 Mar 2018 EMEA/OD/052/04/T/03
EU/3/18/2006 IQVIA RDS Ireland Limited Orphan designation 21 Mar 2018 EMA/OD/234/17
EU/3/18/2005 IQVIA RDS Ireland Limited Orphan designation 21 Mar 2018 EMA/OD/222/17
EU/3/18/2004 IQVIA RDS Ireland Limited Orphan designation 21 Mar 2018 EMA/OD/217/17
EU/3/18/2003 Pharmadev Healthcare Ltd Orphan designation 21 Mar 2018 EMA/OD/225/17
EU/3/18/2002 Pharmadev Healthcare Ltd Orphan designation 21 Mar 2018 EMA/OD/224/17
EU/3/18/2001 Soligenix UK Ltd Orphan designation 21 Mar 2018 EMA/OD/242/17
EU/3/18/2000 Amicus Therapeutics UK Ltd Orphan designation 21 Mar 2018 EMA/OD/230/17
EU/3/18/1999 uniQure Biopharma B.V. Orphan designation 21 Mar 2018 EMA/OD/232/17
EU/3/18/1998 Blue-Reg Europe Orphan designation 21 Mar 2018 EMA/OD/206/17
EU/3/18/1997 QRC Consultants Ltd Orphan designation 21 Mar 2018 EMA/OD/226/17
EU/3/18/1996 Worphmed Srl Orphan designation 21 Mar 2018 EMA/OD/227/17
EU/3/18/1995 Bayer AG Orphan designation 21 Mar 2018 EMA/OD/213/17
EU/3/18/1994 Quality Regulatory Clinical Ireland Limited Orphan designation 21 Mar 2018 EMA/OD/172/17
EU/3/18/1993 IQVIA RDS Ireland Limited Orphan designation 21 Mar 2018 EMA/OD/218/17
EU/3/18/1992 argenx BVBA Orphan designation 21 Mar 2018 EMA/OD/245/17
EU/3/18/1991 TurnKey PharmaConsulting Ireland Limited Orphan designation 21 Mar 2018 EMA/OD/235/17
EU/3/18/1990 PharmaBio Consulting Orphan designation 21 Mar 2018 EMA/OD/219/17
EU/3/18/1989 FGK Representative Service GmbH Orphan designation 21 Mar 2018 EMA/OD/208/17
EU/3/17/1882 Richardson Associates Regulatory Affairs Ltd Corrigendum 19 Mar 2018
EU/3/16/1711 Akcea Therapeutics UK Ltd Transfer of orphan designation 19 Mar 2018 EMA/OD/082/16/T/01
EU/3/17/1861 Roivant Sciences Ireland Limited Transfer of orphan designation 19 Mar 2018 EMA/OD/299/16/T/01
EU/3/16/1763 IQVIA RDS Ireland Limited Transfer of orphan designation 19 Mar 2018 EMA/OD/150/16/T/01
EU/3/16/1727 IQVIA RDS Ireland Limited Transfer of orphan designation 19 Mar 2018 EMA/OD/116/16/T/01
EU/3/16/1714 IQVIA RDS Ireland Limited Transfer of orphan designation 19 Mar 2018 EMA/OD/119/16/T/01
EU/3/16/1671 IQVIA RDS Ireland Limited Transfer of orphan designation 19 Mar 2018 EMA/OD/023/16/T/01
EU/3/16/1639 IQVIA RDS Ireland Limited Transfer of orphan designation 19 Mar 2018 EMA/OD/252/15/T/01
EU/3/15/1595 IQVIA RDS Ireland Limited Transfer of orphan designation 19 Mar 2018 EMA/OD/162/15/5T/01
EU/3/14/1363 IQVIA RDS Ireland Limited Transfer of orphan designation 19 Mar 2018 EMA/OD/131/14/T/01
EU/3/11/919 Monopar Therapeutics SARL Transfer of orphan designation 19 Mar 2018 EMA/OD/069/11/T/02
Melatonin (burns) Therapicon Srl Corrigendum 13 Mar 2018
EU/3/17/1947 NeuroVive Pharmaceutical AB Corrigendum 13 Mar 2018
EU/3/17/1903 Inventiva Corrigendum 13 Mar 2018
EU/3/14/1362 Inventiva Corrigendum 13 Mar 2018
EU/3/14/1361 Inventiva Corrigendum 13 Mar 2018
Melatonin (burns) Therapicon Srl Refusal of orphan designation 13 Mar 2018 EMA/OD/039/17
EU/3/16/1789 La Jolla Pharmaceutical II BV Transfer of orphan designation 1 Mar 2018 EMA/OD/144/16/T/02
EU/3/15/1555 La Jolla Pharmaceutical II BV Transfer of orphan designation 1 Mar 2018 EMA/OD/092/15/T/02
EU/3/12/975 Voisin Consulting S.A.R.L. Transfer of orphan designation 1 Mar 2018 EMA/OD/119/11/T/01
EU/3/15/1453 Roche Registration GmbH Transfer of orphan designation 25 Feb 2018 EMA/OD/256/14/T/01
EU/3/18/1988 Chiesi Farmaceutici S.p.A. Orphan designation 22 Feb 2018 EMA/OD/203/17
EU/3/18/1987 Richardson Associates Regulatory Affairs Ltd Orphan designation 22 Feb 2018 EMA/OD/185/17
EU/3/18/1986 UCB Biopharma SPRL Orphan designation 22 Feb 2018 EMA/OD/205/17
EU/3/18/1985 Raremoon Consulting Ltd Orphan designation 22 Feb 2018 EMA/OD/221/17
EU/3/18/1984 Omeros London Limited Orphan designation 22 Feb 2018 EMA/OD/200/17
EU/3/18/1983 Medicure Pharma Europe Limited Orphan designation 22 Feb 2018 EMA/OD/201/17
EU/3/18/1982 ATXA Therapeutics Limited Orphan designation 22 Feb 2018 EMA/OD/199/17
EU/3/18/1981 Midatech Pharma Plc Orphan designation 22 Feb 2018 EMA/OD/312/16
EU/3/18/1980 Orion Corporation Orphan designation 22 Feb 2018 EMA/OD/174/17
EU/3/18/1979 Bayer AG Orphan designation 22 Feb 2018 EMA/OD/189/17
EU/3/18/1978 Richardson Associates Regulatory Affairs Ltd Orphan designation 22 Feb 2018 EMA/OD/198/17
EU/3/18/1977 GW Research Ltd Orphan designation 22 Feb 2018 EMA/OD/215/17
EU/3/18/1976 Universitätsmedizin der Johannes Gutenberg-Universität Mainz Orphan designation 22 Feb 2018 EMA/OD/150/17
EU/3/18/1975 Nightstar Therapeutics plc Orphan designation 22 Feb 2018 EMA/OD/220/17
EU/3/18/1974 Takeda Pharma A/S Orphan designation 22 Feb 2018 EMA/OD/193/17
EU/3/18/1973 ProQR Therapeutics IV BV Orphan designation 22 Feb 2018 EMA/OD/197/17
EU/3/18/1972 CATS Consultants GmbH Orphan designation 22 Feb 2018 EMA/OD/202/17
Procedures for centrally authorised veterinary medicinal products
Product Marketing Authorisation Holder Decision Type Decision date EMEA Nr
Leucofeligen FeLV/RCP Virbac Centralised - 2-Monthly update 9 Aug 2018 EMEA/V/C/143/WS/1282/7
Nobivac LeuFel Virbac Centralised - 2-Monthly update 9 Aug 2018 EMEA/V/C/4778/WS/1282/1
Novem Boehringer Ingelheim Vetmedica GmbH Centralised - Yearly update 3 Aug 2018
Cerenia Zoetis Belgium S.A. Centralised - Yearly update 3 Aug 2018
Onsior Elanco GmbH Centralised - Transfer Marketing Authorisation Holder 3 Aug 2018 EMEA/V/C/127/T/19
LETIFEND Laboratorios LETI, S.L.unipersonal Centralised - Yearly update 3 Aug 2018
Apoquel Zoetis Belgium S.A. Centralised - Renewal 26 Jul 2018 EMEA/V/C/2688/R/13
UBAC Laboratorios Hipra, S.A. Centralised - Authorisation 26 Jul 2018 EMEA/V/C/4595
Respiporc Flu3 IDT Biologika GmbH Centralised - Yearly update 23 Jul 2018
Nobivac L4 Intervet International B.V. Centralised - Yearly update 23 Jul 2018
Reconcile Nexcyon Pharmaceuticals Ltd Centralised - Renewal 13 Jul 2018 EMEA/V/C/133/R-18
Procox Bayer Animal Health GmbH Centralised - Yearly update 12 Jul 2018
Econor Elanco Europe Ltd Centralised - Yearly update 10 Jul 2018
Hiprabovis IBR Marker Live Laboratorios Hipra, S.A. Centralised - Yearly update 9 Jul 2018
ERYSENG Laboratorios Hipra, S.A. Centralised - Yearly update 9 Jul 2018
Coliprotec F4/F18 Prevtec Microbia GmbH Centralised - Yearly update 9 Jul 2018
Trocoxil Zoetis Belgium S.A. Centralised - Yearly update 9 Jul 2018
Credelio Elanco Europe Ltd Centralised - Variation 9 Jul 2018 EMEA/V/C/4247/X/1
Pexion Boehringer Ingelheim Vetmedica GmbH Centralised - 2-Monthly update 5 Jul 2018 EMEA/V/C/2543/II/11/G
Zolvix Elanco Europe Ltd Centralised - Yearly update 2 Jul 2018
ERYSENG PARVO Laboratorios Hipra, S.A. Centralised - Yearly update 2 Jul 2018
Evalon Laboratorios Hipra, S.A. Centralised - Yearly update 27 Jun 2018
BROADLINE Merial Centralised - Yearly update 27 Jun 2018
Porcilis PCV M Hyo Intervet International B.V. Centralised - 2-Monthly update 27 Jun 2018 EMEA/V/C/3796/II/7
Rhiniseng Laboratorios Hipra, S.A. Centralised - Yearly update 18 Jun 2018
Aftovaxpur Doe Merial Centralised - Renewal 14 Jun 2018 EMEA/V/C/2292/R/8
Dany's BienenWohl Dany Bienenwohl GmbH Centralised - Authorisation 14 Jun 2018 EMEA/V/C/4667
Veraflox Bayer Animal Health GmbH Centralised - Yearly update 11 Jun 2018
Cepedex CP-Pharma Handelsgesellschaft mbH Centralised - Yearly update 4 Jun 2018
Activyl Intervet International B.V. Centralised - Yearly update 4 Jun 2018
Sevohale Chanelle Pharmaceuticals Manufacturing Limited Centralised - 2-Monthly update 25 May 2018 EMEA/V/C/4199/IB/3
Osurnia Elanco Europe Ltd Centralised - Yearly update 25 May 2018
GALLIPRANT Elanco GmbH Centralised - Transfer Marketing Authorisation Holder 25 May 2018 EMEA/V/C/4222/T/2
Meloxivet Eli Lilly and Company Limited Centralised - Withdrawal 25 May 2018
Profender Bayer Animal Health GmbH Centralised - Yearly update 25 May 2018
BTVPUR AlSap 8 Merial Centralised - Withdrawal 8 May 2018
BTVPUR AlSap 1 Merial Centralised - Withdrawal 8 May 2018
Suvaxyn Aujeszky 783 + O/W Zoetis Belgium S.A. Centralised - Yearly update 8 May 2018
Fevaxyn Pentofel Zoetis Belgium S.A. Centralised - Yearly update 8 May 2018
Bravecto Plus Intervet International B.V. Centralised - Authorisation 8 May 2018 EMEA/V/C/4440
Semintra Boehringer Ingelheim Vetmedica GmbH Centralised - Variation 8 May 2018 EMEA/V/C/2436/X/8
Naxcel Zoetis Belgium S.A. Centralised - Yearly update 26 Apr 2018
CERTIFECT Merial Centralised - Withdrawal 26 Apr 2018
Onsior Elanco GmbH Centralised - 2-Monthly update 26 Apr 2018 EMEA/V/C/127/II/18/G
Meloxidolor Le Vet Beheer B.V. Centralised - Renewal 20 Apr 2018 EMEA/V/C/2590/R/7
BTVPUR Merial Centralised - Yearly update 16 Apr 2018
Equilis West Nile Intervet International B.V. Centralised - Renewal 16 Apr 2018 EMEA/V/2241/R/5
Equip WNV Zoetis Belgium S.A. Centralised - Yearly update 13 Apr 2018
Clevor Orion Corporation Centralised - Authorisation 13 Apr 2018 EMEA/V/C/4417
ProZinc Boehringer Ingelheim Vetmedica GmbH Centralised - Renewal 13 Apr 2018 EMEA/V/C/2634/R/13
Zulvac 8 Ovis Zoetis Belgium S.A. Centralised - Yearly update 11 Apr 2018
Apoquel Zoetis Belgium S.A. Centralised - Yearly update 6 Apr 2018
Stronghold Plus Zoetis Belgium S.A. Centralised - Yearly update 6 Apr 2018
Zulvac 1 Bovis Zoetis Belgium S.A. Centralised - Yearly update 4 Apr 2018
Zulvac 8 Bovis Zoetis Belgium S.A. Centralised - Yearly update 4 Apr 2018
Zulvac 1 Ovis Zoetis Belgium S.A. Centralised - Yearly update 4 Apr 2018
Convenia Zoetis Belgium S.A. Centralised - Yearly update 4 Apr 2018
Stronghold Zoetis Belgium S.A. Centralised - Yearly update 4 Apr 2018
Zulvac 1+8 Ovis Zoetis Belgium S.A. Centralised - Yearly update 27 Mar 2018
Zulvac 1+8 Bovis Zoetis Belgium S.A. Centralised - Yearly update 27 Mar 2018
Versican Plus DHPPi/L4R Zoetis Belgium S.A. Centralised - Yearly update 27 Mar 2018
Versican Plus DHPPi/L4 Zoetis Belgium S.A. Centralised - Yearly update 27 Mar 2018
Versican Plus DHPPi Zoetis Belgium S.A. Centralised - Yearly update 27 Mar 2018
Zulvac SBV Zoetis Belgium S.A. Centralised - Yearly update 27 Mar 2018
Suvaxyn PCV Zoetis Belgium S.A. Centralised - Yearly update 22 Mar 2018
Palladia Zoetis Belgium S.A. Centralised - Yearly update 22 Mar 2018
Suvaxyn CSF Marker Zoetis Belgium S.A. Centralised - Yearly update 22 Mar 2018
Draxxin Zoetis Belgium S.A. Centralised - Yearly update 22 Mar 2018
ERAVAC Laboratorios Hipra, S.A. Centralised - 2-Monthly update 22 Mar 2018 EMEA/V/C/4239/II/3/G
Panacur AquaSol Intervet International B.V. Corrigendum 20 Mar 2018
Panacur AquaSol Intervet International B.V. Centralised - 2-Monthly update 20 Mar 2018 EMEA/V/C/2008/II/15
Oncept IL-2 Merial Centralised - Renewal 20 Mar 2018 EMEA/V/C/2562/R/6
ECOPORC SHIGA IDT Biologika GmbH Centralised - Renewal 20 Mar 2018 EMEA/V/C/2588/R/6
Bravecto Intervet International B.V. Centralised - Yearly update 19 Mar 2018
Metacam Boehringer Ingelheim Vetmedica GmbH Centralised - 2-Monthly update 19 Mar 2018 EMEA/V/C/33/II/127
Porcilis PCV ID Intervet International B.V. Centralised - 2-Monthly update 19 Mar 2018 EMEA/V/C/3942/WS/1277
Porcilis PCV Intervet International B.V. Centralised - Yearly update 20 Feb 2018
Porcilis PCV M Hyo Intervet International B.V. Centralised - Yearly update 20 Feb 2018
Advocate Bayer Animal Health GmbH Centralised - 2-Monthly update 20 Feb 2018 EMEA/V/C/76/II/39/G
Vectormune ND CEVA-Phylaxia Co. Ltd Centralised - 2-Monthly update 20 Feb 2018 EMEA/V/C/3829/II/7
Simparica Zoetis Belgium S.A. Corrigendum 10 Oct 2017
Innovax-ND-IBD Intervet International B.V. Corrigendum 22 Aug 2017
Exzolt Intervet International B.V. Corrigendum 18 Aug 2017
Cardalis Ceva Santé Animale Corrigendum 8 Jun 2017
Procedures for nationally authorised medicinal products for human use
Product Marketing Authorisation Holder Decision Type Decision date EMEA Nr
Scandonest and associated names Septodont Referral 2 Aug 2018 EMEA/H/A-30/1455
Sodium oxybate PSUSA - Modification 2 Aug 2018 EMEA/H/C/PSUSA/10612/201710
HES (hydroxyethyl starch) Referral 17 Jul 2018 EMEA/H/A-107i/1457
pantoprazole PSUSA - Modification 25 Jun 2018 EMEA/H/C/PSUSA/2285/201708
Retinoids (acitretin, adapalene, alitretinoin, bexarotene, isotretinoin, tazarotene, tretinoin) Referral 21 Jun 2018 EMEA/H/A-31/1446
Valproate Referral 31 May 2018 EMEA/H/A-31/1454
methotrexate PSUSA - Modification 16 May 2018 EMEA/H/C/PSUSA/2014/201706
fentanyl (transmucosal route of administration) 4SC AG PSUSA - Modification 30 Apr 2018 EMEA/H/C/PSUSA/1369/201704
Lutetium (177 Lu) chloride PSUSA - Modification 21 Mar 2018 EMEA/H/C/PSUSA/10391/201706
Mycophenolate mofetil, mycophenolic acid PSUSA - Modification 7 Mar 2018 EMEA/H/C/PSUSA/10550/201705
Somatropin PSUSA - Modification 5 Mar 2018 EMEA/H/C/PSUSA/2772/201703
paracetamol, modified and prolonged release Corrigendum 19 Feb 2018
paracetamol, modified and prolonged release Referral 19 Feb 2018 EMEA/H/A-31/1445
Human coagulation factor VIII Corrigendum 10 Nov 2017
Vancomycin Corrigendum 21 Sep 2017
Vancomycin Corrigendum 21 Sep 2017
Vepesid and associated names Corrigendum 26 Jun 2017
Procedures for nationally authorised veterinary medicinal products
Product Marketing Authorisation Holder Decision Type Decision date EMEA Nr
Seresto and its associated name Foresto Bayer Vital GmbH Referral 25 May 2018 EMEA/V/A/125
Girolan and its associated name Apralan Referral 8 May 2018 EMEA/V/A/122