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Pharmaceuticals - Union 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
Yargesa Piramal Critical Care B.V. Centralised - Transfer Marketing Authorisation Holder 12 Feb 2019 EMEA/H/C/004016/T/0005
Buccolam Shire Services BVBA Centralised - Yearly update 12 Feb 2019
Helicobacter Test INFAI INFAI GmbH Centralised - Yearly update 8 Feb 2019
Raxone Santhera Pharmaceuticals (Deutschland) GmbH Centralised - Yearly update 7 Feb 2019
Tarceva Roche Registration GmbH Centralised - Yearly update 7 Feb 2019
Sycrest Organon N.V. Centralised - Yearly update 7 Feb 2019
Dasselta Krka d. d., Novo mesto Centralised - Yearly update 7 Feb 2019
Dacogen Janssen-Cilag International NV PSUSA - Modification 7 Feb 2019 EMEA/H/C/PSUSA/00009118/201805
Zyprexa Velotab Eli Lilly Nederland B.V. Centralised - Yearly update 6 Feb 2019
Mirapexin Boehringer Ingelheim International GmbH Centralised - Yearly update 6 Feb 2019
Terrosa Gedeon Richter Plc. Centralised - Yearly update 6 Feb 2019
Eptifibatide Accord Accord Healthcare S.L.U. Centralised - Transfer Marketing Authorisation Holder 6 Feb 2019 EMEA/H/C/4104/T/05
Accofil Accord Healthcare S.L.U. Centralised - Transfer Marketing Authorisation Holder 6 Feb 2019 EMEA/H/C/3956/T/27
Ivabradine Accord Accord Healthcare S.L.U. Centralised - Transfer Marketing Authorisation Holder 6 Feb 2019 EMEA/H/C/4241/T/03
Mvasi Amgen Europe B.V. Centralised - Yearly update 6 Feb 2019
Axumin Blue Earth Diagnostics Ireland Ltd Centralised - Transfer Marketing Authorisation Holder 6 Feb 2019 EMEA/H/C/004197/T/0012
Taltz Eli Lilly Nederland B.V. Centralised - Yearly update 6 Feb 2019
Revolade Novartis Europharm Limited Centralised - 2-Monthly update 6 Feb 2019 EMEA/H/C/001110/II/0050
Tolucombi Krka d. d., Novo mesto Centralised - Yearly update 6 Feb 2019
Ammonaps Swedish Orphan Biovitrum International AB Centralised - Transfer Marketing Authorisation Holder 6 Feb 2019 EMEA/H/C/000219/T/0054
Epivir ViiV Healthcare BV Centralised - 2-Monthly update 6 Feb 2019 EMEA/H/C/107/II/0108
Taxotere Aventis Pharma S.A. Centralised - Yearly update 31 Jan 2019
Memantine Accord Accord Healthcare S.L.U. Centralised - Transfer Marketing Authorisation Holder 31 Jan 2019 EMEA/H/C/2766/T/12
Reyataz Bristol-Myers Squibb Pharma EEIG Centralised - Yearly update 31 Jan 2019
Respreeza CSL Behring GmbH Centralised - Yearly update 31 Jan 2019
Xaluprine Nova Laboratories Ireland Limited Centralised - Transfer Marketing Authorisation Holder 31 Jan 2019 EMEA/H/C/002022/T/0020
Elmiron bene-Arzneimittel GmbH Centralised - Yearly update 31 Jan 2019
Stalevo Orion Corporation Centralised - Yearly update 31 Jan 2019
Imatinib Medac medac Gesellschaft für klinische Spezialpräparate mbH Centralised - Yearly update 31 Jan 2019
Feraccru Norgine B.V. Centralised - Transfer Marketing Authorisation Holder 31 Jan 2019 EMEA/H/C/2733/T/20
Onivyde Les Laboratoires Servier Centralised - 2-Monthly update 31 Jan 2019 EMEA/H/C/4125/II/08
Olanzapine Glenmark Europe Glenmark Arzneimittel GmbH Centralised - Transfer Marketing Authorisation Holder 31 Jan 2019 EMEA/H/C/1086/T/27
Olanzapine Glenmark Glenmark Arzneimittel GmbH Centralised - Transfer Marketing Authorisation Holder 31 Jan 2019 EMEA/H/C/1085/T/29
Combivir ViiV Healthcare BV Centralised - Transfer Marketing Authorisation Holder 31 Jan 2019 EMEA/H/C/190/T/94
Plenadren Shire Services BVBA Centralised - Yearly update 31 Jan 2019
Privigen CSL Behring GmbH Centralised - 2-Monthly update 31 Jan 2019 EMEA/H/C/831/IB/144
Resolor Shire Pharmaceuticals Ireland Limited Centralised - Yearly update 31 Jan 2019
Revestive Shire Pharmaceuticals Ireland Limited Centralised - 2-Monthly update 31 Jan 2019 EMEA/H/C/2345/II/43
Aripiprazole Accord Accord Healthcare Limited Centralised - Yearly update 31 Jan 2019
Vizarsin Krka d. d., Novo mesto Centralised - Yearly update 31 Jan 2019
Nplate Amgen Europe B.V. Centralised - Yearly update 31 Jan 2019
Clopidogrel Teva Teva B.V. Centralised - Yearly update 31 Jan 2019
Zoely Theramex Ireland Limited Centralised - Transfer Marketing Authorisation Holder 31 Jan 2019 EMEA/H/C/1213/T/47
Trimbow Chiesi Farmaceutici S.p.A. Centralised - 2-Monthly update 23 Jan 2019 EMEA/H/C/4257/II/02
Luxturna Novartis Europharm Limited Centralised - Transfer Marketing Authorisation Holder 23 Jan 2019 EMEA/H/C/4451/T/01
Axumin Blue Earth Diagnostics Ireland Ltd Centralised - Yearly update 23 Jan 2019
Rapiscan GE Healthcare AS Centralised - 2-Monthly update 23 Jan 2019 EMEA/H/C/1176/II/27
Infanrix hexa GlaxoSmithKline Biologicals S.A. Centralised - Yearly update 23 Jan 2019
Rubraca Clovis Oncology Ireland Limited Centralised - 2-Monthly update 23 Jan 2019 EMEA/H/C/4272/II/01
Emtricitabine/Tenofovir disoproxil Zentiva Zentiva, k.s. Centralised - 2-Monthly update 23 Jan 2019 EMEA/H/C/4137/IB/05/G
Topotecan Teva Teva B.V. Centralised - Yearly update 23 Jan 2019
Revestive Shire Pharmaceuticals Ireland Limited Centralised - Yearly update 23 Jan 2019
Pregabalin Accord Accord Healthcare Limited Centralised - Yearly update 23 Jan 2019
Bronchitol Pharmaxis Europe Limited Centralised - Transfer Marketing Authorisation Holder 23 Jan 2019 EMEA/H/C/1252/T/35
Zoely Theramex Ireland Limited Centralised - Yearly update 23 Jan 2019
Biopoin Teva GmbH Centralised - Yearly update 23 Jan 2019
Dacogen Janssen-Cilag International NV Centralised - 2-Monthly update 23 Jan 2019 EMEA/H/C/002221/II/0033
Juluca ViiV Healthcare BV Centralised - Transfer Marketing Authorisation Holder 23 Jan 2019 EMEA/H/C/4427/T/07
Lonquex Teva B.V. Centralised - Transfer Marketing Authorisation Holder 21 Jan 2019 EMEA/H/C/002556/T/0046
Humalog Eli Lilly Nederland B.V. Centralised - Yearly update 21 Jan 2019
Silapo STADA Arzneimittel AG Centralised - 2-Monthly update 18 Jan 2019 EMEA/H/C/000760/IB/0052/G
Blincyto Amgen Europe B.V. Centralised - 2-Monthly update 18 Jan 2019 EMEA/H/C/3731/II/11
Adempas Bayer AG Centralised - Renewal 18 Jan 2019 EMEA/H/C/2737/R/26
Dexdor Orion Corporation PSUSA - Modification 18 Jan 2019 EMEA/H/C/PSUSA/998/201803
Lumigan Allergan Pharmaceuticals Ireland PASS - Modification 18 Jan 2019 EMEA/H/C/PSUSA/413/201803
CRYSVITA Kyowa Kirin Holdings B.V. Centralised - Annual renewal 17 Jan 2019 EMEA/H/C/4275
Anoro Ellipta GlaxoSmithKline (Ireland) Limited Centralised - Renewal 15 Jan 2019 EMEA/H/C/2751/R/22
Cyltezo Boehringer Ingelheim International GmbH Centralised - Withdrawal 15 Jan 2019
RoActemra Roche Registration GmbH PSUSA - Modification 15 Jan 2019 EMEA/H/C/PSUSA/00002980/201804
Natpar Shire Pharmaceuticals Ireland Limited PSUSA - Modification 15 Jan 2019 EMEA/H/C/PSUSA/10591/201804
Orkambi Vertex Pharmaceuticals (Ireland) Limited Centralised - Variation 15 Jan 2019 EMEA/H/C/3954/X/34/G
Caprelsa Genzyme Europe B.V. Centralised - Annual renewal 15 Jan 2019 EMEA/H/C/2315/R/32
Ulunar Breezhaler Novartis Europharm Limited Centralised - Renewal 15 Jan 2019 EMEA/H/C/3875/R/28
Holoclar Chiesi Farmaceutici S.p.A. Centralised - Annual renewal 15 Jan 2019 EMEA/H/C/2450/R/21
Hemangiol Pierre Fabre Dermatologie Centralised - Renewal 15 Jan 2019 EMEA/H/C/2621/R/18
Armisarte Actavis Group PTC ehf. PSUSA - Modification 15 Jan 2019 EMEA/H/C/4109/PSUSA/2330/201802
Cyltezo Boehringer Ingelheim International GmbH Centralised - Yearly update 14 Jan 2019
Erleada Janssen-Cilag International NV Centralised - Authorisation 14 Jan 2019 EMEA/H/C/4452
Onivyde Les Laboratoires Servier PSUSA - Modification 14 Jan 2019 EMEA/H/C/4125/PSUSA/10534/201804
Orbactiv Menarini International Operations Luxembourg S.A. Centralised - Transfer Marketing Authorisation Holder 11 Jan 2019 EMEA/H/C/003785/T/0022
Symkevi Vertex Pharmaceuticals (Ireland) Limited Centralised - Transfer Marketing Authorisation Holder 11 Jan 2019 EMEA/H/C/004682/T/0003
Vizamyl GE Healthcare AS Centralised - Transfer Marketing Authorisation Holder 11 Jan 2019 EMEA/H/C/2557/T/18
Imatinib Actavis Actavis Group PTC ehf. Centralised - 2-Monthly update 11 Jan 2019 EMEA/H/C/002594/IB/0017/G
Ebymect AstraZeneca AB Centralised - 2-Monthly update 11 Jan 2019 EMEA/H/C/4162/IB/34
Savene Clinigen Healthcare B.V. Centralised - Transfer Marketing Authorisation Holder 11 Jan 2019 EMEA/H/C/000682/T/0038
Yervoy Bristol-Myers Squibb Pharma EEIG Centralised - 2-Monthly update 11 Jan 2019 EMEA/H/C/2213/WS/1278
Opdivo Bristol-Myers Squibb Pharma EEIG Centralised - 2-Monthly update 11 Jan 2019 EMEA/H/C/3985/WS/1278
Ovaleap Theramex Ireland Limited Centralised - Transfer Marketing Authorisation Holder 11 Jan 2019 EMEA/H/C/002608/T/0027
Topotecan Actavis Actavis Group PTC ehf. Centralised - Withdrawal 11 Jan 2019
Vepacel Ology Bioservices Ireland LTD Centralised - Transfer Marketing Authorisation Holder 11 Jan 2019 EMEA/H/C/2089/T/19
Tamiflu Roche Registration GmbH Centralised - 2-Monthly update 11 Jan 2019 EMEA/H/C/000402/II/0136
Hemangiol Pierre Fabre Dermatologie PSUSA - Modification 11 Jan 2019 EMEA/H/C/PSUSA/10250/201804
Laventair Ellipta GlaxoSmithKline (Ireland) Limited Centralised - Renewal 11 Jan 2019 EMEA/H/C/3754/R/25
Hizentra CSL Behring GmbH Centralised - 2-Monthly update 11 Jan 2019 EMEA/H/C/2127/II/97G
Macimorelin Aeterna Zentaris Ćterna Zentaris GmbH Centralised - Authorisation 11 Jan 2019 EMEA/H/C/4660
Incruse Ellipta GlaxoSmithKline (Ireland) Limited Centralised - Renewal 11 Jan 2019 EMEA/H/C/2809/R/21
Sirturo Janssen-Cilag International NV Centralised - Annual renewal 11 Jan 2019 EMEA/H/C/2614/R/31
KEYTRUDA Merck Sharp & Dohme B.V. PSUSA - Modification 11 Jan 2019 EMEA/H/C/PSUSA/10403/201803
Procoralan Les Laboratoires Servier PASS - Modification 11 Jan 2019 EMEA/H/C/597/N/PSR/S/19
Corlentor Les Laboratoires Servier PASS - Modification 11 Jan 2019 EMEA/H/C/598/N/PSR/S/19
Omidria Omeros London Limited Centralised - Yearly update 7 Jan 2019
Pregabalin Sandoz GmbH Sandoz GmbH Centralised - Yearly update 7 Jan 2019
Pregabalin Sandoz Sandoz GmbH Centralised - Yearly update 7 Jan 2019
Strensiq Alexion Europe SAS Centralised - Yearly update 7 Jan 2019
Silodosin Recordati Recordati Ireland Ltd Centralised - Authorisation 7 Jan 2019 EMEA/H/C/4964
Thymanax Servier (Ireland) Industries Limited Centralised - Renewal 7 Jan 2019 EMEA/H/C/916/R/40
Ivabradine Anpharm ANPHARM Przedsiebiorstwo Farmaceutyczne S.A. PASS - Modification 7 Jan 2019 EMEA/H/C/4187/PSR/S/19
Eladynos Radius International Ltd Centralised - Refusal of marketing authorisation 7 Jan 2019 EMEA/H/C/4157
Panretin Eisai GmbH Centralised - Transfer Marketing Authorisation Holder 20 Dec 2018 EMEA/H/C/000279/T/0043
Vimizim BioMarin International Limited Centralised - Renewal 20 Dec 2018 EMEA/H/C/2779/R/24
Vihuma Octapharma AB Centralised - Variation 20 Dec 2018 EMEA/H/C/4459/X/6/G
Vectibix Amgen Europe B.V. Centralised - Yearly update 18 Dec 2018
Ledaga Helsinn Birex Pharmaceuticals Ltd. Centralised - Transfer Marketing Authorisation Holder 18 Dec 2018 EMEA/H/C/2826/T/8
Amyvid Eli Lilly Nederland B.V. Centralised - Yearly update 18 Dec 2018
Ravicti Horizon Pharma Ireland Limited Centralised - 2-Monthly update 18 Dec 2018 EMEA/H/C/3822/II/19
Mabthera Roche Registration GmbH Centralised - 2-Monthly update 18 Dec 2018 EMEA/H/C/165/II/149
Darzalex Janssen-Cilag International NV Centralised - 2-Monthly update 18 Dec 2018 EMEA/H/C/4077/II/19
Alimta Eli Lilly Nederland B.V. PSUSA - Modification 18 Dec 2018 EMEA/H/C/PSUSA/2330/201802
Namuscla Lupin Europe GmbH Centralised - Authorisation 18 Dec 2018 EMEA/H/C/4584
Vokanamet Janssen-Cilag International NV Centralised - Renewal 18 Dec 2018 EMEA/H/C/2656/R/39
Granupas Eurocept International B.V. Centralised - Renewal 18 Dec 2018 EMEA/H/C/2709/R/26
Otezla Celgene Europe B.V. PSUSA - Modification 18 Dec 2018 EMEA/H/C/PSUSA/10338/201803
Bevespi Aerosphere AstraZeneca AB Centralised - Authorisation 18 Dec 2018 EMEA/H/C/4245
Dupixent Sanofi-Aventis groupe Centralised - Yearly update 17 Dec 2018
Elaprase Shire Human Genetic Therapies AB Centralised - Yearly update 17 Dec 2018
Epivir ViiV Healthcare BV Centralised - Transfer Marketing Authorisation Holder 17 Dec 2018 EMEA/H/C/000107/T/0109
Macugen PharmaSwiss Ceská republika s.r.o. Centralised - Withdrawal 17 Dec 2018
Zubsolv Mundipharma Corporation (Ireland) Limited Centralised - Transfer Marketing Authorisation Holder 17 Dec 2018 EMEA/H/C/004407/T/0003
Kisqali Novartis Europharm Limited Centralised - 2-Monthly update 17 Dec 2018 EMEA/H/C/4213/II/0004
Emtricitabine/Tenofovir disoproxil Mylan Mylan S.A.S. Centralised - 2-Monthly update 17 Dec 2018 EMEA/H/C/4050/IB/6/G
Zejula TESARO Bio Netherlands B.V. Centralised - Transfer Marketing Authorisation Holder 17 Dec 2018 EMEA/H/C/4249/T/7
Hexyon Sanofi Pasteur Centralised - Yearly update 17 Dec 2018
Hexacima Sanofi Pasteur Centralised - Yearly update 17 Dec 2018
Triumeq ViiV Healthcare BV Centralised - Transfer Marketing Authorisation Holder 12 Dec 2018
Kevzara Sanofi-Aventis groupe Centralised - Yearly update 12 Dec 2018
Trevicta Janssen-Cilag International NV Centralised - Yearly update 12 Dec 2018
Reagila Gedeon Richter Plc. Centralised - Yearly update 12 Dec 2018
Relvar Ellipta GlaxoSmithKline (Ireland) Limited Centralised - Transfer Marketing Authorisation Holder 12 Dec 2018 EMEA/H/C/2673/T/40
Revinty Ellipta GlaxoSmithKline (Ireland) Limited Centralised - Transfer Marketing Authorisation Holder 12 Dec 2018 EMEA/H/C/2745/T/38
Pandemic influenza vaccine H5N1 BAXTER Ology Bioservices Ireland LTD Centralised - Transfer Marketing Authorisation Holder 12 Dec 2018 EMEA/H/C/1200/T/26
Desloratadine Teva Teva B.V. Centralised - Yearly update 12 Dec 2018
KEYTRUDA Merck Sharp & Dohme B.V. Centralised - 2-Monthly update 12 Dec 2018 EMEA/H/C/3820/II/47
Vfend Pfizer Europe MA EEIG PSUSA - Modification 12 Dec 2018 EMEA/H/C/PSUSA/3127/201802
Ogivri Mylan S.A.S. Centralised - Authorisation 12 Dec 2018 EMEA/H/C/4916
Dengvaxia Sanofi Pasteur Centralised - Authorisation 12 Dec 2018 EMEA/H/C/4171
Flucelvax Tetra Seqirus Netherlands B.V. Centralised - Authorisation 12 Dec 2018 EMEA/H/C/4814
OCALIVA Intercept Pharma Ltd Centralised - Annual renewal 12 Dec 2018 EMEA/H/C/4093/R/9
Entyvio Takeda Pharma A/S Centralised - Renewal 12 Dec 2018 EMEA/H/C/2782/R/32
Pregabalin Pfizer Pfizer Europe MA EEIG Centralised - Renewal 12 Dec 2018 EMEA/H/C/3880/R/25
Moventig Kyowa Kirin Holdings B.V. PSUSA - Modification 12 Dec 2018 EMEA/H/C/PSUSA/10317/201803
Evoltra Genzyme Europe B.V. Centralised - Annual reassessment 12 Dec 2018 EMEA/H/C/613/S/59
Valdoxan Les Laboratoires Servier Centralised - Renewal 12 Dec 2018 EMEA/H/C/915/R/42
RXULTI Otsuka Pharmaceutical Netherlands B.V. Centralised - Transfer Marketing Authorisation Holder 12 Dec 2018 EMEA/H/C/3841
Kengrexal Chiesi Farmaceutici S.p.A. Centralised - Yearly update 12 Dec 2018
Mimpara Amgen Europe B.V. Centralised - Yearly update 12 Dec 2018
Praluent Sanofi-Aventis groupe Centralised - Yearly update 12 Dec 2018
Daklinza Bristol-Myers Squibb Pharma EEIG Centralised - Yearly update 10 Dec 2018
Darunavir Krka Krka d. d., Novo mesto Centralised - 2-Monthly update 10 Dec 2018 EMEA/H/C/4273/IB/2/G
Oncaspar Les Laboratoires Servier Centralised - Transfer Marketing Authorisation Holder 10 Dec 2018 EMEA/H/C/3789/T/21
Xolair Novartis Europharm Limited Centralised - 2-Monthly update 10 Dec 2018 EMEA/H/C/606/II/92
Tenofovir disoproxil Zentiva Zentiva, k.s. Centralised - Yearly update 7 Dec 2018
Toujeo Sanofi-Aventis Deutschland GmbH Centralised - Yearly update 7 Dec 2018
Xermelo Ipsen Pharma Centralised - Yearly update 7 Dec 2018
Ziagen ViiV Healthcare BV Centralised - Transfer Marketing Authorisation Holder 7 Dec 2018 EMEA/H/C/252/T/104
EVOTAZ Bristol-Myers Squibb Pharma EEIG Centralised - Yearly update 7 Dec 2018
Ucedane Eurocept International B.V. Centralised - Transfer Marketing Authorisation Holder 7 Dec 2018
Onivyde Les Laboratoires Servier Centralised - Transfer Marketing Authorisation Holder 7 Dec 2018 EMEA/H/C/4125/T/12
Rubraca Clovis Oncology Ireland Limited Centralised - Transfer Marketing Authorisation Holder 7 Dec 2018 EMEA/H/C/4272/T/5
Elocta Swedish Orphan Biovitrum AB (publ) Centralised - Variation 7 Dec 2018 EMEA/H/C/3964/X/21
Ivabradine JensonR JensonR+ Limited Centralised - Withdrawal 6 Dec 2018
Avamys GlaxoSmithKline (Ireland) Limited Centralised - Transfer Marketing Authorisation Holder 6 Dec 2018 EMEA/H/C/770/T/37
Anoro Ellipta GlaxoSmithKline (Ireland) Limited Centralised - Transfer Marketing Authorisation Holder 6 Dec 2018 EMEA/H/C/2751/T/23
Darunavir Mylan Mylan S.A.S. Centralised - 2-Monthly update 6 Dec 2018 EMEA/H/C/4068/IB/7/G
Exondys AVI BioPharma International Ltd Centralised - Refusal of marketing authorisation 6 Dec 2018 EMEA/H/C/4355
Pregabalin Zentiva k.s Zentiva, k.s. Centralised - Yearly update 28 Nov 2018
AMGEVITA Amgen Europe B.V. Centralised - 2-Monthly update 28 Nov 2018 EMEA/H/C/4212/IB/12/G
Spinraza Biogen Netherlands B.V. Centralised - 2-Monthly update 28 Nov 2018 EMEA/H/C/4312/IB/9
Keppra UCB Pharma S.A. Centralised - Yearly update 28 Nov 2018
Pioglitazone Teva Pharma Teva B.V. Centralised - Yearly update 28 Nov 2018
Pioglitazone Teva Teva B.V. Centralised - Yearly update 28 Nov 2018
Pregabalin Mylan Pharma Mylan S.A.S. Rectificative Decision 28 Nov 2018
Anoro Ellipta GlaxoSmithKline (Ireland) Limited Centralised - Yearly update 26 Nov 2018
Darunavir Krka d.d. Krka d. d., Novo mesto Centralised - 2-Monthly update 26 Nov 2018 EMEA/H/C/4891/IB/2/G
Leflunomide ratiopharm ratiopharm GmbH Centralised - Yearly update 26 Nov 2018
Zeffix GlaxoSmithKline (Ireland) Limited Centralised - Transfer Marketing Authorisation Holder 26 Nov 2018 EMEA/H/C/242/T/73
alli GlaxoSmithKline Dungarvan Limited Centralised - Transfer Marketing Authorisation Holder 26 Nov 2018 EMEA/H/C/854/T/59
PHEBURANE Eurocept International BV Centralised - Transfer Marketing Authorisation Holder 26 Nov 2018 EMEA/H/C/2500/T/20
Orkambi Vertex Pharmaceuticals (Ireland) Limited Centralised - Transfer Marketing Authorisation Holder 26 Nov 2018 EMEA/H/C/3954/T/39
Kalydeco Vertex Pharmaceuticals (Ireland) Limited Centralised - Transfer Marketing Authorisation Holder 26 Nov 2018 EMEA/H/C/2494/T/71
Docetaxel Zentiva Zentiva k.s. Centralised - Transfer Marketing Authorisation Holder 26 Nov 2018 EMEA/H/C/808/T/56
Wakix Bioprojet Pharma Centralised - Yearly update 22 Nov 2018
Zinforo Pfizer Ireland Pharmaceuticals Centralised - Yearly update 22 Nov 2018
Kentera Teva B.V. Centralised - Transfer Marketing Authorisation Holder 22 Nov 2018 EMEA/H/C/532/T/49
Soliris Alexion Europe SAS Centralised - Yearly update 22 Nov 2018
Kyprolis Amgen Europe B.V. Centralised - Yearly update 22 Nov 2018
Nyxoid Mundipharma Corporation (Ireland) Limited Centralised - Transfer Marketing Authorisation Holder 22 Nov 2018 EMEA/H/C/4325/T/4
TAKHZYRO Shire Pharmaceuticals Ireland Limited Centralised - Authorisation 22 Nov 2018 EMEA/H/C/4806
Docetaxel Zentiva Zentiva k.s. Centralised - Yearly update 22 Nov 2018
Kalydeco Vertex Pharmaceuticals (Ireland) Limited Centralised - 2-Monthly update 22 Nov 2018 EMEA/H/C/2494/II/69
Synflorix GlaxoSmithKline Biologicals S.A. Centralised - Renewal 22 Nov 2018 EMEA/H/C/973/R/128
Levetiracetam Hospira Pfizer Europe MA EEIG Centralised - Transfer Marketing Authorisation Holder 22 Nov 2018 EMEA/H/C/2783/T/19
Ixiaro Valneva Austria GmbH Centralised - Renewal 22 Nov 2018 EMEA/H/C/963/R/91
Jivi Bayer AG Centralised - Authorisation 22 Nov 2018 EMEA/H/C/4054
Inlyta Pfizer Europe MA EEIG PSUSA - Modification 22 Nov 2018 EMEA/H/C/2406/PSUSA/10022/201801
Bexsero GlaxoSmithKline Vaccines S.r.l. PSUSA - Modification 22 Nov 2018 EMEA/H/C/2333/PSUSA/10043/201801
Erivedge Roche Registration GmbH PSUSA - Modification 22 Nov 2018 EMEA/H/C/PSUSA/10140/201801
Poteligeo Kyowa Kirin Holdings B.V. Centralised - Authorisation 22 Nov 2018 EMEA/H/C/4232
Alunbrig Takeda Pharma A/S Centralised - Authorisation 22 Nov 2018 EMEA/H/C/4248/
GILENYA Novartis Europharm Limited Centralised - Variation 22 Nov 2018 EMEA/H/C/2202/X/44
Viekirax AbbVie Deutschland GmbH & Co. KG PSUSA - Modification 22 Nov 2018 EMEA/H/C/3839/PSUSA/10367/201801
Ziextenzo Sandoz GmbH Centralised - Authorisation 22 Nov 2018 EMEA/H/C/4802
Pifeltro Merck Sharp & Dohme B.V. Centralised - Authorisation 22 Nov 2018 EMEA/H/C/4747
Delstrigo Merck Sharp & Dohme B.V. Centralised - Authorisation 22 Nov 2018 EMEA/H/C/4746
Luxturna Novartis Europharm Limited Centralised - Authorisation 22 Nov 2018 EMEA/H/C/4451
Atripla Bristol-Myers Squibb and Gilead Sciences Limited Centralised - 2-Monthly update 22 Nov 2018 EMEA/H/C/797/II/130
Mirvaso Galderma International Centralised - Renewal 22 Nov 2018 EMEA/H/C/2642/R/21
Ranexa Menarini International Operations Luxembourg S.A. PSUSA - Modification 22 Nov 2018 EMEA/H/C/805/PSUSA/2611/201801
Efient Daiichi Sankyo Europe GmbH PSUSA - Modification 22 Nov 2018 EMEA/H/C/PSUSA/2499/201802
Rapiscan GE Healthcare AS Centralised - Yearly update 20 Nov 2018
Brineura BioMarin International Limited Centralised - Yearly update 20 Nov 2018
NovoSeven Novo Nordisk A/S Centralised - 2-Monthly update 20 Nov 2018 EMEA/H/C/74/II/104
Emtricitabine/Tenofovir disoproxil Krka Krka d. d., Novo mesto Centralised - 2-Monthly update 20 Nov 2018 EMEA/H/C/4215/IB/10G
Rezolsta Janssen-Cilag International NV Centralised - 2-Monthly update 20 Nov 2018 EMEA/H/C/2819/WS1474/27/G
PREZISTA Janssen-Cilag International NV Centralised - 2-Monthly update 20 Nov 2018 EMEA/H/C/707/WS/1474
Symtuza Janssen-Cilag International NV Centralised - 2-Monthly update 20 Nov 2018 EMEA/H/C/4391/WS/1474
Incruse Ellipta GlaxoSmithKline (Ireland) Limited Centralised - Transfer Marketing Authorisation Holder 20 Nov 2018 EMEA/H/C/2809/T/22
Venclyxto AbbVie Deutschland GmbH & Co. KG Centralised - Authorisation - Switch to non-conditional 20 Nov 2018 EMEA/H/C/4106/II/11
Levetiracetam Hospira Pfizer Europe MA EEIG Centralised - Renewal 20 Nov 2018 EMEA/H/C/2783/R/18
Brintellix H. Lundbeck A/S Centralised - Renewal 20 Nov 2018 EMEA/H/C/2717/R/19
Ozurdex Allergan Pharmaceuticals Ireland PSUSA - Modification 20 Nov 2018 EMEA/H/C/1140/PSUSA/985/201801
Orfadin Swedish Orphan Biovitrum International AB PSUSA - Modification 20 Nov 2018 EMEA/H/C/PSUSA/2169/201802
Fluenz Tetra AstraZeneca AB Centralised - Renewal 20 Nov 2018 EMEA/H/C/2617/R/79
Selincro H. Lundbeck A/S PSUSA - Modification 20 Nov 2018 EMEA/H/C/PSUSA/10120/201802
Zoledronic acid Accord Accord Healthcare Limited Centralised - Renewal 20 Nov 2018 EMEA/H/C/2667/R/6
Neuraceq Life Radiopharma Berlin GmbH Centralised - Renewal 20 Nov 2018 EMEA/H/C/2553/R/25
Vabomere Rempex London Limited Centralised - Authorisation 20 Nov 2018 EMEA/H/C/4669/
Apealea Oasmia Pharmaceutical AB Centralised - Authorisation 20 Nov 2018 EMEA/H/C/4154/
Pelmeg Cinfa Biotech S.L. Centralised - Authorisation 20 Nov 2018 EMEA/H/C/4700
Fulphila Mylan S.A.S. Centralised - Authorisation 20 Nov 2018 EMEA/H/C/4915
Buvidal Camurus AB Centralised - Authorisation 20 Nov 2018 EMEA/H/C/4651
Benlysta GlaxoSmithKline (Ireland) Limited Centralised - Transfer Marketing Authorisation Holder 14 Nov 2018 EMEA/H/C/2015/T/60
Incruse Ellipta GlaxoSmithKline (Ireland) Limited Centralised - Yearly update 14 Nov 2018
Laventair Ellipta GlaxoSmithKline (Ireland) Limited Centralised - Transfer Marketing Authorisation Holder 14 Nov 2018 EMEA/H/C/3754/T/26
Latuda Aziende Chimiche Riunite Angelini Francesco - A.C.R.A.F. S.p.A. Centralised - Renewal 14 Nov 2018 EMEA/H/C/2713/R/20
Emgality Eli Lilly Nederland B.V. Centralised - Authorisation 14 Nov 2018 EMEA/H/C/4648
Tecfidera Biogen Idec Limited Centralised - Transfer Marketing Authorisation Holder 14 Nov 2018 EMEA/H/C/2601/T/55
Daptomycin Hospira Hospira UK Limited Centralised - Transfer Marketing Authorisation Holder 14 Nov 2018 EMEA/H/C/4310/T/8
Izba Novartis Europharm Limited Centralised - Renewal 14 Nov 2018 EMEA/H/C/2738/R/11
Jinarc Otsuka Pharmaceutical Netherlands B.V. Centralised - Transfer Marketing Authorisation Holder 12 Nov 2018 EMEA/H/C/2788/T/20
Eperzan GlaxoSmithKline Trading Services Limited Centralised - Withdrawal 12 Nov 2018
Clopidogrel ratiopharm Teva B.V. Centralised - Yearly update 12 Nov 2018
Desloratadine ratiopharm ratiopharm GmbH Centralised - Yearly update 12 Nov 2018
Laventair Ellipta GlaxoSmithKline (Ireland) Limited Centralised - Yearly update 12 Nov 2018
Olanzapine Mylan Mylan S.A.S. Centralised - Transfer Marketing Authorisation Holder 12 Nov 2018 EMEA/H/C/961/T/45
Xigduo AstraZeneca AB Centralised - 2-Monthly update 12 Nov 2018 EMEA/H/C/2672/WS/1380/45
CABOMETYX Ipsen Pharma Centralised - 2-Monthly update 12 Nov 2018 EMEA/H/C/4163/II/5
Bemfola Gedeon Richter Plc. Centralised - Renewal 12 Nov 2018 EMEA/H/C/2615/R/19
Ebymect AstraZeneca AB Centralised - 2-Monthly update 12 Nov 2018 EMEA/H/C/4162/WS/1380
Exviera AbbVie Deutschland GmbH & Co. KG PSUSA - Modification 12 Nov 2018 EMEA/H/C/3837/PSUSA/10363/201801
Edistride AstraZeneca AB Centralised - 2-Monthly update 12 Nov 2018 EMEA/H/C/4161/WS/1380
Forxiga AstraZeneca AB Centralised - 2-Monthly update 12 Nov 2018 EMEA/H/C/2322/WS/1380
Efavirenz/Emtricitabine/Tenofovir disoproxil Zentiva Zentiva, k.s. Centralised - Yearly update 8 Nov 2018
Xeljanz Pfizer Europe MA EEIG Centralised - Transfer Marketing Authorisation Holder 8 Nov 2018 EMEA/H/C/4214/T/15
Ruconest Pharming Group N.V. Centralised - Yearly update 8 Nov 2018
Spinraza Biogen Netherlands B.V. Centralised - Transfer Marketing Authorisation Holder 8 Nov 2018 EMEA/H/C/4312/T/10
Flixabi Samsung Bioepis NL B.V. Centralised - Transfer Marketing Authorisation Holder 8 Nov 2018 EMEA/H/C/4020/T/30
Ontruzant Samsung Bioepis NL B.V. Centralised - Transfer Marketing Authorisation Holder 8 Nov 2018 EMEA/H/C/4323/T/12
Benepali Samsung Bioepis NL B.V. Centralised - Transfer Marketing Authorisation Holder 8 Nov 2018 EMEA/H/C/4007/T/38
Neupro UCB Pharma S.A. Centralised - Yearly update 8 Nov 2018
Tracleer Janssen-Cilag International NV Centralised - Transfer Marketing Authorisation Holder 8 Nov 2018 EMEA/H/C/401/T/88
Irbesartan HCT Zentiva Zentiva k.s. Centralised - Transfer Marketing Authorisation Holder 8 Nov 2018 EMEA/H/C/783/T/100
Benepali Samsung Bioepis NL B.V. Centralised - Yearly update 8 Nov 2018
Neulasta Amgen Europe B.V. Centralised - Yearly update 31 Oct 2018
Samsca Otsuka Pharmaceutical Netherlands B.V. Centralised - Transfer Marketing Authorisation Holder 31 Oct 2018 EMEA/H/C/980/T/36
Arzerra Novartis Europharm Limited Centralised - Transfer Marketing Authorisation Holder 31 Oct 2018 EMEA/H/C/1131/T/57
Trelegy Ellipta GlaxoSmithKline Trading Services Limited Centralised - 2-Monthly update 31 Oct 2018 EMEA/H/C/4363/WS/1369
Elebrato Ellipta GlaxoSmithKline Trading Services Limited Centralised - 2-Monthly update 31 Oct 2018 EMEA/H/C/4781/WS/1369
Symkevi Vertex Pharmaceuticals (Ireland) Limited Centralised - Authorisation 31 Oct 2018 EMEA/H/C/4682
Taxespira Hospira UK Limited Centralised - Withdrawal 30 Oct 2018
Integrilin GlaxoSmithKline (Ireland) Limited Centralised - Transfer Marketing Authorisation Holder 29 Oct 2018 EMEA/H/C/230/T/79
Volibris GlaxoSmithKline (Ireland) Limited Centralised - Transfer Marketing Authorisation Holder 29 Oct 2018 EMEA/H/C/839/T/56
Protopic Leo Pharma A/S Centralised - Yearly update 29 Oct 2018
Evista Daiichi Sankyo Europe GmbH Centralised - Yearly update 29 Oct 2018
Lusduna Merck Sharp & Dohme B.V. Centralised - Withdrawal 29 Oct 2018
AMGEVITA Amgen Europe B.V. Centralised - Yearly update 29 Oct 2018
Venclyxto AbbVie Deutschland GmbH & Co. KG Centralised - 2-Monthly update 29 Oct 2018 EMEA/H/C/4106/II/8
Imraldi Samsung Bioepis NL B.V. Centralised - Transfer Marketing Authorisation Holder 29 Oct 2018 EMEA/H/C/4279/T/15
RoActemra Roche Registration GmbH Centralised - 2-Monthly update 29 Oct 2018 EMEA/H/C/955/II/76
Taxespira Hospira UK Limited Centralised - Yearly update 29 Oct 2018
Eporatio ratiopharm GmbH Centralised - Yearly update 29 Oct 2018
Viramune Boehringer Ingelheim International GmbH Centralised - Yearly update 29 Oct 2018
Synflorix GlaxoSmithKline Biologicals S.A. Centralised - Yearly update 25 Oct 2018
Replagal Shire Human Genetic Therapies AB Centralised - Yearly update 25 Oct 2018
Sustiva Bristol-Myers Squibb Pharma EEIG Centralised - 2-Monthly update 25 Oct 2018 EMEA/H/C/249/II/145/G
Cyltezo Boehringer Ingelheim International GmbH Centralised - 2-Monthly update 25 Oct 2018 EMEA/H/C/4319/IB/5/G
Clopidogrel/Acetylsalicylic acid Zentiva Sanofi-Aventis groupe Centralised - 2-Monthly update 25 Oct 2018 EMEA/H/C/1144/WS1433/51
Plavix Sanofi Clir SNC Centralised - 2-Monthly update 25 Oct 2018 EMEA/H/C/174/WS/1433/130
Iscover Sanofi-Aventis groupe Centralised - 2-Monthly update 25 Oct 2018 EMEA/H/C/175/WS1433/133
Clopidogrel Zentiva Zentiva, k.s. Centralised - 2-Monthly update 25 Oct 2018 EMEA/H/C/975/WS1433/61
DuoPlavin Sanofi Clir SNC Centralised - 2-Monthly update 25 Oct 2018 EMEA/H/C/1143/WS/1433/50
Micardis Boehringer Ingelheim International GmbH Centralised - Yearly update 23 Oct 2018
Xtandi Astellas Pharma Europe B.V. Centralised - 2-Monthly update 23 Oct 2018 EMEA/H/C/2639/II/39G
Cosentyx Novartis Europharm Limited Centralised - 2-Monthly update 23 Oct 2018 EMEA/H/C/3729/II/33
XALKORI Pfizer Europe MA EEIG Centralised - 2-Monthly update 23 Oct 2018 EMEA/H/C/2489/II/55
Zinbryta Biogen Idec Limited Referral 23 Oct 2018 EMEA/H/C/3862/A-20/1462
Velphoro Vifor Fresenius Medical Care Renal Pharma France Centralised - Yearly update 18 Oct 2018
Evoltra Genzyme Europe B.V. Centralised - Yearly update 18 Oct 2018
Forsteo Eli Lilly Nederland B.V. Centralised - Yearly update 18 Oct 2018
Irbesartan / Hydrochlorothiazide Teva Teva B.V. Centralised - Yearly update 18 Oct 2018
Pemetrexed Hospira Pfizer Europe MA EEIG Centralised - Transfer Marketing Authorisation Holder 18 Oct 2018 EMEA/H/C/3970/T/14
Kivexa ViiV Healthcare BV Centralised - Transfer Marketing Authorisation Holder 16 Oct 2018 EMEA/H/C/581/T/76
Leflunomide Zentiva Zentiva k.s. Centralised - Transfer Marketing Authorisation Holder 16 Oct 2018 EMEA/H/C/1129/T/32
ABILIFY MAINTENA Otsuka Pharmaceutical Netherlands B.V. Centralised - Transfer Marketing Authorisation Holder 16 Oct 2018 EMEA/H/C/2755/T/26
Rapamune Pfizer Europe MA EEIG Centralised - Transfer Marketing Authorisation Holder 16 Oct 2018 EMEA/H/C/273/T/168
Sutent Pfizer Europe MA EEIG Centralised - Transfer Marketing Authorisation Holder 16 Oct 2018 EMEA/H/C/687/T/72
Riximyo Sandoz GmbH Centralised - Yearly update 11 Oct 2018
Irbesartan Zentiva Zentiva k.s. Centralised - Transfer Marketing Authorisation Holder 10 Oct 2018 EMEA/H/C/785T/79
Kalydeco Vertex Pharmaceuticals (Ireland) Limited Centralised - 2-Monthly update 10 Oct 2018 EMEA/H/C/2494/II/63/G
Exviera AbbVie Deutschland GmbH & Co. KG Centralised - 2-Monthly update 4 Oct 2018 EMEA/H/C/3837/WS/1348
Palonosetron Hospira Pfizer Europe MA EEIG Centralised - Transfer Marketing Authorisation Holder 4 Oct 2018 EMEA/H/C/4069/T/4
Grastofil Apotex Europe B.V. Centralised - Renewal 4 Oct 2018 EMEA/H/C/2150/R/20
Xofigo Bayer AG Corrigendum 28 Sep 2018
Telzir ViiV Healthcare BV Centralised - Transfer Marketing Authorisation Holder 28 Sep 2018 EMEA/H/C/534/T/93
Pemetrexed Pfizer Pfizer Europe MA EEIG Centralised - Transfer Marketing Authorisation Holder 28 Sep 2018 EMEA/H/C/4488/T/4
Celsentri ViiV Healthcare BV Centralised - Transfer Marketing Authorisation Holder 28 Sep 2018 EMEA/H/C/811/T/56
Zoledronic acid Teva Teva B.V. Centralised - Yearly update 28 Sep 2018
CoAprovel Sanofi Clir SNC Centralised - Yearly update 28 Sep 2018
Lamivudine Teva Pharma B.V. Teva B.V. Centralised - Yearly update 28 Sep 2018
Retacrit Pfizer Europe MA EEIG Centralised - Transfer Marketing Authorisation Holder 28 Sep 2018 EMEA/H/C/872/T/86
Uptravi Janssen-Cilag International NV Centralised - Transfer Marketing Authorisation Holder 28 Sep 2018 EMEA/H/C/3774/T/19
Dynastat Pfizer Europe MA EEIG Centralised - Transfer Marketing Authorisation Holder 28 Sep 2018 EMEA/H/C/381/T/73
Zavesca Janssen-Cilag International NV Centralised - Transfer Marketing Authorisation Holder 28 Sep 2018 EMEA/H/C/435/T/63
Trizivir ViiV Healthcare BV Centralised - Transfer Marketing Authorisation Holder 28 Sep 2018 EMEA/H/C/338/T/108
Intuniv Shire Pharmaceuticals Ireland Limited Centralised - Yearly update 28 Sep 2018
HALAVEN Eisai GmbH Centralised - Transfer Marketing Authorisation Holder 28 Sep 2018 EMEA/H/C/2084/T/46
Ritemvia Celltrion Healthcare Hungary Kft. Centralised - Yearly update 28 Sep 2018
Vfend Pfizer Europe MA EEIG Centralised - Transfer Marketing Authorisation Holder 28 Sep 2018 EMEA/H/C/387/T/130
Vimizim BioMarin International Limited Centralised - Transfer Marketing Authorisation Holder 28 Sep 2018 EMEA/H/C/2779/T/26
Imraldi Samsung Bioepis NL B.V. Centralised - 2-Monthly update 28 Sep 2018 EMEA/H/C/4279/IB/14
Zoledronic acid Actavis Actavis Group PTC ehf. Centralised - Yearly update 28 Sep 2018
Metalyse Boehringer Ingelheim International GmbH Centralised - Yearly update 28 Sep 2018
Nexium Control Pfizer Healthcare Ireland Centralised - Transfer Marketing Authorisation Holder 28 Sep 2018 EMEA/H/C/2618/T/23
Docetaxel Teva Teva B.V. Centralised - Yearly update 28 Sep 2018
Xigduo AstraZeneca AB Centralised - Renewal 28 Sep 2018 EMEA/H/C/2672/R/44
Xofigo Bayer AG Referral 28 Sep 2018 EMEA/H/A-20/1459/C/2653/28
NexoBrid MediWound Germany GmbH PSUSA - Modification 28 Sep 2018 EMEA/H/C/PSUSA/10028/201712
Zoledronic acid Mylan Mylan S.A.S. Centralised - Yearly update 28 Sep 2018
Rebetol Merck Sharp & Dohme B.V. Centralised - Transfer Marketing Authorisation Holder 28 Sep 2018 EMEA/H/C/246/T83
PegIntron Merck Sharp & Dohme B.V. Centralised - Transfer Marketing Authorisation Holder 28 Sep 2018 EMEA/H/C/280/T/135
ViraferonPeg Merck Sharp & Dohme B.V. Centralised - Transfer Marketing Authorisation Holder 28 Sep 2018 EMEA/H/C/329/T/128
IntronA Merck Sharp & Dohme B.V. Centralised - Transfer Marketing Authorisation Holder 28 Sep 2018 EMEA/H/C/281/T/116
Imnovid Celgene Europe B.V. Centralised - Transfer Marketing Authorisation Holder 28 Sep 2018 EMEA/H/C/2682/T/30
IONSYS Incline Therapeutics Europe Ltd Centralised - Withdrawal 27 Sep 2018
Verzenios Eli Lilly Nederland B.V. Centralised - Authorisation 27 Sep 2018 EMEA/H/C/4302
Gefitinib Mylan Mylan S.A.S. Centralised - Authorisation 27 Sep 2018 EMEA/H/C/4826
Trumenba Pfizer Europe MA EEIG Centralised - Transfer Marketing Authorisation Holder 27 Sep 2018 EMEA/H/C/4051/T/9
BeneFIX Pfizer Europe MA EEIG Centralised - Transfer Marketing Authorisation Holder 27 Sep 2018 EMEA/H/C/139/T/152
Ecalta Pfizer Europe MA EEIG Centralised - Transfer Marketing Authorisation Holder 27 Sep 2018 EMEA/H/C/788/T/37
Vimizim BioMarin International Limited Centralised - Yearly update 27 Sep 2018
Prevenar 13 Pfizer Europe MA EEIG Centralised - Transfer Marketing Authorisation Holder 27 Sep 2018 EMEA/H/C/1104/T/170
Fycompa Eisai GmbH Centralised - Transfer Marketing Authorisation Holder 21 Sep 2018 EMEA/H/C/2434/T/40
Opsumit Janssen-Cilag International NV Centralised - Transfer Marketing Authorisation Holder 21 Sep 2018 EMEA/H/C/2697/T/28
Zonegran Eisai GmbH Centralised - Transfer Marketing Authorisation Holder 21 Sep 2018 EMEA/H/C/577/T/90
Voriconazole Hikma Hikma Farmacęutica (Portugal), S.A. Centralised - Yearly update 21 Sep 2018
Inovelon Eisai GmbH Centralised - Transfer Marketing Authorisation Holder 21 Sep 2018 EMEA/H/C/660/T/48
Imfinzi AstraZeneca AB Centralised - Authorisation 21 Sep 2018 EMEA/H/C/4771
Pelgraz Accord Healthcare Limited Centralised - Authorisation 21 Sep 2018 EMEA/H/C/3961
Udenyca ERA Consulting GmbH Centralised - Authorisation 21 Sep 2018 EMEA/H/C/4413/
Tivicay ViiV Healthcare BV Centralised - Renewal 21 Sep 2018 EMEA/H/C/2753/R/40
Brilique AstraZeneca AB PSUSA - Modification 21 Sep 2018 EMEA/H/C/1241/PSUSA/2948/201712
Deferiprone Lipomed Lipomed GmbH Corrigendum 20 Sep 2018
Kanuma Alexion Europe SAS Centralised - Yearly update 20 Sep 2018
Cyramza Eli Lilly Nederland B.V. Centralised - Yearly update 20 Sep 2018
Atazanavir Mylan Mylan S.A.S. Centralised - 2-Monthly update 20 Sep 2018 EMEA/H/C/4048/IB/5
Karvezide Sanofi-Aventis groupe Centralised - Yearly update 20 Sep 2018
Rixathon Sandoz GmbH Centralised - Yearly update 20 Sep 2018
Rasilez Noden Pharma DAC Centralised - Yearly update 20 Sep 2018
Ovitrelle Merck Europe B.V. Centralised - Transfer Marketing Authorisation Holder 20 Sep 2018 EMEA/H/C/320/T/75
NeuroBloc Sloan Pharma S.a.r.l. Centralised - Transfer Marketing Authorisation Holder 20 Sep 2018 EMEA/H/C/301/T/101
Cinqaero Teva B.V. Centralised - Transfer Marketing Authorisation Holder 20 Sep 2018 EMEA/H/C/3912T/18
Topotecan Hospira Pfizer Europe MA EEIG Centralised - Transfer Marketing Authorisation Holder 20 Sep 2018 EMEA/H/C/1192/T/33
Zoledronic acid Hospira Pfizer Europe MA EEIG Centralised - Transfer Marketing Authorisation Holder 20 Sep 2018 EMEA/H/C/2365/T/33
INCRELEX Ipsen Pharma Centralised - Yearly update 20 Sep 2018
Tresiba Novo Nordisk A/S Centralised - Yearly update 20 Sep 2018
Nitisinone MDK MendeliKABS Europe Limited Centralised - Yearly update 20 Sep 2018
Ryzodeg Novo Nordisk A/S Centralised - Yearly update 20 Sep 2018
Blitzima Celltrion Healthcare Hungary Kft. Centralised - Yearly update 20 Sep 2018
Sevelamer carbonate Winthrop Genzyme Europe B.V. Centralised - Variation 20 Sep 2018 EMEA/H/C/3971/X/11
EndolucinBeta ITG Isotope Technologies Garching GmbH PSUSA - Modification 20 Sep 2018 EMEA/H/C/3999/PSUSA/10391/201712
Tecfidera Biogen Idec Limited Centralised - Renewal 20 Sep 2018 EMEA/H/C/2601/R/53
Cosentyx Novartis Europharm Limited PSUSA - Modification 20 Sep 2018 EMEA/H/C/PSUSA/10341/201712
Lumark IDB Holland B.V. PSUSA - Modification 20 Sep 2018 EMEA/H/C/PSUSA/10391/201712
Renvela Genzyme Europe B.V. Centralised - Variation 20 Sep 2018 EMEA/H/C/993/X/39
Dexxience Portola Pharma UK Limited Centralised - Refusal of marketing authorisation 20 Sep 2018 EMEA/H/C/4309
Lenalidomide Accord Accord Healthcare Limited Centralised - Authorisation 20 Sep 2018 EMEA/H/C/4857
Slenyto RAD Neurim Pharmaceuticals EEC Limited Centralised - Authorisation 20 Sep 2018 EMEA/H/C/4425
Kigabeq ORPHELIA Pharma SAS Centralised - Authorisation 20 Sep 2018 EMEA/H/C/4534
Braftovi Pierre Fabre Médicament Centralised - Authorisation 20 Sep 2018 EMEA/H/C/4580/
Mektovi Pierre Fabre Médicament Centralised - Authorisation 20 Sep 2018 EMEA/H/C/4579
Diacomit Biocodex Centralised - Renewal 20 Sep 2018 EMEA/H/C/664/R/21
Iclusig Incyte Biosciences Distribution B.V. PSUSA - Modification 20 Sep 2018 EMEA/H/C/2695/PSUSA/10128/201712
Xerava Tetraphase Pharmaceuticals Ireland Limited Centralised - Authorisation 20 Sep 2018 EMEA/H/C/4237
Deferiprone Lipomed Lipomed GmbH Centralised - Authorisation 20 Sep 2018 EMEA/H/C/4710
Opdivo Bristol-Myers Squibb Pharma EEIG PSUSA - Modification 20 Sep 2018 EMEA/H/C/3985/PSUSA/10379/201801
Neofordex Laboratoires CTRS Centralised - Yearly update 20 Sep 2018
Targretin Eisai GmbH Centralised - Transfer Marketing Authorisation Holder 17 Sep 2018 EMEA/H/C/326/T/50
CRYSVITA Kyowa Kirin Holdings B.V. Centralised - Transfer Marketing Authorisation Holder 17 Sep 2018 EMEA/H/C/4275/T/1
Pregabalin Mylan Pharma Mylan S.A.S. Centralised - Transfer Marketing Authorisation Holder 17 Sep 2018 EMEA/H/C/3962/T/8
Inhixa Techdow Europe AB Centralised - Variation 17 Sep 2018 EMEA/H/C/4264/X/18, 26
Stelara Janssen-Cilag International NV PSUSA - Modification 17 Sep 2018 EMEA/H/C/PSUSA/3085/201712
Ninlaro Takeda Pharma A/S Centralised - Annual renewal 17 Sep 2018 EMEA/H/C/3844/R/12
Kadcyla Roche Registration GmbH Centralised - Renewal 17 Sep 2018 EMEA/H/C/2389/R/39
Fortacin Recordati Ireland Ltd Centralised - Renewal 17 Sep 2018 EMEA/H/C/2693/R/23
Ilumetri Almirall, S.A. Centralised - Authorisation 17 Sep 2018 EMEA/H/C/4514
Sovaldi Gilead Sciences Ireland UC Centralised - Renewal 17 Sep 2018 EMEA/H/C/2798/R/50
Hulio Mylan S.A.S. Centralised - Authorisation 17 Sep 2018 EMEA/H/C/4429
Lartruvo Eli Lilly Nederland B.V. Centralised - Annual renewal 17 Sep 2018 EMEA/H/C/4216/R/10
Tegsedi Akcea Therapeutics UK Ltd. Centralised - Transfer Marketing Authorisation Holder 12 Sep 2018 EMEA/H/C/4782/T/1
Memantine Mylan Mylan S.A.S. Centralised - Transfer Marketing Authorisation Holder 10 Sep 2018 EMEA/H/C/2660/T/12
Pregabalin Mylan Mylan S.A.S. Centralised - Transfer Marketing Authorisation Holder 10 Sep 2018 EMEA/H/C/4078/T/10
ADCETRIS Takeda Pharma A/S Centralised - Annual renewal 10 Sep 2018 EMEA/H/C/2455/R/58
Imnovid Celgene Europe B.V. Centralised - Variation - Decision addressed to Member States 10 Sep 2018 EMEA/H/C/2682/R/28
Akynzeo Helsinn Birex Pharmaceuticals Ltd Centralised - Yearly update 6 Sep 2018
Alkindi Diurnal Europe B.V. Centralised - Transfer Marketing Authorisation Holder 6 Sep 2018 EMEA/H/C/4416/T/3
Retacrit Pfizer Europe MA EEIG Centralised - Yearly update 6 Sep 2018
Silapo STADA Arzneimittel AG Centralised - Yearly update 6 Sep 2018
Venclyxto AbbVie Deutschland GmbH & Co. KG Centralised - Annual renewal 6 Sep 2018 EMEA/H/C/4106/R/13
Olumiant Eli Lilly Nederland B.V. Corrigendum 4 Sep 2018
KEYTRUDA Merck Sharp & Dohme B.V. Centralised - 2-Monthly update 4 Sep 2018 EMEA/H/C/3820/II/43, EMEA/H/C/3820/II42
Olumiant Eli Lilly Nederland B.V. Centralised - 2-Monthly update 4 Sep 2018 EMEA/H/C/4085/II/6
Invokana Janssen-Cilag International NV Centralised - 2-Monthly update 4 Sep 2018 EMEA/H/C/2649/II/34
Epoetin alfa Hexal Hexal AG Centralised - 2-Monthly update 31 Aug 2018 EMEA/H/C/726/II/WS/1406
Binocrit Sandoz GmbH Centralised - 2-Monthly update 31 Aug 2018 EMEA/H/C/725/II/WS/1406
XALKORI Pfizer Europe MA EEIG Centralised - Transfer Marketing Authorisation Holder 31 Aug 2018 EMEA/H/C/2489/T/59
Viekirax AbbVie Deutschland GmbH & Co. KG Centralised - 2-Monthly update 31 Aug 2018 EMEA/H/C/3839/WS/1348
Efavirenz/Emtricitabine/Tenofovir disoproxil Krka Krka d. d., Novo mesto Centralised - 2-Monthly update 31 Aug 2018 EMEA/H/C/4274/IB/2/G
Abseamed Medice Arzneimittel Pütter GmbH & Co KG Centralised - 2-Monthly update 31 Aug 2018 EMEA/H/C/727/WS/1406
Darzalex Janssen-Cilag International NV Centralised - 2-Monthly update 31 Aug 2018 EMEA/H/C/4077/II/11
TAGRISSO AstraZeneca AB Centralised - 2-Monthly update 31 Aug 2018 EMEA/H/C/4124/II/24
Spinraza Biogen Netherlands B.V. Centralised - 2-Monthly update 31 Aug 2018 EMEA/H/C/4312/II/4
Nerlynx Puma Biotechnology, Ltd. Centralised - Authorisation 31 Aug 2018 EMEA/H/C/4030
Cablivi Ablynx N.V. Centralised - Authorisation 31 Aug 2018 EMEA/H/C/4426
VEYVONDI Baxalta Innovations GmbH Centralised - Authorisation 31 Aug 2018 EMEA/H/C/4454
Bavencio Merck Europe B.V. Centralised - Annual renewal 31 Aug 2018 EMEA/H/C/4338/R/3
Fluenz Tetra AstraZeneca AB Centralised - Variation 28 Aug 2018 EMEA/H/C/2617/II/82
Steglatro Merck Sharp & Dohme B.V. Centralised - Transfer Marketing Authorisation Holder 28 Aug 2018 EMEA/H/C/4315/T/2
Victoza Novo Nordisk A/S Centralised - Yearly update 27 Aug 2018
Cinryze Shire Services BVBA Centralised - Yearly update 27 Aug 2018
Zarzio Sandoz GmbH Centralised - Yearly update 27 Aug 2018
Filgrastim Hexal Hexal AG Centralised - Yearly update 27 Aug 2018
Varuby TESARO U.K. Limited Centralised - Yearly update 27 Aug 2018
Tafinlar Novartis Europharm Limited Centralised - 2-Monthly update 27 Aug 2018 EMEA/H/C/2604/WS/1274
Lojuxta Amryt Pharmaceuticals DAC Centralised - Transfer Marketing Authorisation Holder 27 Aug 2018 EMEA/H/C/2578/T/31
Coagadex Bio Products Laboratory Ltd Centralised - 2-Monthly update 27 Aug 2018 EMEA/H/C/3855/II/7
Vokanamet Janssen-Cilag International NV Centralised - 2-Monthly update 27 Aug 2018 EMEA/H/C/2656/II/34
Nucala GlaxoSmithKline Trading Services Limited Centralised - 2-Monthly update 27 Aug 2018 EMEA/H/C/3860/II/13/G
Fulvestrant Mylan Mylan S.A.S. Centralised - 2-Monthly update 27 Aug 2018 EMEA/H/C/4649/IB/1
Mekinist Novartis Europharm Limited Centralised - 2-Monthly update 27 Aug 2018 EMEA/H/C/2643/WS/1274
Onpattro Alnylam Netherlands B.V. Centralised - Authorisation 27 Aug 2018 EMEA/H/C/4699
Xarelto Bayer AG PASS - Modification 27 Aug 2018 EMEA/H/C/944/PSR/S/12
Ulipristal Acetate Gedeon Richter Gedeon Richter Plc. Centralised - Authorisation 27 Aug 2018 EMEA/H/C/5017
BYDUREON AstraZeneca AB Centralised - Variation 27 Aug 2018 EMEA/H/C/2020/X/48/G
Cometriq Ipsen Pharma PSUSA - Modification 27 Aug 2018 EMEA/H/C/PSUSA/10180/201711
ABILIFY MAINTENA Otsuka Pharmaceutical Netherlands B.V. Centralised - Renewal 27 Aug 2018 EMEA/H/C/2755/R/25
Rasilez HCT Noden Pharma DAC Centralised - Renewal 27 Aug 2018 EMEA/H/C/964/R/87
Aranesp Amgen Europe B.V. Centralised - Yearly update 23 Aug 2018
Strimvelis Orchard Therapeutics (Netherlands) B.V. Centralised - Transfer Marketing Authorisation Holder 23 Aug 2018 EMEA/H/C/3854/T/14
LIFMIOR Pfizer Europe MA EEIG Centralised - Transfer Marketing Authorisation Holder 23 Aug 2018 EMEA/H/C/4167T/17
Firazyr Shire Pharmaceuticals Ireland Limited Centralised - Transfer Marketing Authorisation Holder 23 Aug 2018 EMEA/H/C/899T/41
Steglujan Merck Sharp & Dohme B.V. Centralised - Transfer Marketing Authorisation Holder 23 Aug 2018 EMEA/H/C/4313/T/4
Beromun BELPHARMA s.a. Centralised - Transfer Marketing Authorisation Holder 23 Aug 2018 EMEA/H/C/206/T/40
Temodal Merck Sharp & Dohme B.V. Centralised - Transfer Marketing Authorisation Holder 23 Aug 2018 EMEA/H/C/229/T/83
Ristaben Merck Sharp & Dohme B.V. Centralised - Transfer Marketing Authorisation Holder 23 Aug 2018 EMEA/H/C/1234/T/57
Lemtrada Sanofi Belgium Centralised - Transfer Marketing Authorisation Holder 23 Aug 2018 EMEA/H/C/3718/T/24
Biktarvy Gilead Sciences Ireland UC Centralised - Transfer Marketing Authorisation Holder 23 Aug 2018 EMEA/H/C/4449/T/1
Nivestim Pfizer Europe MA EEIG Centralised - Transfer Marketing Authorisation Holder 23 Aug 2018 EMEA/H/C/1142/T/51
Xagrid Shire Pharmaceuticals Ireland Limited Centralised - Transfer Marketing Authorisation Holder 23 Aug 2018 EMEA/H/C/480/T/82
Xarelto Bayer AG Centralised - 2-Monthly update 23 Aug 2018 EMEA/H/C/944/II/58
Abilify Otsuka Pharmaceutical Netherlands B.V. Centralised - Transfer Marketing Authorisation Holder 23 Aug 2018 EMEA/H/C/471/T/131
Somavert Pfizer Europe MA EEIG Centralised - Transfer Marketing Authorisation Holder 23 Aug 2018 EMEA/H/C/409/T/87
Blincyto Amgen Europe B.V. Centralised - 2-Monthly update 23 Aug 2018 EMEA/H/C/3731/II/18
Yescarta Kite Pharma EU B.V. Centralised - Authorisation 23 Aug 2018 EMEA/H/C/4480
Kymriah Novartis Europharm Limited Centralised - Authorisation 23 Aug 2018 EMEA/H/C/4090
Kalydeco Vertex Pharmaceuticals (Ireland) Limited PASS - Modification 23 Aug 2018 EMEA/H/C/2494/RSR/S/14
RoActemra Roche Registration GmbH Centralised - 2-Monthly update 23 Aug 2018 EMEA/H/C/955/II/78
Evicel Omrix Biopharmaceuticals N.V. Centralised - Renewal 23 Aug 2018 EMEA/H/C/898/R/54
Intelence Janssen-Cilag International NV Centralised - Renewal 23 Aug 2018 EMEA/H/C/900/R/52
Arixtra Aspen Pharma Trading Limited PSUSA - Modification 23 Aug 2018 EMEA/H/C/403/PSUSA/1467-201712
Parsabiv Amgen Europe B.V. PSUSA - Modification 23 Aug 2018 EMEA/H/C/3995/PSUSA/10533/201711
Duzallo Grünenthal GmbH Centralised - Authorisation 23 Aug 2018 EMEA/H/C/4412
Vyxeos Jazz Pharmaceuticals Ireland Ltd Centralised - Authorisation 23 Aug 2018 EMEA/H/C/4282
Opsumit Janssen-Cilag International NV Centralised - Renewal 23 Aug 2018 EMEA/H/C/2697/R/27
Entyvio Takeda Pharma A/S PSUSA - Modification 23 Aug 2018 EMEA/H/C/PSUSA/10186/201711
IMBRUVICA Janssen-Cilag International NV PSUSA - Modification 23 Aug 2018 EMEA/H/C/PSUSA/10301/201711
Mepsevii Ultragenyx Germany GmbH Centralised - Authorisation 23 Aug 2018 EMEA/H/C/4438
Venclyxto AbbVie Deutschland GmbH & Co. KG PSUSA - Modification 23 Aug 2018 EMEA/H/C/PSUSA/10556/201712
Orkambi Vertex Pharmaceuticals (Ireland) Limited PSUSA - Modification 23 Aug 2018 EMEA/H/C/PSUSA/10455/201711
Pixuvri CTI Life Sciences Ltd PSUSA - Modification 23 Aug 2018 EMEA/H/C/PSUSA/9261/201711
CABOMETYX Ipsen Pharma PSUSA - Modification 23 Aug 2018 EMEA/H/C/4163/PSUSA/10180/201711
Sovaldi Gilead Sciences Ireland UC PSUSA - Modification 23 Aug 2018 EMEA/H/C/PSUSA/10134/201712
Cholib Mylan IRE Healthcare Ltd Centralised - Transfer Marketing Authorisation Holder 20 Aug 2018 EMEA/H/C/2559/T/20
Luveris Merck Europe B.V. Centralised - Transfer Marketing Authorisation Holder 20 Aug 2018 EMEA/H/C/292/T/77
Pergoveris Merck Europe B.V. Centralised - Transfer Marketing Authorisation Holder 20 Aug 2018 EMEA/H/C/714/T/59
Xelevia Merck Sharp & Dohme B.V. Centralised - Transfer Marketing Authorisation Holder 20 Aug 2018 EMEA/H/C/762/T/69
Lenvima Eisai GmbH Centralised - 2-Monthly update 20 Aug 2018 EMEA/H/C/3727/II/11/G
Komboglyze AstraZeneca AB Corrigendum 13 Aug 2018
Ninlaro Takeda Pharma A/S Corrigendum 6 Jul 2018
Insuman Sanofi-Aventis Deutschland GmbH Corrigendum 14 Jun 2018
Bosulif Pfizer Europe MA EEIG Corrigendum 22 May 2018
Juluca ViiV Healthcare BV Corrigendum 16 May 2018
Procedures for centrally authorised orphan medicinal products for human use
Product Marketing Authorisation Holder Decision Type Decision date EMEA Nr
EU/3/12/1083 Voisin Consulting S.A.R.L. Transfer of orphan designation 30 Jan 2019 EMA/OD/0000003624
EU/3/17/1930 Cymabay Ireland Limited Transfer of orphan designation 30 Jan 2019 EMA/OD/0000002516
EU/3/12/1068 Stéphane Gibaud Transfer of orphan designation 30 Jan 2019 EMA/OD/0000003439
EU/3/17/1951 Clinical Network Services (NL) B.V. Transfer of orphan designation 30 Jan 2019 EMA/OD/0000002857
EU/3/16/1758 Clinical Network Services (NL) B.V. Transfer of orphan designation 30 Jan 2019 EMA/OD/0000003048
EU/3/15/1498 Clinical Network Services (NL) B.V. Transfer of orphan designation 30 Jan 2019 EMA/OD/0000003040
EU/3/10/777 Voisin Consulting S.A.R.L. Transfer of orphan designation 18 Jan 2019 EMA/OD/0000003164
EU/3/14/1422 BioMarin International Limited Transfer of orphan designation 18 Jan 2019 EMA/OD/0000003313
EU/3/10/841 Vanda Pharmaceuticals Germany GmbH Transfer of orphan designation 18 Jan 2019 EMA/OD/0000002557
EU/3/16/1812 FGK Representative Service GmbH Transfer of orphan designation 18 Jan 2019 EMA/OD/0000003324
EU/3/15/1490 S-cubed Pharmaceutical Services ApS Transfer of orphan designation 18 Jan 2019 EMA/OD/0000003126
EU/3/14/1342 S-cubed Pharmaceutical Services ApS Transfer of orphan designation 18 Jan 2019 EMA/OD/0000003128
EU/3/13/1204 S-cubed Pharmaceutical Services ApS Transfer of orphan designation 18 Jan 2019 EMA/OD/0000003156
EU/3/11/872 S-cubed Pharmaceutical Services ApS Transfer of orphan designation 18 Jan 2019 EMA/OD/0000003129
EU/3/05/325 Pharmaxis Europe Limited Transfer of orphan designation 18 Jan 2019 EMA/OD/0000002786
EU/3/18/2133 TLC Biopharmaceuticals B.V. Orphan designation 11 Jan 2019 EMA/OD/0000001988
EU/3/18/2132 Silence Therapeutics GmbH Orphan designation 11 Jan 2019 EMA/OD/0000001845
EU/3/18/2131 UCB Biopharma SPRL Orphan designation 11 Jan 2019 EMA/OD/0000002029
EU/3/18/2130 Arena Pharmaceuticals Limited Orphan designation 11 Jan 2019 EMA/OD/0000002037
EU/3/18/2129 Amicus Therapeutics UK Ltd Orphan designation 11 Jan 2019 EMA/OD/0000002050
EU/3/18/2128 Thiogenesis Therapeutics S.A.R.L Orphan designation 11 Jan 2019 EMA/OD/0000002209
EU/3/18/2127 Therapicon Srl Orphan designation 11 Jan 2019 EMA/OD/0000001921
EU/3/18/2126 Hanmi Europe Limited Orphan designation 11 Jan 2019 EMA/OD/0000001592
EU/3/18/2125 Isabelle Ramirez Orphan designation 11 Jan 2019 EMA/OD/0000001719
EU/3/18/2124 IntraBio Ltd Orphan designation 11 Jan 2019 EMA/OD/0000001741
EU/3/16/1672 Celgene Europe B.V. Transfer of orphan designation 11 Jan 2019 EMA/OD/0000003283
EU/3/12/1062 EUSA Pharma (Netherlands) B.V. Transfer of orphan designation 11 Jan 2019 EMA/OD/0000003198
EU/3/10/833 FGK Representative Service GmbH Transfer of orphan designation 11 Jan 2019 EMA/OD/0000003113
EU/3/16/1680 Chugai Pharma France Transfer of orphan designation 11 Jan 2019 EMA/OD/0000003065
EU/3/13/1170 FGK Representative Service GmbH Transfer of orphan designation 11 Jan 2019 EMA/OD/0000002758
EU/3/08/586 Sarepta Therapeutics Ireland Limited Transfer of orphan designation 11 Jan 2019 EMA/OD/0000003068
EU/3/14/1309 Pharma Gateway AB Transfer of orphan designation 11 Jan 2019 EMA/OD/0000002736
EU/3/13/1150 AstraZeneca AB Transfer of orphan designation 11 Jan 2019 EMA/OD/0000002544
EU/3/08/592 AstraZeneca AB Transfer of orphan designation 11 Jan 2019 EMA/OD/0000002546
EU/3/17/1852 Voisin Consulting S.A.R.L. Transfer of orphan designation 11 Jan 2019 EMA/OD/0000002948
EU/3/15/1545 Seagen Ireland Limited Transfer of orphan designation 14 Dec 2018 EMA/OD/0000002611
EU/3/16/1731 Alnylam Netherlands B.V. Transfer of orphan designation 14 Dec 2018 EMA/OD/0000002858
EU/3/18/2123 IQVIA RDS Ireland Limited Orphan designation 14 Dec 2018 EMA/OD/169/18
EU/3/18/2122 Genzyme Europe B.V. Orphan designation 14 Dec 2018 EMA/OD/148/18
EU/3/18/2121 Ability Pharmaceuticals SL Orphan designation 14 Dec 2018 EMA/OD/142/18
EU/3/18/2120 Takeda Pharma A/S Orphan designation 14 Dec 2018 EMA/OD/164/18
EU/3/18/2119 Celgene Europe B.V. Orphan designation 14 Dec 2018 EMA/OD/161/18
EU/3/18/2118 Eiger Biopharmaceuticals Europe Limited Orphan designation 14 Dec 2018 EMA/OD/159/18
EU/3/18/2117 Vertex Pharmaceuticals (Europe) Limited Orphan designation 14 Dec 2018 EMA/OD/137/18
EU/3/18/2116 Vertex Pharmaceuticals (Europe) Limited Orphan designation 14 Dec 2018 EMA/OD/139/18
EU/3/18/2115 Yes Pharmaceutical Development Services GmbH Orphan designation 14 Dec 2018 EMA/OD/136/18
EU/3/18/2114 Shire Pharmaceuticals Ireland Limited Orphan designation 14 Dec 2018 EMA/OD/173/18
EU/3/18/2113 MUCPharm Pty Ltd Orphan designation 14 Dec 2018 EMA/OD/144/18
EU/3/18/2112 Merck Europe B.V. Orphan designation 14 Dec 2018 EMA/OD/154/18
EU/3/18/2111 Rheacell GmbH & Co. KG Orphan designation 14 Dec 2018 EMA/OD/155/18
EU/3/18/2110 Consorcio Centro de Investigación Biomédica en Red M.P. Orphan designation 14 Dec 2018 EMA/OD/141/18
EU/3/18/2109 Yes Pharmaceutical Development Services GmbH Orphan designation 14 Dec 2018 EMA/OD/153/18
EU/3/18/2108 Pharma Gateway AB Orphan designation 14 Dec 2018 EMA/OD/140/18
EU/3/18/2107 MUCPharm Pty Ltd Orphan designation 14 Dec 2018 EMA/OD/150/18
EU/3/18/2106 AudioCure Pharma GmbH Orphan designation 14 Dec 2018 EMA/OD/170/18
EU/3/18/2105 IQVIA RDS Ireland Limited Orphan designation 14 Dec 2018 EMA/OD/167/18
EU/3/18/2104 Novartis Europharm Limited Orphan designation 14 Dec 2018 EMA/OD/157/18
EU/3/18/2103 Albireo AB Orphan designation 14 Dec 2018 EMA/OD/165/18
EU/3/17/1828 Vertex Pharmaceuticals (Ireland) Limited Transfer of orphan designation 14 Dec 2018 EMA/OD/0000002757
EU/3/12/963 Helsinn Birex Pharmaceuticals Ltd Transfer of orphan designation 14 Dec 2018 EMA/OD/0000002753
EU/3/18/1987 Richardson Associates Regulatory Affairs Ltd Transfer of orphan designation 14 Dec 2018 EMA/OD/0000002643
EU/3/18/1978 Richardson Associates Regulatory Affairs Ltd Transfer of orphan designation 14 Dec 2018 EMA/OD/0000002608
EU/3/17/1882 Richardson Associates Regulatory Affairs Ltd Transfer of orphan designation 14 Dec 2018 EMA/OD/0000002645
EU/3/14/1426 Richardson Associates Regulatory Affairs Ltd Transfer of orphan designation 14 Dec 2018 EMA/OD/0000002646
EU/3/14/1423 Richardson Associates Regulatory Affairs Ltd Transfer of orphan designation 14 Dec 2018 EMA/OD/0000002647
EU/3/14/1319 Richardson Associates Regulatory Affairs Ltd Transfer of orphan designation 14 Dec 2018 EMA/OD/0000002648
EU/3/14/1316 Richardson Associates Regulatory Affairs Ltd Transfer of orphan designation 14 Dec 2018 EMA/OD/0000002649
EU/3/14/1312 Richardson Associates Regulatory Affairs Ltd Transfer of orphan designation 14 Dec 2018 EMA/OD/0000002650
EU/3/13/1169 Richardson Associates Regulatory Affairs Ltd Transfer of orphan designation 14 Dec 2018 EMA/OD/0000002651
EU/3/12/1087 Richardson Associates Regulatory Affairs Ltd Transfer of orphan designation 14 Dec 2018 EMA/OD/0000002652
EU/3/10/760 TESARO Bio Netherlands B.V. Transfer of orphan designation 6 Dec 2018 EMA/OD/0000002385
EU/3/17/1906 PTC Therapeutics International Limited Transfer of orphan designation 6 Dec 2018 EMA/OD/0000002509
EU/3/16/1786 PTC Therapeutics International Limited Transfer of orphan designation 6 Dec 2018 EMA/OD/0000002507
EU/3/16/1651 PTC Therapeutics International Limited Transfer of orphan designation 6 Dec 2018 EMA/OD/0000002508
EU/3/17/1893 SFL Regulatory Services GmbH Transfer of orphan designation 6 Dec 2018 EMA/OD/048/17/T/01
EU/3/16/1802 FGK Representative Service GmbH Transfer of orphan designation 6 Dec 2018 EMA/OD/0000002422
EU/3/16/1662 QRC Ireland Transfer of orphan designation 6 Dec 2018 EMA/OD/011/16/T/01
EU/3/09/628 Nova Laboratories Ireland Limited Transfer of orphan designation 6 Dec 2018 EMA/OD/0000002301
EU/3/11/933 Les Laboratoires Servier Transfer of orphan designation 6 Dec 2018 EMA/OD/051/11/T/02
EU/3/17/1933 Emerald Health Pharmaceuticals Espańa, S.L. Transfer of orphan designation 19 Nov 2018 EMA/OD/0000001966
EU/3/18/2102 IQVIA RDS Ireland Limited Orphan designation 19 Nov 2018 EMA/OD/115/18
EU/3/18/2101 TMC Pharma Services Ltd Orphan designation 19 Nov 2018 EMA/OD/143/18
EU/3/18/2100 Quality Regulatory Clinical Ireland Limited Orphan designation 19 Nov 2018 EMA/OD/103/18
EU/3/18/2099 Celgene Europe Limited Orphan designation 19 Nov 2018 EMA/OD/124/18
EU/3/18/2098 Bayer AG Orphan designation 19 Nov 2018 EMA/OD/117/18
EU/3/18/2097 Bayer AG Orphan designation 19 Nov 2018 EMA/OD/116/18
EU/3/18/2096 Hansa Biopharma AB Orphan designation 19 Nov 2018 EMA/OD/093/18
EU/3/18/2095 United Neuroscience Limited Orphan designation 19 Nov 2018 EMA/OD/146/18
EU/3/18/2094 Y-mAbs Therapeutics A/S Orphan designation 19 Nov 2018 EMA/OD/126/18
EU/3/18/2093 Sanquin Plasma Products B.V. Orphan designation 19 Nov 2018 EMA/OD/109/18
EU/3/18/2092 Dr Regenold GmbH Orphan designation 19 Nov 2018 EMA/OD/145/18
EU/3/18/2091 Pharma Gateway AB Orphan designation 19 Nov 2018 EMA/OD/108/18
EU/3/18/2090 Pfizer Europe MA EEIG Orphan designation 19 Nov 2018 EMA/OD/112/18
EU/3/18/2089 Dystrogen Therapeutics S.A. Orphan designation 19 Nov 2018
EU/3/18/2088 Dystrogen Therapeutics S.A. Orphan designation 19 Nov 2018 EMA/OD/134/18
EU/3/18/2087 Consejo Superior de Investigaciones Cientificas (CSIC) Orphan designation 19 Nov 2018 EMA/OD/135/18
EU/3/18/2086 Santhera Pharmaceuticals (Deutschland) GmbH Orphan designation 19 Nov 2018 EMA/OD/106/18
EU/3/18/2085 Rigenerand S.r.l. Orphan designation 19 Nov 2018 EMA/OD/110/18
EU/3/18/2084 Bayer AG Orphan designation 19 Nov 2018 EMA/OD/258/17
EU/3/18/2083 MaaT PHARMA Orphan designation 19 Nov 2018 EMA/OD/123/18
EU/3/18/2082 Takeda Pharma A/S Orphan designation 19 Nov 2018 EMA/OD/040/18
EU/3/18/2081 Pharma Gateway AB Orphan designation 19 Nov 2018 EMA/OD/096/18
EU/3/08/556 Vertex Pharmaceuticals (Ireland) Limited Transfer of orphan designation 19 Nov 2018 EMA/OD/010/08/T/03
EU/3/17/1923 Pfizer Europe MA EEIG Transfer of orphan designation 19 Nov 2018 EMA/OD/106/17/T/01
EU/3/16/1752 Pfizer Europe MA EEIG Transfer of orphan designation 19 Nov 2018 EMA/OD/093/16/T/01
EU/3/16/1716 Pfizer Europe MA EEIG Transfer of orphan designation 19 Nov 2018 EMA/OD/096/16/T/02
EU/3/13/1184 Pfizer Europe MA EEIG Transfer of orphan designation 19 Nov 2018 EMA/OD/084/13/T/01
EU/3/13/1105 Pfizer Europe MA EEIG Transfer of orphan designation 19 Nov 2018 EMA/OD/164/12/T/01
EU/3/10/726 Pfizer Europe MA EEIG Transfer of orphan designation 19 Nov 2018 EMEA/OD/125/09/T/02
EU/3/15/1567 TMC Pharma (EU) Limited Transfer of orphan designation 19 Nov 2018 EMA/OD/064/15/T/02
EU/3/17/1962 MWB Consulting S.A.R.L. Transfer of orphan designation 19 Nov 2018 EMA/OD/155/17/T/01
EU/3/17/1863 Celgene Europe B.V. Transfer of orphan designation 9 Nov 2018 EMA/OD/270/16/T/02
EU/3/17/1964 Incyte Biosciences Distribution B.V. Transfer of orphan designation 9 Nov 2018 EMA/OD/169/17/T/01
EU/3/17/1836 Zogenix GmbH Transfer of orphan designation 9 Nov 2018 EMA/OD/233/16/T/01
EU/3/13/1219 Zogenix GmbH Transfer of orphan designation 9 Nov 2018 EMA/OD/140/13/T/01
EU/3/18/2080 Freeline Therapeutics Ltd Orphan designation 26 Oct 2018 EMA/OD/127/18
EU/3/18/2079 Spark Therapeutics Ireland Ltd Orphan designation 26 Oct 2018 EMA/OD/104/18
EU/3/18/2078 Sellas Life Sciences Limited Orphan designation 26 Oct 2018 EMA/OD/091/18
EU/3/18/2077 Worphmed Srl Orphan designation 26 Oct 2018 EMA/OD/077/18
EU/3/18/2076 Orphan Europe S.A.R.L. Orphan designation 26 Oct 2018 EMA/OD/100/18
EU/3/18/2075 Consorcio Centro de Investigación Biomédica en Red M.P. Orphan designation 26 Oct 2018 EMA/OD/090/18
EU/3/18/2074 PhaRA bvba Orphan designation 26 Oct 2018 EMA/OD/079/18
EU/3/18/2073 Fondazione Telethon Orphan designation 26 Oct 2018 EMA/OD/113/18
EU/3/18/2072 FGK Representative Service GmbH Orphan designation 26 Oct 2018 EMA/OD/102/18
EU/3/18/2071 Loxo Oncology Limited Orphan designation 26 Oct 2018 EMA/OD/125/18
EU/3/18/2070 Accelsiors CRO and Consultancy Services Ltd Orphan designation 26 Oct 2018 EMA/OD/114/18
EU/3/14/1250 Akcea Therapeutics UK Ltd Transfer of orphan designation 26 Oct 2018 EMA/OD/098/13/T/01
EU/3/17/1966 Sirius Regulatory Consulting EU Limited Transfer of orphan designation 18 Oct 2018
EU/3/15/1532 Sirius Regulatory Consulting EU Limited Transfer of orphan designation 18 Oct 2018
EU/3/16/1689 Alan Boyd Consultants Ltd Transfer of orphan designation 18 Oct 2018 EMA/OD/031/16/T/01
EU/3/16/1704 Drug Development and Regulation S.L. Transfer of orphan designation 18 Oct 2018 EMA/OD/045/16/T/01
EU/3/11/901 Merck Sharp & Dohme B.V. Transfer of orphan designation 18 Oct 2018 EMA/OD/052/11/T/01
EU/3/16/1640 Celgene Europe B.V. Transfer of orphan designation 18 Oct 2018 EMA/OD/253/15/T/01
EU/3/16/1804 Eli Lilly Nederland B.V. Transfer of orphan designation 18 Oct 2018
EU/3/01/075 Eisai GmbH Transfer of orphan designation 18 Oct 2018 EMA/OD/038/01/T/02
EU/3/10/815 Pfizer Europe MA EEIG Transfer of orphan designation 18 Oct 2018 EMA/OD/068/10/T/01
EU/3/15/1495 Ultragenyx Netherlands B.V. Transfer of orphan designation 18 Oct 2018 EMA/OD/007/15/T/02
EU/3/05/264 Roche Registration GmbH Transfer of orphan designation 18 Oct 2018 EMEA/OD/081/04/T/02
EU/3/16/1622 BioMarin International Limited Transfer of orphan designation 27 Sep 2018 EMA/OD/230/15/T/01
EU/3/14/1331 Celgene Europe B.V. Transfer of orphan designation 27 Sep 2018 EMA/OD/048/14/T/02
EU/3/14/1300 Celgene Europe B.V. Transfer of orphan designation 27 Sep 2018 EMA/OD/047/14/T/02
EU/3/16/1762 Pharma Gateway AB Transfer of orphan designation 27 Sep 2018 EMA/OD/107/16/T/01
EU/3/17/1856 Quality Regulatory Clinical Ireland Ltd Transfer of orphan designation 27 Sep 2018 EMA/OD/267/16/T/01
EU/3/11/909 Janssen-Cilag International NV Transfer of orphan designation 27 Sep 2018 EMA/OD/023/11/T/01
EU/3/09/707 Janssen-Cilag International NV Transfer of orphan designation 27 Sep 2018 EMA/OD/104/09/T/01
EU/3/06/351 Janssen-Cilag International NV Transfer of orphan designation 27 Sep 2018 EMA/OD/090/05/T/01
EU/3/14/1242 Neurolixis SAS Transfer of orphan designation 27 Sep 2018 EMA/OD/163/13/T/01
EU/3/11/895 Alan Boyd Consultants Ltd Transfer of orphan designation 27 Sep 2018 EMA/OD/033/11/T/02
EU/3/18/2010 Novartis Europharm Limited Transfer of orphan designation 27 Sep 2018 EMA/OD/249/17/T/01
EU/3/16/1786 PTC Therapeutics International Limited Transfer of orphan designation 27 Sep 2018 EMA/OD/183/16/T/02
EU/3/17/1902 Eisai GmbH Transfer of orphan designation 27 Sep 2018 EMA/OD/052/17/T/01
EU/3/13/1222 Eisai GmbH Transfer of orphan designation 27 Sep 2018 EMA/OD/108/13/T/01
EU/3/08/535 Eisai GmbH Transfer of orphan designation 27 Sep 2018 EMA/OD/110/07/T/02
EU/3/08/550 Oncoscience GmbH Transfer of orphan designation 27 Sep 2018 EMA/OD/006/08/T/01
EU/3/04/220 Oncoscience GmbH Transfer of orphan designation 27 Sep 2018 EMA/OD/038/04/T/01
EU/3/08/582 Shire Pharmaceuticals Ireland Limited Transfer of orphan designation 27 Sep 2018 EMA/OD/052/08/T/01
EU/3/12/976 Biogen Netherlands B.V. Transfer of orphan designation 27 Sep 2018 EMA/OD/141/11/T/02
EU/3/15/1509 Avexis Netherlands B.V. Transfer of orphan designation 27 Sep 2018 EMA/OD/028/15/T/01
EU/3/08/581 Novartis Europharm Limited Transfer of orphan designation 27 Sep 2018 EMA/OD/051/08/T/02
EU/3/11/943 Kyowa Kirin Holdings B.V. Transfer of orphan designation 27 Sep 2018 EMA/OD/104/11/T/02
EU/3/09/647 Shire Pharmaceuticals Ireland Limited Transfer of orphan designation 27 Sep 2018 EMA/OD/008/09/T/02
EU/3/05/328 Celgene Europe B.V. Transfer of orphan designation 27 Sep 2018 EMA/OD/056/05/T/03
EU/3/05/279 Celgene Europe B.V. Transfer of orphan designation 27 Sep 2018 EMA/OD/001/05/T/03
EU/3/16/1654 TM3 Therapeutics B.V. Transfer of orphan designation 27 Sep 2018 EMA/OD/250/15/T/01
EU/3/05/313 Orchard Therapeutics (Netherlands) B.V. Transfer of orphan designation 27 Sep 2018 EMA/OD/053/05/T/03
EU/3/09/657 BioMarin International Limited Transfer of orphan designation 27 Sep 2018 EMEA/OD/017/09/T/01
EU/3/18/1997 QRC Ireland Transfer of orphan designation 27 Sep 2018 EMA/OD/226/17/T/01
EU/3/13/1124 Mallinckrodt Pharmaceuticals Ireland Limited Transfer of orphan designation 27 Sep 2018 EMA/OD/191/12/T/02
EU/3/03/133 Shire Pharmaceuticals Ireland Limited Transfer of orphan designation 27 Sep 2018 EMA/OD/054/02/T/01
EU/3/18/2062 IQVIA RDS Ireland Limited Orphan designation 24 Aug 2018 EMA/OD/098/18
EU/3/18/2061 Pharma Gateway AB Orphan designation 24 Aug 2018 EMA/OD/049/18
EU/3/18/2069 Professor Marjukka Myllärniemi Orphan designation 24 Aug 2018 EMA/OD/039/18
EU/3/18/2068 Novo Nordisk A/S Orphan designation 24 Aug 2018 EMA/OD/041/18
EU/3/18/2060 Biogen Idec Limited Orphan designation 24 Aug 2018 EMA/OD/065/18
EU/3/18/2067 Omeros London Limited Orphan designation 24 Aug 2018 EMA/OD/044/18
EU/3/18/2059 IntraBio Ltd Orphan designation 24 Aug 2018 EMA/OD/095/18
EU/3/18/2058 IQVIA RDS Ireland Limited Orphan designation 24 Aug 2018 EMA/OD/099/18
EU/3/18/2057 Pharm Research Associates (UK) Limited Orphan designation 24 Aug 2018 EMA/OD/051/18
EU/3/18/2056 Nogra Pharma Limited Orphan designation 24 Aug 2018 EMA/OD/075/18
EU/3/18/2055 IQVIA RDS Ireland Limited Orphan designation 24 Aug 2018 EMA/OD/060/18
EU/3/18/2066 Incyte Biosciences Distribution B.V. Orphan designation 24 Aug 2018 EMA/OD/038/18
EU/3/18/2065 SFL Regulatory Services GmbH Orphan designation 24 Aug 2018 EMA/OD/080/18
EU/3/18/2064 Bayer AG Orphan designation 24 Aug 2018 EMA/OD/071/18
EU/3/18/2063 IQVIA RDS Ireland Limited Orphan designation 24 Aug 2018 EMA/OD/088/18
EU/3/18/1979 Bayer AG Corrigendum 22 Feb 2018
EU/3/17/1969 University of Cambridge Corrigendum 17 Jan 2018
Procedures for centrally authorised veterinary medicinal products
Product Marketing Authorisation Holder Decision Type Decision date EMEA Nr
Halagon Emdoka bvba Centralised - Yearly update 8 Feb 2019
Vaxxitek HVT + IBD Merial Centralised - Yearly update 8 Feb 2019
Vectra Felis Ceva Santé Animale Centralised - Renewal 8 Feb 2019 EMEA/V/C/2746/R/08
Kriptazen Virbac Centralised - Authorisation 8 Feb 2019 EMEA/V/C/4868
EVANT Laboratorios Hipra, S.A. Centralised - Authorisation 5 Feb 2019 EMEA/V/C/004902/0000
Equisolon Le Vet B.V. Centralised - Renewal 5 Feb 2019 EMEA/V/C/2382/R/04
Bravecto Intervet International B.V. Centralised - Renewal 5 Feb 2019 EMEA/V/C/2526/R/28
CYTOPOINT Zoetis Belgium S.A. Centralised - Yearly update 4 Feb 2019
Zycortal Dechra Regulatory B.V. Centralised - Transfer Marketing Authorisation Holder 4 Feb 2019 EMEA/V/C/3782/T/02
Clomicalm Elanco GmbH Centralised - Transfer Marketing Authorisation Holder 24 Jan 2019 EMEA/V/C/000039/T/0030
Loxicom Norbrook Laboratories Ltd Centralised - Renewal 23 Jan 2019 EMEA/V/C/141/R/31
Meloxidyl Ceva Santé Animale Centralised - Yearly update 11 Jan 2019
Syvazul BTV LABORATORIOS SYVA, S.A.U. Centralised - Authorisation 9 Jan 2019 EMEA/V/C/V/C/4611
Isemid Ceva Santé Animale Centralised - Authorisation 9 Jan 2019 EMEA/V/C/4345
Parvoduk Merial Centralised - Renewal 9 Jan 2019 EMEA/V/C/2740/R/6
NexGard Merial Centralised - Renewal 19 Dec 2018 EMEA/V/C/2729/R/23
Nobilis IB Primo QX Intervet International B.V. Centralised - Yearly update 18 Dec 2018
NexGard Merial Corrigendum 18 Dec 2018
Ingelvac CircoFLEX Boehringer Ingelheim Vetmedica GmbH Centralised - Yearly update 17 Dec 2018
Nobilis IB 4-91 Intervet International B.V. Centralised - Yearly update 17 Dec 2018
Bovela Boehringer Ingelheim Vetmedica GmbH Centralised - Yearly update 17 Dec 2018
Coxevac Ceva Santé Animale Centralised - Yearly update 17 Dec 2018
Aftovaxpur Doe Merial Centralised - 2-Monthly update 12 Dec 2018 EMEA/V/C/2292/II/9
LONGRANGE Merial Centralised - Refusal of marketing authorisation 12 Dec 2018 EMEA/V/C/4291
Aivlosin ECO Animal Health Ltd Centralised - Yearly update 7 Dec 2018
Imrestor Elanco GmbH Centralised - Transfer Marketing Authorisation Holder 7 Dec 2018 EMEA/V/C/2763/T/8
Econor Elanco GmbH Centralised - Transfer Marketing Authorisation Holder 26 Nov 2018 EMEA/V/C/42/T/54
Inflacam Chanelle Pharmaceuticals Manufacturing Limited Centralised - Variation 26 Nov 2018 EMEA/V/C/2497/X/15
Osurnia Elanco GmbH Centralised - Transfer Marketing Authorisation Holder 19 Nov 2018 EMEA/V/C/3753/T/10
Rheumocam Chanelle Pharmaceuticals Manufacturing Limited Centralised - Variation 19 Nov 2018 EMEA/V/C/121/X/22
Improvac Zoetis Belgium S.A. Centralised - Yearly update 30 Oct 2018
Zolvix Elanco GmbH Centralised - Transfer Marketing Authorisation Holder 30 Oct 2018 EMEA/V/C/154/T/24
Dexdomitor Orion Corporation Centralised - Yearly update 30 Oct 2018
Canigen L4 Intervet International B.V. Centralised - Yearly update 23 Oct 2018
NexGard Merial Centralised - 2-Monthly update 18 Oct 2018 EMEA/V/C/2729/WS/1338/18/G
NEXGARD SPECTRA Merial Centralised - 2-Monthly update 18 Oct 2018 EMEA/V/C/3842/WS/1338/15/G
Recocam Bimeda Animal Health Limited Centralised - Transfer Marketing Authorisation Holder 17 Oct 2018 EMEA/V/C/2247/T/10
MS-H vaccine Pharmsure Veterinary Products Europe Ltd Centralised - Transfer Marketing Authorisation Holder 27 Sep 2018 EMEA/V/C/161/T/11
Credelio Elanco GmbH Centralised - Transfer Marketing Authorisation Holder 27 Sep 2018 EMEA/V/C/4247/T/4
Ingelvac PCV FLEX Boehringer Ingelheim Vetmedica GmbH Centralised - Yearly update 27 Sep 2018
Comfortis Elanco GmbH Centralised - Transfer Marketing Authorisation Holder 24 Sep 2018 EMEA/V/C/2233/T/18
FORTEKOR PLUS Elanco GmbH Centralised - Transfer Marketing Authorisation Holder 24 Sep 2018 EMEA/V/C/2804/T/11
Kexxtone Elanco GmbH Centralised - Transfer Marketing Authorisation Holder 24 Sep 2018 EMEA/V/C/2235/T/10
Sileo Orion Corporation Centralised - Yearly update 24 Sep 2018
BROADLINE Merial Centralised - Renewal 24 Sep 2018 EMEA/V/C/2700/R/20
Prac-Tic Elanco GmbH Centralised - Transfer Marketing Authorisation Holder 27 Aug 2018 EMEA/V/C/103/T/25
Vectra 3D Ceva Santé Animale Centralised - Renewal 27 Aug 2018 EMEA/V/C/2555/R/9
Cortacare Ecuphar NV Centralised - Authorisation 27 Aug 2018 EMEA/V/C/4689
Gripovac 3 Merial Centralised - Withdrawal 20 Aug 2018
CLYNAV Elanco GmbH Centralised - Transfer Marketing Authorisation Holder 20 Aug 2018 EMEA/V/C/2390/T/2
Leucogen Virbac Centralised - 2-Monthly update 20 Aug 2018 EMEA/V/C/144/WS1282/6
BTVPUR Merial Centralised - 2-Monthly update 20 Aug 2018 EMEA/V/C/2231/II/10
Dany's BienenWohl Dany Bienenwohl GmbH Corrigendum 14 Jun 2018
Oxybee Dany Bienenwohl GmbH Corrigendum 1 Feb 2018
Procedures for nationally authorised medicinal products for human use
Product Marketing Authorisation Holder Decision Type Decision date EMEA Nr
Diotop 75 mg / 20 mg modified-release capsules, hard and associated names Referral 31 Jan 2019 EMEA/H/A-29(4)/1474
Diclofenac Sodium Spray Gel 4 % Cutaneous Spray, Solution and associated names Referral 18 Jan 2019 EMEA/H/A-29(4)/1467
bimatoprost PSUSA - Modification 18 Jan 2019 EMEA/H/C/PSUSA/413/201803
Paclitaxel Hetero and associated names Hetero Europe S.L. Referral 11 Jan 2019 EMEA/H//A-29(4)/1466
pemetrexed - PSUSA-2330-201802 Eli Lilly Nederland B.V. PSUSA - Modification 18 Dec 2018 EMEA/H/C/PSUSA/2330/201802
Perlinring and associated names Actavis Group PTC ehf. Referral 18 Dec 2018 EMEA/H/A-29(4)/1473
voriconazole PSUSA - Modification 12 Dec 2018 EMEA/H/C/PSUSA/3127/201802
alitretinoin PSUSA - Modification 14 Nov 2018 EMEA/H/C/PSUSA/90/201801
Retinoids (acitretin, adapalene, alitretinoin, bexarotene, isotretinoin, tazarotene, tretinoin) Rectificative Decision 11 Oct 2018
Lutetium (177 Lu) chloride PSUSA - Modification 28 Sep 2018 EMEA/H/C/PSUSA/10391/201712
Valproate Corrigendum 31 May 2018