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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
Truxima Celltrion Healthcare Hungary Kft. Centralised - Yearly update 11 Apr 2019
Lokelma AstraZeneca AB Centralised - Yearly update 11 Apr 2019
Lamivudine Teva Teva B.V. Centralised - Yearly update 11 Apr 2019
Starlix Novartis Europharm Limited Centralised - Yearly update 11 Apr 2019
Pemetrexed Lilly Eli Lilly Nederland B.V. Centralised - Yearly update 11 Apr 2019
Ebilfumin Actavis Group PTC ehf. Centralised - 2-Monthly update 11 Apr 2019 EMEA/H/C/003717/IB/0013
Leganto UCB Pharma S.A. Centralised - Yearly update 11 Apr 2019
Topotecan Teva Teva B.V. Centralised - Withdrawal 11 Apr 2019
Irbesartan Teva Teva B.V. Referral 11 Apr 2019 EMEA/H/A-31/1471/C/1093/32
Exforge Novartis Europharm Limited Referral 11 Apr 2019 EMEA/H/A-31/1471/C/716/98
Irbesartan / Hydrochlorothiazide Teva Teva B.V. Referral 11 Apr 2019 EMEA/H/A-31/1471/C/1112/0041
Dafiro HCT Novartis Europharm Limited Referral 11 Apr 2019 EMEA/H/A-31/1471/C/1160/70
Copalia HCT Novartis Europharm Limited Referral 11 Apr 2019 EMEA/H/A-31/1471/C/1159/69
Rituzena Celltrion Healthcare Hungary Kft. Centralised - Withdrawal 10 Apr 2019
Esbriet Roche Registration GmbH Centralised - Yearly update 9 Apr 2019
Rituzena Celltrion Healthcare Hungary Kft. Centralised - Yearly update 9 Apr 2019
Trydonis Chiesi Farmaceutici S.p.A. Centralised - 2-Monthly update 9 Apr 2019 EMEA/H/C/4702/WS/1554
Ifirmacombi Krka d. d., Novo mesto Referral 9 Apr 2019 EMEA/H/A-31/1471/C/2302/20
Ritemvia Celltrion Healthcare Hungary Kft. Centralised - Yearly update 8 Apr 2019
Zerit Bristol-Myers Squibb Pharma EEIG Centralised - Yearly update 8 Apr 2019
Iressa AstraZeneca AB Centralised - Yearly update 8 Apr 2019
Lynparza AstraZeneca AB Centralised - 2-Monthly update 8 Apr 2019 EMEA/H/C/003726/II/0020
Actraphane Novo Nordisk A/S Centralised - Yearly update 8 Apr 2019
Lantus Sanofi-Aventis Deutschland GmbH Centralised - Yearly update 8 Apr 2019
Riarify Chiesi Farmaceutici S.p.A. Centralised - 2-Monthly update 8 Apr 2019 EMEA/H/C/4836/WS/1554
Stribild Gilead Sciences Ireland UC Centralised - 2-Monthly update 8 Apr 2019 EMEA/H/C/2574/WS/1401
Tybost Gilead Sciences Ireland UC Centralised - 2-Monthly update 8 Apr 2019 EMEA/H/C/2572/WS/1401
Viread Gilead Sciences Ireland UC Centralised - 2-Monthly update 8 Apr 2019 EMEA/H/C/419/II/191
Capecitabine medac medac Gesellschaft für klinische Spezialpräparate mbH PSUSA - Modification 8 Apr 2019 EMEA/H/C/PSUSA/00000531/201804
M-M-RVAXPRO MSD VACCINS PSUSA - Modification 8 Apr 2019 EMEA/H/C/PSUSA/00001937/201805
Orencia Bristol-Myers Squibb Pharma EEIG Centralised - Variation 8 Apr 2019 EMEA/H/C/000701/X/0117/G
DuoResp Spiromax Teva Pharma B.V. Centralised - Renewal 8 Apr 2019 EMEA/H/C/002348/R/0027
BiResp Spiromax Teva Pharma B.V. Centralised - Renewal 8 Apr 2019 EMEA/H/C/003890/R/0027
Copalia Novartis Europharm Limited Corrigendum 2 Apr 2019
Yervoy Bristol-Myers Squibb/Pfizer EEIG Centralised - Yearly update 2 Apr 2019
Opdivo Bristol-Myers Squibb/Pfizer EEIG Centralised - Yearly update 2 Apr 2019
NULOJIX Bristol-Myers Squibb/Pfizer EEIG Centralised - Yearly update 2 Apr 2019
Empliciti Bristol-Myers Squibb Pharma EEIG Centralised - Yearly update 2 Apr 2019
Clopidogrel BGR Laboratoires BIOGARAN Centralised - Yearly update 2 Apr 2019
Eliquis Bristol-Myers Squibb/Pfizer EEIG Centralised - Yearly update 2 Apr 2019
Numient Amneal Pharma Europe Ltd Centralised - Withdrawal 2 Apr 2019
Karvezide Sanofi-Aventis groupe Referral 2 Apr 2019 EMEA/H/A-31/1471/C/221/188
Karvea Sanofi-Aventis groupe Referral 2 Apr 2019 EMEA/H/A-31/1471/C/142/175
Exforge HCT Novartis Europharm Limited Referral 2 Apr 2019 EMEA/H/A-31/1471/C/1068/68
Zonisamide Mylan Mylan S.A.S. Centralised - Yearly update 2 Apr 2019
Dafiro Novartis Europharm Limited Referral 2 Apr 2019 EMEA/H/A-31/1471/C/776/101
Copalia Novartis Europharm Limited Referral 2 Apr 2019 EMEA/H/A-31/1471/C/774/99
Irbesartan Zentiva Zentiva k.s. Referral 2 Apr 2019 EMEA/H/A-31/1471/C/785/0080
Deltyba Otsuka Novel Products GmbH Centralised - Annual renewal 2 Apr 2019 EMEA/H/C/002552/R/0033
Sylvant Janssen-Cilag International NV Centralised - Renewal 2 Apr 2019 EMEA/H/C/3708/R/0029
Gazyvaro Roche Registration GmbH Centralised - Renewal 2 Apr 2019 EMEA/H/C/2799/R/0031
Capecitabine Accord Accord Healthcare S.L.U. PSUSA - Modification 2 Apr 2019 EMEA/H/C/002386/PSUSA/00000531/201804
Zykadia Novartis Europharm Limited Centralised - Variation 2 Apr 2019 EMEA/H/C/3819/X/25
Steglatro Merck Sharp & Dohme B.V. PSUSA - Modification 2 Apr 2019 EMEA/H/C/PSUSA/10682/201806
Afinitor Novartis Europharm Limited Centralised - Renewal 2 Apr 2019 EMEA/H/C/1038/R/60
Steglujan Merck Sharp & Dohme B.V. PSUSA - Modification 2 Apr 2019 EMEA/H/C/4313/PSUSA/10681/201806
Vidaza Celgene Europe B.V. PSUSA - Modification 2 Apr 2019 EMEA/H/C/978/PSUSA/274/201805
Kromeya Fresenius Kabi Deutschland GmbH Centralised - Authorisation 2 Apr 2019 EMEA/H/C/005158/0000
Idacio Fresenius Kabi Deutschland GmbH Centralised - Authorisation 2 Apr 2019 EMEA/H/C/004475/0000
Vizimpro Pfizer Europe MA EEIG Centralised - Authorisation 2 Apr 2019 EMEA/H/C/4779
Lumark IDB Holland B.V. PSUSA - Modification 2 Apr 2019 EMEA/H/C/PSUSA/00010391/201806
Betmiga Astellas Pharma Europe B.V. PSUSA - Modification 2 Apr 2019 EMEA/H/C/PSUSA/00010031/201806
Jylamvo Therakind (Europe) Limited Centralised - Transfer Marketing Authorisation Holder 29 Mar 2019 EMEA/H/C/3756/T/7
Insulatard Novo Nordisk A/S Centralised - Yearly update 28 Mar 2019
Mixtard Novo Nordisk A/S Centralised - Yearly update 28 Mar 2019
NovoRapid Novo Nordisk A/S Centralised - Yearly update 28 Mar 2019
Galafold Amicus Therapeutics Europe Limited Centralised - Transfer Marketing Authorisation Holder 28 Mar 2019 EMEA/H/C/004059/T/0020
Sialanar Proveca Pharma Limited Centralised - Transfer Marketing Authorisation Holder 28 Mar 2019 EMEA/H/C/3883/T/09
Coagadex BPL Bioproducts Laboratory GmbH Centralised - Transfer Marketing Authorisation Holder 28 Mar 2019 EMEA/H/C/3855/T/14
Jylamvo Therakind (Europe) Limited Centralised - Yearly update 28 Mar 2019
Sustiva Bristol-Myers Squibb Pharma EEIG Centralised - Yearly update 28 Mar 2019
Nerlynx Puma Biotechnology B.V. Centralised - Transfer Marketing Authorisation Holder 28 Mar 2019 EMEA/H/C/4030/T/01
AMGEVITA Amgen Europe B.V. Centralised - 2-Monthly update 28 Mar 2019 EMEA/H/C/004212/IB/0015/G
Imatinib Teva Teva B.V. Centralised - Yearly update 28 Mar 2019
Efavirenz/Emtricitabine/Tenofovir disoproxil Zentiva Zentiva, k.s. Centralised - 2-Monthly update 28 Mar 2019 EMEA/H/C/004250/IB/0009/G
Clopidogrel Krka Krka d. d., Novo mesto Centralised - Yearly update 28 Mar 2019
EVOTAZ Bristol-Myers Squibb Pharma EEIG Centralised - Yearly update 28 Mar 2019
VPRIV Shire Pharmaceuticals Ireland Limited Centralised - Yearly update 28 Mar 2019
Lamivudine / Zidovudine Teva Teva B.V. Centralised - Yearly update 28 Mar 2019
KEYTRUDA Merck Sharp & Dohme B.V. Centralised - 2-Monthly update 28 Mar 2019 EMEA/H/C/003820/II/0062
Genvoya Gilead Sciences Ireland UC Centralised - 2-Monthly update 28 Mar 2019 EMEA/H/C/4042/WS/1401
Bexsero GlaxoSmithKline Vaccines S.r.l. Centralised - 2-Monthly update 28 Mar 2019 EMEA/H/C/2333/II/73
Segluromet Merck Sharp & Dohme B.V. PSUSA - Modification 28 Mar 2019 EMEA/H/C/4314/PSUSA/10680/201806
Perjeta Roche Registration GmbH PSUSA - Modification 28 Mar 2019 EMEA/H/C/2547/PSUSA/10125/201806
Opdivo Bristol-Myers Squibb/Pfizer EEIG PSUSA - Modification 28 Mar 2019 EMEA/H/C/3985/PSUSA/10379/201807
Febuxostat Krka Krka d. d., Novo mesto Centralised - Authorisation 28 Mar 2019 EMEA/H/C/4773
EndolucinBeta ITG Isotope Technologies Garching GmbH PSUSA - Modification 28 Mar 2019 EMEA/H/C/PSUSA/10391/201806
Xeloda Roche Registration GmbH PSUSA - Modification 28 Mar 2019 EMEA/H/C/PSUSA/531/201804
AJOVY Teva GmbH Centralised - Authorisation 28 Mar 2019 EMEA/H/C/4833
Qutenza Grünenthal GmbH Centralised - Renewal 28 Mar 2019 EMEA/H/C/909/R/0047
Strensiq Alexion Europe SAS PSUSA - Modification 28 Mar 2019 EMEA/H/C/3794/PSUSA/10421/201807
Glivec Novartis Europharm Limited PSUSA - Modification 28 Mar 2019 EMEA/H/C/406/PSUSA/1725/201805
Cometriq Ipsen Pharma Centralised - Annual renewal 28 Mar 2019 EMEA/H/C/2640/R/29
Sprycel Bristol-Myers Squibb Pharma EEIG PSUSA - Modification 28 Mar 2019 EMEA/H/C/709/PSUSA/935/201806
Nordimet Nordic Group B.V. Centralised - Yearly update 25 Mar 2019
Clopidogrel Mylan Mylan S.A.S. Centralised - Yearly update 25 Mar 2019
Levemir Novo Nordisk A/S Centralised - Yearly update 25 Mar 2019
Baraclude Bristol-Myers Squibb Pharma EEIG Centralised - Yearly update 25 Mar 2019
Omidria Omeros Ireland Limited Centralised - Transfer Marketing Authorisation Holder 25 Mar 2019 EMEA/H/C/3702/T/10
Edarbi Takeda Pharma A/S Centralised - Yearly update 25 Mar 2019
Zyllt Krka d. d., Novo mesto Centralised - Yearly update 25 Mar 2019
Clopidogrel ratiopharm GmbH Archie Samuel s.r.o. Centralised - Yearly update 25 Mar 2019
ADYNOVI Baxalta Innovations GmbH Centralised - Yearly update 25 Mar 2019
Lutathera Advanced Accelerator Applications Centralised - Yearly update 25 Mar 2019
Daklinza Bristol-Myers Squibb Pharma EEIG Centralised - Yearly update 25 Mar 2019
Spinraza Biogen Netherlands B.V. PSUSA - Modification 25 Mar 2019 EMEA/H/C/PSUSA/10595/201805
Atazanavir Krka Krka d. d., Novo mesto Centralised - Authorisation 25 Mar 2019 EMEA/H/C/4859/00
Rotarix GlaxoSmithKline Biologicals S.A. PSUSA - Modification 25 Mar 2019 EMEA/H/C/PSUSA/2665/201807
Plegridy Biogen Netherlands B.V. Centralised - Renewal 25 Mar 2019 EMEA/H/C/2827/R/51
Velphoro Vifor Fresenius Medical Care Renal Pharma France Centralised - Renewal 25 Mar 2019 EMEA/H/C/2705/R/18
Forxiga AstraZeneca AB Centralised - 2-Monthly update 20 Mar 2019 EMEA/H/C/2322/WS/1344
SCENESSE Clinuvel Europe Limited Centralised - Transfer Marketing Authorisation Holder 20 Mar 2019 EMEA/H/C/2548/T/24
Edistride AstraZeneca AB Centralised - 2-Monthly update 20 Mar 2019 EMEA/H/C/4161/WS/1344
Ongentys Bial - Portela & Cª, SA Centralised - Yearly update 13 Mar 2019
Reyataz Bristol-Myers Squibb Pharma EEIG Centralised - Yearly update 13 Mar 2019
NovoMix Novo Nordisk A/S Centralised - 2-Monthly update 13 Mar 2019 EMEA/H/C/000308/II/0095
Rubraca Clovis Oncology Ireland Limited Centralised - Annual renewal 13 Mar 2019 EMEA/H/C/4272/R/08
Intrarosa Endoceutics S.A. Centralised - Transfer Marketing Authorisation Holder 11 Mar 2019 EMEA/H/C/004138/T/0005
Zoledronic acid Accord Accord Healthcare S.L.U. Centralised - Transfer Marketing Authorisation Holder 11 Mar 2019 EMEA/H/C/002667/T/0007
Pramipexole Accord Accord Healthcare S.L.U. Centralised - Transfer Marketing Authorisation Holder 11 Mar 2019 EMEA/H/C/002291/T/0014
Cresemba Basilea Pharmaceutica Deutschland GmbH Centralised - Transfer Marketing Authorisation Holder 11 Mar 2019 EMEA/H/C/2734/T/20
Stayveer Janssen Pharmaceutica N.V. Centralised - Transfer Marketing Authorisation Holder 11 Mar 2019 EMEA/H/C/2644/T/25
Pelgraz Accord Healthcare S.L.U. Centralised - Transfer Marketing Authorisation Holder 11 Mar 2019 EMEA/H/C/003961/T/0003
Varuby TESARO Bio Netherlands B.V. Centralised - Transfer Marketing Authorisation Holder 11 Mar 2019 EMEA/H/C/4196/T/15
Luminity Lantheus EU Limited Centralised - Transfer Marketing Authorisation Holder 11 Mar 2019 EMEA/H/C/654/T/27
Efavirenz/Emtricitabine/Tenofovir disoproxil Krka Krka d. d., Novo mesto Centralised - 2-Monthly update 11 Mar 2019 EMEA/H/C/4274/IB/04/G
Slenyto RAD Neurim Pharmaceuticals EEC SARL Centralised - Transfer Marketing Authorisation Holder 11 Mar 2019 EMEA/H/C/4425/T/04
Ferriprox Apotex Europe B.V. Centralised - 2-Monthly update 11 Mar 2019 EMEA/H/C/236/II/0126/G
Herceptin Roche Registration GmbH Centralised - Yearly update 11 Mar 2019
INOmax Linde Healthcare AB Centralised - Yearly update 11 Mar 2019
Praluent Sanofi-Aventis groupe Centralised - 2-Monthly update 11 Mar 2019 EMEA/H/C/3882/II/0042
Zykadia Novartis Europharm Limited Centralised - 2-Monthly update 11 Mar 2019 EMEA/H/C/3819/II/26
Qarziba EUSA Pharma (Netherlands) B.V. Centralised - Transfer Marketing Authorisation Holder 11 Mar 2019 EMEA/H/C/3918/T/10
Mabthera Roche Registration GmbH Centralised - 2-Monthly update 11 Mar 2019 EMEA/H/C/000165/II/0150
KEYTRUDA Merck Sharp & Dohme B.V. Centralised - 2-Monthly update 11 Mar 2019 EMEA/H/C/003820/II/0060
Maviret AbbVie Deutschland GmbH & Co. KG Centralised - 2-Monthly update 11 Mar 2019 EMEA/H/C/004430/II/0012
Hemlibra Roche Registration GmbH Centralised - 2-Monthly update 11 Mar 2019 EMEA/H/C/4406/II/02
Actrapid Novo Nordisk A/S Centralised - Yearly update 11 Mar 2019
Senshio Shionogi B.V. Centralised - Transfer Marketing Authorisation Holder 11 Mar 2019 EMEA/H/C/2780/T/26
Aripiprazole Accord Accord Healthcare S.L.U. Centralised - Transfer Marketing Authorisation Holder 5 Mar 2019 EMEA/H/C/4021/T/13
DaTSCAN GE Healthcare B.V. Centralised - Transfer Marketing Authorisation Holder 5 Mar 2019 EMEA/H/C/266/T/57
Instanyl Takeda Pharma A/S Centralised - 2-Monthly update 5 Mar 2019 EMEA/H/C/959/II/47/G
Levetiracetam Actavis Actavis Group PTC ehf. Centralised - Yearly update 5 Mar 2019
Kiovig Baxter AG Centralised - 2-Monthly update 5 Mar 2019 EMEA/H/C/628/IB/88
Pregabalin Accord Accord Healthcare S.L.U. Centralised - Transfer Marketing Authorisation Holder 5 Mar 2019 EMEA/H/C/4024/T/10
Granpidam Accord Healthcare S.L.U. Centralised - Transfer Marketing Authorisation Holder 5 Mar 2019 EMEA/H/C/4289/T/02
Tecentriq Roche Registration GmbH Centralised - 2-Monthly update 5 Mar 2019 EMEA/H/C/4143/II/07/G
Herzuma Celltrion Healthcare Hungary Kft. Centralised - Yearly update 1 Mar 2019
Lacosamide Accord Accord Healthcare S.L.U. Centralised - Transfer Marketing Authorisation Holder 1 Mar 2019 EMEA/H/C/4443/T/02
Lenalidomide Accord Accord Healthcare S.L.U. Centralised - Transfer Marketing Authorisation Holder 1 Mar 2019 EMEA/H/C/4857/T/01
Levetiracetam Accord Accord Healthcare S.L.U. Centralised - Transfer Marketing Authorisation Holder 1 Mar 2019 EMEA/H/C/2290/T/22
Palonosetron Accord Accord Healthcare S.L.U. Centralised - Transfer Marketing Authorisation Holder 1 Mar 2019 EMEA/H/C/4129/T/04
Docetaxel Accord Accord Healthcare S.L.U. Centralised - Transfer Marketing Authorisation Holder 1 Mar 2019 EMEA/H/C/2539/T/41
Tegsedi Akcea Therapeutics Ireland Ltd Centralised - Transfer Marketing Authorisation Holder 1 Mar 2019 EMEA/H/C/004782/T/0003
Temozolomide Accord Accord Healthcare S.L.U. Centralised - Transfer Marketing Authorisation Holder 25 Feb 2019 EMEA/H/C/001125/T/0045
Altargo Glaxo Group Ltd Centralised - Withdrawal 25 Feb 2019
Repaglinide Accord Accord Healthcare S.L.U. Centralised - Transfer Marketing Authorisation Holder 25 Feb 2019 EMEA/H/C/002318/T/0008
Capecitabine Accord Accord Healthcare S.L.U. Centralised - Transfer Marketing Authorisation Holder 25 Feb 2019 EMEA/H/C/002386/T/0030
Hetlioz Vanda Pharmaceuticals Germany GmbH Centralised - Transfer Marketing Authorisation Holder 25 Feb 2019 EMEA/H/C/3870/T/13
AFSTYLA CSL Behring GmbH Centralised - Yearly update 25 Feb 2019
Arzerra Novartis Europharm Limited Centralised - Withdrawal 25 Feb 2019
Fasenra AstraZeneca AB Centralised - Yearly update 25 Feb 2019
Zypadhera Eli Lilly Nederland B.V. Centralised - Yearly update 25 Feb 2019
Zyclara Meda AB Centralised - Yearly update 25 Feb 2019
Miglustat Gen.Orph Gen.Orph Centralised - Yearly update 25 Feb 2019
Pemetrexed Accord Accord Healthcare S.L.U. Centralised - Transfer Marketing Authorisation Holder 25 Feb 2019 EMEA/H/C/4072/T/06
Fiasp Novo Nordisk A/S Centralised - Yearly update 25 Feb 2019
Plavix Sanofi Clir SNC Corrigendum 25 Feb 2019
Entecavir Accord Accord Healthcare S.L.U. Centralised - Transfer Marketing Authorisation Holder 25 Feb 2019 EMEA/H/C/004458/T/0004
Amlodipine/Valsartan Mylan Mylan S.A.S. Centralised - Yearly update 25 Feb 2019
Bortezomib Accord Accord Healthcare S.L.U. Centralised - Transfer Marketing Authorisation Holder 25 Feb 2019 EMEA/H/C/3984/T/17
Zavicefta Pfizer Ireland Pharmaceuticals Centralised - Yearly update 25 Feb 2019
Tecentriq Roche Registration GmbH PSUSA - Modification 25 Feb 2019 EMEA/H/C/4143/PSUSA/10644/201805
Ibandronic acid Accord Accord Healthcare S.L.U. Centralised - Transfer Marketing Authorisation Holder 20 Feb 2019 EMEA/H/C/2638/T/16
Voriconazole Accord Accord Healthcare S.L.U. Centralised - Transfer Marketing Authorisation Holder 20 Feb 2019 EMEA/H/C/2669/T/21
ATryn Laboratoire français du Fractionnement et des Biotechnologies Centralised - Withdrawal 20 Feb 2019
Vabomere Menarini International Operations Luxembourg S.A. Centralised - Transfer Marketing Authorisation Holder 20 Feb 2019 EMEA/H/C/004669/T/0001
Sustiva Bristol-Myers Squibb Pharma EEIG PSUSA - Modification 20 Feb 2019 EMEA/H/C/249/PSUSA/1200/201804
Zytiga Janssen-Cilag International NV PSUSA - Modification 20 Feb 2019 EMEA/H/C/2321/PSUSA/15/201804
Simbrinza Novartis Europharm Limited Centralised - Renewal 20 Feb 2019 EMEA/H/C/3698/R/14
Renvela Genzyme Europe B.V. Centralised - Renewal 20 Feb 2019 EMEA/H/C/993/R/46
Entyvio Takeda Pharma A/S PSUSA - Modification 20 Feb 2019 EMEA/H/C/PSUSA/10186/201805
VELCADE Janssen-Cilag International NV PSUSA - Modification 20 Feb 2019 EMEA/H/C/PSUSA/424/201804
Bortezomib SUN Sun Pharmaceutical Industries Europe BV PSUSA - Modification 20 Feb 2019 EMEA/H/C/4076/PSUSA/424/201804
Bortezomib Accord Accord Healthcare S.L.U. PSUSA - Modification 20 Feb 2019 EMEA/H/C/3984/PSUSA/424/201804
Eurartesim Alfasigma S.p.A. PSUSA - Modification 20 Feb 2019 EMEA/H/C/PSUSA/00001069/201804
Mepact Takeda France SAS Centralised - Renewal 20 Feb 2019 EMEA/H/C/000802/R/0047
Rebif Merck Europe B.V. Corrigendum 19 Feb 2019
Vantobra PARI Pharma GmbH Centralised - Withdrawal 18 Feb 2019
Silgard Merck Sharp & Dohme Limited Centralised - Withdrawal 18 Feb 2019
Zelboraf Roche Registration GmbH Centralised - Yearly update 18 Feb 2019
Zyprexa Eli Lilly Nederland B.V. Centralised - Yearly update 18 Feb 2019
Pixuvri CTI Life Sciences Deutschland GmbH Centralised - Transfer Marketing Authorisation Holder 18 Feb 2019 EMEA/H/C/002055/T/0045
Simponi Janssen Biologics B.V. Centralised - Variation 18 Feb 2019 EMEA/H/C/000992/X/0083/G
Rizmoic Shionogi B.V. Centralised - Authorisation 18 Feb 2019 EMEA/H/C/4256
Miglustat Dipharma Dipharma B.V. Centralised - Authorisation 18 Feb 2019 EMEA/H/C/004904/0000
Advagraf Astellas Pharma Europe B.V. PSUSA - Modification 18 Feb 2019 EMEA/H/C/PSUSA/00002839/201803
Tobramycin PARI PARI Pharma GmbH Centralised - Authorisation 18 Feb 2019 EMEA/H/C/5086
ATryn Laboratoire français du Fractionnement et des Biotechnologies Centralised - Annual reassessment 18 Feb 2019 EMEA/H/C/587/S/35
Lusutrombopag Shionogi Shionogi B.V. Centralised - Authorisation 18 Feb 2019 EMEA/H/C/4720
Bosulif Pfizer Europe MA EEIG Centralised - Annual renewal 18 Feb 2019 EMEA/H/C/2373/R/35
Besremi AOP Orphan Pharmaceuticals AG Centralised - Authorisation 15 Feb 2019 EMEA/H/C/4128/00
Aripiprazole Mylan Pharma Mylan S.A.S. Centralised - Yearly update 14 Feb 2019
Imatinib Accord Accord Healthcare S.L.U. Centralised - Transfer Marketing Authorisation Holder 14 Feb 2019 EMEA/H/C/2681/T/25
Pioglitazone Accord Accord Healthcare S.L.U. Centralised - Transfer Marketing Authorisation Holder 14 Feb 2019 EMEA/H/C/2277/T/16
Imatinib Medac medac Gesellschaft für klinische Spezialpräparate mbH Centralised - Withdrawal 14 Feb 2019
Silgard Merck Sharp & Dohme Limited Centralised - Yearly update 14 Feb 2019
Fotivda EUSA Pharma (Netherlands) B.V. Centralised - Transfer Marketing Authorisation Holder 14 Feb 2019 EMEA/H/C/4131/T/05
Modigraf Astellas Pharma Europe B.V. PSUSA - Modification 14 Feb 2019 EMEA/H/C/954/PSUSA/2839/201803
Bortezomib Hospira Pfizer Europe MA EEIG PSUSA - Modification 14 Feb 2019 EMEA/H/C/4207/PSUSA/424/201804
Hemlibra Roche Registration GmbH PSUSA - Modification 14 Feb 2019 EMEA/H/C/PSUSA/10668/201805
Zirabev Pfizer Europe MA EEIG Centralised - Authorisation 14 Feb 2019 EMEA/H/C/4697
Sutent Pfizer Europe MA EEIG PSUSA - Modification 14 Feb 2019 EMEA/H/C/PSUSA/2833/201804
Jardiance Boehringer Ingelheim International GmbH Centralised - Renewal 14 Feb 2019 EMEA/H/C/2677/R/40
Mekinist Novartis Europharm Limited Centralised - Renewal 14 Feb 2019 EMEA/H/C/2643/R/29
Quinsair Chiesi Farmaceutici S.p.A. Referral 14 Feb 2019 EMEA/H/A-31/1452/C/2789/10
Imraldi Samsung Bioepis NL B.V. Centralised - 2-Monthly update 12 Feb 2019 EMEA/H/C/4279/IB/20
Yargesa Piramal Critical Care B.V. Centralised - Transfer Marketing Authorisation Holder 12 Feb 2019 EMEA/H/C/004016/T/0005
Caspofungin Accord Accord Healthcare S.L.U. Centralised - Transfer Marketing Authorisation Holder 12 Feb 2019 EMEA/H/C/4134/T/07
Buccolam Shire Services BVBA Centralised - Yearly update 12 Feb 2019
Liprolog Eli Lilly Nederland B.V. Centralised - Yearly update 12 Feb 2019
Envarsus Chiesi Farmaceutici S.p.A. PSUSA - Modification 12 Feb 2019 EMEA/H/C/2655/PSUSA/2839/201803
Jinarc Otsuka Pharmaceutical Netherlands B.V. PSUSA - Modification 12 Feb 2019 EMEA/H/C/2788/PSUSA/10395/201805
Ebilfumin Actavis Group PTC ehf. Centralised - Renewal 12 Feb 2019 EMEA/H/C/003717/R/0012
Helicobacter Test INFAI INFAI GmbH Centralised - Yearly update 8 Feb 2019
Raxone Santhera Pharmaceuticals (Deutschland) GmbH Centralised - Yearly update 7 Feb 2019
Teysuno Nordic Group B.V. Centralised - Yearly update 7 Feb 2019
Circadin RAD Neurim Pharmaceuticals EEC SARL Centralised - Transfer Marketing Authorisation Holder 7 Feb 2019 EMEA/H/C/695/T/58
Lenvima Eisai GmbH Centralised - Transfer Marketing Authorisation Holder 7 Feb 2019 EMEA/H/C/3727/T/24
Kisplyx Eisai GmbH Centralised - Transfer Marketing Authorisation Holder 7 Feb 2019 EMEA/H/C/4224/T/22
Tarceva Roche Registration GmbH Centralised - Yearly update 7 Feb 2019
Sycrest Organon N.V. Centralised - Yearly update 7 Feb 2019
Sifrol Boehringer Ingelheim International GmbH 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
ADCETRIS Takeda Pharma A/S Centralised - 2-Monthly update 6 Feb 2019 EMEA/H/C/2455/II/55
Sprycel Bristol-Myers Squibb Pharma EEIG Centralised - 2-Monthly update 6 Feb 2019 EMEA/H/C/709/II/59
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 S.L.U. 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
Axumin Blue Earth Diagnostics Ireland Ltd Corrigendum 23 Jan 2019
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 S.L.U. 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
OCALIVA Intercept Pharma International Ltd. Centralised - Transfer Marketing Authorisation Holder 23 Jan 2019 EMEA/H/C/004093/T/0012
Juluca ViiV Healthcare BV Centralised - Transfer Marketing Authorisation Holder 23 Jan 2019 EMEA/H/C/4427/T/07
Humalog Eli Lilly Nederland B.V. Corrigendum 21 Jan 2019
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
Macimorelin Aeterna Zentaris Æterna Zentaris GmbH Corrigendum 11 Jan 2019
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/Pfizer EEIG Centralised - 2-Monthly update 11 Jan 2019 EMEA/H/C/2213/WS/1278
Opdivo Bristol-Myers Squibb/Pfizer 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 Æterna 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 Ireland 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 International 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 S.L.U. 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 Menarini International Operations Luxembourg S.A. 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 Netherlands B.V. Centralised - Transfer Marketing Authorisation Holder 14 Nov 2018 EMEA/H/C/2601/T/55
Daptomycin Hospira Pfizer Europe MA EEIG 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
Deferiprone Lipomed Lipomed GmbH Corrigendum 20 Sep 2018
Komboglyze AstraZeneca AB Corrigendum 13 Aug 2018
MAVENCLAD Merck Europe B.V. Corrigendum 9 Jul 2018
Insuman Sanofi-Aventis Deutschland GmbH Corrigendum 14 Jun 2018
Procedures for centrally authorised orphan medicinal products for human use
Product Marketing Authorisation Holder Decision Type Decision date EMEA Nr
EU/3/18/2038 PPD Bulgaria EOOD Transfer of orphan designation 10 Apr 2019 EMA/OD/0000005020
EU/3/18/2124 IntraBio Ireland Ltd Transfer of orphan designation 10 Apr 2019 EMA/OD/0000005404
EU/3/18/2059 IntraBio Ireland Ltd Transfer of orphan designation 10 Apr 2019 EMA/OD/0000005399
EU/3/17/1949 IntraBio Ireland Ltd Transfer of orphan designation 10 Apr 2019 EMA/OD/0000005385
EU/3/17/1878 IntraBio Ireland Ltd Transfer of orphan designation 10 Apr 2019 EMA/OD/0000005394
EU/3/17/1848 IntraBio Ireland Ltd Transfer of orphan designation 10 Apr 2019 EMA/OD/0000005357
EU/3/16/1665 Diamond ROC EOOD Transfer of orphan designation 10 Apr 2019 EMA/OD/0000005876
EU/3/15/1556 Diamond ROC EOOD Transfer of orphan designation 10 Apr 2019 EMA/OD/0000005873
EU/3/13/1107 Diamond ROC EOOD Transfer of orphan designation 10 Apr 2019 EMA/OD/0000005875
EU/3/13/1099 Diamond ROC EOOD Transfer of orphan designation 10 Apr 2019 EMA/OD/0000005874
EU/3/07/440 Diamond ROC EOOD Transfer of orphan designation 10 Apr 2019 EMA/OD/0000005871
EU/3/18/2126 JVM Europe B.V. Transfer of orphan designation 10 Apr 2019 EMA/OD/0000005194
EU/3/18/2035 JVM Europe B.V. Transfer of orphan designation 10 Apr 2019 EMA/OD/0000005050
EU/3/18/2022 JVM Europe B.V. Transfer of orphan designation 10 Apr 2019 EMA/OD/0000005277
EU/3/18/1977 GW Pharma (International) B.V Transfer of orphan designation 10 Apr 2019 EMA/OD/0000004768
EU/3/17/1959 GW Pharma (International) B.V Transfer of orphan designation 10 Apr 2019 EMA/OD/0000004767
EU/3/17/1921 GW Pharma (International) B.V Transfer of orphan designation 10 Apr 2019 EMA/OD/0000004766
EU/3/17/1920 GW Pharma (International) B.V Transfer of orphan designation 10 Apr 2019 EMA/OD/0000004765
EU/3/17/1855 GW Pharma (International) B.V Transfer of orphan designation 10 Apr 2019 EMA/OD/0000004607
EU/3/16/1621 GW Pharma (International) B.V Transfer of orphan designation 10 Apr 2019 EMA/OD/0000004763
EU/3/14/1339 GW Pharma (International) B.V Transfer of orphan designation 10 Apr 2019 EMA/OD/0000004708
EU/3/15/1520 GW Pharma (International) B.V Transfer of orphan designation 1 Apr 2019 EMA/OD/0000004600
EU/3/16/1628 New B Innovation Biopharmaceutical (Ireland) Limited Transfer of orphan designation 1 Apr 2019 EMA/OD/0000003473
EU/3/14/1378 New B Innovation Biopharmaceutical (Ireland) Limited Transfer of orphan designation 1 Apr 2019 EMA/OD/0000003420
EU/3/19/2151 Voisin Consulting S.A.R.L. Orphan designation 1 Apr 2019 EMA/OD/0000002304
EU/3/19/2150 Real Regulatory Limited Orphan designation 1 Apr 2019 EMA/OD/0000002333
EU/3/19/2149 Brainvectis Orphan designation 1 Apr 2019 EMA/OD/0000002264
EU/3/19/2148 Takeda Pharma A/S Orphan designation 1 Apr 2019 EMA/OD/0000002821
EU/3/19/2147 Gilead Sciences Ireland UC Orphan designation 1 Apr 2019 EMA/OD/0000002498
EU/3/19/2146 Taiho Pharma Europe Limited Orphan designation 1 Apr 2019 EMA/OD/0000002457
EU/3/16/1721 Araim Pharmaceuticals Europe Limited Transfer of orphan designation 1 Apr 2019 EMA/OD/0000005497
EU/3/13/1191 Araim Pharmaceuticals Europe Limited Transfer of orphan designation 1 Apr 2019 EMA/OD/0000004909
EU/3/16/1648 Tracon Pharma International Limited Transfer of orphan designation 1 Apr 2019 EMA/OD/0000004633
EU/3/14/1284 Basilea Pharmaceutica Deutschland GmbH Transfer of orphan designation 1 Apr 2019 EMA/OD/0000004336
EU/3/14/1276 Basilea Pharmaceutica Deutschland GmbH Transfer of orphan designation 1 Apr 2019 EMA/OD/0000004334
EU/3/09/641 Atlantic Healthcare Europe B.V. Transfer of orphan designation 1 Apr 2019 EMA/OD/0000004618
EU/3/17/1842 EUDRAC GmbH Transfer of orphan designation 1 Apr 2019 EMA/OD/0000004449
EU/3/06/374 Therakos Europe Limited Transfer of orphan designation 25 Mar 2019 EMA/OD/0000004676
EU/3/15/1510 Mitsubishi Tanabe Pharma GmbH Transfer of orphan designation 25 Mar 2019 EMA/OD/0000004451
EU/3/13/1217 SFL Regulatory Services GmbH Transfer of orphan designation 25 Mar 2019 EMA/OD/0000004699
EU/3/13/1216 SFL Regulatory Services GmbH Transfer of orphan designation 25 Mar 2019 EMA/OD/0000004691
EU/3/13/1215 SFL Regulatory Services GmbH Transfer of orphan designation 25 Mar 2019 EMA/OD/0000004666
EU/3/13/1214 SFL Regulatory Services GmbH Transfer of orphan designation 25 Mar 2019 EMA/OD/0000004351
EU/3/17/1868 Diamond ROC EOOD Transfer of orphan designation 25 Mar 2019 EMA/OD/0000004677
EU/3/16/1643 Clinical Network Services (NL) B.V. Transfer of orphan designation 25 Mar 2019 EMA/OD/0000005318
EU/3/17/1910 FGK Representative Service GmbH Transfer of orphan designation 25 Mar 2019 EMA/OD/0000005428
EU/3/10/753 Intercept Pharma International Limited Transfer of orphan designation 25 Mar 2019 EMA/OD/0000002873
EU/3/16/1711 Akcea Therapeutics Ireland Limited Transfer of orphan designation 25 Mar 2019 EMA/OD/0000004196
EU/3/14/1409 Polaris Pharmaceuticals Ireland Limited Transfer of orphan designation 25 Mar 2019 EMA/OD/0000004587
EU/3/10/807 Pharma Gateway AB Transfer of orphan designation 25 Mar 2019 EMA/OD/0000004926
EU/3/10/806 Pharma Gateway AB Transfer of orphan designation 25 Mar 2019 EMA/OD/0000005102
EU/3/10/805 Pharma Gateway AB Transfer of orphan designation 25 Mar 2019 EMA/OD/0000005087
EU/3/10/804 Pharma Gateway AB Transfer of orphan designation 25 Mar 2019 EMA/OD/0000005100
EU/3/16/1689 Boyd Consultants Limited Transfer of orphan designation 25 Mar 2019 EMA/OD/0000004935
EU/3/16/1664 Boyd Consultants Limited Transfer of orphan designation 25 Mar 2019 EMA/OD/0000004883
EU/3/14/1428 Boyd Consultants Limited Transfer of orphan designation 25 Mar 2019 MA/OD/0000004995
EU/3/18/2036 Regulis Consulting Europe Limited Transfer of orphan designation 25 Mar 2019 EMA/OD/0000004889
EU/3/18/2102 TherAchon SAS Transfer of orphan designation 25 Mar 2019 EMA/OD/0000004473
EU/3/15/1467 Holostem Terapie Avanzate S.r.l. Transfer of orphan designation 25 Mar 2019 EMA/OD/0000004602
EU/3/15/1466 Holostem Terapie Avanzate S.r.l. Transfer of orphan designation 25 Mar 2019 EMA/OD/0000004603
EU/3/15/1465 Holostem Terapie Avanzate S.r.l. Transfer of orphan designation 25 Mar 2019 EMA/OD/0000004545
EU/3/14/1379 Maxia Strategies-Europe Limited Transfer of orphan designation 25 Mar 2019 EMA/OD/0000004589
EU/3/18/2000 Amicus Therapeutics Europe Limited Transfer of orphan designation 25 Mar 2019 EMA/OD/0000004425
EU/3/13/1232 Amicus Therapeutics Europe Limited Transfer of orphan designation 25 Mar 2019 EMA/OD/0000004625
EU/3/06/368 Amicus Therapeutics Europe Limited Transfer of orphan designation 25 Mar 2019 EMA/OD/0000004426
EU/3/14/1280 Orchard Therapeutics (Europe) Limited Transfer of orphan designation 25 Mar 2019 EMA/OD/0000003985
EU/3/13/1134 Orchard Therapeutics (Netherlands) B.V. Transfer of orphan designation 25 Mar 2019 EMA/OD/0000003982
EU/3/07/446 Orchard Therapeutics (Netherlands) B.V. Transfer of orphan designation 25 Mar 2019 EMA/OD/0000003632
Diacerein Therapicon Srl Refusal of orphan designation 22 Mar 2019 EMA/OD/131/18
EU/3/07/471 BPL Bioproducts Laboratory GmbH Transfer of orphan designation 14 Mar 2019 EMA/OD/0000004129
EU/3/18/2052 Dicerna Ireland Limited Transfer of orphan designation 14 Mar 2019 EMA/OD/0000004770
EU/3/16/1742 Worphmed Srl Transfer of orphan designation 14 Mar 2019 EMA/OD/0000004715
EU/3/10/823 Amryt Pharmaceuticals Designated Activity Company Transfer of orphan designation 14 Mar 2019 EMA/OD/0000004233
EU/3/18/2101 TMC Pharma (EU) Limited Transfer of orphan designation 14 Mar 2019 EMA/OD/0000004764
EU/3/16/1703 TMC Pharma (EU) Limited Transfer of orphan designation 14 Mar 2019 EMA/OD/0000004730
EU/3/16/1688 TMC Pharma (EU) Limited Transfer of orphan designation 14 Mar 2019 EMA/OD/0000004734
EU/3/16/1633 Diamond ROC EOOD Transfer of orphan designation 14 Mar 2019 EMA/OD/0000003815
EU/3/15/1587 Diamond ROC EOOD Transfer of orphan designation 14 Mar 2019 EMA/OD/0000003811
EU/3/15/1584 Diamond ROC EOOD Transfer of orphan designation 14 Mar 2019 EMA/OD/0000003801
EU/3/14/1329 Diamond ROC EOOD Transfer of orphan designation 14 Mar 2019 EMA/OD/0000003809
EU/3/14/1247 Diamond ROC EOOD Transfer of orphan designation 14 Mar 2019 EMA/OD/0000003818
EU/3/13/1154 Diamond ROC EOOD Transfer of orphan designation 14 Mar 2019 EMA/OD/0000003817
EU/3/04/195 Diamond ROC EOOD Transfer of orphan designation 14 Mar 2019 EMA/OD/0000003813
EU/3/14/1249 Akcea Therapeutics Ireland Limited Transfer of orphan designation 13 Mar 2019 EMA/OD/0000004954
EU/3/16/1800 Boyd Consultants Limited Transfer of orphan designation 13 Mar 2019 EMA/OD/0000005192
EU/3/16/1629 Boyd Consultants Limited Transfer of orphan designation 13 Mar 2019 EMA/OD/0000005191
EU/3/14/1396 Boyd Consultants Limited Transfer of orphan designation 13 Mar 2019 EMA/OD/0000005074
EU/3/11/895 Boyd Consultants Limited Transfer of orphan designation 13 Mar 2019 EMA/OD/0000005321
EU/3/19/2139 Clinical Network Services (NL) B.V. Transfer of orphan designation 13 Mar 2019 EMA/OD/0000004280
EU/3/06/349 Vectura Ireland Limited Transfer of orphan designation 13 Mar 2019 EMA/OD/0000004495
EU/3/15/1597 Otsuka Pharmaceutical Netherlands B.V. Transfer of orphan designation 13 Mar 2019 EMA/OD/0000004914
EU/3/11/936 BPL Bioproducts Laboratory GmbH Transfer of orphan designation 13 Mar 2019 EMA/OD/0000004485
EU/3/15/1487 Leadiant GmbH Transfer of orphan designation 6 Mar 2019 EMA/OD/0000004452
EU/3/14/1281 Vertex Pharmaceuticals (Ireland) Limited Transfer of orphan designation 6 Mar 2019 EMA/OD/0000004132
EU/3/08/563 Vertex Pharmaceuticals (Ireland) Limited Transfer of orphan designation 6 Mar 2019 EMA/OD/0000004115
EU/3/14/1285 Clinuvel Europe Limited Transfer of orphan designation 6 Mar 2019 EMA/OD/0000004300
EU/3/09/648 Clinuvel Europe Limited Transfer of orphan designation 6 Mar 2019 EMA/OD/0000004299
EU/3/08/545 Clinuvel Europe Limited Transfer of orphan designation 6 Mar 2019 EMA/OD/0000004293
EU/3/08/541 Clinuvel Europe Limited Transfer of orphan designation 6 Mar 2019 EMA/OD/0000004019
EU/3/14/1337 ESPL Regulatory Consulting Limited Transfer of orphan designation 6 Mar 2019 EMA/OD/0000004283
EU/3/14/1404 Richardson Associates Regulatory Affairs Ltd Transfer of orphan designation 6 Mar 2019 EMA/OD/0000004496
EU/3/17/1894 Granzer Regulatory Consulting & Services Transfer of orphan designation 6 Mar 2019 EMA/OD/0000004025
EU/3/16/1757 Imago BioSciences B.V. Transfer of orphan designation 6 Mar 2019 EMA/OD/0000003424
EU/3/16/1738 F2G Biotech GmbH Transfer of orphan designation 6 Mar 2019 EMA/OD/0000004537
EU/3/16/1713 F2G Biotech GmbH Transfer of orphan designation 6 Mar 2019 EMA/OD/0000004529
EU/3/06/381 Clinical Network Services (NL) B.V. Transfer of orphan designation 6 Mar 2019 EMA/OD/0000004486
EU/3/12/968 Clinical Network Services (NL) B.V. Transfer of orphan designation 6 Mar 2019 EMA/OD/0000004447
EU/3/12/997 Sinus Regulatory Consulting EU Limited Transfer of orphan designation 26 Feb 2019 EMA/OD/0000004372
EU/3/12/996 Sinus Regulatory Consulting EU Limited Transfer of orphan designation 26 Feb 2019 EMA/OD/0000004369
EU/3/12/993 Sinus Regulatory Consulting EU Limited Transfer of orphan designation 26 Feb 2019 EMA/OD/0000004343
EU/3/17/1901 Voisin Consulting S.A.R.L. Transfer of orphan designation 26 Feb 2019 EMA/OD/0000004279
EU/3/16/1696 Clinical Network Services (NL) B.V. Transfer of orphan designation 26 Feb 2019 EMA/OD/0000004066
EU/3/16/1695 Clinical Network Services (NL) B.V. Transfer of orphan designation 26 Feb 2019 EMA/OD/0000004064
EU/3/13/1227 Clinical Network Services (NL) B.V. Transfer of orphan designation 26 Feb 2019 EMA/OD/0000004039
EU/3/09/635 Unither Therapeutik GmbH Transfer of orphan designation 26 Feb 2019 EMA/OD/0000004224
EU/3/05/310 Unither Therapeutik GmbH Transfer of orphan designation 26 Feb 2019 EMA/OD/0000004331
EU/3/04/197 Unither Therapeutik GmbH Transfer of orphan designation 26 Feb 2019 EMA/OD/0000004330
EU/3/18/2091 S-cubed Pharmaceutical Services ApS Transfer of orphan designation 26 Feb 2019 EMA/OD/0000004177
EU/3/15/1607 TMC Pharma (EU) Limited Transfer of orphan designation 26 Feb 2019 EMA/OD/0000004004
EU/3/15/1563 TMC Pharma (EU) Limited Transfer of orphan designation 26 Feb 2019 EMA/OD/0000003921
EU/3/14/1250 Akcea Therapeutics Ireland Limited Transfer of orphan designation 26 Feb 2019 EMA/OD/0000004311
EU/3/19/2145 Roche Registration GmbH Orphan designation 26 Feb 2019 EMA/OD/0000001899
EU/3/19/2144 Accelsiors CRO And Consultancy Services Ltd. Orphan designation 26 Feb 2019 EMA/OD/0000002552
EU/3/19/2143 Pharma Mar S.A. Orphan designation 26 Feb 2019 EMA/OD/0000001317
EU/3/19/2142 3R Pharma Consulting GmbH Orphan designation 26 Feb 2019 EMA/OD/0000002383
EU/3/19/2141 Fondazione Telethon Orphan designation 26 Feb 2019 EMA/OD/0000002293
EU/3/19/2140 Artemida Pharma Europe Limited Orphan designation 26 Feb 2019 EMA/OD/0000001793
EU/3/19/2139 Clinical Network Services (NL) B.V. Orphan designation 26 Feb 2019 EMA/OD/0000001655
EU/3/19/2138 Common Services Agency (National Health Services - Scotland) Orphan designation 26 Feb 2019 EMA/OD/0000002426
EU/3/19/2137 Enzyvant Therapeutics Ireland Limited Orphan designation 26 Feb 2019 EMA/OD/0000002979
EU/3/19/2136 Enzyvant Therapeutics Ireland Limited Orphan designation 26 Feb 2019 EMA/OD/0000002977
EU/3/19/2135 Enzyvant Therapeutics Ireland Limited Orphan designation 26 Feb 2019 EMA/OD/0000002975
EU/3/19/2134 FGK Representative Service GmbH Orphan designation 26 Feb 2019 EMA/OD/0000002279
EU/3/16/1674 Bellicum Pharma GmbH Transfer of orphan designation 21 Feb 2019 EMA/OD/0000004083
EU/3/16/1666 Bellicum Pharma GmbH Transfer of orphan designation 21 Feb 2019 EMA/OD/0000004057
EU/3/17/1880 Chemocentryx Ireland Limited Transfer of orphan designation 21 Feb 2019 EMA/OD/0000004221
EU/3/14/1373 Chemocentryx Ireland Limited Transfer of orphan designation 21 Feb 2019 EMA/OD/0000004220
EU/3/14/1372 Chemocentryx Ireland Limited Transfer of orphan designation 21 Feb 2019 EMA/OD/0000004218
EU/3/14/1259 Insmed Netherlands B.V. Transfer of orphan designation 21 Feb 2019 EMA/OD/0000003885
EU/3/06/387 Insmed Netherlands B.V. Transfer of orphan designation 21 Feb 2019 EMA/OD/0000003770
EU/3/10/732 Southwood Research Limited Transfer of orphan designation 21 Feb 2019 EMA/OD/0000004131
EU/3/11/888 DLRC Pharma Services Ltd Transfer of orphan designation 21 Feb 2019 EMA/OD/0000003766
EU/3/11/887 DLRC Pharma Services Ltd Transfer of orphan designation 21 Feb 2019 EMA/OD/0000003764
EU/3/11/886 DLRC Pharma Services Ltd Transfer of orphan designation 21 Feb 2019 EMA/OD/0000003767
EU/3/15/1526 Ultragenyx Netherlands B.V. Transfer of orphan designation 21 Feb 2019 EMA/OD/0000003558
EU/3/12/1091 bluebird bio (Netherlands) B.V. Transfer of orphan designation 21 Feb 2019 EMA/OD/0000003556
EU/3/12/1003 bluebird bio (Netherlands) B.V. Transfer of orphan designation 21 Feb 2019 EMA/OD/0000003636
EU/3/18/2026 Alnylam Netherlands B.V. Transfer of orphan designation 21 Feb 2019 EMA/OD/0000003989
EU/3/16/1637 Alnylam Netherlands B.V. Transfer of orphan designation 21 Feb 2019 EMA/OD/0000003680
EU/3/05/301 Taro Pharmaceuticals Europe B.V. Transfer of orphan designation 21 Feb 2019 EMA/OD/0000003835
EU/3/05/288 Teva GmbH Transfer of orphan designation 21 Feb 2019 EMA/OD/0000003804
EU/3/15/1518 Novartis Europharm Limited Transfer of orphan designation 21 Feb 2019 EMA/OD/0000003549
EU/3/12/981 Novartis Europharm Limited Transfer of orphan designation 21 Feb 2019 EMA/OD/0000003485
EU/3/10/798 Diurnal Europe B.V. Transfer of orphan designation 12 Feb 2019 EMA/OD/0000003061
EU/3/07/441 Diurnal Europe B.V. Transfer of orphan designation 12 Feb 2019 EMA/OD/0000002999
EU/3/05/296 Diurnal Europe B.V. Transfer of orphan designation 12 Feb 2019 EMA/OD/0000002750
EU/3/11/914 Quality Regulatory Clinical Ireland Limited Transfer of orphan designation 12 Feb 2019 EMA/OD/0000003741
EU/3/18/2117 Vertex Pharmaceuticals (Ireland) Limited Transfer of orphan designation 12 Feb 2019 EMA/OD/0000003788
EU/3/18/2116 Vertex Pharmaceuticals (Ireland) Limited Transfer of orphan designation 12 Feb 2019 EMA/OD/0000003732
EU/3/14/1394 Pharma Gateway AB Transfer of orphan designation 12 Feb 2019 EMA/OD/0000002720
EU/3/18/2011 Kyowa Kirin Holdings B.V. Transfer of orphan designation 12 Feb 2019 EMA/OD/0000003746
EU/3/18/2012 IDEA Innovative Drug European Associates (Ireland) Limited Transfer of orphan designation 12 Feb 2019 EMA/OD/0000003115
EU/3/11/850 IDEA Innovative Drug European Associates (Ireland) Limited Transfer of orphan designation 12 Feb 2019 EMA/OD/0000003233
EU/3/08/554 IDEA Innovative Drug European Associates (Ireland) Limited Transfer of orphan designation 12 Feb 2019 EMA/OD/0000003232
EU/3/17/1956 TxCell S.A. Transfer of orphan designation 12 Feb 2019 EMA/OD/0000003578
EU/3/17/1955 TxCell S.A. Transfer of orphan designation 12 Feb 2019 EMA/OD/0000003576
EU/3/17/1874 TxCell S.A. Transfer of orphan designation 12 Feb 2019 EMA/OD/0000003577
EU/3/17/1969 Maria Livadiotis Transfer of orphan designation 12 Feb 2019 EMA/OD/0000003568
EU/3/15/1525 Ultragenyx Netherlands B.V. Transfer of orphan designation 12 Feb 2019 EMA/OD/0000003845
EU/3/15/1524 Ultragenyx Netherlands B.V. Transfer of orphan designation 12 Feb 2019 EMA/OD/0000003772
EU/3/15/1508 Ultragenyx Netherlands B.V. Transfer of orphan designation 12 Feb 2019 EMA/OD/0000003846
EU/3/16/1656 Sellas Life Sciences Limited Transfer of orphan designation 12 Feb 2019 EMA/OD/0000003557
EU/3/16/1655 Sellas Life Sciences Limited Transfer of orphan designation 12 Feb 2019 EMA/OD/0000003572
EU/3/12/1089 Alexion Europe SAS Transfer of orphan designation 12 Feb 2019 EMA/OD/0000003805
EU/3/15/1499 Voisin Consulting S.A.R.L. Transfer of orphan designation 12 Feb 2019 EMA/OD/0000003671
EU/3/15/1534 DLRC Pharma Services Ltd Transfer of orphan designation 12 Feb 2019 EMA/OD/0000003637
EU/3/15/1529 DLRC Pharma Services Ltd Transfer of orphan designation 12 Feb 2019 EMA/OD/0000003304
EU/3/14/1290 Nightstar Europa Limited Transfer of orphan designation 12 Feb 2019 EMA/OD/0000003290
EU/3/18/1975 Nightstar Europa Limited Transfer of orphan designation 12 Feb 2019 EMA/OD/0000003405
EU/3/16/1702 Clinical Network Services (NL) B.V. Transfer of orphan designation 12 Feb 2019 EMA/OD/0000003601
EU/3/17/1840 LSK Biopharma Limited Transfer of orphan designation 12 Feb 2019 EMA/OD/0000003244
EU/3/12/1051 AstraZeneca AB Transfer of orphan designation 12 Feb 2019 EMA/OD/0000003174
EU/3/15/1478 Florence Porte Thomé Transfer of orphan designation 12 Feb 2019 EMA/OD/0000003005
EU/3/18/2099 Celgene Europe B.V. Transfer of orphan designation 12 Feb 2019 EMA/OD/0000003330
EU/3/18/2018 Celgene Europe B.V. Transfer of orphan designation 12 Feb 2019 EMA/OD/0000003327
EU/3/17/1890 Celgene Europe B.V. Transfer of orphan designation 12 Feb 2019 EMA/OD/0000003329
EU/3/12/1094 BioMarin International Limited Transfer of orphan designation 12 Feb 2019 EMA/OD/0000003587
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/3/14/1363 FarmaStrateegia OÜ Transfer of orphan designation 30 Jan 2019 EMA/OD/0000002992
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 JVM Europe B.V. 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 Ireland 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/3/16/1609 Celerion Austria GmbH Transfer of orphan designation 11 Jan 2019 EMA/OD/0000002887
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 (Ireland) Limited Orphan designation 14 Dec 2018 EMA/OD/137/18
EU/3/18/2116 Vertex Pharmaceuticals (Ireland) 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 España, S.L. Transfer of orphan designation 19 Nov 2018 EMA/OD/0000001966
EU/3/18/2102 TherAchon SAS Orphan designation 19 Nov 2018 EMA/OD/115/18
EU/3/18/2101 TMC Pharma (EU) Limited 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 B.V. 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 S-cubed Pharmaceutical Services ApS 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 Limited 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 Ireland Limited 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 Boyd Consultants Limited 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
Procedures for centrally authorised veterinary medicinal products
Product Marketing Authorisation Holder Decision Type Decision date EMEA Nr
Suvaxyn PRRS MLV Zoetis Belgium S.A. Centralised - Yearly update 11 Apr 2019
Convenia Zoetis Belgium S.A. Centralised - Yearly update 11 Apr 2019
Versican Plus Pi/L4 Zoetis Belgium S.A. Centralised - Renewal 11 Apr 2019 EMEA/V/C/3683/R/11
Versican Plus L4 Zoetis Belgium S.A. Centralised - Renewal 8 Apr 2019 EMEA/V/C/3680/R/07
Versican Plus DHPPi/L4R Zoetis Belgium S.A. Centralised - Renewal 8 Apr 2019 EMEA/V/C/2759/R/14
Versican Plus DHPPi/L4 Zoetis Belgium S.A. Centralised - Renewal 8 Apr 2019 EMEA/V/C/3678/R/13
Arti-Cell Forte Global Stem cell Technology (G.S.T.) NV Centralised - Authorisation 29 Mar 2019 EMEA/V/C/4727
Activyl Tick Plus Intervet International B.V. Centralised - Yearly update 27 Mar 2019
Versican Plus Pi Zoetis Belgium S.A. Centralised - Renewal 27 Mar 2019 EMEA/V/C/3681/R/11
Versican Plus DHPPi Zoetis Belgium S.A. Centralised - Renewal 27 Mar 2019 EMEA/V/C/3679/R/13
Loxicom Norbrook Laboratories (Ireland) Limited Centralised - Transfer Marketing Authorisation Holder 14 Mar 2019 EMEA/V/C/141/T/32
Fungitraxx Avimedical B.V. Centralised - Renewal 14 Mar 2019 EMEA/V/C/002722/R/0004
Suprelorin VIRBAC S.A. Centralised - Yearly update 12 Mar 2019
Reconcile Pegasus Laboratories Ireland Limited Centralised - Transfer Marketing Authorisation Holder 12 Mar 2019 EMEA/V/C/133/T/31
Aivlosin ECO Animal Health Europe Limited Centralised - Transfer Marketing Authorisation Holder 12 Mar 2019 EMEA/V/C/83/T/77
Melosus CP-Pharma Handelsgesellschaft mbH Centralised - 2-Monthly update 1 Mar 2019 EMEA/V/C/2001/IB/07
Prevomax Le Vet Beheer B.V. Centralised - Yearly update 1 Mar 2019
BLUEVAC BTV8 CZ Veterinaria, S.A. Centralised - Yearly update 21 Feb 2019
Zulvac BTV Zoetis Belgium S.A. Centralised - Variation 21 Feb 2019 EMEA/V/C/4185/X/01
Halagon Emdoka bvba Centralised - Yearly update 8 Feb 2019
Vaxxitek HVT + IBD Merial Centralised - Yearly update 8 Feb 2019
STARTVAC Laboratorios Hipra, S.A. 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. Corrigendum 5 Feb 2019
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 (Ireland) Limited 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 Corrigendum 19 Dec 2018
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 Europe Limited 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
Dany's BienenWohl Dany Bienenwohl GmbH Corrigendum 14 Jun 2018
Oxybee Dany Bienenwohl GmbH Corrigendum 1 Feb 2018
FORTEKOR PLUS Elanco GmbH Corrigendum 8 Sep 2015
Procedures for nationally authorised medicinal products for human use
Product Marketing Authorisation Holder Decision Type Decision date EMEA Nr
capecitabine PSUSA - Modification 11 Apr 2019 EMEA/H/C/PSUSA/531/201804
Angiotensin-II-receptor antagonists (sartans) containing a tetrazole group Referral 2 Apr 2019 EMEA/H//A-31/1471
Lutetium (177 Lu) chloride PSUSA - Modification 28 Mar 2019 EMEA/H/C/PSUSA/10390/201806
imatinib PSUSA - Modification 28 Mar 2019 EMEA/H/C/PSUSA/1725/201805
Metamizole Referral 20 Mar 2019 EMEA/H/R/A-31/1469
Quinolone and fluoroquinolone medicinal products for systemic and inhalation use Referral 11 Mar 2019 EMEA/H/A-31/1452/C/2789
Bortezomib PSUSA - Modification 20 Feb 2019 EMEA/H/C/PSUSA/00000424/201804
Efavirenz PSUSA - Modification 18 Feb 2019 EMEA/H/C//PSUSA/00001200/201804
dexmedetomidine PSUSA - Modification 18 Feb 2019 EMEA/H/C/PSUSA/998/201803
tacrolimus (systemic formulations) PSUSA - Modification 14 Feb 2019 EMEA/H/C/PSUSA/00002839/201803
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
Valproate Corrigendum 31 May 2018
Procedures for nationally authorised veterinary medicinal products
Product Marketing Authorisation Holder Decision Type Decision date EMEA Nr
Fortekor and associated names Corrigendum 6 Feb 2012