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Pharmaceuticals - Community Register

  

Newly adopted Marketing Authorisation Decisions (last six months)

Procedures for centrally authorised medicinal products for human use
Product Marketing Authorisation Holder Decision Type Decision date EMEA Nr
Rapiscan GE Healthcare AS Centralised - Transfer Marketing Authorisation Holder 11 Dec 2017 EMEA/H/C/1176/T/29
Tarceva Roche Registration Limited Centralised - 2-Monthly update 11 Dec 2017 EMEA/H/C/618/II/51
Zyclara Meda AB Centralised - 2-Monthly update 11 Dec 2017 EMEA/H/C/2387/II/13
Reyataz Bristol-Myers Squibb Pharma EEIG Centralised - 2-Monthly update 11 Dec 2017 EMEA/H/C/494/WS/1193
Holoclar Chiesi Farmaceutici S.p.A. Centralised - Annual renewal 11 Dec 2017 EMEA/H/C/2450/R/15
Odefsey Gilead Sciences International Limited Centralised - 2-Monthly update 11 Dec 2017 EMEA/H/C/4156/WS/1251
Neupro UCB Pharma S.A. PSUSA - Modification 11 Dec 2017 EMEA/H/C/PSUSA/2667/201702
Lutathera Advanced Accelerator Applications Corrigendum 11 Dec 2017
Ceplene Noventia Pharma Srl Centralised - Transfer Marketing Authorisation Holder 8 Dec 2017 EMEA/H/C/796/T/33
Esbriet Roche Registration Limited Centralised - 2-Monthly update 8 Dec 2017 EMEA/H/C/2154/II/43
Genvoya Gilead Sciences International Limited Centralised - 2-Monthly update 8 Dec 2017 EMEA/H/C/4042/II/26
Januvia Merck Sharp & Dohme Limited Centralised - 2-Monthly update 8 Dec 2017 EMEA/H/C/722/WS1211/59
Humira AbbVie Ltd Centralised - Variation 8 Dec 2017 EMEA/H/C/481/X/164
Oncaspar Baxalta Innovations GmbH Centralised - Variation 8 Dec 2017 EMEA/H/C/3789/X/8
GILENYA Novartis Europharm Limited PSUSA - Modification 8 Dec 2017 EMEA/H/C/2202/PSUSA/1393/201702
Esmya Gedeon Richter Plc. PSUSA - Modification 8 Dec 2017 EMEA/H/C/2041/PSUSA/9325/201702
Perjeta Roche Registration Limited Centralised - Renewal 8 Dec 2017 EMEA/H/C/2547/R/31
JETREA ThromboGenics NV Centralised - Renewal 8 Dec 2017 EMEA/H/C/2381/R/33
KEYTRUDA Merck Sharp & Dohme Limited PSUSA - Modification 8 Dec 2017 EMEA/H/C/3820/PSUSA/10403/201703
Tacforius Teva B.V. Centralised - Authorisation 8 Dec 2017 EMEA/H/C/4435
Truberzi Allergan Pharmaceuticals International Limited PSUSA - Modification 8 Dec 2017 EMEA/H/C/PSUSA/10528/201703
Xiapex Swedish Orphan Biovitrum AB (publ) PSUSA - Modification 8 Dec 2017 EMEA/H/C/2048/PSUSA/871/201702
Moventig Kyowa Kirin Limited PSUSA - Modification 8 Dec 2017 EMEA/H/C/PSUSA/10317/201703
Dexdor Orion Corporation PSUSA - Modification 8 Dec 2017 EMEA/H/C/2268/998/201703
Taltz Eli Lilly Nederland B.V. PSUSA - Modification 8 Dec 2017 EMEA/H/C/3943/PSUSA/10493/201703
Human IgG1 monoclonal antibody specific for human interleukin-1 alpha XBiotech XBiotech Germany GmbH Centralised - Refusal of marketing authorisation 8 Dec 2017 EMEA/H/C/4388
Thymanax Servier (Ireland) Industries Limited Centralised - Yearly update 1 Dec 2017
Hetlioz Vanda Pharmaceuticals Limited Centralised - Yearly update 1 Dec 2017
OCALIVA Intercept Pharma Ltd Centralised - Annual renewal 1 Dec 2017 EMEA/H/C/4093/R/2
Jakavi Novartis Europharm Limited PSUSA - Modification 1 Dec 2017 EMEA/H/C/2464/PSUSA/10015/201702
Alecensa Roche Registration Limited Centralised - Annual renewal 1 Dec 2017 EMEA/H/C/4164/R/7
Zepatier Merck Sharp & Dohme Limited Centralised - Yearly update 30 Nov 2017
Entacapone Orion Orion Corporation Centralised - Yearly update 28 Nov 2017
Prepandrix GlaxoSmithKline Biologicals S.A. Centralised - Renewal 28 Nov 2017 EMEA/H/C/822/R/71
Privigen CSL Behring GmbH Centralised - Renewal 28 Nov 2017 EMEA/H/C/831/R/122
Nuwiq Octapharma AB Referral 24 Nov 2017 EMEA/H/C/2813/A31/15
Advate Baxter AG Referral 24 Nov 2017 EMEA/H/C/520/A-31
Optimark Guerbet Referral 23 Nov 2017 EMEA/H/A-31/1437/C/745/34
Levemir Novo Nordisk A/S Centralised - Yearly update 16 Nov 2017
ATryn Laboratoire français du Fractionnement et des Biotechnologies Centralised - Transfer Marketing Authorisation Holder 16 Nov 2017 EMEA/H/C/587/T/31
Levetiracetam Accord Accord Healthcare Limited Centralised - Yearly update 16 Nov 2017
Cubicin Merck Sharp & Dohme Limited Centralised - 2-Monthly update 16 Nov 2017 EMEA/H/C/637/II/61
KOGENATE Bayer Bayer AG Referral 16 Nov 2017 EMEA/H/C/275/A31/185
Helixate NexGen Bayer AG Referral 16 Nov 2017 EMEA/H/C/276/A31/178
Elocta Swedish Orphan Biovitrum AB (publ) Referral 16 Nov 2017 EMEA/H/C/3964/A31/6
Taxotere Aventis Pharma S.A. PSUSA - Modification 16 Nov 2017 EMEA/H/C/73/PSUSA/1152/201611
Docetaxel Winthrop Aventis Pharma S.A. PSUSA - Modification 16 Nov 2017 EMEA/H/C/PSUSA/1152/201611
Adlumiz Helsinn Birex Pharmaceuticals Ltd Centralised - Refusal of marketing authorisation 16 Nov 2017 EMEA/H/C/3847
Zejula TESARO UK LIMITED Centralised - Authorisation 16 Nov 2017 EMEA/H/C/4249
Zydelig Gilead Sciences International Limited PSUSA - Modification 16 Nov 2017 EMEA/H/C/3843/PSUSA/10303-201701
Imvanex Bavarian Nordic A/S Centralised - Yearly update 15 Nov 2017
Emtricitabine/Tenofovir disoproxil Krka Krka d. d., Novo Mesto Centralised - 2-Monthly update 15 Nov 2017 EMEA/H/C/4215/IB/5G
Saxenda Novo Nordisk A/S Centralised - Yearly update 15 Nov 2017
Aripiprazole Accord Accord Healthcare Limited Centralised - Yearly update 15 Nov 2017
Bortezomib SUN Sun Pharmaceutical Industries Europe BV Centralised - Yearly update 15 Nov 2017
Lemtrada Genzyme Therapeutics Ltd Centralised - 2-Monthly update 15 Nov 2017 EMEA/H/C/3718/II/17
Zytiga Janssen-Cilag International NV Centralised - 2-Monthly update 15 Nov 2017 EMEA/H/C/2321/II/47
Savene Clinigen Healthcare Limited Centralised - 2-Monthly update 15 Nov 2017 EMEA/H/C/682/II/34
EVARREST Omrix Biopharmaceuticals N.V. Centralised - Withdrawal 15 Nov 2017
Viekirax AbbVie Ltd PSUSA - Modification 15 Nov 2017 EMEA/H/C/3839/PSUSA/10367/201701
Ontruzant Samsung Bioepis UK Limited Centralised - Authorisation 15 Nov 2017 EMEA/H/C/4323
Ozurdex Allergan Pharmaceuticals Ireland PSUSA - Modification 15 Nov 2017 EMEA/H/C/1140/PSUSA/985/201701
NovoEight Novo Nordisk A/S Referral 15 Nov 2017 EMEA/H/C/2719/A31/14
ReFacto AF Pfizer Limited Referral 15 Nov 2017 EMEA/H/C/232/A31/134
Voncento CSL Behring GmbH Referral 15 Nov 2017 EMEA/H/C/2493/A31/22
Kyprolis Amgen Europe B.V. PSUSA - Modification 15 Nov 2017 EMEA/H/C/PSUSA/10448/201701
Imatinib Teva B.V. Teva B.V. Centralised - Authorisation 15 Nov 2017 EMEA/H/C/4748
Elebrato Ellipta GlaxoSmithKline Trading Services Limited Centralised - Authorisation 15 Nov 2017 EMEA/H/C/4781
Trelegy Ellipta GlaxoSmithKline Trading Services Limited Centralised - Authorisation 15 Nov 2017 EMEA/H/C/4363
Tasigna Novartis Europharm Limited Centralised - Variation 15 Nov 2017 EMEA/H/C/798/X/88/G
Tandemact Takeda Pharma A/S Centralised - Yearly update 10 Nov 2017
Mepact Takeda France SAS Centralised - Yearly update 10 Nov 2017
Kolbam Retrophin Europe Limited Centralised - Yearly update 10 Nov 2017
Ovitrelle Merck Serono Europe Limited Centralised - Yearly update 10 Nov 2017
Valdoxan Les Laboratoires Servier Centralised - Yearly update 10 Nov 2017
Prevenar Pfizer Limited Centralised - Withdrawal 10 Nov 2017
Revatio Pfizer Limited Centralised - Yearly update 10 Nov 2017
Faslodex AstraZeneca UK Limited Centralised - 2-Monthly update 10 Nov 2017 EMEA/H/C/540/II/59
BYDUREON AstraZeneca AB Centralised - 2-Monthly update 10 Nov 2017 EMEA/H/C/2020/II/45
Emtricitabine /Tenofovir disoproxil Krka d.d. Krka d. d., Novo Mesto Centralised - 2-Monthly update 10 Nov 2017 EMEA/H/C/4686/IB/2/G
Pegasys Roche Registration Limited Centralised - 2-Monthly update 10 Nov 2017 EMEA/H/C/395/II/91
ellaOne Laboratoire HRA Pharma Centralised - Variation 10 Nov 2017 EMEA/H/C/1027/X/45
Glubrava Takeda Pharma A/S Centralised - Renewal 10 Nov 2017 EMEA/H/C/893/R/54
Cyltezo Boehringer Ingelheim International GmbH Centralised - Authorisation 10 Nov 2017 EMEA/H/C/4319
Ritonavir Mylan Mylan S.A.S. Centralised - Authorisation 10 Nov 2017 EMEA/H/C/4549
Benlysta Glaxo Group Ltd Centralised - Variation 10 Nov 2017 EMEA/H/C/2015/X/46G
Exviera AbbVie Ltd PSUSA - Modification 10 Nov 2017 EMEA/H/C/3837/PSUSA/10363/201701
Selincro H. Lundbeck A/S Centralised - Renewal 10 Nov 2017 EMEA/H/C/2583/R/22
APTIVUS Boehringer Ingelheim International GmbH PSUSA - Modification 10 Nov 2017 EMEA/H/C/PSUSA/2973/201612
Nyxoid Mundipharma Corporation Limited Centralised - Authorisation 10 Nov 2017 EMEA/H/C/4325
Kovaltry Bayer AG Referral 10 Nov 2017 EMEA/H/C/3825/A31/4
Humira AbbVie Ltd PSUSA - Modification 10 Nov 2017 EMEA/H/C/481/PSUSA/57/201612
Teysuno Nordic Group B.V. PSUSA - Modification 10 Nov 2017 EMEA/H/C/PSUSA/2875/201701
TOOKAD Steba Biotech S.A Centralised - Authorisation 10 Nov 2017 EMEA/H/C/4182
Zubsolv Mundipharma Corporation Limited Centralised - Authorisation 10 Nov 2017 EMEA/H/C/4407
Iblias Bayer AG Referral 10 Nov 2017 EMEA/H/C/4147/A31
VeraSeal Instituto Grifols, S.A. Centralised - Authorisation 10 Nov 2017 EMEA/H/C/4446
Miglustat Gen.Orph Gen.Orph Centralised - Authorisation 10 Nov 2017 EMEA/H/C/4366
Tremfya Janssen-Cilag International NV Centralised - Authorisation 10 Nov 2017 EMEA/H/C/4271
Plegridy Biogen Idec Limited PSUSA - Modification 10 Nov 2017 EMEA/H/C/PSUSA/10275/201701
Exjade Novartis Europharm Limited Centralised - Variation 10 Nov 2017 EMEA/H/C/670/X/54
ADCETRIS Takeda Pharma A/S Centralised - Annual renewal 10 Nov 2017 EMEA/H/C/2455/R/51
NexoBrid MediWound Germany GmbH Centralised - Renewal 10 Nov 2017 EMEA/H/C/2246/R/31
Competact Takeda Pharma A/S Centralised - Yearly update 30 Oct 2017
Epclusa Gilead Sciences International Ltd. Centralised - Yearly update 30 Oct 2017
Tarceva Roche Registration Limited Centralised - Yearly update 30 Oct 2017
Multaq Sanofi-Aventis groupe Centralised - Yearly update 30 Oct 2017
Ultibro Breezhaler Novartis Europharm Limited Centralised - Yearly update 30 Oct 2017
Fortacin Recordati Ireland Ltd. Centralised - Transfer Marketing Authorisation Holder 30 Oct 2017 EMEA/H/C/2693/T/19
Ibandronic Acid Teva Teva B.V. Centralised - Yearly update 30 Oct 2017
Firdapse BioMarin Europe Ltd. Centralised - Yearly update 30 Oct 2017
Venclyxto AbbVie Ltd Centralised - Annual renewal 30 Oct 2017 EMEA/H/C/4106/R/5
Menveo GSK Vaccines S.r.l. Rectificative Decision 30 Oct 2017
Instanyl Takeda Pharma A/S Centralised - Yearly update 23 Oct 2017
Olanzapine Glenmark Europe Glenmark Pharmaceuticals Europe Limited Centralised - Yearly update 23 Oct 2017
Olanzapine Glenmark Glenmark Pharmaceuticals Europe Limited Centralised - Yearly update 23 Oct 2017
Levetiracetam Actavis Group Actavis Group PTC ehf. Centralised - Yearly update 23 Oct 2017
Giotrif Boehringer Ingelheim International GmbH Centralised - Yearly update 23 Oct 2017
Prevenar 13 Pfizer Limited Centralised - Yearly update 23 Oct 2017
Liprolog Eli Lilly Nederland B.V. Centralised - 2-Monthly update 23 Oct 2017 EMEA/H/C/393/WS/1158/G
Revestive Shire Pharmaceuticals Ireland Limited Centralised - 2-Monthly update 19 Oct 2017 EMEA/H/C/2345/II/37
Firazyr Shire Orphan Therapies GmbH Centralised - 2-Monthly update 19 Oct 2017 EMEA/H/C/899/II/34/G
Xarelto Bayer AG Centralised - 2-Monthly update 19 Oct 2017 EMEA/H/C/944/II/52/G
Yondelis Pharma Mar S.A. Centralised - 2-Monthly update 19 Oct 2017 EMEA/H/C/773/II/51
Mozobil Genzyme Europe B.V. Centralised - 2-Monthly update 19 Oct 2017 EMEA/H/C/1030/II/32
Stribild Gilead Sciences International Limited Centralised - 2-Monthly update 19 Oct 2017 EMEA/H/C/2574/II/79
Humalog Eli Lilly Nederland B.V. Centralised - 2-Monthly update 19 Oct 2017 EMEA/H/C/88/WS/1158/G
Pradaxa Boehringer Ingelheim International GmbH Centralised - 2-Monthly update 19 Oct 2017 EMEA/H/C/829/II/103
Opdivo Bristol-Myers Squibb Pharma EEIG Centralised - 2-Monthly update 19 Oct 2017 EMEA/H/C/3985/II/32
Emend Merck Sharp & Dohme Limited Centralised - 2-Monthly update 19 Oct 2017 EMEA/H/C/527/II/55
Ulunar Breezhaler Novartis Europharm Limited Centralised - Yearly update 13 Oct 2017
JETREA ThromboGenics NV Centralised - Yearly update 13 Oct 2017
Amlodipine/Valsartan Mylan Mylan S.A.S. Centralised - Yearly update 13 Oct 2017
Wakix Bioprojet Pharma Centralised - 2-Monthly update 13 Oct 2017 EMEA/H/C/2616/II/4/G
Twinrix Paediatric GlaxoSmithKline Biologicals S.A. Centralised - Yearly update 13 Oct 2017
Emtricitabine/Tenofovir disoproxil Zentiva Zentiva, k.s. Centralised - 2-Monthly update 13 Oct 2017 EMEA/H/C/4137/IB/2/G
Erivedge Roche Registration Limited Centralised - Yearly update 9 Oct 2017
Ambirix GlaxoSmithKline Biologicals S.A. Centralised - Yearly update 9 Oct 2017
Twinrix Adult GlaxoSmithKline Biologicals S.A. Centralised - Yearly update 4 Oct 2017
Empliciti Bristol-Myers Squibb Pharma EEIG Centralised - Yearly update 4 Oct 2017
LIFMIOR Pfizer Limited Rectificative Decision 4 Oct 2017
Ristaben Merck Sharp & Dohme Limited Centralised - Yearly update 3 Oct 2017
Beromun Boehringer Ingelheim International GmbH Centralised - Yearly update 3 Oct 2017
Lantus Sanofi-Aventis Deutschland GmbH Centralised - Yearly update 3 Oct 2017
Toujeo Sanofi-Aventis Deutschland GmbH Centralised - Yearly update 3 Oct 2017
Zoely Teva B.V. Centralised - Yearly update 3 Oct 2017
Synflorix GlaxoSmithKline Biologicals S.A. Centralised - Yearly update 3 Oct 2017
Ristempa Amgen Europe B.V. Centralised - Withdrawal 28 Sep 2017
Neupro UCB Pharma S.A. Centralised - Transfer Marketing Authorisation Holder 28 Sep 2017 EMEA/H/C/626/T/80
Revolade Novartis Europharm Limited Referral - Decision addressed to Member States 28 Sep 2017 EMEA/H/C/PSUSA/1205/201609
Ristempa Amgen Europe B.V. Centralised - Yearly update 26 Sep 2017
Xoterna Breezhaler Novartis Europharm Limited Centralised - Yearly update 26 Sep 2017
TachoSil Takeda Austria GmbH Centralised - Yearly update 26 Sep 2017
Stayveer Marklas Nederland B.V. PSUSA - Modification 26 Sep 2017 EMEA/H/C/2644/425/201611
Tracleer Actelion Registration Ltd PSUSA - Modification 26 Sep 2017 EMEA/H/C/PSUSA/425/201611
Onbrez Breezhaler Novartis Europharm Limited PSUSA - Modification 26 Sep 2017 EMEA/H/C/PSUSA/1730/201611
Hirobriz Breezhaler Novartis Europharm Limited PSUSA - Modification 26 Sep 2017 EMEA/H/C/PSUSA/1730/201611
Entecavir Accord Accord Healthcare Limited Centralised - Authorisation 26 Sep 2017 EMEA/H/C/4458
Dupixent Sanofi-Aventis groupe Centralised - Authorisation 26 Sep 2017 EMEA/H/C/4390
Lutathera Advanced Accelerator Applications Centralised - Authorisation 26 Sep 2017 EMEA/H/C/4123
Revinty Ellipta Glaxo Group Ltd Centralised - Yearly update 21 Sep 2017
Relvar Ellipta Glaxo Group Ltd Centralised - Yearly update 21 Sep 2017
Plenadren Shire Services BVBA Centralised - Yearly update 21 Sep 2017
Lenvima Eisai Europe Limited Centralised - Yearly update 21 Sep 2017
Xtandi Astellas Pharma Europe B.V. Centralised - Variation 21 Sep 2017 EMEA/H/C/2639/X/29
Symtuza Janssen-Cilag International NV Centralised - Authorisation 21 Sep 2017 EMEA/H/C/4391
Tecentriq Roche Registration Limited Centralised - Authorisation 21 Sep 2017 EMEA/H/C/4143
Iclusig Incyte Biosciences UK Ltd PSUSA - Modification 21 Sep 2017 EMEA/H/C/PSUSA/10128/201612
EndolucinBeta ITG Isotope Technologies Garching GmbH PSUSA - Modification 21 Sep 2017 EMEA/H/C/PSUSA/10391/201612
Lartruvo Eli Lilly Nederland B.V. Centralised - Annual renewal 21 Sep 2017 EMEA/H/C/4216/R/4
ZALTRAP Sanofi-Aventis groupe Centralised - Renewal 21 Sep 2017 EMEA/H/C/2532/R/37
Amyvid Eli Lilly Nederland B.V. Centralised - Renewal 21 Sep 2017 EMEA/H/C/2422/R/26
Ryzodeg Novo Nordisk A/S Centralised - Renewal 21 Sep 2017 EMEA/H/C/2499/R/24
Tresiba Novo Nordisk A/S Centralised - Renewal 21 Sep 2017 EMEA/H/C/2498/R/27
Nivestim Hospira UK Limited Centralised - Yearly update 18 Sep 2017
NovoRapid Novo Nordisk A/S Centralised - Yearly update 18 Sep 2017
Abseamed Medice Arzneimittel Pütter GmbH & Co KG Centralised - Yearly update 18 Sep 2017
Zypadhera Eli Lilly Nederland B.V. Centralised - Yearly update 18 Sep 2017
Gazyvaro Roche Registration Limited Centralised - Variation 18 Sep 2017 EMEA/H/C/2799/II/16
RoActemra Roche Registration Limited Centralised - 2-Monthly update 18 Sep 2017 EMEA/H/C/955/II/66
Zebinix Bial - Portela & CŞ, SA Centralised - 2-Monthly update 18 Sep 2017 EMEA/H/C/988/IB/63/G
Retacrit Hospira UK Limited Centralised - Yearly update 18 Sep 2017
Ibandronic acid Accord Accord Healthcare Limited Centralised - Renewal 18 Sep 2017 EMEA/H/C/2638/R/13
Opdivo Bristol-Myers Squibb Pharma EEIG PSUSA - Modification 18 Sep 2017 EMEA/H/C/PSUSA/10379/201701
Blincyto Amgen Europe B.V. PSUSA - Modification 18 Sep 2017 EMEA/H/C/PSUSA/10460/201612
Prolia Amgen Europe B.V. Centralised - Variation 18 Sep 2017 EMEA/H/C/1120/X/59/G
Samsca Otsuka Pharmaceutical Europe Ltd. Centralised - Variation 18 Sep 2017 EMEA/H/C/980/X/24
Xgeva Amgen Europe B.V. Centralised - Variation 18 Sep 2017 EMEA/H/C/2173/X/48/G
Mozobil Genzyme Europe B.V. PSUSA - Modification 18 Sep 2017 EMEA/H/C/1030/PSUSA/2451/201612
Oslif Breezhaler Novartis Europharm Limited PSUSA - Modification 18 Sep 2017 EMEA/H/C/1210
Signifor Novartis Europharm Limited Centralised - Variation 18 Sep 2017 EMEA/H/C/2052/X/30/G
Lacosamide Accord Accord Healthcare Limited Centralised - Authorisation 18 Sep 2017 EMEA/H/C/4443
Ninlaro Takeda Pharma A/S Centralised - Annual renewal 18 Sep 2017 EMEA/H/C/3844/R/3
Lyxumia Sanofi-Aventis groupe Centralised - Renewal 18 Sep 2017 EMEA/H/C/2445/R/23
Betmiga Astellas Pharma Europe B.V. Centralised - Renewal 18 Sep 2017 EMEA/H/C/2388/R/26
Rydapt Novartis Europharm Limited Centralised - Authorisation 18 Sep 2017 EMEA/H/C/4095
Lumark IDB Holland B.V. PSUSA - Modification 18 Sep 2017 EMEA/H/C/PSUSA/10391/201612
Bavencio Merck Serono Europe Limited Centralised - Authorisation 18 Sep 2017 EMEA/H/C/4338
Entecavir Mylan Mylan S.A.S. Centralised - Authorisation 18 Sep 2017 EMEA/H/C/4377
Xermelo Ipsen Pharma Centralised - Authorisation 18 Sep 2017 EMEA/H/C/3937
Bexsero GlaxoSmithKline Vaccines S.r.l. Centralised - Renewal 18 Sep 2017 EMEA/H/C/2333/R/53
Imatinib Teva Teva B.V. Centralised - Renewal 18 Sep 2017 EMEA/H/C/2585/R/28
NexoBrid MediWound Germany GmbH PSUSA - Modification 18 Sep 2017 EMEA/H/C/PSUSA/10028/201612
Revlimid Celgene Europe Limited PSUSA - Modification 18 Sep 2017 EMEA/H/C/PSUSA/1838/201612
Lynparza AstraZeneca AB PSUSA - Modification 18 Sep 2017 EMEA/H/C/PSUSA/10322/201612
RotaTeq MSD VACCINS PSUSA - Modification 18 Sep 2017 EMEA/H/C/PSUSA/2666/201611
Vimpat UCB Pharma S.A. Corrigendum 14 Sep 2017
Angiox The Medicines Company UK Ltd Centralised - Yearly update 14 Sep 2017
Eurartesim Alfasigma S.p.A. Centralised - Transfer Marketing Authorisation Holder 14 Sep 2017 EMEA/H/C/1199/T/29
Wakix Bioprojet Pharma Centralised - Yearly update 14 Sep 2017
Ebixa H. Lundbeck A/S Centralised - Yearly update 14 Sep 2017
Olazax Disperzi Glenmark Pharmaceuticals s.r.o. Centralised - Yearly update 14 Sep 2017
Ifirmasta Krka d. d., Novo Mesto Centralised - Yearly update 14 Sep 2017
Vimpat UCB Pharma S.A. Centralised - 2-Monthly update 14 Sep 2017 EMEA/H/C/863/II/65/G
Olanzapine Apotex Apotex Europe B.V. Centralised - Yearly update 14 Sep 2017
Trevicta Janssen-Cilag International NV Centralised - Yearly update 14 Sep 2017
Glidipion Actavis Group PTC ehf. Centralised - Yearly update 14 Sep 2017
Sovaldi Gilead Sciences International Limited Centralised - 2-Monthly update 14 Sep 2017 EMEA/H/C/2798/II/36
Januvia Merck Sharp & Dohme Limited Centralised - Yearly update 11 Sep 2017
Ventavis Bayer Pharma AG Centralised - Yearly update 11 Sep 2017
Votrient Novartis Europharm Limited Centralised - Yearly update 11 Sep 2017
Simponi Janssen Biologics B.V. Centralised - Yearly update 11 Sep 2017
Jinarc Otsuka Pharmaceutical Europe Ltd. Centralised - Yearly update 11 Sep 2017
Protelos Les Laboratoires Servier Centralised - Yearly update 11 Sep 2017
Osseor Les Laboratoires Servier Centralised - Yearly update 11 Sep 2017
Zerit Bristol-Myers Squibb Pharma EEIG Centralised - Yearly update 11 Sep 2017
Tesavel Merck Sharp & Dohme Limited Centralised - Yearly update 11 Sep 2017
Xelevia Merck Sharp & Dohme Limited Centralised - Yearly update 11 Sep 2017
Zyprexa Eli Lilly Nederland B.V. Centralised - Yearly update 11 Sep 2017
Tysabri Biogen Idec Limited Centralised - Yearly update 11 Sep 2017
Methylthioninium chloride Proveblue Provepharm S.A.S. Centralised - Yearly update 11 Sep 2017
Infanrix hexa GlaxoSmithKline Biologicals S.A. Centralised - Yearly update 11 Sep 2017
Neparvis Novartis Europharm Limited Centralised - Yearly update 11 Sep 2017
Epoetin alfa Hexal Hexal AG Centralised - Yearly update 7 Sep 2017
Binocrit Sandoz GmbH Centralised - Yearly update 7 Sep 2017
Taltz Eli Lilly Nederland B.V. Centralised - Yearly update 7 Sep 2017
Fexeric Keryx Biopharma UK Ltd. Centralised - Yearly update 7 Sep 2017
Intanza Sanofi Pasteur Europe Centralised - Variation 7 Sep 2017 EMEA/H/C/957/II/54
Olazax Glenmark Pharmaceuticals s.r.o. Centralised - Yearly update 5 Sep 2017
Thorinane Techdow Pharma Netherlands B.V. Centralised - Transfer Marketing Authorisation Holder 5 Sep 2017 EMEA/H/C/3795/T/3
Humira AbbVie Ltd Centralised - 2-Monthly update 5 Sep 2017 EMEA/H/C/481/II/163
Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan Mylan S.A.S. Centralised - Authorisation 5 Sep 2017 EMEA/H/C/4240
Cuprior gmp-orphan SA Centralised - Authorisation 5 Sep 2017 EMEA/H/C/4005
Zinbryta Biogen Idec Limited Rectificative Decision 29 Aug 2017
Rasilez HCT Noden Pharma DAC Centralised - Transfer Marketing Authorisation Holder 28 Aug 2017 EMEA/H/C/964/T/82
Irbesartan HCT Zentiva Sanofi-Aventis groupe PSUSA - Modification 28 Aug 2017 EMEA/H/C/783/PSUSA/1653/201609
Mimpara Amgen Europe B.V. Centralised - Variation 28 Aug 2017 EMEA/H/C/570/X/55/G
Ecalta Pfizer Limited Centralised - Renewal 28 Aug 2017 EMEA/H/C/788/R/33
Forxiga AstraZeneca AB Centralised - Renewal 28 Aug 2017 EMEA/H/C/2322/R/35
Constella Allergan Pharmaceuticals International Limited Centralised - Renewal 28 Aug 2017 EMEA/H/C/2490/R/32
Aranesp Amgen Europe B.V. Centralised - 2-Monthly update 24 Aug 2017 EMEA/H/C/332/II/141
Fluenz Tetra AstraZeneca AB Centralised - Variation 24 Aug 2017 EMEA/H/C/2617/II/72
Invega Janssen-Cilag International NV Centralised - 2-Monthly update 24 Aug 2017 EMEA/H/C/746/II/56/G
Norvir AbbVie Ltd Centralised - 2-Monthly update 24 Aug 2017 EMEA/H/C/127/II/147
Kaletra AbbVie Ltd Centralised - 2-Monthly update 24 Aug 2017 EMEA/H/C/368/WS/1178
BYDUREON AstraZeneca AB Centralised - 2-Monthly update 24 Aug 2017 EMEA/H/C/2020/II/41
Dacogen Janssen-Cilag International NV Centralised - 2-Monthly update 24 Aug 2017 EMEA/H/C/2221/II/31
KEYTRUDA Merck Sharp & Dohme Limited Centralised - 2-Monthly update 24 Aug 2017 EMEA/H/C/3820/II/23/G
EDURANT Janssen-Cilag International NV Centralised - 2-Monthly update 24 Aug 2017 EMEA/H/C/2264/II/24
Karvezide Sanofi-Aventis groupe PSUSA - Modification 24 Aug 2017 EMEA/H/C/PSUSA/1653/201609
Imraldi Samsung Bioepis UK Limited Centralised - Authorisation 24 Aug 2017 EMEA/H/C/4279
Skilarence Almirall, S.A. Rectificative Decision 24 Aug 2017
Orkambi Vertex Pharmaceuticals (Europe) Limited PSUSA - Modification 24 Aug 2017 EMEA/H/C/PSUSA/10455/201611
Zoledronic acid Hospira Hospira UK Limited Centralised - Renewal 24 Aug 2017 EMEA/H/C/2365/R/26
Ruconest Pharming Group N.V. PSUSA - Modification 24 Aug 2017 EMEA/H/C/PSUSA/873/201610
IMBRUVICA Janssen-Cilag International NV PSUSA - Modification 24 Aug 2017 EMEA/H/C/PSUSA/10301/201611
Nitisinone MDK MendeliKABS Europe Limited Centralised - Authorisation 24 Aug 2017 EMEA/H/C/4281
Fotivda EUSA Pharma (UK) Limited Centralised - Authorisation 24 Aug 2017 EMEA/H/C/4131
SonoVue Bracco International B.V. Corrigendum 22 Aug 2017
MAVENCLAD Merck Serono Europe Limited Corrigendum 22 Aug 2017
MAVENCLAD Merck Serono Europe Limited Corrigendum 22 Aug 2017
Rasilez Noden Pharma DAC Centralised - Transfer Marketing Authorisation Holder 22 Aug 2017 EMEA/H/C/780/T/114
Xarelto Bayer AG Centralised - 2-Monthly update 22 Aug 2017 EMEA/H/C/944/II/50
CoAprovel Sanofi Clir SNC PSUSA - Modification 22 Aug 2017 EMEA/H/C/222//PSUSA/1653/201609
SonoVue Bracco International B.V. Centralised - Variation 22 Aug 2017 EMEA/H/C/303/X/34
Ketoconazole HRA Laboratoire HRA Pharma PSUSA - Modification 22 Aug 2017 EMEA/H/C/EMEA/H/C/3906/10316/201611
MAVENCLAD Merck Serono Europe Limited Centralised - Authorisation 22 Aug 2017 EMEA/H/C/4230
Kisqali Novartis Europharm Limited Centralised - Authorisation 22 Aug 2017 EMEA/H/C/4213
Xofigo Bayer AG PSUSA - Modification 14 Aug 2017 EMEA/H/C/2653/PSUSA/10132/201611
Soliris Alexion Europe SAS Centralised - 2-Monthly update 14 Aug 2017 EMEA/H/C/791/II/90
Mekinist Novartis Europharm Limited PSUSA - Modification 14 Aug 2017 EMEA/H/C/PSUSA/10262/201611
Vargatef Boehringer Ingelheim International GmbH PSUSA - Modification 14 Aug 2017 EMEA/H/C/PSUSA/10318/201611
Exjade Novartis Europharm Limited PSUSA - Modification 14 Aug 2017 EMEA/H/C/PSUSA/939/201610
Nordimet Nordic Group B.V. Centralised - Yearly update 7 Aug 2017
Stivarga Bayer AG Centralised - Transfer Marketing Authorisation Holder 7 Aug 2017 EMEA/H/C/2573/T/23
Colobreathe Teva B.V. Centralised - Transfer Marketing Authorisation Holder 7 Aug 2017 EMEA/H/C/1225/T/28
Abilify Otsuka Pharmaceutical Europe Ltd. Centralised - Yearly update 3 Aug 2017
Apidra Sanofi-Aventis Deutschland GmbH Centralised - Yearly update 3 Aug 2017
Zyllt Krka d. d., Novo Mesto Centralised - 2-Monthly update 2 Aug 2017 EMEA/H/C/1058/IB/29/G
Stivarga Bayer AG Centralised - 2-Monthly update 2 Aug 2017 EMEA/H/C/2573/II/20
Bridion Merck Sharp & Dohme Limited Centralised - Yearly update 26 Jul 2017
Aripiprazole Mylan Pharma Mylan S.A.S. Centralised - Yearly update 26 Jul 2017
Velphoro Vifor Fresenius Medical Care Renal Pharma France Centralised - Yearly update 26 Jul 2017
Oprymea Krka d. d., Novo Mesto Centralised - Yearly update 26 Jul 2017
Yellox PharmaSwiss Ceská republika s.r.o. Centralised - Yearly update 26 Jul 2017
Maviret AbbVie Ltd Centralised - Authorisation 26 Jul 2017 EMEA/H/C/4430
Vosevi Gilead Sciences International Limited Centralised - Authorisation 26 Jul 2017 EMEA/H/C/4350
Votubia Novartis Europharm Limited Centralised - 2-Monthly update 26 Jul 2017 EMEA/H/C/2311/II/44
Kaletra AbbVie Ltd Centralised - 2-Monthly update 26 Jul 2017 EMEA/H/C/368/II/161/G
Tovanor Breezhaler Novartis Europharm Limited Centralised - Renewal 26 Jul 2017 EMEA/H/C/2690/R/22
Zykadia Novartis Europharm Limited Centralised - Authorisation - Switch to non-conditional 26 Jul 2017 EMEA/H/C/3819/II/10
Olanzapine Mylan Generics [UK] Limited Centralised - Yearly update 25 Jul 2017
Granupas Lucane Pharma Centralised - Yearly update 25 Jul 2017
Victoza Novo Nordisk A/S Centralised - 2-Monthly update 25 Jul 2017 EMEA/H/C/1026/II/42
Rivastigmine 1 A Pharma 1 A Pharma GmbH Centralised - Yearly update 25 Jul 2017
Faslodex AstraZeneca UK Limited Centralised - 2-Monthly update 25 Jul 2017 EMEA/H/C/540/II/57
Voncento CSL Behring GmbH Centralised - 2-Monthly update 25 Jul 2017 EMEA/H/C/2493/II/17/G
Orencia Bristol-Myers Squibb Pharma EEIG Centralised - 2-Monthly update 25 Jul 2017 EMEA/H/C/701/II/105
Harvoni Gilead Sciences International Limited Centralised - 2-Monthly update 19 Jul 2017 EMEA/H/C/3850/II/39
Clopidogrel Krka Krka d. d., Novo Mesto Centralised - 2-Monthly update 19 Jul 2017 EMEA/H/C/1056/IB/29/G
Qtern AstraZeneca AB Centralised - 2-Monthly update 19 Jul 2017 EMEA/H/C/4057/IB/7
Grepid Pharmathen S.A. Centralised - 2-Monthly update 19 Jul 2017 EMEA/H/C/1059/IB/40/G
Repso Teva B.V. Centralised - Withdrawal 19 Jul 2017
Zavesca Actelion Registration Ltd Centralised - Yearly update 19 Jul 2017
Zavicefta Pfizer Ireland Pharmaceuticals Centralised - Transfer Marketing Authorisation Holder 19 Jul 2017 EMEA/H/C/4027/T/6
Enzepi Allergan Pharmaceuticals International Limited Centralised - Withdrawal 19 Jul 2017
Tracleer Actelion Registration Ltd Centralised - Yearly update 19 Jul 2017
Clopidogrel TAD TAD Pharma GmbH Centralised - 2-Monthly update 19 Jul 2017 EMEA/H/C/1136/IB/28/G
Raxone Santhera Pharmaceuticals (Deutschland) GmbH Centralised - Yearly update 19 Jul 2017
Clopidogrel BGR Laboratoires BIOGARAN Centralised - 2-Monthly update 19 Jul 2017 EMEA/H/C/1138/IB/31/G
Cuprymina SPARKLE S.r.l. Centralised - Renewal 19 Jul 2017 EMEA/H/C/2136/R/14
Synjardy Boehringer Ingelheim International GmbH PSUSA - Modification 19 Jul 2017 EMEA/H/C/PSUSA/10388/201610
Ofev Boehringer Ingelheim International GmbH PSUSA - Modification 19 Jul 2017 EMEA/H/C/PSUSA/10319/201610
Revolade Novartis Europharm Limited PSUSA - Modification 19 Jul 2017 EMEA/H/C/PSUSA/1205/201609
Forxiga AstraZeneca AB PSUSA - Modification 19 Jul 2017 EMEA/H/C/PSUSA/10029/201610
Seebri Breezhaler Novartis Europharm Limited Centralised - Renewal 19 Jul 2017 EMEA/H/C/2430/R/20
Insulin lispro Sanofi Sanofi-Aventis groupe Centralised - Authorisation 19 Jul 2017 EMEA/H/C/4303
Veltassa Vifor Fresenius Medical Care Renal Pharma France Centralised - Authorisation 19 Jul 2017 EMEA/H/C/4180
Jardiance Boehringer Ingelheim International GmbH PSUSA - Modification 19 Jul 2017 EMEA/H/C/PSUSA/10388/201610
Rivastigmine Sandoz Sandoz GmbH Centralised - Yearly update 17 Jul 2017
Qarziba EUSA Pharma (UK) Limited Centralised - Transfer Marketing Authorisation Holder 17 Jul 2017 EMEA/H/C/3918/T/1
Opsumit Actelion Registration Ltd Centralised - Yearly update 17 Jul 2017
Zinforo Pfizer Ireland Pharmaceuticals Centralised - Transfer Marketing Authorisation Holder 17 Jul 2017 EMEA/H/C/2252/T/34
Thorinane Techdow Pharma Netherlands B.V. Centralised - 2-Monthly update 17 Jul 2017 EMEA/H/C/3795/IB/2
Inhixa Techdow Europe AB Centralised - 2-Monthly update 17 Jul 2017 EMEA/H/C/4264/IB/14/G
Trimbow Chiesi Farmaceutici S.p.A. Centralised - Authorisation 17 Jul 2017 EMEA/H/C/4257
Kyntheum Leo Pharma A/S Centralised - Authorisation 17 Jul 2017 EMEA/H/C/3959
Efavirenz/Emtricitabine/Tenofovir disoproxil Zentiva Zentiva, k.s. Centralised - Authorisation 17 Jul 2017 EMEA/H/C/4250
Zinbryta Biogen Idec Limited Referral 14 Jul 2017 EMEA/H/A-20/1456/C/3862/10
Enurev Breezhaler Novartis Europharm Limited Corrigendum 13 Jul 2017
Zevalin Spectrum Pharmaceuticals B.V. Rectificative Decision 13 Jul 2017
Praxbind Boehringer Ingelheim International GmbH Centralised - Yearly update 13 Jul 2017
Zoledronic acid Accord Accord Healthcare Limited Centralised - Yearly update 13 Jul 2017
Xultophy Novo Nordisk A/S PSUSA - Modification 13 Jul 2017 EMEA/H/C/PSUSA/10272/201609
Rituzena Celltrion Healthcare Hungary Kft. Centralised - Authorisation 13 Jul 2017 EMEA/H/C/4724
Reagila Gedeon Richter Plc. Centralised - Authorisation 13 Jul 2017 EMEA/H/C/2770
Lixiana Daiichi Sankyo Europe GmbH PSUSA - Modification 13 Jul 2017 EMEA/H/C/2629/PSUSA/10387/201610
Memantine Merz Merz Pharmaceuticals GmbH Centralised - Renewal 13 Jul 2017 EMEA/H/C/2711/R/12
Zalmoxis MolMed S.p.A. Centralised - Annual renewal 13 Jul 2017 EMEA/H/C/2801/R/3
Enurev Breezhaler Novartis Europharm Limited Centralised - Renewal 13 Jul 2017 EMEA/H/C/2691/R/20
Isentress Merck Sharp & Dohme Limited Centralised - Variation 13 Jul 2017 EMEA/H/C/860/X/59
Xaluprine Nova Laboratories Limited PSUSA - Modification 13 Jul 2017 EMEA/H/C/PSUSA/1988/201609
Kuvan BioMarin International Limited Centralised - Variation 13 Jul 2017 EMEA/H/C/943/X/47
Blitzima Celltrion Healthcare Hungary Kft. Centralised - Authorisation 13 Jul 2017 EMEA/H/C/4723
Torisel Pfizer Limited Centralised - Renewal 13 Jul 2017 EMEA/H/C/799/R/65
Ritemvia Celltrion Healthcare Hungary Kft. Centralised - Authorisation 13 Jul 2017 EMEA/H/C/4725
Latuda Sunovion Pharmaceuticals Europe Ltd PSUSA - Modification 13 Jul 2017 EMEA/H/C/PSUSA/10114/201610
Eylea Bayer AG Centralised - Renewal 13 Jul 2017 EMEA/H/C/2392/R/33
Picato LEO Laboratories Ltd. Centralised - Renewal 13 Jul 2017 EMEA/H/C/2275/R/23
Incruse Glaxo Group Ltd PSUSA - Modification 13 Jul 2017 EMEA/H/C/PSUSA/10263/201610
Edistride AstraZeneca AB PSUSA - Modification 13 Jul 2017 EMEA/H/C/PSUSA/10029/201610
Memantine Accord Accord Healthcare Limited Centralised - Yearly update 10 Jul 2017
Xeloda Roche Registration Limited Centralised - Yearly update 10 Jul 2017
Spherox CO.DON AG Centralised - Authorisation 10 Jul 2017 EMEA/H/C/2736
Myozyme Genzyme Europe B.V. PSUSA - Modification 10 Jul 2017 EMEA/H/C/PSUSA/86/201609
Nexavar Bayer AG Centralised - Transfer Marketing Authorisation Holder 6 Jul 2017 EMEA/H/C/690/T/42
Toviaz Pfizer Limited Centralised - Yearly update 6 Jul 2017
Kivexa ViiV Healthcare UK Limited Centralised - Yearly update 6 Jul 2017
Imlygic Amgen Europe B.V. Centralised - Yearly update 6 Jul 2017
OXERVATE Dompé farmaceutici S.p.A. Centralised - Authorisation 6 Jul 2017 EMEA/H/C/4209
Clopidogrel Krka d.d. Krka d. d., Novo Mesto Centralised - 2-Monthly update 6 Jul 2017 EMEA/H/C/1137/IB/24/G
Celsentri ViiV Healthcare UK Limited Centralised - Variation 6 Jul 2017 EMEA/H/C/811/X/46/G
Xyrem UCB Pharma Ltd Centralised - Yearly update 29 Jun 2017
IKERVIS Santen Oy Centralised - Yearly update 29 Jun 2017
Vizamyl GE Healthcare Ltd Centralised - Yearly update 29 Jun 2017
Ibandronic acid Sandoz Sandoz GmbH Centralised - Yearly update 29 Jun 2017
Clopidogrel HCS HCS bvba Centralised - 2-Monthly update 29 Jun 2017 EMEA/H/C/2255/IB/22
Clopidogrel ratiopharm Teva B.V. Centralised - 2-Monthly update 29 Jun 2017 EMEA/H/C/4006/IB/7
Uptravi Actelion Registration Ltd Centralised - 2-Monthly update 29 Jun 2017 EMEA/H/C/3774/II/7
alli Glaxo Group Ltd Centralised - Renewal 29 Jun 2017 EMEA/H/C/854/R/54
Besponsa Pfizer Limited Centralised - Authorisation 29 Jun 2017 EMEA/H/C/4119
Mirapexin Boehringer Ingelheim International GmbH Rectificative Decision 29 Jun 2017
Sifrol Boehringer Ingelheim International GmbH Rectificative Decision 29 Jun 2017
Grastofil Apotex Europe B.V. Centralised - Yearly update 26 Jun 2017
Voriconazole Accord Accord Healthcare Limited Centralised - Yearly update 26 Jun 2017
Noxafil Merck Sharp & Dohme Limited Centralised - Yearly update 26 Jun 2017
Triumeq ViiV Healthcare UK Limited Centralised - Yearly update 26 Jun 2017
Macugen PharmaSwiss Ceská republika s.r.o. Centralised - Yearly update 26 Jun 2017
Onglyza AstraZeneca AB Centralised - 2-Monthly update 26 Jun 2017 EMEA/H/C/1039/WS/1078
Pregabalin Accord Accord Healthcare Limited Centralised - 2-Monthly update 26 Jun 2017 EMEA/H/C/4024/IB/5
Renvela Genzyme Europe B.V. Centralised - 2-Monthly update 26 Jun 2017 EMEA/H/C/993/WS/965
Komboglyze AstraZeneca AB Centralised - 2-Monthly update 26 Jun 2017 EMEA/H/C/2059/WS/1078
Evra Janssen-Cilag International NV Centralised - 2-Monthly update 23 Jun 2017 EMEA/H/C/410/II/41
Rapamune Pfizer Limited Centralised - Yearly update 23 Jun 2017
Pandemic influenza vaccine H5N1 AstraZeneca AstraZeneca AB Centralised - Transfer Marketing Authorisation Holder 23 Jun 2017 EMEA/H/C/3963/T/5
Clopidogrel Teva Teva B.V. Centralised - 2-Monthly update 23 Jun 2017 EMEA/H/C/1053/IB/42/G
Zykadia Novartis Europharm Limited Centralised - 2-Monthly update 23 Jun 2017 EMEA/H/C/3819/II/12
Zontivity Merck Sharp & Dohme Limited Centralised - Withdrawal 23 Jun 2017
Emselex Merus Labs Luxco S.ŕ R.L. Centralised - Yearly update 23 Jun 2017
Sevelamer carbonate Zentiva Genzyme Europe B.V. Centralised - 2-Monthly update 23 Jun 2017 EMEA/H/C/3971/WS/965
Izba Novartis Europharm Limited Centralised - 2-Monthly update 23 Jun 2017 EMEA/H/C/2738/II/5
KEYTRUDA Merck Sharp & Dohme Limited Centralised - 2-Monthly update 23 Jun 2017 EMEA/H/C/3820/II/25
Revestive Shire Pharmaceuticals Ireland Limited Centralised - Renewal 23 Jun 2017 EMEA/H/C/2345/R/38, EMEA/H/C/2345/X/29
Farydak Novartis Europharm Limited PSUSA - Modification 23 Jun 2017 EMEA/H/C/PSUSA/10409/201608
Sebivo Novartis Europharm Limited PSUSA - Modification 23 Jun 2017 EMEA/H/C/PSUSA/2880/201608
ALPROLIX Swedish Orphan Biovitrum AB (publ) PSUSA - Modification 23 Jun 2017 EMEA/H/C/PSUSA/10499/201609
Mysimba Orexigen Therapeutics Ireland Limited PSUSA - Modification 23 Jun 2017 EMEA/H/C/3687/PSUSA/10366/201609
Xarelto Bayer AG PSUSA - Modification 23 Jun 2017 EMEA/H/C/944/PSUSA/2653/201609
Prolia Amgen Europe B.V. PSUSA - Modification 23 Jun 2017 EMEA/H/C/1120/PSUSA/954/201609
Skilarence Almirall, S.A. Centralised - Authorisation 23 Jun 2017 EMEA/H/C/2157
Ucedane Lucane Pharma Centralised - Authorisation 23 Jun 2017 EMEA/H/C/4019
Kevzara Sanofi-Aventis groupe Centralised - Authorisation 23 Jun 2017 EMEA/H/C/4254
Erelzi Sandoz GmbH Centralised - Authorisation 23 Jun 2017 EMEA/H/C/4192
Flixabi Samsung Bioepis UK Limited Centralised - Yearly update 23 Jun 2017
Tadalafil Mylan Generics [UK] Limited Referral 23 Jun 2017 EMEA/H/C/1450/A31/3787/5
Sivextro Merck Sharp & Dohme Limited Centralised - Yearly update 16 Jun 2017
Trizivir ViiV Healthcare UK Limited Centralised - Yearly update 16 Jun 2017
Clopidogrel ratiopharm GmbH Archie Samuel s.r.o. Centralised - 2-Monthly update 16 Jun 2017 EMEA/H/C/1165/IB/33/G
Cubicin Merck Sharp & Dohme Limited PSUSA - Modification 16 Jun 2017 EMEA/H/C/PSUSA/931/201609
Xgeva Amgen Europe B.V. PSUSA - Modification 16 Jun 2017 EMEA/H/C/2173/PSUSA/9119/201609
Intuniv Shire Pharmaceuticals Ireland Limited PSUSA - Modification 16 Jun 2017 EMEA/H/C/3759/PSUSA/10413/201609
Sirturo Janssen-Cilag International NV PSUSA - Modification 16 Jun 2017 EMEA/H/C/PSUSA/10074/201609
Atriance Novartis Europharm Limited Centralised - Renewal 16 Jun 2017 EMEA/H/C/752/R/37
Capecitabine medac medac Gesellschaft für klinische Spezialpräparate mbH Centralised - Renewal 16 Jun 2017 EMEA/H/C/2568/R/17
KEYTRUDA Merck Sharp & Dohme Limited PSUSA - Modification 16 Jun 2017 EMEA/H/C/3820/PSUSA/10403/201609
Yondelis Pharma Mar S.A. PSUSA - Modification 16 Jun 2017 EMEA/H/C/PSUSA/3001/201609
Trulicity Eli Lilly Nederland B.V. PSUSA - Modification 16 Jun 2017 EMEA/H/C/PSUSA/10311/201609
Zoledronic acid Hospira Hospira UK Limited PSUSA - Modification 16 Jun 2017 EMEA/H/C/PSUSA/3149/201608
Zoledronic acid medac medac Gesellschaft für klinische Spezialpräparate mbH PSUSA - Modification 16 Jun 2017 EMEA/H/C/PSUSA/3149/201608
INCRELEX Ipsen Pharma Centralised - Renewal 16 Jun 2017 EMEA/H/C/704/R/42
Translarna PTC Therapeutics International Limited Centralised - Annual renewal 16 Jun 2017 EMEA/H/C/2720/R/32
Xagrid Shire Pharmaceutical Contracts Ltd PSUSA - Modification 16 Jun 2017 EMEA/H/C/480/PSUSA/208/201609
Eporatio ratiopharm GmbH Centralised - Yearly update 15 Jun 2017
Clopidogrel Mylan Mylan S.A.S. Centralised - 2-Monthly update 15 Jun 2017 EMEA/H/C/1134/IB/35/G
Clopidogrel Teva Pharma Teva B.V. Centralised - Withdrawal 15 Jun 2017
Riximyo Sandoz GmbH Centralised - Authorisation 15 Jun 2017 EMEA/H/C/4729
Febuxostat Mylan Mylan S.A.S. Centralised - Authorisation 15 Jun 2017 EMEA/H/C/4374
Rixathon Sandoz GmbH Centralised - Authorisation 15 Jun 2017 EMEA/H/C/3903
Zometa Novartis Europharm Limited PSUSA - Modification 15 Jun 2017 EMEA/H/C/336/PSUSA/3149/201608
AUBAGIO Sanofi-Aventis groupe PSUSA - Modification 15 Jun 2017 EMEA/H/C/PSUSA/10135/201609
Nexium Control Pfizer Consumer Healthcare Limited Centralised - Variation 15 Jun 2017 EMEA/H/C/2618/X/16
Busilvex Pierre Fabre Médicament Corrigendum 24 May 2017
NovoThirteen Novo Nordisk A/S Centralised - Renewal 24 May 2017 EMEA/H/C/2284/R/20
Xeloda Roche Registration Limited Corrigendum 14 Jan 2016
Eptifibatide Accord Accord Healthcare Limited Corrigendum 11 Jan 2016
Moventig Kyowa Kirin Limited Corrigendum 8 Dec 2014
Telmisartan Actavis Actavis Group PTC ehf. Corrigendum 4 Sep 2014
Dafiro HCT Novartis Europharm Limited Corrigendum 4 Sep 2014
Dafiro Novartis Europharm Limited Corrigendum 4 Sep 2014
Copalia HCT Novartis Europharm Limited Corrigendum 4 Sep 2014
Copalia Novartis Europharm Limited Corrigendum 4 Sep 2014
Exforge HCT Novartis Europharm Limited Corrigendum 4 Sep 2014
Exforge Novartis Europharm Limited Corrigendum 4 Sep 2014
MicardisPlus Boehringer Ingelheim International GmbH Corrigendum 4 Sep 2014
Micardis Boehringer Ingelheim International GmbH Corrigendum 4 Sep 2014
Kinzalmono Bayer Pharma AG Corrigendum 4 Sep 2014
Kinzalkomb Bayer Pharma AG Corrigendum 4 Sep 2014
Epoetin alfa Hexal Hexal AG Corrigendum 21 Mar 2014
Binocrit Sandoz GmbH Corrigendum 21 Mar 2014
Abseamed Medice Arzneimittel Pütter GmbH & Co KG Corrigendum 21 Mar 2014
Daxas AstraZeneca AB Corrigendum 5 Jul 2010
Procedures for centrally authorised orphan medicinal products for human use
Product Marketing Authorisation Holder Decision Type Decision date EMEA Nr
EU/3/17/1953 Protalix B.V Orphan designation 12 Dec 2017 EMA/OD/138/17
EU/3/17/1952 PhaseRx Ireland, Ltd Orphan designation 12 Dec 2017 EMA/OD/153/17
EU/3/17/1949 IntraBio Ltd Orphan designation 12 Dec 2017 EMA/OD/158/17
EU/3/17/1948 Premier Research Group Limited Orphan designation 12 Dec 2017 EMA/OD/135/17
EU/3/17/1947 NeuroVive Pharmaceutical AB Orphan designation 12 Dec 2017 EMA/OD/132/17
EU/3/17/1946 FGK Representative Service GmbH Orphan designation 12 Dec 2017 EMA/OD/156/17
EU/3/05/272 Noventia Pharma Srl Transfer of orphan designation 8 Dec 2017 EMEA/OD/094/04/T/03
EU/3/13/1134 Orchard Therapeutics Ltd Transfer of orphan designation 30 Nov 2017 EMA/OD/014/13/T/01
EU/3/09/641 Atlantic Pharmaceuticals (Holdings) Ltd Transfer of orphan designation 30 Nov 2017 EMEA/OD/007/09/T/01
EU/3/12/968 Global Regulatory Limited Transfer of orphan designation 30 Nov 2017 EMA/OD/128/11/T/01
EU/3/12/1025 Aegerion Pharmaceuticals B.V. Transfer of orphan designation 30 Nov 2017 EMA/OD/036/12/T/04
EU/3/12/1024 Aegerion Pharmaceuticals B.V. Transfer of orphan designation 30 Nov 2017 EMA/OD/035/12/T/04
EU/3/12/1023 Aegerion Pharmaceuticals B.V. Transfer of orphan designation 30 Nov 2017 EMA/OD/034/12/T/04
EU/3/12/1022 Aegerion Pharmaceuticals B.V. Transfer of orphan designation 30 Nov 2017 EMA/OD/033/12/T/04
EU/3/15/1606 Loxo Oncology Limited Transfer of orphan designation 30 Nov 2017 EMA/OD/184/15/T/01
EU/3/16/1799 TMC Pharma Services Ltd Transfer of orphan designation 24 Nov 2017 EMA/OD/169/16/T/01
EU/3/16/1806 Abeona Therapeutics Europe SL Transfer of orphan designation 20 Nov 2017 EMA/OD/195/16/T/01
EU/3/14/1337 1st Regulatory Ltd Transfer of orphan designation 16 Nov 2017 EMA/OD/137/14/T/01
EU/3/15/1551 Shire Pharmaceuticals Ireland Limited Transfer of orphan designation 16 Nov 2017 EMA/OD/075/15/T/01
EU/3/14/1339 GW Research Ltd Transfer of orphan designation 16 Nov 2017 EMA/OD/083/14/T/01
EU/3/12/1033 Idorsia Pharmaceuticals Deutschland GmbH Transfer of orphan designation 16 Nov 2017 EMA/OD/EMA/OD/042/12/T/01
EU/3/17/1835 Abeona Therapeutics Europe SL Transfer of orphan designation 10 Nov 2017 EMA/OD/283/16/T/01
EU/3/16/1825 Abeona Therapeutics Europe SL Transfer of orphan designation 10 Nov 2017 EMA/OD/226/16/T/01
EU/3/16/1761 Abeona Therapeutics Europe SL Transfer of orphan designation 10 Nov 2017 EMA/OD/164/16/T/01
EU/3/15/1536 Enzyvant Farber Ireland Limited Transfer of orphan designation 10 Nov 2017 EMA/OD/061/15/T/01
EU/3/17/1945 Medical Need Europe AB Orphan designation 8 Nov 2017 EMA/OD/128/17
EU/3/17/1944 Duchenne UK Orphan designation 8 Nov 2017 EMA/OD/133/17
EU/3/17/1943 REGENXBIO EU Limited Orphan designation 8 Nov 2017 EMA/OD/134/17
EU/3/17/1942 Celleron Therapeutics Limited Orphan designation 8 Nov 2017 EMA/OD/121/17
EU/3/17/1941 Capnia (UK) Ltd Orphan designation 8 Nov 2017 EMA/OD/115/17
EU/3/17/1940 Novo Nordisk A/S Orphan designation 8 Nov 2017 EMA/OD/116/17
EU/3/17/1939 CSL Behring GmbH Orphan designation 8 Nov 2017 EMA/OD/105/17
EU/3/17/1938 ProQR Therapeutics VII BV Orphan designation 8 Nov 2017 EMA/OD/140/17
EU/3/17/1937 Quintiles Ireland Limited Orphan designation 8 Nov 2017 EMA/OD/118/17
EU/3/17/1936 Worldwide Clinical Trials Limited Orphan designation 8 Nov 2017 EMA/OD/119/17
EU/3/17/1935 Edvince AB Orphan designation 8 Nov 2017 EMA/OD/120/17
EU/3/17/1934 Edison Orphan Pharma BV Orphan designation 8 Nov 2017 EMA/OD/136/17
EU/3/17/1933 Quintiles Ireland Limited Orphan designation 8 Nov 2017 EMA/OD/142/17
EU/3/11/919 Monopar Therapeutics Inc Transfer of orphan designation 19 Oct 2017 EMA/OD/069/11/T/01
EU/3/01/028 ElsaLys Biotech SAS Transfer of orphan designation 19 Oct 2017 EMA/OD/038/00/T/01
EU/3/14/1278 Spark Therapeutics Ireland Ltd Transfer of orphan designation 19 Oct 2017 EMA/OD/015/14/T/01
EU/3/16/1786 Diamond BioPharm Limited Transfer of orphan designation 19 Oct 2017 EMA/OD/183/16/T/01
EU/3/17/1932 Alizé Pharma Orphan designation 16 Oct 2017 EMA/OD/066/17
EU/3/17/1931 ITB-MED AB Orphan designation 16 Oct 2017 EMA/OD/104/17
EU/3/17/1930 Larode Ltd Orphan designation 16 Oct 2017 EMA/OD/114/17
EU/3/17/1929 Envestia Limited Orphan designation 16 Oct 2017 EMA/OD/087/17
EU/3/17/1928 Pharma Gateway AB Orphan designation 16 Oct 2017 EMA/OD/060/17
EU/3/17/1927 Helsinn Birex Pharmaceuticals Ltd Orphan designation 16 Oct 2017 EMA/OD/101/17
EU/3/17/1926 Envigo Pharma Consulting Ltd Orphan designation 16 Oct 2017 EMA/OD/035/17
EU/3/17/1925 GlaxoSmithKline Trading Services Limited Orphan designation 16 Oct 2017 EMA/OD/077/17
EU/3/17/1924 Immune Design Ltd Orphan designation 16 Oct 2017 EMA/OD/103/17
EU/3/17/1923 Pfizer Limited Orphan designation 16 Oct 2017 EMA/OD/106/17
EU/3/17/1922 Gilead Sciences International Ltd. Orphan designation 16 Oct 2017 EMA/OD/040/17
EU/3/17/1921 GW Research Ltd Orphan designation 16 Oct 2017 EMA/OD/100/17
EU/3/17/1920 GW Research Ltd Orphan designation 16 Oct 2017 EMA/OD/076/17
EU/3/17/1919 Roche Registration Limited Orphan designation 16 Oct 2017 EMA/OD/112/17
EU/3/17/1918 CellProtect Nordic Pharmaceuticals AB Orphan designation 16 Oct 2017 EMA/OD/125/17
EU/3/17/1917 Sagetis Biotech, S.L. Orphan designation 16 Oct 2017 EMA/OD/111/17
EU/3/17/1916 Voisin Consulting S.A.R.L. Orphan designation 16 Oct 2017 EMA/OD/124/17
EU/3/17/1915 Repositioning SAS Orphan designation 16 Oct 2017 EMA/OD/055/17
EU/3/17/1914 Pharma Gateway AB Orphan designation 16 Oct 2017 EMA/OD/079/17
EU/3/15/1482 Inserm-Transfert SA Transfer of orphan designation 13 Oct 2017 EMA/OD/312/14/T/01
EU/3/17/1863 Celgene Europe Limited Transfer of orphan designation 13 Oct 2017 EMA/OD/270/16/T/01
EU/3/14/1270 Mundipharma Corporation Limited Transfer of orphan designation 13 Oct 2017 EMA/OD/199/13/T/01
EU/3/16/1660 GlaxoSmithKline Trading Services Limited Transfer of orphan designation 5 Sep 2017 EMA/OD/024/16/T/01
EU/3/03/182 Idorsia Pharmaceuticals Deutschland GmbH Transfer of orphan designation 5 Sep 2017 EMEA/OD/057/03/T/02
EU/3/12/1062 EUSA Pharma (UK) Limited Transfer of orphan designation 5 Sep 2017 EMA/OD/112/12/T/01
EU/3/16/1740 Allergan Pharmaceuticals International Limited Transfer of orphan designation 5 Sep 2017 EMA/OD/158/16/T/01
EU/3/14/1269 ITM Solucin GmbH Transfer of orphan designation 28 Aug 2017 EMA/OD/196/13/T/01
EU/3/07/518 Bayer AG Transfer of orphan designation 28 Aug 2017 EMEA/OD/088/07/T/02
EU/3/06/364 Bayer AG Transfer of orphan designation 28 Aug 2017 EMEA/OD/109/05/T/02
EU/3/17/1904 Axelar AB Corrigendum 23 Aug 2017
EU/3/17/1912 VIVUS B.V. Corrigendum 23 Aug 2017
EU/3/17/1901 Mayne Pharma UK Limited Corrigendum 23 Aug 2017
EU/3/15/1567 TMC Pharma Services Ltd Transfer of orphan designation 23 Aug 2017 EMA/OD/064/15/T/01
EU/3/15/1563 TMC Pharma Services Ltd Transfer of orphan designation 23 Aug 2017 EMA/OD/112/15/T/01
EU/3/17/1913 Neupharma S.r.l. Orphan designation 23 Aug 2017 EMA/OD/085/17
EU/3/17/1912 VIVUS B.V. Orphan designation 23 Aug 2017 EMA/OD/099/17
EU/3/17/1911 Ability Pharmaceuticals SL Orphan designation 23 Aug 2017 EMA/OD/078/17
EU/3/17/1910 Best Regulatory Consulting Ltd Orphan designation 23 Aug 2017 EMA/OD/047/17
EU/3/17/1909 Vaximm GmbH Orphan designation 23 Aug 2017 EMA/OD/069/17
EU/3/17/1908 Dorian Regulatory Affairs BV Orphan designation 23 Aug 2017 EMA/OD/086/17
EU/3/17/1907 Trimunocor Ltd Orphan designation 23 Aug 2017 EMA/OD/049/17
EU/3/17/1906 Voisin Consulting S.A.R.L. Orphan designation 23 Aug 2017 EMA/OD/093/17
EU/3/17/1905 Archivel Farma S.L. Orphan designation 23 Aug 2017 EMA/OD/098/17
EU/3/17/1904 Axelar AB Orphan designation 23 Aug 2017 EMA/OD/068/17
EU/3/17/1903 Inventiva Orphan designation 23 Aug 2017 EMA/OD/043/17
EU/3/17/1902 Eisai Europe Limited Orphan designation 23 Aug 2017 EMA/OD/052/17
EU/3/17/1901 Mayne Pharma UK Limited Orphan designation 23 Aug 2017 EMA/OD/056/17
EU/3/17/1900 Apogenix AG Orphan designation 23 Aug 2017 EMA/OD/050/17
EU/3/17/1899 ProQR Therapeutics IV BV Orphan designation 23 Aug 2017 EMA/OD/094/17
EU/3/17/1898 Vivet Therapeutics SAS Orphan designation 23 Aug 2017 EMA/OD/084/17
EU/3/07/469 Bayer AG Transfer of orphan designation 17 Aug 2017 EMEA/OD/092/06/T/02
EU/3/14/1299 Bayer AG Transfer of orphan designation 17 Aug 2017 EMA/OD/044/14/T/01
EU/3/13/1200 Bayer AG Transfer of orphan designation 17 Aug 2017 EMA/OD/093/13/T/01
EU/3/13/1199 Bayer AG Transfer of orphan designation 17 Aug 2017 EMA/OD/092/13/T/01
EU/3/12/1073 Bayer AG Transfer of orphan designation 17 Aug 2017 EMA/OD/063/12/T/01
EU/3/10/847 Bayer AG Transfer of orphan designation 17 Aug 2017 EMA/OD/128/10/T/01
EU/3/04/210 Breath Therapeutics GmbH Transfer of orphan designation 3 Aug 2017 EMA/OD/022/04/T/01
EU/3/04/209 Breath Therapeutics GmbH Transfer of orphan designation 3 Aug 2017 EMA/OD/012/04/T/01
EU/3/15/1522 Biogen Idec Limited Transfer of orphan designation 3 Aug 2017 EMA/OD/044/15/T/01
EU/3/14/1280 Orchard Therapeutics Ltd Transfer of orphan designation 3 Aug 2017 EMA/OD/006/14
EU/3/16/1686 Mereo Biopharma 3 Limited Transfer of orphan designation 3 Aug 2017 EMA/OD/052/16
EU/3/17/1897 PhaRA bvba Orphan designation 17 Jul 2017 EMA/OD/038/17
EU/3/17/1896 Raremoon Consulting Ltd Orphan designation 17 Jul 2017 EMA/OD/025/17
EU/3/17/1895 orphanix GmbH Orphan designation 17 Jul 2017 EMA/OD/051/17
EU/3/17/1894 The Medical & Regulatory Partnership Limited Orphan designation 17 Jul 2017 EMA/OD/030/17
EU/3/17/1893 SFL Regulatory Affairs Consulting Ltd Orphan designation 17 Jul 2017 EMA/OD/048/17
EU/3/17/1892 RDD Pharma Limited Orphan designation 17 Jul 2017 EMA/OD/325/16
EU/3/17/1891 Allena Pharmaceuticals Ireland Limited Orphan designation 17 Jul 2017 EMA/OD/058/17
EU/3/17/1890 Celgene Europe Limited Orphan designation 17 Jul 2017 EMA/OD/045/17
EU/3/17/1889 PhaRA bvba Orphan designation 17 Jul 2017 EMA/OD/037/17
EU/3/16/1789 Cogas Pharma Limited Transfer of orphan designation 10 Jul 2017 EMA/OD/144/16/T/01
EU/3/14/1249 Akcea Therapeutics UK Ltd. Transfer of orphan designation 6 Jul 2017 EMA/OD/180/13/T/01
EU/3/15/1494 Voisin Consulting S.A.R.L. Transfer of orphan designation 6 Jul 2017 EMA/OD/005/15/T/01
EU/3/15/1555 Cogas Pharma Limited Transfer of orphan designation 6 Jul 2017 EMA/OD/092/15/T/01
EU/3/17/1888 Advicenne Pharma SA Orphan designation 20 Jun 2017 EMA/OD/016/17
EU/3/17/1887 Zealand Pharma A/S Orphan designation 20 Jun 2017 EMA/OD/002/17
EU/3/17/1886 Vale Pharmaceuticals Limited Orphan designation 20 Jun 2017 EMA/OD/007/17
EU/3/17/1885 Avivia Beheer BV Orphan designation 20 Jun 2017 EMA/OD/304/16
EU/3/17/1884 Voisin Consulting S.A.R.L. Orphan designation 20 Jun 2017 EMA/OD/018/17
EU/3/17/1883 NeuroScios GmbH Orphan designation 20 Jun 2017 EMA/OD/034/17
EU/3/17/1882 Richardson Associates Regulatory Affairs Ltd Orphan designation 20 Jun 2017 EMA/OD/013/17
EU/3/17/1881 Ulrich Muehlner Orphan designation 20 Jun 2017 EMA/OD/008/17
EU/3/17/1880 ChemoCentryx Limited Orphan designation 20 Jun 2017 EMA/OD/028/17
EU/3/17/1879 Envigo Pharma Consulting Ltd Orphan designation 20 Jun 2017 EMA/OD/031/17
EU/3/17/1870 Vall d'Hebron Institute of Research Corrigendum 20 Apr 2017
EU/3/16/1790 Dr Ulrich Granzer Corrigendum 18 Nov 2016
Procedures for centrally authorised veterinary medicinal products
Product Marketing Authorisation Holder Decision Type Decision date EMEA Nr
Circovac Ceva-Phylaxia Zrt. Centralised - Transfer Marketing Authorisation Holder 21 Nov 2017 EMEA/V/C/114/T/14
Pexion Boehringer Ingelheim Vetmedica GmbH Centralised - Renewal 21 Nov 2017 EMEA/V/C/2543/R/10
Bovilis Blue-8 Intervet International B.V. Centralised - Authorisation 21 Nov 2017 EMEA/V/C/4776
Contacera Zoetis Belgium S.A. Centralised - Renewal 15 Nov 2017 EMEA/V/C/2612/R/9
SevoFlo Zoetis Belgium S.A. Centralised - 2-Monthly update 14 Nov 2017 EMEA/V/C/72/II/20
Nobivac LeuFel Virbac Centralised - Authorisation 6 Nov 2017 EMEA/V/C/4778
Pexion Boehringer Ingelheim Vetmedica GmbH Centralised - Yearly update 31 Oct 2017
Inflacam Chanelle Pharmaceuticals Manufacturing Limited Centralised - Yearly update 24 Oct 2017
Ingelvac CircoFLEX Boehringer Ingelheim Vetmedica GmbH Centralised - Yearly update 24 Oct 2017
Bovela Boehringer Ingelheim International GmbH Centralised - Yearly update 19 Oct 2017
Simparica Zoetis Belgium S.A. Centralised - 2-Monthly update 10 Oct 2017 EMEA/V/C/3991/II/6
Equisolon Le Vet B.V. Centralised - Yearly update 5 Oct 2017
ProZinc Boehringer Ingelheim Vetmedica GmbH Centralised - Yearly update 28 Sep 2017
Versican Plus Pi/L4 Zoetis Belgium S.A. Centralised - Yearly update 28 Sep 2017
Versican Plus Pi Zoetis Belgium S.A. Centralised - Yearly update 28 Sep 2017
Versican Plus L4 Zoetis Belgium S.A. Centralised - Yearly update 28 Sep 2017
Metacam Boehringer Ingelheim Vetmedica GmbH Centralised - Yearly update 25 Sep 2017
Equilis Prequenza Te Intervet International B.V. Centralised - Yearly update 25 Sep 2017
Bovalto Ibraxion Merial Centralised - Yearly update 21 Sep 2017
Pirsue Zoetis Belgium S.A. Centralised - Yearly update 21 Sep 2017
Sevohale Chanelle Pharmaceuticals Manufacturing Limited Centralised - Yearly update 21 Sep 2017
Equilis Te Intervet International B.V. Centralised - Yearly update 14 Sep 2017
Rheumocam Chanelle Pharmaceuticals Manufacturing Limited Centralised - Yearly update 14 Sep 2017
Nobivac Myxo-RHD Intervet International B.V. Centralised - Yearly update 14 Sep 2017
LETIFEND Laboratorios LETI, S.L.unipersonal Centralised - Yearly update 14 Sep 2017
SevoFlo Zoetis Belgium S.A. Centralised - Yearly update 7 Sep 2017
Suvaxyn PRRS MLV Zoetis Belgium S.A. Centralised - Authorisation 24 Aug 2017 EMEA/V/C/4276
Innovax-ND-IBD Intervet International B.V. Centralised - Authorisation 22 Aug 2017 EMEA/V/C/4422
Exzolt Intervet International B.V. Centralised - Authorisation 18 Aug 2017 EMEA/V/C/4344
VEPURED Laboratorios Hipra, S.A. Corrigendum 17 Aug 2017
VEPURED Laboratorios Hipra, S.A. Centralised - Authorisation 17 Aug 2017 EMEA/V/C/4364
Canigen L4 Intervet International B.V. Centralised - Yearly update 10 Aug 2017
BLUEVAC BTV8 CZ Veterinaria, S.A. Centralised - Yearly update 3 Aug 2017
EQUIOXX Ceva Santé Animale Corrigendum 3 Aug 2017
Loxicom Norbrook Laboratories Ltd Centralised - Yearly update 28 Jul 2017
Vaxxitek HVT + IBD Merial Centralised - Yearly update 28 Jul 2017
Aivlosin ECO Animal Health Ltd Centralised - Yearly update 19 Jul 2017
Nobilis IB Primo QX Intervet International B.V. Centralised - Yearly update 14 Jul 2017
Zolvix Elanco Europe Ltd. Centralised - Yearly update 14 Jul 2017
Onsior Elanco Europe Ltd. Centralised - Yearly update 10 Jul 2017
EQUIOXX Ceva Santé Animale Centralised - Transfer Marketing Authorisation Holder 29 Jun 2017 EMEA/V/C/142/T/19
CLYNAV Elanco Europe Ltd. Centralised - Authorisation 27 Jun 2017 EMEA/V/C/2390
Prevomax Le Vet Beheer B.V. Centralised - Authorisation 19 Jun 2017 EMEA/V/C/4331
Cardalis Ceva Santé Animale Corrigendum 8 Jun 2017
Poulvac E. coli Zoetis Belgium S.A. Corrigendum 15 May 2017
CYTOPOINT Zoetis Belgium S.A. Corrigendum 25 Apr 2017
NEXGARD SPECTRA Merial Corrigendum 15 Jan 2015
Procedures for nationally authorised medicinal products for human use
Product Marketing Authorisation Holder Decision Type Decision date EMEA Nr
Docetaxel PSUSA - Modification 24 Nov 2017 EMEA/H/C/PSUSA/1152/201611
Gadolinium Referral 23 Nov 2017 EMEA/H/A-31/1437
pramipexole Rectificative Decision 15 Nov 2017
Human coagulation factor VIII Referral 10 Nov 2017 EMEA/H/A-31/1448
Vancomycin Corrigendum 21 Sep 2017
Vancomycin Referral 21 Sep 2017 EMEA/H/A-31/1440
bosentan PSUSA - Modification 18 Sep 2017 EMEA/H/C/PSUSA/425/201611
Interferon alfa 2-b PSUSA - Modification 18 Sep 2017 EMEA/H/C/PSUSA/1758/201609
Symbioflor 2 and associated names containing Escherichia coli bacteria (cells and autolysate) Referral 28 Aug 2017 EMEA/H/A-31/1441
hydrochlorothiazide / irbesartan PSUSA - Modification 24 Aug 2017 EMEA/H/C/PSUSA/1653/201609
Paracetamol / ibuprofen 500 mg / 150 mg Film-coated tablets (Paracomb) Referral 7 Aug 2017 EMEA/H/A-29(4)/1447
busulfan PSUSA - Modification 26 Jul 2017 EMEA/H/C/PSUSA/464/201607
Cardioxane Art 13 Referral 19 Jul 2017 EMEA/H/A-13/1453
pramipexole Rectificative Decision 17 Jul 2017
Mercaptopurine PSUSA - Modification 13 Jul 2017 EMEA/H/C/PSUSA/1988/201609
RAS-acting agents - Renin-angiotensin system Corrigendum 29 Jun 2017
Vepesid and associated names Referral 26 Jun 2017 EMEA/H/A-30/1425
Etopophos and associated names Referral 26 Jun 2017 EMEA/H/A-30/1417
Micro therapeutic Research Labs Referral 23 Jun 2017 EMEA/H/A-31/1450
anagrelide PSUSA - Modification 16 Jun 2017 EMEA/H/C/PSUSA/208/201609
Zoledronic acid (indicated for cancer and fractures) PSUSA - Modification 16 Jun 2017 EMEA/H/C/PSUSA/3149/201608
Procedures for nationally authorised veterinary medicinal products
Product Marketing Authorisation Holder Decision Type Decision date EMEA Nr
Lincocin and its associated names Referral 5 Oct 2017 EMEA/V/A-34/123
Zanil and associated names, and generic products thereof Referral 28 Sep 2017 EMEA/V/A/124
moxidectin - Veterinary medicinal products to be administered orally, topically or subcutaneously to cattle, sheep and horses Corrigendum 25 Sep 2017
moxidectin - Veterinary medicinal products to be administered orally, topically or subcutaneously to cattle, sheep and horses Referral 25 Sep 2017 EMEA/V/A/116
Denagard 45% and associated names Elanco Deutschland GmbH Referral 14 Jul 2017 EMEA/V/A/114
veterinary medicinal products containing tylosin that are administered parenterally and intended for the treatment of bovine mastitis caused by Mycoplasma spp. Referral 10 Jul 2017 EMEA/V/A/121
Zinc oxide - Veterinary medicinal products containing zinc oxide to be administered orally to food producing species Referral 26 Jun 2017 EMEA/V/A-35/118
Veterinary medicinal products containing methylprednisolone hydrogen succinate presented as solutions for injection for use in target species cattle Zoetis France Referral 20 Jun 2017 EMEA/V/A/119