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Community Register of medicinal products
Newly adopted Marketing Authorisation Decisions (last six months)
- Centralised procedures of medicinal products for human use >>
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- Community referrals for veterinary medicinal products >>
Centralised procedures of medicinal products for human use | ||||
| Product | Marketing Authorisation Holder | Decision Type | Decision date | EMEA Nr |
| Topotecan Hospira | Hospira UK Limited | Centralised - Update Type IA-IAin-IB - (Acceptance modification) | 15 May 2012 | |
| Vizarsin | KRKA, d.d., Novo mesto | Centralised - Annex II extension adding new number | 15 May 2012 | EMEA/H/C/1076/X/6 |
| Mircera | Roche Registration Limited | Centralised - Renewal after maximum 5 years | 15 May 2012 | EMEA/H/C/739/R/37 |
| TOBI Podhaler | Novartis Europharm Limited | Centralised - Update Type IA-IAin-IB - (Acceptance modification) | 14 May 2012 | |
| Luveris | Merck Serono Europe Limited | Centralised - Update Type IA-IAin-IB - (Acceptance modification) | 14 May 2012 | |
| JEVTANA | SANOFI | Centralised - Update Type IA-IAin-IB - (Acceptance modification) | 14 May 2012 | |
| Possia | AstraZeneca AB | Centralised - Update Type IA-IAin-IB - (Acceptance modification) | 14 May 2012 | |
| Brilique | AstraZeneca AB | Centralised - Update Type IA-IAin-IB - (Acceptance modification) | 14 May 2012 | |
| Invega | Janssen-Cilag International NV | Centralised - Renewal after maximum 5 years | 14 May 2012 | EMEA/H/C/746/R/34 |
| Trobalt | Glaxo Group Limited | Centralised - Update Type IA-IAin-IB - (Acceptance modification) | 10 May 2012 | |
| Telmisartan Actavis | Actavis Group PTC ehf. | Centralised - Update Type IA-IAin-IB - (Acceptance modification) | 10 May 2012 | |
| Ibandronic Acid Teva | Teva Pharma B.V. | Centralised - Update Type IA-IAin-IB - (Acceptance modification) | 10 May 2012 | |
| Telmisartan Teva | Teva Pharma B.V. | Centralised - Update Type IA-IAin-IB - (Acceptance modification) | 10 May 2012 | |
| Abilify | Otsuka Pharmaceutical Europe Ltd | Centralised - Update Type IA-IAin-IB - (Acceptance modification) | 10 May 2012 | |
| Eurartesim | Sigma-Tau Industrie Farmaceutiche Riunite S.p.A | Corrigendum | 10 May 2012 | |
| Irbesartan / Hydrochlorothiazide Teva | Teva Pharma B.V. | Centralised - Update Type IA-IAin-IB - (Acceptance modification) | 10 May 2012 | |
| Valtropin | BioPartners GmbH | Centralised - Withdrawal on holders request | 10 May 2012 | |
| Siklos | ADDMEDICA | Centralised - Update Type IA-IAin-IB - (Acceptance modification) | 10 May 2012 | |
| CoAprovel | Sanofi Pharma Bristol-Myers Squibb SNC | Centralised - Update Type IA-IAin-IB - (Acceptance modification) | 10 May 2012 | |
| Pixuvri | CTI Life Sciences Ltd | Centralised - Conditional autorisation | 10 May 2012 | EMEA/H/C/2055 |
| Intanza | Sanofi Pasteur MSD SNC | Centralised - Variation Type IB - (Worksharing) | 7 May 2012 | EMEA/H/C/957/IB/WS/240 |
| Ovitrelle | Merck Serono Europe Limited | Centralised - Update Type IA-IAin-IB - (Acceptance modification) | 7 May 2012 | |
| Riluzole Zentiva | Aventis Pharma S.A. | Centralised - Authorisation of a duplicate | 7 May 2012 | EMEA/H/C/2622 |
| Eurartesim | Sigma-Tau Industrie Farmaceutiche Riunite S.p.A | Corrigendum | 2 May 2012 | |
| Neupro | Schwarz Pharma Ltd | Corrigendum | 2 May 2012 | |
| Revolade | GlaxoSmithKline Trading Services Limited | Centralised - Update Type IA-IAin-IB - (Acceptance modification) | 26 Apr 2012 | |
| Yervoy | Bristol-Myers Squibb Pharma EEIG | Centralised - Variation Type II - (Acceptance modification) | 26 Apr 2012 | EMEA/H/C/2213/II/1 |
| Temomedac | medac Gesellschaft für klinische Spezialpräparate mbH | Centralised - Update Type IA-IAin-IB - (Acceptance modification) | 24 Apr 2012 | |
| Menveo | Novartis Vaccines and Diagnostics S.r.l. | Centralised - Variation Type II - (Acceptance modification) | 24 Apr 2012 | EMEA/H/C/1095/II/17 |
| Refludan | Celgene Europe Ltd | Centralised - Withdrawal on holders request | 24 Apr 2012 | |
| Rasilez HCT | Novartis Europharm Ltd | Centralised - Art. 20 - (Amend) With Annex IV | 24 Apr 2012 | EMEA/H/C/964/A-20/26 |
| Signifor | Novartis Europharm Limited | Centralised - Authorisation of orphan medicinal product | 24 Apr 2012 | EMEA/H/C/2052 |
| Samsca | Otsuka Pharmaceutical Europe Ltd | Centralised - Variation Type II - (Acceptance modification) | 20 Apr 2012 | EMEA/H/C/980/II/5, 6, 7 |
| Prolia | Amgen Europe B.V. | Centralised - Variation Type II - (Acceptance modification) | 20 Apr 2012 | EMEA/H/C/1120/II/12 |
| Victoza | Novo Nordisk A/S | Centralised - Variation Type II - (Acceptance modification) | 20 Apr 2012 | EMEA/H/C/1026/II/11 |
| Vidaza | Celgene Europe Ltd | Centralised - Variation Type II - (Acceptance modification) | 20 Apr 2012 | EMEA/H/C/978/II/18 |
| Abraxane | Celgene Europe Limited | Centralised - Variation Type II - (Acceptance modification) | 20 Apr 2012 | EMEA/H/C/778/II/34 |
| Silodyx | Recordati Ireland Ltd. | Centralised - Variation Type II - (Acceptance modification) | 20 Apr 2012 | EMEA/H/C/1209/WS/197 |
| Aflunov | Novartis Vaccines and Diagnostics S.r.l. | Centralised - Variation Type II - (Acceptance modification) | 20 Apr 2012 | EMEA/H/C/2094/II/1 |
| ProQuad | Sanofi Pasteur MSD, SNC | Centralised - Variation Type II - (Acceptance modification) | 20 Apr 2012 | EMEA/H/C/622/II/55 |
| Ventavis | Bayer Pharma AG | Centralised - Variation Type II - (Acceptance modification) | 20 Apr 2012 | EMEA/H/C/474/II/38/G |
| Norvir | Abbott Laboratories Ltd | Centralised - Variation Type II - (Acceptance modification) | 20 Apr 2012 | EMEA/H/C/127/II/113 |
| Focetria | Novartis Vaccines and Diagnostics S.r.l. | Centralised - Variation Type II - (Acceptance modification) | 20 Apr 2012 | EMEA/H/C/710/II/30 |
| Iressa | AstraZeneca AB | Centralised - Variation Type II - (Acceptance modification) | 20 Apr 2012 | EMEA/H/C/1016/II/5 |
| Apidra | Sanofi-Aventis Deutschland GmbH | Centralised - Variation Type II - (Acceptance modification) | 20 Apr 2012 | EMEA/H/C/557/WS/208 |
| Insulin Human Winthrop | Sanofi-Aventis Deutschland GmbH | Centralised - Variation Type II - (Acceptance modification) | 20 Apr 2012 | EMEA/H/C/761/WS/208 |
| Insuman | Sanofi-Aventis Deutschland GmbH | Centralised - Variation Type II - (Acceptance modification) | 20 Apr 2012 | EMEA/H/C/201/WS/208 |
| Urorec | Recordati Ireland Ltd. | Centralised - Variation Type II - (Acceptance modification) | 20 Apr 2012 | EMEA/H/C/1092/WS/197 |
| PhotoBarr | Pinnacle Biologics B.V. | Centralised - Withdrawal on holders request | 20 Apr 2012 | |
| Optimark | Covidien Deutschland GmbH | Centralised - Variation Type II - (Acceptance modification) | 20 Apr 2012 | EMEA/H/C/745/II/10 |
| Optisulin | Sanofi-Aventis Deutschland GmbH | Centralised - Variation Type II - (Acceptance modification) | 20 Apr 2012 | EMEA/H/C/309/WS/208 |
| Lantus | Sanofi-Aventis Deutschland GmbH | Centralised - Variation Type II - (Acceptance modification) | 20 Apr 2012 | EMEA/H/C/284/WS/208 |
| Prandin | Novo Nordisk A/S | Centralised - Variation Type II - (Acceptance modification) | 20 Apr 2012 | EMEA/H/C/362/WS/223 |
| NovoNorm | Novo Nordisk A/S | Centralised - Variation Type II - (Acceptance modification) | 20 Apr 2012 | EMEA/H/C/187/WS/223 |
| Exelon | Novartis Europharm Ltd | Centralised - Variation Type II - (Acceptance modification) | 20 Apr 2012 | EMEA/H/C/169/WS/132 |
| Yttriga | Eckert & Ziegler Radiopharma GmbH | Centralised - Update Type IA-IAin-IB - (Acceptance modification) | 20 Apr 2012 | |
| Preotact | Nycomed Danmark ApS | Centralised - Variation Type II - (Additional pack size) | 20 Apr 2012 | EMEA/H/C/659/II/17 |
| Vfend | Pfizer Ltd | Centralised - Variation Type II - (Acceptance modification) | 20 Apr 2012 | EMEA/H/C/387/II/84 |
| Kogenate Bayer | Bayer Pharma AG | Centralised - Variation Type II - (Acceptance modification) | 20 Apr 2012 | |
| Helixate NexGen | Bayer Pharma AG | Centralised - Variation Type II - (Acceptance modification) | 20 Apr 2012 | EMEA/H/C/276/WS/193 |
| Aclasta | Novartis Europharm Ltd | Centralised - Variation Type II - (Acceptance modification) | 20 Apr 2012 | EMEA/H/C/595/II/34 |
| Humira | Abbott Laboratories Ltd | Centralised - Variation Type II - (Acceptance modification) | 20 Apr 2012 | EMEA/H/C/481/II/86/G |
| HALAVEN | Eisai Europe Limited | Centralised - Variation Type II - (Acceptance modification) | 20 Apr 2012 | EMEA/H/C/2084/II/4 |
| IOA | N.V. Organon | Centralised - Rectificative decision for a Paediatric use marketing auhtorisation | 20 Apr 2012 | EMEA/H/C/2068 |
| Trevaclyn | Merck Sharp & Dohme Ltd | Centralised - Variation Type II - (Acceptance modification) | 20 Apr 2012 | EMEA/H/C/897/II/WS/217 |
| Tredaptive | Merck Sharp & Dohme Ltd | Centralised - Variation Type II - (Acceptance modification) | 20 Apr 2012 | EMEA/H/C/889/II/WS/217 |
| Pelzont | Merck Sharp & Dohme Ltd | Centralised - Variation Type II - (Acceptance modification) | 20 Apr 2012 | EMEA/H/C/903/II/WS/217 |
| Zoely | Theramex S.r.l. | Centralised - Rectificative decision for a Paediatric use marketing auhtorisation | 20 Apr 2012 | |
| Brinavess | Merck Sharp & Dohme Limited | Centralised - Variation Type II - Art 127a - Decision addressed to Member State | 20 Apr 2012 | |
| Opgenra | Olympus Biotech International Limited | Centralised - Update Type IA-IAin-IB - (Acceptance modification) | 20 Apr 2012 | |
| Ceplene | EpiCept GmbH | Centralised - Annual reassessment | 20 Apr 2012 | EMEA/H/C/796/S/12 |
| Valdoxan | Les Laboratoires Servier | Centralised - Variation Type II - Art 127a - Decision addressed to Member State | 20 Apr 2012 | EMEA/H/C/915/II/9 |
| Xenical | Roche Registration Limited | Centralised - Art. 20 - (Amend) With Annex IV | 20 Apr 2012 | EMEA/H/C/154/A-20/57 |
| Rasilamlo | Novartis Europharm Ltd | Centralised - Art. 20 - (Amend) With Annex IV | 20 Apr 2012 | EMEA/H/C/2073/A-20/16 |
| Rasilez | Novartis Europharm Ltd | Centralised - Art. 20 - (Maintain) Title IV | 20 Apr 2012 | EMEA/H/C/780/A-20/63 |
| Riprazo | Novartis Europharm Ltd | Centralised - Art. 20 - (Maintain) Title IV | 20 Apr 2012 | EMEA/H/C/853/A-20/69 |
| Nimenrix | GlaxoSmithKline Biologicals S.A. | Centralised - Authorisation | 20 Apr 2012 | EMEA/H/C/2226 |
| SANCUSO | ProStrakan Limited | Centralised - Authorisation | 20 Apr 2012 | EMEA/H/C/2296 |
| Rasitrio | Novartis Europharm Limited | Centralised - Art. 20 - (Amend) With Annex IV | 20 Apr 2012 | EMEA/H/C/2017/A-20/1 |
| Sprimeo | Novartis Europharm Ltd | Centralised - Art. 20 - (Amend) With Annex IV | 20 Apr 2012 | EMEA/H/C/851/A-20/67 |
| Riprazo HCT | Novartis Europharm Limited | Centralised - Art. 20 - (Maintain) Title IV | 20 Apr 2012 | EMEA/H/C/2420/A-20/15 |
| Sprimeo HCT | Novartis Europharm Limited | Centralised - Art. 20 - (Maintain) Title IV | 20 Apr 2012 | EMEA/H/C/2421/A-20/11 |
| Capecitabine Teva | TEVA Pharma B.V. | Centralised - Authorisation | 20 Apr 2012 | EMEA/H/C/2362/ |
| Capecitabine Krka | KRKA, d.d | Centralised - Authorisation of a duplicate | 20 Apr 2012 | EMEA/H/C/2605/ |
| Capecitabine Accord | Accord Healthcare Limited | Centralised - Authorisation | 20 Apr 2012 | EMEA/H/C/2386 |
| Circadin | RAD Neurim Pharmaceuticals EEC Limited | Centralised - Renewal after maximum 5 years | 20 Apr 2012 | EMEA/H/C/695/R/31 |
| Tracleer | Actelion Registration Ltd | Centralised - Renewal after maximum 5 years | 20 Apr 2012 | EMEA/H/C/40/R/55 |
| Sebivo | Novartis Europharm Ltd | Centralised - Renewal with additional 5 years (Annex IV) | 20 Apr 2012 | EMEA/H/C/713/R/23 |
| Zoledronic acid Actavis | Actavis Group PTC ehf. | Centralised - Authorisation | 20 Apr 2012 | EMEA/H/C/2488/ |
| Altargo | Glaxo Group Limited | Centralised - Renewal after maximum 5 years | 20 Apr 2012 | EMEA/H/C/757/R/23 |
| Thymanax | Servier (Ireland) Industries Limited | Centralised - Variation Type II - Art 127a - Decision addressed to Member State | 20 Apr 2012 | EMEA/H/C/916/II/8 |
| Prometax | Novartis Europharm Ltd | Centralised - Variation Type II - (Acceptance modification) | 13 Apr 2012 | EMEA/H/C/225/WS/132 |
| Soliris | Alexion Europe S.A.S. | Centralised - Variation Type II - (Acceptance modification) | 13 Apr 2012 | EMEA/H/C/791/II/38/G |
| Foscan | Biolitec pharma Ltd | Centralised - Update Type IA-IAin-IB - (Acceptance modification) | 13 Apr 2012 | |
| Revatio | Pfizer Limited | Centralised - Variation Type II - (Acceptance modification) | 13 Apr 2012 | EMEA/H/C/638/II/40 |
| Volibris | Glaxo Group Ltd | Centralised - Variation Type II - (Acceptance modification) | 13 Apr 2012 | EMEA/H/C/839/II/24 |
| Pradaxa | Boehringer Ingelheim International GmbH | Centralised - Variation Type II - (Acceptance modification) | 13 Apr 2012 | EMEA/H/C/829/II/25 |
| Champix | Pfizer Ltd | Centralised - Variation Type II - (Acceptance modification) | 13 Apr 2012 | EMEA/H/C/699/II/39 |
| Viramune | Boehringer Ingelheim International GmbH | Centralised - Annex II paediatric extension adding new number | 13 Apr 2012 | EMEA/H/C/183/X/95 |
| alli | Glaxo Group Limited | Centralised - Art. 20 - (Amend) With Annex IV | 13 Apr 2012 | EMEA/H/C/854/A-20/29 |
| Revlimid | Celgene Europe Limited | Centralised - Renewal with additional 5 years (Annex IV) | 13 Apr 2012 | EMEA/H/C/717/R/54 |
| Advagraf | Astellas Pharma Europe B.V. | Centralised - Renewal after maximum 5 years | 13 Apr 2012 | EMEA/H/C/712/R/23 |
| Bronchitol | Pharmaxis Pharmaceuticals Limited | Centralised - Authorisation of an orphan medicinal product under art 127a - Decision addressed to Member State | 13 Apr 2012 | EMEA/H/C/1252 |
| Bronchitol | Pharmaxis Pharmaceuticals Limited | Centralised - Authorisation of an orphan medicinal product under art 127a - Decision addressed to the Marketing Authorisation Holder | 13 Apr 2012 | EMEA/H/C/1252 |
| Evoltra | Genzyme Europe BV | Centralised - Annual reassessment | 13 Apr 2012 | EMEA/H/C/613/S/33 |
| Sabervel | Pharmathen S.A. | Centralised - Authorisation | 13 Apr 2012 | EMEA/H/C/2510 |
| Tyverb | Glaxo Group Limited | Centralised - Annual renewal of conditional autorisation | 13 Apr 2012 | EMEA/H/C/795/R/21 |
| Vedrop | Orphan Europe SARL | Centralised - Update Type IA-IAin-IB - (Acceptance modification) | 10 Apr 2012 | |
| Telzir | ViiV Healthcare UK Ltd | Centralised - Update Type IA-IAin-IB - (Acceptance modification) | 4 Apr 2012 | |
| Plavix | Sanofi Pharma Bristol-Myers Squibb SNC | Centralised - Variation Type II - (Acceptance modification) | 4 Apr 2012 | Corrects EMEA/H/C/174/II/98 (annexes not affected) |
| Sprycel | Bristol-Myers Squibb Pharma EEIG | Corrigendum | 4 Apr 2012 | |
| Rebetol | Schering Plough Europe | Centralised - Transfer Marketing Authorisation Holder | 4 Apr 2012 | EMEA/H/C/246/T/62 |
| Humira | Abbott Laboratories Ltd | Centralised - Variation Type II - (Acceptance modification) | 4 Apr 2012 | EMEA/H/C/481/II/82, 91 |
| Kinzalkomb | Bayer Pharma AG | Centralised - Update Type IA-IAin-IB - (Acceptance modification) | 3 Apr 2012 | |
| Kinzalmono | Bayer Pharma AG | Centralised - Update Type IA-IAin-IB - (Acceptance modification) | 30 Mar 2012 | |
| Rebetol | Schering Plough Europe | Centralised - Variation Type II - (Acceptance modification) | 30 Mar 2012 | EMEA/H/C/246/WS/216 |
| ViraferonPeg | Merck Sharp & Dohme Limited | Centralised - Variation Type II - (Acceptance modification) | 30 Mar 2012 | EMEA/H/C/329/WS/216 |
| Zonegran | Eisai Limited | Centralised - Variation Type II - (Acceptance modification) | 30 Mar 2012 | EMEA/H/C/577/II/60 |
| Nimvastid | KRKA, d.d., Novo mesto | Centralised - Update Type IA-IAin-IB - (Acceptance modification) | 26 Mar 2012 | |
| Eurartesim | Sigma-Tau Industrie Farmaceutiche Riunite S.p.A | Centralised - Variation Type II - (Acceptance modification) | 26 Mar 2012 | EMEA/H/C/1199/II/1/G |
| Neupro | Schwarz Pharma Ltd | Centralised - Update Type IA-IAin-IB - (Acceptance modification) | 26 Mar 2012 | |
| Azilect | Teva Pharma GmbH | Centralised - Update Type IA-IAin-IB - (Acceptance modification) | 26 Mar 2012 | |
| Brinavess | Merck Sharp & Dohme Limited | Centralised - Variation Type II - Art 127a - Decision addressed to the Marketing Authorisation Holder | 26 Mar 2012 | EMEA/H/C/1215/II/7 |
| Puregon | Organon N.V. | Centralised - Update Type IA-IAin-IB - (Acceptance modification) | 26 Mar 2012 | |
| Plenadren | DuoCort Pharma AB | Centralised - Transfer Marketing Authorisation Holder | 26 Mar 2012 | EMEA/H/C/2185 |
| PegIntron | Schering Plough Europe | Centralised - Variation Type II - (Acceptance modification) | 26 Mar 2012 | EMEA/H/C/280/WS/216 |
| Valdoxan | Les Laboratoires Servier | Centralised - Variation Type II - Art 127a - Decision addressed to the Marketing Authorisation Holder | 26 Mar 2012 | EMEA/H/C/915/II/9 |
| VPRIV | Shire Pharmaceuticals Ireland Limited | Centralised - Variation Type II - (Acceptance modification) | 26 Mar 2012 | EMEA/H/C/1249/II/4 |
| ViraferonPeg | Schering Plough Europe | Centralised - Transfer Marketing Authorisation Holder | 26 Mar 2012 | EMEA/H/C/329/T/99 |
| Pandemic influenza vaccine H5N1 BAXTER | Baxter AG | Centralised - Variation Type II - (Acceptance modification) | 26 Mar 2012 | EMEA/H/C/1200/II/6 |
| Pioglitazone Teva Pharma | Teva Pharma B.V. | Centralised - Authorisation under art 127a - Decision addressed to Member State | 26 Mar 2012 | EMEA/H/C/2410 |
| Pioglitazone Teva Pharma | Teva Pharma B.V. | Centralised - Authorisation under art 127a - Decision addressed to Marketing Authorisation Holder | 26 Mar 2012 | EMEA/H/C/2410 |
| Pioglitazone Teva | Teva Pharma B.V. | Centralised - Authorisation under art 127a - Decision addressed to Member State | 26 Mar 2012 | EMEA/H/C/2297 |
| Pioglitazone Teva | Teva Pharma B.V. | Centralised - Authorisation under art 127a - Decision addressed to Marketing Authorisation Holder | 26 Mar 2012 | EMEA/H/C/2297 |
| Atriance | Glaxo Group Limited | Centralised - Variation Type II - (Acceptance modification) | 21 Mar 2012 | EMEA/H/C/752/II/12 |
| Volibris | Glaxo Group Ltd | Centralised - Variation Type II - (Acceptance modification) | 21 Mar 2012 | EMEA/H/C/839/II/19, 0021 |
| Clopidogrel Krka d.d. | KRKA, d.d., Novo mesto | Centralised - Update Type IA-IAin-IB - (Acceptance modification) | 21 Mar 2012 | |
| Xgeva | Amgen Europe B.V. | Centralised - Variation Type II - (Acceptance modification) | 21 Mar 2012 | EMEA/H/C/2173/II/3 |
| Victrelis | Merck Sharp & Dohme Limited | Centralised - Variation Type II - (Acceptance modification) | 21 Mar 2012 | EMEA/H/C/2332/II/4 |
| Integrilin | Glaxo Group Ltd | Centralised - Variation Type II - (Acceptance modification) | 21 Mar 2012 | EMEA/H/C/230/II/56 |
| Rapiscan | Rapidscan Pharma Solutions EU Ltd. | Centralised - Variation Type II - (Acceptance modification) | 21 Mar 2012 | EMEA/H/C/1176/II/5 |
| Zostavax | Sanofi Pasteur MSD, SNC | Centralised - Variation Type II - (Acceptance modification) | 21 Mar 2012 | EMEA/H/C/674/II/46 |
| Foclivia | Novartis Vaccines and Diagnostics S.r.l. | Centralised - Variation Type II - (Acceptance modification) | 21 Mar 2012 | EMEA/H/C/1208/II/6, 7 |
| Thymanax | Servier (Ireland) Industries Limited | Centralised - Variation Type II - Art 127a - Decision addressed to the Marketing Authorisation Holder | 21 Mar 2012 | EMEA/H/C/916/II/8 |
| Champix | Pfizer Ltd | Centralised - Variation Type II - (Acceptance modification) | 21 Mar 2012 | EMEA/H/C/699/II/38 |
| Revatio | Pfizer Limited | Centralised - Annex II extension adding new number | 21 Mar 2012 | EMEA/H/C/638/X/37 |
| VELCADE | Janssen-Cilag International NV | Centralised - Variation Type II - (Acceptance modification) | 21 Mar 2012 | EMEA/H/C/539/II/54 |
| Evoltra | Genzyme Europe BV | Corrigendum | 21 Mar 2012 | |
| Pioglitazone Accord | Accord Healthcare Limited | Centralised - Authorisation under art 127a - Decision addressed to Member State | 21 Mar 2012 | EMEA/H/C/2277 |
| Pioglitazone Accord | Accord Healthcare Limited | Centralised - Authorisation under art 127a - Decision addressed to Marketing Authorisation Holder | 21 Mar 2012 | EMEA/H/C/2277 |
| Pioglitazone Krka | KRKA, d. d., Novo mesto | Centralised - Authorisation under art 127a - Decision addressed to Member State | 21 Mar 2012 | EMEA/H/C/2453 |
| Pioglitazone Krka | KRKA, d. d., Novo mesto | Centralised - Authorisation under art 127a - Decision addressed to Marketing Authorisation Holder | 21 Mar 2012 | EMEA/H/C/2453 |
| Paglitaz | KRKA, d. d., Novo mesto | Centralised - Authorisation under art 127a - Decision addressed to Member State | 21 Mar 2012 | EMEA/H/C/2309 |
| Paglitaz | KRKA, d. d., Novo mesto | Centralised - Authorisation under art 127a - Decision addressed to Marketing Authorisation Holder | 21 Mar 2012 | EMEA/H/C/2309 |
| Refludan | Celgene Europe Ltd | Centralised - Update Type IA-IAin-IB - (Acceptance modification) | 19 Mar 2012 | |
| Levitra | Bayer Pharma AG | Centralised - Variation Type II - (Acceptance modification) | 19 Mar 2012 | EMEA/H/C/475/II/43 |
| Norvir | Abbott Laboratories Ltd | Centralised - Variation Type II - (Acceptance modification) | 19 Mar 2012 | EMEA/H/C/127/II/109 |
| ProQuad | Sanofi Pasteur MSD, SNC | Centralised - Variation Type II - (Acceptance modification) | 19 Mar 2012 | EMEA/H/C/622/II/56 |
| Fasturtec | SANOFI | Centralised - Variation Type II - (Acceptance modification) | 19 Mar 2012 | EMEA/H/C/331/II/30, 31 |
| Intanza | Sanofi Pasteur MSD SNC | Centralised - Variation Type II - (Acceptance modification) | 19 Mar 2012 | EMEA/H/C/957/II/WS/219 |
| Leflunomide Winthrop | Sanofi-Aventis Deutschland GmbH | Centralised - Variation Type II - (Acceptance modification) | 19 Mar 2012 | EMEA/H/C/1129/II/6 |
| Avastin | Roche Registration Limited | Centralised - Variation Type II - (Acceptance modification) | 19 Mar 2012 | EMEA/H/C/582/II/47/G |
| PegIntron | Schering Plough Europe | Centralised - Transfer Marketing Authorisation Holder | 19 Mar 2012 | EMA/134131/2012 |
| Tasmar | Meda AB | Centralised - Update Type IB - (Acceptance modification) | 19 Mar 2012 | |
| IDflu | Sanofi Pasteur SA | Centralised - Variation Type II - (Acceptance modification) | 19 Mar 2012 | |
| Afinitor | Novartis Europharm Ltd | Centralised - Variation Type II - (Acceptance modification) | 19 Mar 2012 | EMEA/H/C/1038/II/15 |
| Isentress | Merck Sharp & Dohme Limited | Centralised - Variation Type II - (Acceptance modification) | 19 Mar 2012 | EMEA/H/C/860/II/28 |
| Benlysta | Glaxo Group Limited | Centralised - Variation Type II - (Acceptance modification) | 19 Mar 2012 | EMEA/H/C/2015/II/4 |
| Intelence | Janssen-Cilag International NV | Centralised - Variation Type II - (Acceptance modification) | 19 Mar 2012 | EMEA/H/C/900/II/20 |
| Arava | Sanofi-Aventis Deutschland GmbH | Centralised - Variation Type II - (Acceptance modification) | 19 Mar 2012 | EMEA/H/C/235/II/50 |
| Zerit | Bristol-Myers Squibb Pharma EEIG | Corrigendum | 19 Mar 2012 | |
| Privigen | CSL Behring GmbH | Centralised - Variation Type II - (Acceptance modification) | 19 Mar 2012 | EMEA/H/C/831/II/58 |
| Resolor | Shire-Movetis NV | Centralised - Variation Type II - (Acceptance modification) | 19 Mar 2012 | EMEA/H/C/1012/II/13 |
| Incivo | Janssen-Cilag International NV | Centralised - Variation Type II - (Additional pack size) | 19 Mar 2012 | EMEA/H/C/2313/II/3, 4 |
| Votrient | Glaxo Group Limited | Centralised - Variation Type II - (Acceptance modification) | 19 Mar 2012 | EMEA/H/C/1141/II/9 |
| Prevenar 13 | Wyeth-Lederle Vaccines S.A. | Centralised - Variation Type II - (Acceptance modification) | 19 Mar 2012 | |
| Byetta | Eli Lilly Nederland B.V. | Centralised - Variation Type II - (Acceptance modification) | 19 Mar 2012 | EMEA/H/C/698/ii/29 |
| Ranexa | Menarini International Operations Luxembourg S.A. | Centralised - Variation Type II - (Acceptance modification) | 19 Mar 2012 | EMEA/H/C/805/II/30 |
| Remicade | Janssen Biologics B.V. | Centralised - Variation Type II - (Extension of indication for paediatric use) | 19 Mar 2012 | EMEA/H/C/240/II/161 |
| Kogenate Bayer | Bayer Pharma AG | Centralised - Variation Type II - (Acceptance modification) | 19 Mar 2012 | EMEA/H/C/275/WS/198 |
| Helixate NexGen | Bayer Schering Pharma AG | Centralised - Variation Type II - (Acceptance modification) | 19 Mar 2012 | EMEA/H/C/275/WS/198 |
| Vimpat | UCB Pharma SA. | Centralised - Variation Type II - (Acceptance modification) | 19 Mar 2012 | EMEA/H/C/863/II/31 |
| Vizarsin | KRKA, d.d., Novo mesto | Centralised - Update Type IA-IAin-IB - (Acceptance modification) | 15 Mar 2012 | |
| Prolia | Amgen Europe B.V. | Centralised - Variation Type II - (Acceptance modification) | 15 Mar 2012 | EMEA/H/C/1120/II/10, 11 |
| Avamys | Glaxo Group Ltd | Centralised - Variation Type II - (Acceptance modification) | 15 Mar 2012 | EMEA/H/C/770/II/10 |
| Carbaglu | Orphan Europe | Centralised - Update Type IA-IAin-IB - (Acceptance modification) | 15 Mar 2012 | |
| Livensa | Warner Chilcott Deutschland Gmbh | Centralised - Withdrawal on holders request | 15 Mar 2012 | |
| Ventavis | Bayer Pharma AG | Centralised - Annual reassessment | 15 Mar 2012 | EMEA/H/C/474/S/39 |
| Orencia | Bristol-Myers Squibb Pharma EEIG | Centralised - Renewal after maximum 5 years | 15 Mar 2012 | EMEA/H/C/701/R/55 |
| Toviaz | Pfizer Limited | Centralised - Renewal after maximum 5 years | 15 Mar 2012 | EMEA/H/C/723/R/34 |
| Glidipion | Actavis Group PTC ehf. | Centralised - Authorisation of a duplicate | 15 Mar 2012 | EMEA/H/C/2558 |
| Glidipion | Actavis Group PTC ehf. | Centralised - Authorisation under art 127a - Decision addressed to Member State | 15 Mar 2012 | |
| Pioglitazone Actavis | Actavis Group PTC ehf. | Centralised - Authorisation under art 127a - Decision addressed to Member State | 15 Mar 2012 | EMEA/H/C/2324 |
| Pioglitazone Actavis | Actavis Group PTC ehf. | Centralised - Authorisation under art 127a - Decision addressed to Marketing Authorisation Holder | 15 Mar 2012 | EMEA/H/C/2324 |
| Samsca | Otsuka Pharmaceutical Europe Ltd | Centralised - Update Type IA-IAin-IB - (Acceptance modification) | 9 Mar 2012 | |
| Sepioglin | Vaia S.A. | Centralised - Authorisation under art 127a - Decision addressed to Member State | 9 Mar 2012 | EMEA/H/C/2021 |
| Sepioglin | Vaia S.A. | Centralised - Authorisation under art 127a - Decision addressed to Marketing Authorisation Holder | 9 Mar 2012 | EMEA/H/C/2021 |
| Aclasta | Novartis Europharm Ltd | Centralised - Variation Type II - Art 127a - Decision addressed to Member State | 9 Mar 2012 | EMEA/H/C/595/II/28 |
| Mercaptopurine Nova Laboratories | Nova Laboratories Limited | Centralised - Authorisation of orphan medicinal product | 9 Mar 2012 | EMEA/H/C/2022 |
| PritorPlus | Bayer Pharma AG | Centralised - Update Type IA-IAin-IB - (Acceptance modification) | 8 Mar 2012 | |
| Pritor | Bayer Pharma AG | Centralised - Update Type IA-IAin-IB - (Acceptance modification) | 8 Mar 2012 | |
| Firazyr | Shire Orphan Therapies GmbH | Centralised - Update Type IA-IAin-IB - (Acceptance modification) | 8 Mar 2012 | |
| Docetaxel Winthrop | Aventis Pharma S.A. | Centralised - Renewal after maximum 5 years | 8 Mar 2012 | EMEA/H/C/808/R/21 |
| Rivastigmine Teva | Teva Pharma B.V. | Centralised - Update Type IA-IAin-IB - (Acceptance modification) | 6 Mar 2012 | |
| Clopidogrel Acino | Acino Pharma GmbH | Centralised - Transfer Marketing Authorisation Holder | 6 Mar 2012 | EMEA/H/C/1166/T/8 |
| Repso | Teva Pharma B.V. | Centralised - Update Type IA-IAin-IB - (Acceptance modification) | 6 Mar 2012 | |
| Topotecan Actavis | Actavis Group PTC ehf. | Centralised - Update Type IA-IAin-IB - (Acceptance modification) | 6 Mar 2012 | |
| Esbriet | InterMune UK Ltd | Centralised - Update Type IA-IAin-IB - (Acceptance modification) | 2 Mar 2012 | |
| Libertek | Nycomed GmbH | Centralised - Update Type IA-IAin-IB - (Acceptance modification) | 2 Mar 2012 | |
| Daliresp | Nycomed GmbH | Centralised - Update Type IA-IAin-IB - (Acceptance modification) | 2 Mar 2012 | |
| Leflunomide Teva | Teva Pharma B.V. | Centralised - Update Type IA-IAin-IB - (Acceptance modification) | 2 Mar 2012 | |
| Ruconest | Pharming Group N.V. | Centralised - Update Type IA-IAin-IB - (Acceptance modification) | 2 Mar 2012 | |
| Invirase | Roche Registration Limited | Centralised - Variation Type II - (Acceptance modification) | 2 Mar 2012 | EMEA/H/C/113/II/93 |
| Fampyra | Biogen Idec Limited | Centralised - Update Type IA-IAin-IB - (Acceptance modification) | 2 Mar 2012 | |
| NutropinAq | Ipsen Pharma | Centralised - Art. 20 - (Amend) With Annex IV | 2 Mar 2012 | EMEA/H/C/315/A-20/40 |
| Omnitrope | Sandoz GmbH | Centralised - Art. 20 - (Amend) With Annex IV | 2 Mar 2012 | EMEA/H/C/607/A-20/21 |
| Tandemact | Takeda Global Research and Development Centre (Europe) Ltd. | Centralised - Renewal with additional 5 years (Annex IV) | 2 Mar 2012 | EMEA/H/C/680/R/23 |
| ATryn | GTC Biotherapeutics UK Limited | Centralised - Annual reassessment | 2 Mar 2012 | EMEA/H/C/587/S/13 |
| Valtropin | BioPartners GmbH | Centralised - Art. 20 - (Amend) With Annex IV | 2 Mar 2012 | EMEA/H/C/602/A-20/8 |
| Instanyl | Nycomed Danmark ApS | Centralised - Update Type IA-IAin-IB - (Acceptance modification) | 27 Feb 2012 | |
| Evicel | Omrix Biopharmaceuticals N.V. | Centralised - Update Type IA-IAin-IB - (Acceptance modification) | 27 Feb 2012 | |
| Twynsta | Boehringer Ingelheim International GmbH | Centralised - Update Type IA-IAin-IB - (Acceptance modification) | 27 Feb 2012 | |
| Olanzapine Glenmark | Glenmark Generics (Europe) Limited | Centralised - Variation Type IB - (Worksharing) | 27 Feb 2012 | EMEA/H/C/1085/WS/202 |
| Olanzapine Glenmark Europe | Glenmark Generics (Europe) Limited | Centralised - Variation Type IB - (Worksharing) | 27 Feb 2012 | EMEA/H/C/1086/WS/202 |
| Bridion | N.V. Organon | Centralised - Variation Type II - (Acceptance modification) | 27 Feb 2012 | EMEA/H/C/885/II/8/G |
| Prolia | Amgen Europe B.V. | Centralised - Variation Type II - (Acceptance modification) | 27 Feb 2012 | EMEA/H/C/1120/II/9 |
| Irbesartan HCT Zentiva (Ex-Winthrop) | SANOFI | Centralised - Renewal after maximum 5 years | 27 Feb 2012 | EMEA/H/C/783/R/49 |
| Clopidogrel Qualimed | Qualimed | Centralised - Update Type IA-IAin-IB - (Acceptance modification) | 23 Feb 2012 | |
| Resolor | Shire-Movetis NV | Centralised - Variation Type II - (Acceptance modification) | 23 Feb 2012 | EMEA/H/C/1012/II/14 |
| Januvia | Merck Sharp & Dohme Ltd | Centralised - Renewal after maximum 5 years | 23 Feb 2012 | EMEA/H/C/722/R/14 |
| Esmya | PregLem France SAS. | Centralised - Authorisation under art 127a - Decision addressed to Member State | 23 Feb 2012 | EMEA/H/C/2041 |
| Esmya | PregLem France SAS. | Centralised - Authorisation under art 127a - Decision addressed to Marketing Authorisation Holder | 23 Feb 2012 | EMEA/H/C/2041 |
| Victoza | Novo Nordisk A/S | Centralised - Variation Type II - (Acceptance modification) | 21 Feb 2012 | EMEA/H/C/1026/II/10 |
| Fertavid | Merck Sharp & Dohme Ltd. | Centralised - Update Type IA-IAin-IB - (Acceptance modification) | 21 Feb 2012 | |
| Visudyne | Novartis Europharm Ltd | Centralised - Update Type IA-IAin-IB - (Acceptance modification) | 21 Feb 2012 | |
| Aloxi | Helsinn Birex Pharmaceuticals Ltd | Centralised - Variation Type II - (Acceptance modification) | 21 Feb 2012 | EMEA/H/C/563/II/27 |
| Remicade | Janssen Biologics B.V. | Centralised - Variation Type II - (Acceptance modification) | 21 Feb 2012 | |
| Cubicin | Novartis Europharm Ltd | Centralised - Variation Type II - (Acceptance modification) | 21 Feb 2012 | EMEA/H/C/637/II/39 |
| Stelara | Janssen-Cilag International NV | Centralised - Variation Type II - (Acceptance modification) | 21 Feb 2012 | EMEA/H/C/958/II/21 |
| Vivanza | Bayer Pharma AG | Centralised - Variation Type II - (Acceptance modification) | 21 Feb 2012 | EMEA/H/C/488/WS/207 |
| Levitra | Bayer Pharma AG | Centralised - Variation Type II - (Acceptance modification) | 21 Feb 2012 | EMEA/H/C/475/WS/207 |
| Evra | Janssen-Cilag International NV | Centralised - Variation Type II - (Acceptance modification) | 21 Feb 2012 | EMEA/H/C/410/II/26 |
| RotaTeq | Sanofi Pasteur MSD, SNC | Centralised - Variation Type II - (Extension of indication for paediatric use) | 21 Feb 2012 | EMEA/H/C/669/II/31 |
| Cholestagel | Genzyme Europe B.V. | Centralised - Variation Type II - (Acceptance modification) | 21 Feb 2012 | EMEA/H/C/512/II/24 |
| ProQuad | Sanofi Pasteur MSD, SNC | Centralised - Variation Type II - (Acceptance modification) | 21 Feb 2012 | EMEA/H/C/622/II/53, 54 |
| Angiox | The Medicines Company UK Ltd | Centralised - Variation Type II - (Acceptance modification) | 21 Feb 2012 | |
| Kaletra | Abbott Laboratories | Centralised - Variation Type II - (Acceptance modification) | 21 Feb 2012 | EMEA/H/C/368/II/110, 114 |
| Sprycel | Bristol-Myers Squibb Pharma EEIG | Centralised - Variation Type II - (Acceptance modification) | 21 Feb 2012 | EMEA/H/C/709/II/31 |
| Mimpara | Amgen Europe B.V. | Centralised - Variation Type II - (Acceptance modification) | 21 Feb 2012 | |
| Zostavax | Sanofi Pasteur MSD, SNC | Centralised - Variation Type II - (Acceptance modification) | 21 Feb 2012 | EMEA/H/C/674/II/45 |
| PREZISTA | Janssen-Cilag International NV | Centralised - Variation Type II - (Acceptance modification) | 21 Feb 2012 | EMEA/H/C/707/II/44/G |
| Glivec | Novartis Europharm Ltd | Centralised - Variation Type II - (Acceptance modification) | 21 Feb 2012 | EMEA/H/C/406/II/70 |
| Vimpat | UCB Pharma SA. | Centralised - Annex II extension adding new number | 21 Feb 2012 | EMEA/H/C/863/X/27 |
| Vfend | Pfizer Ltd | Centralised - Renewal with additional 5 years (Annex IV) | 21 Feb 2012 | EMEA/H/C/387/II/79, EMEA/H/C/387/R/82 |
| Olanzapine Teva | Teva Pharma B.V. | Centralised - Update Type IA-IAin-IB - (Acceptance modification) | 17 Feb 2012 | |
| Tractocile | Ferring Pharmaceuticals A/S | Centralised - Update Type IA-IAin-IB - (Acceptance modification) | 17 Feb 2012 | |
| Herceptin | Roche Registration Limited | Centralised - Variation Type II - (Acceptance modification) | 17 Feb 2012 | |
| Aerinaze | Merck Sharp & Dohme Ltd | Centralised - Update Type IA-IAin-IB - (Acceptance modification) | 17 Feb 2012 | |
| Olazax | Glenmark Pharmaceuticals s.r.o. | Centralised - Variation Type IB - (Worksharing) | 17 Feb 2012 | EMEA/H/C/1087/WS/202 |
| Rivastigmine 1 A Pharma | 1 A Pharma GmbH | Centralised - Variation Type II - (Acceptance modification) | 17 Feb 2012 | EMEA/H/C/1181/II/5, 6/G |
| Rivastigmine Sandoz | Sandoz Pharmaceuticals GmbH | Centralised - Variation Type II - (Acceptance modification) | 17 Feb 2012 | EMEA/H/C/1183/II/5, 6/G |
| Neoclarityn | Merck Sharp & Dohme Ltd. | Centralised - Update Type IA-IAin-IB - (Acceptance modification) | 17 Feb 2012 | |
| Faslodex | AstraZeneca UK Limited | Centralised - Variation Type II - (Acceptance modification) | 17 Feb 2012 | EMEA/H/C/540/II/33, 34 |
| Isentress | Merck Sharp & Dohme Limited | Centralised - Variation Type II - (Acceptance modification) | 17 Feb 2012 | EMEA/H/C/860/II/25 |
| Gliolan | medac Gesellschaft für klinische Spezialpräparate mbH | Centralised - Update Type IA+IB - (Acceptance modification) | 17 Feb 2012 | |
| Elonva | N.V. Organon | Centralised - Update Type IA-IAin-IB - (Acceptance modification) | 17 Feb 2012 | |
| Myocet | Cephalon Europe | Centralised - Update Type IA-IAin-IB - (Acceptance modification) | 17 Feb 2012 | |
| Fablyn | Pfizer Limited | Centralised - Transfer Marketing Authorisation Holder | 17 Feb 2012 | EMEA/H/C/977/T/3 |
| Replagal | Shire Human Genetic Therapies AB | Centralised - Annual reassessment | 17 Feb 2012 | EMEA/H/C/369/S/68 |
| Zelboraf | Roche Registration Limited | Centralised - Authorisation | 17 Feb 2012 | EMEA/H/C/2409 |
| Vepacel | Baxter Innovations GmbH | Centralised - Authorisation | 17 Feb 2012 | EMEA/H/C/2089 |
| Vectibix | Amgen Europe B.V. | Centralised - Annual renewal of conditional autorisation | 17 Feb 2012 | EMEA/H/C/741/R/34 |
| Caprelsa | AstraZeneca AB | Centralised - Authorisation under art 127a - Decision addressed to Member State | 17 Feb 2012 | EMEA/H/C/2315 |
| Caprelsa | AstraZeneca AB | Centralised - Conditional authorisation of an orphan medicinal product with Annex IV | 17 Feb 2012 | EMEA/H/C/2315 |
| Colobreathe | Forest Laboratories UK Ltd | Centralised - Authorisation under art 127a - Decision addressed to Member State | 17 Feb 2012 | EMEA/H/C/1225 |
| NULOJIX | Bristol-Myers Squibb Pharma EEIG | Centralised - Variation Type II - (Acceptance modification) | 14 Feb 2012 | EMEA/H/C/2098/II/4 |
| Circadin | RAD Neurim Pharmaceuticals EEC Limited | Centralised - Update Type IA-IAin-IB - (Acceptance modification) | 13 Feb 2012 | |
| Clopidogrel Acino Pharma GmbH | Acino Pharma GmbH | Centralised - Withdrawal on holders request | 13 Feb 2012 | |
| Colobreathe | Forest Laboratories UK Ltd | Centralised - Authorisation under art 127a - Decision addressed to Marketing Authorisation Holder | 13 Feb 2012 | EMEA/H/C/1225 |
| Cystadane | Orphan Europe S.a.r.l. | Centralised - Renewal with additional 5 years (Annex IV) | 13 Feb 2012 | EMEA/H/C/678/R/6 |
| Aerius | Merck Sharp & Dohme Ltd. | Centralised - Update Type IA-IAin-IB - (Acceptance modification) | 9 Feb 2012 | |
| Azomyr | Merck Sharp & Dohme Limited | Centralised - Update Type IA-IAin-IB - (Acceptance modification) | 9 Feb 2012 | |
| Olazax Disperzi | Glenmark Pharmaceuticals s.r.o. | Centralised - Variation Type IB - (Worksharing) | 9 Feb 2012 | EMEA/H/C/1088/IB/WS/202 |
| Rivastigmine HEXAL | HEXAL AG | Centralised - Variation Type II - (Acceptance modification) | 9 Feb 2012 | |
| Clopidogrel Acino Pharma | Acino Pharma GmbH | Centralised - Withdrawal on holders request | 9 Feb 2012 | |
| Procoralan | Les Laboratoires Servier | Centralised - Variation Type II - (Acceptance modification) | 9 Feb 2012 | EMEA/H/C/597/II/18 |
| Clopidogrel Hexal | Acino Pharma GmbH | Centralised - Withdrawal on holders request | 9 Feb 2012 | |
| Prepandemic Influenza | Novartis Vaccines and Diagnostics S.r.l. | Centralised - Variation Type II - (Acceptance modification) | 9 Feb 2012 | EMEA/H/C/2269/II/3 |
| Pradaxa | Boehringer Ingelheim International GmbH | Centralised - Variation Type II - (Acceptance modification) | 9 Feb 2012 | EMEA/H/C/829/II/23/127a/MAH |
| Prepandemic Influenza | Novartis Vaccines and Diagnostics S.r.l. | Centralised - Update Type IA-IAin-IB - (Acceptance modification) | 9 Feb 2012 | |
| Arzerra | Glaxo Group Ltd | Centralised - Annual renewal of conditional autorisation | 9 Feb 2012 | EMEA/H/C/1131/R/11 |
| Dificlir | FGK Representative Service GmbH | Centralised - Transfer Marketing Authorisation Holder | 6 Feb 2012 | EMEA/H/C/2087/T/1 |
| Corlentor | Les Laboratoires Servier | Centralised - Variation Type II - (Acceptance modification) | 6 Feb 2012 | EMEA/H/C/598/II/18 |
| Yellox | Croma-Pharma GmbH | Centralised - Update Type IA-IAin-IB - (Acceptance modification) | 6 Feb 2012 | |
| Votubia | Novartis Europharm Limited | Centralised - Variation Type II - (Acceptance modification) | 6 Feb 2012 | |
| Rilonacept Regeneron | Regeneron UK Limited | Centralised - Variation Type II - (Acceptance modification) | 6 Feb 2012 | EMEA/H/C/1047/II/5 |
| Erbitux | Merck KGaA | Centralised - Variation Type II - (Acceptance modification) | 6 Feb 2012 | EMEA/H/C/558/II/48 |
| Sonata | Meda AB | Centralised - Variation Type II - (Acceptance modification) | 6 Feb 2012 | EMEA/H/C/227/II/31/G |
| Aflunov | Novartis Vaccines and Diagnostics S.r.l. | Centralised - Variation Type II - (Acceptance modification) | 6 Feb 2012 | EMEA/H/C/2094/II/3 |
| Ambirix | GlaxoSmithKline Biologicals S.A. | Centralised - Variation Type II - (Acceptance modification) | 6 Feb 2012 | EMEA/H/C/426/II/34 |
| Tevagrastim | Teva GmbH | Centralised - Update Type IA-IAin-IB - (Acceptance modification) | 6 Feb 2012 | |
| Simponi | Janssen Biologics B.V. | Centralised - Variation Type II - (Acceptance modification) | 6 Feb 2012 | EMEA/H/C/992/II/27 |
| Prialt | Eisai Limited | Centralised - Update Type IA-IAin-IB - (Acceptance modification) | 6 Feb 2012 | |
| Olanzapine Apotex | Apotex Europe B.V. | Centralised - Update Type IA-IAin-IB - (Acceptance modification) | 6 Feb 2012 | |
| Rapamune | Pfizer Limited | Centralised - Update Type IA-IAin-IB - (Acceptance modification) | 6 Feb 2012 | |
| Taxotere | Aventis Pharma S.A. | Centralised - Variation Type II - (Acceptance modification) | 6 Feb 2012 | EMEA/H/C/73/II/100 |
| Aclasta | Novartis Europharm Ltd | Centralised - Variation Type II - Art 127a - Decision addressed to the Marketing Authorisation Holder | 6 Feb 2012 | EMEA/H/C/595/II/28 |
| Intanza | Sanofi Pasteur MSD SNC | Centralised - Update Type IA-IAin-IB - (Acceptance modification) | 6 Feb 2012 | |
| Remicade | Janssen Biologics B.V. | Centralised - Update Type IA-IAin-IB - (Acceptance modification) | 6 Feb 2012 | |
| Optimark | Covidien Deutschland GmbH | Centralised - Update Type IA-IAin-IB - (Acceptance modification) | 6 Feb 2012 | |
| Orencia | Bristol-Myers Squibb Pharma EEIG | Centralised - Update Type IA-IAin-IB - (Acceptance modification) | 6 Feb 2012 | |
| Avastin | Roche Registration Limited | Centralised - Variation Type II - (Acceptance modification) | 6 Feb 2012 | EMEA/H/C/582/II/48 |
| Temodal | Schering Plough Europe | Centralised - Transfer Marketing Authorisation Holder | 31 Jan 2012 | EMEA/H/C/229/T/58 |
| Viread | Gilead Sciences International Limited | Centralised - Variation Type II - (Acceptance modification) | 31 Jan 2012 | EMEA/H/C/419/II/104 |
| Docetaxel Winthrop | Aventis Pharma S.A. | Centralised - Variation Type II - (Acceptance modification) | 31 Jan 2012 | EMEA/H/C/808/II/22 |
| Tyverb | Glaxo Group Limited | Centralised - Update Type IA-IAin-IB - (Acceptance modification) | 31 Jan 2012 | |
| Xyrem | UCB Pharma Ltd. | Centralised - Update Type IA-IAin-IB - (Acceptance modification) | 31 Jan 2012 | |
| Synflorix | GlaxoSmithKline Biologicals S.A. | Centralised - Variation Type II - (Acceptance modification) | 31 Jan 2012 | EMEA/H/C/973/II/29 |
| Xgeva | Amgen Europe B.V. | Centralised - Update Type IA-IAin-IB - (Acceptance modification) | 31 Jan 2012 | |
| InductOs | Medtronic Biopharma BV | Centralised - Update Type IA-IAin-IB - (Acceptance modification) | 31 Jan 2012 | |
| Yondelis | Pharma Mar, S.A. | Centralised - Variation Type II - (Acceptance modification) | 31 Jan 2012 | EMEA/H/C/773/II/22/G |
| Teysuno | Nordic Group BV | Centralised - Variation Type II - (Acceptance modification) | 31 Jan 2012 | EMEA/H/C/1242/II/2 |
| Docetaxel Mylan | Mylan S.A.S | Centralised - Authorisation | 31 Jan 2012 | EMEA/H/C/2317 |
| Leflunomide medac | medac Gesellschaft für klinische Spezialpräparate mbH | Centralised - Update Type IA-IAin-IB - (Acceptance modification) | 30 Jan 2012 | |
| Xiliarx | Novartis Europharm Ltd | Centralised - Variation Type II - (Acceptance modification) | 30 Jan 2012 | EMEA/H/C/1051/WS/187 |
| Jalra | Novartis Europharm Ltd | Centralised - Variation Type II - (Acceptance modification) | 30 Jan 2012 | EMEA/H/C/1048/WS/187 |
| Galvus | Novartis Europharm Ltd | Centralised - Variation Type II - (Acceptance modification) | 30 Jan 2012 | EMEA/H/C/771/WS/187 |
| alli | Glaxo Group Limited | Centralised - Update Type IA-IAin-IB - (Acceptance modification) | 30 Jan 2012 | |
| IDflu | Sanofi Pasteur SA | Centralised - Update Type IA-IAin-IB - (Acceptance modification) | 30 Jan 2012 | |
| Resolor | Shire-Movetis NV | Centralised - Variation Type II - (Acceptance modification) | 30 Jan 2012 | EMEA/H/C/1012/II/16 |
| Mimpara | Amgen Europe B.V. | Centralised - Update Type IA-IAin-IB - (Acceptance modification) | 30 Jan 2012 | |
| Simulect | Novartis Europharm Ltd | Centralised - Variation Type II - (Acceptance modification) | 30 Jan 2012 | |
| Celvapan | Baxter AG | Centralised - Update Type IA-IAin-IB - (Acceptance modification) | 24 Jan 2012 | |
| Adenuric | Menarini International Operations Luxembourg S.A. | Centralised - Variation Type II - (Acceptance modification) | 24 Jan 2012 | EMEA/H/C/777/II/23 |
| Cerezyme | Genzyme Europe B.V. | Centralised - Update Type IA-IAin-IB - (Acceptance modification) | 24 Jan 2012 | |
| Dynastat | Pfizer Ltd | Centralised - Renewal after maximum 5 years | 24 Jan 2012 | EMEA/H/C/381/R/45 |
| Humira | Abbott Laboratories Ltd | Centralised - Variation Type II - (Acceptance modification) | 20 Jan 2012 | EMEA/H/C/481/II/87 |
| Champix | Pfizer Ltd | Centralised - Variation Type II - (Acceptance modification) | 20 Jan 2012 | EMEA/H/C/699/II/36 |
| Glivec | Novartis Europharm Ltd | Centralised - Variation Type II - (Acceptance modification) | 20 Jan 2012 | EMEA/H/C/406/II/72, 73 |
| Sprycel | Bristol-Myers Squibb Pharma EEIG | Centralised - Variation Type II - (Acceptance modification) | 20 Jan 2012 | EMEA/H/C/709/II/30 |
| Vectibix | Amgen Europe B.V. | Centralised - Variation Type II - (Acceptance modification) | 20 Jan 2012 | EMEA/H/C/741/II/32 |
| Zostavax | Sanofi Pasteur MSD, SNC | Centralised - Variation Type II - (Acceptance modification) | 20 Jan 2012 | EMEA/H/C/674/II/37 |
| Ameluz | Biofrontera Bioscience GmbH | Corrigendum | 20 Jan 2012 | |
| Clopidogrel ratiopharm GmbH | Acino Pharma GmbH | Centralised - Update Type IA-IAin-IB - (Acceptance modification) | 20 Jan 2012 | |
| Clopidogrel Acino Pharma | Acino Pharma GmbH | Centralised - Update Type IA-IAin-IB - (Acceptance modification) | 20 Jan 2012 | |
| ChondroCelect | TiGenix NV | Centralised - Update Type IA-IAin-IB - (Acceptance modification) | 20 Jan 2012 | |
| Xelevia | Merck Sharp & Dohme Ltd | Centralised - Renewal after maximum 5 years | 20 Jan 2012 | EMEA/H/C/762/R/31 |
| Rebif | Merck Serono Europe Limited | Centralised - Variation Type II - (Acceptance modification) | 20 Jan 2012 | EMEA/H/C/136/II/88/G |
| Irbesartan Zentiva | SANOFI | Centralised - Renewal after maximum 5 years | 20 Jan 2012 | EMEA/H/C/785/R/41 |
| Suboxone | RB Pharmaceuticals Limited | Corrigendum | 20 Jan 2012 | |
| Trajenta | Boehringer Ingelheim International GmbH | Corrigendum | 13 Jan 2012 | |
| Olanzapine Mylan | Generics [UK] Limited | Centralised - Update Type IA-IAin-IB - (Acceptance modification) | 13 Jan 2012 | |
| Temodal | Schering Plough Europe | Centralised - Update Type IA-IAin-IB - (Acceptance modification) | 13 Jan 2012 | |
| Twinrix Paediatric | GlaxoSmithKline Biologicals S.A. | Centralised - Variation Type II - (Acceptance modification) | 13 Jan 2012 | EMEA/H/C/129/WS/153, EMEA/H/C/129/II/65 |
| Twinrix Adult | GlaxoSmithKline Biologicals S.A. | Centralised - Variation Type II - (Acceptance modification) | 13 Jan 2012 | EMEA/H/C/112/WS/153, EMEA/H/C/112/II64 |
| Erbitux | Merck KGaA | Centralised - Variation Type II - (Acceptance modification) | 13 Jan 2012 | EMEA/H/C/558/II/47 |
| NovoSeven | Novo Nordisk A/S | Centralised - Variation Type II - (Acceptance modification) | 13 Jan 2012 | EMEA/H/C/74/II/69 |
| Stelara | Janssen-Cilag International NV | Centralised - Variation Type II - (Acceptance modification) | 13 Jan 2012 | |
| Ilaris | Novartis Europharm Limited | Centralised - Annual reassessment | 13 Jan 2012 | EMEA/H/C/1109/S/12 |
| Diacomit | Biocodex | Centralised - Annual renewal of conditional autorisation | 13 Jan 2012 | EMEA/H/C/664/R/11 |
| Desloratadine ratiopharm | ratiopharm GmbH | Centralised - Authorisation | 13 Jan 2012 | EMEA/H/C/2404 |
| Desloratadine Actavis | Actavis Group PTC ehf. | Centralised - Authorisation | 13 Jan 2012 | EMEA/H/C/2435 |
| Revlimid | Celgene Europe Limited | Centralised - Art. 20 - (Maintain) Title IV | 13 Jan 2012 | EMEA/H/C/717/A-20/48 |
| Revlimid | Celgene Europe Limited | Centralised - Update Type IA-IAin-IB - (Acceptance modification) | 9 Jan 2012 | |
| Leganto | UCB Manufacturing Ireland Ltd. | Centralised - Variation Type II - (Acceptance modification) | 9 Jan 2012 | EMEA/H/C/2380/II/1 |
| Pumarix | GlaxoSmithKline Biologicals S.A. | Centralised - Variation Type II - (Acceptance modification) | 9 Jan 2012 | EMEA/H/C/1212/WS/153 |
| Inovelon | Eisai Limited | Centralised - Renewal after maximum 5 years | 9 Jan 2012 | EMEA/H/C/660/R/20 |
| Sutent | Pfizer Ltd | Centralised - Renewal with additional 5 years (Annex IV) | 9 Jan 2012 | EMEA/H/C/687/R/30, EMEA/H/C/687/II/31/G |
| Efavirenz Teva | Teva Pharma BV | Centralised - Authorisation | 9 Jan 2012 | EMAE/H/C/2352 |
| Arzerra | Glaxo Group Ltd | Centralised - Variation Type II - (Acceptance modification) | 22 Dec 2011 | EMEA/H/C/1131/II/9, 10 |
| Vidaza | Celgene Europe Ltd | Centralised - Variation Type II - (Acceptance modification) | 22 Dec 2011 | EMEA/H/C/978/II/11 |
| Ivemend | Merck Sharp & Dohme Limited | Centralised - Variation Type II - (Acceptance modification) | 22 Dec 2011 | EMEA/H/C/743/WS/180 |
| Ristaben | Merck Sharp & Dohme Ltd. | Centralised - Variation Type II - (Acceptance modification) | 22 Dec 2011 | EMEA/H/C/1234/WS/179 |
| Renvela | Genzyme Europe B.V. | Centralised - Variation Type II - (Acceptance modification) | 22 Dec 2011 | EMEA/H/C/993/WS/188 |
| Prepandrix | GlaxoSmithKline Biologicals S.A. | Centralised - Variation Type II - (Acceptance modification) | 22 Dec 2011 | EMEA/H/C/822/WS/153, 161/G |
| Renagel | Genzyme Europe B.V. | Centralised - Variation Type II - (Acceptance modification) | 22 Dec 2011 | |
| Nevanac | Alcon Laboratories (UK) Ltd. | Centralised - Variation Type II - (Acceptance modification) | 22 Dec 2011 | EMEA/H/C/818/II/7/G |
| Zavesca | Actelion Registration Ltd | Centralised - Variation Type II - (Acceptance modification) | 22 Dec 2011 | EMEA/H/C/435/II/34 |
| Onglyza | Bristol Myers Squibb/AstraZeneca EEIG | Centralised - Variation Type II - (Acceptance modification) | 22 Dec 2011 | EMEA/H/C/1039/II/14 |
| Norvir | Abbott Laboratories Ltd | Centralised - Variation Type II - (Acceptance modification) | 22 Dec 2011 | EMEA/H/C/127/II/111 |
| Xelevia | Merck Sharp & Dohme Ltd | Centralised - Variation Type II - (Acceptance modification) | 22 Dec 2011 | EMEA/H/C/762/WS/179 |
| Ambirix | GlaxoSmithKline Biologicals S.A. | Centralised - Variation Type II - (Acceptance modification) | 22 Dec 2011 | EMEA/H/C/426/WS/153 |
| Ozurdex | Allergan Pharmaceuticals Ireland | Centralised - Variation Type II - (Acceptance modification) | 22 Dec 2011 | EMEA/H/C/1140/II/5 |
| Pandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) GlaxoSmithKline Biologicals | GlaxoSmithKline Biologicals S.A. | Centralised - Variation Type II - (Acceptance modification) | 22 Dec 2011 | EMEA/H/C/1206/WS/153, 161/G |
| Januvia | Merck Sharp & Dohme Ltd | Centralised - Variation Type II - (Acceptance modification) | 22 Dec 2011 | EMEA/H/C/722/WS/179 |
| Pradaxa | Boehringer Ingelheim International GmbH | Centralised - Variation Type II - Art 127a - Decision addressed to Member State | 22 Dec 2011 | EMEA/H/C/829/II/22/127a to MS |
| Invanz | Merck Sharp & Dohme Ltd | Centralised - Renewal after maximum 5 years | 22 Dec 2011 | EMEA/H/C/389/R/36 |
| Topotecan Eagle | Eagle Laboratories Limited | Centralised - Authorisation under art 127a - Decision addressed to Member State | 22 Dec 2011 | EMEA/H/C/2261 |
| Topotecan Eagle | Eagle Laboratories Limited | Centralised - Authorisation under art 127a - Decision addressed to Marketing Authorisation Holder | 22 Dec 2011 | EMEA/H/C/2261 |
| Repaglinide Accord | Accord Healthcare Limited | Centralised - Authorisation | 22 Dec 2011 | EMEA/H/C/2318 |
| Multaq | SANOFI | Centralised - Art. 20 - Modification art 127a addressed to Member States | 22 Dec 2011 | EMEA/H/C/1043/A-20/5 |
| Multaq | SANOFI | Centralised - Art. 20 - Modification art 127a addressed to Marketing Autorisation Holder | 22 Dec 2011 | EMEA/H/C/1043/A-20/5 |
| Competact | Takeda Global Research and Development Centre (Europe) Ltd | Centralised - Art. 20 - Modification art 127a addressed to Member States | 22 Dec 2011 | EMEA/H/C/655/A-20/30 |
| Competact | Takeda Global Research and Development Centre (Europe) Ltd | Centralised - Art. 20 - Modification art 127a addressed to Marketing Autorisation Holder | 22 Dec 2011 | EMEA/H/C/655/A-20/30 |
| Glubrava | Takeda Global Research and Development Centre (Europe) Ltd | Centralised - Art. 20 - Modification art 127a addressed to Member States | 22 Dec 2011 | EMEA/H/C/893/A-20/15 |
| Actos | Takeda Global Research and Development Centre (Europe) Ltd | Centralised - Art. 20 - Modification art 127a addressed to Marketing Autorisation Holder | 22 Dec 2011 | EMEA/H/C/285/A-20/46 |
| Glustin | Takeda Global Research and Development Centre (Europe) Ltd | Centralised - Art. 20 - Modification art 127a addressed to Member States | 22 Dec 2011 | EMEA/H/C/286/A-20/44 |
| Actos | Takeda Global Research and Development Centre (Europe) Ltd | Centralised - Art. 20 - Modification art 127a addressed to Member States | 22 Dec 2011 | EMEA/H/C/285/A-20/46 |
| Glubrava | Takeda Global Research and Development Centre (Europe) Ltd | Centralised - Art. 20 - Modification art 127a addressed to Marketing Autorisation Holder | 22 Dec 2011 | EMEA/H/C/893/A-20/15 |
| Glustin | Takeda Global Research and Development Centre (Europe) Ltd | Centralised - Art. 20 - Modification art 127a addressed to Marketing Autorisation Holder | 22 Dec 2011 | EMEA/H/C/286/A-20/44 |
| Tandemact | Takeda Global Research and Development Centre (Europe) Ltd. | Centralised - Art. 20 - Modification art 127a addressed to Member States | 22 Dec 2011 | EMEA/H/C/680/A-20/22 |
| Tandemact | Takeda Global Research and Development Centre (Europe) Ltd. | Centralised - Art. 20 - Modification art 127a addressed to Marketing Autorisation Holder | 22 Dec 2011 | EMEA/H/C/680/A-20/22 |
| Humira | Abbott Laboratories Ltd | Centralised - Variation Type II - (Acceptance modification) | 19 Dec 2011 | EMEA/H/C/481/II/83 |
| Levemir | Novo Nordisk A/S | Centralised - Variation Type II - (Acceptance modification) | 19 Dec 2011 | EMEA/H/C/528/II/52 |
| Kentera | Nicobrand Limited | Centralised - Update Type IA-IAin-IB - (Acceptance modification) | 19 Dec 2011 | |
| Pandemrix | GlaxoSmithKline Biologicals S.A. | Centralised - Variation Type II - (Acceptance modification) | 19 Dec 2011 | EMEA/H/C/832/WS/153 |
| APTIVUS | Boehringer Ingelheim International GmbH | Centralised - Variation Type II - (Acceptance modification) | 19 Dec 2011 | EMEA/H/C/631/II/52 |
| Fendrix | GlaxoSmithKline Biologicals S.A. | Centralised - Variation Type II - (Acceptance modification) | 19 Dec 2011 | EMEA/H/C/550/WS/153 |
| Synagis | Abbott Laboratories Ltd | Centralised - Variation Type II - (Acceptance modification) | 19 Dec 2011 | EMEA/H/C/257/II/64, 65 |
| Tesavel | Merck Sharp & Dohme Ltd | Centralised - Variation Type II - (Acceptance modification) | 19 Dec 2011 | EMEA/H/C/910/II/WS/179 |
| Tracleer | Actelion Registration Ltd | Centralised - Variation Type II - (Acceptance modification) | 19 Dec 2011 | |
| Herceptin | Roche Registration Limited | Centralised - Variation Type II - (Acceptance modification) | 19 Dec 2011 | EMEA/H/C/278/II/57 |
| Noxafil | Merck Sharp & Dohme Ltd. | Centralised - Variation Type II - (Acceptance modification) | 19 Dec 2011 | |
| Somavert | Pfizer Ltd | Centralised - Variation Type II - (Acceptance modification) | 19 Dec 2011 | EMEA/H/C/409/II/51 |
| Pandemic influenza vaccine H5N1 BAXTER | Baxter AG | Centralised - Variation Type II - (Acceptance modification) | 19 Dec 2011 | EMEA/H/C/1200/II/3/G |
| Silgard | Merck Sharp & Dohme Ltd | Centralised - Variation Type II - (Acceptance modification) | 19 Dec 2011 | EMEA/H/C/732/II/WS/142 |
| Gardasil | Sanofi Pasteur MSD, SNC | Centralised - Variation Type II - (Acceptance modification) | 19 Dec 2011 | EMEA/H/C/703/II/WS/142 |
| Exjade | Novartis Europharm Ltd | Centralised - Variation Type II - (Acceptance modification) | 19 Dec 2011 | EMEA/H/C/670/II/22 |
| Tasigna | Novartis Europharm Ltd | Centralised - Variation Type II - (Acceptance modification) | 19 Dec 2011 | EMEA/H/C/798/II/37 |
| Emend | Merck Sharp & Dohme Ltd | Centralised - Variation Type II - (Acceptance modification) | 19 Dec 2011 | EMEA/H/C/527/WS/180 |
| Hepsera | Gilead Sciences International Limited | Centralised - Variation Type II - (Acceptance modification) | 19 Dec 2011 | EMEA/H/C/485/II/52/G |
| Clopidogrel Acino Pharma GmbH | Acino Pharma GmbH | Centralised - Update Type IA-IAin-IB - (Acceptance modification) | 19 Dec 2011 | |
| Advate | Baxter AG | Centralised - Annex II extension adding new number | 19 Dec 2011 | EMEA/H/C/520/X/41 |
| Avastin | Roche Registration Limited | Centralised - Variation Type II - (Acceptance modification) | 19 Dec 2011 | EMEA/H/C/582/II/41, 42 |
| Mabthera | Roche Registration Limited | Centralised - Variation Type II - (Acceptance modification) | 14 Dec 2011 | EMEA/H/C/165/II/76 |
| Clopidogrel ratiopharm | Acino Pharma GmbH | Centralised - Update Type IA-IAin-IB - (Acceptance modification) | 14 Dec 2011 | |
| Vfend | Pfizer Ltd | Centralised - Variation Type II - (Acceptance modification) | 14 Dec 2011 | |
| Glivec | Novartis Europharm Ltd | Centralised - Variation Type II - (Acceptance modification) | 14 Dec 2011 | EMEA/H/C/406/II/71 |
| Volibris | Glaxo Group Ltd | Centralised - Variation Type II - (Acceptance modification) | 14 Dec 2011 | EMEA/H/C/839/II/20 |
| Pegasys | Roche Registration Limited | Centralised - Variation Type II - (Acceptance modification) | 14 Dec 2011 | EMEA/H/C/395/II/55 |
| Emselex | Novartis Europharm Ltd | Centralised - Variation Type II - (Acceptance modification) | 14 Dec 2011 | EMEA/H/C/554/II/47 |
| Simulect | Novartis Europharm Ltd | Centralised - Variation Type II - (Acceptance modification) | 14 Dec 2011 | EMEA/H/C/207/II/63, 64, 65 |
| Viread | Gilead Sciences International Limited | Centralised - Renewal after maximum 5 years | 14 Dec 2011 | EMEA/H/C/419/R/103 |
| Lucentis | Novartis Europharm Ltd | Centralised - Renewal with additional 5 years (Annex IV) | 14 Dec 2011 | EMEA/H/C/715/R/24 |
| Insulatard | Novo Nordisk A/S | Centralised - Update Type IA-IAin-IB - (Acceptance modification) | 14 Dec 2011 | |
| GILENYA | Novartis Europharm Ltd | Centralised - Variation Type II - Art 127a - Decision addressed to Member State | 14 Dec 2011 | EMEA/H/C/2202/II/2 |
| GILENYA | Novartis Europharm Ltd | Centralised - Variation Type II - Art 127a - Decision addressed to the Marketing Authorisation Holder | 14 Dec 2011 | EMEA/H/C/2202/II/2 |
| Levetiracetam SUN | Sun Pharmaceutical Industries Europe BV | Centralised - Authorisation | 14 Dec 2011 | EMEA/H/C/2051 |
| Ameluz | Biofrontera Bioscience GmbH | Centralised - Authorisation | 14 Dec 2011 | EMEA/H/C/2204 |
| Xarelto | Bayer Pharma AG | Centralised - Annex II extension under art 127a - Decision addressed to Member State | 14 Dec 2011 | EMEA/H/C/944/X/10 & EMEA/H/C/944/II-12 |
| Vistide | Gilead Sciences International Limited | Centralised - Art. 20 - temporary measures - suspension | 12 Dec 2011 | EMEA/H/C/121/A-20/ |
| Xiliarx | Novartis Europharm Ltd | Corrigendum | 9 Dec 2011 | |
| Xiliarx | Novartis Europharm Ltd | Corrigendum | 9 Dec 2011 | |
| Zeffix | Glaxo Group Ltd. | Centralised - Update Type IA-IAin-IB - (Acceptance modification) | 9 Dec 2011 | |
| Rasilamlo | Novartis Europharm Ltd | Centralised - Variation Type II - (Acceptance modification) | 9 Dec 2011 | EMEA/H/C/2073/WS/145, 146, EMEA/H/C/2073/II/3 |
| Xarelto | Bayer Pharma AG | Centralised - Annex II extension under art 127a - Decision addressed to marketing autorisation holder | 9 Dec 2011 | EMEA/H/C/944/X/10 & EMEA/H/C/944/II-12 |
| Ceplene | EpiCept GmbH | Centralised - Art. 20 - (Amend) With Annex IV | 8 Dec 2011 | EMEA/H/C/796/A-20/11 |
| Luminity | Lantheus MI UK Limited | Centralised - Art. 20 - temporary measures - suspension | 7 Dec 2011 | EMEA/H/C/654/A-20/13 |
| Torisel | Pfizer Limited | Centralised - Art. 20 - (Amend) With Annex IV | 7 Dec 2011 | EMEA/H/C/799/A-20/45 |
| Ecalta | Pfizer Limited | Centralised - Art. 20 - temporary measures - suspension | 7 Dec 2011 | EMEA/H/C/788/A-20/19 |
| Prometax | Novartis Europharm Ltd | Centralised - Variation Type IB - (Worksharing) | 7 Dec 2011 | EMEA/H/C/225/WS/178 |
| Pantoloc Control | Nycomed GmbH | Centralised - Variation Type II - (Acceptance modification) | 7 Dec 2011 | EMEA/H/C/1100/WS/122 |
| Pantecta Control | Nycomed GmbH | Centralised - Variation Type II - (Acceptance modification) | 7 Dec 2011 | EMEA/H/C/1099/WS/122 |
| Clopidogrel Teva Pharma | Teva Pharma B.V. | Centralised - Update Type IA-IAin-IB - (Acceptance modification) | 7 Dec 2011 | |
| Ipreziv | Takeda Global Research and Development Centre (Europe) Ltd | Centralised - Authorisation of a duplicate | 7 Dec 2011 | EMEA/H/C/2517 |
| Edarbi | Takeda Global Research and Development Centre (Europe) Ltd | Centralised - Authorisation | 7 Dec 2011 | EMEA/H/C/2293 |
| Somac Control | Nycomed GmbH | Centralised - Variation Type II - (Acceptance modification) | 5 Dec 2011 | EMEA/H/C/1098/WS/122 |
| Controloc Control | Nycomed GmbH | Centralised - Variation Type II - (Acceptance modification) | 5 Dec 2011 | EMEA/H/C/1097/WS/122 |
| Pantozol Control | Nycomed GmbH | Centralised - Variation Type II - (Acceptance modification) | 5 Dec 2011 | EMEA/H/C/1013/WS/122 |
| Cervarix | GlaxoSmithKline Biologicals S.A. | Centralised - Variation Type II - (Acceptance modification) | 5 Dec 2011 | EMEA/H/C/721/II/21, EMEA/H/C/721II/22 |
| Xenical | Roche Registration Limited | Centralised - Update Type IA-IAin-IB - (Acceptance modification) | 5 Dec 2011 | |
| Clopidogrel Hexal | Acino Pharma GmbH | Centralised - Update Type IA-IAin-IB - (Acceptance modification) | 5 Dec 2011 | |
| Aranesp | Amgen Europe B.V. | Centralised - Variation Type II - (Acceptance modification) | 5 Dec 2011 | EMEA/H/C/332/II/92/G |
| Clopidogrel Acino | Acino Pharma GmbH | Centralised - Update Type IA-IAin-IB - (Acceptance modification) | 5 Dec 2011 | |
| Levetiracetam Actavis Group | Actavis Group PTC ehf. | Centralised - Authorisation | 5 Dec 2011 | EMEA/H/C/2305 |
| Dificlir | FGK Representative Service GmbH | Centralised - Authorisation | 5 Dec 2011 | EMEA/H/C/2087 |
| Pradaxa | Boehringer Ingelheim International GmbH | Centralised - Variation Type II - Art 127a - Decision addressed to the Marketing Authorisation Holder | 28 Nov 2011 | EMEA/H/C/829/II/22/127a to MAH |
| Zutectra | Biotest Pharma GmbH | Centralised - Update Type IA-IAin-IB - (Acceptance modification) | 28 Nov 2011 | |
| Zyllt | KRKA, d.d., Novo mesto | Centralised - Update Type IA-IAin-IB - (Acceptance modification) | 28 Nov 2011 | |
| Xigris | Eli Lilly Nederland B.V. | Centralised - Withdrawal on holders request | 28 Nov 2011 | |
| Dasselta | KRKA, d.d., Novo mesto | Centralised - Authorisation | 28 Nov 2011 | EMEA/H/C/2310 |
| Eviplera | Gilead Sciences International Limited | Centralised - Authorisation | 28 Nov 2011 | EMEA/H/C/2312 |
| EDURANT | Janssen Cilag International NV | Centralised - Authorisation | 28 Nov 2011 | EMEA/H/C/2264 |
| Tamiflu | Roche Registration Limited | Centralised - Annex II extension adding new number | 28 Nov 2011 | EMEA/H/C/402/X/85 |
| Emend | Merck Sharp & Dohme Ltd | Centralised - Annex II extension adding new number | 28 Nov 2011 | EMEA/H/C/527/X/28 |
| Vidaza | Celgene Europe Ltd | Centralised - Art. 20 - temporary measures - suspension | 24 Nov 2011 | EMEA/H/C/978/A-20/17 |
| VELCADE | Janssen-Cilag International NV | Centralised - Art. 20 - temporary measures - suspension | 24 Nov 2011 | EMEA/H/C/539/A-20/ |
| Busilvex | Pierre Fabre Médicament | Centralised - Art. 20 - temporary measures - suspension | 24 Nov 2011 | |
| Caelyx | Janssen-Cilag International NV | Centralised - Art. 20 - temporary measures - suspension | 24 Nov 2011 | EMEA/H/C/89/A-20/61 |
| Zypadhera | Eli Lilly Nederland B.V. | Centralised - Variation Type II - (Acceptance modification) | 24 Nov 2011 | EMEA/H/C/890/WS/127 |
| ReFacto AF | Pfizer Limited | Centralised - Update Type IA-IAin-IB - (Acceptance modification) | 24 Nov 2011 | |
| Zomarist | Novartis Europharm Ltd | Centralised - Variation Type II - (Acceptance modification) | 24 Nov 2011 | EMEA/H/C/1049/WS/125 |
| Adenuric | Menarini International Operations Luxembourg S.A. | Centralised - Update Type IA-IAin-IB - (Acceptance modification) | 24 Nov 2011 | |
| Eucreas | Novartis Europharm Ltd | Centralised - Variation Type II - (Acceptance modification) | 24 Nov 2011 | EMEA/H/C/807/WS/125 |
| Xiliarx | Novartis Europharm Ltd | Centralised - Variation Type II - (Acceptance modification) | 24 Nov 2011 | EMEA/H/C/1051/WS/125, 149 |
| Jalra | Novartis Europharm Ltd | Centralised - Variation Type II - (Acceptance modification) | 24 Nov 2011 | EMEA/H/C/1048/WS/125, 149 |
| Galvus | Novartis Europharm Ltd | Centralised - Variation Type II - (Acceptance modification) | 24 Nov 2011 | EMEA/H/C/771/WS/125, 149 |
| Zyprexa | Eli Lilly Nederland B.V. | Centralised - Variation Type II - (Acceptance modification) | 24 Nov 2011 | EMEA/H/C/115/WS/127 |
| Clopidogrel Teva Generics B.V. | Teva Generics B.V. | Centralised - Update Type IA-IAin-IB - (Acceptance modification) | 24 Nov 2011 | |
| Clopidogrel HCS | HCS bvba | Centralised - Update Type IA-IAin-IB - (Acceptance modification) | 24 Nov 2011 | |
| Zyprexa Velotab | Eli Lilly Nederland B.V. | Centralised - Variation Type II - (Acceptance modification) | 24 Nov 2011 | EMEA/H/C/287/WS/127 |
| Avastin | Roche Registration Limited | Centralised - Variation Type II - (Acceptance modification) | 24 Nov 2011 | EMEA/H/C/582/II/45 |
| Icandra | Novartis Europharm Ltd | Centralised - Variation Type II - (Acceptance modification) | 24 Nov 2011 | EMEA/H/C/1050/WS/125 |
| Intelence | Janssen-Cilag International NV | Centralised - Annex II extension adding new number | 24 Nov 2011 | EMEA/H/C/900/X/12 |
| Vimpat | UCB Pharma SA. | Centralised - Art. 20 - (Maintain) Title IV | 24 Nov 2011 | EMEA/H/C/863/A-20/26 |
| Soliris | Alexion Europe S.A.S. | Centralised - Variation Type II - Art 127a - Decision addressed to Member State | 24 Nov 2011 | EMEA/H/C/791/II/27 |
| Soliris | Alexion Europe S.A.S. | Centralised - Variation Type II - Art 127a - Decision addressed to the Marketing Authorisation Holder | 24 Nov 2011 | EMEA/H/C/791/II/27 |
| Desloratadine Teva | Teva Pharma B.V. | Centralised - Authorisation | 24 Nov 2011 | EMEA/H/C/2419 |
| Komboglyze | Bristol Myers Squibb/AstraZeneca EEIG | Centralised - Authorisation | 24 Nov 2011 | EMEA/H/C/2059 |
| Onduarp | Boehringer Ingelheim International GmbH | Centralised - Authorisation of a duplicate | 24 Nov 2011 | EMEA/H/C/2118 |
| Atriance | Glaxo Group Limited | Centralised - Annual reassessment | 24 Nov 2011 | EMEA/H/C/752/S/10 |
Centralised procedures of orphan medicinal products for human use | ||||
| Product | Marketing Authorisation Holder | Decision Type | Decision date | EMEA Nr |
| EU/3/09/636 | Eyegate Pharma SAS | Centralised Orphan - Transfer of orphan designation | 8 May 2012 | |
| EU/3/07/510 | Sigma-tau Pharma UK | Centralised Orphan - Transfer of orphan designation | 26 Apr 2012 | |
| EU/3/12/995 | Novo Nordisk A/S | Centralised Orphan - Initial orphan designation | 26 Apr 2012 | EMA/OD/144/11 |
| EU/3/12/993 | Sirius Regulatory Consulting Limited | Centralised Orphan - Initial orphan designation | 26 Apr 2012 | EMA/OD/164/11 |
| EU/3/12/992 | Prosensa Therapeutics B.V. | Centralised Orphan - Initial orphan designation | 26 Apr 2012 | EMA/OD/143/11 |
| EU/3/12/991 | Prosensa Therapeutics B.V. | Centralised Orphan - Initial orphan designation | 26 Apr 2012 | EMA/OD/142/11 |
| EU/3/12/990 | Sunesis Europe Ltd | Centralised Orphan - Initial orphan designation | 26 Apr 2012 | EMA/OD/158/11 |
| EU/3/12/989 | Merck Sharp & Dohme Limited | Centralised Orphan - Initial orphan designation | 26 Apr 2012 | EMA/OD/151/11 |
| EU/3/12/988 | Biological Consulting Europe Ltd | Centralised Orphan - Initial orphan designation | 26 Apr 2012 | EMA/OD/162/11 |
| EU/3/12/987 | JJGConsultancy Ltd | Centralised Orphan - Initial orphan designation | 26 Apr 2012 | EMA/OD/161/11 |
| EU/3/12/986 | Celgene Europe Limited | Centralised Orphan - Initial orphan designation | 26 Apr 2012 | EMA/OD/163/11 |
| EU/3/12/985 | ProRetina Therapeutics, S.L. | Centralised Orphan - Initial orphan designation | 26 Apr 2012 | EMA/OD/006/12 |
| EU/3/12/984 | Nexus Oncology Ltd. | Centralised Orphan - Initial orphan designation | 26 Apr 2012 | EMA/OD/156/11 |
| EU/3/12/983 | Fresenius Medical Care Deutschland GmbH | Centralised Orphan - Initial orphan designation | 26 Apr 2012 | EMA/OD/153/11 |
| EU/3/11/943 | Gregory Fryer Associates Ltd | Centralised Orphan - Transfer of orphan designation | 23 Apr 2012 | |
| EU/3/05/278 | Voisin Consulting SARL | Centralised Orphan - Transfer of orphan designation | 23 Apr 2012 | |
| EU/3/12/965 | Laboratoire HRA Pharma | Centralised Orphan - Initial orphan designation | 23 Apr 2012 | EMA/OD/125/11 |
| EU/3/12/964 | Dafra Pharma International NV | Centralised Orphan - Initial orphan designation | 23 Apr 2012 | EMA/OD/135/11 |
| EU/3/12/982 | Chiesi Farmaceutici S.P.A. | Centralised Orphan - Initial orphan designation | 2 Apr 2012 | EMA/OD/148/11 |
| EU/3/12/981 | Alan Boyd Consultants Ltd | Centralised Orphan - Initial orphan designation | 2 Apr 2012 | EMA/OD/150/11 |
| EU/3/12/980 | Axcentua Pharmaceuticals AB | Centralised Orphan - Initial orphan designation | 2 Apr 2012 | EMA/OD/130/11 |
| EU/3/12/979 | Aptiv Solutions (UK) Limited | Centralised Orphan - Initial orphan designation | 2 Apr 2012 | EMA/OD/149/11 |
| EU/3/12/978 | Dr Nicola J Robertson | Centralised Orphan - Initial orphan designation | 2 Apr 2012 | EMA/OD/133/11 |
| EU/3/12/977 | Astellas Pharma Europe B.V. | Centralised Orphan - Initial orphan designation | 2 Apr 2012 | EMA/OD/145/11 |
| EU/3/12/976 | Isis USA Ltd | Centralised Orphan - Initial orphan designation | 2 Apr 2012 | EMA/OD/141/11 |
| EU/3/12/955 | Giampaolo Merlini | Centralised Orphan - Initial orphan designation | 2 Apr 2012 | EMA/OD/113/11 |
| EU/3/11/889 | Alizé Pharma II | Centralised Orphan - Transfer of orphan designation | 21 Mar 2012 | |
| EU/3/05/301 | Albany Regulatory Consulting Ltd | Centralised Orphan - Transfer of orphan designation | 21 Mar 2012 | |
| EU/3/12/975 | Ferring Pharmaceuticals A/S | Centralised Orphan - Initial orphan designation | 21 Mar 2012 | EMA/OD/119/11 |
| EU/3/12/974 | Amsterdam Molecular Therapeutics BV | Centralised Orphan - Initial orphan designation | 21 Mar 2012 | EMA/OD/123/11 |
| EU/3/12/973 | NDA Regulatory Science Ltd | Centralised Orphan - Initial orphan designation | 21 Mar 2012 | EMA/OD/127/11 |
| EU/3/10/747 | Aveo Pharma Ltd | Centralised Orphan - Transfer of orphan designation | 5 Mar 2012 | EMA/OD/148/09 |
| EU/3/12/972 | NDA Regulatory Science Ltd | Centralised Orphan - Initial orphan designation | 5 Mar 2012 | EMA/OD/126/11 |
| EU/3/12/971 | Fresenius Medical Care Deutschland GmbH | Centralised Orphan - Initial orphan designation | 5 Mar 2012 | EMA/OD/124/11 |
| EU/3/12/970 | ICON Clinical Research (UK) Limited | Centralised Orphan - Initial orphan designation | 5 Mar 2012 | EMA/OD/138/11 |
| EU/3/12/968 | Envestia Limited | Centralised Orphan - Initial orphan designation | 5 Mar 2012 | EMA/OD/128/11 |
| EU/3/12/966 | Nexus Oncology Ltd. | Centralised Orphan - Initial orphan designation | 5 Mar 2012 | EMA/OD110/11 |
| EU/3/12/967 | FGK Representative Service GmbH | Centralised Orphan - Initial orphan designation | 5 Mar 2012 | EMA/OD/111/11 |
| EU/3/12/961 | Giampaolo Merlini | Centralised Orphan - Initial orphan designation | 5 Mar 2012 | EMA/OD/120/11 |
| EU/3/12/960 | Biodel UK Limited | Centralised Orphan - Initial orphan designation | 5 Mar 2012 | EMA/OD/140/11 |
| EU/3/11/887 | Cres Pharmaceuticals Limited | Centralised Orphan - Transfer of orphan designation | 27 Feb 2012 | |
| EU/3/11/886 | Cres Pharmaceuticals Limited | Centralised Orphan - Transfer of orphan designation | 27 Feb 2012 | |
| EU/3/06/372 | DuoCort Pharma AB | Centralised Orphan - Transfer of orphan designation | 27 Feb 2012 | |
| EU/3/10/823 | Dimensione Ricerca S.r.l | Centralised Orphan - Transfer of orphan designation | 15 Feb 2012 | |
| EU/3/11/888 | Cres Pharmaceuticals Limited | Centralised Orphan - Transfer of orphan designation | 15 Feb 2012 | |
| EU/3/10/826 | Lucane Pharma SAS | Centralised Orphan - Transfer of orphan designation | 15 Feb 2012 | |
| EU/3/02/101 | PPD Global Ltd | Centralised Orphan - Transfer of orphan designation | 15 Feb 2012 | |
| EU/3/10/806 | Dr Hans Moebius | Centralised Orphan - Transfer of orphan designation | 15 Feb 2012 | |
| EU/3/10/804 | Dr Hans Moebius | Centralised Orphan - Transfer of orphan designation | 15 Feb 2012 | |
| EU/3/10/807 | Dr Hans Moebius | Centralised Orphan - Transfer of orphan designation | 15 Feb 2012 | |
| EU/3/10/805 | Dr Hans Moebius | Centralised Orphan - Transfer of orphan designation | 15 Feb 2012 | |
| EU/3/12/959 | Endocyte Europe B.V. | Centralised Orphan - Initial orphan designation | 9 Feb 2012 | EMA/OD/094/11 |
| EU/3/12/958 | Endocyte Europe B.V. | Centralised Orphan - Initial orphan designation | 9 Feb 2012 | EMA/OD/095/11 |
| EU/3/12/957 | Généthon | Centralised Orphan - Initial orphan designation | 9 Feb 2012 | EMA/OD/118/11 |
| EU/3/12/956 | PinCell s.r.l. | Centralised Orphan - Initial orphan designation | 9 Feb 2012 | EMA/OD/116/11 |
| EU/3/12/954 | University of Sheffield | Centralised Orphan - Initial orphan designation | 9 Feb 2012 | EMA/OD/106/11 |
| EU/3/12/953 | Catalent Pharma Solutions Limited | Centralised Orphan - Initial orphan designation | 9 Feb 2012 | EMA/OD/109/11 |
| EU/3/12/952 | Conventia Medical LLP | Centralised Orphan - Initial orphan designation | 9 Feb 2012 | EMA/OD/099/11 |
| EU/3/12/951 | Lucane Pharma SA | Centralised Orphan - Initial orphan designation | 9 Feb 2012 | EMA/OD/098/11 |
| EU/3/12/950 | Lucane Pharma SA | Centralised Orphan - Initial orphan designation | 9 Feb 2012 | EMA/OD/097/11 |
| EU/3/12/949 | Lucane Pharma SA | Centralised Orphan - Initial orphan designation | 9 Feb 2012 | EMA/OD/096/11 |
| EU/3/08/554 | Lung Rx Limited | Centralised Orphan - Transfer of orphan designation | 9 Feb 2012 | |
| EU/3/10/776 | Prima Biomed Europe Ltd | Centralised Orphan - Transfer of orphan designation | 9 Feb 2012 | |
| EU/3/11/926 | ADIENNE S.r.l. | Corrigendum | 13 Jan 2012 | |
| EU/3/11/948 | GMP-Orphan SAS | Centralised Orphan - Initial orphan designation | 11 Jan 2012 | EMA/OD/089/11 |
| EU/3/11/947 | Syntaxin Limited | Centralised Orphan - Initial orphan designation | 11 Jan 2012 | EMA/OD/108/11 |
| EU/3/11/946 | Astellas Pharma Europe B.V. | Centralised Orphan - Initial orphan designation | 11 Jan 2012 | EMA/OD/103/11 |
| EU/3/11/945 | Dr Ulrich Granzer | Centralised Orphan - Initial orphan designation | 11 Jan 2012 | EMA/OD/105/11 |
| EU/3/11/944 | CTI Science Limited | Centralised Orphan - Initial orphan designation | 11 Jan 2012 | EMA/OD/093/11 |
| EU/3/11/943 | Gregory Fryer Associates Ltd | Centralised Orphan - Initial orphan designation | 11 Jan 2012 | EMA/OD/104/11 |
| EU/3/11/942 | Celator (UK) Ltd | Centralised Orphan - Initial orphan designation | 11 Jan 2012 | EMA/OD/070/11 |
| EU/3/11/941 | Diomune S.L. | Centralised Orphan - Initial orphan designation | 11 Jan 2012 | EMA/OD/085/11 |
| EU/3/11/940 | Miragen Therapeutics Europe Ltd | Centralised Orphan - Initial orphan designation | 11 Jan 2012 | EMA/OD/107/11 |
| EU/3/11/939 | Takeda Global Research and Development Centre (Europe) Ltd | Centralised Orphan - Initial orphan designation | 11 Jan 2012 | EMA/OD/100/11 |
| EU/3/11/938 | Amsterdam Molecular Therapeutics BV | Centralised Orphan - Initial orphan designation | 11 Jan 2012 | EMA/OD/090/11 |
| EU/3/06/406 | Wainwright Associates Ltd | Centralised Orphan - Transfer of orphan designation | 11 Jan 2012 | |
| EU/3/09/712 | Voisin Consulting S.A.R.L. | Centralised Orphan - Transfer of orphan designation | 11 Jan 2012 | |
| EU/3/11/937 | Edison Orphan Pharma BV | Centralised Orphan - Initial orphan designation | 9 Dec 2011 | EMA/OD/071/11 |
| EU/3/11/936 | Bio Products Laboratory Ltd | Centralised Orphan - Initial orphan designation | 9 Dec 2011 | EMA/OD/092/11 |
| EU/3/11/935 | Prof. Roberto Testi | Centralised Orphan - Initial orphan designation | 9 Dec 2011 | EMA/OD/084/11 |
| EU/3/11/934 | Celgene Europe Ltd | Centralised Orphan - Initial orphan designation | 9 Dec 2011 | EMA/OD/091/11 |
| EU/3/11/933 | Merrimack Pharmaceuticals UK Limited | Centralised Orphan - Initial orphan designation | 9 Dec 2011 | EMA/OD/051/11 |
| EU/3/11/932 | AOP Orphan Pharmaceuticals AG | Centralised Orphan - Initial orphan designation | 9 Dec 2011 | EMA/OD/055/11 |
| EU/3/11/931 | Genzyme Europe B.V. | Centralised Orphan - Initial orphan designation | 9 Dec 2011 | EMA/OD/074/11 |
| EU/3/11/930 | 4SC AG | Centralised Orphan - Initial orphan designation | 9 Dec 2011 | EMA/OD/083/11 |
| EU/3/11/929 | Fondazione Telethon | Centralised Orphan - Initial orphan designation | 9 Dec 2011 | EMA/OD/063/11 |
| EU/3/11/928 | NovaBiotics Ltd | Centralised Orphan - Initial orphan designation | 9 Dec 2011 | EMA/OD/046/11 |
| EU/3/10/796 | XOMA Ireland Ltd | Centralised Orphan - Transfer of orphan designation | 9 Dec 2011 | |
| EU/3/09/683 | Special Products Ltd | Centralised Orphan - Transfer of orphan designation | 9 Dec 2011 | |
Centralised procedures of veterinary medicinal products | ||||
| Product | Marketing Authorisation Holder | Decision Type | Decision date | EMEA Nr |
| Netvax | Intervet International B.V. | Centralised - Update Type IA-IAin-IB - (Acceptance modification) | 10 May 2012 | |
| Circovac | Merial | Centralised - Renewal after maximum 5 years | 10 May 2012 | EMEA/V/C/114/R/7 |
| Meloxivet | Janssen Pharmaceutica N.V. | Centralised - Transfer Marketing Authorisation Holder | 20 Apr 2012 | EMEA/V/C/124/T/7 |
| Loxicom | Norbrook Laboratories Limited | Centralised - Update Type IA-IAin-IB - (Acceptance modification) | 20 Apr 2012 | |
| BTVPUR AlSap 1-8 | MERIAL | Centralised - Annual reassessment | 20 Apr 2012 | EMEA/V/C/2231/S/1 |
| BTVPUR AlSap 1 | MERIAL | Centralised - Annual reassessment | 20 Apr 2012 | EMEA/V/C/2230/S/1 |
| Cerenia | Pfizer Ltd | Centralised - Variation Type II - (Acceptance modification) | 13 Apr 2012 | EMEA/V/C/106/II/13 |
| Slentrol | Pfizer Ltd | Centralised - Renewal after maximum 5 years | 10 Apr 2012 | EMEA/V/C/116/R/3 |
| Poulvac FluFend H5N3 RG | Pfizer Limited | Centralised - Withdrawal on holders request | 30 Mar 2012 | |
| Aivlosin | ECO Animal Health Ltd | Centralised - Update Type IA-IAin-IB - (Acceptance modification) | 26 Mar 2012 | |
| Gonazon | Intervet International B.V. | Centralised - Withdrawal on holders request | 19 Mar 2012 | |
| Zubrin | Intervet International B.V. | Centralised - Withdrawal on holders request | 19 Mar 2012 | |
| Recuvyra | Nexcyon Pharmaceuticals Ltd. | Centralised - Transfer Marketing Authorisation Holder | 15 Mar 2012 | EMEA/V/C/2239/T/5 |
| BTVPUR AlSap 8 | MERIAL | Centralised - Update Type IA-IAin-IB - (Acceptance modification) | 15 Mar 2012 | |
| Masivet | AB Science S.A. | Centralised - Variation Type II - (Acceptance modification) | 15 Mar 2012 | EMEA/V/C/128/II/14 |
| Purevax Rabies | MERIAL | Centralised - Variation Type II - (Acceptance modification) | 9 Mar 2012 | EMEA/V/C/2003/II/2 |
| Zulvac 1+8 Bovis | Pfizer Limited | Centralised - Authorisation under exceptional circumstances | 8 Mar 2012 | EMEA/V/C/2473 |
| Flexicam | Dechra Veterinary Products A/S | Centralised - Update Type IA-IAin-IB - (Acceptance modification) | 2 Mar 2012 | |
| Easotic | VIRBAC S.A. | Centralised - Variation Type II - (Acceptance modification) | 2 Mar 2012 | EMEA/V/C/140/II/3/G |
| Reconcile | Eli Lilly and Company Ltd | Centralised - Update Type IA-IAin-IB - (Acceptance modification) | 27 Feb 2012 | |
| RevitaCAM | Abbott Laboratories Limited | Centralised - Authorisation | 23 Feb 2012 | EMEA/V/C/2379 |
| Dicural | Pfizer Limited | Centralised - Update Type IA-IAin-IB - (Acceptance modification) | 21 Feb 2012 | |
| Purevax Rabies | MERIAL | Centralised - Update Type IA-IAin-IB - (Acceptance modification) | 17 Feb 2012 | |
| Metacam | Boehringer Ingelheim Vetmedica GmbH | Centralised - Update Type IA-IAin-IB - (Acceptance modification) | 31 Jan 2012 | |
| Suvaxyn Aujeszky 783 +O/W | Pfizer Limited | Centralised - Update Type IA-IAin-IB - (Acceptance modification) | 31 Jan 2012 | |
| Zubrin | Intervet International B.V. | Centralised - Update Type IB - (Acceptance modification) | 31 Jan 2012 | |
| Procox | Bayer Animal Health GmbH | Centralised - Update Type IA-IAin-IB - (Acceptance modification) | 31 Jan 2012 | |
| Rheumocam | Chanelle Pharmaceuticals Manufacturing Limited | Centralised - Annex II extension adding new number | 24 Jan 2012 | EMEA/V/C/121/X/8 |
| Posatex | Intervet International B.V. | Centralised - Variation Type II - (Acceptance modification) | 20 Jan 2012 | EMEA/V/C/122/II/12 |
| Hiprabovis IBR Marker Live | Laboratorios Hipra, S.A. | Centralised - Variation Type II - (Acceptance modification) | 9 Jan 2012 | EMEA/V/C/158/II/1 |
| Activyl Tick Plus | Intervet International B.V. | Centralised - Authorisation | 9 Jan 2012 | EMEA/V/C/2234 |
| Coxevac | CEVA SANTE ANIMALE | Corrigendum | 22 Dec 2011 | |
| Ypozane | VIRBAC S.A. | Centralised - Renewal after maximum 5 years | 19 Dec 2011 | EMEA/V/C/112/R/1 |
| Meloxidyl | CEVA SANTE ANIMALE | Centralised - Renewal after maximum 5 years | 19 Dec 2011 | EMEA/V/C/115/R/11 |
| Zulvac 1 Bovis | Pfizer Limited | Centralised - Variation Type IB - (Worksharing) | 14 Dec 2011 | EMEA/V/C/2334/IB/WS/5 |
| Zuprevo | Intervet International B.V. | Corrigendum | 14 Dec 2011 | |
| Trocoxil | Pfizer Limited | Centralised - Update Type IA-IAin-IB - (Acceptance modification) | 14 Dec 2011 | |
| TruScient | Pfizer Limited | Centralised - Authorisation | 14 Dec 2011 | EMEA/V/C/2000 |
| Masivet | AB Science S.A. | Centralised - Update Type IA-IAin-IB - (Acceptance modification) | 9 Dec 2011 | |
| Zulvac 1 Ovis | Pfizer Limited | Centralised - Variation Type IB - (Worksharing) | 9 Dec 2011 | EMEA/V/C/2235/IB/WS/5 |
| Panacur AquaSol | Intervet International B.V. | Centralised - Authorisation | 9 Dec 2011 | EMEA/V/C/2008 |
| Inflacam | Chanelle Pharmaceuticals Manufacturing Limited | Centralised - Authorisation of a duplicate | 9 Dec 2011 | EMEA/V/C/2497 |
| MS-H vaccine | Pharmsure Ltd | Corrigendum | 7 Dec 2011 | |
| Circovac | Merial | Centralised - Update Type IA-IAin-IB - (Acceptance modification) | 5 Dec 2011 | |
| Porcilis Porcoli | Intervet International B.V. | Centralised - Update Type IA-IAin-IB - (Acceptance modification) | 5 Dec 2011 | |
| Melosus | CP-Pharma Handelsgesellschaft mbH | Centralised - Update Type IA-IAin-IB - (Acceptance modification) | 28 Nov 2011 | |
| Ingelvac CircoFLEX | Boehringer Ingelheim Vetmedica GmbH | Centralised - Update Type IA-IAin-IB - (Acceptance modification) | 24 Nov 2011 | |
| Coxevac | CEVA SANTE ANIMALE | Centralised - Update Type IA-IAin-IB - (Acceptance modification) | 24 Nov 2011 | |
Community referrals for human medicinal products | ||||
| Product | Marketing Authorisation Holder | Decision Type | Decision date | EMEA Nr |
| Vivaglobin and associated names | Community Referrals - Art 36 Type I - (Acceptance Modification) | 7 May 2012 | EMEA/H/A-36/1296 | |
| Orlistat | Community Referrals - Art 31 - (Issuing and modification) | 24 Apr 2012 | EMEA/H/A-31/1318 | |
| meprobamate | Community Referrals - Art 107 - (Single measures) | 30 Mar 2012 | EMEA/H/A-107/1316 | |
| Norditropin | Community Referrals - Art 13 | 6 Mar 2012 | EMEA/H/A-13/1304 | |
| Topamax | Corrigendum | 2 Mar 2012 | ||
| Somatropin | Community Referrals - Art 107 - (Single measures) | 27 Feb 2012 | EMEA/H/A-107/1287 | |
| Pholcodine-containing medicinal products | Community Referrals - Art 31 - (Maintain) | 17 Feb 2012 | EMEA/H/A-31/1292 | |
| buflomedil | Community Referrals - Art 107 - (Single measures) | 13 Feb 2012 | EMEA/H/A-107/1293 | |
| Sumatriptan Galpharm | Galpharm Healthcare Ltd. | Centralised - Refusal after appeal | 9 Feb 2012 | EMEA/H/C/002140 |
| Priligy and associated names | Community Referrals - Art 29 - (Issuing and modification) | 20 Jan 2012 | EMEA/H/A-29/1294 | |
| Luveniq | Lux Biosciences GmbH | Centralised - Refusal without appeal | 20 Jan 2012 | EMEA/H/C/2069 |
| Terpenic derivatives | Community Referrals - Art 31 - (Modification) | 20 Jan 2012 | EMEA/H/A-1284 | |
| Nimesulide containing medicinal products for systemic use | Community Referrals - Art 31 - (Modification) | 20 Jan 2012 | EMEA/H/A-31/1261 | |
| Tecovirimat (variola) | SIGA Pharmaceuticals (Europe) Ltd | Centralised Orphan - Refusal of orphan designation | 11 Jan 2012 | EMA/OD/051/10 |
| Tecovirimat (monkeypox) | SIGA Pharmaceuticals (Europe) Ltd | Centralised Orphan - Refusal of orphan designation | 11 Jan 2012 | EMA/OD/050/10 |
| Dianeal, Extraneal, Nutrineal, Monosol and sodium chloride 0,9% solution for haemodialysis (Baxter - Castlebar site) | Baxter group of companies and associated companies | Community Referrals - Art 31 - (Modification) | 16 Dec 2011 | EMEA/H/A-31/1290 |
Community referrals for veterinary medicinal products | ||||
| Product | Marketing Authorisation Holder | Decision Type | Decision date | EMEA Nr |
| Fortekor and associated names | Community Referrals - Art 34 - Veterinary | 6 Feb 2012 | EMEA/V/A/055 | |
| Cephalosporins | Community Referrals - Art 35 - (Amend) | 13 Jan 2012 | EMEA/V/A/070 | |