Centralised procedures of medicinal products for human use
|
| Product |
Marketing Authorisation Holder |
Decision Type |
Decision date |
EMEA Nr |
| Yttriga |
Eckert & Ziegler Nuclitec GmbH |
Centralised - Update Type IA - (Acceptance modification) |
2 Feb 2010 |
|
| Clopidogrel Winthrop |
Sanofi Pharma Bristol-Myers Squibb SNC |
Centralised - Transfer Marketing Authorisation Holder |
29 Jan 2010 |
EMEA/H/C/975/T/18- |
| Urorec |
Recordati Ireland Ltd. |
Centralised - Authorisation under art 127a - Decision addressed to Member State |
29 Jan 2010 |
EMEA/H/C/1092 |
| Urorec |
Recordati Ireland Ltd. |
Centralised - Authorisation under art 127a - Decision addressed to Marketing Authorisation Holder |
29 Jan 2010 |
EMEA/H/C/1092 |
| Silodyx |
Recordati Ireland Ltd. |
Centralised - Authorisation under art 127a - Decision addressed to Member State |
29 Jan 2010 |
EMEA/H/C/1209 |
| Silodyx |
Recordati Ireland Ltd. |
Centralised - Authorisation under art 127a - Decision addressed to Marketing Authorisation Holder |
29 Jan 2010 |
EMEA/H/C/1209 |
| Azopt |
Alcon Laboratories (UK) Ltd. |
Centralised - Renewal after maximum 5 years |
29 Jan 2010 |
EMEA/H/C/267/R/39 |
| Rapamune |
Wyeth Europa Limited |
Centralised - Variation Type II - (Acceptance modification) |
28 Jan 2010 |
EMEA/H/C/273/II/94 |
| Temozolomide Teva |
Teva Pharma B.V. |
Centralised - Autorisation |
28 Jan 2010 |
EMEA/H/C/1126 |
| Arava |
Sanofi-Aventis Deutschland GmbH |
Centralised - Variation Type II - (Acceptance modification) |
27 Jan 2010 |
EMEA/H/C/235/II/45 |
| Rivastigmine Teva |
Teva Pharma B.V. |
Centralised - Update Type IA - (Acceptance modification) |
27 Jan 2010 |
|
| Sonata |
Meda AB |
Centralised - Update Type IA - (Acceptance modification) |
27 Jan 2010 |
|
| Zerene |
Meda AB |
Centralised - Update Type IA - (Acceptance modification) |
27 Jan 2010 |
|
| TORISEL |
Wyeth Europa Ltd |
Centralised - Variation Type II - (Acceptance modification) |
25 Jan 2010 |
EMEA/H/C/799/II/15 |
| Betaferon |
Bayer Schering Pharma AG |
Centralised - Variation Type II - (Acceptance modification) |
25 Jan 2010 |
EMEA/H/C/81/II/64 |
| Bondronat |
Roche Registration Limited |
Centralised - Variation Type II - (Acceptance modification) |
25 Jan 2010 |
EMEA/H/C/101/II/49-050 |
| Somavert |
Pfizer Ltd |
Centralised - Variation Type II - (Acceptance modification) |
25 Jan 2010 |
EMEA/H/C/409/II/36 |
| Sebivo |
Novartis Europharm Limited |
Centralised - Variation Type II - (Acceptance modification) |
25 Jan 2010 |
EMEA/H/C/713/II/9 |
| Combivir |
Glaxo Group Ltd. |
Centralised - Variation Type II - (Acceptance modification) |
25 Jan 2010 |
EMEA/H/C/190/II/56 |
| Avamys |
Glaxo Group Ltd |
Centralised - Variation Type II - (Acceptance modification) |
25 Jan 2010 |
EMEA/H/C/770/II/4 |
| Alisade |
Glaxo Group Ltd |
Centralised - Variation Type II - (Acceptance modification) |
25 Jan 2010 |
EMEA/H/C/1019/II/5 |
| Altargo |
Glaxo Group Limited |
Centralised - Variation Type II - (Acceptance modification) |
25 Jan 2010 |
EMEA/H/C/757/II/15 |
| Temomedac |
ALFRED E. TIEFENBACHER, (GmbH & Co. KG) |
Centralised - Autorisation |
25 Jan 2010 |
EMEA/H/C/1124 |
| Norvir |
Abbott Laboratories Ltd |
Centralised - Annex II extension adding new number |
25 Jan 2010 |
EMEA/H/C/127/X/90 |
| HBVAXPRO |
Sanofi Pasteur MSD, SNC |
Centralised - Variation Type II - (Acceptance modification) |
20 Jan 2010 |
EMEA/H/C/373/II/27 |
| Telzir |
Glaxo Group Ltd. |
Centralised - Variation Type II - (Acceptance modification) |
20 Jan 2010 |
EMEA/H/C/534/II/48 |
| Atriance |
Glaxo Group Limited |
Centralised - Variation Type II - (Acceptance modification) |
20 Jan 2010 |
EMEA/H/C/752/II/6 |
| Arixtra |
Glaxo Group Ltd. |
Centralised - Variation Type II - (Acceptance modification) |
20 Jan 2010 |
EMEA/H/C/403/II/43 |
| Epoetin alfa Hexal |
Hexal AG. |
Centralised - Variation Type II - (Acceptance modification) |
20 Jan 2010 |
EMEA/H/C/726/II/18 |
| Binocrit |
Sandoz GmbH |
Centralised - Variation Type II - (Acceptance modification) |
20 Jan 2010 |
EMEA/H/C/725/II/18 |
| AVANDIA |
SmithKline Beecham Ltd. |
Centralised - Variation Type II - (Acceptance modification) |
20 Jan 2010 |
EMEA/H/C/268/II/72 |
| Avaglim |
SmithKline Beecham Ltd. |
Centralised - Variation Type II - (Acceptance modification) |
20 Jan 2010 |
EMEA/H/C/675/II/26 |
| Tracleer |
Actelion Registration Ltd |
Centralised - Variation Type II - (Acceptance modification) |
20 Jan 2010 |
EMEA/H/C/401/II/47 |
| Avandamet |
SmithKline Beecham Ltd. |
Centralised - Variation Type II - (Acceptance modification) |
20 Jan 2010 |
EMEA/H/C/522/II/60 |
| Hycamtin |
SmithKline Beecham Ltd. |
Centralised - Variation Type II - (Acceptance modification) |
20 Jan 2010 |
EMEA/H/C/123/II/55 |
| NeoRecormon |
Roche Registration Limited |
Centralised - Variation Type II - (Acceptance modification) |
20 Jan 2010 |
EMEA/H/C/116/II/63 |
| Elaprase |
Shire Human Genetic Therapies AB |
Centralised - Variation Type II - (Acceptance modification) |
20 Jan 2010 |
EMEA/H/C/700/II/22-EMEA/H/C/700/II23-24 |
| Abseamed |
Medice Arzneimittel Pütter GmbH & Co KG |
Centralised - Variation Type II - (Acceptance modification) |
20 Jan 2010 |
EMEA/H/C/727/II/18 |
| Volibris |
Glaxo Group Ltd |
Centralised - Variation Type II - (Acceptance modification) |
20 Jan 2010 |
EMEA/H/C/839/II/10 |
| Zostavax |
Sanofi Pasteur MSD, SNC |
Centralised - Variation Type II - (Acceptance modification) |
20 Jan 2010 |
EME/H/C/674/II/27 |
| RotaTeq |
Sanofi Pasteur MSD, SNC |
Centralised - Variation Type II - (Acceptance modification) |
20 Jan 2010 |
EMEA/H/C/669/II/21 |
| Tyverb |
Glaxo Group Limited |
Centralised - Variation Type II - (Acceptance modification) |
20 Jan 2010 |
EMEA/H/C/795/II/9 |
| Integrilin |
Glaxo Group Ltd |
Centralised - Variation Type II - (Acceptance modification) |
20 Jan 2010 |
EMEA/H/C/230/II/47 |
| Ziagen |
Glaxo Group Ltd |
Centralised - Variation Type II - (Acceptance modification) |
20 Jan 2010 |
EMEA/H/C/252/II/55 |
| ORENCIA |
Bristol-Myers Squibb Pharma EEIG |
Centralised - Variation Type II - (Extension of indication for paediatric use) |
20 Jan 2010 |
EMEA/H/C/701/II/24 |
| Thyrogen |
Genzyme Europe B.V. |
Centralised - Variation Type II - (Acceptance modification) |
20 Jan 2010 |
EMEA/H/C/220/II/38 |
| Viracept |
Roche Registration Limited |
Centralised - Variation Type II - (Acceptance modification) |
20 Jan 2010 |
EMEA/H/C/164/II/16 |
| Orgalutran |
N.V. Organon |
Centralised - Variation Type II - (Acceptance modification) |
20 Jan 2010 |
EMEA/H/C/274/II/16 |
| Tamiflu |
Roche Registration Limited |
Centralised - Variation Type II - (Acceptance modification) |
20 Jan 2010 |
EMEA/H/C/402/II/76 |
| Avastin |
Roche Registration Limited |
Centralised - Variation Type II - (Rejection of modification) |
20 Jan 2010 |
EMEA/H/C/582/II/28 |
| Erbitux |
Merck KGaA |
Centralised - Variation Type II - (Rejection of modification) |
20 Jan 2010 |
EMEA/H/C/558/II/29 |
| Truvada |
Gilead Sciences International Limited |
Centralised - Renewal after maximum 5 years |
20 Jan 2010 |
EMEA/H/C/594/R/62 |
| Herceptin |
Roche Registration Limited |
Centralised - Variation Type II - (Acceptance modification) |
19 Jan 2010 |
EMEA/H/C/278/II/47 |
| Gardasil |
Sanofi Pasteur MSD, SNC |
Centralised - Variation Type II - (Acceptance modification) |
19 Jan 2010 |
EMEA/H/C/703/II/24 |
| ProQuad |
Sanofi Pasteur MSD, SNC |
Centralised - Variation Type II - (Acceptance modification) |
19 Jan 2010 |
EMEA/H/C/622/II/26 |
| M-M-RVAXPRO |
Sanofi Pasteur MSD, SNC |
Centralised - Variation Type II - (Acceptance modification) |
19 Jan 2010 |
EMEA/H/C/604/II/20 |
| IRESSA |
AstraZeneca AB |
Centralised - Variation Type II - (Acceptance modification) |
19 Jan 2010 |
EMEA/H/C/1016/II/2 |
| Orfadin |
Swedish Orphan International AB |
Centralised - Renewal after maximum 5 years |
19 Jan 2010 |
EMEA/H/C/555/R/21 |
| Thyrogen |
Genzyme Europe B.V. |
Centralised - Renewal after maximum 5 years |
15 Jan 2010 |
EMEA/H/C/220/II/R/42 |
| EMEND |
Merck Sharp & Dohme Ltd |
Centralised - Variation Type II - (Acceptance modification) |
12 Jan 2010 |
EMEA/H/C/527/II/24 |
| Revlimid |
Celgene Europe Limited |
Centralised - Variation Type II - (Acceptance modification) |
12 Jan 2010 |
EMEA/H/C/717/II/28 |
| Prialt |
Eisai Limited |
Centralised - Renewal with additional 5 years (Annex IV) |
12 Jan 2010 |
EMEA/H/C/551/R/30 |
| Apidra |
Sanofi-Aventis Deutschland GmbH |
Centralised - Annex II extension without new number |
12 Jan 2010 |
EMEA/H/C/557/X/23 |
| CoAprovel |
Sanofi Pharma Bristol-Myers Squibb SNC |
Centralised - Variation Type II - (Acceptance modification) |
11 Jan 2010 |
EMEA/H/C/222/II/123 |
| Nplate |
Amgen Europe B.V. |
Centralised - Annex II extension adding new number |
11 Jan 2010 |
EMEA/H/C/942/X/4 |
| Scintimun |
CIS bio international |
Centralised - Autorisation |
11 Jan 2010 |
EMEA/H/C/1045 |
| Ratiograstim |
ratiopharm GmbH |
Centralised - Variation Type II - (Acceptance modification) |
8 Jan 2010 |
EMEA/H/C/825/II/1 |
| Protelos |
Les Laboratoires Servier |
Centralised - Variation Type II - (Acceptance modification) |
8 Jan 2010 |
EMEA/H/C/560/II/27 |
| Osseor |
Les Laboratoires Servier |
Centralised - Variation Type II - (Acceptance modification) |
8 Jan 2010 |
EMEA/H/C/561/II/22 |
| Kaletra |
Abbott Laboratories Ltd |
Centralised - Variation Type II - (Acceptance modification) |
8 Jan 2010 |
EMEA/H/C/368/II/81 |
| Revlimid |
Celgene Europe Limited |
Centralised - Variation Type II - with introduction of art 127a - Decision addressed to the Member State |
8 Jan 2010 |
EMEA/H/C/717/II/29 |
| Revlimid |
Celgene Europe Limited |
Centralised - Variation Type II - with introduction of art 127a - Decision addressed to the Marketing Authorisation Holder |
8 Jan 2010 |
EMEA/H/C/717/II/29 |
| Leflunomide Winthrop |
Sanofi-Aventis Deutschland GmbH |
Centralised - Autorisation |
8 Jan 2010 |
EMEA/H/C/1129 |
| Lumigan |
Allergan Pharmaceuticals Ireland |
Centralised - Annex II extension adding new number |
7 Jan 2010 |
EMEA/H/C/391/X/26 |
| Focetria |
Novartis Vaccines and Diagnostics S.r.l. |
Centralised - Variation Type II - (Acceptance modification) |
23 Dec 2009 |
EMEA/H/C/710/II/16-018 |
| Biograstim |
CT Arzneimittel GmbH |
Centralised - Variation Type II - (Acceptance modification) |
23 Dec 2009 |
EMEA/H/C/826/II/1 |
| Alisade |
Glaxo Group Ltd |
Centralised - Variation Type II - (Acceptance modification) |
23 Dec 2009 |
EMEA/H/C/1019/II/4 |
| IVEMEND |
Merck Sharp & Dohme Limited |
Centralised - Variation Type II - (Acceptance modification) |
23 Dec 2009 |
EMEA/H/C/743/II/5 |
| TORISEL |
Wyeth Europa Ltd |
Centralised - Variation Type II - (Acceptance modification) |
23 Dec 2009 |
EMEA/H/C/799/II/10 |
| Retacrit |
HOSPIRA Enterprises B.V. |
Centralised - Variation Type II - (Acceptance modification) |
23 Dec 2009 |
|
| Sildenafil ratiopharm |
ratiopharm GmbH |
Centralised - Autorisation |
23 Dec 2009 |
EMEA/H/C/1080 |
| Zenas |
EUSA Pharma SAS |
Centralised - Authorisation of an orphan medicinal product under exceptional circumstances |
23 Dec 2009 |
EMEA/H/C/1032 |
| Tractocile |
Ferring Pharmaceuticals A/S |
Centralised - Renewal after maximum 5 years |
23 Dec 2009 |
EMEA/H/C/253/R/51 |
| CELVAPAN |
Baxter AG |
Centralised - Variation Type II - (Acceptance modification) |
22 Dec 2009 |
EMEA/H/C/982/II/9 |
| Pandemrix |
GlaxoSmithKline Biologicals s.a. |
Centralised - Variation Type II - (Acceptance modification) |
22 Dec 2009 |
EMEA/H/C/832/II/32-34 |
| STELARA |
Janssen-Cilag International NV |
Centralised - Variation Type II - (Acceptance modification) |
22 Dec 2009 |
EMEA/H/C/958/II/1 |
| Crixivan |
Merck Sharp & Dohme Ltd |
Centralised - Variation Type II - (Acceptance modification) |
22 Dec 2009 |
EMEA/H/C/128/II/81 |
| RELISTOR |
Wyeth Europa Limited |
Centralised - Variation Type II - (Acceptance modification) |
22 Dec 2009 |
EMEA/H/C/870/II/7 |
| Replagal |
Shire Human Genetic Therapies AB |
Centralised - Variation Type II - (Acceptance modification) |
22 Dec 2009 |
EMEA/H/C/369/II/54 |
| Evra |
Janssen-Cilag International NV |
Centralised - Variation Type II - (Acceptance modification) |
22 Dec 2009 |
EMEA/H/C/410/II/22 |
| Tasigna |
Novartis Europharm Limited |
Centralised - Variation Type II - (Acceptance modification) |
22 Dec 2009 |
EMEA/H/C/798/II/26 |
| Tevagrastim |
Teva Generics GmbH |
Centralised - Variation Type II - (Acceptance modification) |
21 Dec 2009 |
EMEA/H/C/827/II/4 |
| Thelin |
Encysive (UK) Limited |
Centralised - Variation Type II - (Acceptance modification) |
21 Dec 2009 |
EMEA/H/C/679/II/18 |
| Irbesartan HCT Winthrop |
SANOFI PHARMA BRISTOL MYERS SQUIBB SNC |
Centralised - Variation Type II - (Acceptance modification) |
21 Dec 2009 |
EMEA/H/C/783/II/34 |
| Altargo |
Glaxo Group Limited |
Centralised - Variation Type II - (Acceptance modification) |
21 Dec 2009 |
EMEA/H/C/757/II/13 |
| Agenerase |
Glaxo Group Limited |
Centralised - Variation Type II - (Acceptance modification) |
21 Dec 2009 |
EMEA/H/C/264/II44 |
| Vimpat |
UCB Pharma SA. |
Centralised - Variation Type II - (Acceptance modification) |
21 Dec 2009 |
EMEA/H/C/863/II/7 |
| Avamys |
Glaxo Group Ltd |
Centralised - Variation Type II - (Acceptance modification) |
21 Dec 2009 |
EMEA/H/C/770/II/3 |
| Karvezide |
Bristol-Myers Squibb Pharma EEIG |
Centralised - Variation Type II - (Acceptance modification) |
21 Dec 2009 |
EMEA/H/C/221/II/128 |
| Rapamune |
Wyeth Europa Limited |
Centralised - Variation Type II - (Acceptance modification) |
21 Dec 2009 |
EMEA/H/C/273/II/90 |
| Soliris |
Alexion Europe S.A.S. |
Centralised - Variation Type II - (Acceptance modification) |
21 Dec 2009 |
EMEA/H/C/791/II/13 |
| Lyrica |
Pfizer Ltd |
Centralised - Variation Type II - (Acceptance modification) |
21 Dec 2009 |
EMEA/H/C/546/II/35 |
| ZYPADHERA |
Eli Lilly Nederland B.V. |
Centralised - Variation Type II - (Acceptance modification) |
21 Dec 2009 |
EMEA/H/C/890/II/4 |
| AZARGA |
Alcon Laboratories (UK) Ltd. |
Centralised - Variation Type II - (Acceptance modification) |
21 Dec 2009 |
EMEA/H/C/960/II/1 |
| Taxotere |
Aventis Pharma S.A. |
Centralised - Variation Type II - (Acceptance modification) |
21 Dec 2009 |
EMEA/H/C/73/II/87 |
| Revasc |
Canyon Pharmaceuticals Ltd |
Centralised - Variation Type II - (Acceptance modification) |
21 Dec 2009 |
EMEA/H/C/104/II/28 |
| Volibris |
Glaxo Group Ltd |
Centralised - Variation Type II - (Acceptance modification) |
21 Dec 2009 |
EMEA/H/C/839/II/8 |
| Zyprexa |
Eli Lilly Nederland B.V. |
Centralised - Variation Type II - (Acceptance modification) |
21 Dec 2009 |
EMEA/H/C/115/II/10 |
| Zyprexa Velotab |
Eli Lilly Nederland B.V. |
Centralised - Variation Type II - (Acceptance modification) |
21 Dec 2009 |
EMEA/H/C/287/II/72 |
| Avastin |
Roche Registration Limited |
Centralised - Renewal with additional 5 years (Annex IV) |
21 Dec 2009 |
EMEA/H/C/582/R/31 |
| Zonegran |
Eisai Limited |
Centralised - Renewal after maximum 5 years |
21 Dec 2009 |
|
| Revatio |
Pfizer Limited |
Centralised - Annex II externsion under art 127a - Decision addressed to Member State |
21 Dec 2009 |
EMEA/H/C/638/X/19 |
| Emtriva |
Gilead Sciences International Limited |
Centralised - Update Type IA - (Acceptance modification) |
18 Dec 2009 |
|
| Litak |
Lipomed GmbH |
Centralised - Update Type IA - (Acceptance modification) |
18 Dec 2009 |
|
| Aloxi |
Helsinn Birex Pharmaceuticals Ltd |
Centralised - Update Type IB - (Acceptance modification) |
18 Dec 2009 |
|
| Adenuric |
Ipsen Pharma |
Centralised - Transfer Marketing Authorisation Holder |
18 Dec 2009 |
EMEA/H/C/777/T/14 |
| Docetaxel Winthrop |
Aventis Pharma S.A. |
Centralised - Variation Type II - (Acceptance modification) |
18 Dec 2009 |
EMEA/H/C/808/II/9 |
| Epoetin alfa Hexal |
Hexal AG. |
Centralised - Variation Type II - (Acceptance modification) |
16 Dec 2009 |
EMEA/H/C/726/II/15 |
| Binocrit |
Sandoz GmbH |
Centralised - Variation Type II - (Acceptance modification) |
16 Dec 2009 |
EMEA/H/C/725/II/15 |
| Silapo |
STADA Arzneimittel AG |
Centralised - Variation Type II - (Acceptance modification) |
16 Dec 2009 |
EMEA/H/C/760/II/15 |
| Revlimid |
Celgene Europe Limited |
Centralised - Variation Type II - with introduction of art 127a - Decision addressed to the Member State |
16 Dec 2009 |
EMEA/H/C/717/II/26 |
| Revlimid |
Celgene Europe Limited |
Centralised - Variation Type II - with introduction of art 127a - Decision addressed to the Marketing Authorisation Holder |
16 Dec 2009 |
EMEA/H/C/717/II/26 |
| Exalief |
BIAL - Portela & Ca, SA |
Centralised - Update Type IA - (Acceptance modification) |
14 Dec 2009 |
|
| Zebinix |
BIAL - Portela & Ca, SA |
Centralised - Update Type IA - (Acceptance modification) |
14 Dec 2009 |
|
| Efient |
Eli Lilly Nederland B.V. |
Centralised - Update Type IA - (Acceptance modification) |
14 Dec 2009 |
|
| Clopidogrel MYLAN Pharma |
Mylan S.A.S |
Centralised - Transfer Marketing Authorisation Holder |
11 Dec 2009 |
EMEA/H/C/1189/T/1- |
| EVICEL |
OMRIX biopharmaceuticals S.A. / N.V. |
Centralised - Variation Type II - (Acceptance modification) |
11 Dec 2009 |
EMEA/H/C/898/II/5 |
| Abseamed |
Medice Arzneimittel Pütter GmbH & Co KG |
Centralised - Variation Type II - (Acceptance modification) |
11 Dec 2009 |
EMEA/H/C/727/II/15 |
| Rivastigmine Sandoz |
Sandoz Pharmaceuticals GmbH |
Centralised - Autorisation |
11 Dec 2009 |
EMEA/H/C/1183 |
| Kivexa |
Glaxo Group Ltd |
Centralised - Renewal with additional 5 years (Annex IV) |
11 Dec 2009 |
EMEA/H/C/581/R/23 |
| Olazax |
Glenmark Pharmaceuticals s.r.o. |
Centralised - Autorisation |
11 Dec 2009 |
EMEA/H/C/1087 |
| Rivastigmine 1 A Pharma |
1 A Pharma GmbH |
Centralised - Autorisation |
11 Dec 2009 |
EMEA/H/C/1181 |
| Rivastigmine HEXAL |
HEXAL AG |
Centralised - Autorisation |
11 Dec 2009 |
EMEA/H/C/1182 |
| Evoltra |
Genzyme Europe BV |
Centralised - Update Type IA+IB - (Acceptance modification) |
10 Dec 2009 |
|
| Truvada |
Gilead Sciences International Limited |
Centralised - Update Type IB - (Acceptance modification) |
10 Dec 2009 |
|
| Synflorix |
GlaxoSmithKline Biologicals S.A. |
Centralised - Update Type IB - (Acceptance modification) |
10 Dec 2009 |
|
| Effentora |
Cephalon Europe |
Centralised - Variation Type II - (Acceptance modification) |
10 Dec 2009 |
EMEA/H/C/833/II/4-5 |
| Effentora |
Cephalon Europe |
Centralised - Variation Type II - with introduction of art 127a - Decision addressed to the Member State |
10 Dec 2009 |
EMEA/H/C/833/II/3 |
| Effentora |
Cephalon Europe |
Centralised - Variation Type II - with introduction of art 127a - Decision addressed to the Marketing Authorisation Holder |
10 Dec 2009 |
EMEA/H/C/833/II/3 |
| Sildenafil Actavis |
Actavis Group PTC ehf. |
Centralised - Autorisation |
10 Dec 2009 |
EMEA/H/C/1090 |
| Lamivudine Teva Pharma B.V. |
Teva Pharma B.V. |
Centralised - Autorisation |
10 Dec 2009 |
EMEA/H/C/1111 |
| Olazax Disperzi |
Glenmark Pharmaceuticals s.r.o. |
Centralised - Autorisation |
10 Dec 2009 |
EMEA/H/C/1088 |
| Revatio |
Pfizer Limited |
Centralised - Annex II externsion under art 127a - Decision addressed to marketing autorisation holder |
10 Dec 2009 |
EMEA/H/C/638/X/19 |
| Fendrix |
GlaxoSmithKline Biologicals s.a. |
Centralised - Renewal with additional 5 years (Annex IV) |
10 Dec 2009 |
EMEA/H/C/550/R/12 |
| Pandemrix |
GlaxoSmithKline Biologicals s.a. |
Centralised - Variation Type II - (Acceptance modification) |
9 Dec 2009 |
EMEA/H/C/832/II/28 |
| Sustiva |
Bristol-Myers Squibb Pharma EEIG |
Centralised - Variation Type II - (Acceptance modification) |
9 Dec 2009 |
EMEA/H/C/249/II/97 |
| Stocrin |
Merck Sharp & Dohme Ltd |
Centralised - Variation Type II - (Acceptance modification) |
9 Dec 2009 |
EMEA/H/C/250/II/79 |
| Prevenar 13 |
Wyeth Lederle Vaccines S.A. |
Centralised - Autorisation |
9 Dec 2009 |
EMEA/H/C/1104 |
| Xigris |
Eli Lilly Nederland B.V. |
Centralised - Annual reassessment |
8 Dec 2009 |
EMEA/H/C/396/S/28 |
| Renagel |
Genzyme Europe B.V. |
Centralised - Renewal with additional 5 years (Annex IV) |
8 Dec 2009 |
EMEA/H/C/254/R/84 |
| Champix |
Pfizer Ltd |
Centralised - Variation Type II - (Acceptance modification) |
3 Dec 2009 |
EMEA/C/H/699/II/26 |
| Rasilez |
Novartis Europharm Limited |
Centralised - Variation Type II - (Acceptance modification) |
3 Dec 2009 |
EMEA/H/C/780/II/36 |
| Olanzapine Glenmark Europe |
Glenmark Generics (Europe) Limited |
Centralised - Autorisation |
3 Dec 2009 |
EMEA/H/C/1086 |
| Olanzapine Glenmark |
Glenmark Generics (Europe) Limited |
Centralised - Autorisation |
3 Dec 2009 |
EMEA/H/C/1085 |
| Adcirca |
Eli Lilly Nederland B.V. |
Centralised - Variation Type II - (Deletion pack size) |
30 Nov 2009 |
EMEA/H/C/1021/II/1 |
| Hirobriz Breezhaler |
Novartis Europharm Limited |
Centralised - Autorisation |
30 Nov 2009 |
EMEA/H/C/1211 |
| Zutectra |
Biotest Pharma GmbH |
Centralised - Autorisation |
30 Nov 2009 |
EMEA/H/C/1089 |
| Onbrez Breezhaler |
Novartis Europharm Limited |
Centralised - Autorisation |
30 Nov 2009 |
EMEA/H/C/1114 |
| Nevirapine Teva |
Teva Pharma B.V. |
Centralised - Autorisation |
30 Nov 2009 |
EMEA/H/C/1119 |
| Champix |
Pfizer Ltd |
Centralised - Variation Type II - (Acceptance modification) |
30 Nov 2009 |
EMEA/H/C/699/II/28 |
| Docetaxel Winthrop |
Aventis Pharma S.A. |
Centralised - Annex II extension adding new number |
30 Nov 2009 |
EMEA/H/C/808/X/8 |
| Oslif Breezhaler |
Novartis Europharm Limited |
Centralised - Autorisation |
30 Nov 2009 |
EMEA/H/C/1210 |
| Sildenafil Teva |
Teva Pharma B.V. |
Centralised - Autorisation |
30 Nov 2009 |
EMEA/H/C/1073 |
| Taxotere |
Aventis Pharma S.A. |
Centralised - Annex II extension adding new number |
30 Nov 2009 |
EMEA/H/C/73/X/86 |
| Velcade |
Janssen-Cilag International NV |
Centralised - Annual reassessment |
30 Nov 2009 |
EMEA/H/C/539/S/35 |
| Focetria |
Novartis Vaccines and Diagnostics S.r.l. |
Centralised - Variation Type II - (Acceptance modification) |
27 Nov 2009 |
EMEA/H/C/710/II/13-15 |
| Pandemrix |
GlaxoSmithKline Biologicals s.a. |
Centralised - Variation Type II - (Acceptance modification) |
27 Nov 2009 |
EMEA/H/C/832/II/23-24-25-26 |
| INTELENCE |
Janssen-Cilag International NV |
Centralised - Variation Type II - (Acceptance modification) |
27 Nov 2009 |
EMEA/H/C/900/II/4 |
| Paxene |
Norton Healthcare Limited |
Centralised - Withdrawal on holders request |
26 Nov 2009 |
|
| Multaq |
Sanofi-Aventis |
Centralised - Authorisation under art 127a - Decision addressed to Member State |
26 Nov 2009 |
EMEA/H/C/1043 |
| Multaq |
Sanofi-Aventis |
Centralised - Authorisation under art 127a - Decision addressed to Marketing Authorisation Holder |
26 Nov 2009 |
EMEA/H/C/1043 |
| Irbesartan / Hydrochlorothiazide Teva |
Teva Pharma B.V. |
Centralised - Autorisation |
26 Nov 2009 |
EMEA/H/C/1112 |
| Abseamed |
Medice Arzneimittel Pütter GmbH & Co KG |
Centralised - Annex II extension adding new number |
26 Nov 2009 |
EMEA/H/C/727/X/14 |
| Diacomit |
Biocodex |
Centralised - Annual renewal of conditional autorisation |
26 Nov 2009 |
EMEA/H/C/664/R/6 |
| Enbrel |
Wyeth Europa Limited |
Centralised - Renewal after maximum 5 years |
26 Nov 2009 |
EMEA/H/C/262/R/110 |
| Enbrel |
Wyeth Europa Limited |
Centralised - Variation Type II - (Acceptance modification) |
26 Nov 2009 |
EMEA/H/C/262/II/111 |
| Kivexa |
Glaxo Group Ltd |
Centralised - Variation Type II - (Acceptance modification) |
25 Nov 2009 |
EMEA/H/C/581/II/24 |
| Synagis |
Abbott Laboratories Ltd |
Centralised - Variation Type II - (Acceptance modification) |
24 Nov 2009 |
EMEA/H/C/257/II/59 |
| alli |
Glaxo Group Limited |
Centralised - Variation Type II - (Acceptance modification) |
24 Nov 2009 |
EMEA/H/C/854/II/9 |
| Kaletra |
Abbott Laboratories Ltd |
Centralised - Variation Type II - (Acceptance modification) |
23 Nov 2009 |
EMEA/H/C/368/II/77-79 |
| Invega |
Janssen-Cilag International NV |
Centralised - Variation Type II - (Acceptance modification) |
23 Nov 2009 |
EMEA/H/C/746/II/21 |
| Cervarix |
GlaxoSmithKline Biologicals S.A. |
Centralised - Variation Type II - (Acceptance modification) |
23 Nov 2009 |
EMEA/H/C/721/II/12-013 |
| Pritor |
Bayer Schering Pharma AG |
Centralised - Variation Type II - (Acceptance modification) |
23 Nov 2009 |
EMEA/H/C/210/II/84 |
| TRIZIVIR |
Glaxo Group Ltd. |
Centralised - Variation Type II - (Acceptance modification) |
23 Nov 2009 |
EMEA/H/C/338/II/57 |
| Nexavar |
Bayer Schering Pharma AG |
Centralised - Variation Type II - (Acceptance modification) |
23 Nov 2009 |
EMEA/H/C/690/II/16 |
| Puregon |
Organon N.V. |
Centralised - Variation Type II - (Acceptance modification) |
23 Nov 2009 |
EMEA/H/C/86/II/63 |
| Exjade |
Novartis Europharm Limited |
Centralised - Variation Type II - (Acceptance modification) |
23 Nov 2009 |
EMEA/H/C/670/II/9-18 |
| Noxafil |
SP Europe |
Centralised - Variation Type II - (Acceptance modification) |
23 Nov 2009 |
EMEA/H/C/610/II17 |
| AZILECT |
Teva Pharma GmbH |
Centralised - Variation Type II - (Acceptance modification) |
23 Nov 2009 |
EMEA/H/C/574/II/39 |
| Aptivus |
Boehringer Ingelheim International GmbH |
Centralised - Variation Type II - (Acceptance modification) |
23 Nov 2009 |
EMEA/H/C/631/II/36 |
| Micardis |
Boehringer Ingelheim International GmbH |
Centralised - Variation Type II - (Acceptance modification) |
23 Nov 2009 |
EMEA/H/C/209/II/73 |
| Kinzalmono |
Bayer Schering Pharma AG |
Centralised - Variation Type II - (Acceptance modification) |
23 Nov 2009 |
EMEA/H/C/211/II/72 |
| Telzir |
Glaxo Group Ltd. |
Centralised - Variation Type II - (Acceptance modification) |
23 Nov 2009 |
EMEA/H/C/534/II/39-44 |
| Bondronat |
Roche Registration Limited |
Centralised - Update Type IA+IB - (Acceptance modification) |
20 Nov 2009 |
|
| Ziagen |
Glaxo Group Ltd |
Centralised - Variation Type II - (Acceptance modification) |
20 Nov 2009 |
EMEA/H/C/252/II/54 |
| RoActemra |
Roche Registration Limited |
Centralised - Variation Type II - (Acceptance modification) |
20 Nov 2009 |
EMEA/H/C/955/II/5 |
| Agenerase |
Glaxo Group Limited |
Centralised - Variation Type II - (Acceptance modification) |
20 Nov 2009 |
EMEA/H/C/264/II/42 |
| Circadin |
RAD Neurim Pharmaceuticals EEC Limited |
Centralised - Variation Type II - (Acceptance modification) |
20 Nov 2009 |
EMEA/H/C/695/II/20 |
| Angiox |
The Medicines Company UK Ltd |
Centralised - Variation Type II - (Acceptance modification) |
20 Nov 2009 |
EMEA/H/C/562/II/24 |
| Somavert |
Pfizer Ltd |
Centralised - Variation Type II - (Acceptance modification) |
20 Nov 2009 |
EMEA/H/C/409/II/35 |
| REYATAZ |
Bristol-Myers Squibb Pharma EEIG |
Centralised - Variation Type II - (Acceptance modification) |
20 Nov 2009 |
EMEA/H/C/494/II/59 |
| NeoRecormon |
Roche Registration Limited |
Centralised - Variation Type II - (Acceptance modification) |
20 Nov 2009 |
EMEA/H/C/116/II/62 |
| Mycamine |
Astellas Pharma Europe B.V. |
Centralised - Variation Type II - (Acceptance modification) |
20 Nov 2009 |
EMEA/H/C/734/II/4 |
| Ebixa |
H. Lundbeck A/S |
Centralised - Variation Type II - (Acceptance modification) |
20 Nov 2009 |
EMEA/H/C/463/II/62 |
| MabCampath |
Genzyme Europe B.V. |
Centralised - Variation Type II - (Acceptance modification) |
20 Nov 2009 |
EMEA/H/C/353/II/48 |
| Regranex |
Janssen-Cilag International NV |
Centralised - Variation Type II - (Acceptance modification) |
20 Nov 2009 |
EMEA/H/C/212/II/34 |
| Xeristar |
Boehringer Ingelheim International GmbH |
Centralised - Variation Type II - (Acceptance modification) |
20 Nov 2009 |
EMEA/H/C/573/II/36 |
| Cymbalta |
Eli Lilly Nederland B.V. |
Centralised - Variation Type II - (Acceptance modification) |
20 Nov 2009 |
EMEA/H/C/572/II/36 |
| Clopidogrel Teva Pharma |
HCS bvba |
Centralised - Transfer Marketing Authorisation Holder |
19 Nov 2009 |
EMEA/H/C/1133/T/3 |
| IntronA |
Schering Plough Europe |
Centralised - Variation Type II - (Acceptance modification) |
19 Nov 2009 |
EMEA/H/C//281/II/75 |
| Imprida HCT |
Novartis Europharm Limited |
Corrigendum |
12 Nov 2009 |
|
| INTELENCE |
Janssen-Cilag International NV |
Centralised - Variation Type II - (Acceptance modification) |
12 Nov 2009 |
EMEA/H/C/900/II/7 |
| Clopidogrel BMS |
BRISTOL MYERS SQUIBB PHARMA EEIG |
Centralised - Withdrawal on holders request |
12 Nov 2009 |
|
| IntronA |
Schering Plough Europe |
Centralised - Variation Type II - (Acceptance modification) |
12 Nov 2009 |
EMEA/H/C/281/II65 |
| ViraferonPeg |
Schering Plough Europe |
Centralised - Variation Type II - (Extension of indication for paediatric use) |
12 Nov 2009 |
EMEA/H/C/329/II/84-86 |
| Irbesartan HCT BMS |
Bristol-Myers Squibb Pharma EEIG |
Centralised - Withdrawal on holders request |
11 Nov 2009 |
|
| Soliris |
Alexion Europe S.A.S. |
Centralised - Update Type IA - (Acceptance modification) |
11 Nov 2009 |
|
| CELVAPAN |
Baxter AG |
Centralised - Variation Type II - (Acceptance modification) |
11 Nov 2009 |
EMEA/H/C/982/II/6 |
| Focetria |
Novartis Vaccines and Diagnostics S.r.l. |
Centralised - Variation Type II - (Acceptance modification) |
11 Nov 2009 |
EMEA/H/C/710/II/8-09-10-11 |
| Pandemrix |
GlaxoSmithKline Biologicals s.a. |
Centralised - Variation Type II - (Acceptance modification) |
11 Nov 2009 |
EMEA/H/C/832/II/19 |
| PegIntron |
Schering Plough Europe |
Centralised - Variation Type II - (Extension of indication for paediatric use) |
11 Nov 2009 |
EMEA/H/C/280/II/85-87-EMEA/H/C/II/280/87 |
| Rebetol |
Schering Plough Europe |
Centralised - Variation Type II - (Extension of indication for paediatric use) |
11 Nov 2009 |
EMEA/H/C/246/II/45-48-49 |
| Irbesartan BMS |
Bristol-Myers Squibb Pharma EEIG |
Centralised - Withdrawal on holders request |
11 Nov 2009 |
|
| Insuman |
Sanofi-Aventis Deutschland GmbH |
Centralised - Variation Type II - (Acceptance modification) |
11 Nov 2009 |
EMEA/H/C/201/II/70 |
| Januvia |
Merck Sharp & Dohme Ltd |
Centralised - Variation Type II - (Acceptance modification) |
9 Nov 2009 |
EMEA/H/C/722/II/11 |
| FOSAVANCE |
Merck Sharp & Dohme Ltd |
Centralised - Variation Type II - (Acceptance modification) |
6 Nov 2009 |
EMEA/H/C/619/II/13 |
| Foscan |
Biolitec pharma Ltd |
Centralised - Update Type IB - (Acceptance modification) |
5 Nov 2009 |
|
| CELSENTRI |
Pfizer Limited |
Centralised - Variation Type II - (Acceptance modification) |
5 Nov 2009 |
EMEA/H/C/811/II/6 |
| Tyverb |
Glaxo Group Limited |
Centralised - Variation Type II - (Acceptance modification) |
5 Nov 2009 |
EMEA/H/C/795/II/5 |
| Invega |
Janssen-Cilag International NV |
Centralised - Variation Type II - (Acceptance modification) |
5 Nov 2009 |
EMEA/H/C/746/II/22 |
| Abilify |
Otsuka Pharmaceutical Europe Ltd |
Centralised - Variation Type II - (Acceptance modification) |
5 Nov 2009 |
EMEA/H/C/471/II/68 |
| Prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) GlaxoSmithKline Biologicals |
GlaxoSmithKline Biologicals s.a. |
Centralised - Variation Type II - (Acceptance modification) |
5 Nov 2009 |
EMEA/H/C/1015/II/13 |
| Pandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) GlaxoSmithKline Biologicals |
GlaxoSmithKline Biologicals s.a. |
Centralised - Authorisation under exceptional circumstances |
5 Nov 2009 |
EMEA/H/C/1206 |
| Lantus |
Sanofi-Aventis Deutschland GmbH |
Centralised - Variation Type II - (Acceptance modification) |
4 Nov 2009 |
EMEA/H/C/284/II/57 |
| Optisulin |
Sanofi-Aventis Deutschland GmbH |
Centralised - Variation Type II - (Acceptance modification) |
4 Nov 2009 |
EMEA/H/C/309/II/46 |
| INTELENCE |
Janssen-Cilag International NV |
Centralised - Variation Type II - (Acceptance modification) |
4 Nov 2009 |
EMEA/H/C/900/II/6 |
| Ketek |
Aventis Pharma S.A. |
Centralised - Variation Type II - (Acceptance modification) |
4 Nov 2009 |
EMEA/H/C/354/II/49 |
| Osseor |
Les Laboratoires Servier |
Centralised - Renewal with additional 5 years (Annex IV) |
4 Nov 2009 |
EMEA/H/C/561/R/21 |
| Repaglinide Krka |
KRKA, d. d., Novo mesto |
Centralised - Autorisation |
4 Nov 2009 |
EMEA/H/C/1066 |
| Protelos |
Les Laboratoires Servier |
Centralised - Renewal with additional 5 years (Annex IV) |
4 Nov 2009 |
EMEA/H/C/560/R/24 |
| Dafiro HCT |
Novartis Europharm Limited |
Centralised - Autorisation |
4 Nov 2009 |
EMEA/H/C/1160 |
| Copalia HCT |
Novartis Europharm Limited |
Centralised - Autorisation |
4 Nov 2009 |
EMEA/H/C/1159 |
| Insulin Human Winthrop |
Sanofi-Aventis Deutschland GmbH |
Centralised - Variation Type II - (Acceptance modification) |
30 Oct 2009 |
EMEA/H/C/761/II/43 |
| Zalasta |
KRKA, d.d., Novo mesto |
Centralised - Variation Type II - (Acceptance modification) |
30 Oct 2009 |
EMEA/H/C/792/II/9 |
| Xagrid |
Shire Pharmaceutical Contracts Ltd |
Centralised - Renewal with additional 5 years (Annex IV) |
30 Oct 2009 |
EMEA/H/C/480/R/30 |
| Irbesartan Teva |
Teva Pharma B.V. |
Centralised - Autorisation |
30 Oct 2009 |
EMEA/H/C/1093 |
| INOmax |
INO Therapeutics AB |
Centralised - Variation Type II - (Acceptance modification) |
29 Oct 2009 |
EMEA/H/C/337/II/17 |
| Remicade |
Centocor B.V. |
Centralised - Variation Type II - (Acceptance modification) |
29 Oct 2009 |
EMEA/H/C/240/II/135 |
| ADROVANCE |
Merck Sharp & Dohme Ltd |
Centralised - Variation Type II - (Acceptance modification) |
29 Oct 2009 |
EMEA/H/C/759/II/11 |
| Sebivo |
Novartis Europharm Limited |
Centralised - Variation Type II - (Acceptance modification) |
29 Oct 2009 |
EMEA/H/C/713/II/8 |
| Eporatio |
ratiopharm GmbH |
Centralised - Autorisation |
29 Oct 2009 |
EMEA/H/C/1033 |
| Aranesp |
Amgen Europe B.V. |
Centralised - Variation Type II - (Acceptance modification) |
28 Oct 2009 |
EMEA/H/C/332/II/75 |
| Efficib |
Merck Sharp & Dohme Ltd. |
Centralised - Variation Type II - (Acceptance modification) |
28 Oct 2009 |
EMEA/H/C/896/II/13 |
| Velmetia |
Merck Sharp & Dohme Ltd. |
Centralised - Variation Type II - (Acceptance modification) |
28 Oct 2009 |
EMEA/H/C/862/II/14 |
| Janumet |
Merck Sharp & Dohme Ltd. |
Centralised - Variation Type II - (Acceptance modification) |
28 Oct 2009 |
EMEA/H/C/861/II/13 |
| Beromun |
Boehringer Ingelheim International GmbH |
Centralised - Update Type IA - (Acceptance modification) |
28 Oct 2009 |
|
| SUTENT |
Pfizer Ltd |
Centralised - Variation Type II - (Acceptance modification) |
28 Oct 2009 |
EMEA/H/C/687/II/16 |
| Integrilin |
Glaxo Group Ltd |
Centralised - Variation Type II - (Acceptance modification) |
28 Oct 2009 |
EMEA/H/C/230/II/46 |
| Pradaxa |
Boehringer Ingelheim International GmbH |
Centralised - Variation Type II - (Acceptance modification) |
28 Oct 2009 |
EMEA/H/C/829/II/11 |
| Myozyme |
Genzyme Europe B.V. |
Centralised - Variation Type II - (Acceptance modification) |
28 Oct 2009 |
EMEA/H/C/636/II/7 |
| TESAVEL |
Merck Sharp & Dohme Ltd |
Centralised - Variation Type II - (Acceptance modification) |
28 Oct 2009 |
EMEA/H/C/910/II/9 |
| Arava |
Sanofi-Aventis Deutschland GmbH |
Centralised - Variation Type II - (Acceptance modification) |
28 Oct 2009 |
EMEA/H/C/235/II/43 |
| Yondelis |
Pharma Mar, S.A. |
Centralised - Variation Type II - (Acceptance modification) |
28 Oct 2009 |
EMEA/H/C/773/II/8 |
| RoActemra |
Roche Registration Limited |
Centralised - Variation Type II - (Acceptance modification) |
28 Oct 2009 |
EMEA/H/C/955/II/3-4 |
| Zerit |
Bristol-Myers Squibb Pharma EEIG |
Centralised - Variation Type II - (Acceptance modification) |
28 Oct 2009 |
EMEA/H/C/110/II/72 |
| Noxafil |
SP Europe |
Centralised - Variation Type II - (Acceptance modification) |
28 Oct 2009 |
EMEA/H/C/610/II/12 |
| Xelevia |
Merck Sharp & Dohme Ltd |
Centralised - Variation Type II - (Acceptance modification) |
28 Oct 2009 |
EMEA/H/C/762/II/12 |
| Zostavax |
Sanofi Pasteur MSD, SNC |
Centralised - Variation Type II - (Acceptance modification) |
28 Oct 2009 |
EMEA/H/C/674/II/26 |
| Epivir |
Glaxo Group Ltd. |
Centralised - Variation Type II - (Acceptance modification) |
28 Oct 2009 |
EMEA/H/C/107/II/71 |
| BeneFIX |
Wyeth Europa Ltd. |
Centralised - Variation Type II - (Acceptance modification) |
28 Oct 2009 |
EMEA/H/C/139/II/82 |
| IXIARO |
Intercell AG |
Centralised - Variation Type II - (Acceptance modification) |
28 Oct 2009 |
EMEA/H/C/963/II/1-2 |
| Velcade |
Janssen-Cilag International NV |
Centralised - Variation Type II - (Acceptance modification) |
28 Oct 2009 |
EMEA/H/C/539/II/36 |
| Ellaone |
Laboratoire HRA Pharma |
Centralised - Variation Type II - (Acceptance modification) |
23 Oct 2009 |
EMEA/H/C/1027/II/1 |
| Olanzapine Mylan |
Generics [UK] Limited |
Centralised - Variation Type II - (Acceptance modification) |
23 Oct 2009 |
EMEA/H/C/961/II/2 |
| Rebif |
Merck Serono Europe Limited |
Centralised - Variation Type II - (Acceptance modification) |
23 Oct 2009 |
EMEA/H/C/136/II/74 |
| PEGASYS |
Roche Registration Limited |
Centralised - Variation Type II - (Acceptance modification) |
23 Oct 2009 |
EMEA/H/C/395/II/43 |
| Procoralan |
Les Laboratoires Servier |
Centralised - Variation Type II - (Acceptance modification) |
23 Oct 2009 |
EMEA/H/C/597/II/10 |
| Corlentor |
Les Laboratoires Servier |
Centralised - Variation Type II - (Acceptance modification) |
23 Oct 2009 |
EMEA/H/C/598/II/10 |
| Invanz |
Merck Sharp & Dohme Ltd |
Centralised - Variation Type II - (Acceptance modification) |
23 Oct 2009 |
EMEA/H/C/389/II/31 |
| Tamiflu |
Roche Registration Limited |
Centralised - Variation Type II - (Acceptance modification) |
23 Oct 2009 |
EMEA/H/C/402/II/70-71 |
| Neulasta |
Amgen Europe B.V. |
Centralised - Variation Type II - (Acceptance modification) |
23 Oct 2009 |
EMEA/H/C/420/II/40 |
| Vistide |
Gilead Sciences International Limited |
Centralised - Variation Type II - (Acceptance modification) |
23 Oct 2009 |
EMEA/H/C/121/II/29 |
| Prezista |
Janssen-Cilag International NV |
Centralised - Variation Type II - (Acceptance modification) |
23 Oct 2009 |
EMEA/H/C/707/II/24-26-27 |
| Norvir |
Abbott Laboratories Ltd |
Centralised - Variation Type II - (Acceptance modification) |
23 Oct 2009 |
EMEA/H/C/127/II/92 |
| Teslascan |
GE Healthcare AS |
Centralised - Variation Type II - (Acceptance modification) |
23 Oct 2009 |
EMEA/H/C/137/II/16 |
| RotaTeq |
Sanofi Pasteur MSD, SNC |
Centralised - Variation Type II - (Acceptance modification) |
23 Oct 2009 |
EMEA/H/C/669/II/20 |
| ARCALYST |
Regeneron UK Limited |
Centralised - Authorisation of an orphan medicinal product under art 127a under exceptional circumstances - Decision addressed to the Marketing Authorisation Holder |
23 Oct 2009 |
EMEA/H/C/1047 |
| ARCALYST |
Regeneron UK Limited |
Centralised - Authorisation of an orphan medicinal product under art 127a under exceptional circumstances- Decision addressed to Member State |
23 Oct 2009 |
EMEA/H/C/1047 |
| ILARIS |
Novartis Europharm Limited |
Centralised - Authorisation of an orphan medicinal product under art 127a under exceptional circumstances- Decision addressed to Member State |
23 Oct 2009 |
EMEA/H/C/1109 |
| ILARIS |
Novartis Europharm Limited |
Centralised - Authorisation of an orphan medicinal product under art 127a under exceptional circumstances - Decision addressed to the Marketing Authorisation Holder |
23 Oct 2009 |
EMEA/H/C/1109 |
| Lamivudine Teva |
Teva Pharma B.V. |
Centralised - Autorisation |
23 Oct 2009 |
EMEA/H/C/1113 |
| Biopoin |
CT Arzneimittel GmbH |
Centralised - Autorisation |
23 Oct 2009 |
EMEA/H/C/1036 |
| Zarzio |
Sandoz GmbH |
Centralised - Variation Type II - (Acceptance modification) |
21 Oct 2009 |
EMEA/H/C/917/II/2 |
| Filgrastim Hexal |
HEXAL AG |
Centralised - Variation Type II - (Acceptance modification) |
21 Oct 2009 |
EMEA/H/C/918/II/2 |
| Xarelto |
Bayer Schering Pharma AG |
Centralised - Variation Type II - (Acceptance modification) |
21 Oct 2009 |
EMEA/H/C/944/II/3 |
| Metalyse |
Boehringer Ingelheim International GmbH |
Centralised - Update Type IA - (Acceptance modification) |
21 Oct 2009 |
|
| Vidaza |
Celgene Europe Ltd |
Centralised - Variation Type II - (Acceptance modification) |
20 Oct 2009 |
EMEA/H/C/978/II/1 |
| Prepandrix |
GlaxoSmithKline Biologicals s.a. |
Centralised - Variation Type II - (Acceptance modification) |
19 Oct 2009 |
EMEA/H/C/822/II/13 |
| Revlimid |
Celgene Europe Limited |
Centralised - Variation Type II - (Acceptance modification) |
19 Oct 2009 |
EMEA/H/C/717/II/24 |
| Thalidomide Celgene |
Celgene Europe Limited |
Centralised - Variation Type II - (Acceptance modification) |
19 Oct 2009 |
EMEA/H/C/823/II/7 |
| Ribavirin Teva Pharma BV |
Teva Pharma B.V. |
Centralised - Variation Type II - (Acceptance modification) |
19 Oct 2009 |
EMEA/H/C/1064/II/1 |
| Olanzapine Teva |
Teva Pharma B.V. |
Centralised - Variation Type II - (Acceptance modification) |
19 Oct 2009 |
EMEA/H/C/810/II/37 |
| Foclivia |
Novartis Vaccines and Diagnostics S.r.l. |
Centralised - Authorisation under exceptional circumstances |
19 Oct 2009 |
EMEA/H/C/1208 |
| Wilzin |
Orphan Europe S.a.r.l. |
Centralised - Renewal after maximum 5 years |
19 Oct 2009 |
EMEA/H/C/535/R/5 |
| Helixate NexGen |
Bayer Schering Pharma AG |
Centralised - Variation Type II - (Acceptance modification) |
16 Oct 2009 |
EMEA/H/C/276/II/99 |
| KOGENATE Bayer |
Bayer Schering Pharma AG |
Centralised - Variation Type II - (Acceptance modification) |
16 Oct 2009 |
EMEA/H/C/275/II/101 |
| Aptivus |
Boehringer Ingelheim International GmbH |
Centralised - Variation Type II - (Acceptance modification) |
16 Oct 2009 |
EMEA/H/C/631/II/37 |
| Pandemic influenza vaccine H5N1 BAXTER |
Baxter AG |
Centralised - Authorisation under exceptional circumstances |
16 Oct 2009 |
EMEA/H/C/1200 |
| ALENDRONATE SODIUM AND COLECALCIFEROL, MSD |
Merck Sharp & Dohme Ltd. |
Centralised - Autorisation |
16 Oct 2009 |
EMEA/H/C/1180 |
| Exforge HCT |
Novartis Europharm Limited |
Centralised - Autorisation |
16 Oct 2009 |
EMEA/H/C/1068 |
| Clopidogrel MYLAN Pharma |
Mylan S.A.S |
Centralised - Autorisation |
16 Oct 2009 |
EMEA/H/C/1189 |
| Nexavar |
Bayer Schering Pharma AG |
Centralised - Variation Type II - (Acceptance modification) |
15 Oct 2009 |
EMEA/H/C/690/II/15 |
| Resolor |
Movetis NV |
Centralised - Autorisation |
15 Oct 2009 |
EMEA/H/C/1012 |
| Imprida HCT |
Novartis Europharm Limited |
Centralised - Autorisation |
15 Oct 2009 |
EMEA/H/C/1161 |
| TORISEL |
Wyeth Europa Ltd |
Centralised - Variation Type II - Art 14(11) - grant 1 year marketing protection |
14 Oct 2009 |
EMEA/H/C/799/II/1 |
| PritorPlus |
Bayer Schering Pharma AG |
Centralised - Variation Type II - (Acceptance modification) |
14 Oct 2009 |
EMEA/H/C/414/II/64 |
| alli |
Glaxo Group Limited |
Centralised - Update Type IA - (Acceptance modification) |
14 Oct 2009 |
|
| Ammonaps |
Swedish Orphan International AB |
Centralised - Renewal after maximum 5 years |
14 Oct 2009 |
EMEA/H/C/219/R/34 |
| Enyglid |
KRKA, d. d., Novo mesto |
Centralised - Autorisation |
14 Oct 2009 |
EMEA/H/C/1065 |
| Onsenal |
Pfizer Limited |
Centralised - Annual reassessment |
14 Oct 2009 |
EMEA/H/C/466/S/26 |
| Kinzalkomb |
Bayer Schering Pharma AG |
Centralised - Variation Type II - (Acceptance modification) |
13 Oct 2009 |
EMEA/H/C/415/II/57 |
| Olanzapine Neopharma |
Neopharma Limited |
Centralised - Variation Type II - (Acceptance modification) |
13 Oct 2009 |
EMEA/H/C/793/II/5 |
| CellCept |
Roche Registration Limited |
Centralised - Variation Type II - (Acceptance modification) |
13 Oct 2009 |
EMEA/H/C/82/II/93 |
| NovoMix |
Novo Nordisk A/S |
Centralised - Variation Type II - (Acceptance modification) |
13 Oct 2009 |
EMEA/H/C/308/II/57-58 |
| Circadin |
RAD Neurim Pharmaceuticals EEC Limited |
Centralised - Update Type IA - (Acceptance modification) |
8 Oct 2009 |
|
| Nplate |
Amgen Europe B.V. |
Centralised - Update Type IB - (Acceptance modification) |
8 Oct 2009 |
|
| Sifrol |
Boehringer Ingelheim International GmbH |
Centralised - Annex II extension adding new number |
8 Oct 2009 |
EMEA/H/C/133/X/51 |
| Optison |
GE Healthcare AS |
Centralised - Lift of suspension |
8 Oct 2009 |
EMEA/H/C/166/Z/32 |
| Mirapexin |
Boehringer Ingelheim International GmbH |
Centralised - Annex II extension adding new number |
8 Oct 2009 |
EMEA/H/C/134/X/59 |
| Agenerase |
Glaxo Group Limited |
Centralised - Update Type IA - (Acceptance modification) |
7 Oct 2009 |
|
| IntronA |
Schering Plough Europe |
Centralised - Update Type IB - (Acceptance modification) |
7 Oct 2009 |
|
| CELVAPAN |
Baxter AG |
Centralised - Variation - Strain update vaccine |
6 Oct 2009 |
EMEA/H/C/982/PU/2 |
| ChondroCelect |
TiGenix NV |
Centralised - Authorisation under art 127a - Decision addressed to Members States - (Advanced therapy) |
5 Oct 2009 |
EMEA/H/C/878 |
| ChondroCelect |
TiGenix NV |
Centralised - Authorisation under art 127a - Decision addressed to Marketing Authorisation Holder - (Advanced therapy) |
5 Oct 2009 |
EMEA/H/C/878 |
| Tasmar |
Meda AB |
Centralised - Renewal with additional 5 years (Annex IV) |
2 Oct 2009 |
EMEA/H/C/123/R/39 |
| Actrapid |
Novo Nordisk A/S |
Centralised - Annex II extension without new number |
1 Oct 2009 |
EMEA/H/C/424/X/8 |
| Actraphane |
Novo Nordisk A/S |
Centralised - Annex II extension without new number |
1 Oct 2009 |
EMEA/H/C/427/X/9 |
| Insulatard |
Novo Nordisk A/S |
Centralised - Annex II extension without new number |
1 Oct 2009 |
EMEA/H/C/441/X/9 |
| Mixtard |
Novo Nordisk A/S |
Centralised - Annex II extension without new number |
1 Oct 2009 |
EMEA/H/C/428/X/9 |
| Protaphane |
Novo Nordisk A/S |
Centralised - Annex II extension without new number |
1 Oct 2009 |
EMEA/H/C/442/X/9 |
| Cimzia |
UCB Pharma SA. |
Centralised - Authorisation under art 127a - Decision addressed to Marketing Authorisation Holder |
1 Oct 2009 |
EMEA/H/C/1037 |
| Cimzia |
UCB Pharma SA. |
Centralised - Authorisation under art 127a - Decision addressed to Member State |
1 Oct 2009 |
EMEA/H/C/1037 |
| Epoetin alfa Hexal |
Hexal AG. |
Centralised - Annex II extension adding new number |
1 Oct 2009 |
EMEA/H/C/726/X/10 |
| Binocrit |
Sandoz GmbH |
Centralised - Annex II extension adding new number |
1 Oct 2009 |
EMEA/H/C/725/X/10 |
| Onglyza |
Bristol Myers Squibb/AstraZeneca EEIG |
Centralised - Autorisation |
1 Oct 2009 |
EMEA/H/C/1039 |
| Simponi |
Centocor B.V. |
Centralised - Authorisation under art 127a - Decision addressed to Marketing Authorisation Holder |
1 Oct 2009 |
EMEA/H/C/992 |
| Simponi |
Centocor B.V. |
Centralised - Authorisation under art 127a - Decision addressed to Member State |
1 Oct 2009 |
EMEA/H/C/992 |
| Pandemrix |
GlaxoSmithKline Biologicals s.a. |
Centralised - Variation - Strain update vaccine |
29 Sep 2009 |
EMEA/H/C/832/PU/17 |
| Focetria |
Novartis Vaccines and Diagnostics S.r.l. |
Centralised - Variation - Strain update vaccine |
29 Sep 2009 |
EMEA/H/C/710/PU/5 |
| Zyllt |
KRKA, d.d., Novo mesto |
Centralised - Autorisation |
28 Sep 2009 |
EMEA/H/C/1058 |
| Clopidogrel Acino Pharma |
Acino Pharma GmbH |
Centralised - Autorisation |
28 Sep 2009 |
EMEA/H/C/1172 |
| Qutenza |
NeurogesX UK Limited |
Centralised - Transfer Marketing Authorisation Holder |
25 Sep 2009 |
EMEA/H/C/909/T/1 |
| Emselex |
Novartis Europharm Limited |
Centralised - Renewal after maximum 5 years |
24 Sep 2009 |
EMEA/H/C/554/R/39 |
| Clopidogrel Qualimed |
Qualimed |
Centralised - Autorisation |
23 Sep 2009 |
EMEA/H/C/1135 |
| Clopidogrel TAD |
TAD Pharma GmbH |
Centralised - Autorisation |
23 Sep 2009 |
EMEA/H/C/1136 |
| Clopidogrel Krka |
KRKA, d. d., Novo mesto |
Centralised - Autorisation |
23 Sep 2009 |
EMEA/H/C/1056 |
| Clopidogrel ratiopharm |
Acino Pharma GmbH |
Centralised - Autorisation |
23 Sep 2009 |
EMEA/H/C/1173 |
| Mimpara |
Amgen Europe B.V. |
Centralised - Renewal after maximum 5 years |
23 Sep 2009 |
EMEA/H/C/570/R/20 |
| Vizarsin |
KRKA, d.d., Novo mesto |
Centralised - Autorisation |
21 Sep 2009 |
EMEA/H/C/1076 |
| Javlor |
Pierre Fabre Médicament |
Centralised - Autorisation |
21 Sep 2009 |
EMEA/H/C/983 |
| Topotecan Teva |
Teva Pharma B.V. |
Centralised - Autorisation |
21 Sep 2009 |
EMEA/H/C/1071 |
| Cayston |
Gilead Sciences International Limited |
Centralised - Conditional authorisation of an orphan medicinal product |
21 Sep 2009 |
EMEA/H/C/996 |
| Ferriprox |
Apotex Europe B.V. |
Centralised - Renewal after maximum 5 years |
21 Sep 2009 |
EMEA/H/C/236/R/54 |
| Clopidogrel Teva Pharma |
HCS bvba |
Centralised - Autorisation |
21 Sep 2009 |
EMEA/H/C/1133 |
| Clopidogrel DURA |
Mylan dura GmbH |
Centralised - Autorisation |
21 Sep 2009 |
EMEA/H/C/560 |
| Clopidogrel Mylan |
Mylan S.A.S |
Centralised - Autorisation |
21 Sep 2009 |
EMEA/H/C/1134 |
| Zopya |
Norpharm Regulatory Services Ltd |
Centralised - Autorisation |
21 Sep 2009 |
EMEA/H/C/1137 |
| Clopidogrel Acino Pharma GmbH |
Acino Pharma GmbH |
Centralised - Autorisation |
21 Sep 2009 |
EMEA/H/C/1175 |
| Zylagren |
KRKA, d. d., Novo mesto |
Centralised - Autorisation |
21 Sep 2009 |
EMEA/H/C/1138 |
| Clopidogrel Sandoz |
Acino Pharma GmbH |
Centralised - Autorisation |
21 Sep 2009 |
EMEA/H/C/1174 |
| Trisenox |
Cephalon Europe |
Centralised - Annual reassessment |
21 Sep 2009 |
EMEA/H/C/388/S/33 |
| Orfadin |
Swedish Orphan International AB |
Centralised - Annual reassessment |
21 Sep 2009 |
EMEA/H/C/555/S/19 |
| Elaprase |
Shire Human Genetic Therapies AB |
Centralised - Annual reassessment |
21 Sep 2009 |
EMEA/H/C/700/S/19 |
| AZILECT |
Teva Pharma GmbH |
Centralised - Renewal after maximum 5 years |
21 Sep 2009 |
EMEA/H/C/574/R/36 |
| Alimta |
Eli Lilly Nederland B.V. |
Centralised - Renewal after maximum 5 years |
21 Sep 2009 |
EMEA/H/C/564/R/18 |
| Glustin |
Takeda Global Research and Development Centre (Europe) Ltd |
Centralised - Variation Type II - (Acceptance modification) |
17 Sep 2009 |
EMEA/H/C/286/II/40 |
| Actos |
Takeda Global Research and Development Centre (Europe) Ltd |
Centralised - Variation Type II - (Acceptance modification) |
17 Sep 2009 |
EMEA/H/C/285/II/41 |
| Doribax |
Janssen-Cilag International NV |
Centralised - Variation Type II - (Acceptance modification) |
17 Sep 2009 |
EMEA/H/C/891/II/5 |
| Glubrava |
Takeda Global Research and Development Centre (Europe) Ltd |
Centralised - Variation Type II - (Acceptance modification) |
17 Sep 2009 |
EMEA/H/C/893/II/10-11 |
| DULOXETINE BOEHRINGER INGELHEIM |
Boehringer Ingelheim International GmbH |
Centralised - Variation Type II - (Acceptance modification) |
17 Sep 2009 |
EMEA/H/C/1007/II/11 |
| Lantus |
Sanofi-Aventis Deutschland GmbH |
Centralised - Variation Type II - (Acceptance modification) |
17 Sep 2009 |
EMEA/H/C/284/II/55 |
| Optisulin |
Sanofi-Aventis Deutschland GmbH |
Centralised - Variation Type II - (Acceptance modification) |
17 Sep 2009 |
EMEA/H/C/309/II/44 |
| Ribavirin Teva |
Teva Pharma B.V. |
Centralised - Variation Type II - (Acceptance modification) |
17 Sep 2009 |
EMEA/H/C/1018/II/1 |
| Velmetia |
Merck Sharp & Dohme Ltd. |
Centralised - Variation Type II - (Acceptance modification) |
16 Sep 2009 |
EMEA/H/C/862/II/13 |
| Efficib |
Merck Sharp & Dohme Ltd. |
Centralised - Variation Type II - (Acceptance modification) |
16 Sep 2009 |
EMEA/H/C/896/II/12 |
| Janumet |
Merck Sharp & Dohme Ltd. |
Centralised - Variation Type II - (Acceptance modification) |
16 Sep 2009 |
EMEA/H/C/861/II/12 |
| Lyrica |
Pfizer Ltd |
Centralised - Variation Type II - (Rejection of modification) |
14 Sep 2009 |
EMEA/H/C/546/II/24 |
| Avaglim |
SmithKline Beecham plc |
Centralised - Variation Type II - (Acceptance modification) |
14 Sep 2009 |
EMEA/H/C/675/II/23-24 |
| Tamiflu |
Roche Registration Limited |
Centralised - Variation Type II - (Acceptance modification) |
14 Sep 2009 |
EMEA/H/C/402/II/65 |
| Tamiflu |
Roche Registration Limited |
Centralised - Variation Type II - (Acceptance modification) |
9 Sep 2009 |
EMEA/H/C/402/II/67-68 |
| ISENTRESS |
Merck Sharp & Dohme Limited |
Centralised - Variation Type II - Art 14(11) - refusal 1 year marketing protection |
9 Sep 2009 |
EMEA/H/C/860/II/10 |
| Sebivo |
Novartis Europharm Limited |
Centralised - Variation Type II - (Acceptance modification) |
7 Sep 2009 |
EMEA/H/C/713/II/6 |
| Prialt |
Eisai Limited |
Centralised - Update Type IA - (Acceptance modification) |
4 Sep 2009 |
|
| Zevalin |
Bayer Schering Pharma AG |
Centralised - Variation Type II - (Acceptance modification) |
4 Sep 2009 |
EMEA/H/C/547/II/24 |
| Inovelon |
Eisai Limited |
Centralised - Update Type IA - (Acceptance modification) |
2 Sep 2009 |
|
| Tekturna |
Novartis Europharm Limited |
Centralised - Withdrawal on holders request |
2 Sep 2009 |
|
| Zomarist |
Novartis Europharm Limited |
Centralised - Variation Type II - (Acceptance modification) |
2 Sep 2009 |
EMEA/H/C/1049/II/3 |
| Silgard |
Merck Sharp & Dohme Ltd |
Centralised - Variation Type II - (Acceptance modification) |
2 Sep 2009 |
EMEA/H/C/732/II/18 |
| Norvir |
Abbott Laboratories Ltd |
Centralised - Variation Type II - (Acceptance modification) |
2 Sep 2009 |
EMEA/H/C/127/II/91 |
| Lumigan |
Allergan Pharmaceuticals Ireland |
Centralised - Variation Type II - (Acceptance modification) |
2 Sep 2009 |
EMEA/H/C/391/II/28 |
| Keppra |
UCB Pharma SA. |
Centralised - Variation Type II - (Additional pack size) |
2 Sep 2009 |
EMEA/H/C/277/II/97 |
| Gardasil |
Sanofi Pasteur MSD, SNC |
Centralised - Variation Type II - (Acceptance modification) |
31 Aug 2009 |
EMEA/H/C/703/II/20 |
| Icandra |
Novartis Europharm Limited |
Centralised - Variation Type II - (Acceptance modification) |
31 Aug 2009 |
EMEA/H/C/1050/II/3 |
| Mimpara |
Amgen Europe B.V. |
Centralised - Variation Type II - (Acceptance modification) |
31 Aug 2009 |
EMEA/H/C/570/II/21 |
| Neupro |
Schwarz Pharma Ltd |
Centralised - Variation Type II - (Acceptance modification) |
31 Aug 2009 |
EMEA/H/C/626/II/34-35 |
| Tandemact |
Takeda Global Research and Development Centre (Europe) Ltd. |
Centralised - Variation Type II - (Acceptance modification) |
31 Aug 2009 |
EMEA/H/C/680/II/18 |
| Betaferon |
Bayer Schering Pharma AG |
Centralised - Update Type IA - (Acceptance modification) |
31 Aug 2009 |
|
| Atripla |
Bristol-Myers Squibb and Gilead Sciences Limited |
Centralised - Update Type IA+IB - (Acceptance modification) |
31 Aug 2009 |
|
| Plavix |
Sanofi Pharma Bristol-Myers Squibb SNC |
Centralised - Variation Type II - (Acceptance modification) |
28 Aug 2009 |
EMEA/H/C/174/II/82 |
| Eucreas |
Novartis Europharm Limited |
Centralised - Variation Type II - (Acceptance modification) |
28 Aug 2009 |
EMEA/H/C/807/II/4 |
| MicardisPlus |
Boehringer Ingelheim International GmbH |
Centralised - Variation Type II - (Acceptance modification) |
28 Aug 2009 |
EMEA/H/C/413/II/53 |
| Invanz |
Merck Sharp & Dohme Ltd |
Centralised - Variation Type II - (Acceptance modification) |
28 Aug 2009 |
EMEA/H/C/389/II/30 |
| Forsteo |
Eli Lilly Nederland B.V. |
Centralised - Variation Type II - (Acceptance modification) |
28 Aug 2009 |
EMEA/H/C/425/II/21 |
| Xelevia |
Merck Sharp & Dohme Ltd |
Centralised - Variation Type II - (Acceptance modification) |
28 Aug 2009 |
EMEA/H/C/762/II/10 |
| Zerit |
Bristol-Myers Squibb Pharma EEIG |
Centralised - Variation Type II - (Acceptance modification) |
28 Aug 2009 |
EMEA/H/C/110/II/66 |
| Aldara |
Meda AB |
Centralised - Variation Type II - (Acceptance modification) |
28 Aug 2009 |
EMEA/H/C/179/II/46 |
| Ifirmasta (Ex Irbesartan Krka) |
KRKA, d.d., Novo mesto |
Centralised - Variation Type II - (Acceptance modification) |
28 Aug 2009 |
EMEA/H/C/962/II/1 |
| Panretin |
Eisai Limited |
Centralised - Update Type IA - (Acceptance modification) |
28 Aug 2009 |
|
| Trevaclyn |
Merck Sharp & Dohme Ltd |
Centralised - Variation Type II - (Acceptance modification) |
28 Aug 2009 |
EMEA/H/C/897/II/8 |
| Tredaptive |
Merck Sharp & Dohme Ltd |
Centralised - Variation Type II - (Acceptance modification) |
28 Aug 2009 |
EMEA/H/C/889/II/8 |
| Pelzont |
Merck Sharp & Dohme Ltd |
Centralised - Variation Type II - (Acceptance modification) |
28 Aug 2009 |
EMEA/H/C/903/II/8 |
| Humira |
Abbott Laboratories Ltd |
Centralised - Variation Type II - (Acceptance modification) |
28 Aug 2009 |
EMEA/H/C/481/II/64-66 |
| Volibris |
Glaxo Group Ltd |
Centralised - Variation Type II - (Acceptance modification) |
28 Aug 2009 |
EMEA/H/C/839/II/6 |
| Abseamed |
Medice Arzneimittel Pütter GmbH & Co KG |
Centralised - Variation Type II - (Acceptance modification) |
28 Aug 2009 |
EMEA/H/C/727/II/13 |
| Iscover |
Bristol-Myers Squibb Pharma EEIG |
Centralised - Variation Type II - (Acceptance modification) |
27 Aug 2009 |
EMEA/H/C/175/II/84 |
| Xeristar |
Boehringer Ingelheim International GmbH |
Centralised - Variation Type II - (Acceptance modification) |
27 Aug 2009 |
EMEA/H/C/573/II/44 |
| Vfend |
Pfizer Ltd |
Centralised - Variation Type II - (Acceptance modification) |
27 Aug 2009 |
EMEA/H/C/387/II/63 |
| CELVAPAN |
Baxter AG |
Centralised - Variation Type II - (Acceptance modification) |
27 Aug 2009 |
EMEA/H/C/982/II/1 |
| Thalidomide Celgene |
Celgene Europe Limited |
Centralised - Variation Type II - (Acceptance modification) |
27 Aug 2009 |
EMEA/H/C/823/II/8 |
| Champix |
Pfizer Ltd |
Centralised - Variation Type II - (Acceptance modification) |
27 Aug 2009 |
EMEA/H/C/699/II/22-23 |
| Zeffix |
Glaxo Group Ltd. |
Centralised - Renewal with additional 5 years (Annex IV) |
27 Aug 2009 |
EMEA/H/C/242/R/46 |
| Xiliarx |
Novartis Europharm Limited |
Centralised - Variation Type II - (Acceptance modification) |
25 Aug 2009 |
EMEA/H/C/1051/II/1 |
| Epoetin alfa Hexal |
Hexal AG. |
Centralised - Variation Type II - (Acceptance modification) |
25 Aug 2009 |
EMEA/H/C/726/II/14 |
| Binocrit |
Sandoz GmbH |
Centralised - Variation Type II - (Acceptance modification) |
25 Aug 2009 |
EMEA/H/C/725/II/14 |
| Avandamet |
SmithKline Beecham plc |
Centralised - Variation Type II - (Acceptance modification) |
25 Aug 2009 |
EMEA/H/C/522/II/57-58 |
| Tasigna |
Novartis Europharm Limited |
Centralised - Variation Type II - (Acceptance modification) |
25 Aug 2009 |
EMEA/H/C/798/II/16-18 |
| Ranexa |
Menarini International Operations Luxembourg S.A. |
Centralised - Variation Type II - (Acceptance modification) |
25 Aug 2009 |
EMEA/H/C/805/IB/II/18-19-20 |
| TARGRETIN |
Eisai Limited |
Centralised - Update Type IA - (Acceptance modification) |
21 Aug 2009 |
|
| Jalra |
Novartis Europharm Limited |
Centralised - Variation Type II - (Acceptance modification) |
21 Aug 2009 |
EMEA/H/C/1048/II/2 |
| Galvus |
Novartis Europharm Limited |
Centralised - Variation Type II - (Acceptance modification) |
21 Aug 2009 |
EMEA/H/C/771/II/4 |
| AVANDIA |
SmithKline Beecham plc |
Centralised - Variation Type II - (Acceptance modification) |
21 Aug 2009 |
EMEA/H/C/268/II/70 |
| Mabthera |
Roche Registration Limited |
Centralised - Variation Type II - (Acceptance modification) |
21 Aug 2009 |
EMEA/H/C/165/II/64 |
| Mycophenolate mofetil Teva |
Teva Pharma B.V. |
Centralised - Variation Type II - (Acceptance modification) |
21 Aug 2009 |
EMEA/H/C/882/II/4 |
| Myfenax |
Teva Pharma B.V. |
Centralised - Variation Type II - (Acceptance modification) |
21 Aug 2009 |
EMEA/H/C/884/II/4 |
| Rotarix |
GlaxoSmithKline Biologicals s.a. |
Centralised - Variation Type II - (Acceptance modification) |
21 Aug 2009 |
EMEA/H/C/639/II/17-18 |
| PEGASYS |
Roche Registration Limited |
Centralised - Variation Type II - (Acceptance modification) |
21 Aug 2009 |
EMEA/H/C/395/II/41-42 |
| TORISEL |
Wyeth Europa Ltd |
Centralised - Variation Type II - Art 14(11) - grant 1 year marketing protection |
21 Aug 2009 |
EMEA/H/C/799/II/1 |
| Privigen |
CSL Behring GmbH |
Centralised - Variation Type II - (Acceptance modification) |
21 Aug 2009 |
EMEA/H/C/831/II/13-17 |
| Abilify |
Otsuka Pharmaceutical Europe Ltd |
Centralised - Variation Type II - (Acceptance modification) |
21 Aug 2009 |
EMEA/H/C/471/II/48 |
| Competact |
Takeda Global Research and Development Centre (Europe) Ltd |
Centralised - Variation Type II - (Acceptance modification) |
21 Aug 2009 |
EMEA/H/C/655/II/22-23 |
| Kaletra |
Abbott Laboratories Ltd |
Centralised - Variation Type II - (Acceptance modification) |
21 Aug 2009 |
EMEA/H/C/368/II/67 |
| Januvia |
Merck Sharp & Dohme Ltd |
Centralised - Variation Type II - (Acceptance modification) |
21 Aug 2009 |
EMEA/H/C/722/II/9 |
| Myozyme |
Genzyme Europe B.V. |
Centralised - Variation Type II - (Acceptance modification) |
21 Aug 2009 |
EMEA/H/C/636/II/13 |
| Luminity |
Lantheus MI UK Limited |
Centralised - Variation Type II - (Acceptance modification) |
21 Aug 2009 |
EMEA/H/C/654/II/7 |
| Pradaxa |
Boehringer Ingelheim International GmbH |
Centralised - Variation Type II - (Acceptance modification) |
20 Aug 2009 |
EMEA/H/C/829/II/12 |
| TESAVEL |
Merck Sharp & Dohme Ltd |
Centralised - Variation Type II - (Acceptance modification) |
20 Aug 2009 |
EMEA/H/C/910/II/7 |
| Pramipexole Teva |
Teva Pharma B.V. |
Centralised - Variation Type II - (Acceptance modification) |
20 Aug 2009 |
EMEA/H/C/490/II/3 |
| Lyrica |
Pfizer Ltd |
Centralised - Variation Type II - (Acceptance modification) |
20 Aug 2009 |
EMEA/H/C/546/II/34 |
| SUTENT |
Pfizer Ltd |
Centralised - Variation Type II - (Acceptance modification) |
20 Aug 2009 |
EMEA/H/C/687/II/15 |
| Apidra |
Sanofi-Aventis Deutschland GmbH |
Centralised - Renewal after maximum 5 years |
20 Aug 2009 |
EMEA/H/C/557/R/25 |
| Clopidogrel BMS |
BRISTOL MYERS SQUIBB PHARMA EEIG |
Centralised - Variation Type II - (Acceptance modification) |
13 Aug 2009 |
EMEA/H/C/974/II/8 |
| Clopidogrel Winthrop |
Sanofi Pharma Bristol-Myers Squibb SNC |
Centralised - Variation Type II - (Acceptance modification) |
13 Aug 2009 |
EMEA/H/C/975/II/8 |
| Oprymea |
KRKA, d. d., Novo mesto |
Centralised - Variation Type II - (Acceptance modification) |
13 Aug 2009 |
EMEA/H/C/941/II/4 |
| Lyrica |
Pfizer Ltd |
Centralised - Variation Type II - (Acceptance modification) |
7 Aug 2009 |
EMEA/H/C/546/II/33 |
| CELSENTRI |
Pfizer Limited |
Centralised - Variation Type II - (Acceptance modification) |
7 Aug 2009 |
EMEA/H/C/811/II/5-7 |
| Revlimid |
Celgene Europe Limited |
Centralised - Variation Type II - (Acceptance modification) |
7 Aug 2009 |
EMEA/H/C/717/II/25 |
| Prepandrix |
GlaxoSmithKline Biologicals s.a. |
Centralised - Annex II extension adding new number |
7 Aug 2009 |
EMEA/H/C/822/X/4 |
Centralised procedures of orphan medicinal products for human use
|
| Product |
Marketing Authorisation Holder |
Decision Type |
Decision date |
EMEA Nr |
| EU/3/04/230 |
Sorin Group Italia S.r.l. |
Centralised - Transfer of orphan designation |
8 Jan 2010 |
EMEA/OD/39/04/T/1 |
| EU/3/05/317 |
Henogen S.A. |
Centralised - Transfer of orphan designation |
8 Jan 2010 |
EMEA/OD/46/05/T/1 |
| EU/3/09/696 |
Abiogen Pharma S.p.A. |
Centralised - Initial orphan designation |
30 Nov 2009 |
EMEA/OD/6/09 |
| EU/3/09/695 |
Merck Sharp & Dohme Limited |
Centralised - Initial orphan designation |
30 Nov 2009 |
EMEA/OD/86/09 |
| EU/3/09/700 |
Sirius Regulatory Consulting Limited |
Centralised - Initial orphan designation |
26 Nov 2009 |
EMEA/OD/76/09 |
| EU/3/09/699 |
LFB-Biotechnologies |
Centralised - Initial orphan designation |
26 Nov 2009 |
EMEA/OD/90/09 |
| EU/3/09/698 |
Voisin Consulting S.A.R.L. |
Centralised - Initial orphan designation |
26 Nov 2009 |
EMEA/OD/75/09 |
| EU/3/09/694 |
Only For Children Pharmaceuticals |
Centralised - Initial orphan designation |
26 Nov 2009 |
EMEA/OD/84/09 |
| EU/3/09/693 |
Astex Therapeutics Limited |
Centralised - Initial orphan designation |
26 Nov 2009 |
EMEA/OD/91/09 |
| EU/3/09/697 |
Novartis Europharm Limited |
Centralised - Initial orphan designation |
25 Nov 2009 |
EMEA/OD/48/09 |
| EU/3/09/692 |
Biogenera srl |
Centralised - Initial orphan designation |
25 Nov 2009 |
EMEA/OD/93/09 |
| EU/3/05/334 |
Apoxis (UK) Ltd |
Centralised - Transfer of orphan designation |
23 Nov 2009 |
EMEA/OD/64/05/T02 |
| EU/3/05/271 |
OneWorld Health |
Centralised - Transfer of orphan designation |
20 Nov 2009 |
EMEA/OD/86/04/T/1 |
| EU/3/09/690 |
Emergent Sales and Marketing Germany GmbH |
Centralised - Initial orphan designation |
9 Nov 2009 |
EMEA/OD/64/09 |
| EU/3/09/689 |
CuraVac Europe SPRL |
Centralised - Initial orphan designation |
9 Nov 2009 |
EMEA/OD/78/09 |
| EU/3/09/686 |
MolMed S.p.A. |
Centralised - Initial orphan designation |
9 Nov 2009 |
EMEA/OD/70/09 |
| EU/3/09/685 |
Merck KGaA |
Centralised - Initial orphan designation |
9 Nov 2009 |
EMEA/OD/69/09 |
| EU/3/09/691 |
Emergent Sales and Marketing Germany GmbH |
Centralised - Initial orphan designation |
5 Nov 2009 |
EMEA/OD/65/09 |
| EU/3/09/688 |
Novartis Europharm Limited |
Centralised - Initial orphan designation |
5 Nov 2009 |
EMEA/OD/50/09 |
| EU/3/09/687 |
Novartis Europharm Limited |
Centralised - Initial orphan designation |
5 Nov 2009 |
EMEA/OD/49/09 |
| EU/3/09/684 |
AB Science |
Centralised - Initial orphan designation |
28 Oct 2009 |
EMEA/OD/63/09 |
| EU/3/09/683 |
Special Products Ltd. |
Centralised - Initial orphan designation |
28 Oct 2009 |
EMEA/OD/80/09 |
| EU/3/09/682 |
MedImmune Ltd |
Centralised - Initial orphan designation |
28 Oct 2009 |
EMEA/OD/71/09 |
| EU/3/09/681 |
Siena Biotech SpA |
Centralised - Initial orphan designation |
28 Oct 2009 |
EMEA/OD/66/09 |
| EU/3/09/680 |
Clavis Pharma ASA |
Centralised - Initial orphan designation |
28 Oct 2009 |
EMEA/OD/67/09 |
| EU/3/09/679 |
NOSCIRA, S.A. |
Centralised - Initial orphan designation |
28 Oct 2009 |
EMEA/OD/74/09 |
| EU/3/04/226 |
Novo Nordisk A/S |
Centralised - Transfer of orphan designation |
9 Oct 2009 |
EMEA/OD/35/04/T/1 |
| EU/3/07/432 |
Quintiles UK Limited |
Centralised - Transfer of orphan designation |
9 Oct 2009 |
EMEA/OD/68/06/T/1 |
| EU/3/09/675 |
Bayer Schering Pharma AG |
Centralised - Initial orphan designation |
9 Oct 2009 |
EMEA/OD/31/09 |
| EU/3/09/674 |
RegPak BioPharma Consulting |
Centralised - Initial orphan designation |
9 Oct 2009 |
EMEA/OD/39/09 |
| EU/3/09/673 |
Affimed Therapeutics AG |
Centralised - Initial orphan designation |
9 Oct 2009 |
EMEA/OD/46/09 |
| EU/3/09/669 |
TikoMed AB |
Centralised - Initial orphan designation |
9 Oct 2009 |
EMEA/OD/20/09 |
| EU/3/09/678 |
Gregory Fryer Associates Ltd |
Centralised - Initial orphan designation |
8 Oct 2009 |
EMEA/OD/36/09 |
| EU/3/09/677 |
Apeptico Forschung und Entwicklung GmbH |
Centralised - Initial orphan designation |
8 Oct 2009 |
EMEA/OD/15/09 |
| EU/3/09/676 |
Bayer Schering Pharma AG |
Centralised - Initial orphan designation |
8 Oct 2009 |
EMEA/OD/62/09 |
| EU/3/09/672 |
Celgene Europe Limited |
Centralised - Initial orphan designation |
8 Oct 2009 |
EMEA/OD/53/09 |
| EU/3/09/671 |
Novartis Europharm Limited |
Centralised - Initial orphan designation |
8 Oct 2009 |
EMEA/OD/52/09 |
| EU/3/09/670 |
Novartis Europharm Limited |
Centralised - Initial orphan designation |
8 Oct 2009 |
EMEA/OD/51/09 |
| EU/3/09/668 |
ViroPharma SPRL |
Centralised - Initial orphan designation |
8 Oct 2009 |
EMEA/OD/26/09 |
| EU/3/09/667 |
Cellerix S.A. |
Centralised - Initial orphan designation |
8 Oct 2009 |
EMEA/OD/54/09 |
| EU/3/09/666 |
S.L.A. Pharma (UK) Ltd |
Centralised - Initial orphan designation |
8 Oct 2009 |
EMEA/OD/40/09 |
| EU/3/09/665 |
Teva Pharma GmbH |
Centralised - Initial orphan designation |
8 Oct 2009 |
EMEA/OD/35/09 |
| EU/3/09/664 |
Teva Pharma GmbH |
Centralised - Initial orphan designation |
8 Oct 2009 |
EMEA/OD/33/09 |
| EU/3/09/663 |
Amsterdam Molecular Therapeutics (AMT) B.V. |
Centralised - Initial orphan designation |
8 Oct 2009 |
EMEA/OD/44/09 |
| EU/3/09/662 |
Antisoma Research Ltd |
Centralised - Initial orphan designation |
8 Oct 2009 |
EMEA/OD/16/09 |
| EU/3/09/661 |
Lexicon Celtic Limited |
Centralised - Initial orphan designation |
8 Oct 2009 |
EMEA/OD/47/09 |
| EU/3/06/401 |
ICON Clinical Research Limited |
Centralised - Transfer of orphan designation |
14 Sep 2009 |
EMEA/OD/32/06/T/1 |
| EU/3/07/487 |
The Medicines Company (Leipzig) GmbH |
Centralised - Transfer of orphan designation |
14 Sep 2009 |
EMEA/OD/57/07/T/1 |
| EU/3/05/307 |
Tercica Europe Limited |
Centralised - Transfer of orphan designation |
14 Sep 2009 |
EMEA/OD/25/05/T/2 |
Centralised procedures of veterinary medicinal products
|
| Product |
Marketing Authorisation Holder |
Decision Type |
Decision date |
EMEA Nr |
| Quadrisol |
Intervet International B.V. |
Centralised - Transfer Marketing Authorisation Holder |
29 Jan 2010 |
EMEA/V/C/32/T/34 |
| Purevax RCP |
Merial |
Centralised - Renewal after maximum 5 years |
25 Jan 2010 |
EMEA/V/C/90/R/7 |
| Convenia |
Pfizer Ltd |
Centralised - Variation Type II - (Acceptance modification) |
15 Jan 2010 |
EMEA/V/C/98/II/6 |
| Zulvac 8 Bovis |
Fort Dodge Animal Health Ltd |
Centralised - Authorisation under exceptional circumstances |
15 Jan 2010 |
EMEA/V/C/145 |
| Zulvac 8 Ovis |
Fort Dodge Animal Health Ltd |
Centralised - Authorisation under exceptional circumstances |
15 Jan 2010 |
EMEA/V/C/147 |
| Purevax RC |
Merial |
Centralised - Renewal after maximum 5 years |
15 Jan 2010 |
EMEA/V/C/91/R/7 |
| Purevax RCCh |
Merial |
Centralised - Renewal after maximum 5 years |
15 Jan 2010 |
EMEA/V/C/92/R/7 |
| Purevax RCPCh FeLV |
Merial |
Centralised - Renewal after maximum 5 years |
15 Jan 2010 |
EMEA/V/C/85/R/7 |
| Purevax RCP FeLV |
Merial |
Centralised - Renewal after maximum 5 years |
15 Jan 2010 |
|
| Poulvac FluFend H5N3 RG |
Fort Dodge Animal Health Ltd |
Centralised - Update Type IB - (Acceptance modification) |
14 Jan 2010 |
|
| RESPIPORC FLU3 |
IDT Biologika GmbH |
Centralised - Autorisation |
14 Jan 2010 |
EMEA/V/C/153 |
| Gripovac 3 |
MERIAL |
Centralised - Autorisation |
14 Jan 2010 |
EMEA/V/C/157 |
| Dexdomitor |
Orion Corporation |
Corrigendum |
12 Jan 2010 |
|
| BTVPUR Alsap 8 |
MERIAL |
Centralised - Variation Type II - (Acceptance modification) |
12 Jan 2010 |
EMEA/V/C/146/II/1 |
| Porcilis PCV |
Intervet International B.V. |
Centralised - Variation Type II - (Acceptance modification) |
12 Jan 2010 |
EMEA/V/C/135/II/1 |
| Previcox |
Merial |
Centralised - Variation Type II - (Acceptance modification) |
12 Jan 2010 |
EMEA/V/C/82/II/23 |
| METACAM |
Boehringer Ingelheim Vetmedica GmbH |
Centralised - Variation Type II - (Additional pack size) |
12 Jan 2010 |
EMEA/V/C/33/II/75 |
| METACAM |
Boehringer Ingelheim Vetmedica GmbH |
Corrigendum |
8 Jan 2010 |
|
| Onsior |
Novartis Animal Health UK Ltd |
Centralised - Update Type IA - (Acceptance modification) |
22 Dec 2009 |
|
| BTVPUR Alsap 8 |
MERIAL |
Corrigendum |
22 Dec 2009 |
|
| Flexicam |
Omnipharm Ltd. |
Centralised - Transfer Marketing Authorisation Holder |
21 Dec 2009 |
EMEA/V/C/102/T/4 |
| Equioxx |
MERIAL |
Centralised - Annex II extension adding new number |
18 Dec 2009 |
EMEA/V/C/142/X/1 |
| Aivlosin |
ECO Animal Health Ltd |
Centralised - Annex II extension adding new number |
14 Dec 2009 |
EMEA/H/C/83/X/36-37 |
| Halocur |
Intervet International B.V. |
Centralised - Renewal after maximum 5 years |
23 Nov 2009 |
EMEA/V/C/40/R/6 |
| METACAM |
Boehringer Ingelheim Vetmedica GmbH |
Centralised - Variation Type II - (Additional pack size) |
20 Nov 2009 |
EMEA/V/C/33/II/78 |
| Improvac |
PFIZER Limited |
Centralised - Variation Type II - (Acceptance modification) |
19 Nov 2009 |
EMEA/V/C/136/II/1 |
| Dexdomitor |
Orion Corporation |
Centralised - Variation Type II - (Acceptance modification) |
18 Nov 2009 |
EMEA/V/C/70/II/18 |
| ZOLVIX |
Novartis Healthcare A/S |
Centralised - Autorisation |
4 Nov 2009 |
EMEA/V/C/154 |
| Easotic |
VIRBAC S.A. |
Centralised - Update Type IB - (Acceptance modification) |
30 Oct 2009 |
|
| Suprelorin |
VIRBAC S.A. |
Centralised - Update Type IA - (Acceptance modification) |
21 Oct 2009 |
|
| Rheumocam |
Chanelle Pharmaceuticals Manufacturing Limited |
Centralised - Annex II extension adding new number |
8 Oct 2009 |
EMEA/V/C/121/X/4 |
| Meloxidyl |
CEVA SANTE ANIMALE |
Centralised - Annex II extension adding new number |
8 Oct 2009 |
EMEA/V/C/115/X/2 |
| Naxcel |
Pfizer Ltd |
Centralised - Annex II extension adding new number |
8 Oct 2009 |
EMEA/V/C/79/X/7 |
| Nobilis Influenza H5N2 |
Intervet International B.V. |
Centralised - Annual reassessment |
6 Oct 2009 |
EMEA/V/C/118/S/4 |
| Stronghold |
Pfizer Ltd |
Centralised - Renewal after maximum 5 years |
1 Oct 2009 |
EMEA/V/C/50/R/36 |
| Oxyglobin |
Biopure Netherlands B.V. |
Centralised - Renewal after maximum 5 years |
1 Oct 2009 |
EMEA/V/C/45/R/13 |
| Palladia |
Pfizer Ltd |
Centralised - Autorisation |
23 Sep 2009 |
EMEA/V/C/150 |
| Posatex |
Intervet International B.V. |
Centralised - Variation Type II - (Acceptance modification) |
8 Sep 2009 |
EMEA/V/C/122/II/2 |
| Cerenia |
Pfizer Ltd |
Centralised - Variation Type II - (Acceptance modification) |
2 Sep 2009 |
EMEA/V/C/106/II/6 |
| Locatim |
Biokema Anstalt |
Centralised - Update Type IA - (Acceptance modification) |
31 Aug 2009 |
|
| Aivlosin |
ECO Animal Health Ltd |
Centralised - Renewal with additional 5 years (Annex IV) |
27 Aug 2009 |
EMEA/V/C/83/R/38 |
| ZACTRAN |
MERIAL |
Corrigendum |
21 Aug 2009 |
|
| Nobilis Influenza H5N6 |
Intervet International B.V. |
Centralised - Annual reassessment |
18 Aug 2009 |
EMEA/V/C/125/S/1 |
Community referrals for human medicinal products
|
| Product |
Marketing Authorisation Holder |
Decision Type |
Decision date |
EMEA Nr |
| Gemesis |
BioMimetic Therapeutics, Ltd. |
Centralised - Refusal after appeal |
29 Jan 2010 |
EMEA/H/C/997 |
| Teicoplanin Hospira and associated names |
|
Community Referrals - Art 29 - (Withdrawal) |
29 Jan 2010 |
EMEA/H/A-29/1084 |
| Extraneal |
|
Community Referrals - Art 35 - (Amend) Var type II |
10 Jan 2010 |
EMEA/H/A-6(12)/1203 |
| Arimidex |
|
Community Referrals - Art 29 - (Modification) |
6 Nov 2009 |
EMEA/HA/A-29/1190 |
| Fentanyl (Matripain) |
|
Community Referrals - Art 29 - (Withdrawal) |
30 Oct 2009 |
EMEA/H/A-29/842 |
| Fentanyl (Fentrans) |
|
Community Referrals - Art 29 - (Suspension) |
30 Oct 2009 |
EMEA/H/A-29/844 |
| Fentanyl (Fentador) |
|
Community Referrals - Art 29 - (Withdrawal) |
30 Oct 2009 |
EMEA/H/A-29/841 |
| Fentanyl (Fentastad) |
|
Community Referrals - Art 29 - (Withdrawal) |
30 Oct 2009 |
EMEA/H/A-29/840 |
| Fentanyl (Matrigesic) |
|
Community Referrals - Art 29 - (Withdrawal) |
30 Oct 2009 |
EMEA/H/A-29/843 |
| Augmentin |
|
Community Referrals - Art 30 - (Modification) |
19 Oct 2009 |
EMEA/H/A-30/979 |
| Nimesulide |
|
Community Referrals - Art 107 (single measures) |
16 Oct 2009 |
|
| Meronem |
|
Community Referrals - Art 30 - (Modification) |
15 Oct 2009 |
EMEA/H/A-30/1003 |
| Fentrix |
|
Community Referrals - Art 29 - (Issuing) |
6 Oct 2009 |
EMEA/H/A-29/1168 |
| Octegra |
|
Community Referrals - Art 29 - (Issuing and modification) |
2 Oct 2009 |
EMEA/H/A-29/1083 |
| Avalox |
|
Community Referrals - Art 29 - (Issuing and modification) |
2 Oct 2009 |
EMEA/H/A-29/1082 |
| Topamax |
|
Community Referrals - Art 30 - (Modification) |
1 Oct 2009 |
EMEA/H/A-30/999 |
Community referrals for veterinary medicinal products
|
| Product |
Marketing Authorisation Holder |
Decision Type |
Decision date |
EMEA Nr |
| APPM Respipharm |
|
Community Referrals - Art 31 - (Suspension) |
27 Jan 2010 |
EMEA/V/A/44 |
| Pulmotil 40 VET Premix, Pulmotil 100 VET Premix, Pulmotil 200 VET Premix |
|
Corrigendum |
8 Jan 2010 |
|
| Pulmotil 40 VET Premix, Pulmotil 100 VET Premix, Pulmotil 200 VET Premix |
|
Community Referrals - Art 34 - Veterinary |
15 Oct 2009 |
EMEA/V/A/037 |
| Pulmotil AC |
|
Community Referrals - Art 34 - Veterinary |
15 Oct 2009 |
EMEA/V/A/041 |
| Ivermectin containing products |
|
Community Referrals - Art 35 - (Amend) |
1 Oct 2009 |
EMEA/V/A/027-027 |
