| Vantavo (previously Alendronate sodium and colecalciferol, MSD) |
Human |
alendronic acid;colecalciferol |
alendronic acid;colecalciferol |
EMEA/H/C/001180 |
Organon N.V. |
2009/10/16
|
Authorised |
| Clopidogrel Viatris (previously Clopidogrel Taw Pharma) |
Human |
clopidogrel |
clopidogrel besilate |
EMEA/H/C/001189 |
Viatris Limited |
2009/10/16
|
Authorised |
| Pandemic Influenza Vaccine H5N1 Baxter AG |
Human |
pandemic influenza vaccine (H5N1) (whole virion, inactivated, prepared in cell culture) |
influenza vaccine (whole virion, inactivated) containing antigen of: A/Vietnam/1203/2004 (H5N1) |
EMEA/H/C/001200 |
Resilience Biomanufacturing Ireland Limited |
2009/10/16
|
Withdrawn |
| Exforge HCT |
Human |
amlodipine besilate;valsartan;hydrochlorothiazide |
valsartan;hydrochlorothiazide;amlodipine besilate |
EMEA/H/C/001068 |
Novartis Europharm Limited |
2009/10/15
|
Authorised |
| Imprida HCT |
Human |
amlodipine;valsartan;hydrochlorothiazide |
amlodipine;valsartan;hydrochlorothiazide |
EMEA/H/C/001161 |
Novartis Europharm Ltd. |
2009/10/15
|
Lapsed |
| Resolor |
Human |
prucalopride |
prucalopride succinate |
EMEA/H/C/001012 |
Takeda Pharmaceuticals International AG Ireland |
2009/10/14
|
Authorised |
| Enyglid |
Human |
repaglinide |
repaglinide |
EMEA/H/C/001065 |
Krka, d.d., Novo mesto |
2009/10/13
|
Authorised |
| Adjupanrix (previously Pandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) GlaxoSmithKline Biologicals) |
Human |
pandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) |
split influenza virus, inactivated, containing antigen: A/VietNam/1194/2004 (H5N1) like strain used (NIBRG-14) |
EMEA/H/C/001206 |
GlaxoSmithKline Biologicals S.A. |
2009/10/10
|
Authorised |
| ChondroCelect |
Human |
characterised viable autologous cartilage cells expanded ex vivo expressing specific marker proteins |
characterised viable autologous cartilage cells expanded ex vivo expressing specific marker proteins |
EMEA/H/C/000878 |
TiGenix N.V. |
2009/10/05
|
Withdrawn |
| Simponi |
Human |
golimumab |
golimumab |
EMEA/H/C/000992 |
Janssen Cilag International NV |
2009/10/01
|
Authorised |
| Cimzia |
Human |
certolizumab pegol |
certolizumab pegol |
EMEA/H/C/001037 |
UCB Pharma |
2009/10/01
|
Authorised |
| Onglyza |
Human |
saxagliptin |
saxagliptin |
EMEA/H/C/001039 |
AstraZeneca AB |
2009/09/30
|
Authorised |
| Zyllt |
Human |
clopidogrel |
clopidogrel (as hydrogen sulfate) |
EMEA/H/C/001058 |
Krka, d.d., Novo mesto |
2009/09/28
|
Authorised |
| Clopidogrel Krka |
Human |
clopidogrel |
clopidogrel (as hydrochloride) |
EMEA/H/C/001056 |
Krka, d.d., Novo mesto |
2009/09/23
|
Authorised |
| Clopidogrel TAD |
Human |
clopidogrel |
clopidogrel (as hydrochloride) |
EMEA/H/C/001136 |
Tad Pharma GmbH |
2009/09/23
|
Authorised |
| Clopidogrel Qualimed |
Human |
clopidogrel |
clopidogrel (as hydrochloride) |
EMEA/H/C/001135 |
Qualimed |
2009/09/23
|
Withdrawn |
| Clopidogrel ratiopharm |
Human |
clopidogrel |
clopidogrel |
EMEA/H/C/001173 |
Archie Samuel s.r.o. |
2009/09/23
|
Withdrawn |
| Cayston |
Human |
aztreonam |
aztreonam lysine |
EMEA/H/C/000996 |
Gilead Sciences Ireland UC |
2009/09/21
|
Authorised |
| Javlor |
Human |
vinflunine |
vinflunine |
EMEA/H/C/000983 |
Pierre Fabre Medicament |
2009/09/21
|
Authorised |
| Clopidogrel Taw Pharma (previously Clopidogrel Mylan) |
Human |
clopidogrel |
clopidogrel hydrochloride |
EMEA/H/C/001134 |
Taw Pharma (Ireland) Limited |
2009/09/21
|
Authorised |