| Efficib |
Human |
sitagliptin;metformin |
sitagliptin;metformin hydrochloride |
EMEA/H/C/000896 |
Merck Sharp and Dohme B.V |
2008/07/15
|
Authorised |
| Firazyr |
Human |
icatibant |
icatibant |
EMEA/H/C/000899 |
Takeda Pharmaceuticals International AG |
2008/07/11
|
Authorised |
| Ranexa (previously Latixa) |
Human |
ranolazine |
ranolazine |
EMEA/H/C/000805 |
Menarini International Operations Luxembourg S.A. (MIOL) |
2008/07/08
|
Authorised |
| Trevaclyn |
Human |
laropiprant;nicotinic acid |
laropiprant;nicotinic acid |
EMEA/H/C/000897 |
Merck Sharp Dohme Ltd |
2008/07/03
|
Withdrawn |
| Pelzont |
Human |
laropiprant;nicotinic acid |
laropiprant;nicotinic acid |
EMEA/H/C/000903 |
Merck Sharp Dohme Ltd |
2008/07/03
|
Withdrawn |
| Tredaptive |
Human |
laropiprant;nicotinic acid |
laropiprant;nicotinic acid |
EMEA/H/C/000889 |
Merck Sharp Dohme Ltd. |
2008/07/03
|
Withdrawn |
| Relistor |
Human |
methylnaltrexone bromide |
methylnaltrexone bromide |
EMEA/H/C/000870 |
Bausch Health Ireland Limited |
2008/07/01
|
Authorised |
| Tyverb |
Human |
lapatinib |
lapatinib |
EMEA/H/C/000795 |
Novartis Europharm Limited |
2008/06/10
|
Authorised |
| Extavia |
Human |
interferon beta-1b |
interferon beta-1b |
EMEA/H/C/000933 |
Novartis Europharm Limited |
2008/05/20
|
Withdrawn |
| Pandemrix |
Human |
influenza vaccine (H1N1)v (split virion, inactivated, adjuvanted) |
split influenza virus inactivated, containing antigen equivalent to A/California/07/2009 (H1N1)-derived strain used NYMC X-179A |
EMEA/H/C/000832 |
GlaxoSmithKline Biologicals S.A. |
2008/05/20
|
Expired |
| Prepandrix |
Human |
prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) |
A/Indonesia/05/2005 (H5N1) like strain used (PR8-IBCDC-RG2) |
EMEA/H/C/000822 |
GlaxoSmithKline Biologicals S.A. |
2008/05/14
|
Withdrawn |
| Mycamine |
Human |
micafungin |
micafungin |
EMEA/H/C/000734 |
Sandoz Pharmaceuticals d.d. |
2008/04/25
|
Authorised |
| Privigen |
Human |
human normal immunoglobulin (IVIg) |
human normal immunoglobulin (IVIg) |
EMEA/H/C/000831 |
CSL Behring GmbH |
2008/04/24
|
Authorised |
| Adenuric |
Human |
febuxostat |
febuxostat |
EMEA/H/C/000777 |
Menarini International Operations Luxembourg S.A. (MIOL) |
2008/04/21
|
Authorised |
| Volibris |
Human |
ambrisentan |
ambrisentan |
EMEA/H/C/000839 |
GlaxoSmithKline Trading Services Limited |
2008/04/20
|
Authorised |
| Thalidomide BMS (previously Thalidomide Celgene) |
Human |
thalidomide |
thalidomide |
EMEA/H/C/000823 |
Bristol-Myers Squibb Pharma EEIG |
2008/04/16
|
Authorised |
| Effentora |
Human |
fentanyl |
fentanyl |
EMEA/H/C/000833 |
Phoenix Labs Unlimited Company |
2008/04/04
|
Authorised |
| Pradaxa |
Human |
dabigatran etexilate |
dabigatran etexilate mesilate |
EMEA/H/C/000829 |
Boehringer Ingelheim International GmbH |
2008/03/17
|
Authorised |
| Mycophenolate mofetil Teva |
Human |
mycophenolate mofetil |
mycophenolate mofetil |
EMEA/H/C/000882 |
Teva Pharma B.V. |
2008/02/21
|
Authorised |
| Myfenax |
Human |
mycophenolate mofetil |
mycophenolate mofetil |
EMEA/H/C/000884 |
Teva B.V. |
2008/02/21
|
Authorised |