| Unituxin |
Human |
dinutuximab |
Dinutuximab |
EMEA/H/C/002800 |
United Therapeutics Europe Ltd |
2015/08/14
|
Withdrawn |
| Omidria |
Human |
phenylephrine;ketorolac |
ketorolac;phenylephrine |
EMEA/H/C/003702 |
Rayner Surgical (Ireland) Limited |
2015/07/28
|
Authorised |
| Bortezomib Accord |
Human |
bortezomib |
bortezomib |
EMEA/H/C/003984 |
Accord Healthcare S.L.U. |
2015/07/20
|
Authorised |
| Nivolumab BMS |
Human |
nivolumab |
nivolumab |
EMEA/H/C/003840 |
Bristol-Myers Squibb Pharma EEIG |
2015/07/20
|
Withdrawn |
| Repatha |
Human |
evolocumab |
Evolocumab |
EMEA/H/C/003766 |
Amgen Europe B.V. |
2015/07/17
|
Authorised |
| Keytruda |
Human |
pembrolizumab |
pembrolizumab |
EMEA/H/C/003820 |
Merck Sharp & Dohme B.V. |
2015/07/17
|
Authorised |
| Pregabalin Zentiva |
Human |
pregabalin |
pregabalin |
EMEA/H/C/003900 |
Zentiva, k.s. |
2015/07/17
|
Authorised |
| Evotaz |
Human |
atazanavir;cobicistat |
cobicistat;atazanavir |
EMEA/H/C/003904 |
Bristol-Myers Squibb Pharma EEIG |
2015/07/13
|
Authorised |
| Hetlioz |
Human |
tasimelteon |
tasimelteon |
EMEA/H/C/003870 |
Vanda Pharmaceuticals Netherlands B.V. |
2015/07/03
|
Authorised |
| Aripiprazole Mylan Pharma (previously Aripiprazole Pharmathen) |
Human |
aripiprazole |
aripiprazole |
EMEA/H/C/003803 |
Mylan Pharmaceuticals Limited |
2015/06/30
|
Authorised |
| Aripiprazole Zentiva |
Human |
aripiprazole |
aripiprazole |
EMEA/H/C/003899 |
Zentiva, k.s. |
2015/06/25
|
Authorised |
| Pregabalin Mylan Pharma |
Human |
pregabalin |
pregabalin |
EMEA/H/C/003962 |
Mylan S.A.S. |
2015/06/25
|
Withdrawn |
| Pregabalin Viatris (previously Pregabalin Mylan) |
Human |
pregabalin |
pregabalin |
EMEA/H/C/004078 |
Viatris Limited |
2015/06/24
|
Authorised |
| Opdivo |
Human |
nivolumab |
nivolumab |
EMEA/H/C/003985 |
Bristol-Myers Squibb Pharma EEIG |
2015/06/19
|
Authorised |
| Pregabalin Sandoz |
Human |
pregabalin |
pregabalin |
EMEA/H/C/004010 |
Sandoz GmbH |
2015/06/19
|
Authorised |
| Duloxetine Viatris (previously Duloxetine Mylan) |
Human |
duloxetine |
duloxetine |
EMEA/H/C/003981 |
Viatris Limited |
2015/06/19
|
Authorised |
| Lixiana |
Human |
edoxaban |
edoxaban tosilate |
EMEA/H/C/002629 |
Daiichi Sankyo Europe GmbH |
2015/06/19
|
Authorised |
| Pregabalin Sandoz GmbH |
Human |
pregabalin |
pregabalin |
EMEA/H/C/004070 |
Sandoz GmbH |
2015/06/19
|
Withdrawn |
| Lumark |
Human |
lutetium (177Lu) chloride |
lutetium (177Lu) chloride |
EMEA/H/C/002749 |
I.D.B. Radiopharmacy B.V. |
2015/06/18
|
Authorised |
| Gardasil 9 |
Human |
human papillomavirus 9-valent vaccine (recombinant, adsorbed) |
human papillomavirus vaccine [types 6, 11, 16, 18, 31, 33, 45, 52, 58] (recombinant, adsorbed) |
EMEA/H/C/003852 |
Merck Sharp & Dohme B.V. |
2015/06/10
|
Authorised |