| Rolufta Ellipta (previously Rolufta) |
Human |
umeclidinium |
umeclidinium bromide |
EMEA/H/C/004654 |
GlaxoSmithKline Trading Services Limited |
2017/03/20
|
Authorised |
| Ledaga |
Human |
chlormethine |
chlormethine |
EMEA/H/C/002826 |
Helsinn Birex Pharmaceuticals Ltd. |
2017/03/03
|
Authorised |
| Pregabalin Zentiva k.s. |
Human |
pregabalin |
pregabalin |
EMEA/H/C/004277 |
Zentiva k.s. |
2017/02/27
|
Withdrawn |
| Truxima |
Human |
rituximab |
rituximab |
EMEA/H/C/004112 |
Celltrion Healthcare Hungary Kft. |
2017/02/17
|
Authorised |
| Alecensa |
Human |
alectinib |
alectinib hydrochloride |
EMEA/H/C/004164 |
Roche Registration GmbH |
2017/02/16
|
Authorised |
| Olumiant |
Human |
baricitinib |
Baricitinib |
EMEA/H/C/004085 |
Eli Lilly Nederland B.V. |
2017/02/13
|
Authorised |
| Lifmior |
Human |
etanercept |
etanercept |
EMEA/H/C/004167 |
Pfizer Europe MA EEIG |
2017/02/13
|
Lapsed |
| Vihuma |
Human |
simoctocog alfa |
simoctocog alfa |
EMEA/H/C/004459 |
Octapharma AB |
2017/02/13
|
Authorised |
| Zinplava |
Human |
bezlotoxumab |
Bezlotoxumab |
EMEA/H/C/004136 |
Merck Sharp & Dohme B.V. |
2017/01/18
|
Authorised |
| Cystadrops |
Human |
mercaptamine |
mercaptamine hydrochloride |
EMEA/H/C/003769 |
Recordati Rare Diseases |
2017/01/18
|
Authorised |
| Movymia |
Human |
teriparatide |
teriparatide |
EMEA/H/C/004368 |
STADA Arzneimittel AG |
2017/01/11
|
Authorised |
| Suliqua |
Human |
insulin glargine;lixisenatide |
insulin glargine;lixisenatide |
EMEA/H/C/004243 |
Sanofi Winthrop Industrie |
2017/01/11
|
Authorised |
| Fiasp |
Human |
insulin aspart |
insulin aspart |
EMEA/H/C/004046 |
Novo Nordisk A/S |
2017/01/09
|
Authorised |
| Talmanco (previously Tadalafil Generics) |
Human |
tadalafil |
tadalafil |
EMEA/H/C/004297 |
Viatris Limited |
2017/01/09
|
Authorised |
| Vemlidy |
Human |
tenofovir alafenamide |
tenofovir alafenamide fumarate |
EMEA/H/C/004169 |
Gilead Sciences Ireland UC |
2017/01/09
|
Authorised |
| Afstyla |
Human |
lonoctocog alfa |
lonoctocog alfa |
EMEA/H/C/004075 |
CSL Behring GmbH |
2017/01/04
|
Authorised |
| Terrosa |
Human |
teriparatide |
teriparatide |
EMEA/H/C/003916 |
Gedeon Richter Plc. |
2017/01/04
|
Authorised |
| Lusduna |
Human |
insulin glargine |
insulin glargine |
EMEA/H/C/004101 |
Merck Sharp & Dohme B.V. |
2017/01/03
|
Withdrawn |
| Darunavir Viatris (previously Darunavir Mylan) |
Human |
darunavir |
darunavir |
EMEA/H/C/004068 |
Viatris Limited |
2017/01/03
|
Authorised |
| Emtricitabine/Tenofovir disoproxil Mylan |
Human |
emtricitabine;tenofovir disoproxil |
emtricitabine;tenofovir disoproxil maleate |
EMEA/H/C/004050 |
Mylan Pharmaceuticals Limited |
2016/12/16
|
Authorised |