| 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 |
| Vihuma |
Human |
simoctocog alfa |
simoctocog alfa |
EMEA/H/C/004459 |
Octapharma AB |
2017/02/13
|
Authorised |
| Lifmior |
Human |
etanercept |
etanercept |
EMEA/H/C/004167 |
Pfizer Europe MA EEIG |
2017/02/13
|
Lapsed |
| Olumiant |
Human |
baricitinib |
Baricitinib |
EMEA/H/C/004085 |
Eli Lilly Nederland B.V. |
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 |
| 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 |
| Fiasp |
Human |
insulin aspart |
insulin aspart |
EMEA/H/C/004046 |
Novo Nordisk A/S |
2017/01/09
|
Authorised |
| Terrosa |
Human |
teriparatide |
teriparatide |
EMEA/H/C/003916 |
Gedeon Richter Plc. |
2017/01/04
|
Authorised |
| Afstyla |
Human |
lonoctocog alfa |
lonoctocog alfa |
EMEA/H/C/004075 |
CSL Behring GmbH |
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Withdrawn |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 |
| Ocaliva |
Human |
obeticholic acid |
obeticholic acid |
EMEA/H/C/004093 |
Advanz Pharma Limited |
2016/12/12
|
Revoked |
| Rekovelle |
Human |
follitropin delta |
follitropin delta |
EMEA/H/C/003994 |
Ferring Pharmaceuticals A/S |
2016/12/12
|
Authorised |
| Emtricitabine/Tenofovir disoproxil Krka |
Human |
emtricitabine;tenofovir disoproxil |
emtricitabine;tenofovir disoproxil succinate |
EMEA/H/C/004215 |
KRKA, d.d., Novo mesto |
2016/12/09
|
Authorised |