| Ingelvac PCV FLEX |
Veterinary |
porcine circovirus vaccine (inactivated) |
porcine circovirus type 2 ORF2 protein |
EMEA/V/C/004645 |
Boehringer Ingelheim Vetmedica GmbH |
2017/05/24
|
Withdrawn |
| Ivabradine Accord |
Human |
ivabradine |
ivabradine hydrochloride |
EMEA/H/C/004241 |
Accord Healthcare S.L.U. |
2017/05/22
|
Authorised |
| Axumin |
Human |
fluciclovine (18F) |
fluciclovine (18F) |
EMEA/H/C/004197 |
Blue Earth Diagnostics Ireland Ltd |
2017/05/21
|
Authorised |
| Qarziba (previously Dinutuximab beta EUSA and Dinutuximab beta Apeiron) |
Human |
dinutuximab beta |
Dinutuximab beta |
EMEA/H/C/003918 |
Recordati Netherlands B.V. |
2017/05/08
|
Authorised |
| Emtricitabine/Tenofovir disoproxil Krka d.d. |
Human |
emtricitabine;tenofovir disoproxil |
emtricitabine;tenofovir disoproxil succinate |
EMEA/H/C/004686 |
KRKA, d.d., Novo mesto |
2017/04/28
|
Authorised |
| Pemetrexed Pfizer (previously Pemetrexed Hospira UK Limited) |
Human |
pemetrexed |
pemetrexed ditromethamine |
EMEA/H/C/004488 |
Pfizer Europe MA EEIG |
2017/04/24
|
Withdrawn |
| Natpar |
Human |
parathyroid hormone |
parathyroid hormone |
EMEA/H/C/003861 |
Takeda Pharmaceuticals International AG Ireland Branch |
2017/04/24
|
Authorised |
| Varuby |
Human |
rolapitant |
rolapitant |
EMEA/H/C/004196 |
TESARO Bio Netherlands B.V. |
2017/04/19
|
Withdrawn |
| Roteas |
Human |
edoxaban |
edoxaban tosilate |
EMEA/H/C/004339 |
Berlin-Chemie AG |
2017/04/19
|
Authorised |
| Chenodeoxycholic acid Leadiant (previously Chenodeoxycholic acid sigma-tau) |
Human |
chenodeoxycholic acid |
chenodeoxycholic acid |
EMEA/H/C/004061 |
Leadiant GmbH |
2017/04/10
|
Authorised |
| Jylamvo |
Human |
methotrexate |
methotrexate |
EMEA/H/C/003756 |
Oresund Pharma ApS |
2017/03/29
|
Authorised |
| Yargesa |
Human |
miglustat |
miglustat |
EMEA/H/C/004016 |
Piramal Critical Care B.V. |
2017/03/22
|
Authorised |
| Tadalafil Lilly |
Human |
tadalafil |
tadalafil |
EMEA/H/C/004666 |
Eli Lilly Nederland B.V. |
2017/03/22
|
Authorised |
| Solymbic |
Human |
adalimumab |
adalimumab |
EMEA/H/C/004373 |
Amgen Europe B.V. |
2017/03/22
|
Withdrawn |
| Xeljanz |
Human |
tofacitinib |
tofacitinib |
EMEA/H/C/004214 |
Pfizer Europe MA EEIG |
2017/03/22
|
Authorised |
| Daptomycin Hospira |
Human |
daptomycin |
daptomycin |
EMEA/H/C/004310 |
Pfizer Europe MA EEIG |
2017/03/22
|
Authorised |
| Amgevita |
Human |
adalimumab |
adalimumab |
EMEA/H/C/004212 |
Amgen Europe B.V. |
2017/03/21
|
Authorised |
| 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 |