| Lenvima |
Human |
lenvatinib |
lenvatinib mesilate |
EMEA/H/C/003727 |
Eisai GmbH |
2015/05/28
|
Authorised |
| Akynzeo |
Human |
netupitant;palonosetron |
netupitant;palonosetron hydrochloride |
EMEA/H/C/003728 |
Helsinn Birex Pharmaceuticals Ltd |
2015/05/27
|
Authorised |
| Synjardy |
Human |
empagliflozin;metformin |
empagliflozin;metformin |
EMEA/H/C/003770 |
Boehringer Ingelheim |
2015/05/27
|
Authorised |
| Jinarc |
Human |
tolvaptan |
tolvaptan |
EMEA/H/C/002788 |
Otsuka Pharmaceutical Netherlands B.V. |
2015/05/27
|
Authorised |
| Voriconazole Hikma (previously Voriconazole Hospira) |
Human |
voriconazole |
voriconazole |
EMEA/H/C/003737 |
Hikma Farmaceutica (Portugal) S.A. |
2015/05/27
|
Authorised |
| Zykadia |
Human |
ceritinib |
ceritinib |
EMEA/H/C/003819 |
Novartis Europharm Limited |
2015/05/06
|
Authorised |
| Ristempa |
Human |
pegfilgrastim |
pegfilgrastim |
EMEA/H/C/003910 |
Amgen Europe B.V. |
2015/04/13
|
Withdrawn |
| Mysimba |
Human |
naltrexone;bupropion |
bupropion hydrochloride;naltrexone hydrochloride |
EMEA/H/C/003687 |
Orexigen Therapeutics Ireland Limited |
2015/03/26
|
Authorised |
| Dutrebis |
Human |
lamivudine;raltegravir potassium |
lamivudine;raltegravir potassium |
EMEA/H/C/003823 |
Merck Sharp Dohme Limited |
2015/03/26
|
Withdrawn |
| Quinsair |
Human |
levofloxacin |
levofloxacin |
EMEA/H/C/002789 |
Chiesi Farmaceutici S.p.A |
2015/03/25
|
Authorised |
| Kengrexal |
Human |
cangrelor |
cangrelor |
EMEA/H/C/003773 |
Chiesi Farmaceutici S.p.A. |
2015/03/23
|
Authorised |
| Saxenda |
Human |
liraglutide |
liraglutide |
EMEA/H/C/003780 |
Novo Nordisk A/S |
2015/03/23
|
Authorised |
| Sivextro |
Human |
tedizolid phosphate |
|
EMEA/H/C/002846 |
Merck Sharp & Dohme B.V. |
2015/03/23
|
Authorised |
| Tenkasi (previously Orbactiv) |
Human |
oritavancin |
oritavancin (diphosphate) |
EMEA/H/C/003785 |
Menarini International Operations Luxembourg S.A. |
2015/03/19
|
Authorised |
| Ikervis |
Human |
ciclosporin |
ciclosporin |
EMEA/H/C/002066 |
Santen Oy |
2015/03/19
|
Authorised |
| Raplixa |
Human |
human fibrinogen;human thrombin |
human fibrinogen;human thrombin |
EMEA/H/C/002807 |
Mallinckrodt Pharmaceuticals Ireland Limited |
2015/03/19
|
Withdrawn |
| Vantobra |
Human |
tobramycin |
tobramycin |
EMEA/H/C/002633 |
Pari Pharma GmbH |
2015/03/18
|
Withdrawn |
| Coliprotec F4 |
Veterinary |
Escherichia coli, type 08, strain K87 (live) |
live non-pathogenic Escherichia coli O8:K87 |
EMEA/V/C/003797 |
Prevtec Microbia GmbH |
2015/03/16
|
Withdrawn |
| Tasermity |
Human |
sevelamer hydrochloride |
sevelamer hydrochloride |
EMEA/H/C/003968 |
Genzyme Europe BV |
2015/02/25
|
Lapsed |
| Xadago |
Human |
safinamide |
safinamide methanesulfonate |
EMEA/H/C/002396 |
Zambon SpA |
2015/02/23
|
Authorised |