| Procysbi |
Human |
mercaptamine |
mercaptamine bitartrate |
EMEA/H/C/002465 |
Chiesi Farmaceutici S.p.A |
2013/09/05
|
Authorised |
| Cholib |
Human |
fenofibrate;simvastatin |
fenofibrate;simvastatin |
EMEA/H/C/002559 |
Viatris Healthcare Limited |
2013/08/26
|
Authorised |
| Aubagio |
Human |
teriflunomide |
teriflunomide |
EMEA/H/C/002514 |
Sanofi Winthrop Industrie |
2013/08/26
|
Authorised |
| Tafinlar |
Human |
dabrafenib |
dabrafenib mesilate |
EMEA/H/C/002604 |
Novartis Europharm Limited |
2013/08/26
|
Authorised |
| Stivarga |
Human |
regorafenib |
regorafenib |
EMEA/H/C/002573 |
Bayer Pharma AG |
2013/08/26
|
Authorised |
| Nexium Control |
Human |
esomeprazole |
esomeprazole |
EMEA/H/C/002618 |
Haleon Ireland Dungarvan Limited |
2013/08/26
|
Authorised |
| Voncento |
Human |
human coagulation factor VIII / human von willebrand factor |
human coagulation factor VIII;human von willebrand factor |
EMEA/H/C/002493 |
CSL Behring GmbH |
2013/08/12
|
Authorised |
| Imnovid (previously Pomalidomide Celgene) |
Human |
pomalidomide |
Pomalidomide |
EMEA/H/C/002682 |
Bristol-Myers Squibb Pharma EEIG |
2013/08/05
|
Authorised |
| Somatropin Biopartners |
Human |
somatropin |
somatropin |
EMEA/H/C/002196 |
BioPartners GmbH |
2013/08/05
|
Lapsed |
| Imvanex |
Human |
smallpox and monkeypox vaccine (Live Modified Vaccinia Virus Ankara) |
modified vaccinia Ankara - Bavarian Nordic (MVA-BN) virus |
EMEA/H/C/002596 |
Bavarian Nordic A/S |
2013/07/31
|
Authorised |
| Lojuxta |
Human |
lomitapide |
Lomitapide |
EMEA/H/C/002578 |
Chiesi Farmaceutici SpA |
2013/07/31
|
Authorised |
| Atosiban SUN |
Human |
atosiban |
atosiban (as acetate) |
EMEA/H/C/002329 |
Sun Pharmaceutical Industries Europe B.V. |
2013/07/31
|
Authorised |
| Pheburane |
Human |
sodium phenylbutyrate |
sodium phenylbutyrate |
EMEA/H/C/002500 |
Eurocept International B. V. |
2013/07/30
|
Authorised |
| Lonquex |
Human |
lipegfilgrastim |
lipegfilgrastim |
EMEA/H/C/002556 |
Teva B.V. |
2013/07/25
|
Authorised |
| Aftovaxpur DOE |
Veterinary |
inactivated vaccine against foot-and-mouth disease |
Maximum three of the following purified, inactivated foot-and-mouth disease virus strains: O1 Manisa ≥ 6 PD50*; O1 BFS ≥ 6 PD50*; O Taiwan 3/97 ≥ 6 PD50*; A22 Iraq ≥ 6 PD50*; A24 Cruzeiro ≥ 6 PD50*; A Turkey 14/98 ≥ 6 PD50*; Asia 1 Shamir ≥ 6 PD50*; SAT2 Saudi Arabia ≥ 6 PD50*; * PD50 – 50% protective dose in cattle as described in Ph. Eur. monograph 0063. |
EMEA/V/C/002292 |
Boehringer Ingelheim Vetmedica GmbH |
2013/07/15
|
Withdrawn |
| Erivedge |
Human |
vismodegib |
vismodegib |
EMEA/H/C/002602 |
Roche Registration GmbH |
2013/07/12
|
Authorised |
| Iclusig |
Human |
ponatinib |
Ponatinib |
EMEA/H/C/002695 |
Incyte Biosciences Distribution B.V. |
2013/07/01
|
Authorised |
| Imatinib Accord |
Human |
imatinib |
imatinib |
EMEA/H/C/002681 |
Accord Healthcare S.L.U. |
2013/06/30
|
Authorised |
| Maci |
Human |
matrix-applied characterised autologous cultured chondrocytes |
autologous cultured chondrocytes |
EMEA/H/C/002522 |
Vericel Denmark ApS |
2013/06/27
|
Expired |
| Stayveer |
Human |
bosentan monohydrate |
bosentan (as monohydrate) |
EMEA/H/C/002644 |
Janssen-Cilag International NV |
2013/06/24
|
Authorised |