| Vipdomet |
Human |
alogliptin;metformin |
alogliptin benzoate;metformin hydrochloride |
EMEA/H/C/002654 |
Takeda Pharma A/S |
2013/09/18
|
Authorised |
| Vipidia |
Human |
alogliptin benzoate |
alogliptin |
EMEA/H/C/002182 |
Takeda Pharma A/S |
2013/09/18
|
Authorised |
| Orphacol |
Human |
cholic acid |
cholic acid |
EMEA/H/C/001250 |
Theravia |
2013/09/12
|
Authorised |
| Lemtrada |
Human |
alemtuzumab |
alemtuzumab |
EMEA/H/C/003718 |
Sanofi Belgium |
2013/09/12
|
Authorised |
| Remsima |
Human |
infliximab |
infliximab |
EMEA/H/C/002576 |
Celltrion Healthcare Hungary Kft. |
2013/09/10
|
Authorised |
| Inflectra |
Human |
infliximab |
infliximab |
EMEA/H/C/002778 |
Pfizer Europe MA EEIG |
2013/09/10
|
Authorised |
| Provenge |
Human |
autologous peripheral-blood mononuclear cells activated with prostatic acid phosphatase granulocyte-macrophage colony-stimulating factor (sipuleucel-T) |
autologous peripheral-blood mononuclear cells including a minimum of 50 million autologous CD54+ cells activated with prostatic acid phosphatase granulocyte-macrophage colony-stimulating factor |
EMEA/H/C/002513 |
Dendreon UK Ltd |
2013/09/06
|
Withdrawn |
| Procysbi |
Human |
mercaptamine |
mercaptamine bitartrate |
EMEA/H/C/002465 |
Chiesi Farmaceutici S.p.A |
2013/09/05
|
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 |
| 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 |
| 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 |