| Tybost |
Human |
cobicistat |
cobicistat |
EMEA/H/C/002572 |
Gilead Sciences Ireland UC |
2013/09/19
|
Authorised |
| Incresync |
Human |
alogliptin;pioglitazone |
alogliptin;pioglitazone |
EMEA/H/C/002178 |
Takeda Pharma A/S |
2013/09/19
|
Authorised |
| Trifexis |
Veterinary |
spinosad;milbemycin oxime |
spinosad;milbemycin oxime |
EMEA/V/C/002635 |
Eli Lilly and Company Limited |
2013/09/19
|
Expired |
| Xoterna Breezhaler |
Human |
indacaterol;glycopyrronium bromide |
indacaterol;glycopyrronium bromide |
EMEA/H/C/003755 |
Novartis Europharm Limited |
2013/09/18
|
Authorised |
| 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 |
| Lemtrada |
Human |
alemtuzumab |
alemtuzumab |
EMEA/H/C/003718 |
Sanofi Belgium |
2013/09/12
|
Authorised |
| Orphacol |
Human |
cholic acid |
cholic acid |
EMEA/H/C/001250 |
Theravia |
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Withdrawn |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 |
| 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 |