| Xermelo |
Human |
telotristat ethyl |
telotristat etiprate |
EMEA/H/C/003937 |
SERB SAS |
2017/09/17
|
Authorised |
| Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan |
Human |
efavirenz;emtricitabine;tenofovir disoproxil |
efavirenz;emtricitabine;tenofovir disoproxil maleate |
EMEA/H/C/004240 |
Mylan Pharmaceuticals Limited |
2017/09/05
|
Authorised |
| Cuprior |
Human |
trientine |
trientine tetrahydrochloride |
EMEA/H/C/004005 |
Orphalan |
2017/09/05
|
Authorised |
| Imraldi |
Human |
adalimumab |
adalimumab |
EMEA/H/C/004279 |
Samsung Bioepis NL B.V. |
2017/08/24
|
Authorised |
| Fotivda |
Human |
tivozanib hydrochloride monohydrate |
tivozanib |
EMEA/H/C/004131 |
Recordati Netherlands B.V. |
2017/08/24
|
Authorised |
| Nitisinone MDK (previously Nitisinone MendeliKABS) |
Human |
nitisinone |
nitisinone |
EMEA/H/C/004281 |
MendeliKABS Europe Ltd |
2017/08/24
|
Withdrawn |
| Kisqali |
Human |
ribociclib |
ribociclib succinate |
EMEA/H/C/004213 |
Novartis Europharm Limited |
2017/08/22
|
Authorised |
| Mavenclad |
Human |
cladribine |
Cladribine |
EMEA/H/C/004230 |
Merck Europe B.V. |
2017/08/22
|
Authorised |
| Maviret |
Human |
glecaprevir;pibrentasvir |
glecaprevir;pibrentasvir |
EMEA/H/C/004430 |
AbbVie Deutschland GmbH & Co. KG |
2017/07/26
|
Authorised |
| Vosevi |
Human |
sofosbuvir;velpatasvir;voxilaprevi |
sofosbuvir;velpatasvir;voxilaprevi |
EMEA/H/C/004350 |
Gilead Sciences Ireland UC |
2017/07/26
|
Authorised |
| Insulin lispro Sanofi |
Human |
insulin lispro |
insulin lispro |
EMEA/H/C/004303 |
Sanofi Winthrop Industrie |
2017/07/19
|
Authorised |
| Veltassa |
Human |
patiromer |
patiromer sorbitex calcium |
EMEA/H/C/004180 |
Vifor Fresenius Medical Care Renal Pharma France |
2017/07/19
|
Authorised |
| Kyntheum |
Human |
brodalumab |
brodalumab |
EMEA/H/C/003959 |
LEO Pharma A/S |
2017/07/17
|
Authorised |
| Efavirenz/Emtricitabine/Tenofovir disoproxil Zentiva |
Human |
efavirenz;emtricitabine;tenofovir disoproxil |
efavirenz;emtricitabine;tenofovir disoproxil phosphate |
EMEA/H/C/004250 |
Zentiva k.s. |
2017/07/17
|
Authorised |
| Trimbow |
Human |
beclometasone;formoterol;glycopyrronium bromide |
beclometasone dipropionate;formoterol fumarate dihydrate;glycopyrronium bromide |
EMEA/H/C/004257 |
Chiesi Farmaceutici S.p.A. |
2017/07/17
|
Authorised |
| Reagila |
Human |
cariprazine |
cariprazine hydrochloride |
EMEA/H/C/002770 |
Gedeon Richter |
2017/07/13
|
Authorised |
| Blitzima |
Human |
rituximab |
rituximab |
EMEA/H/C/004723 |
Celltrion Healthcare Hungary Kft. |
2017/07/13
|
Authorised |
| Ritemvia |
Human |
rituximab |
rituximab |
EMEA/H/C/004725 |
Celltrion Healthcare Hungary Kft. |
2017/07/13
|
Withdrawn |
| Rituzena (previously Tuxella) |
Human |
rituximab |
rituximab |
EMEA/H/C/004724 |
Celltrion Healthcare Hungary Kft. |
2017/07/13
|
Withdrawn |
| Spherox |
Human |
spheroids of human autologous matrix-associated chondrocytes |
spheroids of human autologous matrix-associated chondrocytes |
EMEA/H/C/002736 |
CO.DON Gmbh |
2017/07/10
|
Authorised |