| Entecavir Accord |
Human |
entecavir |
Entecavir |
EMEA/H/C/004458 |
Accord Healthcare S.L.U. |
2017/09/25
|
Authorised |
| Symtuza |
Human |
darunavir;cobicistat;emtricitabine;tenofovir alafenamide |
darunavir;cobicistat;emtricitabine;tenofovir alafenamide |
EMEA/H/C/004391 |
Janssen-Cilag International NV |
2017/09/21
|
Authorised |
| Tecentriq |
Human |
atezolizumab |
atezolizumab |
EMEA/H/C/004143 |
Roche Registration GmbH |
2017/09/20
|
Authorised |
| Entecavir Viatris (previously Entecavir Mylan) |
Human |
entecavir |
entecavir monohydrate |
EMEA/H/C/004377 |
Viatris Limited |
2017/09/18
|
Authorised |
| Lacosamide Accord |
Human |
lacosamide |
lacosamide |
EMEA/H/C/004443 |
Accord Healthcare S.L.U. |
2017/09/18
|
Authorised |
| Bavencio |
Human |
avelumab |
avelumab |
EMEA/H/C/004338 |
Merck Europe B.V. |
2017/09/18
|
Authorised |
| Rydapt |
Human |
midostaurin |
Midostaurin |
EMEA/H/C/004095 |
Novartis Europharm Ltd |
2017/09/18
|
Authorised |
| 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Withdrawn |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 |