| Cabometyx |
Human |
cabozantinib |
cabozantinib (s)-malate |
EMEA/H/C/004163 |
Ipsen Pharma |
2016/09/09
|
Authorised |
| Kisplyx |
Human |
lenvatinib |
lenvatinib mesilate |
EMEA/H/C/004224 |
Eisai GmbH |
2016/08/25
|
Authorised |
| Atazanavir Viatris (previously Atazanavir Mylan) |
Human |
atazanavir |
atazanavir (as sulfate) |
EMEA/H/C/004048 |
Viatris Limited |
2016/08/22
|
Authorised |
| Nordimet |
Human |
methotrexate |
methotrexate |
EMEA/H/C/003983 |
Nordic Group B.V. |
2016/08/18
|
Authorised |
| Zalmoxis |
Human |
allogeneic T cells genetically modified with a retroviral vector encoding for a truncated form of the human low affinity nerve growth factor receptor (ΔLNGFR) and the herpes simplex I virus thymidine kinase (HSV-TK Mut2) |
allogeneic T cells genetically modified with a retroviral vector encoding for a truncated form of the human low affinity nerve growth factor receptor (ΔLNGFR) and the herpes simplex I virus thymidine kinase (HSV-TK Mut2) |
EMEA/H/C/002801 |
MolMed SpA |
2016/08/18
|
Withdrawn |
| Aerivio Spiromax |
Human |
salmeterol;fluticasone propionate |
salmeterol xinafoate;fluticasone propionate |
EMEA/H/C/002752 |
Teva B.V. |
2016/08/18
|
Withdrawn |
| Airexar Spiromax |
Human |
salmeterol xinafoate;fluticasone propionate |
salmeterol;fluticasone propionate |
EMEA/H/C/004267 |
Teva B.V. |
2016/08/18
|
Withdrawn |
| Cinqaero |
Human |
reslizumab |
reslizumab |
EMEA/H/C/003912 |
Teva B.V. |
2016/08/15
|
Authorised |
| Zepatier |
Human |
elbasvir;grazoprevir |
elbasvir;grazoprevir |
EMEA/H/C/004126 |
Merck Sharp & Dohme B.V. |
2016/07/22
|
Authorised |
| Bortezomib Sun |
Human |
bortezomib |
bortezomib |
EMEA/H/C/004076 |
SUN Pharmaceutical Industries (Europe) B.V. |
2016/07/22
|
Authorised |
| Bortezomib Hospira |
Human |
bortezomib |
bortezomib |
EMEA/H/C/004207 |
Pfizer Europe MA EEIG |
2016/07/22
|
Authorised |
| Pemetrexed Fresenius Kabi |
Human |
pemetrexed |
pemetrexed |
EMEA/H/C/003895 |
Fresenius Kabi Deutschland GmbH |
2016/07/22
|
Authorised |
| Qtern |
Human |
saxagliptin;dapagliflozin |
saxagliptin;dapagliflozin propanediol monohydrate |
EMEA/H/C/004057 |
Astra Zeneca AB |
2016/07/15
|
Authorised |
| EndolucinBeta |
Human |
lutetium (177Lu) chloride |
lutetium (177Lu) chloride |
EMEA/H/C/003999 |
ITM Medical Isotopes GmbH |
2016/07/06
|
Authorised |
| Epclusa |
Human |
sofosbuvir;velpatasvir |
sofosbuvir;velpatasvir |
EMEA/H/C/004210 |
Gilead Sciences Ireland UC |
2016/07/06
|
Authorised |
| Zinbryta |
Human |
daclizumab |
daclizumab |
EMEA/H/C/003862 |
Biogen Idec Ltd |
2016/07/01
|
Withdrawn |
| Enzepi |
Human |
pancreas powder |
pancreas powder |
EMEA/H/C/002070 |
Allergan Pharmaceuticals International Limited |
2016/06/29
|
Withdrawn |
| Ongentys |
Human |
opicapone |
opicapone |
EMEA/H/C/002790 |
Bial - Portela Cª, S.A. |
2016/06/24
|
Authorised |
| Zavicefta |
Human |
ceftazidime;avibactam |
avibactam sodium;ceftazidime pentahydrate |
EMEA/H/C/004027 |
Pfizer Ireland Pharmaceuticals Unlimited Company |
2016/06/23
|
Authorised |
| Odefsey |
Human |
emtricitabine;rilpivirine;tenofovir alafenamide |
emtricitabine;rilpivirine hydrochloride;tenofovir alafenamide |
EMEA/H/C/004156 |
Gilead Sciences Ireland UC |
2016/06/21
|
Authorised |