| Kanuma |
Human |
sebelipase alfa |
sebelipase alfa |
EMEA/H/C/004004 |
Alexion Europe SAS |
2015/08/28
|
Authorised |
| Strensiq |
Human |
asfotase alfa |
asfotase alfa |
EMEA/H/C/003794 |
Alexion Europe SAS |
2015/08/28
|
Authorised |
| Farydak |
Human |
panobinostat |
panobinostat lactate anhydrous |
EMEA/H/C/003725 |
pharmaand GmbH |
2015/08/28
|
Authorised |
| Pregabalin Accord |
Human |
pregabalin |
pregabalin |
EMEA/H/C/004024 |
Accord Healthcare S.L.U. |
2015/08/28
|
Authorised |
| Taxespira (previously Docetaxel Hospira UK Limited ) |
Human |
docetaxel |
docetaxel trihydrate |
EMEA/H/C/003925 |
Hospira UK Limited |
2015/08/28
|
Withdrawn |
| Aripiprazole Sandoz |
Human |
aripiprazole |
aripiprazole |
EMEA/H/C/004008 |
Sandoz GmbH |
2015/08/20
|
Authorised |
| Respreeza |
Human |
alpha1-proteinase inhibitor (human) |
human alpha1-proteinase inhibitor |
EMEA/H/C/002739 |
CSL Behring GmbH |
2015/08/20
|
Authorised |
| Duloxetine Zentiva |
Human |
duloxetine |
duloxetine |
EMEA/H/C/003935 |
Zentiva, k.s. |
2015/08/20
|
Authorised |
| Odomzo |
Human |
sonidegib |
sonidegib diphosphate |
EMEA/H/C/002839 |
Sun Pharmaceutical Industries Europe B.V. |
2015/08/14
|
Authorised |
| Unituxin |
Human |
dinutuximab |
Dinutuximab |
EMEA/H/C/002800 |
United Therapeutics Europe Ltd |
2015/08/14
|
Withdrawn |
| Omidria |
Human |
phenylephrine;ketorolac |
ketorolac;phenylephrine |
EMEA/H/C/003702 |
Rayner Surgical (Ireland) Limited |
2015/07/28
|
Authorised |
| Bortezomib Accord |
Human |
bortezomib |
bortezomib |
EMEA/H/C/003984 |
Accord Healthcare S.L.U. |
2015/07/20
|
Authorised |
| Nivolumab BMS |
Human |
nivolumab |
nivolumab |
EMEA/H/C/003840 |
Bristol-Myers Squibb Pharma EEIG |
2015/07/20
|
Withdrawn |
| Keytruda |
Human |
pembrolizumab |
pembrolizumab |
EMEA/H/C/003820 |
Merck Sharp & Dohme B.V. |
2015/07/17
|
Authorised |
| Pregabalin Zentiva |
Human |
pregabalin |
pregabalin |
EMEA/H/C/003900 |
Zentiva, k.s. |
2015/07/17
|
Authorised |
| Repatha |
Human |
evolocumab |
Evolocumab |
EMEA/H/C/003766 |
Amgen Europe B.V. |
2015/07/17
|
Authorised |
| Evotaz |
Human |
atazanavir;cobicistat |
cobicistat;atazanavir |
EMEA/H/C/003904 |
Bristol-Myers Squibb Pharma EEIG |
2015/07/13
|
Authorised |
| Hetlioz |
Human |
tasimelteon |
tasimelteon |
EMEA/H/C/003870 |
Vanda Pharmaceuticals Netherlands B.V. |
2015/07/03
|
Authorised |
| Aripiprazole Mylan Pharma (previously Aripiprazole Pharmathen) |
Human |
aripiprazole |
aripiprazole |
EMEA/H/C/003803 |
Mylan Pharmaceuticals Limited |
2015/06/30
|
Authorised |
| Aripiprazole Zentiva |
Human |
aripiprazole |
aripiprazole |
EMEA/H/C/003899 |
Zentiva, k.s. |
2015/06/25
|
Authorised |