| Edistride |
Human |
dapagliflozin |
dapagliflozin propanediol monohydrate |
EMEA/H/C/004161 |
AstraZeneca AB |
2015/11/09
|
Authorised |
| Cresemba |
Human |
isavuconazole |
isavuconazole |
EMEA/H/C/002734 |
Basilea Pharmaceutica Deutschland GmbH |
2015/10/15
|
Authorised |
| Praluent |
Human |
alirocumab |
alirocumab |
EMEA/H/C/003882 |
Sanofi Winthrop Industrie |
2015/09/23
|
Authorised |
| Fexeric |
Human |
ferric citrate coordination complex |
ferric citrate coordination complex |
EMEA/H/C/003776 |
Akebia Europe Limited |
2015/09/23
|
Lapsed |
| Zerbaxa |
Human |
ceftolozane;tazobactam |
ceftolozane sulfate;tazobactam sodium |
EMEA/H/C/003772 |
Merck Sharp & Dohme B.V. |
2015/09/18
|
Authorised |
| Pemetrexed Sandoz |
Human |
pemetrexed |
pemetrexed disodium hemipentahydrate |
EMEA/H/C/004011 |
Sandoz GmbH |
2015/09/18
|
Withdrawn |
| Zalviso |
Human |
sufentanil |
sufentanil |
EMEA/H/C/002784 |
FGK Representative Service GmbH |
2015/09/18
|
Withdrawn |
| Intuniv |
Human |
guanfacine |
guanfacine hydrochloride |
EMEA/H/C/003759 |
Takeda Pharmaceuticals International AG Ireland |
2015/09/17
|
Authorised |
| Pemetrexed Lilly |
Human |
pemetrexed |
pemetrexed |
EMEA/H/C/004114 |
Eli Lilly Netherlands |
2015/09/14
|
Withdrawn |
| Ivabradine Anpharm |
Human |
ivabradine |
ivabradine |
EMEA/H/C/004187 |
"Anpharm" Przedsiębiorstwo Farmaceutyczne S.A. |
2015/09/08
|
Authorised |
| Raxone |
Human |
idebenone |
idebenone |
EMEA/H/C/003834 |
Chiesi Farmaceutici S.p.A |
2015/09/08
|
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 |
| Strensiq |
Human |
asfotase alfa |
asfotase alfa |
EMEA/H/C/003794 |
Alexion Europe SAS |
2015/08/28
|
Authorised |
| Kanuma |
Human |
sebelipase alfa |
sebelipase alfa |
EMEA/H/C/004004 |
Alexion Europe SAS |
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Withdrawn |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 |