| Skyrizi |
Human |
risankizumab |
risankizumab |
EMEA/H/C/004759 |
AbbVie Deutschland GmbH & Co. KG |
2019/04/26
|
Authorised |
| Ondexxya |
Human |
andexanet alfa |
andexanet alfa |
EMEA/H/C/004108 |
AstraZeneca AB |
2019/04/26
|
Authorised |
| Dectova |
Human |
zanamivir |
zanamivir |
EMEA/H/C/004102 |
GlaxoSmithKline Trading Services Limited |
2019/04/26
|
Authorised |
| Zynquista |
Human |
sotagliflozin |
sotagliflozin |
EMEA/H/C/004889 |
Guidehouse Germany GmbH |
2019/04/26
|
Withdrawn |
| Idacio |
Human |
adalimumab |
adalimumab |
EMEA/H/C/004475 |
Fresenius Kabi Deutschland GmbH |
2019/04/02
|
Authorised |
| Vizimpro |
Human |
dacomitinib |
dacomitinib monohydrate |
EMEA/H/C/004779 |
Pfizer Europe MA EEIG |
2019/04/02
|
Authorised |
| Kromeya |
Human |
adalimumab |
adalimumab |
EMEA/H/C/005158 |
Fresenius Kabi Deutschland GmbH |
2019/04/02
|
Withdrawn |
| Ajovy |
Human |
fremanezumab |
fremanezumab |
EMEA/H/C/004833 |
Teva GmbH |
2019/03/28
|
Authorised |
| Febuxostat Krka |
Human |
febuxostat |
febuxostat |
EMEA/H/C/004773 |
Krka, d.d., Novo mesto |
2019/03/28
|
Authorised |
| Atazanavir Krka |
Human |
atazanavir |
atazanavir (as sulfate) |
EMEA/H/C/004859 |
Krka, d.d., Novo mesto |
2019/03/25
|
Withdrawn |
| Rizmoic |
Human |
naldemedine |
naldemedine tosilate |
EMEA/H/C/004256 |
Shionogi B.V. |
2019/02/18
|
Authorised |
| Miglustat Dipharma |
Human |
miglustat |
miglustat |
EMEA/H/C/004904 |
Dipharma Arzneimittel GmbH |
2019/02/18
|
Authorised |
| Mulpleo (previously Lusutrombopag Shionogi) |
Human |
lusutrombopag |
Lusutrombopag |
EMEA/H/C/004720 |
Shionogi B.V. |
2019/02/18
|
Authorised |
| Vantobra (previously Tobramycin PARI) |
Human |
tobramycin |
tobramycin |
EMEA/H/C/005086 |
Pari Pharma GmbH |
2019/02/18
|
Authorised |
| Besremi |
Human |
ropeginterferon alfa-2b |
ropeginterferon alfa-2b |
EMEA/H/C/004128 |
AOP Orphan Pharmaceuticals GmbH |
2019/02/15
|
Authorised |
| Zirabev |
Human |
bevacizumab |
bevacizumab |
EMEA/H/C/004697 |
Pfizer Europe MA EEIG |
2019/02/14
|
Authorised |
| Erleada |
Human |
apalutamide |
apalutamide |
EMEA/H/C/004452 |
Janssen-Cilag International NV |
2019/01/14
|
Authorised |
| Ghryvelin (previously Macimorelin Aeterna Zentaris) |
Human |
macimorelin |
macimorelin acetate |
EMEA/H/C/004660 |
Atnahs Pharma Netherlands B.V. |
2019/01/11
|
Authorised |
| Silodosin Recordati |
Human |
silodosin |
silodosin |
EMEA/H/C/004964 |
Recordati Ireland Ltd |
2019/01/07
|
Authorised |
| Namuscla |
Human |
mexiletine hcl |
Mexiletine hydrochloride |
EMEA/H/C/004584 |
Lupin Europe GmbH |
2018/12/18
|
Authorised |