| Kyntheum |
Human |
brodalumab |
brodalumab |
EMEA/H/C/003959 |
LEO Pharma A/S |
2017/07/17
|
Authorised |
| Ritemvia |
Human |
rituximab |
rituximab |
EMEA/H/C/004725 |
Celltrion Healthcare Hungary Kft. |
2017/07/13
|
Withdrawn |
| Rituzena (previously Tuxella) |
Human |
rituximab |
rituximab |
EMEA/H/C/004724 |
Celltrion Healthcare Hungary Kft. |
2017/07/13
|
Withdrawn |
| Blitzima |
Human |
rituximab |
rituximab |
EMEA/H/C/004723 |
Celltrion Healthcare Hungary Kft. |
2017/07/13
|
Authorised |
| Reagila |
Human |
cariprazine |
cariprazine hydrochloride |
EMEA/H/C/002770 |
Gedeon Richter |
2017/07/13
|
Authorised |
| Spherox |
Human |
spheroids of human autologous matrix-associated chondrocytes |
spheroids of human autologous matrix-associated chondrocytes |
EMEA/H/C/002736 |
CO.DON Gmbh |
2017/07/10
|
Authorised |
| Oxervate |
Human |
cenegermin |
recombinant human nerve growth factor |
EMEA/H/C/004209 |
Dompe' Farmaceutici S.p.A. |
2017/07/06
|
Authorised |
| Besponsa |
Human |
inotuzumab ozogamicin |
Inotuzumab ozogamicin |
EMEA/H/C/004119 |
Pfizer Europe MA EEIG |
2017/06/28
|
Authorised |
| Erelzi |
Human |
etanercept |
etanercept |
EMEA/H/C/004192 |
Sandoz GmbH |
2017/06/23
|
Authorised |
| Kevzara |
Human |
sarilumab |
sarilumab |
EMEA/H/C/004254 |
Sanofi Winthrop Industrie |
2017/06/23
|
Authorised |
| Skilarence |
Human |
dimethyl fumarate |
dimethyl fumarate |
EMEA/H/C/002157 |
Almirall, S.A. |
2017/06/23
|
Authorised |
| Ucedane |
Human |
carglumic acid |
carglumic acid |
EMEA/H/C/004019 |
Eurocept International BV |
2017/06/23
|
Authorised |
| Febuxostat Viatris (previously Febuxostat Mylan) |
Human |
febuxostat |
febuxostat |
EMEA/H/C/004374 |
Viatris Limited |
2017/06/15
|
Authorised |
| Rixathon |
Human |
rituximab |
rituximab |
EMEA/H/C/003903 |
Sandoz GmbH |
2017/06/15
|
Authorised |
| Riximyo |
Human |
rituximab |
rituximab |
EMEA/H/C/004729 |
Sandoz GmbH |
2017/06/15
|
Authorised |
| Elmiron |
Human |
pentosan polysulfate sodium |
pentosan polysulfate sodium |
EMEA/H/C/004246 |
bene-Arzneimittel GmbH |
2017/06/02
|
Authorised |
| Refixia |
Human |
nonacog beta pegol |
nonacog beta pegol |
EMEA/H/C/004178 |
Novo Nordisk A/S |
2017/06/02
|
Authorised |
| Brineura |
Human |
cerliponase alfa |
cerliponase alfa |
EMEA/H/C/004065 |
BioMarin International Limited |
2017/05/30
|
Authorised |
| Spinraza |
Human |
nusinersen |
nusinersen sodium |
EMEA/H/C/004312 |
Biogen Netherlands B.V. |
2017/05/30
|
Authorised |
| Trumenba |
Human |
meningococcal group b vaccine (recombinant, adsorbed) |
Neisseria meningitidis serogroup B fHbp (recombinant lipidated fHbp (factor H binding protein)) subfamily A; Neisseria meningitidis serogroup B fHbp (recombinant lipidated fHbp (factor H binding protein)) subfamily B |
EMEA/H/C/004051 |
Pfizer Europe MA EEIG |
2017/05/24
|
Authorised |