| Reblozyl |
Human |
luspatercept |
Luspatercept |
EMEA/H/C/004444 |
Bristol Myers Squibb Pharma EEIG |
2020/06/25
|
Authorised |
| Fingolimod Accord |
Human |
fingolimod |
fingolimod hydrochloride |
EMEA/H/C/005191 |
Accord Healthcare S.L.U. |
2020/06/25
|
Authorised |
| Byannli (previously Paliperidone Janssen-Cilag International) |
Human |
paliperidone |
paliperidone palmitate |
EMEA/H/C/005486 |
Janssen-Cilag International N.V. |
2020/06/18
|
Authorised |
| Atectura Breezhaler |
Human |
indacaterol;mometasone |
indacaterol acetate;mometasone furoate |
EMEA/H/C/005067 |
Novartis Europharm Limited |
2020/05/30
|
Authorised |
| Bemrist Breezhaler |
Human |
indacaterol;mometasone |
indacaterol;mometasone furoate |
EMEA/H/C/005516 |
Novartis Europharm Limited |
2020/05/30
|
Authorised |
| Sarclisa |
Human |
isatuximab |
Isatuximab |
EMEA/H/C/004977 |
Sanofi Winthrop Industrie |
2020/05/30
|
Authorised |
| Zeposia |
Human |
ozanimod |
ozanimod hydrochloride |
EMEA/H/C/004835 |
Bristol-Myers Squibb Pharma EEIG |
2020/05/20
|
Authorised |
| Nepexto |
Human |
etanercept |
etanercept |
EMEA/H/C/004711 |
Biosimilar Collaborations Ireland Limited |
2020/05/20
|
Authorised |
| Fluad Tetra |
Human |
influenza vaccine (surface antigen, inactivated, adjuvanted) |
A/Victoria/4897/2022 (H1N1)pdm09-like strain (A/Victoria/4897/2022, IVR-238) / A/Thailand/8/2022 (H3N2)-like strain (A/Thailand/8/2022 IVR-237) / B/Austria/1359417/2021-like strain (B/Austria/1359417/2021, BVR-26) / B/Phuket/3073/2013-like strain (B/Phuket/3073/2013, BVR-1B) influenza virus |
EMEA/H/C/004993 |
Seqirus Netherlands B.V. |
2020/05/20
|
Authorised |
| Zolgensma |
Human |
onasemnogene abeparvovec |
onasemnogene abeparvovec |
EMEA/H/C/004750 |
Novartis Europharm Limited |
2020/05/18
|
Authorised |
| Fetcroja |
Human |
cefiderocol |
cefiderocol sulfate tosilate |
EMEA/H/C/004829 |
Shionogi B.V. |
2020/04/23
|
Authorised |
| Tigecycline Accord |
Human |
tigecycline |
tigecycline |
EMEA/H/C/005114 |
Accord Healthcare S.L.U. |
2020/04/17
|
Authorised |
| Rybelsus |
Human |
semaglutide |
semaglutide |
EMEA/H/C/004953 |
Novo Nordisk A/S |
2020/04/03
|
Authorised |
| Trepulmix |
Human |
treprostinil |
treprostinil sodium |
EMEA/H/C/005207 |
SciPharm Sàrl |
2020/04/03
|
Authorised |
| GoResp Digihaler (previously Budesonide/Formoterol Teva Pharma B.V.) |
Human |
budesonide;formoterol fumarate dihydrate |
Budesonide;formoterol fumarate dihydrate |
EMEA/H/C/004882 |
Teva Pharma B.V. |
2020/04/03
|
Authorised |
| Cinacalcet Accordpharma |
Human |
cinacalcet |
cinacalcet hydrochloride |
EMEA/H/C/005236 |
Accord Healthcare S.L.U. |
2020/04/03
|
Authorised |
| Vaxchora |
Human |
cholera vaccine, oral, live |
vibrio cholerae, strain cvd 103-hgr, live |
EMEA/H/C/003876 |
Bavarian Nordic A/S |
2020/04/01
|
Authorised |
| Ruxience |
Human |
rituximab |
rituximab |
EMEA/H/C/004696 |
Pfizer Europe MA EEIG |
2020/04/01
|
Authorised |
| Nilemdo |
Human |
bempedoic acid |
bempedoic acid |
EMEA/H/C/004958 |
Daiichi Sankyo Europe GmbH |
2020/04/01
|
Authorised |
| Arsenic trioxide Mylan |
Human |
arsenic trioxide |
arsenic trioxide |
EMEA/H/C/005235 |
Mylan Ireland Limited |
2020/04/01
|
Withdrawn |