| 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Withdrawn |
| Azacitidine Mylan |
Human |
azacitidine |
azacitidine |
EMEA/H/C/004984 |
Mylan Pharmaceuticals Limited |
2020/03/27
|
Authorised |
| Nubeqa |
Human |
darolutamide |
darolutamide |
EMEA/H/C/004790 |
Bayer AG |
2020/03/27
|
Authorised |
| Nustendi |
Human |
bempedoic acid;ezetimibe |
bempedoic acid;ezetimibe |
EMEA/H/C/004959 |
Daiichi Sankyo Europe GmbH |
2020/03/27
|
Authorised |
| Staquis |
Human |
crisaborole |
Crisaborole |
EMEA/H/C/004863 |
Pfizer Europe MA EEIG |
2020/03/27
|
Withdrawn |
| Lyumjev (previously Liumjev) |
Human |
insulin lispro |
insulin lispro |
EMEA/H/C/005037 |
Eli Lilly Nederland B.V. |
2020/03/24
|
Authorised |
| Azacitidine betapharm |
Human |
azacitidine |
azacitidine |
EMEA/H/C/005075 |
betapharm Arzneimittel GmbH |
2020/03/24
|
Authorised |
| Givlaari |
Human |
givosiran |
Givosiran |
EMEA/H/C/004775 |
Alnylam Netherlands B.V. |
2020/03/02
|
Authorised |
| Amsparity |
Human |
adalimumab |
adalimumab |
EMEA/H/C/004879 |
Pfizer Europe MA EEIG |
2020/02/13
|
Authorised |
| Azacitidine Accord |
Human |
azacitidine |
azacitidine |
EMEA/H/C/005147 |
Accord Healthcare S.L.U. |
2020/02/13
|
Authorised |
| Beovu |
Human |
brolucizumab |
brolucizumab |
EMEA/H/C/004913 |
Novartis Europharm Limited |
2020/02/13
|
Authorised |
| Recarbrio |
Human |
imipenem;cilastatin;relebactam |
imipenem monohydrate;cilastatin sodium;relebactam monohydrate |
EMEA/H/C/004808 |
Merck Sharp & Dohme B.V. |
2020/02/13
|
Authorised |