| Ayvakyt |
Human |
avapritinib |
avapritinib |
EMEA/H/C/005208 |
Blueprint Medicines (Netherlands) B.V. |
2020/09/24
|
Authorised |
| Fampridine Accord |
Human |
fampridine |
Fampridine |
EMEA/H/C/005359 |
Accord Healthcare S.L.U. |
2020/09/24
|
Authorised |
| Jyseleca |
Human |
filgotinib |
filgotinib maleate |
EMEA/H/C/005113 |
Alfasigma S.p.A. |
2020/09/24
|
Authorised |
| Zynrelef |
Human |
bupivacaine;meloxicam |
bupivacaine;meloxicam |
EMEA/H/C/005205 |
Heron Therapeutics, B.V. |
2020/09/24
|
Withdrawn |
| Equidacent |
Human |
bevacizumab |
bevacizumab |
EMEA/H/C/005181 |
Centus Biotherapeutics Europe Limited |
2020/09/24
|
Withdrawn |
| Arsenic trioxide medac |
Human |
arsenic trioxide |
arsenic trioxide |
EMEA/H/C/005218 |
medac Gesellschaft für klinische Spezialpräparate mbH |
2020/09/17
|
Authorised |
| Cabazitaxel Accord |
Human |
cabazitaxel |
cabazitaxel |
EMEA/H/C/005178 |
Accord Healthcare S.L.U. |
2020/08/28
|
Authorised |
| Livogiva |
Human |
teriparatide |
teriparatide |
EMEA/H/C/005087 |
Theramex Ireland Limited |
2020/08/27
|
Authorised |
| Qutavina |
Human |
teriparatide |
teriparatide |
EMEA/H/C/005388 |
EuroGenerics Holdings B.V. |
2020/08/27
|
Withdrawn |
| Idefirix |
Human |
imlifidase |
imlifidase |
EMEA/H/C/004849 |
Hansa Biopharma AB |
2020/08/25
|
Authorised |
| Blenrep |
Human |
belantamab mafodotin |
belantamab mafodotin |
EMEA/H/C/004935 |
GlaxoSmithKline Trading Services Limited |
2020/08/25
|
Expired |
| Kaftrio |
Human |
ivacaftor;tezacaftor;elexacaftor |
ivacaftor;tezacaftor;elexacaftor |
EMEA/H/C/005269 |
Vertex Pharmaceuticals (Ireland) Limited |
2020/08/21
|
Authorised |
| Aybintio |
Human |
bevacizumab |
bevacizumab |
EMEA/H/C/005106 |
Samsung Bioepis NL B.V. |
2020/08/19
|
Authorised |
| Lumeblue (previously Methylthioninium chloride Cosmo) |
Human |
methylthioninium chloride |
methylthioninium chloride |
EMEA/H/C/002776 |
Cosmo Technologies Ltd |
2020/08/19
|
Authorised |
| Gencebok |
Human |
caffeine citrate |
Caffeine citrate |
EMEA/H/C/005435 |
Gennisium Pharma |
2020/08/19
|
Authorised |
| Hepcludex |
Human |
bulevirtide |
bulevirtide acetate |
EMEA/H/C/004854 |
Gilead Sciences Ireland UC |
2020/07/31
|
Authorised |
| Rozlytrek |
Human |
entrectinib |
Entrectinib |
EMEA/H/C/004936 |
Roche Registration GmbH |
2020/07/31
|
Authorised |
| Dovprela (previously Pretomanid FGK) |
Human |
pretomanid |
pretomanid |
EMEA/H/C/005167 |
Mylan IRE Healthcare Limited |
2020/07/31
|
Authorised |
| Piqray |
Human |
alpelisib |
alpelisib |
EMEA/H/C/004804 |
Novartis Europharm Limited |
2020/07/27
|
Authorised |
| Xenleta |
Human |
lefamulin |
lefamulin acetate |
EMEA/H/C/005048 |
Nabriva Therapeutics Ireland DAC |
2020/07/27
|
Authorised |