| Sunitinib Accord |
Human |
sunitinib |
sunitinib |
EMEA/H/C/005419 |
Accord Healthcare S.L.U. |
2021/02/11
|
Authorised |
| Tukysa |
Human |
tucatinib |
tucatinib |
EMEA/H/C/005263 |
Pfizer Europe MA EEIG |
2021/02/11
|
Authorised |
| Yuflyma |
Human |
adalimumab |
adalimumab |
EMEA/H/C/005188 |
Celltrion Healthcare Hungary Kft. |
2021/02/11
|
Authorised |
| Ogluo |
Human |
glucagon |
Glucagon |
EMEA/H/C/005391 |
Strongbridge Dublin Limited |
2021/02/11
|
Authorised |
| Lenalidomide Krka (previously Lenalidomide Krka d.d. Novo mesto) |
Human |
lenalidomide |
lenalidomide hydrochloride monohydrate |
EMEA/H/C/005348 |
Krka, d.d., Novo mesto |
2021/02/11
|
Authorised |
| Lenalidomide Krka d.d. |
Human |
lenalidomide |
lenalidomide hydrochloride hydrate |
EMEA/H/C/005729 |
Krka, d.d., Novo mesto |
2021/02/11
|
Withdrawn |
| Lenalidomide Krka d.d. Novo mesto (previously Lenalidomide Krka) |
Human |
lenalidomide |
lenalidomide hydrochloride monohydrate |
EMEA/H/C/005734 |
Krka, d.d., Novo mesto |
2021/02/11
|
Authorised |
| Inrebic |
Human |
fedratinib |
fedratinib dihydrochloride monohydrate |
EMEA/H/C/005026 |
Bristol Myers Squibb Pharma EEIG |
2021/02/08
|
Authorised |
| Lumoxiti |
Human |
moxetumomab pasudotox |
moxetumomab pasudotox |
EMEA/H/C/005322 |
AstraZeneca AB |
2021/02/08
|
Withdrawn |
| Kirsty (previously Kixelle) |
Human |
insulin aspart |
insulin aspart |
EMEA/H/C/004965 |
Biosimilar Collaborations Ireland Limited |
2021/02/05
|
Authorised |
| Rukobia |
Human |
fostemsavir |
fostemsavir trometamol |
EMEA/H/C/005011 |
ViiV Healthcare B.V. |
2021/02/04
|
Authorised |
| Vaxzevria (previously COVID-19 Vaccine AstraZeneca) |
Human |
COVID-19 Vaccine (ChAdOx1-S [recombinant]) |
ChAdOx1-SARS-COV-2 |
EMEA/H/C/005675 |
AstraZeneca AB |
2021/01/29
|
Withdrawn |
| Enhertu |
Human |
trastuzumab deruxtecan |
trastuzumab deruxtecan |
EMEA/H/C/005124 |
Daiichi Sankyo Europe GmbH |
2021/01/18
|
Authorised |
| Onbevzi |
Human |
bevacizumab |
bevacizumab |
EMEA/H/C/005640 |
Samsung Bioepis NL B.V. |
2021/01/11
|
Withdrawn |
| Xofluza |
Human |
baloxavir marboxil |
Baloxavir marboxil |
EMEA/H/C/004974 |
Roche Registration GmbH |
2021/01/07
|
Authorised |
| Elzonris |
Human |
tagraxofusp |
tagraxofusp |
EMEA/H/C/005031 |
Stemline Therapeutics B.V. |
2021/01/07
|
Authorised |
| Roclanda |
Human |
latanoprost / netarsudil |
Latanoprost;netarsudil mesilate |
EMEA/H/C/005107 |
Santen Oy |
2021/01/07
|
Authorised |
| Spikevax (previously COVID-19 Vaccine Moderna) |
Human |
COVID-19 mRNA vaccine |
single-stranded, 5’-capped messenger RNA (mRNA) produced using a cell-free in vitro transcription from the corresponding DNA templates, encoding the viral spike (S) protein of SARS-CoV-2 |
EMEA/H/C/005791 |
Moderna Biotech Spain, S.L. |
2021/01/06
|
Authorised |
| Comirnaty |
Human |
COVID-19 mRNA vaccine |
single-stranded, 5’-capped messenger RNA produced using a cell-free in vitro transcription from the corresponding DNA templates, encoding the viral spike (S) protein of SARS-CoV-2 |
EMEA/H/C/005735 |
BioNTech Manufacturing GmbH |
2020/12/21
|
Authorised |
| Phesgo |
Human |
pertuzumab;trastuzumab |
pertuzumab;trastuzumab |
EMEA/H/C/005386 |
Roche Registration GmbH |
2020/12/21
|
Authorised |