| Oyavas |
Human |
bevacizumab |
bevacizumab |
EMEA/H/C/005556 |
STADA Arzneimittel AG |
2021/03/26
|
Authorised |
| Seffalair Spiromax |
Human |
salmeterol;fluticasone propionate |
fluticasone propionate;salmeterol xinafoate |
EMEA/H/C/004881 |
Teva B.V. |
2021/03/26
|
Authorised |
| Ontozry |
Human |
cenobamate |
cenobamate |
EMEA/H/C/005377 |
Angelini Pharma S.p.A |
2021/03/26
|
Authorised |
| Byfavo |
Human |
remimazolam |
remimazolam besilate |
EMEA/H/C/005246 |
Paion Pharma GmbH |
2021/03/26
|
Authorised |
| BroPair Spiromax |
Human |
salmeterol;fluticasone propionate |
salmeterol xinafoate;fluticasone propionate |
EMEA/H/C/005591 |
Teva B.V. |
2021/03/26
|
Withdrawn |
| Thiotepa Riemser |
Human |
thiotepa |
thiotepa |
EMEA/H/C/005434 |
Esteve Pharmaceuticals GmbH |
2021/03/26
|
Authorised |
| Pemazyre |
Human |
pemigatinib |
pemigatinib |
EMEA/H/C/005266 |
Incyte Biosciences Distribution B.V. |
2021/03/26
|
Authorised |
| Nexpovio |
Human |
selinexor |
selinexor |
EMEA/H/C/005127 |
Stemline Therapeutics B.V. |
2021/03/26
|
Authorised |
| Jcovden (previously COVID-19 Vaccine Janssen) |
Human |
COVID-19 vaccine (Ad26.COV2-S [recombinant]) |
adenovirus type 26 encoding the SARS-CoV-2 spike glycoprotein (Ad26.COV2-S) |
EMEA/H/C/005737 |
Janssen-Cilag International NV |
2021/03/11
|
Withdrawn |
| Heplisav B |
Human |
hepatitis B surface antigen |
hepatitis B surface antigen |
EMEA/H/C/005063 |
Dynavax GmbH |
2021/02/18
|
Authorised |
| Retsevmo |
Human |
selpercatinib |
selpercatinib |
EMEA/H/C/005375 |
Eli Lilly Nederland B.V. |
2021/02/11
|
Authorised |
| Yuflyma |
Human |
adalimumab |
adalimumab |
EMEA/H/C/005188 |
Celltrion Healthcare Hungary Kft. |
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 |
| 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 |
| Ogluo |
Human |
glucagon |
Glucagon |
EMEA/H/C/005391 |
Strongbridge Dublin Limited |
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Withdrawn |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 |