| Orladeyo |
Human |
berotralstat |
berotralstat dihydrochloride |
EMEA/H/C/005138 |
BioCryst Ireland Limited |
2021/04/30
|
Authorised |
| Abiraterone Accord |
Human |
abiraterone |
abiraterone acetate |
EMEA/H/C/005408 |
Accord Healthcare S.L.U. |
2021/04/26
|
Authorised |
| Jemperli |
Human |
dostarlimab |
dostarlimab |
EMEA/H/C/005204 |
GlaxoSmithKline Trading Services Limited |
2021/04/21
|
Authorised |
| Abevmy |
Human |
bevacizumab |
bevacizumab |
EMEA/H/C/005327 |
Biosimilar Collaborations Ireland Limited |
2021/04/21
|
Authorised |
| Sogroya |
Human |
somapacitan |
somapacitan |
EMEA/H/C/005030 |
Novo Nordisk A/S |
2021/03/31
|
Authorised |
| Seffalair Spiromax |
Human |
salmeterol;fluticasone propionate |
fluticasone propionate;salmeterol xinafoate |
EMEA/H/C/004881 |
Teva B.V. |
2021/03/26
|
Authorised |
| Kesimpta |
Human |
ofatumumab |
ofatumumab |
EMEA/H/C/005410 |
Novartis Europharm Limited |
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 |
| Oyavas |
Human |
bevacizumab |
bevacizumab |
EMEA/H/C/005556 |
STADA Arzneimittel AG |
2021/03/26
|
Authorised |
| Evrysdi |
Human |
risdiplam |
risdiplam |
EMEA/H/C/005145 |
Roche Registration 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Withdrawn |
| Vazkepa |
Human |
icosapent ethyl |
Icosapent ethyl |
EMEA/H/C/005398 |
Amarin Pharmaceuticals Ireland Limited |
2021/03/26
|
Authorised |
| Alymsys |
Human |
bevacizumab |
bevacizumab |
EMEA/H/C/005286 |
Mabxience Research SL |
2021/03/26
|
Authorised |
| 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Withdrawn |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 |