| Zepzelca |
Human |
lurbinectedin |
lurbinectedin |
EMEA/H/C/006673 |
Pharma Mar S.A. |
2026/05/29
|
Authorised |
| Joenja |
Human |
leniolisib |
leniolisib phosphate |
EMEA/H/C/005927 |
Pharming Technologies B.V. |
2026/05/21
|
Authorised |
| Bysumlog |
Human |
insulin lispro |
insulin lispro |
EMEA/H/C/006158 |
Gan & Lee Pharmaceuticals Europe GmbH |
2026/05/06
|
Authorised |
| Zandoriah |
Human |
teriparatide |
teriparatide |
EMEA/H/C/006688 |
CinnaGen Co Unipessoal LDA |
2026/04/27
|
Authorised |
| Dazparda |
Human |
insulin aspart |
insulin aspart |
EMEA/H/C/006187 |
Gan & Lee Pharmaceuticals Europe GmbH |
2026/04/27
|
Authorised |
| Tuyory |
Human |
tocilizumab |
|
EMEA/H/C/006416 |
Chemical Works of Gedeon Richter Plc. (Gedeon Richter Plc.) |
2026/04/27
|
Authorised |
| Xolremdi |
Human |
mavorixafor |
mavorixafor |
EMEA/H/C/006496 |
X4 Pharmaceuticals GmbH |
2026/04/27
|
Authorised |
| Onerji |
Human |
levodopa;carbidopa |
levodopa;carbidopa |
EMEA/H/C/006429 |
Tanabe Pharma GmbH |
2026/04/27
|
Authorised |
| Fubelv |
Human |
etanercept |
etanercept |
EMEA/H/C/006738 |
Biosimilar Collaborations Ireland Limited |
2026/04/23
|
Authorised |
| Poherdy |
Human |
pertuzumab |
pertuzumab |
EMEA/H/C/006583 |
Organon N.V. |
2026/04/23
|
Authorised |
| Rhapsido |
Human |
remibrutinib |
remibrutinib |
EMEA/H/C/006313 |
Novartis Europharm Limited |
2026/04/23
|
Authorised |
| Palsonify |
Human |
paltusotine |
paltusotine hydrochloride |
EMEA/H/C/006636 |
Crinetics Pharmaceuticals Europe GmbH |
2026/04/23
|
Authorised |
| Ojemda |
Human |
tovorafenib |
tovorafenib |
EMEA/H/C/006140 |
Ipsen Pharma |
2026/04/20
|
Authorised |
| mCombriax |
Human |
influenza mRNA vaccine;COVID-19 mRNA vaccine |
single-stranded, 5’-capped messenger RNAs (mRNAs) produced using a cell-free in vitro transcription from the corresponding DNA template, encoding seasonal influenza haemagglutinin (HA) glycoproteins: A/H1N1, A/H3N2, B/Victoria |
EMEA/H/C/006472 |
Moderna Biotech Spain, S.L. |
2026/04/20
|
Authorised |
| Enflonsia |
Human |
clesrovimab |
clesrovimab |
EMEA/H/C/006497 |
Merck Sharp Dohme Limited |
2026/04/15
|
Authorised |
| Supemtek |
Human |
trivalent influenza vaccine (recombinant, prepared in cell culture) |
A/California/07/2009 (H1N1)pdm09-like strain (A/California/07/2009);A/Texas/50/2012 (H3N2)-like strain (A/Texas/50/2012);B/Brisbane/60/2008-like strain (B/Brisbane/60/2008) |
EMEA/H/C/006674 |
Sanofi Winthrop Industrie |
2026/03/30
|
Authorised |
| Kygevvi |
Human |
doxecitine;doxribtimine |
doxecitine;Doxribtimine |
EMEA/H/C/005119 |
UCB Pharma |
2026/03/26
|
Authorised |
| Kayshild |
Human |
semaglutide |
semaglutide |
EMEA/H/C/006426 |
Novo Nordisk A/S |
2026/03/26
|
Authorised |
| Fylrevy |
Human |
estetrol |
estetrol monohydrate |
EMEA/H/C/006213 |
Gedeon Richter Plc. |
2026/03/26
|
Authorised |
| Ilumira |
Human |
lutetium (177Lu) chloride |
lutetium (177Lu) chloride |
EMEA/H/C/006596 |
Shine Europe B.V. |
2026/03/26
|
Authorised |