| Kisunla |
Human |
donanemab |
donanemab |
EMEA/H/C/006024 |
Eli Lilly Nederland B.V. |
2025/09/24
|
Authorised |
| Bildyos |
Human |
denosumab |
denosumab |
EMEA/H/C/006434 |
Henlius Europe GmbH |
2025/09/17
|
Authorised |
| Bilprevda |
Human |
denosumab |
denosumab |
EMEA/H/C/006435 |
Henlius Europe GmbH |
2025/09/17
|
Authorised |
| Tryngolza |
Human |
olezarsen |
olezarsen sodium |
EMEA/H/C/006477 |
Ionis Ireland Limited |
2025/09/17
|
Authorised |
| Ekterly |
Human |
sebetralstat |
sebetralstat |
EMEA/H/C/006211 |
Kalvista Pharmaceuticals (Ireland) Limited |
2025/09/17
|
Authorised |
| Usrenty |
Human |
ustekinumab |
ustekinumab |
EMEA/H/C/006794 |
Biosimilar Collaborations Ireland Limited |
2025/09/17
|
Authorised |
| Voranigo |
Human |
vorasidenib |
vorasidenib |
EMEA/H/C/006284 |
Les Laboratoires Servier |
2025/09/17
|
Authorised |
| Romvimza |
Human |
vimseltinib |
vimseltinib dihydrate |
EMEA/H/C/006363 |
Deciphera Pharmaceuticals (Netherlands) B.V. |
2025/09/17
|
Authorised |
| Eyluxvi |
Human |
aflibercept |
aflibercept |
EMEA/H/C/006282 |
Biolitec pharma Limited Zweigniederlassung Jena |
2025/09/15
|
Authorised |
| Zemcelpro |
Human |
allogeneic umbilical cord-derived CD34- cells, non-expanded;dorocubicel |
allogeneic umbilical cord-derived CD34- cells, non-expanded;dorocubicel |
EMEA/H/C/005772 |
Cordex Biologics International Limited |
2025/08/25
|
Authorised |
| Yeytuo |
Human |
lenacapavir |
lenacapavir sodium |
EMEA/H/C/006658 |
Gilead Sciences Ireland Unlimited Company |
2025/08/25
|
Authorised |
| Nintedanib Viatris |
Human |
nintedanib |
nintedanib |
EMEA/H/C/006486 |
Viatris Limited |
2025/08/22
|
Authorised |
| Emtricitabine / Rilpivirine / Tenofovir Alafenamide Viatris |
Human |
emtricitabine;rilpivirine;tenofovir alafenamide |
emtricitabine;rilpivirine hydrochloride;tenofovir alafenamide fumarate |
EMEA/H/C/006491 |
Viatris Limited |
2025/08/19
|
Authorised |
| Rezdiffra |
Human |
resmetirom |
resmetirom |
EMEA/H/C/006220 |
Madrigal Pharmaceuticals EU Limited |
2025/08/18
|
Authorised |
| Mynzepli |
Human |
aflibercept |
aflibercept |
EMEA/H/C/006438 |
Advanz Pharma Limited |
2025/08/18
|
Authorised |
| Vivlipeg |
Human |
pegfilgrastim |
pegfilgrastim |
EMEA/H/C/006739 |
Biosimilar Collaborations Ireland Limited |
2025/08/18
|
Authorised |
| Usymro |
Human |
ustekinumab |
ustekinumab |
EMEA/H/C/006467 |
Gedeon Richter Plc. |
2025/08/14
|
Authorised |
| Vgenfli |
Human |
aflibercept |
aflibercept |
EMEA/H/C/006192 |
Zaklady FarmaFarmaceutyczne Polpharma S.Aceutyczne Polpharma S.A. |
2025/08/14
|
Authorised |
| Ogsiveo |
Human |
nirogacestat |
nirogacestat hydrobromide |
EMEA/H/C/006071 |
SpringWorks Therapeutics Ireland Limited |
2025/08/14
|
Authorised |
| Maapliv |
Human |
amino acids |
glycine,L-alanine,L-arginine,L-aspartic acid,L-cysteine hydrochloride monohydrate,L-histidine,L-methionine,L-phenylalanine,L-proline,L-serine,L-threonine,L-tryptophan,L-tyrosine,L-glutamic acid,L-lysine monohydrate,taurine |
EMEA/H/C/005557 |
Recordati Rare Diseases |
2025/07/28
|
Authorised |