| 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 |
| Eiyzey |
Human |
aflibercept |
aflibercept |
EMEA/H/C/006745 |
Zaklady FarmaFarmaceutyczne Polpharma S.Aceutyczne Polpharma S.A. |
2025/08/14
|
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 |
| Riulvy |
Human |
tegomil fumarate |
tegomil fumarate |
EMEA/H/C/006427 |
Neuraxpharm Pharmaceuticals S.L. |
2025/07/28
|
Authorised |
| Blenrep |
Human |
belantamab mafodotin |
belantamab mafodotin |
EMEA/H/C/006511 |
GlaxoSmithKline Trading Services Limited |
2025/07/23
|
Authorised |
| Conexxence |
Human |
denosumab |
denosumab |
EMEA/H/C/006268 |
Fresenius Kabi Deutschland GmbH |
2025/07/18
|
Authorised |
| Itovebi |
Human |
inavolisib |
inavolisib |
EMEA/H/C/006353 |
Roche Registration GmbH |
2025/07/18
|
Authorised |
| Emtricitabine / Tenofovir alafenamide Viatris |
Human |
emtricitabine;tenofovir alafenamide |
emtricitabine;tenofovir alafenamide fumarate |
EMEA/H/C/006469 |
Viatris Limited |
2025/07/18
|
Authorised |
| Rolcya |
Human |
denosumab |
denosumab |
EMEA/H/C/006507 |
Sandoz GmbH |
2025/07/17
|
Authorised |
| Bomyntra |
Human |
denosumab |
denosumab |
EMEA/H/C/006269 |
Fresenius Kabi Deutschland GmbH |
2025/07/17
|
Authorised |
| Attrogy |
Human |
diflunisal |
diflunisal |
EMEA/H/C/006248 |
Purpose Pharma International AB |
2025/07/17
|
Authorised |
| Ezmekly |
Human |
mirdametinib |
mirdametinib |
EMEA/H/C/006460 |
SpringWorks Therapeutics Ireland Limited |
2025/07/17
|
Authorised |
| Aucatzyl |
Human |
obecabtagene autoleucel |
obecabtagene autoleucel |
EMEA/H/C/005907 |
Autolus GmbH |
2025/07/17
|
Authorised |
| Oczyesa |
Human |
octreotide |
octreotide hydrochloride |
EMEA/H/C/006322 |
Camurus AB |
2025/06/30
|
Authorised |
| Alyftrek |
Human |
deutivacaftor / tezacaftor / vanzacaftor |
deutivacaftor;tezacaftor;vanzacaftor calcium dihydrate |
EMEA/H/C/006382 |
Vertex Pharmaceuticals (Ireland) Limited |
2025/06/30
|
Authorised |