| Fareston |
Human |
toremifene |
toremifene |
EMEA/H/C/000091 |
Orion Corporation |
1996/02/14
|
Authorised |
| Betaferon |
Human |
interferon beta-1b |
interferon beta-1b |
EMEA/H/C/000081 |
Bayer AG |
1995/11/30
|
Authorised |
| Taxotere |
Human |
docetaxel |
docetaxel |
EMEA/H/C/000073 |
Sanofi Winthrop Industrie |
1995/11/27
|
Authorised |
| GONAL-f |
Human |
follitropin alfa |
follitropin alfa |
EMEA/H/C/000071 |
Merck Europe B.V. |
1995/10/20
|
Authorised |
| Blarcamesine Anavex |
Human |
blarcamesine |
blarcamesine hydrochloride |
EMEA/H/C/006475 |
|
|
Opinion under re-examination |
| Omforro |
Human |
midazolam |
Midazolam Hydrochloride |
EMEA/H/C/005657 |
Regulatory Pharma Net S.r.l. |
|
Application withdrawn |
| Gotenfia |
Human |
golimumab |
golimumab |
EMEA/H/C/006621 |
Stada Arzneimittel AG |
|
Opinion |
| Jelrix |
Human |
autologous cartilage-derived articular chondrocytes, in-vitro expanded |
|
EMEA/H/C/004594 |
TETEC Tissue Engineering Technologies AG |
|
Application withdrawn |
| Anktiva |
Human |
nogapendekin alfa inbakicept |
nogapendekin alfa inbakicept |
EMEA/H/C/006622 |
Serum Life Science Europe GmbH |
|
Opinion |
| Aumseqa |
Human |
Aumolertinib |
Aumolertinib mesilate |
EMEA/H/C/006069 |
SFL Pharmaceuticals Deutschland GmbH |
|
Opinion |
| Exdensur |
Human |
depemokimab |
depemokimab |
EMEA/H/C/006446 |
GlaxoSmithKline Trading Services Limited |
|
Opinion |
| mNexspike |
Human |
COVID-19 mRNA vaccine |
mRNA encoding for the linked NTD and RBD domains of the spike glycoprotein of SARS-CoV-2 (mRNA-1283) |
EMEA/H/C/006428 |
Moderna Biotech Spain, S.L. |
|
Opinion |
| Ranluspec |
Human |
ranibizumab |
ranibizumab |
EMEA/H/C/006502 |
Lupin Europe GmbH |
|
Opinion |
| Myqorzo |
Human |
aficamten |
aficamten |
EMEA/H/C/006228 |
Cytokinetics (Ireland) Limited |
|
Opinion |
| Sirolimus TriviumVet |
Veterinary |
sirolimus |
sirolimus |
EMEA/V/C/006230 |
TriviumVet DAC |
|
Application withdrawn |
| Firocoxib CP-Pharma |
Veterinary |
firocoxib |
firocoxib |
EMEA/V/C/006921 |
CP-Pharma Handelsgesellschaft mbH |
|
Opinion |
| Varenzin |
Veterinary |
molidustat |
molidustat sodium |
EMEA/V/C/006513 |
Elanco GmbH |
|
Opinion |
| Epizootic haemorrhagic disease vaccine (recombinant protein) Laboratorios Syva S.A. |
Veterinary |
Epizootic haemorrhagic disease vaccine (recombinant protein) |
Epizootic hemorrhagic disease virus, serotype 8, VP2 protein |
EMEA/V/C/006804 |
Laboratorios Syva S.A. |
|
Opinion |
| Tuzodi |
Human |
midazolam |
Midazolam Hydrochloride |
EMEA/H/C/005658 |
Regulatory Pharma Net S.r.l. |
|
Application withdrawn |
| Hemosyvet |
Veterinary |
etamsylate |
Etamsylate |
EMEA/V/C/006461 |
|
|
Authorised |