| Supemtek |
Human |
trivalent influenza vaccine (recombinant, prepared in cell culture) |
Influenza A virus subtype H1N1 haemagglutinin, recombinant |
EMEA/H/C/006674 |
Sanofi Winthrop Industrie |
|
Opinion |
| Equilis EHV 1+4 |
Veterinary |
Equine herpesvirus vaccine (inactivated) |
equine herpesvirus 1, strain RAC-H and equine herpesvirus 4, strain 2252 |
EMEA/V/C/006147 |
Intervet International BV |
|
Application withdrawn |
| Varenzin |
Veterinary |
molidustat |
molidustat sodium |
EMEA/V/C/006513 |
|
|
Authorised |
| Lotilaner / Milbemycin Elanco |
Veterinary |
lotilaner;milbemycin oxime |
lotilaner;milbemycin oxime |
EMEA/V/C/006911 |
Elanco GmbH |
|
Opinion |
| Tolvaptan Accord |
Human |
tolvaptan |
tolvaptan |
EMEA/H/C/005961 |
Accord Healthcare S.L.U. |
|
Authorised |
| Nurzigma |
Human |
pridopidine |
pridopidine hydrochloride |
EMEA/H/C/006261 |
Prilenia Therapeutics B.V. |
|
Application withdrawn |
| Ecovaxxin MS |
Veterinary |
Mycoplasma synoviae, strain K588A, Live |
Mycoplasma synoviae, strain K588A, Live |
EMEA/V/C/006604 |
|
|
Authorised |
| Vaxxinact H5 |
Veterinary |
Avian influenza virus, subtype H5, haemagglutinin (recombinant) |
Avian influenza virus, subtype H5, haemagglutinin (recombinant) |
EMEA/V/C/006717 |
|
|
Authorised |
| Blarcamesine Anavex |
Human |
blarcamesine |
blarcamesine hydrochloride |
EMEA/H/C/006475 |
|
|
Opinion under re-examination |
| Exdensur |
Human |
depemokimab |
depemokimab |
EMEA/H/C/006446 |
GlaxoSmithKline Trading Services Limited |
|
Opinion |
| Gotenfia |
Human |
golimumab |
golimumab |
EMEA/H/C/006621 |
Stada Arzneimittel AG |
|
Opinion |
| Omforro |
Human |
midazolam |
Midazolam Hydrochloride |
EMEA/H/C/005657 |
Regulatory Pharma Net S.r.l. |
|
Application withdrawn |
| 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 |
| 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Application withdrawn |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 |
| 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 |
|
|
Authorised |