| 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Application withdrawn |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Application withdrawn |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 |
| Atropine sulfate FGK |
Human |
atropine |
atropine sulfate |
EMEA/H/C/006385 |
FGK Representative Service GmbH |
|
Refused |
| Librela |
Veterinary |
bedinvetmab |
bedinvetmab |
EMEA/V/C/005180 |
|
|
Authorised |
| Lenivia |
Veterinary |
izenivetmab |
izenivetmab |
EMEA/V/C/006455 |
|
|
Authorised |
| Hydrocortisone Aguettant |
Human |
|
hydrocortisone |
EMEA/H/C005201 |
Laboratoire Aguettant |
|
Application withdrawn |
| Vaxxitek HVT+IBD+H5 |
Veterinary |
avian influenza vaccine (live recombinant) |
Turkey herpesvirus, strain rHVT-IBD-H5 (cell-associated), expressing the VP2 protein gene of Infectious bursal disease virus and haemagglutinin gene of Avian influenza virus subtype H5, live |
EMEA/V/C/006751 |
|
|
Authorised |
| Teizeild |
Human |
teplizumab |
teplizumab |
EMEA/H/C/005496 |
Sanofi Winthrop Industrie |
|
Opinion |
| Kizfizo |
Human |
temozolomide |
temozolomide |
EMEA/H/C/006169 |
ORPHELIA Pharma |
|
Refused |
| Enflonsia |
Human |
clesrovimab |
clesrovimab |
EMEA/H/C/006497 |
Merck Sharp Dohme Limited |
|
Opinion |
| Ohtuvayre |
Human |
ensifentrine |
ensifentrine |
EMEA/H/C/006742 |
Verona Pharma Ireland Limited |
|
Application withdrawn |
| Insulin Aspart Injection |
Human |
insulin aspart |
insulin aspart |
EMEA/H/C/006720 |
Masuu Pharma Europe Limited |
|
Application withdrawn |
| Aqneursa |
Human |
L-acetylleucine |
L-acetylleucine |
EMEA/H/C/006327 |
Intrabio Ireland Limited |
|
Opinion |
| Enzalutamide Accordpharma |
Human |
enzalutamide |
enzalutamide |
EMEA/H/C/006612 |
Accord Healthcare |
|
Opinion |
| Rezurock |
Human |
Belumosudil |
Belumosudil mesilate |
EMEA/H/C/006421 |
Sanofi Winthrop Industrie |
|
Opinion |