Creon

Orphan designation: 1-{[2-(3,6-Diazabicyclo[3.1.1]heptan-3-yl)-7-(1,3-thiazol-2-yl)-1,3-benzoxazol-4-yl]oxy}-1,1-difluoro-2-methylpropan-2-ol Treatment of palmoplantar pustulosis Positive

PSUSA/00000415/202508

PSUSA/00000813/202508

Veterinary medicines European public assessment report (EPAR): Bluevac BTV (previously Bluevac BTV8), Status: Authorised

Human medicines European public assessment report (EPAR): Spevigo, spesolimab, Date of authorisation: 09/12/2022, Revision: 5, Status: Authorised

Human medicines European public assessment report (EPAR): Pavblu, aflibercept, Revision: 2, Status: Authorised

Human medicines European public assessment report (EPAR): Vfend, voriconazole, Date of authorisation: 19/03/2002, Revision: 58, Status: Authorised

Orphan designation: rinatabart sesutecan Treatment of ovarian cancer Positive

Orphan designation: adeno-associated viral vector serotype 44.9 containing the human HRS1 gene Treatment of inherited retinal dystrophy due to dysfunction in the human retinoschisin (RS1) gene, 23/02/2026 Positive