Orphan designation: lisaftoclax Treatment of myelodysplastic syndromes, 13/04/2026 Positive
Orphan designation: acetylleucine Treatment of CACNA1A disorders, 25/03/2026 Positive
Orphan designation: exaluren sulfate Treatment of Alport syndrome, 25/03/2026 Positive
Human medicines European public assessment report (EPAR): Dabigatran Etexilate Accord, dabigatran etexilate, Date of authorisation: 26/05/2023, Revision: 3, Status: Authorised
Orphan designation: tacrolimus monohydrate Treatment of vernal keratoconjunctivitis, 25/03/2026 Positive
Human medicines European public assessment report (EPAR): Erleada, apalutamide, Date of authorisation: 14/01/2019, Revision: 23, Status: Authorised
Human medicines European public assessment report (EPAR): Rybelsus, semaglutide, Date of authorisation: 03/04/2020, Revision: 17, Status: Authorised
Orphan designation: atigotatug,nivolumab Treatment of pulmonary neuroendocrine carcinoma, 25/03/2026 Positive
Orphan designation: irpagratinib tosilate monohydrate Treatment of hepatocellular carcinoma, 25/03/2026 Positive
Orphan designation: telisotuzumab adizutecan Treatment of pancreatic cancer, 25/03/2026 Positive