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): Forxiga, dapagliflozin, Date of authorisation: 11/11/2012, Revision: 33, Status: Authorised

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): Ozempic, semaglutide, Date of authorisation: 08/02/2018, Revision: 21, Status: Authorised

Human medicines European public assessment report (EPAR): Rybelsus, semaglutide, Date of authorisation: 03/04/2020, Revision: 17, Status: Authorised

Human medicines European public assessment report (EPAR): Noxafil, posaconazole, Date of authorisation: 25/10/2005, Revision: 43, Status: Authorised

Human medicines European public assessment report (EPAR): Rotarix, rotavirus vaccine, live, Date of authorisation: 21/02/2006, Revision: 46, Status: Authorised