Veterinary medicines European public assessment report (EPAR): Clomicalm, clomipramine, Status: Authorised

Human medicines European public assessment report (EPAR): Beyonttra, acoramidis, Date of authorisation: 10/02/2025, Revision: 2, Status: Authorised

Human medicines European public assessment report (EPAR): Eurartesim, piperaquine tetraphosphate,artenimol, Date of authorisation: 27/10/2011, Revision: 15, Status: Authorised

Human medicines European public assessment report (EPAR): Topotecan Hospira, topotecan, Date of authorisation: 09/06/2010, Revision: 21, Status: Authorised

Human medicines European public assessment report (EPAR): Skyclarys, omaveloxolone, Date of authorisation: 09/02/2024, Revision: 7, Status: Authorised

Orphan designation: relacorilant Treatment of ovarian cancer, 25/07/2023 Positive

Orphan designation: human IgG1 (296-cysteine,301-glycine,306-cysteine) monoclonal antibody against TREM2 Treatment of CSF1R-related leukoencephalopathy, 13/10/2023 Withdrawn

Orphan designation: adeno-associated viral vector containing a modified U7 snRNA gene Treatment of Duchenne muscular dystrophy, 27/07/2005 Withdrawn

Orphan designation: adeno-associated virus vector serotype 9 encoding human gigaxonin gene Treatment of giant axonal neuropathy, 13/04/2022 Withdrawn

Orphan designation: hydrocortisone Treatment of adrenal insufficiency, 20/03/2007 Withdrawn