Orphan designation: domvanalimab Treatment of gastric cancer, 09/12/2025 Positive
Submitted by Anonymous (not verified) on 27 March 2026 - 15:37
Orphan designation: domvanalimab Treatment of gastric cancer, 09/12/2025 Positive
Orphan designation: [4-(6-aminopyridazin-3-yl)piperidin-1-yl][5-(4-fluorophenoxy)-4-methoxypyridin-2-yl]methanone Treatment of focal segmental glomerulosclerosis, 09/12/2025 Positive
Submitted by Anonymous (not verified) on 27 March 2026 - 15:33
Orphan designation: [4-(6-aminopyridazin-3-yl)piperidin-1-yl][5-(4-fluorophenoxy)-4-methoxypyridin-2-yl]methanone Treatment of focal segmental glomerulosclerosis, 09/12/2025 Positive
Orphan designation: amsulostat Treatment of myelofibrosis, 09/12/2025 Positive
Submitted by Anonymous (not verified) on 27 March 2026 - 15:28
Orphan designation: amsulostat Treatment of myelofibrosis, 09/12/2025 Positive
Orphan designation: efdoralprin alfa Treatment of alpha-1 antitrypsin deficiency, 09/12/2025 Positive
Submitted by Anonymous (not verified) on 27 March 2026 - 15:25
Orphan designation: efdoralprin alfa Treatment of alpha-1 antitrypsin deficiency, 09/12/2025 Positive
Orphan designation: surovatamig Treatment of B-lymphoblastic leukaemia/lymphoma, 21/11/2025 Positive
Submitted by Anonymous (not verified) on 27 March 2026 - 15:17
Orphan designation: surovatamig Treatment of B-lymphoblastic leukaemia/lymphoma, 21/11/2025 Positive
Orphan designation: rezatapopt Treatment of ovarian cancer, 09/12/2025 Positive
Submitted by Anonymous (not verified) on 27 March 2026 - 15:15
Orphan designation: rezatapopt Treatment of ovarian cancer, 09/12/2025 Positive
Human medicines European public assessment report (EPAR): Wakix, pitolisant, Date of authorisation: 31/03/2016, Revision: 19, Status: Authorised
Submitted by Anonymous (not verified) on 27 March 2026 - 15:10
Human medicines European public assessment report (EPAR): Wakix, pitolisant, Date of authorisation: 31/03/2016, Revision: 19, Status: Authorised
Human medicines European public assessment report (EPAR): Atazanavir Krka, atazanavir, Date of authorisation: 25/03/2019, Revision: 3, Status: Withdrawn
Submitted by Anonymous (not verified) on 27 March 2026 - 15:03
Human medicines European public assessment report (EPAR): Atazanavir Krka, atazanavir, Date of authorisation: 25/03/2019, Revision: 3, Status: Withdrawn
Human medicines European public assessment report (EPAR): Duvyzat, givinostat, Date of authorisation: 06/06/2025, Revision: 1, Status: Authorised
Submitted by Anonymous (not verified) on 27 March 2026 - 14:48
Human medicines European public assessment report (EPAR): Duvyzat, givinostat, Date of authorisation: 06/06/2025, Revision: 1, Status: Authorised
EU implementation strategy of ICH E2D(R1) Guideline - Post-approval safety data: Definitions and standards for management and reporting of individual case safety reports
Submitted by Anonymous (not verified) on 27 March 2026 - 14:40
EU implementation strategy of ICH E2D(R1) Guideline - Post-approval safety data: Definitions and standards for management and reporting of individual case safety reports