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Last updated 19 minutes ago
Applications for new human medicines under evaluation: May 2026
25 minutes ago
Applications for new human medicines under evaluation: May 2026
Herbal medicinal product: Hamamelidis cortex, Hamamelis virginiana L., F: Assessment finalised
42 minutes ago
Herbal medicinal product: Hamamelidis cortex, Hamamelis virginiana L., F: Assessment finalised
Herbal medicinal product: Hamamelidis folium, Hamamelis virginiana L., F: Assessment finalised
43 minutes ago
Herbal medicinal product: Hamamelidis folium, Hamamelis virginiana L., F: Assessment finalised
Herbal medicinal product: Hamamelidis folium et cortex aut ramunculus destillatum, Hamamelis virginiana L., F: Assessment finalised
44 minutes ago
Herbal medicinal product: Hamamelidis folium et cortex aut ramunculus destillatum, Hamamelis virginiana...
Antimicrobial Sales and Use (ASU) Platform: Release notes
about 1 hour ago
Antimicrobial Sales and Use (ASU) Platform: Release notes
Agenda - EnprEMA & ACT EU workshop on paediatric clinical trials
about 2 hours ago
Agenda - EnprEMA & ACT EU workshop on paediatric clinical trials
Human medicines European public assessment report (EPAR): Ojemda, tovorafenib, Date of authorisation: 21/04/2026, Status: Authorised
about 4 hours ago
Human medicines European public assessment report (EPAR): Ojemda, tovorafenib, Date of authorisation...
Orphan designation: Adeno-associated viral vector serotype Anc80 containing the 3' portion of human OTOF gene, adeno-associated viral vector serotype Anc80 containing the 5' portion of human OTOF gene Treatment of otoferlin gene-mediated hearing loss, 19/
about 4 hours ago
Orphan designation: Adeno-associated viral vector serotype Anc80 containing the 3' portion of...
Orphan designation: 2-((2-fluoro-4-iodophenyl)amino)-N-(2-hydroxyethoxy)-1-methyl-1H-pyrrolo[2,3-b]pyridine-3-carboxamide Treatment of neurofibromatosis type 1, 22/05/2023 Positive
about 4 hours ago
Orphan designation: 2-((2-fluoro-4-iodophenyl)amino)-N-(2-hydroxyethoxy)-1-methyl-1H-pyrrolo[2,3-b]pyridine-3-carboxamide Treatment of neurofibromatosis type 1, 22/05/2023 Positive
Orphan designation: encaleret Treatment of hypoparathyroidism, 15/10/2021 Positive
about 4 hours ago
Orphan designation: encaleret Treatment of hypoparathyroidism, 15/10/2021 Positive
Orphan designation: eltanexor Treatment of myelodysplastic syndromes, 21/06/2022 Positive
about 4 hours ago
Orphan designation: eltanexor Treatment of myelodysplastic syndromes, 21/06/2022 Positive
Orphan designation: (Z)-3-(3-(3,5-bis(trifluoromethyl)phenyl)-1H-1,2,4-triazol-1-yl)-N'-(pyrazin-2-yl)acrylohydrazide Treatment of diffuse large B-cell lymphoma, 22/08/2014 Positive
about 4 hours ago
Orphan designation: (Z)-3-(3-(3,5-bis(trifluoromethyl)phenyl)-1H-1,2,4-triazol-1-yl)-N'-(pyrazin-2-yl)acrylohydrazide Treatment of diffuse large B-cell lymphoma, 22/08/2014 Positive