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Last updated about 1 hour ago
Human medicines European public assessment report (EPAR): Chenodeoxycholic acid Leadiant (previously Chenodeoxycholic acid sigma-tau), chenodeoxycholic acid, Date of authorisation: 10/04/2017, Revision: 8, Status: Authorised
about 2 hours ago
Human medicines European public assessment report (EPAR): Chenodeoxycholic acid Leadiant (previously Chenodeoxycholic...
Human medicines European public assessment report (EPAR): Izamby, denosumab, Date of authorisation: 26/06/2025, Revision: 3, Status: Authorised
about 2 hours ago
Human medicines European public assessment report (EPAR): Izamby, denosumab, Date of authorisation...
Data in regulation: Big data and other sources
about 2 hours ago
Data in regulation: Big data and other sources
Human medicines European public assessment report (EPAR): Rotarix, rotavirus vaccine, live, Date of authorisation: 21/02/2006, Revision: 48, Status: Authorised
about 2 hours ago
Human medicines European public assessment report (EPAR): Rotarix, rotavirus vaccine, live, Date...
Human medicines European public assessment report (EPAR): Ixchiq, Chikungunya vaccine (live), Date of authorisation: 28/06/2024, Revision: 8, Status: Authorised
about 2 hours ago
Human medicines European public assessment report (EPAR): Ixchiq, Chikungunya vaccine (live), Date...
Orphan designation: dasatinib Treatment of Diamond-Blackfan anaemia, 22/06/2026 Positive
about 4 hours ago
Orphan designation: dasatinib Treatment of Diamond-Blackfan anaemia, 22/06/2026 Positive
Orphan designation: short hairpin RNA against NANOG mRNA Treatment of glioma, 23/06/2026 Positive
about 4 hours ago
Orphan designation: short hairpin RNA against NANOG mRNA Treatment of glioma, 23/06/2026...
Orphan designation: satralizumab Treatment of myelin oligodendrocyte glycoprotein antibody-associated disease, 22/06/2026 Positive
about 4 hours ago
Orphan designation: satralizumab Treatment of myelin oligodendrocyte glycoprotein antibody-associated disease, 22/06/2026 Positive
Orphan designation: humanised IgG4 monoclonal antibody against activated protein C Treatment of progressive multifocal leukoencephalopathy, 22/06/2026 Positive
about 4 hours ago
Orphan designation: humanised IgG4 monoclonal antibody against activated protein C Treatment of...
Orphan designation: (S)-Quinuclidin-3-yl((R)-5-(3-chloro-4-isopropoxyphenyl)-2,2-dimethyl-2,3-dihydro-1H-inden-1-yl)carbamate ((1S,4R)-7,7-dimethyl-2-oxobicyclo[2.2.1]heptan-1-yl)methanesulfonate Treatment of Gaucher disease, 22/06/2026 Positive
about 5 hours ago
Orphan designation: (S)-Quinuclidin-3-yl((R)-5-(3-chloro-4-isopropoxyphenyl)-2,2-dimethyl-2,3-dihydro-1H-inden-1-yl)carbamate ((1S,4R)-7,7-dimethyl-2-oxobicyclo[2.2.1]heptan-1-yl)methanesulfonate Treatment of Gaucher disease, 22/06/2026 Positive
Orphan designation: human IgG1 monoclonal antibody against JC polyomavirus, major capsid protein VP1 Treatment of progressive multifocal leukoencephalopathy, 22/06/2026 Positive
about 5 hours ago
Orphan designation: human IgG1 monoclonal antibody against JC polyomavirus, major capsid protein...
Orphan designation: cyclo(arginyl-glycyl-aspartyl-D-tyrosyl-lysyl)-nizaracianine-1 Treatment of head and neck cancer, 22/06/2026 Positive
about 5 hours ago
Orphan designation: cyclo(arginyl-glycyl-aspartyl-D-tyrosyl-lysyl)-nizaracianine-1 Treatment of head and neck cancer, 22/06/2026 Positive