Orphan designation: annamycin Treatment of acute myeloid leukaemia, 16/04/2024 Positive
Orphan designation: Humanised IgG1 (K322A) monoclonal antibody against disialoganglioside GD2 Treatment of neuroblastoma, 16/04/2024 Positive
Orphan designation: Autologous adipose-derived mesenchymal stem cells embedded in an extracellular matrix with hydroxyapatite/beta-tricalcium phosphate particles Treatment of congenital pseudarthrosis of long bones, 16/04/2024 Positive
Orphan designation: Autologous adipose-derived stem cells Treatment of spinal cord injury, 16/04/2024 Positive
Orphan designation: Sevasemten Treatment of Duchenne muscular dystrophy, 16/04/2024 Positive
Human medicines European public assessment report (EPAR): Prezista, darunavir, Date of authorisation: 11/02/2007, Revision: 55, Status: Authorised
Paliperidone palmitate depot suspension for injection (every 3 months) 175, 263, 350 and 525 mg product-specific bioequivalence guidance
Human medicines European public assessment report (EPAR): Lenalidomide Krka (previously Lenalidomide Krka d.d. Novo mesto), lenalidomide, Date of authorisation: 11/02/2021, Revision: 5, Status: Authorised
Paliperidone palmitate depot suspension for injection (every 3 months) 175, 263, 350 and 525 mg product-specific bioequivalence guidance
Questions and answers on standard animal weights for estimating worst-case consumer exposure scenarios