GGO Vergunningendatabase

C/NL/06/01_001 Suntory Flowers Limited Application for renewal of consent for marketing approval under Directive 2001/18/EC (Event FLORIGENE®Moonaqua™(FLO-4Ø689-6)) 09-11-2018 Vergunning verleend
IM-MV 18-003_000 UMCG Study of Adeno-Associated Virus (AAV) Serotype 8 (AAV8)-Mediated Gene Transfer of Glucose-6-Phosphatase (G6Pase) in subjects with Glycogen Storage Disease Type la (GSDIa) Ontwerpbesluit genomen
IM-MV 18-004_000 Universitair Medisch Centrum Utrecht Phase I/II multicenter clinical trial of VXM01 in combination with avelumab in patients with progressive glioblastoma and further clinical studies with VXM01 in patients with solid malignancies. Ontwerpbesluit genomen
IM-MV 18-009_000 Universitair Medisch Centrum Utrecht Clinical testing of KITE-585, an autologous cellular immunotherapy composed of T cells genetically modified ex vivo to express a chimeric antigen receptor (CAR) that, upon reinfusion into the patient, recognize and kill B-cell maturation antigen (BCMA)-expressing tumor cells Ontwerpbesluit genomen
IM-MV 18-010_000 Prinses Máxima Centrum Testing the safety and efficacy of JCAR017 in patients with aggressive B cell malignancies Ontwerpbesluit genomen
IM-MV 18-015_000 Erasmus MC A Study of BAY 2599023 (DTX201), an Adeno-Associated Virus (AAV) hu37-Mediated Gene Transfer of B-Domain Deleted Human Factor VIII, in patients with Severe Hemophilia A Ontwerpbesluit genomen