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Full notification Final report - General information Notification Number B/NL/23/011 Member State to which the notification was sent Netherlands Date of acknowledgement from the Member State Competent Authority 06/07/2023 Title of the Project Evaluation of safety and efficacy of an intravenous injection of GNT0003, a suspension of recombinant AAV8 viral vector carrying the human UGT1A1 transgene, in patients with Crigler-Najjar syndrome Proposed period of release: 18/08/2023 to 01/12/2030 Name of the Institute(s) or Company(ies) Academic Medical Center, Amsterdam
Is the same GMO been notified elsewhere by the same notifier? Yes:
France; Italy; Has the same GMO been notified elsewhere by the same notifier? Yes If yes, notification number(s): GMO characterization GMO is a: DNA Virus Identity of the GMO: Order: Parvoviridae; Genus: Dependoparvovirus; Species: Adeno-associated virus (AAV) Information relating to the recipient or parental organisms from which the GMO is derived Common Name: Genus: Dependoparvovirus Species: Adeno-associated virus (AAV) Subspecies: Strain: AAV2/8 or AAV8 ITRs present in the vector genome are derived from AAV serotype 2 The capsid consists of a capsid of AAV serotype 8 Pathovar: European Commission administrative Information Consent given by the Member State Competent Authority: Yes
10/11/2023