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Full notification Final report - General information Notification Number B/HU/23/02 Member State to which the notification was sent Hungary Date of acknowledgement from the Member State Competent Authority 03/10/2023 Title of the Project A Randomized, Partially Masked, Controlled, Phase 3 Clinical Study to Evaluate the Efficacy and Safety of RGX-314 Gene Therapy in Participants with nAMD (ASCENT) Proposed period of release: 30/11/2023 to 30/11/2025 Name of the Institute(s) or Company(ies) AbbVie Inc, Germany
Is the same GMO been notified elsewhere by the same notifier? Yes:
Hungary; Has the same GMO been notified elsewhere by the same notifier? No GMO characterization GMO is a: DNA Virus Identity of the GMO: Family: Parvoviridae Genus: Dependoparvovirus Species: Adeno-associated virus (recombinant AAV-derived-replication-deficient viral vector) Information relating to the recipient or parental organisms from which the GMO is derived Common Name: Genus: Dependoparvovirus Species: Adeno-associated dependoparvovirus Subspecies: N/A Strain: N/A Pathovar: N/A European Commission administrative Information Consent given by the Member State Competent Authority: Not known