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Full notification Final report - General information Notification Number B/DE/22/PEI4996 Member State to which the notification was sent Germany Date of acknowledgement from the Member State Competent Authority 08/08/2022 Title of the Project COAV101B12302: Phase IIIb, openlabel, single-arm, multi-center study to evaluate the safety, tolerability and efficacy of OAV101 administered intrathecally (1.2 x 1014 vector genomes) to participants 2 to 12 years of age with spinal muscular atrophy (SMA) who have discontinued treatment with nusinersen (Spinraza ®) or Risdiplam (Evrysdi®)… Proposed period of release: 15/12/2022 to 10/10/2023 Name of the Institute(s) or Company(ies) Novartis Pharma AG, Postfach, 4002 Basel, Switzerland
Is the same GMO been notified elsewhere by the same notifier? Yes:
Belgium; Spain; France; Italy; Netherlands;
Has the same GMO been notified elsewhere by the same notifier? No GMO characterization GMO is a: DNA Virus Identity of the GMO: Information relating to the recipient or parental organisms from which the GMO is derived Common Name: AAV9 Genus: Dependoparvovirus Species: Adeno-associated virus Subspecies: Strain: Serotype 9 Pathovar: European Commission administrative Information Consent given by the Member State Competent Authority: Not known
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