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Full notification Final report - General information Notification Number B/ES/22/20 Member State to which the notification was sent Spain Date of acknowledgement from the Member State Competent Authority 22/07/2022 Title of the Project A Phase 1/2, Open-Label, Dose-Escalation Study to Determine the Safety, Tolerability, and Efficacy of BMN 331, an Adeno-Associated Virus (AAV) Vector-Mediated Gene Transfer of Human SERPING1, in Subjects with Hereditary Angioedema (HAE) due to Human C1 Esterase Inhibitor (C1-INH) Deficiency Proposed period of release: 01/06/2023 to 30/09/2028 Name of the Institute(s) or Company(ies) BioMarin Pharmaceutical Inc.
Is the same GMO been notified elsewhere by the same notifier? Yes:
France;
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: Adeno-associated virus Genus: Dependoparvovirus Species: Adeno-associated virus Subspecies: serotype 5 (AAV5) Strain: Pathovar: European Commission administrative Information Consent given by the Member State Competent Authority: Not known
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