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Full notification Final report - General information Notification Number B/DE/22/PEI4910 Member State to which the notification was sent Germany Date of acknowledgement from the Member State Competent Authority 27/05/2022 Title of the Project A Phase 1/2 Safety, Tolerability, and Efficacy Study of BMN 270, an Adeno-Associated Virus Vector-Mediated Gene Transfer of Human Factor VIII in Hemophilia A Patients with Active or Prior Inhibitors (Protocol number: 270-205)  Proposed period of release: 01/12/2022 to 31/12/2023 Name of the Institute(s) or Company(ies) BioMarin Pharmaceutical Inc.
Is the same GMO been notified elsewhere by the same notifier? No Has the same GMO been notified elsewhere by the same notifier? Yes If yes, notification number(s): B/BE/19/BVW2; B/ES/18/11, B/ES/18/12; GMO characterization GMO is a: DNA Virus Identity of the GMO: Genus: Dependovirus, Species: Adeno-associated virus/ serotype 5 (AAV 5)  Information relating to the recipient or parental organisms from which the GMO is derived Common Name: Adeno-associated virus Genus: Dependovirus 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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