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Full notification Final report - General information Notification Number B/ES/22/19 Member State to which the notification was sent Spain Date of acknowledgement from the Member State Competent Authority 09/06/2022 Title of the Project A two-part, open-label systemic gene delivery study to evaluate the safety and expression of RO7494222 (SRP-9001) in subjects under the age of four with Duchenne Muscular Dystrophy  Proposed period of release: 01/10/2022 to 31/12/2032 Name of the Institute(s) or Company(ies) F. Hoffmann-La Roche, Ltd., Bldg. 74, Grenzacherstrasse 124 4070 Basel Switzerland
Is the same GMO been notified elsewhere by the same notifier? Yes:
Belgium; Germany; France; Italy;
Has the same GMO been notified elsewhere by the same notifier? No GMO characterization GMO is a: DNA Virus Identity of the GMO: Genus: Dependoparvovirus Species: Adeno Associated Virus (AAV) serotype rh74 (replication-deficient viral vector containing human hMicro-Dys cDNA) (c) Genetic stability – according to Annex IIIa, II, A(10) Information relating to the recipient or parental organisms from which the GMO is derived Common Name: AAV rh74 Genus: Dependovirus Species: Adeno-associated virus Subspecies: Strain: Pathovar: Serotype rh74 European Commission administrative Information Consent given by the Member State Competent Authority: Not known
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