Full notification file
General informationNotification NumberB/NL/18/020Member State to which the notification was sentNetherlandsDate of acknowledgement from the Member State Competent Authority07/12/2018Title of the ProjectClinical Study 19429, “A Phase 1/2 Open-Label Safety and Dose-Finding Study of BAY 2599023 (DTX201), an Adeno-Associated Virus (AAV) hu37-Mediated Gene Transfer of B-Domain Deleted Human Factor VIII, in Adults with Severe Hemophilia A”Proposed period of release:01/07/2018 to 31/12/2030Name of the Institute(s) or Company(ies)Bayer AG, D-51368 Leverkusen
Germany;
3. Is the same GMO release planned elsewhere in the Community?Yes: Germany; Spain; France; United Kingdom; Bulgaria; Has the same GMO been notified elsewhere by the same notifier?NoGMO characterizationGMO is a:DNA VirusIdentity of the GMO:Genus: Dependoparvovirus
Species: Adeno-associated virus human serotype 37 (AAVhu37)Information relating to the recipient or parental organisms from wich the GMO is derivedCommon Name | Genus | Species | Subspecies | Strain | Pathovar | N/A | Dependoparvovirus | Adeno-associated Virus | N/A | serotype hu37 | N/A |
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European Commission administrative informationConsent given by the Member State Competent Authority:Not known