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Notification report


Full notification file


General information

Notification Number
B/ES/18/05

Member State to which the notification was sent
Spain

Date of acknowledgement from the Member State Competent Authority
26/03/2018

Title of the Project
Clinical 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:
01/08/2018 to 31/03/2020

Name 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; France; United Kingdom; Netherlands; Bulgaria;

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 human serotype 37 (AAVhu37)


Information relating to the recipient or parental organisms from wich the GMO is derived
Common NameGenusSpeciesSubspeciesStrainPathovar
-DependoparvovirusAdeno-associated Virus-serotype hu37-

European Commission administrative information

Consent given by the Member State Competent Authority:
Not known