Notification report

Full notification file

General information

Notification Number

Member State to which the notification was sent

Date of acknowledgement from the Member State Competent Authority

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:
01/07/2018 to 31/12/2030

Name of the Institute(s) or Company(ies)
Bayer AG, D-51368 Leverkusen

3. Is the same GMO release planned elsewhere in the Community?
Germany; Spain; France; United Kingdom; Bulgaria;

Has the same GMO been notified elsewhere by the same notifier?

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
N/ADependoparvovirusAdeno-associated VirusN/Aserotype hu37N/A

European Commission administrative information

Consent given by the Member State Competent Authority:
Not known