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Notification report


Full notification file


General information

Notification Number
B/DE/17/PEI3208

Member State to which the notification was sent
Germany

Date of acknowledgement from the Member State Competent Authority
25/05/2018

Title of the Project
A Global, Open-Label, Multicenter, Phase 1/2 Study of the Safety and Dose Escalation of BAX 888, an Adeno-Associated Virus Serotype 8 (AAV8) Vector Expressing B-Domain Deleted Factor VIII (BDD-FVIII) in Severe Hemophilia A Subjects Administered a Single Intravenous Infusion

Proposed period of release:
15/03/2018 to 15/03/2023

Name of the Institute(s) or Company(ies)
Baxalta Innovations GmbH, ;


3. Is the same GMO release planned elsewhere in the Community?
Yes:
Austria; Germany; Spain; France; Italy; Hungary;

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

If yes, notification number(s):


GMO characterization

GMO is a:
DNA Virus

Identity of the GMO:
Genus: Dependovirus
Species: Adeno-associated virus


Information relating to the recipient or parental organisms from wich the GMO is derived
Common NameGenusSpeciesSubspeciesStrainPathovar
AAV8DependoparvovirusAdeno-associated Virus---

European Commission administrative information

Consent given by the Member State Competent Authority:
Yes
08/05/2018 00:00:00
Remarks: