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Notification report


Full notification file


General information

Notification Number
B/BE/20/BVW4

Member State to which the notification was sent
Belgium

Date of acknowledgement from the Member State Competent Authority
18/09/2020

Title of the Project
A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of PF-06939926 for the Treatment of Duchenne Muscular Dystrophy

Proposed period of release:
01/08/2020 to 31/12/2021

Name of the Institute(s) or Company(ies)
Pfizer, Inc., 235 East 42nd Street, New York, NY 10017-5755, USA.;


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

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

If yes, notification number(s):
B/ES/20/08;

GMO characterization

GMO is a:
DNA Virus

Identity of the GMO:
Genus: Dependoparvovirus
Species: Recombinantadeno-associated viral vectorderived from naturally occurring AAV9serotype


Information relating to the recipient or parental organisms from wich the GMO is derived
Common NameGenusSpeciesSubspeciesStrainPathovar
-DependoparvovirusAdeno-associated Virus-AAV9-

European Commission administrative information

Consent given by the Member State Competent Authority:
Not known