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Notification report


Full notification file


General information

Notification Number
B/BE/20/BVW6

Member State to which the notification was sent
Belgium

Date of acknowledgement from the Member State Competent Authority
12/11/2020

Title of the Project
Phase 3, Open-Label, Single-Arm Study to Evaluate the Efficacy and Safety of PF-07055480 (Recombinant AAV2/6 Human Factor VIII Gene Therapy) in Adult Male Participants with Moderately Severe to Severe Hemophilia A (FVIII:C≤1%)

Proposed period of release:
01/10/2020 to 31/10/2020

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; Greece; Italy; Sweden;

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

If yes, notification number(s):
B/ES/20/22;

GMO characterization

GMO is a:
DNA Virus

Identity of the GMO:
Genus: Dependoparvovirus
Species: Recombinant adeno-associated viral vector derived from naturally occurring AAV6 serotype


Information relating to the recipient or parental organisms from wich the GMO is derived
Common NameGenusSpeciesSubspeciesStrainPathovar
-DependoparvovirusAdeno-associated Virus-AAV6-

European Commission administrative information

Consent given by the Member State Competent Authority:
Not known