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Notification report


Full notification file


General information

Notification Number
B/ES/21/12

Member State to which the notification was sent
Spain

Date of acknowledgement from the Member State Competent Authority
04/03/2021

Title of the Project
Phase 3, open label, single arm study to evaluate efficacy and safety of FIX gene transfer with PF-06838435 (rAAV-Spark100-hFIX-Padua) in adult male participants with moderately severe to severe hemophilia B (FIX:C≤2%) (BeneGene-2)

Proposed period of release:
30/11/2021 to 31/03/2023

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:
Belgium; Italy;

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

If yes, notification number(s):
B/ES/20/24;

GMO characterization

GMO is a:
DNA Virus

Identity of the GMO:
Genus: Dependoparvovirus
Species: AAVSpark100 - bioengineered adeno-associated viral vector derived from a naturally occurring AAV serotype (Rh74)


Information relating to the recipient or parental organisms from wich the GMO is derived
Common NameGenusSpeciesSubspeciesStrainPathovar
-DependoparvovirusAdeno-associated Virus-serotype AAV-Spark100-

European Commission administrative information

Consent given by the Member State Competent Authority:
Not known