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Notification report


Full notification file


General information

Notification Number
B/ES/20/24

Member State to which the notification was sent
Spain

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

Title of the Project
Phase 3 open-label study to evaluate efficacy, safety, and tolerability of FIX gene transfer with fidanacogene elaparvovec (PF-06838435) in pediatric male participants <18 years of age with moderately severe to severe hemophilia B (FIX:C≤2%) (BeneGene-3)

Proposed period of release:
01/03/2021 to 31/03/2027

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; France; Italy;

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: 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-AAV-Spark100-

European Commission administrative information

Consent given by the Member State Competent Authority:
Not known