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Full notification Final report - General information Notification Number B/DE22/PEI4673 Member State to which the notification was sent Germany Date of acknowledgement from the Member State Competent Authority 30/09/2021 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: 01/01/2022 to 30/09/2028 Name of the Institute(s) or Company(ies) Pfizer, Inc., 235 East 42nd Street, New York, NY 10017-5755, USA.
Is the same GMO been notified elsewhere by the same notifier? Yes:
Netherlands;
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 Page 2 of 20 Species: Recombinant adeno-associated viral vector derived from naturally occurring AAV9 serotype Information relating to the recipient or parental organisms from which the GMO is derived Common Name: N/A Genus: Dependoparvovirus Species: Adeno-associated virus Subspecies: Strain: AAV9 Pathovar: European Commission administrative Information Consent given by the Member State Competent Authority: Not known
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