Page contents Back to list Full notification Final report General information GMO characterization European Commission administrative Information Return to search
Full notification Final report - General information Notification Number B/DE/22/PEI4674 Member State to which the notification was sent Germany Date of acknowledgement from the Member State Competent Authority 04/10/2021 Title of the Project A Phase 3, Randomized, Double-blind, Placebo-controlled Study of Adeno-associated Virus Serotype 8-mediated Gene Transfer of Glucose-6-phosphatase in Patients With Glycogen Storage Disease Type Ia Proposed period of release: 01/06/2021 to 31/07/2022 Name of the Institute(s) or Company(ies) Ultragenyx Pharmaceutical, Inc., 60 Leveroni Ct Novato, CA 94949 USA
Is the same GMO been notified elsewhere by the same notifier? Yes:
Germany; Denmark; Spain; France; Italy; Netherlands; Portugal;
Has the same GMO been notified elsewhere by the same notifier? Yes If yes, notification number(s): : B/ES/18/02 (ES), B/NL/18/003 (NL); GMO characterization GMO is a: DNA Virus Identity of the GMO: Genus: Dependoparvovirus Species: Adeno-associated virus serotype 8 (AAV8)  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: serotype 8 Pathovar: European Commission administrative Information Consent given by the Member State Competent Authority: Not known
Close
Select your language
English