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Notification report


Full notification file


General information

Notification Number
B/DE/17/PEI3203

Member State to which the notification was sent
Germany

Date of acknowledgement from the Member State Competent Authority
22/09/2017

Title of the Project
ASPIRO: A Phase 1/2, Randomized, Open-Label, Ascending-Dose, Delayed-Treatment Concurrent Control Clinical Study to Evaluate the Safety and Preliminary Efficacy of AT132, an AAV8-Delivered Gene Therapy in X-Linked Myotubular Myopathy (XLMTM) Patients

Proposed period of release:
11/12/2017 to 10/12/2023

Name of the Institute(s) or Company(ies)
Audentes Therapeutics Inc, ;


3. Is the same GMO release planned elsewhere in the Community?
Yes:
France; United Kingdom;

Has the same GMO been notified elsewhere by the same notifier?
No

GMO characterization

GMO is a:
DNA Virus

Identity of the GMO:
Dependoparvovirus; Species Adeno-associated depenoparvovirus A

Information relating to the recipient or parental organisms from wich the GMO is derived
Common NameGenusSpeciesSubspeciesStrainPathovar
AAVDependoparvovirusAdeno-associated dependoparvovirus-serotype 8

European Commission administrative information

Consent given by the Member State Competent Authority:
Yes
22/05/2018 00:00:00
Remarks: