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Notification report


Full notification file


General information

Notification Number
B/ES/16/08

Member State to which the notification was sent
Spain

Date of acknowledgement from the Member State Competent Authority
25/08/2016

Title of the Project
Clinical Study 301OTC01, “A Phase 1/2, Open-Label Safety and Dose-Finding Study of Adeno-Associated Virus (AAV) Serotype 8 (AAV8)- Mediated Gene Transfer of Human Ornithine Transcarbamylase (OTC) in Adults with Late-Onset OTC Deficiency”

Proposed period of release:
01/02/2017 to 31/08/2018

Name of the Institute(s) or Company(ies)
Dimension Therapeutics, Inc., 840 Memorial Drive
Cambridge, MA 02139
USA;


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?
Yes

If yes, notification number(s):


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 wich the GMO is derived
Common NameGenusSpeciesSubspeciesStrainPathovar
N/ADependoparvovirusAdeno-associated VirusN/Aserotype 8N/A

European Commission administrative information

Consent given by the Member State Competent Authority:
Yes
18/10/2016 00:00:00
Remarks: