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Notification report


Full notification file


General information

Notification Number
B/IT/16/01

Member State to which the notification was sent
Italy

Date of acknowledgement from the Member State Competent Authority
14/07/2016

Title of the Project
AAV8-mediated Low Density Lipoprotein Receptor (LDLR) Gene Replacement in Subjects with Homozygous Familial Hypercholesterolemia (HoFH).

Proposed period of release:
01/01/2017 to 12/12/2018

Name of the Institute(s) or Company(ies)
University of Pennsylvania (UPenn), 3400 Spruce St.
8046 Maloney Building
Philadelphia, PA 19104-4283
United States of America;


3. Is the same GMO release planned elsewhere in the Community?
Yes:
Netherlands;

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

GMO characterization

GMO is a:
DNA Virus

Identity of the GMO:
Family: Parvoviridae
Genus: Dependoparvovirus
Species: Adeno-associated virus (AAV-derived-replication-deficient viral vector)


Information relating to the recipient or parental organisms from wich the GMO is derived
Common NameGenusSpeciesSubspeciesStrainPathovar
Adeno-associated virusDependoparvovirusAdeno-associated Virus-AAV2 (ITRs) /AAV8 (capsid)

European Commission administrative information

Consent given by the Member State Competent Authority:
Yes
11/04/2016 00:00:00
Remarks: