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Notification report


Full notification file


General information

Notification Number
B/IE/10/362

Member State to which the notification was sent
Ireland

Date of acknowledgement from the Member State Competent Authority
07/05/2010

Title of the Project
A Multiple-Site, Phase 2, Safety and Efficacy Trial of a Recombinant Adeno-associated Virus Vector Expressing Alpha 1 Antitrypsin (rAAV1-CB-hAAT) in Patients with Alpha 1 Antitrypsin Deficiency

Proposed period of release:
01/07/2010 to 31/03/2011

Name of the Institute(s) or Company(ies)
TMC Pharma Services Ltd, TMC Pharma Services Ltd, representing:
Applied Genetic Technologies Corporation
11801 Research Drive, Suite D
Alachua, FL 32615, USA;


3. Is the same GMO release planned elsewhere in the Community?
No

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

GMO characterization

GMO is a:
DNA Virus

Identity of the GMO:
Genus: Dependovirus
Species: Recombinant hybrid Adeno-associated Virus (AAV)
rAAV1-CB-hAAT is a recombinant hybrid form of AAV serotypes 1 & 2


Information relating to the recipient or parental organisms from wich the GMO is derived
Common NameGenusSpeciesSubspeciesStrainPathovar
AAV1DependovirusParvoviridaeAdeno-associated VirusSerotype 1-

European Commission administrative information

Consent given by the Member State Competent Authority:
Yes
11/08/2010 00:00:00
Remarks:
Consent was granted subject to nine conditions. The period of release extends from 11th August 2010 to 31st July 2011.