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Notification report

Full notification file


General information

Notification Number
B/FR/13/GT04

Member State to which the notification was sent
France

Date of acknowledgement from the Member State Competent Authority
17/06/2013

Title of the Project
A Phase I/IIa Dose Escalation Safety Study of Subretinally Injected UshStat® Administered to Patients with Retinitis Pigmentosa Associated with Usher Syndrome Type 1B (US1/001/10)

Proposed period of release:
01/09/2013 to 31/08/2015

Name of the Institute(s) or Company(ies)
Oxford BioMedica UK Ltd., Medawar Centre,
Robert Robinson Avenue,
The Oxford Science Park,
Oxford
OX4 4GA, United Kingdom;


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:
RNA Virus

Identity of the GMO:
Replication-defective vector based on a lentivirus, Equine Infectious Anaemia Virus (EIAV), pseudotyped with the vesicular stomatitis virus glycoprotein (VSV-G: rhabdovirus) envelope.

Information relating to the recipient or parental organisms from wich the GMO is derived

Common Name	Genus	Species	Subspecies	Strain	Pathovar
N/A	Lentivirus	Equine Infectious Anaemia Virus	N/A	N/A	N/A

European Commission administrative information

Consent given by the Member State Competent Authority:
Not known