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Notification report


Full notification file


General information

Notification Number
B/NL/15/013

Member State to which the notification was sent
Netherlands

Date of acknowledgement from the Member State Competent Authority
16/12/2015

Title of the Project
Gene therapy Clinical development program comprising of clinical trials using SAR422459, a non-replicating, recombinant lentiviral vector derived from Equine Infectious Anemia Virus (EIAV) to express ATP Binding Cassette A4 (ABCA4) transporter and correct its defective expression or function in photoreceptors of patients with Stargardt macular dystrophy and other ABCA4 retinopathies.

Proposed period of release:
01/01/2015 to 01/11/2050

Name of the Institute(s) or Company(ies)
Aanofi-Aventis Groupe, ;


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

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

GMO characterization

GMO is a:
DNA Virus

Identity of the GMO:
Genus: Lentivirus
Species: Equine Infectious Anemia Virus (EIAV)
SAR422459, replication -defective vector based on a lentivirus, Equine Infectious Anemia Virus (EIAV), pseudotyped with the vesicular stomatitis virus glycoprotein (VSV-G: rhabdovirus) envelop


Information relating to the recipient or parental organisms from wich the GMO is derived
Common NameGenusSpeciesSubspeciesStrainPathovar
EIAVLentiviridaeā€¦Equine Infectious Anemia Virus---

European Commission administrative information

Consent given by the Member State Competent Authority:
Not known