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Notification report


Full notification file


General information

Notification Number
B/DE/19/PEI3619

Member State to which the notification was sent
Germany

Date of acknowledgement from the Member State Competent Authority
23/11/2018

Title of the Project
PIGMENT – Subretinal PDE6A gene therapy for retinitis pigmentosa

Proposed period of release:
01/01/2019 to 31/01/2019

Name of the Institute(s) or Company(ies)
University Hospital Tübingen, Geissweg 3
72076 Tübingen
Germany;


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:
rAAV.hPDE6A is a recombinant Adeno-associated Virus (AAV) pseudotyped with AAV8 capsid proteins. It contains the sequence of the hPDE6A expression cassette flanked by the nucleotides of inverted repeat sequences derived from AAV serotype 2. All native cap and rep sequence of the viral genome have been removed and replaced by the hPDE6A expression cassette.

Information relating to the recipient or parental organisms from wich the GMO is derived
Common NameGenusSpeciesSubspeciesStrainPathovar
AAVDependovirusAdeno-associated Virus--AAV2/AAV8

European Commission administrative information

Consent given by the Member State Competent Authority:
Yes
02/07/2019 00:00:00
Remarks: