Notification report

Full notification file

General information

Notification Number

Member State to which the notification was sent

Date of acknowledgement from the Member State Competent Authority

Title of the Project
A single dose clinical trial to study the safety of ART-I02 in patients with Rheumatoid Arthritis

Proposed period of release:
01/04/2016 to 31/12/2025

Name of the Institute(s) or Company(ies)
Centre of Human Drug Research, Zernikedreef 8
2333 CL Leiden;

3. Is the same GMO release planned elsewhere in the Community?

Has the same GMO been notified elsewhere by the same notifier?

GMO characterization

GMO is a:
DNA Virus

Identity of the GMO:
Genus: Dependovirus
Species: Adeno-associated virus

Information relating to the recipient or parental organisms from wich the GMO is derived
Common NameGenusSpeciesSubspeciesStrainPathovar
AAV2/5DependovirusAdeno-associated Virus-serotype 2 and 5-

European Commission administrative information

Consent given by the Member State Competent Authority:
Not known