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Notification report


Full notification file


General information

Notification Number
B/BE/18/BVW3

Member State to which the notification was sent
Belgium

Date of acknowledgement from the Member State Competent Authority
13/06/2018

Title of the Project
A phase 2, Multi-center, Randomized, Double-blind, Placebo-controlled Study to Assess the Safety and Efficacy of Topically-applied AG013 for the Attenuation of Oral Mucositis in Subjects With Cancers of the Head and Neck Receiving Concomitant Chemoradiation Therapy

Proposed period of release:
01/07/2018 to 30/06/2019

Name of the Institute(s) or Company(ies)
Oragenics, Inc., 4902 Eisenhower Blvd., suite 125 Tampa, FL 33634 United States;


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

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

GMO characterization

GMO is a:
Bacterium

Identity of the GMO:
Lactococcus lactis

Information relating to the recipient or parental organisms from wich the GMO is derived
Common NameGenusSpeciesSubspeciesStrainPathovar
-LactococcusL. LactiscremorisMG1363-

European Commission administrative information

Consent given by the Member State Competent Authority:
Not known