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Notification report


Full notification file


General information

Notification Number
B/DE/19/PEI3565

Member State to which the notification was sent
Germany

Date of acknowledgement from the Member State Competent Authority
28/09/2018

Title of the Project
A phase 1/2A clinical study to evaluate the safety, tolerability and efficacy of single and repeated doses of AUP1602-C as topical treatment of diabetic foot ulcers

Proposed period of release:
01/01/2019 to 01/01/2021

Name of the Institute(s) or Company(ies)
Aurealis Oy, Microkatu 1,
70211 Kuopio, Finland;


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:
Bacterium

Identity of the GMO:
Lactococcus lactis subsp. Cremoris

Information relating to the recipient or parental organisms from wich the GMO is derived
Common NameGenusSpeciesSubspeciesStrainPathovar
-Lactococcusl. LactiscremorisAUC1000-

European Commission administrative information

Consent given by the Member State Competent Authority:
Yes
23/09/2019 00:00:00
Remarks: