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Notification report


Full notification file


General information

Notification Number
B/SE/08/EU-2007-006721-27

Member State to which the notification was sent
Sweden

Date of acknowledgement from the Member State Competent Authority
18/09/2008

Title of the Project
A Phase II, Multicenter, Randomized and Controlled Open-Label Trial Comparing the Safety and Efficacy of Bilateral Intraputaminal (IPu) Administration of CERE-120 (Adeno-Associated Virus Serotype 2 [AAV2]-Neurturin [NTN]) Combined with Best Medical Therapy (BMT) versus BMT-alone in Subjects With Idiopathic Parkinson’s Disease.

Proposed period of release:
01/12/2008 to 30/06/2010

Name of the Institute(s) or Company(ies)
Ceregene Inc, ;


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:
GMO: CERE-120
Genus: Dependovirus
Species: Adeno-associated Virus


Information relating to the recipient or parental organisms from wich the GMO is derived
Common NameGenusSpeciesSubspeciesStrainPathovar
AAV2DependovirusAdeno-associated Virusserotype 2

European Commission administrative information

Consent given by the Member State Competent Authority:
Not known