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Notification report

Full notification file


General information

Notification Number
B/ES/08/47

Member State to which the notification was sent
Spain

Date of acknowledgement from the Member State Competent Authority
29/07/2008

Title of the Project
A Phase II, Multicenter, Randomized, Controlled, Open-Label Trial to Compare 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 BMTalone in Subjects With Idiopathic Parkinson’s Disease.

Proposed period of release:
01/11/2008 to 31/12/2010

Name of the Institute(s) or Company(ies)
Universidad de Navarra, Neurología-Neurociencias Clínica
Universitaria, Avenida de Pío XII, 36, Facultad de Medicina (Pamplona, España);


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


Has the same GMPt 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 Name	Genus	Species	Subspecies	Strain	Pathovar
AAV2	Dependovirus	Adeno-associated Virus		serotype 2

European Commission administrative information

Consent given by the Member State Competent Authority:
Not known