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Notification report


Full notification file


General information

Notification Number
B/NL/12/004

Member State to which the notification was sent
Netherlands

Date of acknowledgement from the Member State Competent Authority
26/04/2013

Title of the Project
A Phase 2b, Double-Blind, Placebo-Controlled, Multinational, Multicenter, Randomized Study Evaluating the Safety and Efficacy of Intracoronary Administration of MYDICAR® (AAV1/SERCA2a) in Subjects with Heart Failure (CUPID Phase 2b Trial)

Proposed period of release:
01/01/2013 to 31/12/2015

Name of the Institute(s) or Company(ies)
University Medical Center Groningen, Hanzeplein 1
9713 GZ Groningen
PO Box 30.001
9700 RB Groningen
The Netherlands;


3. Is the same GMO release planned elsewhere in the Community?
Yes:
Belgium; Germany; Denmark; United Kingdom; Netherlands; Sweden; Czech Republic; Hungary; Poland;

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

If yes, notification number(s):
B/BE/12/BVW2; B/DE/12/PEI1667; B/SE/12/EU-2012-001700-37;

GMO characterization

GMO is a:
DNA Virus

Identity of the GMO:
Genus: Dependovirus
Species: Adeno-associated virus (vector). The AAV1/SERCA2a vector is a recombinant adeno-associated virus (rAAV) vector. It is a pseudotype of AAV serotype 1(AAV1) and is denoted as rAAV1/2. As such, the capsid proteins are from wt AAV1 and the AAV DNA (two 148 base inverted terminal repeats) is from wtAAV2.


Information relating to the recipient or parental organisms from wich the GMO is derived
Common NameGenusSpeciesSubspeciesStrainPathovar
AAV1DependovirusAdeno-associated Virus-Serotype 1-

European Commission administrative information

Consent given by the Member State Competent Authority:
Not known