Notification report

Full notification file

General information

Notification Number

Member State to which the notification was sent

Date of acknowledgement from the Member State Competent Authority

Title of the Project
An Open-Label, Multinational, Phase 1/2 Study of the Safety and Dose Escalation of SHP648, an Adeno-Associated Virus Serotype 8 (AAV8) Vector Expressing FIX Padua in Hemophilia B Subjects

Proposed period of release:
01/01/2020 to 31/05/2023

Name of the Institute(s) or Company(ies)
IQVIA RDS Hungary Ltd., H-1117 Budapest, Budafoki Ășt 91-93.

3. Is the same GMO release planned elsewhere in the Community?
Austria; Germany; Spain; France; Italy; Hungary;

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

If yes, notification number(s):

GMO characterization

GMO is a:
DNA Virus

Identity of the GMO:
Genus: Dependovirus
Species: Adeno-associated virus

Information relating to the recipient or parental organisms from wich the GMO is derived
Common NameGenusSpeciesSubspeciesStrainPathovar
AAV 8DependovirusAdeno-associated Virus---

European Commission administrative information

Consent given by the Member State Competent Authority:
Not known