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Notification report


Full notification file


General information

Notification Number
B/ES/19/13

Member State to which the notification was sent
Spain

Date of acknowledgement from the Member State Competent Authority
19/06/2019

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:
15/05/2019 to 06/03/2023

Name of the Institute(s) or Company(ies)
Baxalta Innovations GmbH, ;


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

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

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