Dossier withdrawn by the notifier

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Study title: 
Dossier withdrawn by the notifier
Long title: 
Phase 3, Open-Label, Single-Arm Study to Evaluate the Efficacy and Safety of PF-07055480 (Recombinant AAV2/6 Human Factor VIII Gene Therapy) in Adult Male Participants with Moderately Severe to Severe Hemophilia A (FVIII:C≤1%)
Date receipt dossier: 
12 Nov 2020
EU record number: 
B/BE/20/BVW6
EudraCT number: 
2019-004451-37
Company / Sponsor: 
Pfizer
Phase: 
III
Treated organism: 
Humans
Indication category: 
Genetic disorders
Disease: 
Adult males with moderately severe to severe Hemophilia A
Therapeutic approach: 
Gene therapy
Genetic modification: 
Non-replicating recombinant vector derived from adeno-associated virus AAV6 serotype, containing a codon-optimised version of the human Factor VIII gene
Method of transfer of nucleic acid of interest: 
Non-replicating, non-integrating recombinant adeno-associated virus serotype 6 (AAV6)
Administered biological material: 
Recombinant virus
Type of procedure: 
Contained use and Deliberate release
Notes: 
Dossier withdrawn by the notifier on 7 December 2020 (before the advice of the Biosafety Council is finalised)