EMEA-002501-PIP01-18

Table of contents

Key facts

Active substance
Factor VIII Fc - von Willebrand factor - XTEN fusion protein (rFVIIIFc-VWF-XTEN)
Therapeutic area
Haematology-Hemostaseology
Decision number
P/0048/2020
PIP number
EMEA-002501-PIP01-18
Pharmaceutical form(s)
Powder and solvent for solution for injection
Condition(s) / indication(s)
Treatment of congenital haemophilia A
Route(s) of administration
Intravenous use
Contact for public enquiries
Bioverativ USA, Inc., a Sanofi Company

Tel.: +31 202453917
E-mail: eumedinfo.gz@sanofi.com

Decision type
P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)

Decision

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