EU/3/19/2176

Table of contents

About

On 28 June 2019, orphan designation EU/3/19/2176 was granted by the European Commission to Swedish Orphan Biovitrum AB (publ), Sweden, for recombinant human coagulation factor VIII Fc - von Willebrand factor - XTEN fusion protein (also known as BIVV001) for the treatment of haemophilia A.

Key facts

Active substance
Recombinant human coagulation factor VIII Fc - von Willebrand factor - XTEN fusion protein
Disease / condition
Treatment of haemophilia A
Date of first decision
28/06/2019
Outcome
Positive
EU designation number
EU/3/19/2176

Sponsor's contact details

Swedish Orphan Biovitrum AB (publ)
Stockholm
112 76 Stockholm
Sweden
Tel. +46 8697 2000
E-mail: medinfo@genzyme.com

Patients' organisations

For contact details of patients’ organisations whose activities are targeted at rare diseases, see:

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