EMEA-002427-PIP01-18

Key facts

Active substance
Adeno-associated viral vector serotype 5 containing a B-domain deleted variant of human coagulation factor VIII gene
Therapeutic area
Haematology-Hemostaseology
Decision number
P/0218/2019
PIP number
EMEA-002427-PIP01-18
Pharmaceutical form(s)
Solution for infusion
Condition(s) / indication(s)
Treatment of Haemophilia A
Route(s) of administration
Intravenous use
Contact for public enquiries
BioMarin International Limited

Tel. +44 2074200800
E-mail: biomarin-europe@bmrn.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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