EMEA-002362-PIP02-19-M01

Table of contents

Key facts

Active substance
fidanacogene elaparvovec
Therapeutic area
Haematology-Hemostaseology
Decision number
P/0382/2021
PIP number
EMEA-002362-PIP02-19-M01
Pharmaceutical form(s)
Solution for infusion
Condition(s) / indication(s)
Treatment of congenital factor IX deficiency (haemophilia B)
Route(s) of administration
Intravenous use
Contact for public enquiries
Pfizer Europe MA EEIG

 E-mail: pip_enquiries@pfizer.com
Tel. +44 1304646607

Decision type
PM: decision on the application for modification of an agreed PIP

Decision

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