EMEA-001902-PIP01-15-M04

Table of contents

Key facts

Invented name
Ondexxya
Active substance
andexanet alfa
Therapeutic area
Other
Decision number
P/0349/2020
PIP number
EMEA-001902-PIP01-15-M04
Pharmaceutical form(s)
Powder for solution for infusion
Condition(s) / indication(s)
  • Prevention of factor Xa inhibitor associated haemorrhage
  • Treatment of factor Xa inhibitor associated haemorrhage
Route(s) of administration
Intravenous use
Contact for public enquiries
Alexion Europe SAS

E-mail: regulatory-eu-lcm@alexion.com
Tel: +353 871138827

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

Decision

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