EMEA-001438-PIP01-13-M01

Table of contents

Key facts

Invented name
Praxbind
Active substance
idarucizumab
Therapeutic area
Other
Decision number
P/0151/2019
PIP number
EMEA-001438-PIP01-13-M01
Pharmaceutical form(s)
Solution for injection/infusion
Condition(s) / indication(s)
  • Prevention of dabigatran associated haemorrhage
  • Treatment of dabigatran associated haemorrhage
Route(s) of administration
Intravenous use
Contact for public enquiries
Boehringer Ingelheim International GmbH

Tel. +49 6132 778271
Email: Paediatrics@boehringer-ingelheim.com

Decision type
PM: decision on the application for modification of an agreed PIP
Compliance procedure number
EMEA-C-001438-PIP01-13-M01
Compliance opinion date
24/07/2020
Compliance outcome
positive

Decision

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