Praxbind

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idarucizumab

Authorised
This medicine is authorised for use in the European Union.

Overview

This is a summary of the European public assessment report (EPAR) for Praxbind. It explains how the Agency assessed the medicine to recommend its authorisation in the EU and its conditions of use. It is not intended to provide practical advice on how to use Praxbind.

For practical information about using Praxbind, patients should read the package leaflet or contact their doctor or pharmacist.

This EPAR was last updated on 16/10/2018

Authorisation details

Product details
Name
Praxbind
Agency product number
EMEA/H/C/003986
Active substance
idarucizumab
International non-proprietary name (INN) or common name
idarucizumab
Therapeutic area (MeSH)
Hemorrhage
Anatomical therapeutic chemical (ATC) code
V03AB
Accelerated assessmentAccelerated assessment

This medicine had an accelerated assessment. This means that it is a medicine of major interest for public health, so its timeframe for review was 150 evaluation days rather than 210. For more information, see Accelerated assessment.

Additional monitoringAdditional monitoring

This medicine is under additional monitoring, meaning that it is monitored even more intensively than other medicines. For more information, see Medicines under additional monitoring.

Publication details
Marketing-authorisation holder
Boehringer Ingelheim International GmbH
Revision
5
Date of issue of marketing authorisation valid throughout the European Union
20/11/2015
Contact address
Binger Strasse 173
D-55216 Ingelheim am Rhein
Germany

Product information

24/08/2018 Praxbind - EMEA/H/C/003986 - IB/0012

Contents

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You are therefore advised to be selective about which sections or pages you wish to print.

Pharmacotherapeutic group

ALL OTHER THERAPEUTIC PRODUCTS

Therapeutic indication

Praxbind is a specific reversal agent for dabigatran and is indicated in adult patients treated with Pradaxa (dabigatran etexilate) when rapid reversal of its anticoagulant effects is required:

  • for emergency surgery/urgent procedures;
  • in life-threatening or uncontrolled bleeding.

Assessment history

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