Praxbind
idarucizumab
Table of contents
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.
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Praxbind : EPAR - Summary for the public (PDF/72.87 KB)
First published: 01/12/2015
Last updated: 01/12/2015 -
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Praxbind : EPAR - Risk-management-plan summary (PDF/39.36 KB)
First published: 01/12/2015
Last updated: 01/12/2015
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 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. |
Publication details | |
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Marketing-authorisation holder |
Boehringer Ingelheim International GmbH
|
Revision |
9
|
Date of issue of marketing authorisation valid throughout the European Union |
20/11/2015
|
Contact address |
Product information
07/01/2021 Praxbind - EMEA/H/C/003986 - IAIN/0021/G
Contents
- Annex I - Summary of product characteristics
- Annex IIA - Manufacturing-authorisation holder responsible for batch release
- Annex IIB - Conditions of the marketing authorisation
- Annex IIIA - Labelling
- Annex IIIB - Package leaflet
Please note that the size of the above document can exceed 50 pages.
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.