ATryn

RSS

antithrombin alfa

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

Overview

This is a summary of the European Public Assessment Report (EPAR) for ATryn. It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for ATryn.

This EPAR was last updated on 09/08/2018

Authorisation details

Product details
Name
ATryn
Agency product number
EMEA/H/C/000587
Active substance
Antithrombin alfa
International non-proprietary name (INN) or common name
antithrombin alfa
Therapeutic area (MeSH)
Antithrombin III Deficiency
Anatomical therapeutic chemical (ATC) code
B01AB02
Additional 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.

Exceptional circumstances

This medicine was authorised under exceptional circumstances, because the applicant was unable to provide comprehensive data on the efficacy and safety of the medicine under normal conditions of use. This can happen because the condition to be treated is rare or because collection of full information is not possible or is unethical. For more information, see Pre-authorisation guidance.

Publication details
Marketing-authorisation holder
Laboratoire Francais du Fractionnement et des Biotechnologies
Revision
15
Date of issue of marketing authorisation valid throughout the European Union
28/07/2006
Contact address
3 Avenue des Tropiques
ZA deCourtaboeuf
91940 Les Ulis
France

Product information

19/07/2018 ATryn - EMEA/H/C/000587 - II/0033/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

Antithrombotic agents

Therapeutic indication

ATryn is indicated for the prophylaxis of venous thromboembolism in surgery of patients with congenital antithrombin deficiency. ATryn is normally given in association with heparin or low molecular weight heparin.

Assessment history

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