ATryn

Withdrawn

This medicine's authorisation has been withdrawn

antithrombin alfa

Overview

On 22 December 2018, the European Commission withdrew the marketing authorisation for ATryn (antithrombin alfa) in the European Union (EU). The withdrawal was at the request of the marketing authorisation holder, Laboratoire Francais du Fractionnement et des Biotechnologies, which notified the European Commission of its decision to permanently discontinue the marketing of the product for commercial reasons. 

ATryn was granted marketing authorisation in the EU on 28 July 2006 for prophylaxis of venous thromboembolism in surgery of patients with congenital antithrombin deficiency. The marketing authorisation was initially valid for a 5-year period. It was subsequently renewed for an additional 5-year period in 2011. It was then granted unlimited validity in 2016. The product had not been marketed in the EU since 2015. 

The European Public Assessment Report (EPAR) for ATryn is updated to indicate that the marketing authorisation is no longer valid.

ATryn : EPAR - Summary for the public

Reference Number: EMA/170731/2010

Product information

ATryn : EPAR - Product Information

ATryn : EPAR - All Authorised presentations

Product details

• Name of medicine:
  ATryn
• 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

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.

Authorisation details

• EMA product number:
  EMEA/H/C/000587
• 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.

• Marketing authorisation holder:
  Laboratoire Francais du Fractionnement et des Biotechnologies

  3 Avenue des Tropiques; ZA deCourtaboeuf; 91940 Les Ulis; France

• Marketing authorisation issued:
  28/07/2006
• Withdrawal of marketing authorisation:
  22/12/2018
• Revision:
  16

Assessment history

Changes since initial authorisation of medicine

ATryn : EPAR - Procedural steps taken and scientific information after authorisation

Initial marketing authorisation documents

ATryn : EPAR - Scientific Discussion

ATryn : EPAR - Procedural steps taken before authorisation