ATryn

Withdrawn

This medicine's authorisation has been withdrawn

antithrombin alfa

Overview

The marketing authorisation for Atryn has been withdrawn at the request of the marketing-authorisation holder.

ATryn : EPAR - Summary for the public

Reference Number: EMA/170731/2010

Product information

ATryn : EPAR - Product Information

Latest procedure affecting product information: IB/0038

22/12/2018

This medicine’s product information is available in all official EU languages.
Select 'available languages' to access the language you need.

 

Product information documents contain:

• summary of product characteristics (annex I);
• manufacturing authorisation holder responsible for batch release (annex IIA);
• conditions of the marketing authorisation (annex IIB);
• labelling (annex IIIA);
• package leaflet (annex IIIB).

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
• 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