antithrombin alfa

This medicine is now withdrawn from use in the European Union.


The marketing authorisation for Atryn has been withdrawn at the request of the marketing-authorisation holder.

This EPAR was last updated on 02/07/2019

Authorisation details

Product details
Agency product number
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
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.

Exceptional circumstancesExceptional 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
Date of issue of marketing authorisation valid throughout the European Union
Contact address

3 Avenue des Tropiques
ZA deCourtaboeuf
91940 Les Ulis

Product information

22/12/2018 ATryn - EMEA/H/C/000587 - IB/0038

Other EU languages available icon This medicine’s product information is available in all official EU languages.
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Product information documents contain:

You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.

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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