Overview

The marketing authorisation for Atryn has been withdrawn at the request of the marketing-authorisation holder.

ATryn : EPAR - Summary for the public

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Product information

ATryn : EPAR - Product Information

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Latest procedure affecting product information: IB/0038

22/12/2018

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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

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português (PT) (464.05 KB - PDF)
română (RO) (536.52 KB - PDF)
slovenčina (SK) (540.26 KB - PDF)
slovenščina (SL) (475.65 KB - PDF)
Suomi (FI) (463.69 KB - PDF)
svenska (SV) (464.01 KB - PDF)

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

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

ATryn : EPAR - Scientific Discussion

ATryn : EPAR - Procedural steps taken before authorisation

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