ATryn
antithrombin alfa
Table of contents
Overview
The marketing authorisation for Atryn has been withdrawn at the request of the marketing-authorisation holder.
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 |
16
|
| Date of issue of marketing authorisation valid throughout the European Union |
28/07/2006
|
| Contact address |
3 Avenue des Tropiques |
Product information
22/12/2018 ATryn - EMEA/H/C/000587 - IB/0038
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).
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.