fondaparinux sodium

This medicine is authorised for use in the European Union.


This is a summary of the European public assessment report (EPAR) for Arixtra. It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Arixtra.

This EPAR was last updated on 14/07/2023

Authorisation details

Product details
Agency product number
Active substance
fondaparinux sodium
International non-proprietary name (INN) or common name
fondaparinux sodium
Therapeutic area (MeSH)
  • Venous Thrombosis
  • Pulmonary Embolism
  • Myocardial Infarction
  • Angina, Unstable
Anatomical therapeutic chemical (ATC) code
Publication details
Marketing-authorisation holder
Mylan IRE Healthcare Limited
Date of issue of marketing authorisation valid throughout the European Union
Contact address

Unit 35/36 Grange Parade
Baldoyle Industrial Estate
Dublin 13

Product information

13/07/2023 Arixtra - EMEA/H/C/000403 - IAIN/0088/G

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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).

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

1.5-mg/0.3-ml and 2.5-mg/0.5-ml solution for injection

Prevention of venous thromboembolic events (VTE) in adults undergoing major orthopaedic surgery of the lower limbs such as hip fracture, major knee surgery or hip-replacement surgery.

Prevention of VTE in adults undergoing abdominal surgery who are judged to be at high risk of thromboembolic complications, such as patients undergoing abdominal cancer surgery.

Prevention of VTE in adult medical patients who are judged to be at high risk for VTE and who are immobilised due to acute illness such as cardiac insufficiency and / or acute respiratory disorders, and / or acute infectious or inflammatory disease.

Treatment of adults with acute symptomatic spontaneous superficial-vein thrombosis of the lower limbs without concomitant deep-vein thrombosis.

2.5-mg/0.5-ml solution for injection

Treatment of unstable angina or non-ST-segment-elevation myocardial infarction (UA/NSTEMI) in adult patients for whom urgent (< 120 mins) invasive management (PCI) is not indicated.

infarction (STEMI) in adult patients who are managed with thrombolytics or who initially are to receive no other form of reperfusion therapy.

5-mg/0.4-ml, 7.5-mg/0.6-ml and 10-mg/0.8-ml solution for injection

Treatment of adults with acute deep-vein thrombosis (DVT) and treatment of acute pulmonary embolism (PE), except in haemodynamically unstable patients or patients who require thrombolysis or pulmonary embolectomy.

Assessment history

Changes since initial authorisation of medicine

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