Arixtra

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fondaparinux sodium

Authorised
This medicine is authorised for use in the European Union.

Overview

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 01/10/2018

Authorisation details

Product details
Name
Arixtra
Agency product number
EMEA/H/C/000403
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
B01AX05
Publication details
Marketing-authorisation holder
Aspen Pharma Trading Limited
Revision
28
Date of issue of marketing authorisation valid throughout the European Union
20/03/2002
Contact address
3016 Lake Drive
City West Business Campus
Dublin
Dublin 24
Ireland

Product information

22/08/2018 Arixtra - EMEA/H/C/000403 - PSUSA/00001467/201712

Contents

  • Annex I - Summary of product characteristics
  • Annex IIA - Manufacturing-authorisation holder responsible for batch release
  • Annex IIB - Conditions of the marketing authorisation
  • Annex IIIA - Labelling
  • Annex IIIB - Package leaflet

Please note that the size of the above document can exceed 50 pages.

You are therefore advised to be selective about which sections or pages you wish to print.

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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