Quixidar

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fondaparinux sodium

Withdrawn
This medicine is now withdrawn from use in the European Union.

Overview

The marketing authorisation for Quixidar has been withdrawn at the request of the marketing authorisation holder.

This EPAR was last updated on 16/05/2008

Authorisation details

Product details
Name
Quixidar
Agency product number
EMEA/H/C/000404
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
Glaxo Group Ltd.
Revision
10
Date of issue of marketing authorisation valid throughout the European Union
21/03/2002
Contact address
Glaxo Group Limited
Greenford Road
Greenford, Middx UB6 0NN
United Kingdom

Product information

24/10/2007 Quixidar - EMEA/H/C/000404 - N/0034

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 patients undergoing major orthopaedic surgery of the lower limbs such as hip fracture, major knee surgery or hip replacement surgery.
Prevention of Venous Thromboembolic Events (VTE) in patients undergoing abdominal surgery who are judged to be at high risk of thromboembolic complications, such as patients undergoing abdominal cancer surgery (see section 5.1).
Prevention of Venous Thromboembolic Events (VTE) in 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.

2.5 mg/0.5 ml, solution for injection:
Treatment of unstable angina or non-ST segment elevation myocardial infarction (UA/NSTEMI) in patients for whom urgent (< 120 mins) invasive management (PCI) is not indicated (see sections 4.4 and 5.1).
Treatment of ST segment elevation myocardial infarction (STEMI) in 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 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

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