Quixidar

Withdrawn

This medicine's authorisation has been withdrawn

fondaparinux sodium

Overview

The Marketing Authorisation Holder (MAH) responsible for Quixidar, Glaxo Group Ltd notified the European Commission on 11 February 2008 of its decision to voluntarily withdraw the marketing authorisation for Quixidar for commercial reasons.

Quixidar was never marketed in the European Union. Arixtra is an identical product available in the European Union. 

On 11 March 2008, the European Union issued a decision to withdraw the marketing authorisation for Quixidar. Pursuant to this decision, the European Public Assessment Report (EPAR) for Quixidar is updated to reflect that the marketing authorisation is no longer valid.

Quixidar : EPAR - Summary for the public

Product information

Quixidar : EPAR - Product Information

Quixidar : EPAR - All Authorised presentations

Product details

• Name of medicine:
  Quixidar
• 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

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.

Authorisation details

• EMA product number:
  EMEA/H/C/000404
• Marketing authorisation holder:
  Glaxo Group Ltd.

  Greenford Road; Greenford, Middx UB6 0NN; United Kingdom

• Marketing authorisation issued:
  21/03/2002
• Withdrawal of marketing authorisation:
  11/03/2008
• Revision:
  10

Assessment history

Changes since initial authorisation of medicine

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

Quixidar-H-C-404-II-24 : EPAR - Scientific Discussion - Variation

Adopted

Quixidar-H-C-404-II-10 : EPAR - Scientific Discussion - Variation

Adopted

Quixidar-H-C-404-II-12 : EPAR - Scientific Discussion - Variation

Adopted

Quixidar-H-C-404-X-25 : EPAR - Scientific Discussion - Variation

Adopted

Initial marketing authorisation documents

Quixidar : EPAR - Scientific Discussion

Quixidar : EPAR - Procedural steps taken before authorisation