🇪🇺 FONDAPARINUX SODIUM in European Union

EMA authorised FONDAPARINUX SODIUM on 21 March 2002

Marketing authorisations

EMA — authorised 21 March 2002

  • Application: EMEA/H/C/000404
  • Marketing authorisation holder: Glaxo Group Ltd.
  • Local brand name: Quixidar
  • 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 immo
  • Status: withdrawn

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EMA

  • Application: EMEA/H/C/000403
  • Local brand name: Arixtra
  • Status: approved

FONDAPARINUX SODIUM in other countries

Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.

Frequently asked questions

Is FONDAPARINUX SODIUM approved in European Union?

Yes. EMA authorised it on 21 March 2002; EMA has authorised it.

Who is the marketing authorisation holder for FONDAPARINUX SODIUM in European Union?

Glaxo Group Ltd. holds the EU marketing authorisation.