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Quixidar (fondaparinux sodium)

Region
🇪🇺 EU
Active substance
fondaparinux sodium
Company
Glaxo Group Ltd.
Status
Withdrawn
Therapeutic area
Venous Thrombosis; Pulmonary Embolism; Myocardial Infarction; Angina, Unstable
EU approval
Thu 21 Mar 2002
Application
EMEA/H/C/000404
ATC
B01AX05
Official record
www.ema.europa.eu

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.

Regulatory milestones

No milestones recorded in the last year.

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Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.