🇪🇺 Fondaparinux Sodium (Arixtra) in European Union

EMA authorised Fondaparinux Sodium (Arixtra) on 20 March 2002

Marketing authorisation

Application: EMEA/H/C/000403
Marketing authorisation holder: Viatris Healthcare Limited
Local brand name: Arixtra
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 respira
Status: approved

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

Is Fondaparinux Sodium (Arixtra) approved in European Union?

Yes. EMA authorised it on 20 March 2002.

Who is the marketing authorisation holder for Fondaparinux Sodium (Arixtra) in European Union?

Viatris Healthcare Limited holds the EU marketing authorisation.