🇪🇺 argatroban or lepirudin in European Union

EMA authorised argatroban or lepirudin on 13 March 1997

Marketing authorisation

EMA — authorised 13 March 1997

  • Application: EMEA/H/C/000122
  • Marketing authorisation holder: Celgene Europe Ltd.
  • Local brand name: Refludan
  • Indication: Anticoagulation in adult patients with heparin-induced thrombocytopenia type II and thromboembolic disease mandating parenteral antithrombotic therapy. The diagnosis should be confirmed by the heparin-induced platelet activation assay or an equivalent test.
  • Status: withdrawn

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argatroban or lepirudin 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 argatroban or lepirudin approved in European Union?

Yes. EMA authorised it on 13 March 1997.

Who is the marketing authorisation holder for argatroban or lepirudin in European Union?

Celgene Europe Ltd. holds the EU marketing authorisation.