🇪🇺 prasugrel/bivalirudin in European Union

EMA authorised prasugrel/bivalirudin on 20 September 2004

Marketing authorisations

EMA — authorised 20 September 2004

  • Application: EMEA/H/C/000562
  • Marketing authorisation holder: The Medicines Company UK Ltd
  • Local brand name: Angiox
  • Indication: Angiox is indicated as an anticoagulant in adult patients undergoing percutaneous coronary intervention (PCI), including patients with ST-segment-elevation myocardial infarction (STEMI) undergoing primary PCI. Angiox is also indicated for the treatment of adult patients with unstable angina / non-ST-segment-elevation myocardial infarction (UA / NSTEMI) planned for urgent or early intervention. Angiox should be administered with aspirin and clopidogrel.
  • Status: withdrawn

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EMA — authorised 24 February 2009

  • Application: EMEA/H/C/000984
  • Marketing authorisation holder: Substipharm
  • Local brand name: Efient
  • Indication: Efient, co-administered with acetylsalicylic acid (ASA), is indicated for the prevention of atherothrombotic events in patients with acute coronary syndrome (i.e. unstable angina, non-ST-segment-elevation myocardial infarction [UA / NSTEMI] or ST-segment-elevation myocardial infarction [STEMI]) undergoing primary or delayed percutaneous coronary intervention (PCI).
  • Status: approved

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prasugrel/bivalirudin in other countries

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

Other Cardiovascular approved in European Union

Frequently asked questions

Is prasugrel/bivalirudin approved in European Union?

Yes. EMA authorised it on 20 September 2004; EMA authorised it on 24 February 2009.

Who is the marketing authorisation holder for prasugrel/bivalirudin in European Union?

The Medicines Company UK Ltd holds the EU marketing authorisation.