🇪🇺 Recombinant Activated Protein C in European Union

EMA authorised Recombinant Activated Protein C on 22 August 2002

Marketing authorisation

EMA — authorised 22 August 2002

  • Application: EMEA/H/C/000396
  • Marketing authorisation holder: Eli Lilly Nederland B.V.
  • Local brand name: Xigris
  • Indication: Xigris is indicated for the treatment of adult patients with severe sepsis with multiple organ failure when added to best standard care. The use of Xigris should be considered mainly in situations when therapy can be started within 24 hours after the onset of organ failure (for further information see section 5.1).
  • Pathway: exceptional circumstances
  • Status: withdrawn

Read official source →

Recombinant Activated Protein C 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 Recombinant Activated Protein C approved in European Union?

Yes. EMA authorised it on 22 August 2002.

Who is the marketing authorisation holder for Recombinant Activated Protein C in European Union?

Eli Lilly Nederland B.V. holds the EU marketing authorisation.