drotrecogin alfa (activated)

This medicine is now withdrawn from use in the European Union.


The marketing authorisation for Xigris has been withdrawn at the request of the marketing authorisation holder.

This EPAR was last updated on 21/02/2012

Authorisation details

Product details
Agency product number
Active substance
drotrecogin alfa (activated)
International non-proprietary name (INN) or common name
drotrecogin alfa (activated)
Therapeutic area (MeSH)
  • Sepsis
  • Multiple Organ Failure
Anatomical therapeutic chemical (ATC) code
Exceptional circumstancesExceptional circumstances

This medicine was authorised under exceptional circumstances, because the applicant was unable to provide comprehensive data on the efficacy and safety of the medicine under normal conditions of use. This can happen because the condition to be treated is rare or because collection of full information is not possible or is unethical. For more information, see Pre-authorisation guidance.

Publication details
Marketing-authorisation holder
Eli Lilly Nederland B.V.
Date of issue of marketing authorisation valid throughout the European Union
Contact address
Eli Lilly Nederland BV
Grootslag 1-5,
NL-3991 RA Houten
The Netherlands

Product information

28/11/2011 Xigris - EMEA/H/C/000396 - S/0029


  • Annex I - Summary of product characteristics
  • Annex IIA - Manufacturing-authorisation holder responsible for batch release
  • Annex IIB - Conditions of the marketing authorisation
  • Annex IIIA - Labelling
  • Annex IIIB - Package leaflet

Please note that the size of the above document can exceed 50 pages.

You are therefore advised to be selective about which sections or pages you wish to print.

Pharmacotherapeutic group

Antithrombotic agents

Therapeutic 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).

Assessment history

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