Xigris

Withdrawn

This medicine's authorisation has been withdrawn

drotrecogin alfa (activated)

Overview

On the 22 August 2002 the European Commission issued a marketing authorisation valid throughout the European Union for the medicinal product Xigris, drotrecogin alfa (activated), which had been approved 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. The marketing authorisation holder (MAH) responsible for Xigris was Eli Lilly Nederland B.V. 

The European Commission was notified by a letter dated 24 October 2011 of the MAH’s decision to voluntarily withdraw the marketing authorisation as of the Commission Decision date for Xigris. On 28 November 2011 the European Commission issued a decision withdrawing the marketing authorisation for Xigris. 

Pursuant to this decision the European Public Assessment Report for Xigris is updated to reflect that the marketing authorisation is no longer valid.

Xigris : EPAR - Summary for the public

Product information

Xigris : EPAR - Product Information

Xigris : EPAR - All Authorised presentations

Product details

• Name of medicine:
  Xigris
• 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:
  B01AD10

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).

Authorisation details

• EMA product number:
  EMEA/H/C/000396
• Exceptional 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.

• Marketing authorisation holder:
  Eli Lilly Nederland B.V.

  Eli Lilly Nederland BV; Grootslag 1-5,; NL-3991 RA Houten; The Netherlands

• Marketing authorisation issued:
  22/08/2002
• Withdrawal of marketing authorisation:
  28/11/2011
• Revision:
  13

Assessment history

Changes since initial authorisation of medicine

Xigris : EPAR - Procedural steps taken and scientific information after authorisation

Xigris-H-C-396-S-29 : EPAR - Assessment Report - Variation

Adopted

Xigris-H-C-396-S-28 : EPAR - Assessment Report - Variation

Adopted Reference Number: EMA/CHMP/729233/2009

Xigris-H-C-396-II-20 : EPAR - Scientific Discussion - Variation

Adopted

Xigris-H-C-396-S-21 : EPAR - Scientific Discussion - Variation

Adopted

Xigris-H-C-396-S-13 : EPAR - Scientific Discussion - Variation

Adopted

Xigris : EPAR - Steps taken after authorisation when a cutoff date has been used

Initial marketing authorisation documents

Xigris : EPAR - Procedural steps taken before authorisation

Xigris : EPAR - Scientific Discussion