Xigris

Withdrawn

This medicine's authorisation has been withdrawn

drotrecogin alfa (activated)

Overview

The marketing authorisation for Xigris has been withdrawn at the request of the marketing authorisation holder.

Xigris : EPAR - Summary for the public

Product information

Xigris : EPAR - Product Information

Latest procedure affecting product information: S/0029

28/11/2011

This medicine’s product information is available in all official EU languages.
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Product information documents contain:

• summary of product characteristics (annex I);
• manufacturing authorisation holder responsible for batch release (annex IIA);
• conditions of the marketing authorisation (annex IIB);
• labelling (annex IIIA);
• package leaflet (annex IIIB).

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
• 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

AdoptedReference 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