- Application under evaluation
- CHMP opinion
- European Commission decision
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decision the European Public Assessment Report for Xigris is updated to reflect that the marketing authorisation is no longer valid.
Product information
This medicine’s product information is available in all official EU languages.
Select 'available languages' to access the language you need.
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).
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 agentsTherapeutic 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).