Xigris
drotrecogin alfa (activated)
Table of contents
Overview
The marketing authorisation for Xigris has been withdrawn at the request of the marketing authorisation holder.
Authorisation details
| Product details | |
|---|---|
| Name |
Xigris
|
| Agency product number |
EMEA/H/C/000396
|
| Active substance |
drotrecogin alfa (activated)
|
| International non-proprietary name (INN) or common name |
drotrecogin alfa (activated)
|
| Therapeutic area (MeSH) |
|
| Anatomical therapeutic chemical (ATC) code |
B01AD10
|
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. |
| Publication details | |
|---|---|
| Marketing-authorisation holder |
Eli Lilly Nederland B.V.
|
| Revision |
13
|
| Date of issue of marketing authorisation valid throughout the European Union |
22/08/2002
|
| 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
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).
You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.
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).