Xigris

drotrecogin alfa (activated)

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The marketing authorisation for Xigris has been withdrawn at the request of the marketing authorisation holder.

Name Language First published Last updated
Xigris : EPAR - Summary for the public BG = bălgarski 2009-12-17 2012-02-21
Xigris : EPAR - Summary for the public ES = español 2009-12-17 2012-02-21
Xigris : EPAR - Summary for the public CS = čeština 2009-12-17 2012-02-21
Xigris : EPAR - Summary for the public DA = dansk 2009-12-17 2012-02-21
Xigris : EPAR - Summary for the public DE = Deutsch 2009-12-17 2012-02-21
Xigris : EPAR - Summary for the public ET = eesti keel 2009-12-17 2012-02-21
Xigris : EPAR - Summary for the public EL = elliniká 2009-12-17 2012-02-21
Xigris : EPAR - Summary for the public EN = English 2009-12-17 2012-02-21
Xigris : EPAR - Summary for the public FR = français 2009-12-17 2012-02-21
Xigris : EPAR - Summary for the public IT = italiano 2009-12-17 2012-02-21
Xigris : EPAR - Summary for the public LV = latviešu valoda 2009-12-17 2012-02-21
Xigris : EPAR - Summary for the public LT = lietuvių kalba 2009-12-17 2012-02-21
Xigris : EPAR - Summary for the public HU = magyar 2009-12-17 2012-02-21
Xigris : EPAR - Summary for the public MT = Malti 2009-12-17 2012-02-21
Xigris : EPAR - Summary for the public NL = Nederlands 2009-12-17 2012-02-21
Xigris : EPAR - Summary for the public PL = polski 2009-12-17 2012-02-21
Xigris : EPAR - Summary for the public PT = português 2009-12-17 2012-02-21
Xigris : EPAR - Summary for the public RO = română 2009-12-17 2012-02-21
Xigris : EPAR - Summary for the public SK = slovenčina 2009-12-17 2012-02-21
Xigris : EPAR - Summary for the public SL = slovenščina 2009-12-17 2012-02-21
Xigris : EPAR - Summary for the public FI = suomi 2009-12-17 2012-02-21
Xigris : EPAR - Summary for the public SV = svenska 2009-12-17 2012-02-21

This EPAR was last updated on 21/02/2012 .

Authorisation details

Product details

Product details for Xigris
NameXigris
Agency product numberEMEA/H/C/000396
Active substance

drotrecogin alfa (activated)

International non-proprietary name (INN) or common name

drotrecogin alfa (activated)

Therapeutic area SepsisMultiple Organ Failure
Anatomical therapeutic chemical (ATC) code B01AD10
Exceptional Circumstances

There were "exceptional circumstances" concerning the approval of this medicine. This happens when the applicant can show that they are unable to provide comprehensive data on the efficacy and safety of the medicine for which authorisation is being sought, due to the rarity of the condition it is intended for, limited scientific knowledge in the area concerned, or ethical considerations involved in the collection of such data.

Publication details

Publication details for Xigris
Marketing-authorisation holder

Eli Lilly Nederland B.V.

Revision13
Date of issue of marketing authorisation valid throughout the European Union22/08/2002

Contact address:

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

Product information

Product information

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

Name Language First published Last updated
Xigris : EPAR - Product Information SV = svenska 2009-12-21 2012-02-21
Xigris : EPAR - Product Information SV = svenska 2009-12-21 2012-02-21
Xigris : EPAR - Product Information SV = svenska 2009-12-21 2012-02-21
Xigris : EPAR - Product Information SV = svenska 2009-12-21 2012-02-21
Xigris : EPAR - Product Information SV = svenska 2009-12-21 2012-02-21
Xigris : EPAR - Product Information SV = svenska 2009-12-21 2012-02-21
Xigris : EPAR - Product Information SV = svenska 2009-12-21 2012-02-21
Xigris : EPAR - Product Information SV = svenska 2009-12-21 2012-02-21
Xigris : EPAR - Product Information SV = svenska 2009-12-21 2012-02-21
Xigris : EPAR - Product Information SV = svenska 2009-12-21 2012-02-21
Xigris : EPAR - Product Information SV = svenska 2009-12-21 2012-02-21
Xigris : EPAR - Product Information SV = svenska 2009-12-21 2012-02-21
Xigris : EPAR - Product Information SV = svenska 2009-12-21 2012-02-21
Xigris : EPAR - Product Information SV = svenska 2009-12-21 2012-02-21
Xigris : EPAR - Product Information SV = svenska 2009-12-21 2012-02-21
Xigris : EPAR - Product Information SV = svenska 2009-12-21 2012-02-21
Xigris : EPAR - Product Information SV = svenska 2009-12-21 2012-02-21
Xigris : EPAR - Product Information SV = svenska 2009-12-21 2012-02-21
Xigris : EPAR - Product Information SV = svenska 2009-12-21 2012-02-21
Xigris : EPAR - Product Information SV = svenska 2009-12-21 2012-02-21
Xigris : EPAR - Product Information SV = svenska 2009-12-21 2012-02-21
Xigris : EPAR - Product Information SV = svenska 2009-12-21 2012-02-21

Contents

  • 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.


Name Language First published Last updated
Xigris : EPAR - All Authorised presentations SV = svenska 2008-04-11 2012-02-21
Xigris : EPAR - All Authorised presentations SV = svenska 2008-04-11 2012-02-21
Xigris : EPAR - All Authorised presentations SV = svenska 2008-04-11 2012-02-21
Xigris : EPAR - All Authorised presentations SV = svenska 2008-04-11 2012-02-21
Xigris : EPAR - All Authorised presentations SV = svenska 2008-04-11 2012-02-21
Xigris : EPAR - All Authorised presentations SV = svenska 2008-04-11 2012-02-21
Xigris : EPAR - All Authorised presentations SV = svenska 2008-04-11 2012-02-21
Xigris : EPAR - All Authorised presentations SV = svenska 2008-04-11 2012-02-21
Xigris : EPAR - All Authorised presentations SV = svenska 2008-04-11 2012-02-21
Xigris : EPAR - All Authorised presentations SV = svenska 2008-04-11 2012-02-21
Xigris : EPAR - All Authorised presentations SV = svenska 2008-04-11 2012-02-21
Xigris : EPAR - All Authorised presentations SV = svenska 2008-04-11 2012-02-21
Xigris : EPAR - All Authorised presentations SV = svenska 2008-04-11 2012-02-21
Xigris : EPAR - All Authorised presentations SV = svenska 2008-04-11 2012-02-21
Xigris : EPAR - All Authorised presentations SV = svenska 2008-04-11 2012-02-21
Xigris : EPAR - All Authorised presentations SV = svenska 2008-04-11 2012-02-21
Xigris : EPAR - All Authorised presentations SV = svenska 2008-04-11 2012-02-21
Xigris : EPAR - All Authorised presentations SV = svenska 2008-04-11 2012-02-21
Xigris : EPAR - All Authorised presentations SV = svenska 2008-04-11 2012-02-21

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

Changes since initial authorisation of medicine

Initial marketing-authorisation documents

Name Language First published Last updated
Xigris : EPAR - Procedural steps taken before authorisation SV = svenska 2005-11-17 2012-02-21
Xigris : EPAR - Scientific Discussion SV = svenska 2005-11-17 2012-02-21

Withdrawn

This medicine is now withdrawn from use in the European Union

More information on Xigris