Incivo

telaprevir

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The marketing authorisation for Incivo has expired following the marketing-authorisation holder's decision not to apply for a renewal. 

Name Language First published Last updated
Incivo : EPAR - Summary for the public BG = bălgarski 2011-10-03 2016-10-06
Incivo : EPAR - Summary for the public ES = español 2011-10-03 2016-10-06
Incivo : EPAR - Summary for the public CS = čeština 2011-10-03 2016-10-06
Incivo : EPAR - Summary for the public DA = dansk 2011-10-03 2016-10-06
Incivo : EPAR - Summary for the public DE = Deutsch 2011-10-03 2016-10-06
Incivo : EPAR - Summary for the public ET = eesti keel 2011-10-03 2016-10-06
Incivo : EPAR - Summary for the public EL = elliniká 2011-10-03 2016-10-06
Incivo : EPAR - Summary for the public EN = English 2011-10-03 2016-10-06
Incivo : EPAR - Summary for the public FR = français 2011-10-03 2016-10-06
Incivo : EPAR - Summary for the public IT = italiano 2011-10-03 2016-10-06
Incivo : EPAR - Summary for the public LV = latviešu valoda 2011-10-03 2016-10-06
Incivo : EPAR - Summary for the public LT = lietuvių kalba 2011-10-03 2016-10-06
Incivo : EPAR - Summary for the public HU = magyar 2011-10-03 2016-10-06
Incivo : EPAR - Summary for the public MT = Malti 2011-10-03 2016-10-06
Incivo : EPAR - Summary for the public NL = Nederlands 2011-10-03 2016-10-06
Incivo : EPAR - Summary for the public PL = polski 2011-10-03 2016-10-06
Incivo : EPAR - Summary for the public PT = português 2011-10-03 2016-10-06
Incivo : EPAR - Summary for the public RO = română 2011-10-03 2016-10-06
Incivo : EPAR - Summary for the public SK = slovenčina 2011-10-03 2016-10-06
Incivo : EPAR - Summary for the public SL = slovenščina 2011-10-03 2016-10-06
Incivo : EPAR - Summary for the public FI = suomi 2011-10-03 2016-10-06
Incivo : EPAR - Summary for the public SV = svenska 2011-10-03 2016-10-06

This EPAR was last updated on 06/10/2016 .

Authorisation details

Product details

Product details for Incivo
NameIncivo
Agency product numberEMEA/H/C/002313
Active substance

telaprevir

International non-proprietary name (INN) or common name

telaprevir

Therapeutic area Hepatitis C, Chronic
Anatomical therapeutic chemical (ATC) code J05AE
Additional monitoring

This medicine is under additional monitoring. This means that it is being monitored even more intensively than other medicines. For more information, see medicines under additional monitoring.

Publication details

Publication details for Incivo
Marketing-authorisation holder

Janssen-Cilag International N.V.

Revision19
Date of issue of marketing authorisation valid throughout the European Union19/09/2011

Contact address:

Janssen-Cilag International N.V.
Turnhoutseweg 30
BE-2340 Beerse
Belgium

Product information

Product information

25/06/2015  Incivo -EMEA/H/C/002313 -II/0035

Name Language First published Last updated
Incivo : EPAR - Product Information SV = svenska 2011-10-03 2016-10-06
Incivo : EPAR - Product Information SV = svenska 2011-10-03 2016-10-06
Incivo : EPAR - Product Information SV = svenska 2011-10-03 2016-10-06
Incivo : EPAR - Product Information SV = svenska 2011-10-03 2016-10-06
Incivo : EPAR - Product Information SV = svenska 2011-10-03 2016-10-06
Incivo : EPAR - Product Information SV = svenska 2011-10-03 2016-10-06
Incivo : EPAR - Product Information SV = svenska 2011-10-03 2016-10-06
Incivo : EPAR - Product Information SV = svenska 2011-10-03 2016-10-06
Incivo : EPAR - Product Information SV = svenska 2011-10-03 2016-10-06
Incivo : EPAR - Product Information SV = svenska 2011-10-03 2016-10-06
Incivo : EPAR - Product Information SV = svenska 2011-10-03 2016-10-06
Incivo : EPAR - Product Information SV = svenska 2011-10-03 2016-10-06
Incivo : EPAR - Product Information SV = svenska 2011-10-03 2016-10-06
Incivo : EPAR - Product Information SV = svenska 2011-10-03 2016-10-06
Incivo : EPAR - Product Information SV = svenska 2011-10-03 2016-10-06
Incivo : EPAR - Product Information SV = svenska 2011-10-03 2016-10-06
Incivo : EPAR - Product Information SV = svenska 2011-10-03 2016-10-06
Incivo : EPAR - Product Information SV = svenska 2011-10-03 2016-10-06
Incivo : EPAR - Product Information SV = svenska 2011-10-03 2016-10-06
Incivo : EPAR - Product Information SV = svenska 2011-10-03 2016-10-06
Incivo : EPAR - Product Information SV = svenska 2011-10-03 2016-10-06
Incivo : EPAR - Product Information SV = svenska 2011-10-03 2016-10-06
Incivo : EPAR - Product Information SV = svenska 2011-10-03 2016-10-06
Incivo : EPAR - Product Information SV = svenska 2011-10-03 2016-10-06
Incivo : EPAR - Product Information SV = svenska 2011-10-03 2016-10-06

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
Incivo : EPAR - All Authorised presentations SV = svenska 2011-10-03 2016-10-06
Incivo : EPAR - All Authorised presentations SV = svenska 2011-10-03 2016-10-06
Incivo : EPAR - All Authorised presentations SV = svenska 2011-10-03 2016-10-06
Incivo : EPAR - All Authorised presentations SV = svenska 2011-10-03 2016-10-06
Incivo : EPAR - All Authorised presentations SV = svenska 2011-10-03 2016-10-06
Incivo : EPAR - All Authorised presentations SV = svenska 2011-10-03 2016-10-06
Incivo : EPAR - All Authorised presentations SV = svenska 2011-10-03 2016-10-06
Incivo : EPAR - All Authorised presentations SV = svenska 2011-10-03 2016-10-06
Incivo : EPAR - All Authorised presentations SV = svenska 2011-10-03 2016-10-06
Incivo : EPAR - All Authorised presentations SV = svenska 2011-10-03 2016-10-06
Incivo : EPAR - All Authorised presentations SV = svenska 2011-10-03 2016-10-06
Incivo : EPAR - All Authorised presentations SV = svenska 2011-10-03 2016-10-06
Incivo : EPAR - All Authorised presentations SV = svenska 2011-10-03 2016-10-06
Incivo : EPAR - All Authorised presentations SV = svenska 2011-10-03 2016-10-06
Incivo : EPAR - All Authorised presentations SV = svenska 2011-10-03 2016-10-06
Incivo : EPAR - All Authorised presentations SV = svenska 2011-10-03 2016-10-06
Incivo : EPAR - All Authorised presentations SV = svenska 2011-10-03 2016-10-06
Incivo : EPAR - All Authorised presentations SV = svenska 2011-10-03 2016-10-06
Incivo : EPAR - All Authorised presentations SV = svenska 2011-10-03 2016-10-06
Incivo : EPAR - All Authorised presentations SV = svenska 2011-10-03 2016-10-06
Incivo : EPAR - All Authorised presentations SV = svenska 2011-10-03 2016-10-06
Incivo : EPAR - All Authorised presentations SV = svenska 2011-10-03 2016-10-06
Incivo : EPAR - All Authorised presentations SV = svenska 2011-10-03 2016-10-06
Incivo : EPAR - All Authorised presentations SV = svenska 2011-10-03 2016-10-06
Incivo : EPAR - All Authorised presentations SV = svenska 2011-10-03 2016-10-06

Name Language First published Last updated
Incivo : EPAR - Conditions imposed on member states for safe and effective use SV = svenska 2011-10-03 2016-10-06
Incivo : EPAR - Conditions imposed on member states for safe and effective use SV = svenska 2011-10-03 2016-10-06
Incivo : EPAR - Conditions imposed on member states for safe and effective use SV = svenska 2011-10-03 2016-10-06
Incivo : EPAR - Conditions imposed on member states for safe and effective use SV = svenska 2011-10-03 2016-10-06
Incivo : EPAR - Conditions imposed on member states for safe and effective use SV = svenska 2011-10-03 2016-10-06
Incivo : EPAR - Conditions imposed on member states for safe and effective use SV = svenska 2011-10-03 2016-10-06
Incivo : EPAR - Conditions imposed on member states for safe and effective use SV = svenska 2011-10-03 2016-10-06
Incivo : EPAR - Conditions imposed on member states for safe and effective use SV = svenska 2011-10-03 2016-10-06
Incivo : EPAR - Conditions imposed on member states for safe and effective use SV = svenska 2011-10-03 2016-10-06
Incivo : EPAR - Conditions imposed on member states for safe and effective use SV = svenska 2011-10-03 2016-10-06
Incivo : EPAR - Conditions imposed on member states for safe and effective use SV = svenska 2011-10-03 2016-10-06
Incivo : EPAR - Conditions imposed on member states for safe and effective use SV = svenska 2011-10-03 2016-10-06
Incivo : EPAR - Conditions imposed on member states for safe and effective use SV = svenska 2011-10-03 2016-10-06
Incivo : EPAR - Conditions imposed on member states for safe and effective use SV = svenska 2011-10-03 2016-10-06
Incivo : EPAR - Conditions imposed on member states for safe and effective use SV = svenska 2011-10-03 2016-10-06
Incivo : EPAR - Conditions imposed on member states for safe and effective use SV = svenska 2011-10-03 2016-10-06
Incivo : EPAR - Conditions imposed on member states for safe and effective use SV = svenska 2011-10-03 2016-10-06
Incivo : EPAR - Conditions imposed on member states for safe and effective use SV = svenska 2011-10-03 2016-10-06
Incivo : EPAR - Conditions imposed on member states for safe and effective use SV = svenska 2011-10-03 2016-10-06
Incivo : EPAR - Conditions imposed on member states for safe and effective use SV = svenska 2011-10-03 2016-10-06
Incivo : EPAR - Conditions imposed on member states for safe and effective use SV = svenska 2011-10-03 2016-10-06
Incivo : EPAR - Conditions imposed on member states for safe and effective use SV = svenska 2011-10-03 2016-10-06
Incivo : EPAR - Conditions imposed on member states for safe and effective use SV = svenska 2011-10-03 2016-10-06
Incivo : EPAR - Conditions imposed on member states for safe and effective use SV = svenska 2011-10-03 2016-10-06

Pharmacotherapeutic group

Antivirals for systemic use

Therapeutic indication

Incivo, in combination with peginterferon alfa and ribavirin, is indicated for the treatment of genotype-1 chronic hepatitis C in adult patients with compensated liver disease (including cirrhosis):

  • who are treatment naïve;
  • who have previously been treated with interferon alfa (pegylated or non-pegylated) alone or in combination with ribavirin, including relapsers, partial responders and null responders.

Assessment History

Changes since initial authorisation of medicine

Initial marketing-authorisation documents

Name Language First published Last updated
Incivo : EPAR - Public assessment report SV = svenska 2011-10-03 2016-10-06
CHMP summary of positive opinion for Incivo SV = svenska 2011-07-22 2016-10-06

Withdrawn

This medicine is now withdrawn from use in the European Union

More information on Incivo