Incivo
telaprevir
Table of contents
Overview
The marketing authorisation for Incivo has expired following the marketing-authorisation holder's decision not to apply for a renewal.
Authorisation details
Product details | |
---|---|
Name |
Incivo
|
Agency product number |
EMEA/H/C/002313
|
Active substance |
telaprevir
|
International non-proprietary name (INN) or common name |
telaprevir
|
Therapeutic area (MeSH) |
Hepatitis C, Chronic
|
Anatomical therapeutic chemical (ATC) code |
J05AE
|
Additional monitoring |
This medicine is under additional monitoring, meaning that it is monitored even more intensively than other medicines. For more information, see Medicines under additional monitoring. |
Publication details | |
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Marketing-authorisation holder |
Janssen-Cilag International N.V.
|
Revision |
19
|
Date of issue of marketing authorisation valid throughout the European Union |
19/09/2011
|
Contact address |
Product information
25/06/2015 Incivo - EMEA/H/C/002313 - II/0035
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
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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.