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 | |
|---|---|
| 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 |
Turnhoutseweg 30
BE-2340 Beerse Belgium |
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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You are therefore advised to be selective about which sections or pages you wish to print.
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.