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
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
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.