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Active Substance: telaprevir
Common Name: telaprevir
ATC Code: J05AE
Marketing Authorisation Holder: Janssen-Cilag International N.V.
Active Substance: telaprevir
Status: Withdrawn
Authorisation Date: 2011-09-19
Therapeutic Area: Hepatitis C, Chronic
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.

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

Source: European Medicines Agency

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