Incivo (telaprevir)
- Region
- 🇪🇺 EU
- Active substance
- telaprevir
- Company
- Janssen-Cilag International
- Status
- Expired
- Therapeutic area
- Hepatitis C, Chronic
- EU approval
- Mon 19 Sep 2011
- Designations
- Additional monitoring
- Application
- EMEA/H/C/002313
- ATC
- J05AE
- Official record
- www.ema.europa.eu
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.
Regulatory milestones
No milestones recorded in the last year.
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Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.