Olysio (simeprevir)
Additional monitoring
- Region
- 🇪🇺 EU
- Active substance
- simeprevir
- Company
- Janssen-Cilag International NV
- Status
- Withdrawn
- Therapeutic area
- Hepatitis C, Chronic
- CHMP opinion
- Thu 20 Mar 2014
- EU approval
- Wed 14 May 2014
- Designations
- Additional monitoring
- Application
- EMEA/H/C/002777
- ATC
- J05AE14
- Official record
- www.ema.europa.eu
Indication
Olysio is indicated in combination with other medicinal products for the treatment of chronic hepatitis C (CHC) in adult patients. For hepatitis C virus (HCV) genotype specific activity.
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.