Cholib (fenofibrate;simvastatin)
- Region
- 🇪🇺 EU
- Active substance
- fenofibrate;simvastatin
- Company
- Viatris Healthcare Limited
- Status
- Authorised
- Therapeutic area
- Dyslipidemias
- CHMP opinion
- Thu 27 Jun 2013
- EU approval
- Mon 26 Aug 2013
- Application
- EMEA/H/C/002559
- ATC
- C10BA04
- Official record
- www.ema.europa.eu
Indication
Cholib is indicated as adjunctive therapy to diet and exercise in high cardiovascular risk adult patients with mixed dyslipidaemia to reduce triglycerides and increase HDL C levels when LDL C levels are adequately controlled with the corresponding dose of simvastatin monotherapy.
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.