Pravafenix (fenofibrate;pravastatin)
- Region
- 🇪🇺 EU
- Active substance
- fenofibrate;pravastatin
- Company
- Laboratoires SMB S.A.
- Status
- Authorised
- Therapeutic area
- Dyslipidemias
- EU approval
- Thu 14 Apr 2011
- Application
- EMEA/H/C/001243
- ATC
- C10BA03
- Official record
- www.ema.europa.eu
Indication
Pravafenix is indicated as an adjunct to diet and other non-pharmacological treatment (e.g. exercise, weight reduction) for the treatment of mixed hyperlipidaemia in adult patients at high cardiovascular risk to reduce triglycerides and increase HDL C when LDL C levels are adequately controlled while on a treatment with pravastatin 40 mg monotherapy or on another moderate-intensity statin regimen.
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.