This is a summary of the European public assessment report (EPAR) for Pravafenix. It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Pravafenix.
Therapeutic Indication
### Therapeutic indication Pravafenix is indicated for the treatment of high-coronary-heart-disease (CHD)-risk adult patients with mixed dyslipidaemia characterised by high triglycerides and low HDL-cholesterol (C) levels whose LDL-C levels are adequately controlled while on a treatment with pravastatin-40-mg monotherapy.
Therapeutic Area (MeSH)
N/AATC Code
C10BA03
ATC Item
pravastatin and fenofibrate
Pharmacotherapeutic Group
Lipid modifying agents
Active Substance (Summary)
N/AINN / Common Names
N/AEMA Name
Pravafenix
Medicine Name
Pravafenix
Aliases
N/ANo risk management plan link.
