Pravafenix

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fenofibrate / pravastatin

Authorised
This medicine is authorised for use in the European Union.

Overview

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.

This EPAR was last updated on 24/04/2020

Authorisation details

Product details
Name
Pravafenix
Agency product number
EMEA/H/C/001243
Active substance
  • fenofibrate
  • Pravastatin
International non-proprietary name (INN) or common name
  • fenofibrate
  • pravastatin
Therapeutic area (MeSH)
Dyslipidemias
Anatomical therapeutic chemical (ATC) code
C10BA03
Publication details
Marketing-authorisation holder
Laboratoires SMB S.A.
Revision
5
Date of issue of marketing authorisation valid throughout the European Union
14/04/2011
Contact address
Rue de la Pastorale 26-28
B-1080 Brussels
Belgium

Product information

19/03/2020 Pravafenix - EMEA/H/C/001243 - II/0028/G

Contents

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Pharmacotherapeutic group

Lipid modifying agents

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.

Assessment history

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