Pravafenix
fenofibrate / pravastatin
Table of contents
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.
Authorisation details
Product details | |
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Name |
Pravafenix
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Agency product number |
EMEA/H/C/001243
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Active substance |
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International non-proprietary name (INN) or common name |
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Therapeutic area (MeSH) |
Dyslipidemias
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Anatomical therapeutic chemical (ATC) code |
C10BA03
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Publication details | |
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Marketing-authorisation holder |
Laboratoires SMB S.A.
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Revision |
5
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Date of issue of marketing authorisation valid throughout the European Union |
14/04/2011
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Contact address |
Product information
19/03/2020 Pravafenix - EMEA/H/C/001243 - II/0028/G
Contents
- Annex I - Summary of product characteristics
- Annex IIA - Manufacturing-authorisation holder responsible for batch release
- Annex IIB - Conditions of the marketing authorisation
- Annex IIIA - Labelling
- Annex IIIB - Package leaflet
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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.