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 | |
---|---|
Name |
Pravafenix
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Agency product number |
EMEA/H/C/001243
|
Active substance |
|
International non-proprietary name (INN) or common name |
|
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.
|
Revision |
8
|
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
27/11/2023 Pravafenix - EMEA/H/C/001243 - N/0036
This medicine’s product information is available in all official EU languages.
Select ‘available languages’ to access the language you need.
Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.
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.