Pravafenix

fenofibrate / pravastatin

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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.

What is Pravafenix?

Pravafenix is a medicine that contains the active substances pravastatin and fenofibrate. It is available as green and olive capsules containing 40 mg pravastatin and 160 mg fenofibrate.

What is Pravafenix used for?

Pravafenix is used in adults at high risk of heart disease whose ‘low-density-lipoprotein’ (LDL or ‘bad’) cholesterol is already being controlled with pravastatin alone but who still need to improve their cholesterol levels and to reduce their levels of triglycerides (a type of fat).

The medicine can only be obtained with a prescription.

How is Pravafenix used?

Before starting treatment with Pravafenix, the doctor should first investigate all possible causes of the patient’s abnormal cholesterol and triglycerides levels and place the patient on a suitable diet.

The recommended dose is one capsule a day taken during the evening meal. The medicine should always be taken with food as it is less well absorbed from an empty stomach. The patient’s blood should be monitored regularly to see how the medicine is working. The doctor should stop treatment if an adequate response is not seen within three months.

How does Pravafenix work?

The active substances in Pravafenix, pravastatin and fenofibrate, work in different ways and their actions have a complementary effect.

Pravastatin belongs to the group called ‘statins’. It reduces total blood cholesterol by blocking the action of 3-hydroxy-3-methyl-glutaryl-coenzyme-A (HMG-CoA) reductase, an enzyme in the liver involved in the production of cholesterol. As the liver needs cholesterol to produce bile, the reduced blood cholesterol level causes the liver cells to produce receptors that draw cholesterol from the blood, reducing its level even further. The cholesterol drawn out of the blood in this way is the LDL, or ‘bad’ cholesterol.

Fenofibrate is a ‘peroxisome-proliferator-activated-receptor (PPAR) agonist’. It activates a type of receptor called the ‘PPAR alpha’, which is involved in breaking down fat from the diet, especially triglycerides. When the receptors are activated, the breakdown of fats is accelerated, and this helps clear the blood of cholesterol and triglycerides.

How has Pravafenix been studied?

Because pravastatin and fenofibrate have been used in medicines for a number of years, the company presented information from the scientific literature in addition to results from its own studies.

The company carried out one main study, in which Pravafenix was compared with pravastatin alone in 248 patients at high risk of heart disease who had abnormal levels of cholesterol and triglyceride fats. The main measure of effectiveness was the reduction in the level of cholesterol after 12 weeks (excluding HDL or ‘good’ cholesterol).

What benefit has Pravafenix shown during the studies?

In the main study Pravafenix was shown to be more effective than pravastatin alone in reducing non-HDL-cholesterol levels. Non-HDL-cholesterol levels were reduced on average by around 14% in patients taking Pravafenix compared with 6% in patients taking pravastatin alone.

What is the risk associated with Pravafenix?

The most common side effects with Pravafenix (seen in between 1 and 10 patients in 100) are abdominal distension (bloating), abdominal pain (stomach ache), constipation, diarrhoea, dry mouth, dyspepsia (heartburn), eructation (belching), flatulence (gas), nausea (feeling sick), abdominal discomfort, vomiting and raised blood levels of liver enzymes. For the full list of all side effects reported with Pravafenix, see the package leaflet.

Pravafenix should not be used in people who may be hypersensitive (allergic) to the active substances or any of the other ingredients. Pravafenix must not be used in patients aged below 18 years or in patients with severe liver problems, moderate to severe kidney problems, photo-allergy or phototoxic reactions (allergic reaction or skin damage due to light exposure) during treatment with fibrates or ketoprofen. It must also not be used in patients with gall-bladder disease, chronic or acute pancreatitis (inflammation of the pancreas) or a history of myopathy (muscle disorders) or rhabdomyolysis (breakdown of muscle fibres) following treatment with a statin or a fibrate. It must not be given to women who are pregnant or breastfeeding.

Why has Pravafenix been approved?

The CHMP looked at newly published data on the benefits of the combination of statins and fenofibrate. The Committee also noted that the benefits of Pravafenix were mainly in patients who had high levels of triglyceride fats and low levels of HDL cholesterol. The Committee therefore decided that Pravafenix’s benefits are greater than its risks in this group of patients and recommended that it be given marketing authorisation.

Other information about Pravafenix

The European Commission granted a marketing authorisation valid throughout the European Union for Pravafenix to Laboratoires SMB s.a. on 14 April 2011. The marketing authorisation is valid for five years, after which it can be renewed.

For more information about treatment with Pravafenix, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.

Name Language First published Last updated
Pravafenix : EPAR - Summary for the public BG = bălgarski 2011-05-17  
Pravafenix : EPAR - Summary for the public ES = español 2011-05-17  
Pravafenix : EPAR - Summary for the public CS = čeština 2011-05-17  
Pravafenix : EPAR - Summary for the public DA = dansk 2011-05-17  
Pravafenix : EPAR - Summary for the public DE = Deutsch 2011-05-17  
Pravafenix : EPAR - Summary for the public ET = eesti keel 2011-05-17  
Pravafenix : EPAR - Summary for the public EL = elliniká 2011-05-17  
Pravafenix : EPAR - Summary for the public EN = English 2011-05-17  
Pravafenix : EPAR - Summary for the public FR = français 2011-05-17  
Pravafenix : EPAR - Summary for the public IT = italiano 2011-05-17  
Pravafenix : EPAR - Summary for the public LV = latviešu valoda 2011-05-17  
Pravafenix : EPAR - Summary for the public LT = lietuvių kalba 2011-05-17  
Pravafenix : EPAR - Summary for the public HU = magyar 2011-05-17  
Pravafenix : EPAR - Summary for the public MT = Malti 2011-05-17  
Pravafenix : EPAR - Summary for the public NL = Nederlands 2011-05-17  
Pravafenix : EPAR - Summary for the public PL = polski 2011-05-17  
Pravafenix : EPAR - Summary for the public PT = português 2011-05-17  
Pravafenix : EPAR - Summary for the public RO = română 2011-05-17  
Pravafenix : EPAR - Summary for the public SK = slovenčina 2011-05-17  
Pravafenix : EPAR - Summary for the public SL = slovenščina 2011-05-17  
Pravafenix : EPAR - Summary for the public FI = suomi 2011-05-17  
Pravafenix : EPAR - Summary for the public SV = svenska 2011-05-17  

This EPAR was last updated on 26/02/2016 .

Authorisation details

Product details

Product details for Pravafenix
NamePravafenix
Agency product numberEMEA/H/C/001243
Active substance

fenofibrate / pravastatin

International non-proprietary name (INN) or common name

fenofibrate / pravastatin

Therapeutic area Dyslipidemias
Anatomical therapeutic chemical (ATC) code C10BA03

Publication details

Publication details for Pravafenix
Marketing-authorisation holder

Laboratoires SMB S.A.

Revision4
Date of issue of marketing authorisation valid throughout the European Union14/04/2011

Contact address:

Laboratoires SMB S.A.
Rue de la Pastorale 26-28
B-1080 Brussels
Belgium

Product information

Product information

14/01/2016  Pravafenix -EMEA/H/C/001243 -R/0020

Name Language First published Last updated
Pravafenix : EPAR - Product Information SV = svenska 2011-05-17 2016-02-26
Pravafenix : EPAR - Product Information SV = svenska 2011-05-17 2016-02-26
Pravafenix : EPAR - Product Information SV = svenska 2011-05-17 2016-02-26
Pravafenix : EPAR - Product Information SV = svenska 2011-05-17 2016-02-26
Pravafenix : EPAR - Product Information SV = svenska 2011-05-17 2016-02-26
Pravafenix : EPAR - Product Information SV = svenska 2011-05-17 2016-02-26
Pravafenix : EPAR - Product Information SV = svenska 2011-05-17 2016-02-26
Pravafenix : EPAR - Product Information SV = svenska 2011-05-17 2016-02-26
Pravafenix : EPAR - Product Information SV = svenska 2011-05-17 2016-02-26
Pravafenix : EPAR - Product Information SV = svenska 2011-05-17 2016-02-26
Pravafenix : EPAR - Product Information SV = svenska 2011-05-17 2016-02-26
Pravafenix : EPAR - Product Information SV = svenska 2011-05-17 2016-02-26
Pravafenix : EPAR - Product Information SV = svenska 2011-05-17 2016-02-26
Pravafenix : EPAR - Product Information SV = svenska 2011-05-17 2016-02-26
Pravafenix : EPAR - Product Information SV = svenska 2011-05-17 2016-02-26
Pravafenix : EPAR - Product Information SV = svenska 2011-05-17 2016-02-26
Pravafenix : EPAR - Product Information SV = svenska 2011-05-17 2016-02-26
Pravafenix : EPAR - Product Information SV = svenska 2011-05-17 2016-02-26
Pravafenix : EPAR - Product Information SV = svenska 2011-05-17 2016-02-26
Pravafenix : EPAR - Product Information SV = svenska 2011-05-17 2016-02-26
Pravafenix : EPAR - Product Information SV = svenska 2011-05-17 2016-02-26
Pravafenix : EPAR - Product Information SV = svenska 2011-05-17 2016-02-26
Pravafenix : EPAR - Product Information SV = svenska 2011-05-17 2016-02-26
Pravafenix : EPAR - Product Information SV = svenska 2011-05-17 2016-02-26
Pravafenix : EPAR - Product Information SV = svenska 2011-05-17 2016-02-26

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

Please note that the size of the above document can exceed 50 pages.

You are therefore advised to be selective about which sections or pages you wish to print.


Name Language First published Last updated
Pravafenix : EPAR - All Authorised presentations SV = svenska 2011-05-17 2013-08-29
Pravafenix : EPAR - All Authorised presentations SV = svenska 2011-05-17 2013-08-29
Pravafenix : EPAR - All Authorised presentations SV = svenska 2011-05-17 2013-08-29
Pravafenix : EPAR - All Authorised presentations SV = svenska 2011-05-17 2013-08-29
Pravafenix : EPAR - All Authorised presentations SV = svenska 2011-05-17 2013-08-29
Pravafenix : EPAR - All Authorised presentations SV = svenska 2011-05-17 2013-08-29
Pravafenix : EPAR - All Authorised presentations SV = svenska 2011-05-17 2013-08-29
Pravafenix : EPAR - All Authorised presentations SV = svenska 2011-05-17 2013-08-29
Pravafenix : EPAR - All Authorised presentations SV = svenska 2011-05-17 2013-08-29
Pravafenix : EPAR - All Authorised presentations SV = svenska 2011-05-17 2013-08-29
Pravafenix : EPAR - All Authorised presentations SV = svenska 2011-05-17 2013-08-29
Pravafenix : EPAR - All Authorised presentations SV = svenska 2011-05-17 2013-08-29
Pravafenix : EPAR - All Authorised presentations SV = svenska 2011-05-17 2013-08-29
Pravafenix : EPAR - All Authorised presentations SV = svenska 2011-05-17 2013-08-29
Pravafenix : EPAR - All Authorised presentations SV = svenska 2011-05-17 2013-08-29
Pravafenix : EPAR - All Authorised presentations SV = svenska 2011-05-17 2013-08-29
Pravafenix : EPAR - All Authorised presentations SV = svenska 2011-05-17 2013-08-29
Pravafenix : EPAR - All Authorised presentations SV = svenska 2011-05-17 2013-08-29
Pravafenix : EPAR - All Authorised presentations SV = svenska 2011-05-17 2013-08-29
Pravafenix : EPAR - All Authorised presentations SV = svenska 2011-05-17 2013-08-29
Pravafenix : EPAR - All Authorised presentations SV = svenska 2011-05-17 2013-08-29
Pravafenix : EPAR - All Authorised presentations SV = svenska 2011-05-17 2013-08-29
Pravafenix : EPAR - All Authorised presentations SV = svenska 2011-05-17 2013-08-29
Pravafenix : EPAR - All Authorised presentations SV = svenska 2011-05-17 2013-08-29

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

Changes since initial authorisation of medicine

Name Language First published Last updated
Pravafenix : EPAR - Procedural steps taken and scientific information after authorisation SV = svenska 2013-08-29 2016-02-26

Initial marketing-authorisation documents

Name Language First published Last updated
Pravafenix : EPAR - Public assessment report SV = svenska 2011-05-17  
CHMP summary of positive opinion for Pravafenix SV = svenska 2011-01-21  

Authorised

This medicine is approved for use in the European Union