Source: European Medicines Agency (EU) Revision Year: 2023 Publisher: Laboratoires SMB s.a., Rue de la Pastorale, 26-28, B-1080 Brussels, Belgium Tel. +32 (2) 411 48 28 Fax. +32 (2) 411 28 28
Pravafenix 40 mg/160 mg hard capsules.
Pharmaceutical Form |
---|
Hard capsule. Hard capsule, with light green body and olive cap, containing a waxy white beige mass and a tablet. |
Each hard capsule contains 40 mg pravastatin sodium and 160 mg fenofibrate.
Excipient(s) with known effect: Each hard capsule contains 19 mg of lactose monohydrate and 33.3 mg of sodium.
For the full list of excipients, see section 6.1.
Active Ingredient | Description | |
---|---|---|
Fenofibrate |
Fenofibrate is a fibric acid derivative whose lipid modifying effects reported in humans are mediated via activation of Peroxisome Proliferator Activated Receptor type α (PPARα). Through activation of PPARα, fenofibrate increases lipolysis and elimination of atherogenic triglyceride rich particles from plasma by activating lipoprotein lipase and reducing production of Apoprotein C-III. |
|
Pravastatin |
Pravastatin is a competitive inhibitor of 3-hydroxy–3-methylglutaryl-coenzyme A (HMG-CoA) reductase, the enzyme catalyzing the early rate limiting step in cholesterol biosynthesis, and produces its lipid lowering effect in two ways. |
|
Pravastatin and Fenofibrate |
Pravastatin and fenofibrate, which have different modes of action, show additive effects in terms of reduction of serum lipid. Pravastatin is more effective in reducing LDL-C and total cholesterol but presents only modest effects on TG and HDL-C while fenofibrate is very effective in decreasing TG and increasing HDL-C, but with few effects on LDL-C. Additionally, fibrates have the properties to modify the size and density of LDL-C particles to make them less atherogenic. |
List of Excipients |
---|
Capsule content: Lactose monohydrate Capsule shell: Gelatine |
Polyamide-Aluminium-PVC/aluminium blister packs containing 30, 60 and 90 hard capsules.
Opaque white HDPE bottles containing 14, 30, 60 and 90 hard capsules.
Not all pack sizes may be marketed.
Laboratoires SMB s.a., Rue de la Pastorale, 26-28, B-1080 Brussels, Belgium
Tel. +32 (2) 411 48 28
Fax. +32 (2) 411 28 28
EU/1/11/679/001-007
Date of first authorisation: 14 April 2011
Date of latest renewal: 14 January 2016
Drug | Countries | |
---|---|---|
PRAVAFENIX | Austria, Cyprus, Estonia, Spain, France, Croatia, Ireland, Italy, Lithuania, Netherlands, Poland |
© All content on this website, including data entry, data processing, decision support tools, "RxReasoner" logo and graphics, is the intellectual property of RxReasoner and is protected by copyright laws. Unauthorized reproduction or distribution of any part of this content without explicit written permission from RxReasoner is strictly prohibited. Any third-party content used on this site is acknowledged and utilized under fair use principles.