PRAVAFEN Hard capsule Ref.[50594] Active ingredients: Fenofibrate Pravastatin

Source: Health Sciences Authority (SG)  Revision Year: 2021  Publisher: SMB Technology S.A., Rue du Parc Industriel 39, B-6900 Marche en Famenne, Belgium

Product name and form

Pravafen 40 mg/160 mg hard capsules.

Pharmaceutical Form

Hard capsule.

Pravafen is a hard capsule, with light green body and olive cap, containing a waxy white beige mass and a tablet.

Qualitative and quantitative composition

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.

For a 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.

List of Excipients

Capsule content:

Lactose monohydrate
Cellulose microcrystalline
Ascorbyl palmitate
Povidone K29-32
Sodium starch glycolate
Magnesium stearate
Talc
Triacetin
Sodium hydrogen carbonate
Lauroyl macrogolglycerides Type 1500
Hydroxypropylcellulose
Macrogol 20 000

Capsule shell:

Gelatine
Indigo carmine (E132)
Black iron oxide (E172)
Titanium dioxide (E171)
Yellow iron oxide (E172)

Pack sizes and marketing

Opaque white HDPE bottles containing 30 hard capsules.

Marketing authorization holder

SMB Technology S.A., Rue du Parc Industriel 39, B-6900 Marche en Famenne, Belgium

Drugs

Drug Countries
PRAVAFEN Singapore

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