FLUVASTATIN Capsules Ref.[8165] Active ingredients: Fluvastatin

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2019  Publisher: Sandoz Limited, Frimley Business Park, Frimley, Camberley, Surrey, GU16 7SR

Product name and form

Fluvastatin 20 mg hard Capsules.

Pharmaceutical Form

Capsule, hard.

Brown coloured hard gelatine capsule containing off-white to pale-yellow powder.

Qualitative and quantitative composition

Each hard capsule contains 21.06 mg fluvastatin sodium corresponding to 20 mg fluvastatin.

For the full list of excipients, see section 6.1.

Active Ingredient Description
Fluvastatin

Fluvastatin, a fully synthetic cholesterol-lowering agent, is a competitive inhibitor of HMG-CoA reductase, which is responsible for the conversion of HMG-CoA to mevalonate, a precursor of sterols, including cholesterol. Fluvastatin reduces total-C, LDL-C, Apo B, and triglycerides, and increases HDL-C in patients with hypercholesterolaemia and mixed dyslipidaemia.

List of Excipients

Capsule contents:

Calcium carbonate
Cellulose microcrystalline
Pregelatinised starch
Talc
Sodium hydrogen carbonate
Magnesium stearate

Hard gelatin capsule:

Gelatin
Titanium dioxide (E171)
Iron oxide red (E172)
Sodium lauryl sulphate

Pack sizes and marketing

OPA/Al/PVC/Al blister: 14, 20, 28, 30, 50, 56, 84, 90, 98, 100, 490 hard capsules.

HDPE bottle with PP cap: 98 hard capsules.

Not all pack sizes may be marketed.

Marketing authorization holder

Sandoz Limited, Frimley Business Park, Frimley, Camberley, Surrey, GU16 7SR

Marketing authorization dates and numbers

PL 04416/0748

30/11/2007

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