SIMVASTATIN Film-coated tablet Ref.[7094] Active ingredients: Simvastatin

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2023  Publisher: Sandoz Limited, Park View, Riverside Way, Watchmoor Park, Camberley, Surrey, GU15 3YL, United Kingdom

Product name and form

Simvastatin 20 mg film-coated tablets.

Pharmaceutical Form

Film-coated tablet.

Orange coated, oval, biconvex tablet with score line on both sides, coded “20” on one side.

The tablet can be divided into equal doses.

Qualitative and quantitative composition

Each film-coated tablet contains 20 mg of simvastatin.

Excipient with known effect: Each film-coated tablets contains 58.2 mg of lactose (as monohydrate).

For the full list of excipients, see section 6.1.

Active Ingredient Description
Simvastatin

Simvastatin has a potent activity in inhibiting HMG-CoA reductase (3-hydroxy–3-ethylglutaryl-CoA-reductase). Simvastatin has been shown to reduce both normal and elevated LDL-C concentrations.

List of Excipients

Tablet core:

Pregelatinized starch
Lactose monohydrate
Cellulose, microcrystalline
Butylhydroxyanisole (E320)
Citric acid monohydrate (E330)
Magnesium stearate

Film-coating:

Hypromellose
Talc
Titanium dioxide (E171)
Iron oxide, red (E172)
Iron oxide, yellow (E172)

Pack sizes and marketing

Blister (Al/PVC).

Pack sizes: 10, 20, 28, 30, 40, 49, 50, 50 × 1, 60, 84, 90, 98 and 100 film-coated tablets.

Polyethylene tablet container with screw cap.

Pack sizes: 10, 20, 28, 30, 40, 50, 84, 90, 100, 120 and 250 film-coated tablets.

Not all pack sizes or pack types may be marketed.

Marketing authorization holder

Sandoz Limited, Park View, Riverside Way, Watchmoor Park, Camberley, Surrey, GU15 3YL, United Kingdom

Marketing authorization dates and numbers

PL 04416/0679

Date of first authorisation: 21 July 2006

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