PRAVASTATIN SODIUM Tablet Ref.[7340] Active ingredients: Pravastatin

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2019  Publisher: Accord Healthcare Limited, Sage House, 319, Pinner Road, North Harrow, Middlesex HA1 4 HF, United Kingdom

Product name and form

Pravastatin Sodium 10 mg Tablets.

Pharmaceutical Form

Tablet.

Pravastatin Tablets 10 mg: Yellow colored, rounded rectangular shaped, biconvex, uncoated tablets debossed ‘PDT’ on one side and ‘10’ on the other side.

Qualitative and quantitative composition

Each tablet contains 10 mg pravastatin sodium.

Excipient: Lactose monohydrate 71.65 mg. For a full list of excipients, see section 6.1.

Active Ingredient Description
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

Lactose monohydrate
Croscarmellose sodium
Magnesium stearate
Light magnesium oxide
Microcelac
Povidone
Yellow ferric oxide (E172)

Pack sizes and marketing

The immediate container for Pravastatin Sodium Tablets 10 mg is a laminated aluminium/aluminium foil pack containing 10, 14, 20, 50, 28, 30, 56, 60, 90, 98 or 100 tablets. The blister strips are packed in a carton.

Not all pack sizes may be marketed.

Marketing authorization holder

Accord Healthcare Limited, Sage House, 319, Pinner Road, North Harrow, Middlesex HA1 4 HF, United Kingdom

Marketing authorization dates and numbers

PL 20075/0018

15/09/2008

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