Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2023 Publisher: Upjohn UK Limited, Ramsgate Road, Sandwich, Kent, CT13 9NJ, United Kingdom
Lipitor 10 mg film-coated tablets.
| Pharmaceutical Form |
|---|
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Film-coated tablet. White, round, 5.6 mm, film-coated tablets debossed ‘10’ on one side and ‘ATV’ on the other. |
Each film-coated tablet contains 10 mg atorvastatin (as atorvastatin calcium trihydrate).
Excipient(s) with known effect: Each Lipitor 10 mg film-coated tablet contains 27.25 mg lactose monohydrate and 0.00004 mg benzoic acid.
For the full list of excipients, see section 6.1.
| Active Ingredient |
|---|
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Atorvastatin is a selective, competitive inhibitor of HMG-CoA reductase. Atorvastatin lowers plasma cholesterol and lipoprotein serum concentrations by inhibiting HMG-CoA reductase and subsequently cholesterol biosynthesis in the liver and increases the number of hepatic LDL receptors on the cell surface for enhanced uptake and catabolism of LDL. |
| List of Excipients |
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Tablet core: Calcium carbonate Film coat: Film coating containing: Hypromellose Simeticone emulsion containing: Simeticone |
The blisters consist of a forming film made of polyamide/aluminium foil/polyvinyl chloride and a backing made of aluminium foil/vinyl heat-seal coating.
The bottle is made of HDPE, containing desiccant, with squeeze-and-turn child-resistant closure.
Blister packs containing 4, 7, 10, 14, 20, 28, 30, 50, 56, 84, 90, 98 and 100 film-coated tablets.
Hospital packs containing 50, 84, 100, 200 (10 × 20) or 500 film-coated tablets.
HDPE bottle containing 90 film-coated tablets.
Not all pack sizes may be marketed.
Upjohn UK Limited, Ramsgate Road, Sandwich, Kent, CT13 9NJ, United Kingdom
PL 50622/0036
Date of first authorisation: 8 September 1997
Date of latest renewal: 03 March 2013
| Drug | Countries | |
|---|---|---|
| LIPITOR | Australia, Brazil, Canada, Cyprus, Germany, Ecuador, Finland, Hong Kong, Ireland, Israel, Japan, Malta, Mexico, Nigeria, Netherlands, New Zealand, Singapore, Turkey, United Kingdom, United States, South Africa |
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