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LIPITOR Film-coated tablets (2019)

Active ingredients: Atorvastatin

Product Name and Form

Lipitor 10 mg film-coated tablets.

Pharmaceutical form

Film-coated tablet.

White, round, 5.6 mm, film-coated tablets debossed ‘10’ on one side and ‘ATV’ on the other.

Qualitative and Quantitative Composition

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.

For the full list of excipients, see section 6.1.

Chemical substance
Description
Atorvastatin

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

Tablet core:

Calcium carbonate
Microcrystalline cellulose
Lactose monohydrate
Croscarmellose sodium
Polysorbate 80
Hydroxypropyl cellulose
Magnesium stearate

Film coat:

Film coating containing:

Hypromellose
Macrogol 8000
Titanium dioxide (E171)
Talc

Simethicone emulsion containing:

Simethicone
Stearate emulsifiers (polyethylene glycol sorbitan tristearate, polyethoxylate stearate, glycerides)
Thickeners (methylcellulose, xanthan gum)
Benzoic acid
Sorbic acid
Sulfuric acid

Pack sizes and Marketing

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.

Marketing authorization holder
Authorization dates

Pfizer Ireland Pharmaceuticals, Operations Support Group, Ringaskiddy, Co Cork, Ireland

Date of first authorisation: 8 September 1997
Date of latest renewal: 03 March 2013

Marketing authorization number:

PL 39933/0001