ATORSTAN Film-coated tablet Ref.[50518] Active ingredients: Atorvastatin

Source: Υπουργείο Υγείας (CY)  Revision Year: 2022  Publisher: Remedica Ltd, Aharnon Str., Limassol Industrial Estate, 3056 Limassol, Cyprus

Product name and form

Atorstan 10 mg film-coated tablets.

Atorstan 20 mg film-coated tablets.

Atorstan 40 mg film-coated tablets.

Atorstan 80 mg film-coated tablets.

Pharmaceutical Form

Film-coated tablet.

White, oval-shaped, film-coated tablets, blank on both sides.

Qualitative and quantitative composition

Atorstan 10 mg film-coated tablets: Each film-coated tablet contains atorvastatin calcium equivalent to 10 mg atorvastatin.

Atorstan 20 mg film-coated tablets: Each film-coated tablet contains atorvastatin calcium equivalent to 20 mg atorvastatin.

Atorstan 40 mg film-coated tablets: Each film-coated tablet contains atorvastatin calcium equivalent to 40 mg atorvastatin.

Atorstan 80 mg film-coated tablets: Each film-coated tablet contains atorvastatin calcium equivalent to 80 mg atorvastatin.

Excipient(s) with known effect:

Each Atorstan 10 mg film-coated tablet contains 33 mg lactose.

Each Atorstan 20 mg film-coated tablet contains 66 mg lactose.

Each Atorstan 40 mg film-coated tablet contains 132 mg lactose.

Each Atorstan 80 mg film-coated tablet contains 264 mg lactose.

For full list of excipients, see section 6.1.

Active Ingredient 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

Core:

Cellulose, microcrystalline
Croscarmellose sodium
Lactose monohydrate
Polysorbate 80
Hydroxypropylcellulose
Calcium carbonate
Magnesium stearate

Coating:

Hypromellose
Titanium dioxide
Macrogol 400

Pack sizes and marketing

Aluminium/Aluminium blisters. Pack-sizes of 14, 28, 30, 100 and 1000 film-coated tablets.

Not all pack sizes may be marketed.

Marketing authorization holder

Remedica Ltd, Aharnon Str., Limassol Industrial Estate, 3056 Limassol, Cyprus

Marketing authorization dates and numbers

Atorstan 10 mg film-coated tablet: 20937
Atorstan 20 mg film-coated tablet: 20938
Atorstan 40 mg film-coated tablet: 20939
Atorstan 80 mg film-coated tablet: 20940

Date of first authorization: 16 May 2011
Date of latest renewal: 16 September 2015

Drugs

Drug Countries
ATORSTAN Cyprus

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