CRESTOR Film-coated tablet Ref.[7075] Active ingredients: Rosuvastatin

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2026  Publisher: AstraZeneca UK Limited, 1 Francis Crick Avenue, Cambridge, CB2 0AA, UK

Product name and form

Crestor 10 mg film-coated tablets.

Pharmaceutical Form

Round, pink coloured tablets, intagliated with 'ZD4522' and '10' on one side and plain on the reverse.

Qualitative and quantitative composition

Each tablet contains 10 mg rosuvastatin (as rosuvastatin calcium). Each tablet contains 91.3 mg lactose monohydrate.

For a full list of excipients, see section 6.1.

Active Ingredient

Rosuvastatin is a selective and competitive inhibitor of HMG-CoA reductase. Rosuvastatin increases the number of hepatic LDL receptors on the cell-surface, enhancing uptake and catabolism of LDL and it inhibits the hepatic synthesis of VLDL, thereby reducing the total number of VLDL and LDL particles.
List of Excipients

Tablet core:

Lactose monohydrate
Microcrystalline cellulose
Calcium phosphate
Crospovidone
Magnesium stearate

Tablet coat:

Lactose monohydrate
Hypromellose
Triacetin
Titanium dioxide (E171)
Ferric oxide, red (E172)

Pack sizes and marketing

Blisters of aluminium laminate/aluminium foil of 7, 14, 15, 20, 28, 30, 42, 50, 56, 60, 84, 90, 98 and 100 tablets

HDPE containers: 30 and 100 tablets.

Not all pack sizes may be marketed.

Marketing authorization holder

AstraZeneca UK Limited, 1 Francis Crick Avenue, Cambridge, CB2 0AA, UK

Marketing authorization dates and numbers

PL 17901/0201

21st March 2003/6th November 2012

Drugs

Drug Countries
CRESTOR Austria, Australia, Brazil, Canada, Cyprus, Germany, Ecuador, Estonia, Spain, Finland, France, Hong Kong, Ireland, Israel, Italy, Japan, Lithuania, Malta, Mexico, Nigeria, Netherlands, New Zealand, Poland, Romania, Singapore, Tunisia, Turkey, United Kingdom, United States, South Africa
 
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