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

Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2018 Publisher: AstraZeneca UK Ltd, 600 Capability Green, Luton, LU1 3LU, United Kingdom

Product name and form

Crestor 5 mg film-coated tablets.
Crestor 10 mg film-coated tablets.
Crestor 20 mg film-coated tablets.
Crestor 40 mg film-coated tablets.

Pharmaceutical Form
5 mg: Film-coated tablet. Round, yellow coloured tablets, intagliated with ‘ZD4522’ and ‘5’ on one side and plain on the reverse. 10 mg: Film-coated tablet. Round, pink coloured tablets, intagliated with ‘ZD4522’ and ‘10’ on one side and plain on the reverse. 20 mg: Film-coated tablet. Round, pink coloured tablets, intagliated with ‘ZD4522’ and ‘20’ on one side and plain on the reverse. 40 mg: Film-coated tablet. Oval, pink coloured tablets, intagliated with ‘ZD4522’ on one side and ‘40’ on the reverse.

Qualitative and quantitative composition

5 mg: Each tablet contains 5 mg rosuvastatin (as rosuvastatin calcium). Each tablet contains 94.88 mg lactose monohydrate.

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

20 mg: Each tablet contains 20 mg rosuvastatin (as rosuvastatin calcium). Each tablet contains 182.6 mg lactose monohydrate.

40 mg: Each tablet contains 40 mg rosuvastatin (as rosuvastatin calcium). Each tablet contains 168.32 mg lactose monohydrate.

For a full list of excipients, see section 6.1.

Active Ingredient	Description
Rosuvastatin	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, yellow (E172) (5 mg tablet)Ferric oxide, red (E172) (10 mg, 20 mg and 40 mg tablets)

Pack sizes and marketing

5 mg, 10 mg, 20 mg and 40 mg: 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 Ltd, 600 Capability Green, Luton, LU1 3LU, United Kingdom

Marketing authorization dates and numbers

5 mg: PL 17901/0243
10 mg: PL 17901/0201
20 mg: PL 17901/0202
40 mg: PL 17901/0203

21^st March 2003/6^th 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

Next: Usage >

© All content on this website, including data entry, data processing, decision support tools, "RxReasoner" logo and graphics, is the intellectual property of RxReasoner and is protected by copyright laws. Unauthorized reproduction or distribution of any part of this content without explicit written permission from RxReasoner is strictly prohibited. Any third-party content used on this site is acknowledged and utilized under fair use principles.