Source: Health Products Regulatory Authority (ZA) Revision Year: 2023 Publisher: AstraZeneca Pharmaceuticals (Pty) Ltd, Building 2, Northdowns Office Park, 17 Georgian Crescent West, Bryanston, Johannesburg, 2191, South Africa
ZUVAMOR 5: 5 mg film-coated tablets.
ZUVAMOR 10: 10 mg film-coated tablets.
ZUVAMOR 20: 20 mg film-coated tablets.
ZUVAMOR 40: 40 mg film-coated tablets.
| Pharmaceutical Form |
|---|
|
Film-coated Tablets. ZUVAMOR 5: Yellow, film-coated, round‚ biconvex, approximately 7 mm (diameter) intagliated tablet; obverse side “ZD4522 5”, reverse side none. ZUVAMOR 10: Pink‚ film-coated, round‚ biconvex, approximately 7 mm (diameter) intagliated tablet; obverse side “ZD4522 10”, reverse side none. ZUVAMOR 20: Pink‚ film-coated, round‚ biconvex, approximately 9,1 mm (diameter) intagliated tablet; obverse side “ZD4522 20”, reverse side none. ZUVAMOR 40: Pink‚ film-coated, oval‚ biconvex, approximately 11,5 × 7,1 mm (length x width) intagliated tablet; obverse side “ZD4522”, reverse side “40”. |
ZUVAMOR 5: Each tablet contains 5 mg rosuvastatin as rosuvastatin calcium.
ZUVAMOR 10: Each tablet contains 10 mg rosuvastatin as rosuvastatin calcium.
ZUVAMOR 20: Each tablet contains 20 mg rosuvastatin as rosuvastatin calcium.
ZUVAMOR 40: Each tablet contains 40 mg rosuvastatin as rosuvastatin calcium.
Contains sugar: lactose monohydrate.
ZUVAMOR 5: Each tablet contains 94,88 mg lactose monohydrate.
ZUVAMOR 10: Each tablet contains 91,30 mg lactose monohydrate.
ZUVAMOR 20: Each tablet contains 182,60 mg lactose monohydrate.
ZUVAMOR 40: Each tablet contains 168,32 mg lactose monohydrate.
For 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: Calcium phosphate Tablet coat: Glycerol triacetate |
ZUVAMOR 5 mg, 10 mg, 20 mg and 40 mg tablets:
Aluminium laminate/aluminium foil blister packs of 28 or 30 tablets.
ZUVAMOR 5 mg, 10 mg, 20 mg and 40 mg tablets:
HDPE bottles: bottles containing 30, 90 or 100 tablets.
AstraZeneca Pharmaceuticals (Pty) Ltd, Building 2, Northdowns Office Park, 17 Georgian Crescent West, Bryanston, Johannesburg, 2191, South Africa
ZUVAMOR 5: 43/7.5/138
ZUVAMOR 10: 36/7.5/0353
ZUVAMOR 20: 36/7.5/0354
ZUVAMOR 40: 36/7.5/0355
Date of first authorization:
ZUVAMOR 5: 27 July 2017
ZUVAMOR 10: 07 April 2006
ZUVAMOR 20: 07 April 2006
ZUVAMOR 40: 07 April 2006
| Drug | Countries | |
|---|---|---|
| ZUVAMOR | South Africa |
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