Source: Υπουργείο Υγείας (CY) Revision Year: 2021 Publisher: Delorbis Pharmaceuticals Ltd., 17 Athinon Street, Ergates Industrial Area, 2643 Ergates, P.O. Box 28629, 2081 Lefkosia, Cyprus, European Union
Statol 5 mg film-coated tablets.
Statol 10 mg film-coated tablets.
Statol 20 mg film-coated tablets.
Statol 40 mg film-coated tablets.
| Pharmaceutical Form |
|---|
|
Film-coated tablets. 5 mg: Yellow, round, biconvex, coated tablet, embossed ‘ROS’ over ‘5’ on one side and nothing on the other, with diameter 7 mm. 10 mg: Pink, round, biconvex, coated tablet, embossed ‘ROS’ over ‘10’ on one side and nothing on the other, with diameter 7 mm. 20 mg: Pink, round, biconvex, coated tablet, embossed ‘ROS’ over ‘20’ on one side and nothing on the other, with diameter 9 mm. 40 mg: Pink, oval, biconvex, coated tablet, embossed ‘ROS’ on one side and ‘40’ on the other side, with dimensions 6.8 × 11.4 mm. |
Each tablet contains 5 mg rosuvastatin (as rosuvastatin calcium).
Excipient(s) with known effect:
Each tablet contains 100.915 mg lactose monohydrate.
Each tablet contains 10 mg rosuvastatin (as rosuvastatin calcium).
Excipient(s) with known effect:
Each tablet contains 95.706 mg lactose monohydrate.
Each tablet contains 20 mg rosuvastatin (as rosuvastatin calcium).
Excipient(s) with known effect:
Each tablet contains 191.412 mg lactose monohydrate.
Each tablet contains 40 mg rosuvastatin (as rosuvastatin calcium).
Excipient(s) with known effect:
Each tablet contains 172.824 mg lactose monohydrate.
For the 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: Microcrystalline cellulose Tablet coat: 5 mg tablet: Opadry II Yellow 33K12488 (Hypromellose, titanium dioxide (E171), lactose monohydrate, triacetin, iron oxide yellow (E172)). 10 mg tablet: Opadry II Pink 33K94423 (Hypromellose, titanium dioxide (E171), lactose monohydrate, triacetin, iron oxide red (E172)). 20 mg tablet: Opadry II Pink 33K94423 (Hypromellose, titanium dioxide (E171), lactose monohydrate, triacetin, iron oxide red (E172)). 40 mg tablet: Opadry II Pink 33K94424 (Hypromellose, titanium dioxide (E171), lactose monohydrate, triacetin, iron oxide red (E172)). |
OPA-Al-PVC/Al blisters.
Pack sizes: 14, 20, 28, 30, 56, 60, 84, 90 and 100 film-coated tablets.
Not all pack sizes may be marketed.
Delorbis Pharmaceuticals Ltd., 17 Athinon Street, Ergates Industrial Area, 2643 Ergates, P.O. Box 28629, 2081 Lefkosia, Cyprus, European Union
Statol 5 mg film-coated tablets: 022934
Statol 10 mg film-coated tablets: 022935
Statol 20 mg film-coated tablets: 022936
Statol 40 mg film-coated tablets: 022937
Date of first authorisation: 22/04/2019
| Drug | Countries | |
|---|---|---|
| STATOL | Cyprus, Malta |
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