Source: Health Products Regulatory Authority (ZA) Revision Year: 2024 Publisher: Viatris Healthcare (Pty) Ltd, 4 Brewery Street, Isando, Gauteng, 1601
VASTOR 10 mg (film-coated tablets).
VASTOR 20 mg (film-coated tablets).
VASTOR 40 mg (film-coated tablets).
VASTOR 80 mg (film-coated tablets).
| Pharmaceutical Form |
|---|
|
VASTOR 10 mg: White, oval, biconvex, film coated tablet, plain on one side and debossed '10' on the other side. VASTOR 20 mg: White, oval biconvex, film coated tablet with break line on one side and debossed '20' on the other side. VASTOR 40 mg: White, oval, biconvex film coated tablet with break line on one side and debossed '40' on the other side. VASTOR 80 mg: White, oval, biconvex, film coated table with break line on one side and debossed '80' on the other side. |
VASTOR 10 mg: Each film-coated tablet contains atorvastatin calcium equivalent to 10 mg atorvastatin. Contains sugar: Lactose anhydrous 42,5 mg
VASTOR 20 mg: Each film-coated tablet contains atorvastatin calcium equivalent to 20 mg atorvastatin. Contains sugar: Lactose anhydrous 85 mg
VASTOR 40 mg: Each film-coated tablet contains atorvastatin calcium equivalent to 40 mg atorvastatin. Contains sugar: Lactose anhydrous 170 mg
VASTOR 80 mg: Each film-coated tablet contains atorvastatin calcium equivalent to 80 mg atorvastatin.
Contains sugar: Lactose anhydrous 340 mg.
For full list of excipients, see section 6.1.
| Active Ingredient |
|---|
|
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 |
|---|
|
Tablet core: Croscarmellose sodium Film-coat: Opadry AMB white OY-B-28920 |
HDPE bottle pack (without stabilox):
High-density polyethylene (HDPE) bottle pack comprises of white opaque HDPE bottle provided along with a polypropylene (PP) screw cap.
The HDPE bottle is placed in a carton (excl. Tender).
Pack sizes: 28's, 30's, 90's and 500's.
HDPE bottle pack (with activated carbon):
High-density polyethylene (HDPE) bottle pack comprises of white opaque HDPE bottle with desiccant (activated Carbon Minipax) sachet provided with a polypropylene (PP) screw cap.
The HDPE bottle is placed in a carton (exc. Tender).
Pack sizes: 28's, 30's 90's and 500's.
Cold Form Blister Pack:
Cold form blister pack (marketable pack) comprises of cold form laminate on one side [aluminium foil laminated to oriented polyamide on one side and laminated to PVC on other side, (i.e. OPA/AI/PVC)] and hard tempered aluminium foil coated with heat seal lacquer on the other side.
The blisters are placed in a carton. 7 or 10 tablets per blister strip packed as 28's or 30's.
PVC/Aclar Blister Pack:
PVC/Aclar blister pack comprises of clear, transparent, PVC laminated with Aclar on one side and hard tempered aluminium foil coated with VMCH heat seal lacquer on the other side.
The blisters are placed in a carton. 7, 10 or 15 tablets per blister strip packed as 28's or 30's.
Not all packs may be marketed.
Viatris Healthcare (Pty) Ltd, 4 Brewery Street, Isando, Gauteng, 1601
VASTOR 10 mg: 45/7.5/0527
VASTOR 20 mg: 45/7.5/0528
VASTOR 40 mg: 45/7.5/0529
VASTOR 80 mg: 45/7.5/0530
21 June 2013
| Drug | Countries | |
|---|---|---|
| VASTOR | South Africa |
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