Source: European Medicines Agency (EU) Revision Year: 2023 Publisher: Viatris Healthcare Limited, Damastown Industrial Park, Mulhuddart, Dublin 15, Dublin, Ireland
Cholib 145 mg/20 mg film-coated tablets.
Pharmaceutical Form |
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Film-coated tablet (tablet). Oval, biconvex, tan coloured, film-coated tablet, with bevelled edges and 145/20 on one side. The diameter dimensions are 19.3 × 9.3 mm approximately and the tablet weight is about 734 mg. |
One film-coated tablet contains 145 mg of fenofibrate and 20 mg of simvastatin.
Excipient(s) with known effect: One film-coated tablet contains 160.1 mg of lactose (as monohydrate), 145 mg of sucrose, 0.7 mg of lecithin (derived from soya bean (E322)) and 0.17 mg of sunset yellow FCF (E110).
For the full list of excipients, see section 6.1.
Active Ingredient | Description | |
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Fenofibrate |
Fenofibrate is a fibric acid derivative whose lipid modifying effects reported in humans are mediated via activation of Peroxisome Proliferator Activated Receptor type α (PPARα). Through activation of PPARα, fenofibrate increases lipolysis and elimination of atherogenic triglyceride rich particles from plasma by activating lipoprotein lipase and reducing production of Apoprotein C-III. |
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Simvastatin |
Simvastatin has a potent activity in inhibiting HMG-CoA reductase (3-hydroxy–3-ethylglutaryl-CoA-reductase). Simvastatin has been shown to reduce both normal and elevated LDL-C concentrations. |
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Simvastatin and Fenofibrate |
The effects of simvastatin and fenofibrate are complementary. Simvastatin has a potent activity in inhibiting HMG-CoA reductase, an enzyme that catalyses the conversion of HMG-CoA to mevalonate, an early and rate-limiting step in the biosynthesis of cholesterol. Fenofibrate is a fibric acid derivative whose lipid modifying effects reported in humans are mediated via activation of Peroxisome Proliferator Activated Receptor type alpha (PPARα). Through activation of PPARα, fenofibrate activates lipoprotein lipase production and reduces production of apoprotein CIII. |
List of Excipients |
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Tablet core: Butylhydroxyanisole (E320) Film-coating: Poly (vinyl alcohol), partially hydrolysed (E1203) |
Alu/Alu blisters.
Pack sizes: 10, 30 and 90 film-coated tablets.
Not all pack sizes may be marketed.
Viatris Healthcare Limited, Damastown Industrial Park, Mulhuddart, Dublin 15, Dublin, Ireland
EU/1/13/866/001-002
EU/1/13/866/005
Date of first authorisation: 26 August 2013
Date of latest renewal: 16 May 2018
Drug | Countries | |
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CHOLIB | Austria, Cyprus, Estonia, Hong Kong, Croatia, Ireland, Lithuania, Poland, Singapore, United Kingdom |
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