LOVASTATIN MYLAN Tablets Ref.[8308] Active ingredients: Lovastatin

Source: European Medicines Agency (EU)  Revision Year: 2012  Publisher: Mylan AB

Product name and form

Lovastatin Mylan.

Pharmaceutical Form

Tablets.

20 mg: Pale blue, octagonal tablets marked “LV/20” on one side and “G” on the other, with score-line on one side.

40 mg: Green, octagonal tablets marked “LV/40” on one side and “G” on the other, with score-line on one side.

Qualitative and quantitative composition

Lovastatin 20 mg and 40 mg.

For a full list of excipients see section 6.1.

Active Ingredient Description
Lovastatin

Lovastatin, which is an inactive lactone, is hydrolysed after oral administration to the corresponding β-hydroxyacid. This is the major metabolite and an inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase, an enzyme that catalyses an early and rate-limiting step in the biosynthesis of cholesterol.

List of Excipients

20 mg:

Pregelatinised starch
Microcrystalline cellulose
Magnesium stearate
Butylated hydroxyanisole (E320)
Indigo carmine (E132)

40 mg:

Pregelatinised starch
Microcrystalline cellulose
Mmagnesium stearate
Butylated hydroxyanisole (E320)
Indigo carmine (E132)
Quinoline yellow (E104)

Pack sizes and marketing

Aluminium/aluminium blister.

Pack sizes: 10, 28, 30, 50, 100. Not all pack sizes may be marketed.

Marketing authorization holder

Mylan AB

Marketing authorization dates and numbers

20 mg: 32379

40 mg: 32380

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