LIVAZO Film-coated tablet Ref.[8040] Active ingredients: Pitavastatin

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2017  Publisher: Kowa Pharmaceutical Europe Co. Ltd., Winnersh Triangle, Wokingham RG41 5RB, UK

Product name and form

Livazo 1mg film-coated tablets.

Livazo 2mg film-coated tablets.

Livazo 4mg film-coated tablets.

Pharmaceutical Form

Film-coated tablet.

Round white film-coated tablets embossed ‘KC’ on one face and ‘1’ on the reverse.

Round white film-coated tablets embossed ‘KC’ on one face and ‘2’ on the reverse.

Round white film-coated tablets embossed ‘KC’ on one face and ‘4’ on the reverse.

Qualitative and quantitative composition

1mg: Each film-coated tablet contains pitavastatin calcium equivalent to 1mg pitavastatin. Excipient(s) include 63.085mg Lactose monohydrate.

For a full list of excipients see section 6.1.

2mg: Each film-coated tablet contains pitavastatin calcium equivalent to 2mg pitavastatin. Excipient(s) include 126.17mg Lactose monohydrate.

For a full list of excipients see section 6.1.

4mg: Each film-coated tablet contains pitavastatin calcium equivalent to 4mg pitavastatin. Excipient(s) include 252.34mg Lactose monohydrate.

For a full list of excipients see section 6.1.

Active Ingredient Description
Pitavastatin

Pitavastatin competitively inhibits HMG-CoA reductase, the rate-limiting enzyme in the biosynthesis of cholesterol, and inhibits cholesterol synthesis in the liver.

List of Excipients

Tablet core:

Lactose monohydrate
Low substituted hydroxypropylcellulose
Hypromellose (E464)
Magnesium Aluminometasilicate
Magnesium stearate

Film coating:

Hypromellose (E464)
Titanium dioxide (E171)
Triethyl citrate (E1505)
Colloidal anhydrous silica

Pack sizes and marketing

1mg: White PVdC coated PVC/AL blisters in cartons of 7, 28, 30, 90 or 100 tablets. Not all pack sizes may be marketed.

2mg: White PVdC coated PVC/AL blisters in cartons of 7, 28, 30, 90 or 100 tablets. Not all pack sizes may be marketed.

4mg: White PVdC coated PVC/AL blisters in cartons of 7, 28 or 30 tablets. Not all pack sizes may be marketed.

Marketing authorization holder

Kowa Pharmaceutical Europe Co. Ltd., Winnersh Triangle, Wokingham RG41 5RB, UK

Marketing authorization dates and numbers

1mg: PL32363/0011
2mg: PL32363/0001
4mg: PL32363/0002

12/08/2010

Drugs

Drug Countries
LIVAZO Germany, Spain, Ireland, Poland

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