AVANDIA Film-coated tablet Ref.[108135] Active ingredients: Rosiglitazone

Source: European Medicines Agency (EU)  Publisher: SmithKline Beecham Ltd, 980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom

Product name and form

AVANDIA 2 mg film-coated tablets.

Pharmaceutical Form

Film-coated tablet.

Pink film-coated tablets debossed with “GSK” on one side and “2” on the other side.

Qualitative and quantitative composition

Each tablet contains rosiglitazone maleate corresponding to 2 mg rosiglitazone.

Excipient: Contains lactose (approximately 108 mg).

For a full list of excipients, see section 6.1.

Active Ingredient Description
Rosiglitazone

Rosiglitazone is a selective agonist at the PPARγ (peroxisomal proliferator activated receptor gamma) nuclear receptor and is a member of the thiazolidinedione class of anti-diabetic agents. It reduces glycaemia by reducing insulin resistance at adipose tissue, skeletal muscle and liver.

List of Excipients

Tablet core:

Sodium starch glycollate (Type A)
Hypromellose
Microcrystalline cellulose
Lactose monohydrate
Magnesium stearate

Film coating (Opadry pink OY-L-24802):

Hypromellose 6cP
Titanium dioxide E171
Macrogol 3000
Lactose monohydrate
Glycerol triacetate
Iron oxide red E172

Pack sizes and marketing

Opaque blister packs (PVC/aluminium). 56, 112, 168 or 180 film-coated tablets or 56 film-coated tablets, unit dose pack.

Not all pack sizes may be marketed.

Marketing authorization holder

SmithKline Beecham Ltd, 980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom

Marketing authorization dates and numbers

EU/1/00/137/002-004
EU/1/00/137/013
EU/1/00/137/016

Date of first authorisation: 11 July 2000
Date of latest renewal: 11 July 2005

Drugs

Drug Countries
AVANDIA Lithuania, United States

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