Avodart 0.5mg soft capsules Ref.[2774] Active ingredients: Dutasteride

Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2012 Publisher: GlaxoSmithKline UK Limited 980 Great West Road Brentford Middlesex TW8 9GS United Kingdom Trading as: GlaxoSmithKline UK Ltd Stockley Park West Uxbridge Middlesex UB11 1BT

Product name and form

Avodart 0.5 mg soft capsules.

Pharmaceutical Form
Capsules, soft. The capsules are opaque, yellow, oblong soft gelatin capsules imprinted with GX CE2 on one side in red ink.

Qualitative and quantitative composition

Each capsule contains 0.5 mg dutasteride.

For a full list of excipients, see section 6.1.

Active Ingredient	Description
Dutasteride	Dutasteride reduces circulating levels of dihydrotestosterone (DHT) by inhibiting both type 1 and type 2, 5α-reductase isoenzymes which are responsible for the conversion of testosterone to DHT.

List of Excipients
Capsule contents: Mono- and diglycerides of caprylic/capric acid Butylhydroxytoluene (E321) Capsule shell: Gelatin Glycerol Titanium dioxide (E171) Iron oxide yellow (E172) Triglycerides, medium chain Lecithin Red printing ink containing: iron oxide red (E172) as the colourant, polyvinyl acetate phthalate, propylene glycol and Macrogol 400

Pack sizes and marketing

Blisters of opaque PVC/PVDC film containing 10 soft gelatin capsules packed into containers of 10, 30, 60 and 90 capsules. Not all pack sizes may be marketed.

Marketing authorization holder

GlaxoSmithKline UK Limited
980 Great West Road
Brentford
Middlesex
TW8 9GS
United Kingdom

Trading as:

GlaxoSmithKline UK Ltd
Stockley Park West
Uxbridge
Middlesex
UB11 1BT

Marketing authorization dates and numbers

19494/0006

17 January 2003 / 13 February 2008

Drugs

Drug	Countries
AVODART	Austria, Australia, Brazil, Canada, Cyprus, Germany, Ecuador, Estonia, Finland, France, Hong Kong, Croatia, Ireland, Israel, Italy, Lithuania, Malta, Mexico, Netherlands, Poland, Romania, Singapore, Tunisia, Turkey, United Kingdom, United States, South Africa

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