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Avodart 0.5mg soft capsules (2012)

Active ingredients: Dutasteride

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.

Chemical substance
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
Authorization dates

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

17 January 2003 / 13 February 2008

Marketing authorization number:

19494/0006