PRODART Soft gelatin capsule Ref.[115228] Active ingredients: Dutasteride

Source: Health Products Regulatory Authority (ZA)  Revision Year: 2023  Publisher: Austell Pharmaceuticals (Pty) Ltd, 1 Sherborne Road, Parktown, JOHANNESBURG, 2193, South Africa, Tel: 0860287835, www.austell.co.za

Product name and form

PRODART 0,5 mg soft gelatin capsules.

Pharmaceutical Form

Soft gelatin capsules.

A dull yellow, opaque colour, oblong shape, soft gelatin capsule containing clear transparent liquid imprinted with “DUTA 05” using black coloured edible ink.

Qualitative and quantitative composition

Each soft gelatin capsule contains 0,5 mg dutasteride.

Sugar free.

For the full list of excipients, see section 6.1.

Active Ingredient

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:

Butylated hydroxy toluene (0,01% m/m)
Glycerol monocrylocaprate

Capsule shell:

Ferric oxide yellow
Gelatin
Glycerine
Glyceryl monocaprylocaprate
Purified water
Titanium dioxide
Printing ink (consisting of black iron oxide, hypromellose, isopropyl alcohol, purified water, propylene glycol)

Pack sizes and marketing

Capsules are packed in white opaque PVC/PVDC and Aluminium foil blister strips of 10, which are further packed in printed cartons, in pack sizes of 30 or 100 capsules.

Not all pack sizes may be marketed.

Marketing authorization holder

Austell Pharmaceuticals (Pty) Ltd, 1 Sherborne Road, Parktown, JOHANNESBURG, 2193, South Africa, Tel: 0860287835, www.austell.co.za

Marketing authorization dates and numbers

52/21.12/1015

24 May 2022

Drugs

Drug Countries
PRODART South Africa

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