Dutasteride APOTEX dutasteride 500 microgram soft capsule blister pack

Active ingredient:

dutasteride, Quantity: 500 microgram

Available from:

Arrotex Pharmaceuticals Pty Ltd

INN (International Name):

Dutasteride

Pharmaceutical form:

Capsule, soft

Composition:

Excipient Ingredients: butylated hydroxytoluene; iron oxide yellow; Gelatin; titanium dioxide; glyceryl caprylate/caprate; glycerol; propylene glycol; butan-1-ol; isopropyl alcohol; iron oxide red; strong ammonia solution; simethicone; ethanol; Shellac; sulfuric acid

Administration route:

Oral

Units in package:

30

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

This medicine is indicated for use as monotherapy for the management of symptomatic benign prostatic,hyperplasia (BPH) or as combination therapy with an alpha blocker which is approved for use in BPH and,which has been dose titrated in accordance with the relevant recommendations in the product information,for that alpha blocker.

Product summary:

Visual Identification: An oily colourless to pale yellow liquid absent of visible particles and/or crystals in a pale yellow oblong gelatin capsule printed with with 'A 0.5' on one side in red ink; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Licence status A

Authorization date:

2014-02-28