AKM DUTASTERIDE (Pharmacor Pty Ltd)
Product name
AKM DUTASTERIDE
Sponsor
Date registered
Evaluation commenced
Decision date
Approval time
130 (255 working days)
Active ingredients
dutasteride
Registration type
New generic medicine
Indication
[TRADENAME] 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.