Dutasteride

Main information

  • Trade name:
  • Dutasteride APOTEX dutasteride 500 microgram soft capsule blister pack
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • Dutasteride APOTEX dutasteride 500 microgram soft capsule blister pack
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 212043
  • Last update:
  • 09-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

212043

Dutasteride APOTEX dutasteride 500 microgram soft capsule blister pack

ARTG entry for

Medicine Registered

Sponsor

Apotex Pty Ltd

Postal Address

PO Box 280,NORTH RYDE BC, NSW, 1670

Australia

ARTG Start Date

28/02/2014

Product category

Medicine

Status

Active

Approval area

Drug Safety Evaluation Branch

Conditions

Conditions applicable to all therapeutic goods as specified in the document "Standard Conditions Applying to Registered or Listed Therapeutic Goods

Under Section 28 of the Therapeutic Goods Act 1989" effective 1 July 1995.

Conditions applicable to the relevant category and class of therapeutic goods as specified in the document "Standard Conditions Applying to Registered

or Listed Therapeutic Goods Under Section 28 of the Therapeutic Goods Act 1989" effective 1 July 1995.

Products

1. Dutasteride APOTEX dutasteride 500 microgram soft capsule blister pack

Product Type

Single Medicine Product

Effective date

16/10/2017

Warnings

See Product Information and Consumer Medicine Information for this product

Standard Indications

Specific 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.

Additional Product information

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Blister Pack

PVC/PVDC/Al

24 Months

Store below 25

degrees Celsius

Not recorded

Not recorded

Pack Size/Poison information

Pack Size

Poison Schedule

(S4) Prescription Only Medicine

Components

1. Dutasteride APOTEX dutasteride 500 microgram soft capsule blister pack

Dosage Form

Capsule, soft

Route of Administration

Oral

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

Active Ingredients

Dutasteride

500 microgram

© Commonwealth of Australia.This work is copyright.You are not permitted to re-transmit, distribute or commercialise the material without obtaining prior

written approval from the Commonwealth.Further details can be found at http://www.tga.gov.au/about/website-copyright.htm.

Public Summary

Page 1 of

Produced at 27.11.2017 at 12:46:34 AEDT

This is not an ARTG Certificate document.

The onus is on the reader to verify the current accuracy of the information on the document subsequent to the date shown.

Visit www.tga.gov.au for contact information