ISOTRETINOIN

Main information

  • Trade name:
  • ISOTRETINOIN AN isotretinoin 10mg capsule - soft blister pack
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • ISOTRETINOIN AN isotretinoin 10mg capsule - soft blister pack
    Australia
  • Language:
  • English

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 186339
  • Last update:
  • 13-11-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

186339

ISOTRETINOIN AN isotretinoin 10mg capsule - soft blister pack

ARTG entry for

Medicine Registered

Sponsor

Amneal Pharma Australia Pty Ltd

Postal Address

12 River Street,SOUTH YARRA, VIC, 3141

Australia

ARTG Start Date

8/06/2012

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. ISOTRETINOIN AN isotretinoin 10mg capsule - soft blister pack

Product Type

Single Medicine Product

Effective date

22/09/2015

Warnings

See Product Information and Consumer Medicine Information for this product

Standard Indications

Specific Indications

ISOTRETINOIN AN is indicated for the treatment of severe cystic acne and a single course of therapy has been shown to result in complete and

prolonged remission of disease in many patients. If a second course of therapy is needed, it should not be initiated until at least eight weeks after

completion of the first course, since experience has shown that patients may continue to improve while off the drug. Because of significant adverse

effects associated with its use, isotretinoin should be reserved for patients with severe cystic acne who are unresponsive to conventional therapy,

including systemic antibiotics.

Additional Product information

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Blister Pack

PVC/PVDC/Al

3 Years

Store below 25

degrees Celsius

Not recorded

Protect from Light

Protect from Moisture

Pack Size/Poison information

Pack Size

Poison Schedule

30 capsules

(S4) Prescription Only Medicine

15 capsules

(S4) Prescription Only Medicine

90 capsules

(S4) Prescription Only Medicine

60 capsules

(S4) Prescription Only Medicine

Components

1. Medicine Component

Dosage Form

Capsule, soft

Route of Administration

Oral

Visual Identification

Light violet coloured oblong soft gelatin capsules, containing a

yellow-orange opaque viscous liquid

Active Ingredients

Isotretinoin

10 mg

© 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 29.11.2017 at 02:58:31 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