ZOSTRIX

Main information

  • Trade name:
  • ZOSTRIX capsaicin 0.025%w/w cream tube
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • ZOSTRIX capsaicin 0.025%w/w cream tube
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 19658
  • Last update:
  • 01-12-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

19658

ZOSTRIX capsaicin 0.025%w/w cream tube

ARTG entry for

Medicine Registered

Sponsor

Link Medical Products Pty Ltd T/A Link Pharmaceuticals

Postal Address

PO Box 718,Mona Vale, NSW, 1660

Australia

ARTG Start Date

14/10/1991

Product category

Medicine

Status

Active

Approval area

Non-Prescription Medicines

Conditions

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

Accepted for Registration or Listing as Goods Currently Supplied at the Commencement of the Therapeutic Goods Act 1989"

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. ZOSTRIX capsaicin 0.025%w/w cream tube

Product Type

Single Medicine Product

Effective date

29/08/2012

Warnings

No Warnings included on Record

Standard Indications

Specific Indications

May be useful as an adjunct in the temporary relief of pain associated with arthritis. May be useful for the treatment of post-herpetic neuralgia (pain

following shingles)

Additional Product information

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Tube

HDPE

3 Years

Store below 25

degrees Celsius

Not recorded

Not recorded

Pack Size/Poison information

Pack Size

Poison Schedule

Not scheduled. Not considered by committee

Components

1.

Dosage Form

Cream

Route of Administration

Topical

Visual Identification

Smooth white cream

Active Ingredients

Capsaicin

.25 mg/g

© 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 02.12.2017 at 07:18:38 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

There are no safety alerts related to this product.

11-7-2018

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