Symbion - Nebulizer products

Therapeutic Goods Act 1989

Approval under section 42DF for use of restricted representations by Symbion Pty Ltd

I, Simon Waters, Delegate of the Secretary to the Department of Health, on receipt of an application from Symbion Pty Ltd, have approved under section 42DF of the Therapeutic Goods Act 1989 (the Act) the restricted representations described in paragraph (a) below for use in advertisements directed to consumers, for the product identified in paragraph (b), provided the condition identified in paragraph (c) is met:

1.  
   1. Words to the effect of "delivers prescribed medication related to asthma and other chronic respiratory conditions".
   2. Words to the effect of "helps deliver Asthma and COPD medications efficiently and effectively into the lungs".
   3. Nebuliser therapy systems offer delivery of prescribed medication related to asthma and other chronic respiratory conditions and are recommended for people who:
      • May have difficulty using metered dose inhalers (MDI/puffer)
      • Use large doses of bronchodilators
      • Take medication that cannot be formulated as a metered dose spray.
2.  
   • Nebulizer, non-heated (ARTG No.: 98386);
   • Tubing set, nebulizer (ARTG No: 290689);
   • Tubing set, nebulizer (ARTG No: 290690);
   • Mask, air/oxygen (ARTG No: 290691); and
   • Nebulizer, non-heated (ARTG No: 290692).
3. The statement 'Nebuliser delivery of therapy is not suitable for all medications and conditions. Use only on the advice of your doctor.' must appear whenever any one of, or any combination of, the restricted representations in paragraphs (a)1. to 3. is used.

Dated this 13th day of November 2017

Simon Waters
Delegate of the Secretary to the Department of Health; and
Advertising Compliance Unit
Regulatory Practice, Education and Compliance Branch