Bayer Australia - Canesoral Products

Therapeutic Goods Act 1989

Approval under section 42DF for use of restricted representations by Bayer Australia Ltd

I, Leanne McCauley, Delegate of the Secretary to the Department of Health, on receipt of an application from Bayer Australia 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 products identified in paragraph (B):

1. Consult your healthcare professional before use if:
   • you have diabetes
   • you may have a condition that makes you susceptible to thrush, such as diabetes.
2.  
   • "Canesoral Duo Fluconazole capsule and clotrimazole cream composite pack" (AUST R 203513);
   • "Canesoral Fluconazole Capsule" (AUST R 203514)

Dated this 12th day of July 2019

Signed electronically

Leanne McCauley
Delegate of the Secretary to the Department of Health
Advertising Compliance Unit
Regulatory Practice, Education and Compliance Branch