Therapeutic Goods Act 1989
Approval under section 42DF for use of restricted representations by Sanofi-Aventis Healthcare Pty Ltd t/a Sanofi Consumer Healthcare
I, Leanne McCauley, Director, Advertising Compliance Unit, Regulatory Practice, Education and Compliance Branch and Delegate of the Secretary to the Department of Health, on receipt of an application from Sanofi-Aventis Healthcare Pty Ltd T/A Sanofi Consumer Healthcare, 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 conditions identified in paragraph (c) are met:
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- Early detection test for diabetic foot neuropathy and diagnostic test for sudomotoric dysfunction (Anhydrosis).
- Healthy feet should be a major concern to all people with diabetes.
- An innovative, simple, non-invasive indicator test, developed for the assessment of sweating in order to prevent or counteract the development of diabetic foot syndrome.
- This device may not be suitable for every person with diabetes, seek the advice of your healthcare professional.
- "Neuropad" - Adhesive strip, skin-cover (ARTG No. 275472)
- the representations at (a) above must be accompanied by prominent warning statements to the effect of:
- a normal result does not preclude diabetic foot syndrome or foot neuropathy
- use of Neuropad does not replace the need for patient vigilance for the early signs of diabetic foot neuropathy and regular consultation with their healthcare professional
- common signs of diabetic foot neuropathy include numbness, reduced pain, inability to sense temperature change, tingling or burning sensation, sharp pains or cramps, increased touch sensitivity, muscle weakness, loss of reflexes, loss of balance, ulcers or foot deformity. Consult your doctor if you experience any of these signs even in the event of a normal test result.
Dated this 30th day of September 2016
Leanne McCauley
Delegate of the Secretary to the Department of Health; and
Director
Advertising Compliance Unit
Regulatory Practice, Education and Compliance Branch