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Therapeutic Goods Act 1989
Notification under section 42DG of approval of use of restricted representations by Abbott Australasia Pty Ltd
I, Leanne McCauley, Delegate of the Secretary to the Department of Health for the purposes of section 42DG of the Therapeutic Goods Act 1989 (the Act), advise that following receipt of an application from Abbott Australasia Pty Ltd, the restricted representations described in paragraph (A) below for use in advertisements directed to consumers, for the products identified in paragraph (B), were approved on 16 July 2019:
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- Representations referring to diabetes" in the context of the Applicant's trading name "Abbott Diabetes Care".
- "This product is indicated for measuring interstitial fluid glucose levels in people (aged 4 and older) with insulin-requiring diabetes."
- "for people living with diabetes".
FreeStyle Libre Flash Glucose Monitoring System Sensor (ARTG 269198)
Invasive interstitial-fluid glucose monitoring system (ARTG 233514)
Information system software, application program, home healthcare (ARTG 231278)
Dated this 2nd day of August 2019
Signed electronically
Leanne McCauley
Delegate of the Secretary to the Department of Health
Advertising Compliance Section
Regulatory Education and Compliance Branch