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Protandim (LifeVantage Australia Pty Ltd)
Product Name
Protandim
Sponsor
ARTG details
- 235127
Date of review outcome
Date cancellation takes effect
Date of publication
Mar-21
Outcome
Medicine is no longer permitted to be supplied
Is it safe to continue using this medicine?
Yes, if you follow the recommended actions below
What action should consumers take?
Consider whether the medicine is right for you given that claims about the protection of cells from oxidative stress; the maintenance of liver function, digestive function, immune function, energy, and metabolism; the relief of dyspepsia, anxiety, and stress; and ageing, were not substantiated by the sponsor
Review scope
Targeted
Information reviewed
ARTG Record, Evidence, Labels, Website
Issues related to safety
None
Issues related to efficacy
The sponsor either did not hold evidence or the evidence provided was insufficient to support the claims detailed in 'What action should consumers take?' above. Most of the evidence provided was from animal or in vitro studies. The only human clinical study provided did not have appropriate randomisation of test subjects or adequately control for the placebo effect and test subject diet.
Actions taken during the review
The TGA required the sponsor to correct the issues with the medicine. The sponsor did not provide additional information to address the issues. The TGA cancelled the medicine and withdrew permission for further supply.
Grounds for cancellation
The certification under paragraphs 26A(2)(j) and 26A(2)(ja) of the Act is incorrect (paragraph 30(2)(ba) of the Act).The presentation of the listed goods is unacceptable (paragraph 30(2)(aa) of the Act).