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Revital 8 (McPherson’s Consumer Products Pty Ltd)
Product Name
Revital 8
ARTG
295067
Date of review outcome
Date of publication
Sep-21
Outcome
Medicine continues to be permitted for supply
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 based on the medicine potentially not working as expected in relation to claims to ‘support cardiovascular system health’, and ‘promotes healthy immune function and helps maintain normal health of the gastrointestinal tract, liver, prostate, skin, eyes and joints’
Review scope
Targeted
Information reviewed
ARTG Record, Labels, Manufacturing Documentation, Website
Issues related to safety
None
Issues related to efficacy
The website of the medicine contained claims that it may ‘support cardiovascular health’ and ‘promotes healthy immune function and helps maintain normal health of the gastrointestinal tract, liver, prostate, skin, eyes and joints’. However, these claims were not covered by the sponsor's certification that they held evidence to substantiate them.
Actions taken during the review
The TGA issued an infringement notice for advertising therapeutic uses that were not accepted as indications for this medicine to Global Therapeutics Pty Ltd, the previous sponsor of this medicine. The sponsor at the time of that advertising, Global Therapeutics Pty Ltd, removed ‘promotes healthy immune function and helps maintain normal health of the gastrointestinal tract, liver, prostate, skin, eyes and joints’ from the website of this medicine.
In addition, the TGA required the current sponsor, McPherson’s Consumer Products Pty Ltd, to correct an additional issue with the medicine. This sponsor removed the claim ‘support cardiovascular system health’ from the website.
In addition, the TGA required the current sponsor, McPherson’s Consumer Products Pty Ltd, to correct an additional issue with the medicine. This sponsor removed the claim ‘support cardiovascular system health’ from the website.