Well-Being (Modere Australia Pty Ltd)
Product Name
Well-Being
Sponsor
ARTG
234237
Date of review outcome
Date of publication
Dec-19
Outcome
Medicine continues to be permitted for supply
Is it safe to continue using this medicine?
Yes
What action should consumers take?
Consider whether the medicine is right for you given that the claims about maintenance or improvement of general well-being, increasing endurance, improving stamina, replenishing vital essence and invigorating qi were not substantiated.
Review scope
Targeted
Information reviewed
Labels, Evidence, Manufacturing documentation, Website, ARTG Record
Issues related to safety
None
Issues related to efficacy
The sponsor did not hold sufficient evidence to support the advertised claims related to maintenance and improvement of general well-being, increasing endurance, improving stamina, replenishing vital essence and invigorating qi. The dosages and method of preparation of ingredients in the evidence provided were not relevant to the medicine. The populations described in the evidence were not relevant to the target population of the medicine. The evidence was not relevant to support indications based on a tradition of use in Traditional Chinese Medicine.
Actions taken during the review
TGA issued an educational letter to the sponsor. The sponsor was not required to respond but was expected to correct these issues.