Balance (PuraU)
Product Name
Balance
Sponsor
ARTG
388701
Date of review outcome
Date of publication
Jun-2024
Outcome
Medicine is no longer permitted to be supplied
Is it safe to continue using this medicine?
Yes, based on the sponsor's certification. However, follow the recommended actions below.
What action should consumers take?
Be aware that this medicine is not a substitute for the responsible consumption of alcohol.
Consider whether this medicine is right for you given that it may not work as expected in relation to use in traditional Western herbal medicine to relieve irregular periods, relieve premenstrual tension, support healthy female hormone balance, reduce menstrual cycle irregularity and relieve premenstrual syndrome. reduce the symptoms of acne, reduce the symptoms of congested pores, reduce the symptoms of skin redness and inflammation.
Consider whether this medicine is right for you given that it may not work as expected in relation to use in traditional Western herbal medicine to relieve irregular periods, relieve premenstrual tension, support healthy female hormone balance, reduce menstrual cycle irregularity and relieve premenstrual syndrome. reduce the symptoms of acne, reduce the symptoms of congested pores, reduce the symptoms of skin redness and inflammation.
Review scope
Targeted
Information reviewed
ARTG Record, Labels, Website
Issues related to safety
This medicine made claims related to alcohol-related gut damage. Medicines that make claims related to detoxification cannot refer to or imply alcohol, as it may lead to unsafe use.
However, current data indicates that use of this medicine is unlikely to pose an immediate risk to consumer health and safety.
However, current data indicates that use of this medicine is unlikely to pose an immediate risk to consumer health and safety.
Issues related to efficacy
The website for this medicine contained claims specified in 'What action should consumers take?' above. However, these claims were not covered by the sponsor's certification that they held evidence to substantiate them.
Actions taken during the review
The sponsor cancelled this medicine and withdrew it from further supply. Nevertheless, the TGA issued an educational letter to the sponsor.