Menopause (Global Therapeutics Pty Ltd)
Product Name
Menopause
Sponsor
ARTG
300631
Date of review outcome
Date of publication
Sep-22
Outcome
Medicine is no longer permitted to be supplied
Is it safe to continue using this medicine?
Yes
What action should consumers take?
Consider whether the medicine is right for you given that claims related to the management of menopausal symptoms were not substantiated, except for hot flushes and excessive perspiration.
Review scope
Targeted
Information reviewed
ARTG Record, Evidence, Labels, Website
Issues related to safety
None
Issues related to efficacy
The sponsor did not hold sufficient evidence to support the advertised claims in relation to the use of the medicine, detailed in 'What action should consumers take?’ above. The method of preparation for ingredients, the dosage of some ingredients and/or the product formulation in the evidence did not align with that of the medicine. Some of the evidence was not relevant to the medicine as it described management of menopausal symptoms with hormone replacement therapy or did not describe a use for any of the ingredients in the medicine in the management of menopausal symptoms.
The website for the medicine claimed the medicine was traditionally used in Chinese medicine to relieve moodiness and support reproductive hormone health during menopause. However, these claims were not covered by the sponsor’s certification that they held evidence to substantiate them.
The website for the medicine claimed the medicine was traditionally used in Chinese medicine to relieve moodiness and support reproductive hormone health during menopause. 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 educational letter to the sponsor outlining the issues with the medicine. The sponsor was not required to respond but was expected to correct the identified issues. During the review, sponsorship of the medicine changed to McPherson's Consumer Products Pty Ltd, who cancelled the medicine and withdrew it from further supply.