MENOPAUSE EZE COOL & CALM (Caruso's Natural Health Pty Ltd)
Product Name
MENOPAUSE EZE COOL & CALM
Sponsor
Date of review outcome
Date of publication
Dec-2024
Outcome
Medicine continues to be permitted for supply
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?
Consider whether this medicine is right for you given the claim about maintaining female hormonal balance during menopause was 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 did not hold sufficient evidence to support the claim relating to maintaining female hormonal balance during menopause. The limitations with the evidence included it not being of sufficient quality, and the conclusions not being relevant to the claim.
Actions taken during the review
The sponsor removed the claim from the ARTG record, label and website. Nevertheless, the TGA issued an educational letter to the sponsor outlining the issue with this medicine.