Promensil Menopause Double Strength (Pharmacare Laboratories Pty Ltd)
Product Name
Promensil Menopause Double Strength
Sponsor
Date of review outcome
Date of publication
Mar-22
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 claims related to 'with menopause', 'during menopause' and 'throughout menopause' were not substantiated by the sponsor. Additionally, the medicine my not work as expected in relation to claims associated with vitality and dry skin.
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 claims related to 'with menopause', 'during menopause' and 'throughout menopause'. The evidence was not sufficient as the subjects included in the clinical studies were post-menopausal women only. The label claim for 'vitality' and the website claim for 'relief from dry skin' were not covered by the sponsors certification that they held evidence to substantiate them.
Actions taken during the review
The TGA required the sponsor to correct the issues with the medicine. The sponsor removed claims related to 'with menopause', 'during menopause' and 'throughout menopause' from the label, website and ARTG record. The sponsor removed the claims 'vitality' from the label and 'relief from dry skin' from the website.