PLUMP (Ariya Health)
Product Name
PLUMP
Sponsor
ARTG
Date of review outcome
Date of publication
Sep-2023
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 based on it potentially not working as expected in relation to relieving vulval itch, relieving vaginal discomfort and dryness, supporting healthy vaginal pH, supporting vaginal healthy flora, supporting cholesterol levels, promoting blood vessel health, promoting collagen formation, maintaining healthy mucous membranes, promoting skin regeneration, supporting ulcer healing, promoting bile secretion, relieving dry eye, improving cognitive function, and supporting heart health.
Review scope
Targeted
Information reviewed
ARTG Record, Advertising (other), Labels, Website
Issues related to safety
None
Issues related to efficacy
The website and other advertising for this medicine contained claims specified in 'What actions 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 TGA required the sponsor to correct the issues with this medicine. The sponsor updated the ARTG record, website, and other advertising for this medicine to correct these issues.