GROW (Ariya Health)
Product Name
GROW
Sponsor
ARTG
Date of review outcome
Date of publication
Jun-23
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 growth. This medicine is for oral use only. Do not use this medicine as a pessary for vaginal administration. Do not exceed a maximum dose of 2 capsules per day.
Review scope
Targeted
Information reviewed
ARTG Record, Advertising (other), Labels, Website
Issues related to safety
The advertising for this medicine incorrectly recommended exceeding the maximum dose of 2 capsules per day and also promoted its use as a pessary. However, this information has been removed. Additionally, this medicine's label includes the correct route of administration and maximum daily dose. As such, this medicine is unlikely to pose an immediate risk to consumer health and safety.
Issues related to efficacy
The name of this medicine made claims regarding growth. This medicine was also advertised for supporting vaginal health. At the time of this review, 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.