h max (Aussia Pharma)
Product Name
h max
Sponsor
ARTG
393316
Date of review outcome
Date of publication
Sep-2023
Outcome
Medicine is no longer permitted to be supplied
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 increasing height, bone mineral density, bone formation or bone development in growing children
Review scope
Targeted
Information reviewed
ARTG Record, Labels
Issues related to safety
The safety of this medicine was not assessed as part of this review
Issues related to efficacy
The label and name for this medicine implied it can increase height of a person. In addition, the label claimed that this medicine may help increase bone mineral density, bone formation or bone development in growing children. However, these claims were not covered by the sponsor's certification that they held evidence to substantiate it.
Actions taken during the review
The TGA required the sponsor to correct the issues with this medicine. The sponsor cancelled this medicine and withdrew it from further supply.