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USANA CellSentials Prenatal Core Minerals (Usana Australia Pty Ltd)
Product Name
USANA CellSentials Prenatal Core Minerals
Sponsor
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
What action should consumers take?
None
Review scope
Targeted
Information reviewed
ARTG Record, Labels
Issues related to safety
The ARTG record and label for this medicine contained claims that are not permitted for medicines for pregnant consumers, while this medicine's name suggests its use in this population. Use of this medicine for such claims in this population may pose a safety risk for the mother and/or their unborn baby. However, given this medicine was never marketed, it does not pose an immediate risk to consumer health and safety.
Issues related to efficacy
This medicine made claims regarding pregnancy that are not permitted for listed medicines. 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 and label to correct the issues.