Prenatal + Pregnancy (JSHealth Vitamins Pty Ltd)
Product Name
Prenatal + Pregnancy
Sponsor
ARTG
395976
Date of review outcome
Date of publication
Mar-23
Outcome
Medicine is no longer permitted to be supplied
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
Issues related to safety
The medicine's ARTG record includes claims that are not permitted for pregnant women, while the medicine name suggests the use of this medicine in this population. Use of the medicine for such claims in this population may pose a safety risk for the mother and/or their unborn baby. However, given the medicine was never marketed, it does not pose an immediate risk to consumer health and safety.
Issues related to efficacy
The 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 the medicine. The sponsor cancelled the medicine.