Essential Prenatal (Eimele Pty Ltd)
Product Name
Essential Prenatal
Sponsor
ARTG
396613
Date of review outcome
Date of publication
Mar-23
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 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 labels do not include these claims, 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 updated the ARTG record of the medicine to correct these issues.