OestroSense (Factors Group Australia Pty Ltd)
Product Name
OestroSense
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?
Seek advice from a suitably qualified health professional if you have been taking this medicine to treat or manage hormone (oestrogen) imbalance
Review scope
Targeted
Information reviewed
ARTG Record, Labels, Website
Issues related to safety
The website for this medicine contained claims about horomone (oestrogen) imbalance. This is a serious condition that requires diagnosis, treatment or supervision by a suitably qualified health professional. This is not permitted for medicines that are available for self-selection without prior evaluation by the TGA. These claims have been removed, as such this medicine is unlikely to pose an immediate risk to consumer health and safety.
Issues related to efficacy
The website for this medicine contained claims about hormone (oestrogen) imbalance. However, these claims <are not permitted for listed medicines and> were not covered by the sponsor's certification that they held evidence to substantiate them
Actions taken during the review
The sponsor removed the claims about hormone (oestrogen) imbalance from this medicine's website. Nevertheless, the TGA issued an educational letter to the sponsor outlining the issues with the medicine.