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OestroClear (Bio Concepts Pty Ltd)
Product Name
OestroClear
Sponsor
ARTG details
- 375310
Date of review outcome
Date of publication
Dec-2024
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 removing or clearing oestrogen
Review scope
Targeted
Information reviewed
ARTG Record, Labels, Website
Issues related to safety
The name of this medicine implied it can remove or clear oestrogen. This claim is not permitted for listed medicines without prior evaluation or approval from the TGA. References to non-permitted claims have the potential to lead consumers to delay access to timely advice or treatment from a suitably qualified health professional when required, which may result in adverse outcomes.
However, the label advised consumers to talk to their health professional if symptoms persist. As such, this medicine is unlikely to pose an immediate risk to consumer health and safety.
However, the label advised consumers to talk to their health professional if symptoms persist. As such, this medicine is unlikely to pose an immediate risk to consumer health and safety.
Issues related to efficacy
The name of this medicine implied it can remove or clear oestrogen. However, this claim was 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 issue with this medicine. The sponsor cancelled this medicine and withdrew it from further supply.