EreX (Vitex Pharmaceuticals Pty Ltd)
Product Name
EreX
Sponsor
ARTG
383222
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. However, follow the recommended actions below.
What action should consumers take?
Consider whether the medicine is right for you based on it potentially not working as expected in relation to erectile dysfunction
Review scope
Targeted
Information reviewed
ARTG Record
Issues related to safety
The name of the medicine made claims regarding erectile dysfunction that are not permitted for listed medicines without prior evaluation by the TGA. References to this condition have the potential to lead consumers to delay access to timely medical advice or treatment when required, resulting in adverse outcomes. However, as the medicine was never supplied in Australia, it is unlikely to pose an immediate risk to consumer health and safety.
Issues related to efficacy
The name of the medicine made claims regarding erectile dysfunction. However, 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 and withdrew it from further supply.