Gynophilus (Pacific AgVet Pty Ltd)
Product Name
Gynophilus
Sponsor
ARTG details
389279
Date of review outcome
Date of publication
Mar-2026
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, use of this medicine may pose a safety risk for some people. Follow the recommended actions below.
What action should consumers take?
Seek advice from a suitably qualified health practitioner if you have been using this medicine for the treatment or prevention of mycosis, vaginosis, intimate discomfort or regeneration of vaginal microbiota.
Review scope
Targeted
Information reviewed
ARTG Record, Advertising (other), Labels, Manufacturing Documentation
Issues related to safety
The label and leaflet associated with this medicine contained claims specified in 'What action should consumers take?' above. These claims are 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.
Whilst advertising of this nature is unacceptable, this medicine was never manufactured or supplied in Australia. As such, this medicine is unlikely to pose an immediate risk to consumer health and safety.
Whilst advertising of this nature is unacceptable, this medicine was never manufactured or supplied in Australia. As such, this medicine is unlikely to pose an immediate risk to consumer health and safety.
Issues related to efficacy
The efficacy of this medicine was not assessed as part of this review
Actions taken during the review
The TGA required the sponsor the correct the issues with this medicine. The sponsor cancelled this medicine and withdrew it from further supply.