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v-spot probiotic (Amelia Health Pty Ltd)
Product Name
v-spot probiotic
Sponsor
ARTG details
Date of review outcome
Date of publication
Sep-2025
Outcome
Medicine continues to be permitted for supply
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 doctor if pregnant or likely to become pregnant. Advise your doctor of any medicine you take during pregnancy, particularly in your first trimester.
Seek advice from a suitably qualified health practitioner if you have been using this medicine for the treatment or prevention of bacterial vaginosis, vulvo-vaginal candidiasis (vaginal thrush), mycoplasma and ureaplasma infections.
Consider whether this medicine is right for you given the claims relating to use in fertility, menopause, postpartum and following antibiotic use may not work as expected.
Seek advice from a suitably qualified health practitioner if you have been using this medicine for the treatment or prevention of bacterial vaginosis, vulvo-vaginal candidiasis (vaginal thrush), mycoplasma and ureaplasma infections.
Consider whether this medicine is right for you given the claims relating to use in fertility, menopause, postpartum and following antibiotic use may not work as expected.
Review scope
Targeted
Information reviewed
ARTG Record, Labels, Manufacturing Documentation, Website
Issues related to safety
The website for this medicine contained claims specified in 'What action should consumers take?' above. Some of 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, which may result in adverse outcomes.
The website contained claims that the use of this medicine was safe and without side effects; contained inconsistent directions for use; implied harmful consequences may result from not using this medicine; may delay or discourage persons from seeking necessary medical attention and undertaking treatment prescribed by a medical practitioner; and suggests comparator medicines are harmful or ineffectual. These claims are not permitted as they are inaccurate, unbalanced and misleading, and do not promote the safe and proper use of listed medicines.
Whilst advertising of this nature is unacceptable, these claims have been removed and the website advised consumers if they were pregnant or breastfeeding to talk to their health professional before use. As such, this medicine is unlikely to pose an immediate risk to consumer health and safety.
The website contained claims that the use of this medicine was safe and without side effects; contained inconsistent directions for use; implied harmful consequences may result from not using this medicine; may delay or discourage persons from seeking necessary medical attention and undertaking treatment prescribed by a medical practitioner; and suggests comparator medicines are harmful or ineffectual. These claims are not permitted as they are inaccurate, unbalanced and misleading, and do not promote the safe and proper use of listed medicines.
Whilst advertising of this nature is unacceptable, these claims have been removed and the website advised consumers if they were pregnant or breastfeeding to talk to their health professional before use. 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 specified in 'What action should consumers take?' above. 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 this medicine. The sponsor updated the website to remove the unsupported and non-permitted claims.