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Protectyn (Immuron Ltd)
Product Name
Protectyn
Sponsor
ARTG details
Date of review outcome
Date of publication
Dec-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 suitably qualified health professional if you have been taking this medicine to treat gastrointestinal inflammation, allergies, eczema, high cholesterol, altered liver enzymes, glucose intolerance, insulin resistance, sugar/fructose malabsorption or intolerance, leaky gut, bacterial translocation, irritable bowel syndrome, fatty liver or metabolic syndrome.
Consider whether this medicine is right for you based on this medicine potentially not working as expected in relation to constipation, indigestion, bloating, food sensitivities, fatigue and weight loss.
Consider whether this medicine is right for you based on this medicine potentially not working as expected in relation to constipation, indigestion, bloating, food sensitivities, fatigue and weight loss.
Review scope
Targeted (see Additional Information below)
Information reviewed
ARTG Record, Labels, Website
Issues related to safety
The website for this medicine contained claims specified in the first paragraph of 'What action should consumers take?' above. These are serious conditions that require diagnosis, treatment or supervision by a suitably qualified health professional.
These claims, and references to gastrointestinal inflammation without specifying mild forms of the condition, 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.
While advertising of this nature is unacceptable, these claims have been removed from the website, and the website and label warn consumers to see a healthcare practitioner if symptoms persist. As such, this medicine is unlikely to pose an immediate risk to consumer health and safety.
These claims, and references to gastrointestinal inflammation without specifying mild forms of the condition, 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.
While advertising of this nature is unacceptable, these claims have been removed from the website, and the website and label warn consumers to see a healthcare practitioner if symptoms persist. 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 the second paragraph of '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 correct the issues.
Additional information
This medicine was targeted to check its compliance with warning statement requirements for indications related to diarrhoea