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Intolergest (Thera Health Pty Ltd)
Product Name
Intolergest
Sponsor
ARTG
Date of review outcome
Date of publication
Sep-2024
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 practitioner if you have been using this medicine to prevent mucosal damage of the small intestine associated with Coeliac disease or malabsorption syndrome.
Consider whether this medicine is right for you based on it potentially not working as expected in relation to the digestion or breakdown of gluten, and in supporting digestion in individuals with food intolerances or digestion difficulties.
Consider whether this medicine is right for you based on it potentially not working as expected in relation to the digestion or breakdown of gluten, and in supporting digestion in individuals with food intolerances or digestion difficulties.
Review scope
Targeted
Information reviewed
ARTG Record, Labels, Website
Issues related to safety
The label and 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 when required, which may result in adverse outcomes.
While advertising of this nature is unacceptable, the label advised consumers to talk to their health professional if symptoms persist. In addition, these claims have been removed from the label and website. As such, this medicine is unlikely to pose an immediate risk to consumer health and safety.
While advertising of this nature is unacceptable, the label advised consumers to talk to their health professional if symptoms persist. In addition, these claims have been removed from the label and website. As such, this medicine is unlikely to pose an immediate risk to consumer health and safety.
Issues related to efficacy
The label and 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 label and website for this medicine to correct these issues.