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Orthoplex Intestaclear (Bio Concepts Pty Ltd)
Product Name
Orthoplex Intestaclear
Sponsor
ARTG
300714
Date of review outcome
Date of publication
Dec-22
Outcome
Medicine continues to be permitted for supply
Is it safe to continue using this medicine?
Yes, if you follow the recommended actions below
What action should consumers take?
If you are taking the medicine for previously advertised claims for common gut-related issues, consider if the medicine is right for you as it may not work as expected. These claims include maintaining/supporting general health and wellbeing, traditional uses in European herbal medicine to help remove intestinal threadworms/pinworms, and to maintain/support healthy digestion. These claims were not substantiated by the sponsor.
Review scope
Targeted
Information reviewed
ARTG Record, Evidence, Labels, Manufacturing Documentation, Website
Issues related to safety
The safety of this medicine was not assessed as part of this review
Issues related to efficacy
The advertised claim of aiding against a range of common gut-related clinical presentations, was not covered by the sponsor’s certification that they held evidence to substantiate it. Additionally, the sponsor did not hold sufficient evidence to support the advertised claims detailed in ‘What action should consumers take?’ section above. The limitations with the evidence included dosage, method of preparation, action and traditional use of ingredients that were inconsistent with those for the medicine.
Actions taken during the review
The sponsor updated the ARTG record and website for the medicine to remove the unsupported claims. Nevertheless, the TGA issued an educational letter to the sponsor outlining the issues with the medicine.