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CAPZEA (ATP Science Pty Ltd)

Product Name
CAPZEA
ARTG
267460
Date of review outcome
Date of publication
Sep-22
Outcome
Medicine is no longer permitted to be supplied
Is it safe to continue using this medicine?
Yes, if you follow the recommended actions below
What action should consumers take?
Seek advice from a suitably qualified health professional if you are or have been using this medicine to treat or relieve debilitating nerve pain.
Consider whether the medicine is right for you based on the medicine potentially not working as expected in relation to debilitating nerve pain, aches and pains that are not specifically associated with mild arthritis, mild osteoarthritis or muscles.
Review scope
Targeted
Information reviewed
ARTG Record, Labels, Website
Issues related to safety
The website of the medicine implied that it can relieve debilitating nerve pain, which is a serious condition that require diagnosis, treatment and/or supervision by a suitably qualified health professional. This is not permitted for medicines that are available for self-selection without prior evaluation by the TGA. The reference to debilitating nerve pain has the potential to lead consumers with this condition to delay access to timely medical advice or treatment resulting in adverse outcomes. However, the label and website of the medicine also warned consumers to see a healthcare professional if symptoms persist. As such, the medicine is unlikely to pose an immediate risk to consumer health and safety.
Issues related to efficacy
The label and the website of the medicine claimed that the medicine may relieve debilitating nerve pain, aches and pains not specifically associated with mild arthritis, mild osteoarthritis or muscles. However, the claims were not covered by the sponsor's certification that they held evidence to substantiate them.
Actions taken during the review
The sponsor cancelled the medicine and withdrew it from further supply. Nevertheless, the TGA issued an educational letter to the sponsor outlining the issues with the medicine.

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