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PCT+ (Emrald Labs Pty Ltd)
Product Name
PCT+
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, follow the recommended actions below.
What action should consumers take?
Be aware that this medicine may not work as expected in relation to having clinical effects on mood, learning, memory, pain, anxiety and sleep, and having anti-apoptotic, neuroprotective, anti-inflammatory and antinociceptive properties
Review scope
Targeted
Information reviewed
ARTG Record, Labels, Websites
Issues related to safety
The websites for this medicine contained claims about anti-apoptotic and neuroprotective properties. 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 websites for this medicine did not display the mandatory warning statements 'if symptoms persist, talk to your health professional' required for claims relating to supporting wound healing, and 'always read the label and follow the directions for use'.
While advertising of this nature and the absence of warning statements is unacceptable, the websites for this medicine have been updated and the medicine label displays the required warning statement. As such, this medicine is unlikely to pose an immediate risk to consumer health and safety.
The websites for this medicine did not display the mandatory warning statements 'if symptoms persist, talk to your health professional' required for claims relating to supporting wound healing, and 'always read the label and follow the directions for use'.
While advertising of this nature and the absence of warning statements is unacceptable, the websites for this medicine have been updated and the medicine label displays the required warning statement. As such, this medicine is unlikely to pose an immediate risk to consumer health and safety.
Issues related to efficacy
The websites 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 websites to correct these issues.