Entity RadianiX (iX Biopharma Pty Ltd)
Product Name
Entity RadianiX
Sponsor
ARTG
327273
Date of review outcome
Date of publication
Jun-2024
Outcome
Medicine is no longer permitted to be supplied
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?
The last batch of the medicine supplied expired in December 2022. Do not use this medicine as it has passed its expiry date.
Seek advice from a suitably qualified health professional if you are or have been using this medicine to treat or relieve dry skin related to diabetes.
Consider whether this medicine is right for you based on it potentially not working as expected in relation to protection against photoaging, decreasing excessive melanin production, and skin whitening/brightening/lightening.
Seek advice from a suitably qualified health professional if you are or have been using this medicine to treat or relieve dry skin related to diabetes.
Consider whether this medicine is right for you based on it potentially not working as expected in relation to protection against photoaging, decreasing excessive melanin production, and skin whitening/brightening/lightening.
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 medical advice or treatment when required, and may result in adverse outcomes.
However, the last batch of this medicine expired in December 2022 and there is no stock on the market. As such, this medicine is unlikely to pose an immediate risk to consumer health and safety.
References to non-permitted claims have the potential to lead consumers to delay access to timely medical advice or treatment when required, and may result in adverse outcomes.
However, the last batch of this medicine expired in December 2022 and there is no stock on the market. 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 sponsor cancelled this medicine, withdrew it from further supply, and removed the advertisement from their website.
Nevertheless, the TGA issued an educational letter to the sponsor outlining the issues with this medicine.
Nevertheless, the TGA issued an educational letter to the sponsor outlining the issues with this medicine.