Premium MP50K (Sini Australia Pty Ltd)
Product Name
Premium MP50K
Sponsor
ARTG
326395
Date of review outcome
Date of publication
Sep-2023
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?
Seek advice from a medical practitioner if you have been taking this medicine for treating thyroid disorders, stroke, vascular dementia, angina, arteriosclerosis, myocardial infarction, reducing harmful cholesterol and improving cardiovascular health, preventing cerebrovascular disease, or for 'liver problems'.
The last batch of this medicine (05282A) expired in January 2023 and consumers should not be taking expired medicines.
The last batch of this medicine (05282A) expired in January 2023 and consumers should not be taking expired medicines.
Review scope
Targeted
Information reviewed
ARTG Record, Advertising (other), Labels, Website
Issues related to safety
The website and consumer medicine information leaflet for this medicine contained claims that it could help with the conditions specified in 'What action should consumers take?' above. 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 suitability qualified health professional when required, which may result in adverse outcomes.
However, the last batch of this medicine expired in January 2023 and there is no stock on the market. As such, this medicine is unlikely to pose an immediate risk to consumer health and safety.
However, the last batch of this medicine expired in January 2023 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 website and consumer medicine information leaflet for this medicine contained claims that it could help with the conditions specified in 'What action should consumers take?' above, as well as in relation to enhancing overall health and well-being, 'natural cholesterol detoxification', promoting digestive health, cleansing blood vessels, glucose metabolism, or 'beneficial effects in anti-inflammation and immune system'. 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 cancelled this medicine and withdrew it from further supply.