SQUALENE (Australian By Nature Pty Ltd)
Product Name
SQUALENE
Sponsor
ARTG
Date of review outcome
Date of publication
Mar-20
Outcome
Medicine continues to be permitted for supply. Batches released from 29 February 2020 must carry a corrected label.
Is it safe to continue using this medicine?
Yes
What action should consumers take?
Consider whether the medicine is right for you based on the medicine potentially not working as expected in relation to synthesis of cholesterol, steroid hormone and Vitamin D
Review scope
Targeted
Information reviewed
ARTG Record, Labels, Website
Issues related to safety
None
Issues related to efficacy
The website claimed that the medicine may help in the ‘synthesis of cholesterol, steroid hormones and Vitamin D’. The sponsor did not certify that they hold evidence to substantiate this claim.
Actions taken during the review
TGA required the sponsor to correct the issues with the medicine. The sponsor removed the indication ‘vital for the synthesis of cholesterol, steroid hormone and Vitamin D’ from the website.