Opticbiotics AREDS 2 Formula (Olivebiotics Pty Ltd)
Product Name
Opticbiotics AREDS 2 Formula
Sponsor
ARTG
306689
Date of review outcome
Date of publication
Jun-21
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 medical practitioner if you have been taking this medicine to reduce the risk of age-related eye disease (ARED), advanced age-related macular degeneration (AMD) and/or lung cancer
Review scope
Targeted
Information reviewed
ARTG Record, Labels
Issues related to safety
The label for the medicine refers to age-related eye disease (ARED), advanced age-related macular degeneration (AMD), and lung cancer, which are 'serious' conditions that require diagnosis, treatment or supervision by a medical practitioner. These are not permitted for medicines that are available for self-selection without prior evaluation by the TGA. These references have the potential to lead consumers with these conditions to delay access to timely medical advice or treatment resulting in adverse outcomes. However, as the medicine's label warns consumers to seek medical advice if symptoms persist, the medicine is unlikely to pose an immediate risk to consumers.
Issues related to efficacy
The efficacy of the medicine was not assessed as part of this review
Actions taken during the review
The TGA required the sponsor to correct the issues with the medicine. The sponsor cancelled the medicine and withdrew it from further supply.