Elevit Probiotics Immunity and Gut Health (Bayer Australia Ltd)
Product Name
Elevit Probiotics Immunity and Gut Health
Sponsor
Date of review outcome
Date of publication
Jun-2024
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?
Consider whether this medicine is right for you based on it potentially not working as expected in relation to claims regarding its use during pregnancy
Review scope
Targeted
Information reviewed
ARTG Record, Labels, Website
Issues related to safety
The label and website for this medicine contained claims regarding its use during pregnancy. 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.
While advertising of this nature is unacceptable, the label directed consumers to advise their doctor of any medicines they take during pregnancy. In addition, the claims have been removed from the label and website. As such, this medicine is unlikely to pose an immediate risk to consumer health and safety.
While advertising of this nature is unacceptable, the label directed consumers to advise their doctor of any medicines they take during pregnancy. In addition, the claims have been removed from the label and website. 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 regarding its use during pregnancy. However, these claims are not covered by the sponsor's certification that they hold 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 label and website to correct these issues.