Planned maintenance may cause outages to the Department of Health and Aged Care’s network from 5:15 pm AEDT on 30 November to 10:00 pm AEDT on 1 December 2024. Access to TGA databases such as TBS Portal, ARTG and DAEN may be affected. We apologise for any inconvenience.
Renopace Multivitamin & Minerals Enhanced with Omega-3 (Aesdan Pty Ltd)
Product Name
Renopace Multivitamin & Minerals Enhanced with Omega-3
Sponsor
ARTG
320521
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 treat chronic kidney disease or as a multivitamin supplement while receiving haemodialysis. Consider whether the medicine is right for you based on the medicine potentially not working as expected in relation to boosting the immune system, supporting normal growth and development, and 'helping cells and organs do their jobs'.
Review scope
Targeted
Information reviewed
ARTG Record, Website
Issues related to safety
The website for the medicine advertised its use for chronic kidney disease and patients receiving haemodialysis (a procedure used to treat patients with severe renal failure), which are serious conditions that require diagnosis, treatment or supervision by a medical practitioner. This is not permitted for medicines that are available for self-selection without prior evaluation by the TGA. The references to chronic kidney disease and haemodialysis 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 was never supplied in Australia, it is unlikely to pose an immediate risk to consumer health and safety.
Issues related to efficacy
The website claimed that the medicine may boost the immune system, support normal growth and development, and 'help cells and organs do their jobs'. 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 the medicine. The sponsor cancelled the medicine and withdrew it from further supply.