Urogen Probiotic For Women (Evolution Health Pty Ltd)
Product Name
Urogen Probiotic For Women
Sponsor
ARTG
280393
Date of review outcome
Date of publication
Mar-21
Outcome
Medicine is no longer permitted to be supplied
Is it safe to continue using this medicine?
Yes
What action should consumers take?
Consider whether the medicine is right for you given that claims for reducing the frequency of recurrent cystitis, reducing the adhesion of bacteria to the urinary tract, supporting the health and function of the gastrointestinal tract, and maintaining healthy digestive flora following the use of antibiotics were not substantiated by the sponsor.
Be aware that this medicine had been marketed with the same name as another medicine.
Be aware that this medicine had been marketed with the same name as another medicine.
Review scope
Random
Information reviewed
ARTG Record, Evidence, Labels, Manufacturing Documentation, Website
Issues related to safety
This medicine had been marketed with the same name as another medicine. Having two medicines on the market with the same name makes it difficult to identify the correct medicine for purchase, use and recall.
Issues related to efficacy
The sponsor did not hold sufficient evidence to support the claims detailed in 'What action should consumers take?' above. The limitations with the evidence included that the dosages and method of preparation of ingredients in the evidence provided were not relevant to the medicine, and the populations described in the evidence were not relevant to the target population for the medicine.
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.