Brauer Baby Saline Nasal Spray (Brauer Natural Medicine Pty Ltd)
Product Name
Brauer Baby Saline Nasal Spray
Sponsor
ARTG
281588
Date of review outcome
Date of publication
Dec-22
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?
Consider whether the medicine is right for your child given that the claims related to maintaining general wellbeing, unblocking nasal passages, relieving mild hay fever, sneezing and symptoms of sinusitis were not substantiated by the sponsor
Review scope
Random
Information reviewed
ARTG Record, Evidence, Labels, Manufacturing Documentation, Website
Issues related to safety
None
Issues related to efficacy
The sponsor did not hold sufficient evidence to support claims related to maintaining general wellbeing, unblocking nasal passages, relieving mild hay fever, sneezing and symptoms of sinusitis. The limitations included that the population, dose, dosing regimen, dosage form and the route of administration in the evidence were not relevant to 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.