Sambucol Cold & Flu Liquid (Pharmacare Laboratories Pty Ltd)
Product Name
Sambucol Cold & Flu Liquid
Sponsor
ARTG
167304
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, based on the sponsor’s certification. However, follow the recommended actions below
What action should consumers take?
Consider whether the medicine is right for you given that the claims for reducing the duration of cold and flu by up to 3 days and relieving the symptom severity by 30% were not substantiated by the evidence. The medicine may not work as expected when following the recommended dosage for children aged 2 – 4 years (7.5 – 15 mL per day) and 5 – 12 years (30 mL per day).
Review scope
Targeted
Information reviewed
ARTG Record, Evidence, Labels, Website
Issues related to safety
None
Issues related to efficacy
The evidence provided by the sponsor was insufficient to support the claims detailed in 'What action should consumers take?’ above. While the provided clinical study measured reduction of symptoms, it did not measure the size of reduction (in days and percentage of severity).
Additionally, the doses provided for children aged 2 – 4 years and 5 – 12 years on the label and website for the medicine were not consistent with the evidence.
Additionally, the doses provided for children aged 2 – 4 years and 5 – 12 years on the label and website for the medicine were not consistent with the evidence.
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.