BioSource Lysine 500 mg (Soul Pattinson Manufacturing Pty Ltd)
Product Name
BioSource Lysine 500 mg
ARTG
315033
Date of review outcome
Date of publication
Mar-2025
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?
The last batch of this medicine expired in October 2024. Do not take this medicine as it is past its expiry date.
Be aware that the claim for helping reduce the occurrence of facial cold sores was not substantiated by the sponsor.
Be aware that the claim for helping reduce the occurrence of facial cold sores was not substantiated by the sponsor.
Review scope
Targeted (see Additional Information below)
Information reviewed
ARTG Record, Evidence, Labels, Website
Issues related to safety
None
Issues related to efficacy
The sponsor did not hold sufficient evidence to support the claim related to helping reduce the occurrence of facial cold sores. The limitations with the evidence included the study population, route of administration, active ingredient, dosage and the results of some studies not being relevant to this medicine. Some evidence provided was not of sufficient quality.
Actions taken during the review
The TGA required the sponsor to correct the issues with this medicine. The sponsor cancelled this medicine and withdrew it from further supply.
Additional information
This medicine was targeted to check its compliance in relation to cold sore management claims