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Healthy Care Super Lysine Tablets (previously Healthy Care Super Lysine Cold Sore Relief Tablets) (Nature's Care Manufacture Pty Limited)
Product Name
Healthy Care Super Lysine Tablets (previously Healthy Care Super Lysine Cold Sore Relief Tablets)
ARTG details
Date of review outcome
Date of publication
Jun-2025
Outcome
Medicine continues to be permitted for supply. Batches released from 31 October 2024 must carry a corrected label.
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 this medicine is right for you given the claims for helping reduce the occurrence and symptoms of facial cold sores and enhanced healing from cold sores were not substantiated by the sponsor.
Be aware that this medicine may not work as expected in relation to cold and flu.
Be aware that this medicine may not work as expected in relation to cold and flu.
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 claims in relation to cold sores. The limitations with the evidence included the results of the studies, study population, and dosage not being relevant to this medicine. Some evidence provided was not of sufficient quality.
In addition, the label claimed that this medicine may help with cold and flu. However, this claim was not covered by the sponsor’s certification that they held evidence to substantiate it.
In addition, the label claimed that this medicine may help with cold and flu. However, this claim was not covered by the sponsor’s certification that they held evidence to substantiate it.
Actions taken during the review
The TGA required the sponsor to correct the issues with this medicine. The sponsor updated the ARTG record, label and website to correct the issues.
Additional information
This medicine was targeted to check its compliance in relation to cold sore management claims