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PHARMACY ACTION Vitamin D (Generic Health Pty Ltd)

Product Name
PHARMACY ACTION Vitamin D
Date of review outcome
Date of publication
Jun-2025
Outcome
Medicine continues to be permitted for supply
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 that the claim for helping to enhance or promote bone strength was not substantiated by the sponsor
Review scope
Targeted (see Additional Information below)
Information reviewed
ARTG Record, Evidence, Labels, Website
Issues related to safety
The safety of this medicine was not assessed as part of this review
Issues related to efficacy
The sponsor did not hold sufficient evidence to support the claim related to helping enhance or promote bone strength. The limitations with the evidence included the study population, active ingredient, dosage, and the results of some studies not being relevant to this medicine. The evidence provided was not of sufficient quality.
In addition, the label and website claimed this medicine may help keep bones strong. The label also claimed this medicine may support healthy bone density. At the time of this review, these claims were not covered by the sponsor's certification that they held evidence to substantiate them.
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 these issues.
Additional information
This medicine was targeted to check its compliance in relation to claims about enhancing or promoting bone strength