Vitamin D3 + K2 MK7 (Nature's Care Manufacture Pty Limited)
Product Name
Vitamin D3 + K2 MK7
ARTG
375111
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?
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
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 claimed this medicine could be used in children and infants. However, this claim was not covered by the sponsor's certification that they held evidence to substantiate it.
In addition, the label claimed this medicine could be used in children and infants. 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 cancelled this medicine and withdrew it from further supply.
Additional information
This medicine was targeted to check its compliance in relation to claims about enhancing or promoting bone strength