Sorenandin (McBoben Group)
Product Name
Sorenandin
Sponsor
ARTG
Date of review outcome
Date of publication
Dec-2024
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 promote bone strength was not substantiated by the sponsor.
Be aware that this medicine may also not work as expected in relation to anti-inflammatory effects, helping build up cartilage, increasing bone density in mild-osteoporotic bones and reducing fracture rates, increasing joint mobility, 'anti mild-joint pain', relieving joint pain caused by osteoarthritis and reducing joint stiffness associated with osteoporosis.
Be aware that this medicine may also not work as expected in relation to anti-inflammatory effects, helping build up cartilage, increasing bone density in mild-osteoporotic bones and reducing fracture rates, increasing joint mobility, 'anti mild-joint pain', relieving joint pain caused by osteoarthritis and reducing joint stiffness associated with osteoporosis.
Review scope
Targeted (see Additional Information below)
Information reviewed
ARTG Record, Evidence, Labels, Website
Issues related to safety
The label for this medicine contained claims specified in 'What action should consumers take?' above. Some of these claims, and references to joint pain and stiffness without specifying mild forms of the condition, are not permitted for listed medicines without prior evaluation or approval from the TGA. References to non-permitted claims have the potential to lead consumers to delay access to timely advice or treatment from a suitably qualified health professional when required, which may result in adverse outcomes.
However, the label also advised consumers to see a healthcare professional if symptoms persist. As such, this medicine is unlikely to pose an immediate risk to consumer health and safety.
However, the label also advised consumers to see a healthcare professional if symptoms persist. As such, this medicine is unlikely to pose an immediate risk to consumer health and safety.
Issues related to efficacy
The sponsor did not hold sufficient evidence to support the claim related to helping 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 for this medicine contained claims specified in 'What action should consumers take?' above. However, these claims were not covered by the sponsor's certification that they held evidence to substantiate them.
In addition, the label for this medicine contained claims specified in 'What action should consumers take?' above. However, 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 and label to correct these issues.
Additional information
This medicine was targeted to check its compliance in relation to claims about enhancing or promoting bone strength