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Blood Pressure Pro (KAYLYEA HEALTH TECHNOLOGY PTY LTD)

Product Name
Blood Pressure Pro
ARTG
325105
Date of review outcome
Date of publication
Sep-22
Outcome
Medicine is no longer permitted to be supplied
Is it safe to continue using this medicine?
Yes, if you follow the recommended actions below
What action should consumers take?

Be aware that this medicine is not approved by the TGA to treat diseases of the heart, brain and kidney and COVID-19. Seek advice from a suitably qualified health professional if you have been or are intending on using this medicine for these purposes. Be aware that the medicine may not work as expected in relation to these uses.
Review scope
Targeted
Information reviewed
ARTG Record, Labels, Website
Issues related to safety

The name of the medicine and the website contained claims that the medicine can be used for diseases of the heart, brain and kidney and COVID-19, which are serious conditions that require diagnosis, treatment and/or supervision by a suitably qualified health professional. This is not permitted for medicines that are available for self-selection without prior evaluation by the TGA. References to these diseases have the potential to lead consumers with these conditions to delay access to timely medical advice or treatment resulting in adverse outcomes.
However, as the medicine was never supplied in Australia, it is unlikely to pose an immediate risk to consumer health and safety.
Issues related to efficacy

The website claimed that the medicine can be used for diseases of the heart, brain and kidney and COVID-19. Additionally, the name of the medicine implied that it can be used to treat high blood pressure. 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 the medicine. The sponsor cancelled the medicine and withdrew it from further supply.

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