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NUTRA-LIFE PYLODEFENCE (Vitaco Health Australia Pty Ltd)
Product Name
NUTRA-LIFE PYLODEFENCE
Sponsor
ARTG
406085
Date of review outcome
Date of publication
Sep-2024
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?
Seek advice from a suitably qualified health practitioner if you are or have been using this medicine for protection against Helicobacter pylori infections
Review scope
Targeted
Information reviewed
ARTG Record, Labels, Manufacturing Documentation
Issues related to safety
The name of this medicine made claims regarding protection against Helicobacter pylori infections, which require diagnosis, treatment and/or supervision by a suitably qualified health practitioner. These claims are not permitted for medicines that are available for self-selection without prior evaluation by the TGA. References to these conditions have the potential to lead consumers to delay access to timely medical advice or treatment when required, resulting in adverse outcomes. However, current data indicate that use of this medicine is unlikely to pose an immediate risk to consumer health and safety.
Issues related to efficacy
The name of this medicine made claims regarding protection against Helicobacter pylori infections. 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 cancelled this medicine and withdrew it from further supply.