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Homme-F (AusBioMed)
Product Name
Homme-F
Sponsor
ARTG
281279
Date of review outcome
Date of publication
Jun-20
Outcome
Medicine continues to be permitted for supply
Is it safe to continue using this medicine?
Yes
What action should consumers take?
Consider whether the medicine is right for you given that the medicine may not work as expected in relation to claims that went beyond generalised maintenance of male reproductive system health. Some of these claims included, but were not limited to, ‘supplementation of Vitis vinifera decreases oxidative stress biomarkers in men who smoked heavily, compared to placebo subjects’, ‘supplementation of lycopene improves sperm concentration and motility in men with idiopathic oligoasthenoteratozoospermia’ and ‘supplementation of Vitamin E with Vitamin C can reduce sperm DNA fragmentation and improve pregnancy rates in some subpopulations of infertile men’.
Additionally, consider whether the medicine is right for you given that claims about ‘enhancement of masculine needs’ and the medicine being ‘formulated based on scientific and clinical research’, were unable to be substantiated.
Additionally, consider whether the medicine is right for you given that claims about ‘enhancement of masculine needs’ and the medicine being ‘formulated based on scientific and clinical research’, were unable to be substantiated.
Review scope
Random
Information reviewed
ARTG Record, Evidence, Labels, Manufacturing Documentation, Website
Issues related to safety
None
Issues related to efficacy
The website claimed that supplementation with the medicine’s ingredients Vitis vinifera, lycopene, levocarnitine tartrate, acetyl levocarnitine hydrochloride, ubidecarenone, selenium, d-alpha-tocopherol acid succinate, folic acid, ascorbic acid and zinc had therapeutic effects beyond generalised maintenance of male reproductive system health. However, these claims were not covered by the sponsor's certification that they held evidence to substantiate them. The sponsor did not hold sufficient evidence to support claims related to ‘enhancement of masculine needs’ and the medicine being ‘formulated based on scientific and clinical research’.
Actions taken during the review
TGA required the sponsor to correct the issue with the medicine. The sponsor updated the website to remove the specific claims that were not supported by evidence. The claim about the medicine being ‘formulated based on scientific and clinical research’ was also removed.