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Reproductive Wellness (Fertile Gut Pty Ltd)
Product Name
Reproductive Wellness
Sponsor
ARTG
408016
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 professional if you have been or are intending on using this medicine for prevention of neural tube defects such as spina bifida and/or anencephaly
Review scope
Targeted
Information reviewed
ARTG Record, Labels, Manufacturing Documentation
Issues related to safety
This medicine did not contain the minimum quantity of folic acid required to support the claim related to the prevention of neural tube defects. Not meeting this requirement is unacceptable and has the potential to result in adverse outcomes as the medicine may not work for this claim. However, as this medicine was never supplied, it is unlikely to pose an immediate risk to consumer health and safety.
Issues related to efficacy
This medicine did not contain the minimum required quantity of folic acid to support the claim related to the prevention of neural tube defects
Actions taken during the review
The sponsor cancelled this medicine and withdrew it from further supply. Nevertheless, the TGA issued an educational letter to the sponsor.