MUM-2-B DHA for Pregnancy (Kissun Pharmaceuticals Pty Ltd)
Product Name
MUM-2-B DHA for Pregnancy
Sponsor
ARTG
405301
Date of review outcome
Date of publication
Sep-2023
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, use of this medicine may pose a safety risk for some people. Follow the recommended actions below.
What action should consumers take?
Be aware that this medicine is not permitted by the TGA to make claims regarding maintenance or improvement of brain function, mental clarity, or cognitive performance in pregnant women. Seek advice from a suitably qualified health professional if you have been or are intending to use this medicine for these purposes.
Review scope
Targeted
Information reviewed
ARTG Record
Issues related to safety
The ARTG record for this medicine contained claims specified in 'What action should consumers take?' above. However, these claims are not permitted for medicines for pregnant consumers. Use of this medicine for these claims while pregnant may pose a safety risk for the mother and/or their unborn baby. 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 ARTG record 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 cancelled this medicine and withdrew it from further supply.