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NORMAGUT (Mega Lifesciences (Australia) Pty Ltd)

Product Name
NORMAGUT
Sponsor
Mega Lifesciences (Australia) Pty Ltd
ARTG details
Date of review outcome
Date of publication
Dec-2025
Outcome
Medicine continues to be permitted for supply
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?
Seek medical advice if diarrhoea persists for more than: 6 hours in infants under 6 months, 12 hours in children under 3 years, 24 hours in children aged 3 to 6 years or 48 hours in adults and children over 6 years.
Consider whether this medicine is right for you based on it potentially not working as expected in relation to immunity, symptoms of indigestion and bloating.
Review scope
Targeted (see Additional Information below)
Information reviewed
ARTG Record, Labels
Issues related to safety
The label for this medicine was missing the mandatory warning statement specified in 'What actions should consumers take?' above. This warning statement is necessary to ensure the safe use of this medicine and to alert consumers to safety risks prior to taking this medicine. However, the affected batch was only supplied in Vietnam, and therefore, a recall was not required in Australia. The relevant Vietnamese authority has been notified of this matter.
Issues related to efficacy
The label 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's label. The sponsor updated the label to correct the issues.
Additional information
This medicine was targeted to check its compliance with warning statement requirements for indications related to diarrhoea