The Therapeutic Goods Administration (TGA) conducted targeted compliance reviews of selected listed medicines using indications related to diarrhoea that are required to display the following warning statement:
- ‘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 (or words to that effect).’
The review found that 93% of the targeted medicines complied with the required warning statement, while 7% were missing it. Sponsors of non-compliant medicines were required to update their product labels and/or advertising materials to address the issue.
If you are a sponsor of a listed medicine that uses indications related to diarrhoea, you are encouraged to review the Therapeutic Goods (Permissible Indications) Determination – external site to ensure that all indications used in your products meet the relevant requirements-including the inclusion of the appropriate warning statement on the label.
Visit the Compliance and education for listed medicines
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