TGA
We will be initiating targeted compliance reviews of selected listed medicines 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).'
Sponsors are expected to be familiar with the Therapeutic Goods (Permissible Indications) Determination as it relates to the indications present on their medicines and any specific requirements (such as warning statements) for each indication.
Visit the Compliance and education for listed medicines
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