Answer
Safety and efficacy are not established in the selected product licence for people under 18. In England, specialist commissioning arrangements permit certain non-licensed use for high-risk APL from 12 months of age when specified criteria are met.
Sources for this answer
- Trisenox (arsenic trioxide) 2mg/ml Concentrate for Solution for Infusion — Current selected SmPCemc · Summary of Product Characteristics
- NHS