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SLENYTO RAD Data Australia Pty Ltd
Product name
SLENYTO
Sponsor
Accepted date
Jun-2025
Active ingredients
melatonin
Proposed indication
SLENYTO is for the treatment of insomnia in children and adolescents aged 2-18 due to:
-Autism Spectrum Disorder (ASD) and/or Smith-Magenis syndrome
-Attention Deficit Hyperactivity Disorder (ADHD), or
-various neurogenetic disorders characterised by abnormal melatonin levels and/or nighttime awakenings
-Autism Spectrum Disorder (ASD) and/or Smith-Magenis syndrome
-Attention Deficit Hyperactivity Disorder (ADHD), or
-various neurogenetic disorders characterised by abnormal melatonin levels and/or nighttime awakenings
Application type
C (new indication)
Publication date
Jun-2025