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SLENYTO (RAD Data Australia Pty Ltd)

Product name
SLENYTO
Sponsor
RAD Data Australia Pty Ltd
Date registered
Evaluation commenced
Decision date
Approval time
180 (255 working days)
Active ingredients
melatonin
Registration type
EOI
Indication

SLENYTO is indicated for:

  • treatment of insomnia in children and adolescents aged 2-18 years with Autism Spectrum Disorder (ASD), and / or neurogenetic disorders with aberrant diurnal melatonin secretion and/or nocturnal awakenings, where sleep hygiene measures have been insufficient.
  • treatment of insomnia in children and adolescents aged 6-17 years with attentiondeficit hyperactivity disorder (ADHD) where sleep hygiene measures have been insufficient.

Neurogenetic disorders are those of the central and peripheral nervous systems clearly associated with a characteristic set of symptoms and signs, which are caused by molecular defects in heritable material (usually DNA). Examples include Smith-Magenis syndrome, Angelman syndrome, Rett syndrome, Tuberous sclerosis complex, and Williams syndrome.