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SLENYTO (RAD Data Australia Pty Ltd)
Product name
SLENYTO
Sponsor
Date registered
Evaluation commenced
Decision date
Approval time
171 working days (175)
Active ingredients
melatonin
Registration type
EOI
Indication
SLENYTO (modified release tablet) is now indicated for the treatment of insomnia in children and adolescents aged 2-18 with Autism Spectrum Disorder (ASD) and / or Smith-Magenis syndrome, where sleep hygiene measures have been insufficient.