MELATOMED (Medsurge Pharma Pty Ltd)
Product name
MELATOMED
Sponsor
Date registered
Evaluation commenced
Decision date
Approval time
162 (255 working days)
Active ingredients
melatonin
Registration type
New generic medicine
Indication
Adult
Short-term treatment of jet lag in adults aged 18 and over.
Paediatric
Sleep disorders in children and adolescents aged 6 to 18 with neurodevelopmental disorders including autism spectrum disorder (ASD) and attention deficit hyperactivity disorder (ADHD), where sleep hygiene measures have been insufficient.