GUANFACINE MAPLE (Maple Healthcare Pty Ltd)
Product name
GUANFACINE MAPLE
Sponsor
Date registered
Evaluation commenced
Decision date
Approval time
145 (255 working days)
Active ingredients
guanfacine hydrochloride
Registration type
New generic medicine
Indication
TRADE NAME is indicated for the treatment of attention deficit hyperactivity disorder (ADHD) in children and adolescents 6-17 years old, as monotherapy (when stimulants or atomoxetine are not suitable, not tolerated or have been shown to be ineffective) or as adjunctive therapy to psychostimulants (where there has been a sub-optimal response to psychostimulants).
TRADE NAME must be used as part of a comprehensive ADHD management programme, typically including psychological, educational and social measures.