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RISPERIDONE BNM, RIXADONE (Boucher & Muir Pty Ltd)
Product name
RISPERIDONE BNM, RIXADONE
Sponsor
Date registered
Evaluation commenced
Decision date
Approval time
146 working days (255)
Active ingredients
Risperidone
Registration type
New generic medicine
Indication
RISPERIDONE BNM, RIXADONE (oral liquid solution) are indicated for:
- the treatment of schizophrenia and related psychoses
- the short-term treatment of acute mania associated with Bipolar 1 Disorder
- the treatment (up to 12 weeks) of psychotic symptoms, or persistent agitation or aggression unresponsive to non-pharmacological approaches in patients with moderate to severe dementia of the Alzheimers type
- the treatment of conduct and other disruptive behaviour disorders in children (over 5 years), adolescents and adults with sub-average intellectual functioning or mental retardation in whom destructive behaviours (e.g. aggression, impulsivity and self-injurious behaviours) are prominent
- the treatment of behavioural disorders associated with autism in children and adolescents