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RISPERIDONE GENERICHEALTH (Generic Health Pty Ltd)

Product name
RISPERIDONE GENERICHEALTH
Sponsor
Generic Health Pty Ltd
Date registered
Evaluation commenced
Decision date
Approval time
137 (255 working days
Active ingredients
risperidone
Registration type
New generic medicine
Indication

RISPERIDONE GENERICHEALTH is indicated for the treatment of schizophrenia and related psychoses.

RISPERIDONE GENERICHEALTH is indicated for the short term treatment of acute mania associated with bipolar 1 disorder (see Section 4.2 Dose and Method of Administration – Bipolar Mania).

RISPERIDONE GENERICHEALTH is indicated for 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 Alzheimer type (see Section 4.2 Dose and Method of Administration – Behavioural Disturbances in Dementia).

RISPERIDONE GENERICHEALTH is indicated in 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 (eg. aggression, impulsivity and self-injurious behaviours) are prominent (see Section 5.1 Pharmacodynamic Properties – Clinical Trials).

RISPERIDONE GENERICHEALTH is indicated for the treatment of behavioural disorders associated with autism in children and adolescents (see Section 5.1 Pharmacodynamic Properties – Clinical Trials).

Registration process

First generic
First approval of a medicine that contains the same active ingredient as and is bioequivalent to an existing medicine

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