ARIPADOL (Accord Healthcare Pty Ltd)
Product name
ARIPADOL
Sponsor
Date registered
Evaluation commenced
Decision date
Approval time
154 (255 working days)
Active ingredients
aripiprazole
Registration type
New generic medicine
Indication
[TRADE NAME] is indicated for the treatment of schizophrenia including maintenance of clinical improvement during continuation therapy.
Acute treatment of manic or mixed episodes associated with Bipolar I Disorder in adults as monotherapy and in combination with lithium or valproate;
Maintenance treatment of manic or mixed episodes in Bipolar I Disorder in adults as monotherapy.