ARIPENA (Sun Pharma ANZ Pty Ltd)
Product name
ARIPENA
Sponsor
Date registered
Evaluation commenced
Decision date
Approval time
170 (255 working days)
Active ingredients
aripiprazole monohydrate
Registration type
New generic medicine
Indication
For the acute and maintenance treatment of schizophrenia in adults.
For maintenance treatment to prevent the recurrence of manic or mixed episodes of bipolar I disorder in adult patients as monotherapy.