QUETIAPINE SANDOZ (Sandoz Pty Ltd)
Product name
QUETIAPINE SANDOZ
Sponsor
Date registered
Evaluation commenced
Decision date
Approval time
18 working days (255)
Active ingredients
quetiapine fumarate
Registration type
EOI
Indication
Generic medicine
QUETIAPINE SANDOZ is now also indicated for the maintenance treatment of bipolar I disorder, as monotherapy for the prevention of relapse/recurrence of manic, depressive or mixed episodes
- Treatment of depressive episodes associated with bipolar disorder (see Section 4.2 Dose and method of administration)
- Monotherapy treatment of acute mania associated with bipolar I disorder in children/adolescents aged 10 to 17 years
- Treatment of schizophrenia in adolescents aged 13 to 17 years.