QUETIAQUEL XR, SERAPINE XR, SEROTIAPINE XR, SYQUET XR (Accord Healthcare Pty Ltd)
Product name
QUETIAQUEL XR, SERAPINE XR, SEROTIAPINE XR, SYQUET XR
Sponsor
Date registered
Evaluation commenced
Decision date
Approval time
110 (255 working days)
Active ingredients
fluoxetine hydrochloride; quetiapine fumarate
Registration type
New generic medicine
Indication
QUETIAQUEL XR, SERAPINE XR, SEROTIAPINE XR, SYQUET XR (modified release tablet) is indicated for:
Bipolar disorder
- Maintenance treatment of bipolar I disorder, as monotherapy or in combination with lithium or sodium valproate, 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).
- Treatment of acute mania associated with bipolar I disorder as monotherapy or in combination with lithium or sodium valproate
- Efficacy of quetiapine modified release tablets in the treatment of bipolar disorder indications was established in part, on the basis of extrapolation from the established effectiveness of quetiapine immediate release tablets.
Schizophrenia
Treatment of schizophrenia, prevention of relapse and maintenance of clinical improvement during continuation therapy.
Major depressive disorder
Treatment of recurrent major depressive disorder (MDD) in patients who are intolerant of, or who have an inadequate response to alternative therapies.
Generalised anxiety disorder
Treatment of generalised anxiety disorder (GAD).
Registration process
First generic
First approval of a medicine that contains the same active ingredient as and is bioequivalent to an existing medicine