Summary for ARTG Entry:
SEQUASE XR quetiapine (as fumarate) 50 mg modified release tablet blister pack
ARTG entry for
AstraZeneca Pty Ltd
PO Box 131,NORTH RYDE, NSW, 1670
ARTG Start Date
Drug Safety Evaluation Branch
Conditions applicable to all therapeutic goods as specified in the document "Standard Conditions Applying to Registered or Listed Therapeutic Goods
Under Section 28 of the Therapeutic Goods Act 1989" effective 1 July 1995.
Conditions applicable to the relevant category and class of therapeutic goods as specified in the document "Standard Conditions Applying to Registered
or Listed Therapeutic Goods Under Section 28 of the Therapeutic Goods Act 1989" effective 1 July 1995.
1. SEQUASE XR quetiapine (as fumarate) 50 mg modified release tablet blister pack
Single Medicine Product
See Product Information and Consumer Medicine Information for this product
SEQUASE XR 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 DOSAGE AND ADMINISTRATION) - Treatment of acute mania associated with bipolar I disorder as monotherapy or in combination with
lithium or sodium valproate. Efficacy of SEQUASE XR in the treatment of bipolar disorder indications was established in part, on the basis of
extrapolation from the established effectiveness of quetiapine IR. 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
Additional Product information
Store below 30
Pack Size/Poison information
(S4) Prescription Only Medicine
1. quetiapine (as fumarate) 50 mg modified release tablet
Tablet, modified release
Route of Administration
peach film coated capsule shaped biconvex intagliated tablet with "XR 50"
on 1 side & plain on the other
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