SEQUASE XR quetiapine (as fumarate) 200 mg modified release tablet blister pack

Main information

  • Trade name:
  • SEQUASE XR quetiapine (as fumarate) 200 mg modified release tablet blister pack
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • SEQUASE XR quetiapine (as fumarate) 200 mg modified release tablet blister pack
    Australia
  • Language:
  • English

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization status:
  • Registered
  • Authorization number:
  • 212513
  • Last update:
  • 20-05-2019

Public Assessment Report

Public Summary

Summary for ARTG Entry:

212513

SEQUASE XR quetiapine (as fumarate) 200 mg modified release tablet blister pack

ARTG entry for

Medicine Registered

Sponsor

AstraZeneca Pty Ltd

Postal Address

PO Box 131,NORTH RYDE, NSW, 1670

Australia

ARTG Start Date

3/07/2014

Product category

Medicine

Status

Active

Approval area

Drug Safety Evaluation Branch

Conditions

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.

Products

1. SEQUASE XR quetiapine (as fumarate) 200 mg modified release tablet blister pack

Product Type

Single Medicine Product

Effective date

23/08/2017

Warnings

See Product Information and Consumer Medicine Information for this product

Standard Indications

Specific Indications

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

(GAD).

Additional Product information

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Blister Pack

PVC/PCTFE (Aclar)/Al

3 Years

Store below 30

degrees Celsius

Not recorded

Not recorded

Pack Size/Poison information

Pack Size

Poison Schedule

(S4) Prescription Only Medicine

Components

1. quetiapine (as fumarate) 200 mg modified release tablet

Dosage Form

Tablet, modified release

Route of Administration

Oral

Visual Identification

yellow film coated capsule shaped biconvex intagliated tablet with "XR 200"

on 1 side & plain on the other

Active Ingredients

Quetiapine fumarate

230.26 mg

© Commonwealth of Australia.This work is copyright.You are not permitted to re-transmit, distribute or commercialise the material without obtaining prior

written approval from the Commonwealth.Further details can be found at http://www.tga.gov.au/about/website-copyright.htm.

Public Summary

Page 1 of

Produced at 11.11.2017 at 04:28:51 AEDT

This is not an ARTG Certificate document.

The onus is on the reader to verify the current accuracy of the information on the document subsequent to the date shown.

Visit www.tga.gov.au for contact information