QUETIAPINE SG quetiapine (as fumarate) 200 mg film-coated tablet blister pack

Main information

  • Trade name:
  • QUETIAPINE SG quetiapine (as fumarate) 200 mg film-coated tablet blister pack
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • QUETIAPINE SG quetiapine (as fumarate) 200 mg film-coated tablet blister pack
    Australia
  • Language:
  • English

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization status:
  • Registered
  • Authorization number:
  • 176721
  • Last update:
  • 22-05-2019

Public Assessment Report

Public Summary

Summary for ARTG Entry:

176721

QUETIAPINE SG quetiapine (as fumarate) 200 mg film-coated tablet blister pack

ARTG entry for

Medicine Registered

Sponsor

Amneal Pharma Australia Pty Ltd

Postal Address

12 River Street,SOUTH YARRA, VIC, 3141

Australia

ARTG Start Date

12/12/2011

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. QUETIAPINE SG quetiapine (as fumarate) 200 mg film-coated tablet blister pack

Product Type

Single Medicine Product

Effective date

28/05/2015

Warnings

See Product Information and Consumer Medicine Information for this product

Standard Indications

Specific Indications

Quetiapine is indicated for: Bipolar disorder -Adults- Maintenance treatment of bipolar 1 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. Children/adolescents aged 10 to 17 years - Monotherapy treatment of acute mania associated with bipolar I disorder.

Schizophrenia - Adults and adolescents aged 13 to 17 years -Treatment of schizophrenia

Additional Product information

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Blister Pack

PVC/PVDC/Al

3 Years

Store below 25

degrees Celsius

Not recorded

Protect from Light

Protect from Moisture

Pack Size/Poison information

Pack Size

Poison Schedule

(S4) Prescription Only Medicine

(S4) Prescription Only Medicine

Components

1. QUETIAPINE SG quetiapine (as fumarate) 200 mg film-coated tablet blister pack

Dosage Form

Tablet, film coated

Route of Administration

Oral

Visual Identification

White coloured, round, biconvex, film coated tablet, engraved with 'Q' on

one face and '200' on the other

Active Ingredients

Quetiapine fumarate

230.31 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 29.11.2017 at 12:35:20 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