ARIPIPRAZOLE-GX

Main information

  • Trade name:
  • ARIPIPRAZOLE-GX aripiprazole 20mg tablet blister pack
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • ARIPIPRAZOLE-GX aripiprazole 20mg tablet blister pack
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 217225
  • Last update:
  • 09-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

217225

ARIPIPRAZOLE-GX aripiprazole 20mg tablet blister pack

ARTG entry for

Medicine Registered

Sponsor

Medis Pharma Pty Ltd

Postal Address

PO Box 6127,North Sydney, NSW, 2059

Australia

ARTG Start Date

29/10/2014

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. ARIPIPRAZOLE-GX aripiprazole 20mg tablet blister pack

Product Type

Single Medicine Product

Effective date

29/10/2014

Warnings

See Product Information and Consumer Medicine Information for this product

Standard Indications

Specific Indications

Aripiprazole is indicated for the treatment of schizophrenia including maintenance of clinical improvement during continuation therapy.,Acute treatment of

manic or mixed episodes associated with Bipolar I Disorder in adults as monotherapy and in combination with lithium or valproate;,Maintenance

treatment of manic or mixed episodes in Bipolar I Disorder in adults as monotherapy.

Additional Product information

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Blister Pack

Al/Al

36 Months

Store below 30

degrees Celsius

Not recorded

Store in Original

Container

Pack Size/Poison information

Pack Size

Poison Schedule

(S4) Prescription Only Medicine

Components

1. ARIPIPRAZOLE-GX aripiprazole 20mg tablet blister pack

Dosage Form

Tablet, uncoated

Route of Administration

Oral

Visual Identification

10mm x 6.25mm, capsule-shaped, biconvex, white uncoated tablets with 20

debossed on one side and ZL on the other side

Active Ingredients

aripiprazole

20 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 26.11.2017 at 06:34:00 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

18-10-2018

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Abilify (Otsuka Pharmaceutical Netherlands B.V.)

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