METFORMIN PFIZER metformin hydrochloride 1000 mg tablets Bottle

Main information

  • Trade name:
  • METFORMIN PFIZER metformin hydrochloride 1000 mg tablets Bottle
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • METFORMIN PFIZER metformin hydrochloride 1000 mg tablets Bottle
    Australia
  • Language:
  • English

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization status:
  • Registered
  • Authorization number:
  • 180440
  • Last update:
  • 22-05-2019

Public Assessment Report

Public Summary

Summary for ARTG Entry:

180440

METFORMIN PFIZER metformin hydrochloride 1000 mg tablets Bottle

ARTG entry for

Medicine Registered

Sponsor

Amneal Pharma Australia Pty Ltd

Postal Address

12 River Street,SOUTH YARRA, VIC, 3141

Australia

ARTG Start Date

24/11/2011

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. METFORMIN PFIZER metformin hydrochloride 1000 mg tablets Bottle

Product Type

Single Medicine Product

Effective date

24/05/2012

Warnings

See Product Information and Consumer Medicine Information for this product

Standard Indications

Specific Indications

Metformin is indicated in the treatment of type 2 diabetes mellitus in adults, children from 10 years of age and adolescents, particularly in overweight

patients, when dietary management and exercise alone does not result in adequate glycaemic control.,For adult patients, metformin may be used as

initial treatment or in sulfonylurea failures either alone or in combination with a sulfonylurea and other oral agents or as adjuvant therapy in insulin

requiring type 2 diabetes.

Additional Product information

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Bottle

HDPE

2 Years

Store below 25

degrees Celsius

Not recorded

Store in a Dry Place

Pack Size/Poison information

Pack Size

Poison Schedule

(S4) Prescription Only Medicine

Components

1. METFORMIN PFIZER metformin hydrochloride 1000 mg tablets Bottle

Dosage Form

Tablet, film coated

Route of Administration

Oral

Visual Identification

White, biconvex, oval shaped, film coated tablets with a score line in

between '6' and '2' on one side and 'A' debossed on the other side

Active Ingredients

Metformin hydrochloride

1000 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 08:12:29 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