ONGLYZA

Main information

  • Trade name:
  • ONGLYZA saxagliptin (as hydrochloride) 2.5 mg film-coated tablet blister pack
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • ONGLYZA saxagliptin (as hydrochloride) 2.5 mg film-coated tablet blister pack
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 211214
  • Last update:
  • 09-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

211214

ONGLYZA saxagliptin (as hydrochloride) 2.5 mg film-coated 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

21/03/2014

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. ONGLYZA saxagliptin (as hydrochloride) 2.5 mg film-coated tablet blister pack

Product Type

Single Medicine Product

Effective date

6/07/2017

Warnings

See Product Information and Consumer Medicine Information for this product

Standard Indications

Specific Indications

Add-on combination: ONGLYZA is indicated in patients with type 2 diabetes mellitus to improve glycaemic control in combination with other glucose

lowering medicines, when these together with diet and exercise, do not provide adequate glycaemic control (see Clinical Trials and Precautions for

available data on different add-on combination therapies).,Initial combination: ONGLYZA is indicated for use as initial combination therapy with

metformin, in patients with type 2 diabetes mellitus, to improve glycaemic control as an adjunct to diet and exercise, when dual saxagliptin and metformin

therapy is appropriate (i.e. high initial HbA1c levels and poor prospects for response to 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

Not recorded

Pack Size/Poison information

Pack Size

Poison Schedule

(S4) Prescription Only Medicine

(S4) Prescription Only Medicine

Components

1. ONGLYZA saxagliptin (as hydrochloride) 2.5 mg film-coated tablet blister pack

Dosage Form

Tablet, film coated

Route of Administration

Oral

Visual Identification

Pale yellow biconvex round tablets 2.5 on one side & 4214 on reverse

Active Ingredients

Saxagliptin

2.5 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 20.10.2017 at 06:02:59 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

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