XIGDUO

Main information

  • Trade name:
  • XIGDUO XR 10/500 dapagliflozin 10 mg (as propanediol monohydrate) / metformin hydrochloride 500 mg modified release tablets blis
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • XIGDUO XR 10/500 dapagliflozin 10 mg (as propanediol monohydrate) / metformin hydrochloride 500 mg modified release tablets blis
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 211294
  • Last update:
  • 09-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

211294

XIGDUO XR 10/500 dapagliflozin 10 mg (as propanediol monohydrate) / metformin hydrochloride 500 mg

modified release tablets blister pack

ARTG entry for

Medicine Registered

Sponsor

AstraZeneca Pty Ltd

Postal Address

PO Box 131,NORTH RYDE, NSW, 1670

Australia

ARTG Start Date

18/07/2014

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. XIGDUO XR 10/500 dapagliflozin 10 mg (as propanediol monohydrate) / metformin hydrochloride 500 mg

modified release tablets blister pack

Product Type

Single Medicine Product

Effective date

3/10/2017

Warnings

See Product Information and Consumer Medicine Information for this product

Standard Indications

Specific Indications

XIGDUO XR is indicated as an adjunct to diet and exercise to improve glycaemic control in adults with type 2 diabetes mellitus when treatment with both

dapagliflozin and metformin is appropriate (see CLINICAL TRIALS and PRECAUTIONS for available data on the combination therapy)

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

7 tablets (sample pack)

(S4) Prescription Only Medicine

28 tablets

(S4) Prescription Only Medicine

Components

1. XIGDUO XR 10/500 dapagliflozin 10 mg (as propanediol monohydrate) / metformin hydrochloride 500 mg modified release tablets blister

pack

Dosage Form

Tablet, modified release

Route of Administration

Oral

Visual Identification

pink biconvex, capsule-shaped, film-coated tablet with "1072" and "10/500"

debossed on one side and plain on the other side

Active Ingredients

Dapagliflozin propanediol monohydrate

12.3 mg

Metformin hydrochloride

500 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 27.11.2017 at 01:33:17 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

14-11-2018

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Europe -DG Health and Food Safety

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