XELEVIA

Main information

  • Trade name:
  • XELEVIA sitagliptin (as phosphate monohydrate) 25 mg film-coated tablet blister pack
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • XELEVIA sitagliptin (as phosphate monohydrate) 25 mg film-coated tablet blister pack
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 220109
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

220109

XELEVIA sitagliptin (as phosphate monohydrate) 25 mg film-coated tablet blister pack

ARTG entry for

Medicine Registered

Sponsor

Merck Sharp & Dohme (Australia) Pty Ltd

Postal Address

North Ryde Post Business Centre,Locked Bag 2234,NORTH RYDE BC, NSW, 1670

Australia

ARTG Start Date

19/11/2014

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. XELEVIA sitagliptin (as phosphate monohydrate) 25 mg film-coated tablet blister pack

Product Type

Single Medicine Product

Effective date

10/04/2017

Warnings

See Product Information and Consumer Medicine Information for this product

Standard Indications

Specific Indications

XELEVIA is indicated for the treatment of diabetes mellitus type 2 in persons 18 years of age and older who have failed dietary measures and exercise:,-

as monotherapy, as an adjunct to diet and exercise to improve glycaemic control in patients with type 2 diabetes mellitus, when metformin cannot be

used.

- as dual combination therapy, with metformin, or with a sulfonylurea, or with a thiazolidinedione where the use of a thiazolidinedione is considered

appropriate.

- as triple combination therapy with metformin and a sulfonylurea when combination therapy with both agents does not provide adequate glycaemic

control.

- as add-on combination therapy with insulin (with or without metformin).

Additional Product information

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Blister Pack

PVC/PE/PVDC/Al

3 Years

Store below 30

degrees Celsius

Not recorded

Not recorded

Pack Size/Poison information

Pack Size

Poison Schedule

28 tablets

(S4) Prescription Only Medicine

Components

1. XELEVIA sitagliptin (as phosphate monohydrate) 25 mg film-coated tablet blister pack

Dosage Form

Tablet, film coated

Route of Administration

Oral

Visual Identification

Pink, round, biconvex, film coated tablet with "221" on one side and plain

on the other.

Active Ingredients

sitagliptin phosphate monohydrate

32.13 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 02:49:18 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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