VELMETIA

Main information

  • Trade name:
  • VELMETIA 50/500 sitagliptin (as phosphate monohydrate) 50 mg and metformin hydrochloride 500 mg tablet blister pack
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • VELMETIA 50/500 sitagliptin (as phosphate monohydrate) 50 mg and metformin hydrochloride 500 mg tablet blister pack
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 220155
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

220155

VELMETIA 50/500 sitagliptin (as phosphate monohydrate) 50 mg and metformin hydrochloride 500 mg

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. VELMETIA 50/500 sitagliptin (as phosphate monohydrate) 50 mg and metformin hydrochloride 500 mg

tablet blister pack

Product Type

Single Medicine Product

Effective date

19/09/2017

Warnings

See Product Information and Consumer Medicine Information for this product

Standard Indications

Specific Indications

VELMETIA and VELMETIA XR are indicated as initial therapy in patients with type 2 diabetes mellitus to improve glycaemic control when diet and

exercise do not provide adequate glycaemic control, when dual sitagliptin and metformin therapy is appropriate (i.e. high initial HbA1c levels and poor

prospects of response to monotherapy).,VELMETIA and VELMETIA XR are indicated as an adjunct to diet and exercise to improve glycaemic control in

patients with type 2 diabetes mellitus inadequately controlled on sitagliptin or metformin alone or in patients already being treated with the combination of

sitagliptin and metformin.,VELMETIA and VELMETIA XR are indicated in combination with a sulfonylurea as an adjunct to diet and exercise in patients

with type 2 diabetes mellitus when combination therapy with metformin and sulfonylurea does not provide adequate glycaemic control.,VELMETIA and

VELMETIA XR are indicated as an adjunct to diet and exercise to improve glycaemic control in combination with insulin in patients with type 2 diabetes

mellitus inadequately controlled on insulin and metformin, or in patients already being treated with the combination of sitagliptin, metformin and insulin.

Additional Product information

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Blister Pack

PVC/PE/PVDC/Al

3 Years

Store below 25

degrees Celsius

Not recorded

Not recorded

Pack Size/Poison information

Pack Size

Poison Schedule

56 tablets

(S4) Prescription Only Medicine

14 tablets (starter pack)

(S4) Prescription Only Medicine

Components

1. VELMETIA 50/500 sitagliptin (as phosphate monohydrate) 50 mg and metformin hydrochloride 500 mg tablet blister pack

Dosage Form

Tablet, film coated

Route of Administration

Oral

Visual Identification

Light pink, film coated tablet with "575" on one side and plain on the other.

Active Ingredients

Metformin hydrochloride

500 mg

sitagliptin phosphate monohydrate

64.25 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 02:45:53 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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