OSENI

Main information

  • Trade name:
  • OSENI 12.5/15 12.5 mg alogliptin (as benzoate) / 15 mg pioglitazone (as hydrochloride) film-coated tablet bottle
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • OSENI 12.5/15 12.5 mg alogliptin (as benzoate) / 15 mg pioglitazone (as hydrochloride) film-coated tablet bottle
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 221881
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

221881

OSENI 12.5/15 12.5 mg alogliptin (as benzoate) / 15 mg pioglitazone (as hydrochloride) film-coated tablet

bottle

ARTG entry for

Medicine Registered

Sponsor

Takeda Pharmaceuticals Australia Pty Ltd

Postal Address

GPO Box 2728,Sydney, NSW, 2001

Australia

ARTG Start Date

10/02/2015

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. OSENI 12.5/15 12.5 mg alogliptin (as benzoate) / 15 mg pioglitazone (as hydrochloride) film-coated tablet

bottle

Product Type

Single Medicine Product

Effective date

17/08/2016

Warnings

See Product Information and Consumer Medicine Information for this product

Standard Indications

Specific Indications

OSENI is indicated to improve glycaemic control in adult patients (> or = 18 years old) with type 2 diabetes mellitus when diet and exercise do not

provide adequate glycaemic control and treatment with both alogliptin and pioglitazone is appropriate,- when treatment with metformin or pioglitazone

alone does not provide adequate control; or,- in combination with metformin when dual therapy does not provide adequate control.,OSENI can also be

used to replace separate tablets of alogliptin and pioglitazone in patients already being treated with this combination.

Additional Product information

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Bottle

HDPE

48 Months

Store below 25

degrees Celsius

Child resistant closure

Not recorded

Pack Size/Poison information

Pack Size

Poison Schedule

(S4) Prescription Only Medicine

10 (sample pack)

(S4) Prescription Only Medicine

(S4) Prescription Only Medicine

(S4) Prescription Only Medicine

(S4) Prescription Only Medicine

14 (sample pack)

(S4) Prescription Only Medicine

(S4) Prescription Only Medicine

(S4) Prescription Only Medicine

(S4) Prescription Only Medicine

7 (sample pack)

(S4) Prescription Only Medicine

Components

1. OSENI 12.5/15 12.5 mg alogliptin (as benzoate) / 15 mg pioglitazone (as hydrochloride) film-coated tablet bottle

Dosage Form

Tablet, film coated

Route of Administration

Oral

Visual Identification

Pale yellow, round, biconvex, film-coated tablets with A/P and 12.5/15

printed on one side

Active Ingredients

Alogliptin benzoate

17 mg

Pioglitazone hydrochloride

16.53 mg

Public Summary

Page 1 of

Produced at 26.11.2017 at 12:24:41 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

© 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 2 of

Produced at 26.11.2017 at 12:24:41 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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