DIAFORMIN XR 500 metformin hydrochloride 500 mg extended release tablet blister pack

Australia - English - Department of Health (Therapeutic Goods Administration)

Buy It Now

Active ingredient:
metformin hydrochloride
Available from:
Alphapharm Pty Ltd
Authorization status:
Registered
Authorization number:
318082

Public Summary

Summary for ARTG Entry:

318082

DIAFORMIN XR 500 metformin hydrochloride 500 mg extended release tablet blister pack

ARTG entry for

Medicine Registered

Sponsor

Alphapharm Pty Ltd

Postal Address

PO Box R1462,ROYAL EXCHANGE, NSW, 1225

Australia

ARTG Start Date

8/08/2019

Product category

Medicine

Status

Active

Approval area

Drug Safety Evaluation Branch

Conditions

Conditions applicable to the relevant category and class of therapeutic goods as specified in the document "Conditions Applying to Therapeutic Goods

Accepted for Registration or Listing as Goods Currently Supplied at the Commencement of the Therapeutic Goods Act 1989"

Except where the sponsor has been contracted by an overseas partry to manufacturer the goods and that party will be responsible for placing the goods

on the market in countries other than Australia, the sponsor must have and shall retain, while the goods remain listed, evidence necessary to

substantiate and support the accuracy of the indications in relation to the listed goods, and upon the request of the Head, Office of Prescription

Medicines Authorisation Branch, Therapeutic Goods Administration, shall produce such evidence to this officer.

The conditions applying to these goods when they are exported from Australia are given below:

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, other than condition No. 8 and condition No. 9.

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, other than condition No.11

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.

The therapeutic goods grouped in this registration/listing as export only goods under the following names are included in the Australian Register of

Therapeutic Goods and may not be supplied in Australia. Export Name(s) to be added:

Products

1. DIAFORMIN XR 500 metformin hydrochloride 500 mg extended release tablet blister pack

Product Type

Single Medicine Product

Effective date

8/08/2019

Permitted Indications

Indication Requirements

No Indication Requirements included on Record

Standard Indications

No Standard Indications included on Record

Specific Indications

Treatment of type 2 diabetes mellitus in adults, particularly in overweight patients, when dietary management and exercise alone does not result in

adequate glycaemic control. Diaformin XR 500 may be used as monotherapy or in combination with other oral antidiabetic agents, or with insulin.

Warnings

See Product Information and Consumer Medicine Information for this product

Additional Product information

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Blister Pack

PVC/PVDC/Al

3 Years

Store below 25

degrees Celsius

Not recorded

Not recorded

Pack Size/Poison information

Pack Size

Poison Schedule

60 Tablets

(S4) Prescription Only Medicine

Public Summary

Page 1 of

Produced at 29.08.2019 at 09:27:00 AEST

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

10 Tablets (Starter Pack)

(S4) Prescription Only Medicine

30 Tablets

(S4) Prescription Only Medicine

100 Tablets

(S4) Prescription Only Medicine

90 Tablets

(S4) Prescription Only Medicine

120 Tablets

(S4) Prescription Only Medicine

Components

1. DIAFORMIN XR 500 metformin hydrochloride 500 mg extended release tablet blister pack

Dosage Form

Tablet, modified release

Route of Administration

Oral

Visual Identification

White to off-white, round, biconvex tablet, debossed with 500 on one side.

Active Ingredients

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 2 of

Produced at 29.08.2019 at 09:27:00 AEST

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

Similar products

Search alerts related to this product

Share this information