ASCENT MACROGOL 3350 HALF WITH ELECTROLYTES powder for oral solution sachet

Main information

  • Trade name:
  • ASCENT MACROGOL 3350 HALF WITH ELECTROLYTES powder for oral solution sachet
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • ASCENT MACROGOL 3350 HALF WITH ELECTROLYTES powder for oral solution sachet
    Australia
  • Language:
  • English

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization status:
  • Registered
  • Authorization number:
  • 198162
  • Last update:
  • 21-05-2019

Public Assessment Report

Public Summary

Summary for ARTG Entry:

198162

ASCENT MACROGOL 3350 HALF WITH ELECTROLYTES powder for oral solution sachet

ARTG entry for

Medicine Registered

Sponsor

Medis Pharma Pty Ltd

Postal Address

PO Box 6127,North Sydney, NSW, 2059

Australia

ARTG Start Date

4/06/2012

Product category

Medicine

Status

Active

Approval area

Non-Prescription Medicines

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. ASCENT MACROGOL 3350 HALF WITH ELECTROLYTES powder for oral solution sachet

Product Type

Single Medicine Product

Effective date

17/06/2013

Warnings

No Warnings included on Record

Standard Indications

Specific Indications

For the relief of constipation in adults. For the treatment of chronic constipation in adults and children aged 2 years and older; and the resolution and

prevention of recurrence of faecal impaction (as diagnosed by a doctor) in children aged 2 years and older.

Additional Product information

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Sachet

Al laminated with

LDPE/paper

24 Months

Store below 25

degrees Celsius

Not recorded

Not recorded

Pack Size/Poison information

Pack Size

Poison Schedule

Not Scheduled after consideration by Committee

Not Scheduled after consideration by Committee

Not Scheduled after consideration by Committee

Components

1.

Dosage Form

Powder, oral

Route of Administration

Oral

Visual Identification

White crystalline powder in single dose sachets

Active Ingredients

macrogol 3350

6.563 g

potassium chloride

23.3 mg

sodium bicarbonate

89.25 mg

sodium chloride

175.35 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 28.11.2017 at 11:19:25 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