MACROVIC

Main information

  • Trade name:
  • MACROVIC powder for oral solution sachet
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • MACROVIC powder for oral solution sachet
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 220583
  • Last update:
  • 09-11-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

220583

MACROVIC powder for oral solution sachet

ARTG entry for

Medicine Registered

Sponsor

Arrow Pharma Pty Ltd

Postal Address

15 - 17 Chapel Street,Cremorne, VIC, 3121

Australia

ARTG Start Date

27/02/2014

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. MACROVIC powder for oral solution sachet

Product Type

Single Medicine Product

Effective date

19/10/2016

Warnings

No Warnings included on Record

Standard Indications

Specific Indications

For effective relief from constipation, treatment of constipation, and treatment of faecal impaction defined as refractory constipation with faecal loading of

the rectum and/or colon confirmed by the physical examination of the abdomen and rectum, in adults and children 12 years and over.

Additional Product information

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Sachet

Al laminated with

LDPE/paper

36 Months

Store below 25

degrees Celsius

Neither child resistant

closure nor restricted

flow insert

Not recorded

Pack Size/Poison information

Pack Size

Poison Schedule

2,8,30

Not Scheduled after consideration by Committee

Components

1.

Dosage Form

Powder, oral

Route of Administration

Oral

Visual Identification

A white to almost white fine powder in single-dose sachets.

Active Ingredients

macrogol 3350

13125 mg

potassium chloride

46.6 mg

sodium bicarbonate

178.5 mg

sodium chloride

350.7 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 02:19:17 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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