AMCAL

Main information

  • Trade name:
  • AMCAL NYSTATIN ORAL DROPS nystatin 100,000IU/mL oral solution bottle
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • AMCAL NYSTATIN ORAL DROPS nystatin 100,000IU/mL oral solution bottle
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 211170
  • Last update:
  • 09-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

211170

AMCAL NYSTATIN ORAL DROPS nystatin 100,000IU/mL oral solution bottle

ARTG entry for

Medicine Registered

Sponsor

Cipla Australia Pty Ltd

Postal Address

Level 1 / 132-136 Albert Road,SOUTH MELBOURNE, VIC, 3205

Australia

ARTG Start Date

20/06/2013

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. AMCAL NYSTATIN ORAL DROPS nystatin 100,000IU/mL oral solution bottle

Product Type

Single Medicine Product

Effective date

7/06/2016

Warnings

No Warnings included on Record

Standard Indications

Specific Indications

For the treatment of oral candidal infections only

Additional Product information

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Bottle

Not recorded

24 Months

Store below 25

degrees Celsius

Not recorded

Not recorded

Pack Size/Poison information

Pack Size

Poison Schedule

Amber coloured bottle - 24mLs - glass

(S3) Pharmacist Only Medicine

Components

1.

Dosage Form

Oral Liquid

Route of Administration

Oral Application

Visual Identification

Yellow coloured Homogenous Suspension

Active Ingredients

Nystatin

100000 IU/mL

© 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 27.11.2017 at 01:34:42 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