CHLORAMPHENICOL

Main information

  • Trade name:
  • CHLORAMPHENICOL AH chloramphenicol 5 mg/mL eyedrops bottle
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • CHLORAMPHENICOL AH chloramphenicol 5 mg/mL eyedrops bottle
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 222546
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

222546

CHLORAMPHENICOL AH chloramphenicol 5 mg/mL eyedrops bottle

ARTG entry for

Medicine Registered

Sponsor

Juno Pharmaceuticals Pty Ltd

Postal Address

Level 2 6 Bond Street,South Yarra, VIC, 3141

Australia

ARTG Start Date

15/04/2014

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. CHLORAMPHENICOL AH chloramphenicol 5 mg/mL eyedrops bottle

Product Type

Single Medicine Product

Effective date

15/04/2014

Warnings

No Warnings included on Record

Standard Indications

Specific Indications

For the treatment of bacterial conjunctivitis. For use under medical supervision only in the treatment of other superficial ocular infections caused by

chloramphenicol sensitive organisms.

Additional Product information

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Bottle

LDPE

24 Months

Store at 2 to 8

degrees Celsius

Neither child resistant

closure nor restricted

flow insert

Do not Freeze

Refrigerate

Pack Size/Poison information

Pack Size

Poison Schedule

10 mL

(S3) Pharmacist Only Medicine

Components

1.

Dosage Form

Eye Drops

Route of Administration

Ophthalmic

Visual Identification

A bright colourless to faint yellow aqueous solution, practically clear and

Active Ingredients

Chloramphenicol

5 mg/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 26.11.2017 at 11:07:09 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