GenRx

Main information

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

Documents

Localization

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

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 222549
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

222549

GenRx - CHLORAMPHENICOL chloramphenicol 5 mg/mL eyedrops bottle

ARTG entry for

Medicine Registered

Sponsor

Apotex Pty Ltd

Postal Address

PO Box 280,NORTH RYDE BC, NSW, 1670

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. GenRx - CHLORAMPHENICOL 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 11:06:15 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

1-2-2019

EFSA statement on the risk posed to humans by a vitamin B2 produced by a genetically modified strain of Bacillus subtilis used as a feed additive

EFSA statement on the risk posed to humans by a vitamin B2 produced by a genetically modified strain of Bacillus subtilis used as a feed additive

Published on: Thu, 31 Jan 2019 The detection of recombinant DNA in a vitamin B2 used as feed additive was notified by the Belgian national authorities on 2 October 2018 via the Rapid Alert System for Food and Feed (RASFF). The European Commission requested scientific advice from EFSA on the risk posed to humans by the presence of genetically modified material in the feed additive, particularly with regard to antimicrobial resistance (AMR). EFSA assessed the analytical data from RASFF regarding the prese...

Europe - EFSA - European Food Safety Authority EFSA Journal

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