HYDROGEN

Main information

  • Trade name:
  • HYDROGEN PEROXIDE SOLUTION 3% BP
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • HYDROGEN PEROXIDE SOLUTION 3% BP
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 62624
  • Last update:
  • 01-12-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

62624

HYDROGEN PEROXIDE SOLUTION 3% BP

ARTG entry for

Medicine Listed

Sponsor

Sanofi-Aventis Healthcare Pty Ltd T/A Sanofi Consumer Healthcare

Postal Address

PO Box 403,VIRGINIA, QLD, 4014

Australia

ARTG Start Date

5/12/1997

Product category

Medicine

Status

Active

Approval area

Listed Medicines

Conditions

The medicine is included in the ARTG on the condition that in relation to the use of Hydrogen peroxide, the medicine must contain Hydrogen peroxide as

the only active ingredient. The product must also conform to the requirements of the BP 2004 monograph for Hydrogen peroxide solution and must not

exceed a concentration of 3 per cent w/w.

The sponsor shall keep records relating to this listed medicine as are necessary to: (a) Expedite recall if necessary of any batch of the listed medicine,

(b) Identify the manufacturer(s) of each batch of the listed medicine. Where any part of or step in manufacture in Australia of the listed medicine is

sub-contracted to a third party who is not the sponsor, copies of relevant Good Manufacturing Practice agreements relation to such manufacture shall be

kept.

The sponsor shall retain records of the distribution of the listed medicine for a period of five years and shall provide the records or copies of the records

to the Complementary Medicines Branch, Therapeutic Goods Administration, upon request.

The sponsor of the listed medicine must not, by any means, intentionally or recklessly advertise the medicine for an indication other than those accepted

in relation to the inclusion of the medicine in the Register.

All reports of adverse reactions or similar experiences associated with the use or administration of the listed medicine shall be notified to the Head, Office

of Product Review, Therapeutic Goods Administration, as soon as practicable after the sponsor of the goods becomes aware of those reports. Sponsors

of listed medicines must retain records of such reports for a period of not less than 18 months from the day the Head, Office of Product Review is notified

of the report or reports.

The sponsor shall not supply the listed medicine after the expiry date of the goods.

Where a listed medicine is distributed overseas as well as in Australia, product recall or any other regulatory action taken in relation to the medicine

outside Australia which has or may have relevance to the quality, safety or efficacy of the goods distributed in Australia, must be notified to the National

Manager Therapeutic Goods Administration, immediately the action or information is known to the sponsor.

Products

1. HYDROGEN PEROXIDE SOLUTION 3% BP

Product Type

Single Medicine Product

Effective date

9/07/2013

Warnings

If symptoms persist consult your healthcare practitioner (or words to that effect).

Standard Indications

May assist in the management of minor wounds (cuts, scratches, abrasions)

Specific Indications

Hydrogen peroxide can be used as a powerful bleach or for cuts and wounds.

ADDITIONAL CLAIMS: Antiseptic, Deodorant. Use for disinfecting minor skin wounds. Topical antiseptic and cleansing agent. Anti-infective. May be

used to cleanse wounds and ulcers.

Additional Product information

Pack Size/Poison information

Pack Size

Poison Schedule

Components

1. Formulation 1

Dosage Form

Liquid, multipurpose

Route of Administration

Topical

Visual Identification

Active Ingredients

hydrogen peroxide

30 mg/g

Public Summary

Page 1 of

Produced at 01.12.2017 at 10:50:01 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

© 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 2 of

Produced at 01.12.2017 at 10:50:01 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

21-1-2019

Succinate dehydrogenase inhibitor (SDHI) fungicides: ANSES presents the results of its expert appraisal

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A group of scientists recently warned of the potential health risks of using succinate dehydrogenase inhibitor (SDHI) fungicides in agriculture. In this context, ANSES asked a group of independent experts to examine the hypotheses put forward by these scientists. The experts considered all the available scientific data in order to determine, in particular, whether this evidence constituted a health alert.

France - Agence Nationale du Médicament Vétérinaire

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One lot of Equate brand Lens Care System and Multi-Purpose Solution voluntarily recalled because of a labelling error

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Teva Canada is voluntarily recalling one lot (Lot 150261) of two products because of a labelling error. While the outer carton of Equate brand Lens Care System is correctly labelled, the bottle within the carton is mislabelled as Equate brand Multi-Purpose Solution. Because of the labelling error, the company is recalling both products labelled with Lot 150261. Bottles labelled as Equate Multi-Purpose Solution should contain a 0.0001% w/v polyhexanide based disinfecting solution for rinsing. The mislabel...

Health Canada

9-11-2018

Sargassum seaweed: limit the exposure of residents and workers to hydrogen sulphide

Sargassum seaweed: limit the exposure of residents and workers to hydrogen sulphide

Since August 2014, the French Caribbean and French Guiana have been experiencing successive waves of Sargassum seaweed washing up on their coastlines. Despite the efforts made to clean it up, the seaweed decomposes in situ. This leads to the production of hydrogen sulphide (H2S), which can sometimes be detected at high concentrations. Doctors' reports concerning the health effects suffered by people exposed to H2S, and complaints from the general public relating to the problem of odours, have increased s...

France - Agence Nationale du Médicament Vétérinaire

17-10-2018

Applicability of in silico tools for the prediction of dermal absorption for pesticides

Applicability of in silico tools for the prediction of dermal absorption for pesticides

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Europe - EFSA - European Food Safety Authority Publications

18-9-2018

Peer review of the pesticide risk assessment of the active substance sodium hydrogen carbonate

Peer review of the pesticide risk assessment of the active substance sodium hydrogen carbonate

Published on: Fri, 14 Sep 2018 00:00:00 +0200 The conclusions of EFSA following the peer review of the initial risk assessments carried out by the competent authority of the rapporteur Member State Austria for the pesticide active substance sodium hydrogen carbonate are reported. The context of the peer review was that required by Regulation (EC) No 1107/2009 of the European Parliament and of the Council. The conclusions were reached on the basis of the evaluation of the representative use of sodium hyd...

Europe - EFSA - European Food Safety Authority Publications

26-7-2018

Trek Bicycle Corporation recalls Bontrager Line Pro Flat Bicycle Pedals

Trek Bicycle Corporation recalls Bontrager Line Pro Flat Bicycle Pedals

The pedals may have been manufactured with hydrogen embrittlement in the spindle of the pedals, causing one or both of the pedals to fail. When it fails, the pedal body separates from the spindle. If this happens while the bicycle is being operated, the rider could potentially lose control of the bicycle and fall.

Health Canada

19-2-2019


Opinion/decision on a Paediatric investigation plan (PIP): Potassium citrate monohydrated,Potassium hydrogen carbonate, decision type: , therapeutic area: , PIP number: P/0355/2018

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Europe - EMA - European Medicines Agency

18-12-2018

EU/3/18/2104 (Novartis Europharm Limited)

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Europe -DG Health and Food Safety

27-11-2018


Opinion/decision on a Paediatric investigation plan (PIP): Potassium citrate monohydrated,potassium hydrogen carbonate (ADV7103), decision type: , therapeutic area: , PIP number: P/0214/2018

Opinion/decision on a Paediatric investigation plan (PIP): Potassium citrate monohydrated,potassium hydrogen carbonate (ADV7103), decision type: , therapeutic area: , PIP number: P/0214/2018

Opinion/decision on a Paediatric investigation plan (PIP): Potassium citrate monohydrated,potassium hydrogen carbonate (ADV7103), decision type: , therapeutic area: , PIP number: P/0214/2018

Europe - EMA - European Medicines Agency

2-8-2018

EU/3/18/2052 (Dicerna EU Limited)

EU/3/18/2052 (Dicerna EU Limited)

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Europe -DG Health and Food Safety

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EU/3/15/1606 (Bayer AG)

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Europe -DG Health and Food Safety

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EU/3/18/2008 (StolmAr and Partner PatentanwAlte PartG mbB)

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Europe -DG Health and Food Safety