BA ZHENG

Main information

Documents

Localization

  • Available in:
  • BA ZHENG SAN WAN
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 218321
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

218321

BA ZHENG SAN WAN

ARTG entry for

Medicine Listed

Sponsor

Shen Neng Herbal Medicines Group Pty Ltd

Postal Address

1 Clarke Street,GUILDFORD, NSW, 2161

Australia

ARTG Start Date

10/12/2013

Product category

Medicine

Status

Active

Approval area

Listed Medicines

Conditions

Colouring agents used in listed medicine for ingestion, other than those listed for export only under section 25 of the Act, shall be only those included in

the list of 'Colourings permitted in medicines for oral use'.

Sponsors must confirm the absence of aristolochic acids, or herbal species known to contain these acids, in all medicines containing herbal material

derived from any of the following plant genera - Akebia, Asarum, Bragantia, Clematis, Cocculus, Diploclisia, Menispernum, Saussurea, Sinomenium,

Stephania, Vladimiria.Such confirmation is to be provided to The Director, Complementary Medicines Branch, TGA prior to supply of each batch in

Australia and may take the form of EITHER chemical analysis OR botanical identification as detailed below.Chemical Analysis: This requires the

provision of a certificate of chemical analysis, including raw data generated in the analysis, to the TGA. Each batch of product is to be accompanied by a

Certificate of Analysis confirming the absence of aristolochic acids and including raw data supporting the results. The Certificate and all supporting

evidence must be approved by the TGA prior to supply of the batch in Australia. Methodology used to perform the chemical analysis is to be, at least,

equivalent to the method developed by the FDA in terms of specificity and limits of detection. If methodology other than that of the FDA is used, the

alternative methods are to be submitted to the TGA for approval prior to implementation. All relevant details of the methodology, such as analytical

method validation data, are to be included in the submission. Botanical Identification: This requires the provision of evidence of the botanical

identification of herbal material from any of the affected genera to the TGA, prior to supply of each batch of goods in Australia. This evidence is to be

comprised of a Certificate of Identification, plus information regarding the signatory including full name, contact information and details of qualifications

and experience relevant to the task of identification of botanical material.

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. BA ZHENG SAN WAN

Product Type

Single Medicine Product

Effective date

10/12/2013

Warnings

Products containing activated charcoal should be used with caution in children since it may interfere with absorption of nutrients. Activated charcoal may

interact with other medicines. Activated charcoal is not recommended for long-term use. [or words to that effect]

(If medicine contains one sugar) contains [insert name of sugar] OR (If medicine contains two or more sugars) Contains sugars [or words to that effect].

If fluid retention persists, seek medical advice (or words to that effect).

Standard Indications

Diuretic. Aids or assists in the treatment of fluid retention. [Warning FLRET required]

Specific Indications

TCM formula, designed to clear the heat and fire.

Additional Product information

Pack Size/Poison information

Pack Size

Poison Schedule

Public Summary

Page 1 of

Produced at 26.11.2017 at 05:07:16 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

Components

1. Formulation 1

Dosage Form

Pill

Route of Administration

Oral

Visual Identification

Active Ingredients

Clematis armandii

4.17 mg

Equivalent: Clematis armandii (Dry)

41.7 mg

Dianthus superbus

4.17 mg

Equivalent: Dianthus superbus (Dry)

41.7 mg

Gardenia jasminoides

4.17 mg

Equivalent: Gardenia jasminoides (Dry)

41.7 mg

Glycyrrhiza uralensis

41.7 mg

Equivalent: Glycyrrhiza uralensis (Dry)

41.7 mg

Lysimachia christinae

4.17 mg

Equivalent: Lysimachia christinae (Dry)

41.7 mg

Phellodendron amurense

1.57 mg

Equivalent: Phellodendron amurense (Dry)

15.7 mg

Phellodendron amurense

26 mg

Equivalent: Phellodendron amurense (Dry)

26 mg

Plantago asiatica

4.17 mg

Equivalent: Plantago asiatica (Dry)

41.7 mg

Polygonum aviculare

4.17 mg

Equivalent: Polygonum aviculare (Dry)

41.7 mg

Rheum palmatum

41.7 mg

Equivalent: Rheum palmatum (Dry)

41.7 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 2 of

Produced at 26.11.2017 at 05:07:16 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