HUO XIANG

Main information

Documents

Localization

  • Available in:
  • HUO XIANG ZHENG QI WAN
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 218862
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

218862

HUO XIANG ZHENG QI 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

2/01/2014

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'.

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. HUO XIANG ZHENG QI WAN

Product Type

Single Medicine Product

Effective date

2/01/2014

Warnings

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

If diarrhoea persists for more than 6 hours in infants under 6 months, 12 hours in children under 3 years, 24 hours in children aged 3-6 years or 48 hours

in adults and children over 6 years, seek medical advice (or words to that effect).

Adults only. OR Not to be used in children under two years of age without medical advice (or words to that effect).

Standard Indications

Relief or treatment of diarrhoea. [Warning DIAR required]

Relief of the symptoms of influenza/flu. [Warnings S and COLD required]

Relief or treatment of indigestion/heartburn/reflux. [Warning S required]

Specific Indications

may help in symptomatic relief of stomach conditions such as stomach ache, bloating and diarrhoea.

Additional Product information

Pack Size/Poison information

Pack Size

Poison Schedule

Components

1. Formulation 1

Dosage Form

Pill

Route of Administration

Oral

Visual Identification

Active Ingredients

Public Summary

Page 1 of

Produced at 26.11.2017 at 04:18:27 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

Angelica dahurica

18.95 mg

Equivalent: Angelica dahurica (Dry)

18.95 mg

Areca catechu

1.87 mg

Equivalent: Areca catechu (Dry)

18.95 mg

Atractylodes macrocephala

3.74 mg

Equivalent: Atractylodes macrocephala (Dry)

37.91 mg

Citrus reticulata

3.74 mg

Equivalent: Citrus reticulata (Dry)

37.91 mg

Glycyrrhiza uralensis

25.19 mg

Equivalent: Glycyrrhiza uralensis (Dry)

25.19 mg

Glycyrrhiza uralensis

1.25 mg

Equivalent: Glycyrrhiza uralensis (Dry)

12.72 mg

Magnolia officinalis

3.74 mg

Equivalent: Magnolia officinalis (Dry)

37.91 mg

Perilla frutescens

1.87 mg

Equivalent: Perilla frutescens (Dry)

18.95 mg

Pinellia ternata

3.74 mg

Equivalent: Pinellia ternata (Dry)

37.91 mg

Platycodon grandiflorus

37.91 mg

Equivalent: Platycodon grandiflorus (Dry)

37.91 mg

Pogostemon cablin

5.558 mg

Equivalent: Pogostemon cablin (Dry)

56.61 mg

Poria cocos

18.95 mg

Equivalent: Poria cocos (Dry)

18.95 mg

Zingiber officinale

570 microgram

Equivalent: Zingiber officinale (Fresh)

5.74 mg

Ziziphus jujuba

940 microgram

Equivalent: Ziziphus jujuba (Dry)

9.48 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 04:18:27 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