SANG

Main information

Documents

Localization

  • Available in:
  • SANG JU WAN
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 218857
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

218857

SANG JU 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. SANG JU WAN

Product Type

Single Medicine Product

Effective date

2/01/2014

Warnings

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

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 coughing persists consult your doctor (or a healthcare professional) (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).

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 of the pain associated with tonsillitis. [Warning S required]

Relief of the inflammation associated with tonsillitis.

Temporary relief of headaches. [Warning S required]

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

Relief of coughs. [Warnings COU1 and COU2 required]

May assist in the management of upper respiratory tract infections. [Warnings S and COLD required]

Specific Indications

No Specific Indications included on Record

Additional Product information

Pack Size/Poison information

Pack Size

Poison Schedule

Components

1. Formulation 1

Public Summary

Page 1 of

Produced at 26.11.2017 at 04:20:21 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

Dosage Form

Pill

Route of Administration

Oral

Visual Identification

Active Ingredients

Chrysanthemum sinense

5.73 mg

Equivalent: Chrysanthemum sinense (Dry)

53.71 mg

Forsythia suspensa

53.71 mg

Equivalent: Forsythia suspensa (Dry)

53.71 mg

Glycyrrhiza uralensis

2.02 mg

Equivalent: Glycyrrhiza uralensis (Dry)

18.9 mg

Mentha haplocalyx

2.02 mg

Equivalent: Mentha haplocalyx (Dry)

18.9 mg

Morus alba

5.73 mg

Equivalent: Morus alba (Dry)

53.71 mg

Perilla frutescens

4.88 mg

Equivalent: Perilla frutescens (Dry)

45.76 mg

Phragmites australis

8.17 mg

Equivalent: Phragmites australis (Dry)

76.6 mg

Platycodon grandiflorus

53.71 mg

Equivalent: Platycodon grandiflorus (Dry)

53.71 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 04:20:21 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