Astragalus

Main information

Documents

Localization

  • Available in:
  • Astragalus 8 (tablets)
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 222551
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

222551

Astragalus 8 (tablets)

ARTG entry for

Medicine Listed

Sponsor

Global Therapeutics Pty Ltd

Postal Address

PO Box 1999,BYRON BAY, NSW, 2481

Australia

ARTG Start Date

15/04/2014

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. Astragalus 8 (tablets)

Product Type

Single Medicine Product

Effective date

27/07/2017

Warnings

If symptoms persist consult your healthcare practitioner (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

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

Aids, assists or helps in the maintenance or improvement of general well-being.

May assist in the management of sore throat. [Warning S required]

May assist in the management of chronic fatigue syndrome. [Warning S required]

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

Specific Indications

Recovery and immune health. Immune tonic. Contains herbs traditionally used to promote a healthy immune system (response) and support recovery

during convalescence. Assists in the management of chronic fatigue syndrome, recurrent upper respiratory (tract) infections (URTIs), and recurrent

colds,

flu and sore throats. Symptoms addressed include lowered resistance to minor infections, slow recovery, night sweats, fatigue, muscle aches, poor

appetite, irritability and weakness. Provides immune modulating, antiinflammatory, hepatoprotective and traditionally recognised adaptogenic, antifatigue,

anhydrotic, and detoxicant (detoxifying) actions. Provides antioxidant benefits. Supports healthy ageing.

A Qi (energy) and Blood tonic, classified in traditional Chinese medicine as recuperative/adjunct/adjuvant therapy, called Fu Zheng Pei Ben. In Chinese

medicine, Fu Zheng means to rectify and support the normal, healthy vital energy or Qi of all organs and body systems (especially the Yin

organ-meridian systems - Lung, Spleen, Liver, Kidney and Heart), while Pei Ben means to strengthen the resistance mechanisms of the body, especially

those underpinning healthy immune function.

A biological response modifier (and adaptogen) to strengthen non-specific immunity, increase resistance to stress, improve stamina, enhance vitality and

promote good health. A traditional Chinese medicine tonic to support immune health, increase resistance to stress, improve stamina, enhance vitality

and promote good health.

Additional Product information

Pack Size/Poison information

Public Summary

Page 1 of

Produced at 26.11.2017 at 11:05:28 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

Pack Size

Poison Schedule

Components

1. Formulation 1

Dosage Form

Tablet, film coated

Route of Administration

Oral

Visual Identification

Active Ingredients

Astragalus membranaceus

200 mg

Equivalent: Astragalus membranaceus (Dry)

Atractylodes macrocephala

150 mg

Equivalent: Atractylodes macrocephala (Dry)

750 mg

Codonopsis pilosula

150 mg

Equivalent: Codonopsis pilosula (Dry)

750 mg

Eleutherococcus senticosus

30 mg

Equivalent: Eleutherococcus senticosus (Dry)

450 mg

Ganoderma lucidum

65 mg

Equivalent: Ganoderma lucidum (Dry)

650 mg

Glycyrrhiza uralensis

20 mg

Equivalent: Glycyrrhiza uralensis (Dry)

100 mg

Ligustrum lucidum

100 mg

Equivalent: Ligustrum lucidum (Dry)

1000 mg

Schisandra chinensis

60 mg

Equivalent: Schisandra chinensis (Dry)

300 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 11:05:28 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