Astra

Main information

  • Trade name:
  • Astra Restore
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • Astra Restore
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 222576
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

222576

Astra Restore

ARTG entry for

Medicine Listed

Sponsor

Herbs of Gold Pty Ltd

Postal Address

PO Box 3143,KIRRAWEE, NSW, 2232

Australia

ARTG Start Date

16/04/2014

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. Astra Restore

Product Type

Single Medicine Product

Effective date

6/09/2016

Warnings

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

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

Standard Indications

Beneficial during times of stress. [Warning S required]

Specific Indications

Astragalus has been used for over two thousand years in China.

Astragalus is used in Traditional Chinese Medicine (TCM) for strengthening and restoring Qi, the body's vital energy.

Astragalus is used in Traditional Chinese Medicine to enhance the immune system, to relieve cold and flu symptoms.

Astragalus is used in Traditional Chinese Medicine to increase/restore vitality in cases of frequent/recurrent colds.

By strengthening/restoring the body's vital energy, Astragalus is used in Traditional Chinese Medicine to increase stamina and endurance.

Astragalus is used in Traditional Chinese Medicine to combat fatigue.

Astragalus is traditionally used in Chinese medicine as an adaptogen, promoting resistance and helping the body adapt during times of physical,

emotional or environmental stress.

Astragalus is a Traditional Chinese Medicine tonic used for recuperation/convalescence.

Siberian Ginseng has been used for over 2000 years in Asia.

Siberian Ginseng is traditionally used in Asia as a tonic to increase stamina and endurance.

Siberian Ginseng is traditionally used in Asia as an adaptogen, promoting resistance and helping the body adapt during times of physical, emotional or

environmental stress.

Siberian Ginseng is a revitalising/restorative tonic.

Siberian Ginseng is a tonic used during times of fatigue and/or debility.

Siberian Ginseng helps relieve fatigue.

Siberian Ginseng is beneficial during times of convalescence/recuperation.

Public Summary

Page 1 of

Produced at 26.11.2017 at 11:04:39 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

Siberian Ginseng assists during periods of reduced ability to work or concentrate.

Siberian Ginseng helps to support mental and/or physical performance during/after mental and/or physical stress.

Helps relieve the stress of study or work.

Siberian Ginseng supports vitality and energy during times of stress.

Goji berries have been used for over 2000 years in Traditional Chinese Medicine.

Goji berries are used in Traditional Chinese Medicine to strengthen/restore Yin, for the relief of fatigue.

Goji berries are used in Traditional Chinese Medicine for the relief of fatigue.

Codonopsis is used in Traditional Chinese Medicine as a tonic to strengthen/restore Qi, the body's vital energy.

Codonopsis is used in Traditional Chinese Medicine for the relief of fatigue and/or where there is a lack of strength.

Contains traditional herbs used in China and Asia for:

· Strengthening/restoring Qi, the body's vital energy

· Helping the body adapt to stress

· Recuperation and convalescence

· Relieving fatigue and restoring strength

Additional Product information

Pack Size/Poison information

Pack Size

Poison Schedule

Components

1. Formulation 1

Dosage Form

Tablet, film coated

Route of Administration

Oral

Visual Identification

Active Ingredients

Astragalus membranaceus

300 mg

Equivalent: Astragalus membranaceus (Dry)

Codonopsis pilosula

375 mg

Equivalent: Codonopsis pilosula (Dry)

Eleutherococcus senticosus

66.7 mg

Equivalent: Eleutherococcus senticosus (Dry)

Lycium barbarum

208.3 mg

Equivalent: Lycium barbarum (Dry)

2.5 g

© 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 11:04:39 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