G & W Aust

Main information



  • Available in:
  • G & W Aust CholeSol
  • Language:
  • English

Other information


  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 208090
  • Last update:
  • 10-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:


G & W Aust CholeSol

ARTG entry for

Medicine Listed


G & W Aust Pty Ltd

Postal Address

10 Olive Street,FAIRFIELD, NSW, 2165


ARTG Start Date


Product category




Approval area

Listed Medicines


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


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.

The Ginkgo biloba leaf extract used in the manufacture of this medicine must comply with the requirement of Identification Test B of the monograph

Powdered Ginkgo Extract in the United States Pharmacopeia 32 - National Formulary 27 (USP32-NF27) as in force or existing from time to time. This

condition does not apply to powdered or dried leaf.


1. G & W Aust CholeSol

Product Type

Single Medicine Product

Effective date



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

Standard Indications

Helps maintain healthy digestive function.

May assist blood circulation.

Specific Indications

Helps in the maintenance of normal healthy cholesterol levels and supports a healthy ratio of cholesterol in normal healthy individuals.

Enhances general health in aging.

May have antioxidant effects.

Helps maintain healthy immune function.

Additional Product information

Container information



Life Time





Not recorded

Not recorded

Not recorded

Neither child resistant

closure nor restricted

flow insert

Not recorded

Pack Size/Poison information

Pack Size

Poison Schedule


Public Summary

Page 1 of

Produced at 23.11.2017 at 08:39:30 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

1. Formulation 1

Dosage Form

Capsule, hard

Route of Administration


Visual Identification

Active Ingredients

Camellia sinensis

235 mg

Equivalent: Camellia sinensis (Dry)

4.7 g

Cinnamomum cassia

41.7 mg

Equivalent: Cinnamomum cassia (Dry)

250 mg

Crataegus cuneata

70 mg

Equivalent: Crataegus cuneata (Dry)

2.1 g

Curcuma longa

105 mg

Equivalent: Curcuma longa (Dry)

4.2 g

Ganoderma lucidum

40 mg

Equivalent: Ganoderma lucidum (Dry)

600 mg

Ginkgo biloba

25 mg

Equivalent: Ginkgo biloba (Dry)

1.5 g

Lycium barbarum

50 mg

Equivalent: Lycium barbarum (Dry)

500 mg

Panax notoginseng

25 mg

Equivalent: Panax notoginseng (Dry)

250 mg

Reynoutria japonica

40 mg

Equivalent: Reynoutria japonica (Dry)

1.4 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 23.11.2017 at 08:39:30 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