Australia - English - Department of Health (Therapeutic Goods Administration)

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Active ingredient:
Artemisia annua,Boswellia serrata,Commiphora myrrha,Curcuma longa,Ganoderma lucidum,Malpighia glabra,Phyllanthus emblica
Available from:
ATP Science Pty Ltd
Authorization status:
Authorization number:

Public Summary

Summary for ARTG Entry:



ARTG entry for

Medicine Listed


ATP Science Pty Ltd

Postal Address

PO Box 84,Springwood, QLD, 4127


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.


1. Resilience

Product Type

Single Medicine Product

Effective date


Permitted Indications

Antioxidant/Reduce free radicals formed in the body

Anti-inflammatory/relieve inflammation

Decrease/reduce/relieve mild rheumatic aches and pains

Decrease/reduce/relieve symptoms of mild arthritis/mild osteoarthritis

Decrease/reduce/relieve mild joint inflammation/swelling

Decrease/reduce/relieve mild joint pain/soreness

Decrease/reduce/relieve mild joint stiffness

Maintain/support immune system health

Enhance/improve/promote immune defence/immunity

Helps enhance/improve/promote immune system function

Maintain/support healthy immune system function

Maintain/support immune system to fight illness

Helps stimulate a healthy immune system response

Indication Requirements

Product presentation must only refer to mild rheumatic aches/pains.

Label statement: If symptoms persist, talk to your health professional.

Product presentation must only refer to mild joint symptoms.

Product presentation must not imply or refer to bone disease or disorders e.g. rheumatoid arthritis, juvenile arthritis, debilitating osteoarthritis,


Product presentation must not imply or refer to serious immunological diseases.

Public Summary

Page 1 of

Produced at 29.08.2019 at 06:01:17 AEST

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 for contact information

Standard Indications

No Standard Indications included on Record

Specific Indications


No Warnings included on Record

Additional Product information

Pack Size/Poison information

Pack Size

Poison Schedule


1. Formulation 1

Dosage Form

Capsule, hard

Route of Administration


Visual Identification

Active Ingredients

Artemisia annua

100 mg

Equivalent: Artemisia annua (Fresh)

Boswellia serrata

100 mg

Equivalent: Boswellia serrata (Dry)

400 mg

Commiphora myrrha

75 mg

Equivalent: Commiphora myrrha (Dry)

750 mg

Curcuma longa

100 mg

Equivalent: Curcuma longa (Dry)

2.5 g

Ganoderma lucidum

150 mg

Equivalent: Ganoderma lucidum (Dry)

Malpighia glabra

138.9 mg

Equivalent: Malpighia glabra (Dry)

3.472 g

Phyllanthus emblica

10 mg

Equivalent: Phyllanthus emblica (Fresh)

50 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

Public Summary

Page 2 of

Produced at 29.08.2019 at 06:01:17 AEST

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 for contact information

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