Cordyceps

Main information

  • Trade name:
  • Cordyceps Complex Plus
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • Cordyceps Complex Plus
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 218116
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

218116

Cordyceps Complex Plus

ARTG entry for

Medicine Listed

Sponsor

Golden Health Pty Ltd

Postal Address

542 Somerville Road,SUNSHINE WEST, VIC, 3020

Australia

ARTG Start Date

5/12/2013

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. Cordyceps Complex Plus

Product Type

Single Medicine Product

Effective date

24/05/2017

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).

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

Standard Indications

Male support. Nutritional and herbal support designed to support and enhance masculine needs.

Liver tonic.

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

Male support. Balances and supports normal male physiology and function.

Formula to support the liver.

Male support. May be beneficial to men in satisfying physiological requirements of the male body.

Specific Indications

* Supports/helps maintain healthy immune function.

* Provides support to the immune system.

* Supports healthy immune mechanism.

* Supports healthy liver detoxification processes.?

* Supports/maintains healthy liver function.?

* May assist in protecting the liver and maintaining healthy liver function.

* Contains ganoderma lucidium, which has antioxidant activity and may therefore assist in protecting the body from potential free radical damage.

* Antioxidant/free radical scavenger.

* Has antioxidant activity and therefore assists in protecting against oxidative/free radical damage. ?

* Supports healthy cellular activity.

* Ganoderma lucidum and Cordyceps sinensis, which have a long history of use in Traditional Chinese Medicine to reduce mucous congestion and

relieve cough.

* Ganoderma lucidium has traditionally been used to reduce cough due to cold and coughs with excess phlegm.

* Contains Ganoderma and Cordyceps, which are traditionally used to relieve cough.

* Contains Ganoderma and Cordyceps, which have a long history of use in Traditional Chinese medicine to support the respiratory tract.

* Contains Ganoderma and Cordyceps, which are used in Traditional Chinese medicine for respiratory health.

Public Summary

Page 1 of

Produced at 26.11.2017 at 05:27:01 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

* Contains Cordyceps, which has a long history of use in reducing cough and phlegm.

* In Traditional Chinese Medicine Ganoderma lucidium is used to strengthen the body and tonify qi and blood. ?

* Ganoderma lucidium has a long history of use in traditional Chinese Medicine for the relief of sleeplessness or insomnia. ?

* Ganoderma lucidium has traditionally been used in the Chinese Medicine system to reduce fatigue and listlessness. ?

* In Traditional Chinese Medicine, Ganoderma lucidium is used to strengthen poor digestion and improve the appetite.

* Contains Ganoderma, which is used in Traditional Chinese medicine to strengthen and support gastrointestinal function. ?

* Assists in the maintenance/supports the health of the cardiovascular system.

* Korean ginseng helps maintain stamina, energy and endurance.

* Helps maintain stamina, energy levels and endurance.

* May be useful in times of fatigue.

* Supports energy and vitality.

* Supports stamina and endurance.

* Helps perform in peak condition.

* Panax Ginseng supports mental performance and cognitive function.

* Contains Panax Ginseng, which has an adaptogenic or tonic and nutritive action on the adrenal glands.

* Contains Cordyceps, which has a long history of use in traditional Chinese medicine to support or maintain healthy male sexual function/performance.

* Contains Cordyceps, traditionally used in Chinese Herbal Medicine to support healthy sexual performance/desires.

* Codyceps is traditionally used in Chinese medicine to support or maintains male sexual function/performance.

* Codyceps has a long history of use in Chinese medicine to support/ maintain normal/ healthy male sexual function and libido.

* Supports healthy sexual desires/libido and sexual function.

* Supports the health of the male reproductive system.

* Supports male reproductive health and function.

Additional Product information

Pack Size/Poison information

Pack Size

Poison Schedule

Components

1. Formulation 1

Dosage Form

Capsule, hard

Route of Administration

Oral

Visual Identification

Active Ingredients

Cordyceps sinensis

375 mg

Equivalent: Cordyceps sinensis (Dry)

1.5 g

Ganoderma lucidum

25 mg

Ganoderma lucidum

75 mg

Equivalent: Ganoderma lucidum (Dry)

750 mg

Panax ginseng

166.67 mg

Equivalent: Panax ginseng (Dry)

500 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 05:27:01 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