Wanderlust Reishi

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

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Active ingredient:
Ganoderma lucidum
Available from:
Wanderlust Products Pty Ltd
Authorization status:
Listed
Authorization number:
352098

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Public Summary

Summary for ARTG Entry:

352098

Wanderlust Reishi

ARTG entry for

Medicine Listed

Sponsor

Wanderlust Products Pty Ltd

Postal Address

Level 2 6 Palmer Parade, Cremorne, VIC, 3121

Australia

ARTG Start Date

22/12/2020

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.

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 . Wanderlust Reishi

Product Type

Single Medicine Product

Effective Date

23/12/2020

Permitted Indications

Antioxidant/Reduce free radicals formed in the body

Traditionally used in Chinese medicine to tonify/nourish/strengthen/replenish Qi

Traditionally used in Chinese medicine to maintain/support vitality

Traditionally used in Chinese medicine to relieve weariness/tiredness/fatigue/feeling of weakness

Traditionally used in Chinese medicine to maintain/support general health and wellbeing

Traditionally used in Chinese medicine to maintain/support healthy immune system function

Traditionally used in Chinese medicine to decrease/reduce/relieve cough

Indication Requirements

If TCM terminology is used on medicine label, label statement: Talk to a TCM practitioner/health professional if you are unsure if this medicine is right for

you.

Product presentation must not imply or refer to chronic fatigue syndrome.

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

Product presentation must not imply or refer to serious forms of respiratory disorders/diseases, such as: asthma, pneumonia, COAD, COPD, influenza.

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

Label statement: Adults only, OR Not to be used in children under 2 years of age without medical advice (or words to that effect).

Standard Indications

No Standard Indications included on Record

Specific Indications

No Specific Indications included on Record

Warnings

Contains ethanol. (or words to that effect).

Additional Product information

Pack Size/Poison information

Public Summary

Page 1 of

Produced at 11.01.2021 at 07:53:45 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

Oral Liquid

Route of Administration

Oral

Visual Identification

Active Ingredients

Ganoderma lucidum whole plant Extract liquid

900 microlitre/mL

Equivalent: Ganoderma lucidum (Dry)

450 mg/mL

Other Ingredients (Excipients)

glycerol

Orange Oil

© 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 11.01.2021 at 07:53:45 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

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