CANDA PLEX

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

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Active ingredient:
Echinacea purpurea,Handroanthus impetiginosus,Matricaria chamomilla,Silybum marianum,Uncaria tomentosa
Available from:
The Pharmaceutical Plant Company Pty Ltd
Authorization status:
Listed
Authorization number:
351107

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Public Summary

Summary for ARTG Entry:

351107

CANDA PLEX

ARTG entry for

Medicine Listed

Sponsor

The Pharmaceutical Plant Company Pty Ltd

Postal Address

3 Sigma Drive, Croydon South, VIC, 3136

Australia

ARTG Start Date

8/12/2020

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 . CANDA PLEX

Product Type

Single Medicine Product

Effective Date

8/12/2020

Permitted Indications

Traditionally used in Western herbal medicine to helps reduce occurrence of symptoms of indigestion/dyspepsia

Traditionally used in Western herbal medicine to helps reduce occurrence of symptoms of indigestion/dyspepsia in children over 2 years of age

Traditionally used in Western herbal medicine to decrease/reduce/relieve abdominal bloating/distention in children over 2 years of age

Traditionally used in Western herbal medicine to decrease/reduce/relieve abdominal bloating/distention

Traditionally used in South American medicine to decrease/reduce/relieve symptoms of mild, superficial skin fungal infections

Traditionally used in South American medicine to decrease/reduce/relieve symptoms of mild, superficial skin fungal infections in children over 2 years of age

Indication Requirements

Product presentation must only refer to mild fungal infection.

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

Product presentation must not imply or refer to gastro oesophageal reflux disease.

Standard Indications

No Standard Indications included on Record

Specific Indications

No Specific Indications included on Record

Warnings

Contains ethanol. (or words to that effect).

Not recommended for use by pregnant and lactating women (or words to that effect).

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

Additional Product information

Pack Size/Poison information

Pack Size

Poison Schedule

Components

1 . Formulation 1

Public Summary

Page 1 of

Produced at 11.01.2021 at 09:05:31 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

Dosage Form

Oral Liquid

Route of Administration

Oral

Visual Identification

Active Ingredients

Echinacea purpurea whole plant Extract liquid

100 microlitre/mL

Equivalent: Echinacea purpurea (Dry)

100 mg/mL

Handroanthus impetiginosus stem bark Extract liquid

200 microlitre/mL

Equivalent: Handroanthus impetiginosus (Dry)

100 mg/mL

Matricaria chamomilla flower Extract liquid

200 microlitre/mL

Equivalent: Matricaria chamomilla (Dry)

200 mg/mL

Silybum marianum seed Extract liquid

120 microlitre/mL

Equivalent: Silybum marianum (Dry)

120 mg/mL

Uncaria tomentosa twig bark Extract liquid

160 microlitre/mL

Equivalent: Uncaria tomentosa (Dry)

80 mg/mL

Other Ingredients (Excipients)

glycerol

Mentha X piperita

© 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 09:05:31 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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