Echinacea

Main information

  • Trade name:
  • Echinacea 4000 Complex
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • Echinacea 4000 Complex
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 222400
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

222400

Echinacea 4000 Complex

ARTG entry for

Medicine Listed

Sponsor

Herbs of Gold Pty Ltd

Postal Address

PO Box 3143,KIRRAWEE, NSW, 2232

Australia

ARTG Start Date

11/04/2014

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. Echinacea 4000 Complex

Product Type

Single Medicine Product

Effective date

11/04/2014

Warnings

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

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

Relief of the symptoms of influenza/flu. [Warnings S and COLD required]

For the symptomatic relief of upper respiratory tract infections. [Warnings S and COLD required]

Can assist in the treatment of flu by reducing the severity and duration of symptoms. [Warnings S and COLD required]

Treatment of colds/flu. [Warnings S and COLD required]

Treatment of upper respiratory tract infections. [Warnings S and COLD required]

Relief of the symptoms of colds. [Warnings S and COLD required]

May assist in the management of upper respiratory tract infections. [Warnings S and COLD required]

May reduce the severity and duration of colds. [Warning COLD required]

Specific Indications

Supports healthy immune system function.

Echinacea is traditionally used to relieve the symptoms of mild upper respiratory tract infections / symptoms of colds and flu.

Echinacea is traditionally used to relieve nasal catarrh / congestion.

Echinacea is traditionally used to relieve fever.

Echinacea is traditionally used in Western and Native American herbal medicine for the management of minor skin disorders such as wounds, boils,

abscesses.

Additional Product information

Pack Size/Poison information

Public Summary

Page 1 of

Produced at 26.11.2017 at 11:24:56 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

Tablet, film coated

Route of Administration

Oral

Visual Identification

Active Ingredients

Echinacea angustifolia

166.666 mg

Equivalent: Echinacea angustifolia (Dry)

Echinacea purpurea

200 mg

Equivalent: Echinacea purpurea (Dry)

© 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 11:24:56 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

24-4-2018

One lot of Traditional Medicinals "Throat Coat Lemon Echinacea" herbal tea recalled because of potential contamination with Salmonella

One lot of Traditional Medicinals "Throat Coat Lemon Echinacea" herbal tea recalled because of potential contamination with Salmonella

Health Canada is advising Canadians that one lot of “Throat Coat Lemon Echinacea” herbal tea is being voluntarily recalled by Traditional Medicinals after a company supplier found Salmonella contamination in a tea ingredient (lemon myrtle leaf). An infection caused by Salmonella bacteria may pose serious health risks, particularly for young children, pregnant women, the elderly and people with weak immune systems.

Health Canada