Artemisia

Main information

  • Trade name:
  • Artemisia Plus
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • Artemisia Plus
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 220235
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

220235

Artemisia Plus

ARTG entry for

Medicine Listed

Sponsor

Interclinical Laboratories Pty Ltd

Postal Address

PO Box 6474,ALEXANDRIA, NSW, 2015

Australia

ARTG Start Date

18/02/2014

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. Artemisia Plus

Product Type

Single Medicine Product

Effective date

20/01/2016

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

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

Specific Indications

* Pau d'Arco is traditionally used in South American herbal medicine to support the health and function of the immune system.

* Pau d'arco is traditionally used in South American herbal medicine to help maintain healthy immune function.

* Handroanthus species have a history of therapeutic use in South America for the relief of minor fevers.

* Artemisia is used traditionally in Chinese medicine for the relief of chills and mild fevers.

* Artemisia has been used in traditional Chinese medicine for over 2000 years for the relief of mild fevers.

* May assist to relieve mild digestive upsets.

* May help to relieve flatulence, heartburn and / or nausea.

* May help to relieve flatulence and bloating.

* Helps to support the health of the digestive system.

* May help to relieve spasm of the gastrointestinal tract.

* Fennel is traditionally used in herbal medicine to help relieve pain associated with menstruation and as an expectorant to relieve cough associated with

colds.

* May help to relieve respiratory catarrh.

*May help to relieve flatulence.

*May help to relieve heartburn.

*May help to relieve bloating.

*May help to relieve nausea.

*Traditionally used in herbal medicine systems to assist in relief of mild fever.

*Traditionally used in herbal medicine systems to assist in relief of minor fever.

*Traditionally used in herbal medicine systems to assist in temporary relief of mild fever.

*Traditionally used in herbal medicine systems to assist in temporary relief of minor fever.

*Fennel is traditionally used in herbal medicine to relieve pain associated with menstruation.

*Fennel is traditionally used in herbal medicine as an expectorant to relieve cough associated with colds.

Public Summary

Page 1 of

Produced at 26.11.2017 at 02:42:36 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

*Artemisia annua is a bitter herb.

*Traditional Chinese Remedy.

*Traditional Chinese medicine.

*Traditional South American herbal medicine.

*Fennel is a carminative herb.

*Fennel is a carminative herb that may help to relieve flatulence.

* Fennel is a carminative herb that may help to relieve bloating.

*Pau d'arco assists in the maintenance and improvement of general wellbeing.

*Fennel assists in the maintenance and improvement of general wellbeing.

* Artemisia assists in the maintenance and improvement of general wellbeing.

* Artemisia is used traditionally in Chinese medicine for the relief of chills.

*Artemisia is used traditionally in Chinese medicine for the relief of mild fevers.

*Artemisia is used traditionally in Chinese medicine for the relief of minor fevers.

*Handroanthus species have a history of therapeutic use in South America for the temporary relief of minor fevers.

* Artemisia is used traditionally in Chinese medicine for the temporary relief of chills and mild fevers.

* Artemisia has been used in traditional Chinese medicine for over 2000 years for the temporary relief of mild fevers.

* Artemisia is used traditionally in Chinese medicine for the temporary relief of chills.

*Artemisia is used traditionally in Chinese medicine for the temporary relief of mild fevers.

*Artemisia is used traditionally in Chinese medicine for the temporary relief of minor fevers.

* Natural medicine Supplement.

* Herbal Medicine Complex.

* Complementary Medicine Supplement.

* Natural Herbal Medicine.

*Traditionally used in herbal medicine systems for the relief of mild fever.

*Traditionally used in herbal medicine systems for the relief of minor fever.

*Traditionally used in herbal medicine systems for the temporary relief of mild fever.

*Traditionally used in herbal medicine systems for the temporary relief of minor fever.

Additional Product information

Pack Size/Poison information

Pack Size

Poison Schedule

Components

1. Formulation 1

Dosage Form

Tablet, film coated

Route of Administration

Oral

Visual Identification

Active Ingredients

Artemisia annua

625 mg

Equivalent: Artemisia annua (Dry)

2.5 g

Foeniculum vulgare

60 mg

Equivalent: Foeniculum vulgare (Dry)

600 mg

Handroanthus impetiginosus

150 mg

Equivalent: Handroanthus impetiginosus (Dry)

750 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 02:42:36 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