Main information

  • Trade name:
  • Legalon
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug



  • Available in:
  • Legalon
  • Language:
  • English

Other information


  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 216264
  • Last update:
  • 09-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:



ARTG entry for

Medicine Listed


SFI Australasia

Postal Address

PO Box 1027,CROWS NEST, NSW, 1585


ARTG Start Date


Product category




Approval area

Listed Medicines


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


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.


1. Legalon

Product Type

Single Medicine Product

Effective date



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

Standard Indications

Liver tonic.

Formula to support the liver.

Specific Indications

[1] Milk thistle has been used traditionally in Western herbal medicine as a Hepatotonic and to aid in the relief of mild digestive disorders (such as

indigestion)/Liver tonic

[2] Hepatotonic: Aids/assists in the maintenance or improvement of general well-being by supporting healthy liver function./Helps promote and maintain

healthy liver function

[3] Hepatoprotective: helps to protect liver cells against toxins and support regeneration of liver cells.

[4] The silymarin flavones in Legalon have an antioxidant effect, reducing oxidative stress, helping to protect the liver from damage.

[5] Aids normal, healthy detoxification and elimination processes in the body.

[6] The silymarin (flavones) in Legalon exhibit anti-inflammatory action; inhibiting the activation of inflammatory cells.

[7] May help to normalise serum liver enzymes.

[8] May be of benefit in supporting the liver during recovery from toxic overload (such as the over consumption of alcohol).

[9] May be helpful in the relief of mild gastrointestinal symptoms such as nausea, loss of appetite and epigastric fullness.

[10] May help relieve fatigue due to a liver under stress.

[11] Assists the activation of kupffer cells and hepatic stellate cells, reducing inflammation and hardening of the liver; inhibiting the activation of hepatic

stellate cells that cause fibrosis.

[12] Helps to stimulate protein synthesis and cell regeneration in cases of inflammation and damage

Additional Product information

Pack Size/Poison information

Pack Size

Poison Schedule


1. Formulation 1

Public Summary

Page 1 of

Produced at 26.11.2017 at 07:30:56 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 for contact information

Dosage Form

Capsule, hard

Route of Administration


Visual Identification

Active Ingredients

Silybum marianum

180 mg

Equivalent: Silybum marianum (Dry)

7.2 g

© 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

Public Summary

Page 2 of

Produced at 26.11.2017 at 07:30:56 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 for contact information

There are no safety alerts related to this product.