NATURE'S

Main information

  • Trade name:
  • NATURE'S PATH STANDARDISED MILK THISTLE
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • NATURE'S PATH STANDARDISED MILK THISTLE
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 67030
  • Last update:
  • 01-12-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

67030

NATURE'S PATH STANDARDISED MILK THISTLE Capsule - hard bottle

ARTG entry for

Medicine Listed

Sponsor

MMS International Health Products Pty Ltd

Postal Address

PO Box 2631,SYDNEY, NSW, 2001

Australia

ARTG Start Date

26/11/1998

Product category

Medicine

Status

Active

Approval area

Listed Medicines

Conditions

Except where the sponsor has been contracted by an overseas partry to manufacturer the goods and that party will be responsible for placing the goods

on the market in countries other than Australia, the sponsor must have and shall retain, while the goods remain listed, evidence necessary to

substantiate and support the accuracy of the indications in relation to the listed goods, and upon the request of the Head, Office of Prescription

Medicines Authorisation Branch, Therapeutic Goods Administration, shall produce such evidence to this officer.

A copy of a signed and dated certificate of analysis, which is not more than six months old, for the first batch of goods manufactured is to be provided to

the Head, Listing Treaties & Export Section, Chemical & Non Prescription Drug Branch within six months of the date of supply of the goods.

The conditions applying to these goods when they are exported from Australia are given below:

Conditions applicable to all therapeutic goods as specified in the document "Standard Conditions Applying to Registered or Listed Therapeutic Goods

Under Section 28 of the Therapeutic Goods Act 1989" effective 1 July 1995, other than condition No. 8 and condition No. 9.

Conditions applicable to the relevant category and class of therapeutic goods as specified in the document "Standard Conditions Applying to Registered

or Listed Therapeutic Goods Under Section 28 of the Therapeutic Goods Act 1989" effective 1 July 1995, other than condition No.11

Conditions applicable to all therapeutic goods as specified in the document "Standard Conditions Applying to Registered or Listed Therapeutic Goods

Under Section 28 of the Therapeutic Goods Act 1989" effective 1 July 1995.

Conditions applicable to the relevant category and class of therapeutic goods as specified in the document "Standard Conditions Applying to Registered

or Listed Therapeutic Goods Under Section 28 of the Therapeutic Goods Act 1989" effective 1 July 1995.

Products

1. NATURE'S PATH STANDARDISED MILK THISTLE

Product Type

Single Medicine Product

Effective date

3/07/2002

Warnings

No Warnings included on Record

Standard Indications

Liver tonic. Helps maintain healthy digestive function.

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

Liver tonic. Aids digestion.

Helps maintain healthy digestive function.

Aids digestion.

Specific Indications

No Specific Indications included on Record

Additional Product information

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Bottle

Not recorded

3 Years

Store below 30

degrees Celsius

Not recorded

Not recorded

Pack Size/Poison information

Pack Size

Poison Schedule

Not scheduled. Not considered by committee

Components

1. COMPONENT ONE

Dosage Form

Capsule, hard

Route of Administration

Oral

Visual Identification

Size 0, 2 piece clear hard gelatin capsule with creamy, off white contents

Public Summary

Page 1 of

Produced at 01.12.2017 at 08:55:26 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

Active Ingredients

Holy Thistle Herb Powder

180 mg

Silybum marianum

175 mg

Equivalent: Silybum marianum (Dry)

5.25 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 http://www.tga.gov.au/about/website-copyright.htm.

Public Summary

Page 2 of

Produced at 01.12.2017 at 08:55:26 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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