N Plus Milk Thistle Formula

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

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Active ingredient:
ascorbic acid,Silybum marianum,taurine
Available from:
RBK Nutraceuticals Pty Ltd
INN (International Name):
Ascorbic acid,Silybum marianum,Taurine
Authorization status:
Listed (Export Only)
Authorization number:
291562

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Public Summary

Summary for ARTG Entry:

291562

N Plus Milk Thistle Formula

ARTG entry for

Medicine Listed (Export Only)

Sponsor

RBK Nutraceuticals Pty Ltd

Postal Address

46 Powers Road,SEVEN HILLS, NSW, 2147

Australia

ARTG Start Date

14/07/2017

Product category

Medicine

Status

Active

Approval area

Export only 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.

The sponsor shall hold stability data to support the claimed shelf life of the listed medicine according to the labelled storage conditions except where: (i)

each overseas importer accepts responsibility for holding stability data for this product; (ii) the sponsor has a written agreement to this effect from each

overseas importer; and (iii) the sponsor retains copies of all such agreements while the medicine remains listed on the ARTG.

This product must not be supplied for sale in Australia, including supply via duty free outlets.

Products

1. N Plus Milk Thistle Formula

Product Type

Single Medicine Product

Effective date

14/07/2017

Warnings

No Warnings included on Record

Standard Indications

Specific Indications

No Specific Indications included on Record

Additional Product information

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Bottle

Not recorded

Not recorded

Not recorded

Not recorded

Not recorded

Pack Size/Poison information

Pack Size

Poison Schedule

Components

1.

Dosage Form

Capsule, hard

Route of Administration

Oral

Visual Identification

Size "0" clear vege capsule containing beige coloured mottled free flowing

powder.

Active Ingredients

Ascorbic acid

150 mg

Silybum marianum

260 mg

Equivalent: Silybum marianum (Dry)

18.2 g

Taurine

100 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 1 of

Produced at 24.11.2017 at 07:56:18 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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