UltraLiv

Main information

Documents

Localization

  • Available in:
  • UltraLiv
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 220550
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

220550

UltraLiv

ARTG entry for

Medicine Listed

Sponsor

Biomedica Nutraceuticals Pty Ltd

Postal Address

PO Box 7052,ALEXANDRIA, NSW, 2015

Australia

ARTG Start Date

27/02/2014

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. UltraLiv

Product Type

Single Medicine Product

Effective date

16/09/2015

Warnings

Vitamins can only be of assistance if the dietary vitamin intake is inadequate. OR Vitamin supplements should not replace a balanced diet.

Standard Indications

Liver formula.

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

Liver tonic. Helps maintain healthy digestive function.

Liver tonic. Aids digestion.

Formula to support the liver.

Liver tonic.

Specific Indications

Maintains normal/healthy liver/gallbladder function.

Milk Thistle is an antioxidant herb and therefore assists in decreasing the risk of cell damage attributed to free radicals.

The antioxidant activity of Milk Thistle assists in protecting the body against the damaging effects of free radicals.

Supports the growth of healthy liver cells.

Assists liver detoxification processes

Taurine, methionine, choline, and pyridoxine, folic acid, and cyanocobalamin are necessary for phase two liver detoxification.

Contains Milk Thistle, a hepatoprotective herb, which supports the health and detoxification of the liver and normal liver function.

Milk Thistle helps to protect the liver from the free radicals that may be generated due to toxins and pollution.

Additional Product information

Pack Size/Poison information

Pack Size

Poison Schedule

Public Summary

Page 1 of

Produced at 26.11.2017 at 02:21:08 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

Components

1. Formulation 1

Dosage Form

Capsule, hard

Route of Administration

Oral

Visual Identification

Active Ingredients

Calcium folinate

108.04 microgram

Choline bitartrate

150 mg

Cyanocobalamin

100 microgram

Folic acid

100 microgram

Inositol

100 mg

Methionine

50 mg

Peppermint Oil

4 mg

pyridoxal 5-phosphate

4.02 mg

pyridoxine hydrochloride

3.34 mg

Silybum marianum

171.43 mg

Equivalent: Silybum marianum (Dry)

12 g

Taraxacum officinale

50 mg

Equivalent: Taraxacum officinale (Dry)

200 mg

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 2 of

Produced at 26.11.2017 at 02:21:08 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