BALANCE

Main information

  • Trade name:
  • BALANCE LIQUID CARNITINE
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • BALANCE LIQUID CARNITINE
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 215215
  • Last update:
  • 09-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

215215

BALANCE LIQUID CARNITINE

ARTG entry for

Medicine Listed

Sponsor

Vitaco Health Australia Pty Ltd

Postal Address

PO Box 399,NORTH RYDE BC, NSW, 1670

Australia

ARTG Start Date

25/09/2013

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. BALANCE LIQUID CARNITINE

Product Type

Single Medicine Product

Effective date

25/09/2013

Warnings

(If the medicine contains one sorbate) Contains [insert name of sorbate] OR (if medicine contains two or more sorbates) Contains sorbates [or words to

that effect].

Standard Indications

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

May assist in the maintenance of cholesterol within the normal range in healthy individuals.

May assist in the maintenance of normal/healthy cholesterol levels in healthy individuals.

May assist in the maintenance of cholesterol within the normal/healthy range in healthy individuals and improve the LDL:HDL ratio.

May assist in the maintenance of a normal/healthy LDL:HDL cholesterol ratio.

Specific Indications

* Carnitine is necessary for the movement of long chain fatty acids across the mitochondrial membrane to be used in the cells and an energy source.*

Carnitine assists in the transport of fat across the cell membranes in muscle tissue for use as an energy source.* Carnitine acts as a transporter of

long-chain fatty acids into the mitochondria for beta-oxidation.* Carnitine is essential for the transformation of fatty acids into energy for muscular

activity.* Carnitine is essential for mitochondrial fatty acid oxidation, which is the primary fuel source for the heart and skeletal muscles.* Supports the

transportation and utilization of fats as an energy source.* L-Carnitine plays a role in fat metabolism in the body and in the production of energy in the

muscle tissue. * L-Carnitine is used in the body in the metabolism of fat into energy.* L-Carnitine has roles in fat metabolism and aerobic energy

production.* Supports exercise performance.* Supports exercise capacity and endurance. * Supports stamina and endurance * May help increase

stamina * Supports lipid/fat metabolism and energy production.* Supports the metabolism and transportation of fats. * Supports healthy body

composition.* Supports/maintains the health of the cardiovascular system

Additional Product information

Pack Size/Poison information

Pack Size

Poison Schedule

Components

1. Formulation 1

Public Summary

Page 1 of

Produced at 26.11.2017 at 09:03:31 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

Dosage Form

Oral Liquid

Route of Administration

Oral

Visual Identification

Active Ingredients

levocarnitine tartrate

74 mg/mL

© 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 09:03:31 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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Despite medical advances, cancer remains the leading cause of death in France.  While active smoking, alcohol consumption and an unbalanced diet continue to be the main causes of cancer mortality, the environment has a real impact on the risk of cancer, although it remains difficult to assess.

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