NUTRA-LIFE

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Localization

  • Available in:
  • NUTRA-LIFE MAGNESIUM COMPLETE CALM FORMULA
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 218297
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

218297

NUTRA-LIFE MAGNESIUM COMPLETE CALM FORMULA

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

9/12/2013

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. NUTRA-LIFE MAGNESIUM COMPLETE CALM FORMULA

Product Type

Single Medicine Product

Effective date

18/02/2015

Warnings

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

Contains lactose (or words to that effect).

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

Standard Indications

Helps relieve nervous unrest. [Warning S required]

For vitamin (may state the vitamin) supplementation.

For mineral (may state the mineral) supplementation.

Beneficial during times of stress. [Warning S required]

Help reduce effects of mild anxiety and nervous tension. [Warning S required]

Helps relieve nervous tension, stress and mild anxiety. [Warning S required]

Source of vitamin B12. Can assist in maintaining normal blood. Blood tonic.

Source of vitamin B12. Can assist in maintaining normal blood.

Helps maintain normal blood/blood tonic (Note: These claims are appropriate for folic acid, vitamin B12 and iron, but must not imply anaemic conditions)

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

Specific Indications

* Magnesium plays a necessary role in over 300 enzymatic reactions in the body.

* Magnesium plays a critical role in energy production in the body.

* Magnesium is involved in the production of ATP.

* Magnesium is required for the production of cellular energy.

* Pantothenic acid plays a critical role in energy production.

* Provides nutrients that are essential in the body for the production of energy.

* Contains nutrients that assist in energy metabolism in the body.

* Magnesium plays an important role in cellular activity.

* Magnesium plays a vital role in the metabolism of carbohydrates in the body.

* Contains nutrients essential for carbohydrate, protein and fat metabolism.

Public Summary

Page 1 of

Produced at 26.11.2017 at 05:08:16 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

* Supports healthy metabolism of proteins, carbohydrates and fats in the body.

* Contains cyanocobalamin, which is essential for carbohydrate, protein and fat metabolism.

* Vitamin B6 assists in the metabolism protein/amino acids and fats.

* Magnesium plays a vital role in calcium metabolism.

* Magnesium plays a vital role in the body in neuromuscular transmission.

* Magnesium is necessary for proper muscle and nerve function.

* Magnesium helps to maintain normal healthy functioning of the nervous system.

* Contains nutrients essential for healthy nervous system function.

* Supports the health and function of the nervous system.

* Cyanocobalamin is required in the body for nerve cell function and muscle action.

* Supports neuromuscular function.

* Cyanocobalamin is essential for healthy nervous system function.

*Supports/maintains the health and function of the cardiovascular system/heart.

* Magnesium is an essential constituent of the bones and it supports the health and strength of the bones.

* Magnesium assists in maintaining healthy bone mineral density.

* Adequate magnesium is important for healthy bones.

* Supports healthy bone growth.

* Contains easily absorbable forms of magnesium.

* Supports healthy immune system function.

* Supports the health and function of the immune system.

* Contains nutrients that play important roles in the proper functioning of the immune system.

* Cyanocobalamin is involved in immune system processes in the body.

* Maintains a normal/healthy immune system.

* Withania is traditionally used in Ayurvedic medicine to support immune function.

* Supports healthy brain function.

* Contains nutrients necessary for healthy brain function.

* Supports cognitive function and memory.

* Withania is traditionally used in Ayurvedic medicine to support memory.

* Contains Lemon balm, which may help cognitive performance and mood.

* Supports the health of individuals who follow vegetarian or macrobiotic diets.

* Contains pantothenic acid, which is required for proper function of the adrenal gland.

* Pantothenic acid supports the adrenal glands in the making of cortisone and other adrenal hormones that counteract the stress response.

* Helps the body/you cope with stress.

* Lemon balm can help to calm during times of stress.

* Lemon balm is a calming/relaxing herb/has a calming/relaxing effect on the body

* The human body has increased requirements for the vitamins (especially the B group) and minerals during periods of stress.

* During stress, nutrients such as Vitamin B6, vitamin B5 and magnesium are important for supporting adrenal function.

* Vitamin B5 has long been considered the "anti-stress" vitamin because of its central role in adrenal function and cellular metabolism.

* Some of the B group vitamins, such as vitamin B6 are involved in the manufacture and action of mood enhancing hormones such as serotonin.

* Contains nutrients that are involved in hormone synthesis and modulation.

* Withania is traditionally used in Ayurvedic medicine during times of stress.

* Contains Withania, which has a long history of use in traditional Ayurvedic medicine as a tonic herb and an adaptogen to assist the body in adapting to

various types of stress.

* Withania is traditionally used in Ayurvedic medicine as a nervine sedative during times of stress.

* Withania is traditionally used in Ayurvedic medicine to support the nervous system.

* Withania is traditionally used as a calming herb during times of stress.

* Withania is traditionally used in Ayurvedic medicine as a sedative for the relief of insomnia.

* Withania is traditionally used in Ayurvedic medicine to support general health and wellbeing.

* Withania is traditionally used in Ayurvedic medicine as a rejuvenative herb after illness.

* Withania is traditionally used in Ayurvedic medicine to support healthy aging.

* Withania is traditionally used in Ayurvedic medicine to support vitality.

* Withania is traditionally used in Ayurvedic medicine as a diuretic.

* Withania is traditionally used in Ayurvedic medicine as a herbal remedy to support and enhance masculine needs.

* May help to reduce nervous stomach discomfort.

* Supports digestive health.

* May assist to obtain a restful, undisturbed sleep.

Additional Product information

Pack Size/Poison information

Pack Size

Poison Schedule

Components

1. Formulation 1

Dosage Form

Powder, oral

Route of Administration

Oral

Visual Identification

Active Ingredients

Calcium pantothenate

5.46 mg/g

Cyanocobalamin

8.33 microgram/g

Magnesium citrate

309.41 mg/g

Melissa officinalis

92.86 mg/g

Equivalent: Melissa officinalis (Dry)

650 mg/g

pyridoxine hydrochloride

6.08 mg/g

Withania somnifera

100 mg/g

Equivalent: Withania somnifera (Dry)

1.25 g/g

Public Summary

Page 2 of

Produced at 26.11.2017 at 05:08:16 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

© 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 3 of

Produced at 26.11.2017 at 05:08:16 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