NUTRA-LIFE

Main information

  • Trade name:
  • NUTRA-LIFE ORGANIC MAGNESIUM COMPLETE
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

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

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 211717
  • Last update:
  • 09-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

211717

NUTRA-LIFE ORGANIC MAGNESIUM COMPLETE

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

3/07/2013

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 ORGANIC MAGNESIUM COMPLETE

Product Type

Single Medicine Product

Effective date

3/07/2013

Warnings

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

Standard Indications

Helps relieve nervous unrest. [Warning S required]

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

Beneficial during times of stress. [Warning S required]

May assist in the maintenance of normal blood pressure in healthy individuals.

For the relief of irritability. [Warning S required]

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

Relief of muscular cramps and spasms. [Warning S required]

Relief of muscular aches and pains. [Warning S required]

Relief of pre-menstrual symptoms/syndrome. [Warning S required]

Relief of menstrual symptoms. [Warning S required]

May assist in the management of pre-menstrual tension/syndrome. [Warning S required]

Specific Indications

* For magnesium supplementation.

* Supplies the essential mineral magnesium to help meet normal daily requirements.

* Contains easily absorbed forms of magnesium.

* Contains organic magnesium salts, which are easily absorbed in the body.

* Magnesium is a vital catalyst in many enzymatic reactions in the body.

* Magnesium is involved in more than 300 essential metabolic reactions in the body.

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

* Magnesium is involved in the production of ATP, or cellular energy.

* Magnesium plays an important role in cellular activity.

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

* Magnesium is involved in protein synthesis in the body.

Public Summary

Page 1 of

Produced at 27.11.2017 at 01:02:43 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

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

* Magnesium plays a role in nerve conduction on the body.

* Supports the health and function of the nervous system.

* Magnesium is in vital for muscle activity and contraction and relaxation and vascular tone in the body.

* Provides support to the musculoskeletal system.

* Helps to maintain healthy muscle function.

* Helps to maintain/supports the health of the muscles.

* Magnesium is required for the synthesis of nucleic acids.

* Magnesium plays a necessary role in the synthesis of RNA and replication of DNA.

* 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.

* Supports/helps to maintain healthy bone mineral density.

* Supports the maintenance of strong, healthy bones.

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

* Assists in the maintenance of healthy heart function.

* Supports healthy cardiovascular function.

* Magnesium deficiency may result in fatigue, irritability, insomnia and a predisposition to stress.

Additional Product information

Pack Size/Poison information

Pack Size

Poison Schedule

Components

1. Formulation 1

Dosage Form

Tablet, film coated

Route of Administration

Oral

Visual Identification

Active Ingredients

Magnesium amino acid chelate

1.0305 g

Magnesium aspartate dihydrate

100 mg

Magnesium orotate dihydrate

100 mg

Viburnum opulus

12.5 mg

Equivalent: Viburnum opulus (Dry)

50 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 27.11.2017 at 01:02:43 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

8-9-2009

Decision on future reimbursement status of medicinal products in ATC group A06 (laxatives) and A02AA04 (magnesium compounds)

Decision on future reimbursement status of medicinal products in ATC group A06 (laxatives) and A02AA04 (magnesium compounds)

On 3 september 2009, the Danish Medicines Agency decided on the future reimbursement status of medicinal products in ATC group A06 (laxatives) and A02AA04 (magnesium compounds).

Danish Medicines Agency

4-5-2009

Consultation on the reimbursement status of medicinal products in ATC group A06 (laxatives) and A02AA04 (magnesium hydroxide)

Consultation on the reimbursement status of medicinal products in ATC group A06 (laxatives) and A02AA04 (magnesium hydroxide)

At the Danish Medicines Agency's request, the Reimbursement Committee has reassessed the reimbursement status of medicinal products authorised for marketing in Denmark in ATC group A06 (laxatives) and A02AA04 (magnesium hydroxide)

Danish Medicines Agency

19-6-2018

Dany's BienenWohl (Dany Bienenwohl GmbH)

Dany's BienenWohl (Dany Bienenwohl GmbH)

Dany's BienenWohl (Active substance: oxalic acid dihydrate) - Centralised - Authorisation - Commission Decision (2018)3892 of Tue, 19 Jun 2018 European Medicines Agency (EMA) procedure number: EMEA/V/C/4667

Europe -DG Health and Food Safety

1-6-2018

Valproate

Valproate

Valproate (Active substance: medicinal products containing substances related to valproate (sodium valproate, valproic acid, valproate semisodium, valpromide, valproate magnesium)) - Community Referrals - Art 31 - Commission Decision (2018)3623 of Fri, 01 Jun 2018 European Medicines Agency (EMA) procedure number: EMEA/H/A-31/1454

Europe -DG Health and Food Safety

5-2-2018

Oxybee (Dany Bienenwohl GmbH)

Oxybee (Dany Bienenwohl GmbH)

Oxybee (Active substance: oxalic acid dihydrate) - New authorisation - Commission Decision (2018)684 of Mon, 05 Feb 2018 European Medicines Agency (EMA) procedure number: EMEA/V/C/4296

Europe -DG Health and Food Safety