EAGLE

Main information

Documents

Localization

  • Available in:
  • EAGLE MAG-ORO TABLETS
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 222550
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

222550

EAGLE MAG-ORO TABLETS

ARTG entry for

Medicine Listed

Sponsor

Integria Healthcare Australia Pty Ltd

Postal Address

PO Box 4854,EIGHT MILE PLAINS, QLD, 4113

Australia

ARTG Start Date

15/04/2014

Product category

Medicine

Status

Active

Approval area

Listed Medicines

Products

1. EAGLE MAG-ORO TABLETS

Product Type

Single Medicine Product

Effective date

15/04/2014

Warnings

If symptoms persist consult your healthcare practitioner (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

For the symptomatic relief of pre-menstrual tension/syndrome. [Warning S required]

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

Prevention/treatment of vitamin [XX] and/or mineral [YY] and/or nutritional deficiencies (This indication is not be to used for the treatment of iron

deficiency conditions).

For vitamin (may state the vitamin) supplementation.

For mineral (may state the mineral) supplementation.

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

Aids or assists in the prevention of muscular cramps and spasms.

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

Beneficial during times of stress. [Warning S required]

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

Specific Indications

Assist/aids in the maintenance of muscular health/function

Magnesium plays an important role in skeletal and smooth muscle relaxation

Supports the maintenance of healthy cardiovascular function

Helps to support cardiovascular function

Magnesium is required for cellular energy production

Anxiety and stress increase urinary excretion of magnesium

Magnesium amino acid chelate and magnesium aspartate are better absorbed than magnesium oxide in healthy individuals

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

176.5 mg

magnesium aspartate tetrahydrate

290.15 mg

Magnesium orotate

350 mg

Potassium aspartate

121.1 mg

pyridoxine hydrochloride

5 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 26.11.2017 at 11:05:57 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

1-6-2018

Valproate

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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

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