Pharmacy

Main information

Documents

Localization

  • Available in:
  • Pharmacy Health Magnesium Ultra
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 220548
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

220548

Pharmacy Health Magnesium Ultra

ARTG entry for

Medicine Listed

Sponsor

Australian Pharmaceutical Industries Pty Ltd

Postal Address

Locked Bag 5061,PARRAMATTA, NSW, 2124

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. Pharmacy Health Magnesium Ultra

Product Type

Single Medicine Product

Effective date

27/02/2014

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 mineral (may state the mineral) supplementation.

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

Specific Indications

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

* Contains nutrients essential for enzymatic reactions.

* 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.

* Contains nutrients which are involved in energy production.

* 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.

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

* Pyridoxine supports healthy metabolism of lipids, protein and carbohydrates in the body.

* 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 that are 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.

* Magnesium absorption requires vitamin B6 and Vitamin B6 (Pyridoxine) interacts with magnesium in many enzyme systems in the body.

* Supports healthy brain function.

Public Summary

Page 1 of

Produced at 26.11.2017 at 02:21:35 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

* Contains nutrients necessary for healthy brain function.

* Vitamin C is an important nutritional antioxidant/free radical scavenger.

* As an antioxidant, vitamin C assists in protecting the body from the damaging effects of free radicals.

* Vitamin C is a potent antioxidant that can reduce the risk of cellular damage from free radicals.

* Vitamin C is necessary for the manufacture of collagen in the body.

* Vitamin C plays a role in collagen formation.

* Vitamin C supports the development and maintenance of bones.

* Vitamin C supports the development and maintenance of teeth.

* Vitamin C supports the development and maintenance of cartilage.

* Vitamin C supports connective tissue formation.

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

calcium ascorbate dihydrate

50 mg

colecalciferol

2.5 microgram

heavy magnesium oxide

440 mg

magnesium phosphate pentahydrate

175 mg

Manganese amino acid chelate

40 mg

pyridoxine hydrochloride

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 26.11.2017 at 02:21:35 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