METAGENICS

Main information

  • Trade name:
  • METAGENICS MYOPLEX
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • METAGENICS MYOPLEX
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 217024
  • Last update:
  • 09-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

217024

METAGENICS MYOPLEX

ARTG entry for

Medicine Listed

Sponsor

Health World Ltd

Postal Address

PO Box 675,VIRGINIA BC, QLD, 4014

Australia

ARTG Start Date

8/11/2013

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. METAGENICS MYOPLEX

Product Type

Single Medicine Product

Effective date

8/11/2013

Warnings

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

Standard Indications

For mineral (may state the mineral) supplementation.

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

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

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).

Specific Indications

Passionflower is used as a sedative, hypnotic, relaxant and anti-spasmodic. It is used for tension, anxiety, irritability and insomnia in traditional Western

herbal medicine.

Adequate amounts of magnesium are required by the body for healthy function of the nervous system.

Magnesium deficiency may have effects on the neuromuscular and central nervous system of the body.

Magnesium is an important mineral in the body for the electrical stability of cells, the maintenance of membrane integrity, muscle contraction, nerve

conduction and the regulation of vascular tone.

Magnesium plays an important role in the conduction of nerve impulses and muscle contraction.

Magnesium may assist in the relief of leg cramps.

A magnesium supplement with herbs.

For muscular and nervous system support.

Myoplex has been formulated to assist in the function of the neuromuscular system. It contains magnesium to support muscle contraction, nerve

conduction and the regulation of vascular tone. Myoplex is also useful for the relief of nervous tension, stress and mild anxiety.

Additional Product information

Pack Size/Poison information

Pack Size

Poison Schedule

Components

Public Summary

Page 1 of

Produced at 26.11.2017 at 07:02:24 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

1. Formulation 1

Dosage Form

Tablet, film coated

Route of Administration

Oral

Visual Identification

Active Ingredients

calcium lactate

138.9 mg

Magnesium amino acid chelate

250 mg

Passiflora incarnata

24.3 mg

Equivalent: Passiflora incarnata (Dry)

133.65 mg

Valeriana officinalis

12.5 mg

Equivalent: Valeriana officinalis (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 26.11.2017 at 07:02:24 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

15-11-2018

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Safety evaluation of the food enzyme acetolactate decarboxylase from a genetically modified Bacillus licheniformis (strain NZYM‐JB)

Published on: Wed, 14 Nov 2018 The food enzyme acetolactate decarboxylase (α‐acetolactate decarboxylase; EC 4.1.1.5) is produced with a genetically modified Bacillus licheniformis strain NZYM‐JB by Novozymes A/S. The genetic modifications do not give rise to safety concerns. The food enzyme is free from viable cells of the production organism and recombinant DNA. This acetolactate decarboxylase is intended to be used in distilled alcohol production and brewing processes. Residual amounts of total organi...

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