METAGENICS

Main information

Documents

Localization

  • Available in:
  • METAGENICS FIBROPLEX MAINTAIN
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 215740
  • Last update:
  • 09-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

215740

METAGENICS FIBROPLEX MAINTAIN

ARTG entry for

Medicine Listed

Sponsor

Health World Ltd

Postal Address

PO Box 675,VIRGINIA BC, QLD, 4014

Australia

ARTG Start Date

8/10/2013

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 FIBROPLEX MAINTAIN

Product Type

Single Medicine Product

Effective date

30/07/2015

Warnings

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

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

Standard Indications

Specific Indications

May provide support for muscle aches, pains, cramps and spasms. Magnesium supplementation may be beneficial during times of stress and may help

to maintain a healthy stress response. Helps decrease/reduce/relieve pre-menstrual symptoms (PMS). For magnesium supplementation. Helps

reduce/decrease the frequency of migraines. Magnesium and zinc assist the function of the neuromuscular system. Help maintain/support glucose

transport in the body. To maintain normal healthy stress and energy levels. Magnesium helps maintain/support cellular energy production. Magnesium is

beneficial for premenstrual symptoms. Magnesium plays a role in the Kreb's cycle. Amino acid chelates have been shown to be bioavailable sources of

minerals. Symptoms of magnesium deficiency include: muscle spasms and cramps, muscle weakness, fatigue and lethargy. 100% fully reacted

magnesium diglycinate. MetaMag (R) may not dissociate in the intestine. MetaMag (R) is an exclusive and highly bioavailable for of magnesium.

Magnesium with enhanced bioavailability.

Fibroplex Maintain contains MetaMag (R), an exclusive form of magnesium with enhanced bioavailability. Magnesium may provide support for muscular

aches, pains, cramps and spasms. It helps to support energy production, maintain a healthy stress response and, along with zinc, maintain healthy

muscle and nerve function. Magnesium is also beneficial for premenstrual symptoms.

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

Public Summary

Page 1 of

Produced at 26.11.2017 at 08:13:39 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

Active Ingredients

chromic chloride hexahydrate

1.025 mg

Magnesium amino acid chelate

1 g

Magnesium amino acid chelate

500 mg

pyridoxine hydrochloride

15 mg

Zinc sulfate monohydrate

21.98 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 08:13:39 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

25-10-2018

Safety of zinc chelate of methionine sulfate for the target species

Safety of zinc chelate of methionine sulfate for the target species

Published on: Wed, 24 Oct 2018 00:00:00 +0200 Zinc chelate of methionine sulfate is intended to be used as a nutritional additive (functional group: compounds of trace elements). The additive is zinc chelated with methionine in a molar ratio 1:1. It is intended to supply zinc as a nutritional additive to all animal species/categories. In 2017, the EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) adopted an opinion on the safety and efficacy of zinc chelate of methionine su...

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