WAGNER

Main information

  • Trade name:
  • WAGNER MAGNESIUM FORTE DAILY
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • WAGNER MAGNESIUM FORTE DAILY
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 220522
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

220522

WAGNER MAGNESIUM FORTE DAILY

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

26/02/2014

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. WAGNER MAGNESIUM FORTE DAILY

Product Type

Single Medicine Product

Effective date

26/02/2014

Warnings

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

Standard Indications

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

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

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

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

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

May assist in the maintenance of normal/healthy cholesterol levels in healthy individuals.

May assist in the maintenance of a normal/healthy LDL:HDL cholesterol ratio.

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

Relief of menstrual symptoms. [Warning S required]

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

Specific Indications

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

Magnesium plays a vital role in the body in neuromuscular transmission.* Magnesium plays a role in nerve conduction on the body * Supports the

function of the nervous system* Magnesium is 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 andstrength 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 * Aids/assists in the

maintenance of a healthy cardiovascular system* Supports cardiovascular health. * Magnesium may assist to reduce symptoms of nervousness and mild

anxiety.

Public Summary

Page 1 of

Produced at 26.11.2017 at 02:22:53 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

Additional Product information

Pack Size/Poison information

Pack Size

Poison Schedule

Components

1. Formulation 1

Dosage Form

Capsule, hard

Route of Administration

Oral

Visual Identification

Active Ingredients

Magnesium amino acid chelate

135 mg

Magnesium oxide

564.2 mg

magnesium phosphate pentahydrate

175 mg

zinc oxide

2.49 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 02:22:53 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

31-10-2018

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Safety and efficacy of a super critical carbon dioxide extract of Humulus lupulus L. flos when used as a feed flavouring for all animal species

Published on: Tue, 30 Oct 2018 00:00:00 +0100 Following a request from the European Commission, the EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on the safety and efficacy of a super critical carbon dioxide extract of Humulus lupulus L. flos (hop strobiles) when used as a sensory feed additive for all animal species. The additive is specified to containing 40% beta acids and less than 0.2% alpha acids. Known substances of conce...

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25-10-2018

Safety of zinc chelate of methionine sulfate for the target species

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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...

Europe - EFSA - European Food Safety Authority Publications

6-7-2017

The European Commission's decision concerning veterinary medicinal products containing zinc oxide

The European Commission's decision concerning veterinary medicinal products containing zinc oxide

On 26 June 2017, the European Commission adopted a decision to withdraw all marketing authorisations for veterinary medicinal products containing zinc oxide administered orally to food producing species. The medicinal products affected by the decision appear from Annex I to the decision.

Danish Medicines Agency

21-3-2017

New recommendation for phasing out zinc oxide for young pigs

New recommendation for phasing out zinc oxide for young pigs

The European Medicines Agency's Committee for Medicinal Products for Veterinary Use (CVMP) has confirmed a previous decision to phase out zinc oxide. Consequently, the CVMP has once more recommended to the European Commission that medicinal products containing zinc oxide for the prevention of diarrhoea in young pigs should be withdrawn from the market.

Danish Medicines Agency

5-1-2017

Re-examination of the CVMP's decision to phase out zinc oxide for young pigs

Re-examination of the CVMP's decision to phase out zinc oxide for young pigs

The European Medicines Agency's Committee for Medicinal Products for Veterinary Use (CVMP) will re-examine the decision to phase out medicinal products containing zinc oxide for the prevention of diarrhoea in young pigs.

Danish Medicines Agency

19-12-2016

Zinc oxide for young pigs to be phased out

Zinc oxide for young pigs to be phased out

The European Medicines Agency's Committee for Medicinal Products for Veterinary Use (CVMP) has recommended to the European Commission that medicinal products containing zinc oxide for the prevention of diarrhoea in young pigs should be withdrawn from the market.

Danish Medicines Agency

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

Valproate

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