Catalyst

Main information

Documents

Localization

  • Available in:
  • Catalyst
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 221360
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

221360

Catalyst

ARTG entry for

Medicine Listed

Sponsor

Mannatech Australia Pty Ltd

Postal Address

Level 3 / 69 Christie Street,ST LEONARDS, NSW, 2065

Australia

ARTG Start Date

17/03/2014

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. Catalyst

Product Type

Single Medicine Product

Effective date

17/03/2014

Warnings

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

Do not take while on warfarin therapy without medical advice.

This product contains selenium which is toxic in high doses. A daily dose of 150 micrograms for adults of selenium from dietary supplements should not

be exceeded.

Standard Indications

Source of calcium. A diet deficient in calcium can lead to osteoporosis in later life.

Source of calcium. A calcium supplement formulated to strengthen bone and tissue in growing and mature users. (or) Source of calcium. A calcium

supplement formulated to strengthen bone and tissue for children and older adults.

For mineral (may state the mineral) supplementation.

For vitamin (may state the vitamin) supplementation.

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

Source of folic acid. Can assist in maintaining normal blood.

Specific Indications

Multivitamin and multimineral supplement.

Antioxidant; helps to protect against free radicals formed by environmental pollution.

Nutritional support for normal growth, development and wound healing.

Promotes normal healthy function of the nerves, liver, kidney, digestive tracts, energy metabolism and immune system.

Promotes normal healthy function on bones, teeth, skin, hair and eyes.

Additional Product information

Pack Size/Poison information

Pack Size

Poison Schedule

Components

Public Summary

Page 1 of

Produced at 23.11.2017 at 12:28:31 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

Aloe vera

2.5 mg

alpha lipoic acid

3.75 mg

Ascorbic acid

89.5 mg

Biotin

75 microgram

Calcium carbonate

612.5 mg

calcium citrate tetrahydrate

23.88 mg

Calcium pantothenate

10.92 mg

Choline bitartrate

30.39 mg

chromic chloride hexahydrate

56.4 microgram

colecalciferol

.0055 mg

Cupric citrate hemipentahydrate

477 microgram

Cyanocobalamin

6 microgram

d-alpha-Tocopheryl acid succinate

4.128 mg

Dunaliella salina

9 mg

Folic acid

75 microgram

Ghatti Gum

5 mg

heavy magnesium oxide

248.26 mg

Inositol

12.5 mg

magnesium aspartate tetrahydrate

2.5 mg

Magnesium citrate

2.5 mg

Malpighia glabra

2.5 mg

Equivalent: Malpighia glabra (Dry)

10 mg

Manganese amino acid chelate

5 mg

mixed (low-alpha type) tocopherols concentrate

1.68 mg

Nicotinamide

5 mg

potassium iodide

33 microgram

pyridoxine hydrochloride

2 mg

Riboflavin

1.7 mg

Rosa canina

1.67 mg

Equivalent: Rosa canina (Dry)

10 mg

Selenomethionine

12.5 microgram

Thiamine nitrate

1.5 mg

Tragacanth

2.5 mg

Ubidecarenone

3 mg

zinc citrate dihydrate

11.72 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 23.11.2017 at 12:28:31 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