C-Max

Main information

Documents

Localization

  • Available in:
  • C-Max
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 215594
  • Last update:
  • 09-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

215594

C-Max

ARTG entry for

Medicine Listed

Sponsor

Biomedica Nutraceuticals Pty Ltd

Postal Address

PO Box 7052,ALEXANDRIA, NSW, 2015

Australia

ARTG Start Date

3/10/2013

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. C-Max

Product Type

Single Medicine Product

Effective date

3/10/2013

Warnings

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

Adults only. OR Not to be used in children under two years of age without medical advice (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

May reduce the severity of colds. [Warning COLD required]

Maintain health of capillaries.

Protects capillaries.

May reduce the severity and duration of colds. [Warning COLD required]

May reduce the duration of colds. [Warning COLD required]

May help reduce the severity of the symptoms of colds. ]Warnings S and COLD required]

Relief of the symptoms of colds. [Warnings S and COLD required]

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

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

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

May assist in the management of recurrent upper respiratory tract infections. [Warnings S and COLD required]

For the symptomatic relief of recurrent upper respiratory tract infections. [Warnings S and COLD required]

Treatment of symptoms of mild infections of upper respiratory tract. [Warnings S and COLD required]

May assist in the management of upper respiratory tract infections. [Warnings S and COLD required]

Helps fight mild upper respiratory complaints. [Warnings S and COLD required]

Treatment of upper respiratory tract infections. [Warnings S and COLD required]

Relief of symptoms of mild upper respiratory infections. [Warnings S and COLD required]

For vitamin (may state the vitamin) supplementation.

Public Summary

Page 1 of

Produced at 23.11.2017 at 04:07:37 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

Specific Indications

Maintains a normal/healthy cardiovascular system

Vitamin C and zinc are essential for the proper function of the immune system

Maintains a normal/healthy immune system

Vitamin C maintains the immune system by supporting the activity of the white blood cells and antibody response.

Vitamin C and zinc play a vital role in many immune mechanisms.

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

Vitamin C plays a role in collagen formation.

Vitamin C, vitamin E and zinc are important nutritional antioxidants/free radical scavengers.

As antioxidants, vitamin C, vitamin E and zinc assist in protecting the body from the damaging effects of free radicals.

Vitamin C, vitamin E and zinc are potent antioxidants that can reduce the risk of cellular damage from free radicals.

Vitamin E protects the cells in the body from oxidative damage by destroying or neutralizing free radicals.

Vitamin E is an important nutritional antioxidant, which inhibits the oxidization of fats/lipids in the body/cell membranes.

Vitamin E is an important lipid phase nutritional antioxidant, and therefore assists in protecting the body from free radicals that may be generated from

exposure to pollution, cigarettes, alcohol and stress.

Vitamin E is a fat-soluble antioxidant vitamin that helps protect the cell membranes from damage.

Vitamin C is necessary for wound healing.

Vitamin C is necessary for the maintenance of healthy skin.

Vitamin C can regenerate oxidised Vitamin E in the body

Vitamin C is necessary for healthy gums

Vitamin C increases iron absorption

May help to maintain normal (and/or healthy) cholesterol levels in healthy individuals

May help maintain cholesterol levels within the normal (and/or) healthy range, and improve HDL/LDL ratio in healthy individuals

Additional Product information

Pack Size/Poison information

Pack Size

Poison Schedule

Components

1. Formulation 1

Dosage Form

Powder, oral

Route of Administration

Oral

Visual Identification

Active Ingredients

alpha lipoic acid

2 mg/g

Ascorbic acid

310 mg/g

Betacarotene

.36 mg/g

calcium ascorbate dihydrate

88.4 mg/g

Calcium phosphate

20 mg/g

d-alpha-Tocopheryl acetate

11.78 mg/g

Glycine

150 mg/g

Hesperidin

20 mg/g

Magnesium ascorbate monohydrate

41.25 mg/g

magnesium phosphate pentahydrate

20 mg/g

Phyllanthus emblica

4.8 mg/g

Equivalent: Phyllanthus emblica (Dry)

24 mg/g

Potassium ascorbate dihydrate

38.58 mg/g

rutoside

12 mg/g

sodium ascorbate

53.51 mg/g

zinc citrate dihydrate

3.11 mg/g

© 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 04:07:37 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