Michelle

Main information

Documents

Localization

  • Available in:
  • Michelle Bridges Multivitamin
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 221816
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

221816

Michelle Bridges Multivitamin

ARTG entry for

Medicine Listed

Sponsor

Blackmores Ltd

Postal Address

PO Box 1725,WARRIEWOOD, NSW, 2102

Australia

ARTG Start Date

31/03/2014

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. Michelle Bridges Multivitamin

Product Type

Single Medicine Product

Effective date

31/03/2014

Warnings

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.

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

Standard Indications

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

Specific Indications

Daily energy*

*With B vitamins (B1,B2,B3,B5) which play a role in cellular energy production.

*With B vitamins (B1,B2,B3,B5) [required for/which support] the release of energy from food.

For the support of daily energy.

(Vitamins C, B1, B2, B3, B5, B6, B12 and folic acid) helps reduce fatigue and tiredness [caused by/due to] inadequate dietary intake.

With/includes 8 nutrients (Vitamins C, B1, B2, B3, B5, B6, B12 and folic acid) that can contribute to the reduction of fatigue and tiredness [caused by/due

to] inadequate dietary intake.

Bone and Muscle*

*[Key/important] nutrients for bone health (vitamin D, zinc & manganese) and muscle (vitamin D)[health/performance].

*With vitamin D, zinc and manganese, required for bone health.

For the support of bone and muscle health.

(Immunity)* *With zinc, selenium and vitamins C and D for immune [health/support].

For the support of immunity.

May help to [relieve/reduce] [fatigue/tiredness/lack of energy].

Stress* *With nutrients(B3,B5,B6,Vit C) required during times of stress OR [Delivers/provides] nutrients (B3,B5,B6,Vit C) important for the [body's normal

stress response / body's response to stress].

For nutritional support during times of stress.

Stress support.

Metabolism* *Contains important nutrients (Zn, B1,B2,B3,B5,B6,B12) involved in metabolism.

For the support of metabolism.

Essential nutrients (selenium and iodine) required for healthy thyroid function (which plays a key role in metabolism).

For health and wellbeing.

Additional Product information

Public Summary

Page 1 of

Produced at 23.11.2017 at 12:22:23 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

Pack Size/Poison information

Pack Size

Poison Schedule

Components

1. Formulation 1

Dosage Form

Tablet, multilayer

Route of Administration

Oral

Visual Identification

Active Ingredients

Ascorbic acid

60 mg

Betacarotene

405 microgram

Beta vulgaris

10 mg

Biotin

30 microgram

Brassica oleracea var. viridis

20 mg

Equivalent: Brassica oleracea var. viridis (Fresh)

180 mg

calcified lithothamnion tophiforme

180 mg

calcium hydrogen phosphate

270 mg

Calcium pantothenate

6.55 mg

Chromium picolinate

321.8 microgram

colecalciferol

12.5 microgram

Cupric oxide

563.4 microgram

Cyanocobalamin

2.4 microgram

d-alpha-Tocopheryl acid succinate

10 mg

Eleutherococcus senticosus

133.33 mg

Equivalent: Eleutherococcus senticosus (Dry)

Folic acid

400 microgram

heavy magnesium oxide

138.19 mg

Inositol

50 microgram

Iron amino acid chelate

45 mg

Manganese gluconate

12.02 mg

Nicotinamide

16 mg

Phytomenadione

.07 mg

potassium iodide

196 microgram

pyridoxine hydrochloride

1.3 mg

Reynoutria japonica

2 mg

Equivalent: Reynoutria japonica (Dry)

200 mg

Riboflavin

1.3 mg

Selenomethionine

173.8 microgram

Silybum marianum

25 mg

Equivalent: Silybum marianum (Dry)

750 mg

Thiamine nitrate

1.2 mg

Triticum aestivum

50 mg

Equivalent: Triticum aestivum (Fresh)

1.25 g

zinc amino acid chelate

70 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 12:22:23 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