MACRO

Main information

Documents

Localization

  • Available in:
  • MACRO WOMEN'S MULTI MULTIVITAMIN AND MINERAL CAPSULES.
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 77210
  • Last update:
  • 01-12-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

77210

MACRO WOMEN'S MULTI MULTIVITAMIN AND MINERAL CAPSULES.

ARTG entry for

Medicine Listed

Sponsor

Pfizer Australia Pty Ltd

Postal Address

38-42 Wharf Road,WEST RYDE, NSW, 2114

Australia

ARTG Start Date

20/12/2000

Product category

Medicine

Status

Active

Approval area

Listed Medicines

Conditions

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. MACRO WOMEN'S MULTI MULTIVITAMIN AND MINERAL CAPSULES.

Product Type

Single Medicine Product

Effective date

31/05/2004

Warnings

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

Standard Indications

Specific Indications

Each capsule contains 20 essential vitamins and minerals, and is specially formulated to meet the nutritional needs of women whose diet may be lacking

due to dieting, pregnancy, use of HRT or oral contraceptives. It is high in B group vitamins and also contains folic acid which if taken one month before

conception and during pregnancy may reduce the risk of having a child with neural tube defects such as spina bifida.

Additional Product information

Pack Size/Poison information

Pack Size

Poison Schedule

Components

1. COMPONENT ONE

Dosage Form

Capsule, hard

Route of Administration

Oral

Visual Identification

Active Ingredients

Ascorbic acid

75 mg

Betacarotene

3 mg

calcium hydrogen phosphate

424 mg

Calcium pantothenate

5 mg

colecalciferol

10 microgram

Cupric oxide

1.25 mg

Cyanocobalamin

5 microgram

Public Summary

Page 1 of

Produced at 01.12.2017 at 08:36:57 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

dl-alpha-Tocopheryl acetate

15 mg

Ferrous fumarate

15.2 mg

Folic acid

500 microgram

heavy magnesium oxide

9.95 mg

Lysine hydrochloride

25 mg

Manganese sulfate monohydrate

3.08 mg

Nicotinamide

25 mg

potassium iodide

197 microgram

Potassium sulfate

11.16 mg

pyridoxine hydrochloride

5 mg

riboflavine

10 mg

Thiamine nitrate

10 mg

zinc oxide

6.2 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 01.12.2017 at 08:36:57 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

There are no safety alerts related to this product.

18-12-2018


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Europe - EMA - European Medicines Agency