BLACKMORES

Main information

Documents

Localization

  • Available in:
  • BLACKMORES PREGNANCY AND BREAST-FEEDING GOLD (NZ)
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 220539
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

220539

BLACKMORES PREGNANCY AND BREAST-FEEDING GOLD (NZ)

ARTG entry for

Medicine Listed (Export Only)

Sponsor

Blackmores Ltd

Postal Address

PO Box 1725,WARRIEWOOD, NSW, 2102

Australia

ARTG Start Date

26/02/2014

Product category

Medicine

Status

Active

Approval area

Export only Medicines

Conditions

Except where the sponsor has been contracted by an overseas partry to manufacturer the goods and that party will be responsible for placing the goods

on the market in countries other than Australia, the sponsor must have and shall retain, while the goods remain listed, evidence necessary to

substantiate and support the accuracy of the indications in relation to the listed goods, and upon the request of the Head, Office of Prescription

Medicines Authorisation Branch, Therapeutic Goods Administration, shall produce such evidence to this officer.

The sponsor shall hold stability data to support the claimed shelf life of the listed medicine according to the labelled storage conditions except where: (i)

each overseas importer accepts responsibility for holding stability data for this product; (ii) the sponsor has a written agreement to this effect from each

overseas importer; and (iii) the sponsor retains copies of all such agreements while the medicine remains listed on the ARTG.

This product must not be supplied for sale in Australia, including supply via duty free outlets.

Products

1. BLACKMORES PREGNANCY AND BREAST-FEEDING GOLD (NZ)

Product Type

Single Medicine Product

Effective date

28/03/2017

Warnings

No Warnings included on Record

Standard Indications

Specific Indications

No Specific Indications included on Record

Additional Product information

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Bottle

Not recorded

Not recorded

Not recorded

Not recorded

Not recorded

Pack Size/Poison information

Pack Size

Poison Schedule

Components

1.

Dosage Form

Capsule, soft

Route of Administration

Oral

Visual Identification

Opaque brown oblong soft capsule, filled with red suspension.

Active Ingredients

Ascorbic acid

30 mg

Betacarotene

2.4 mg

Biotin

15 microgram

Calcium carbonate

125 mg

Calcium pantothenate

2.73 mg

Chromium picolinate

121 microgram

colecalciferol

9 microgram

concentrated fish Omega-3 triglycerides

250 mg

Cyanocobalamin

1.3 microgram

d-alpha-Tocopherol

3.5 mg

Folic acid

250 microgram

heavy magnesium oxide

58.1 mg

Iron (II) glycinate

19.22 mg

Nicotinamide

9 mg

Public Summary

Page 1 of

Produced at 23.11.2017 at 12:31:50 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

potassium iodide

98.3 microgram

pyridoxine hydrochloride

1.16 mg

Riboflavin

700 microgram

Selenomethionine

81.3 microgram

Thiamine nitrate

700 microgram

zinc oxide

6.82 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 12:31:50 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