Nuora

Main information

Documents

Localization

  • Available in:
  • Nuora Infant Formulated Supplement 1
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 219745
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

219745

Nuora Infant Formulated Supplement 1

ARTG entry for

Medicine Listed (Export Only)

Sponsor

Functional Foods Global

Postal Address

Level 27 101 Collins Street,MELBOURNE, VIC, 3000

Australia

ARTG Start Date

30/01/2014

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.

Conditions applicable to all therapeutic goods as specified in the document "Standard Conditions Applying to Registered or Listed Therapeutic Goods

Under Section 28 of the Therapeutic Goods Act 1989" effective 1 July 1995, other than condition No. 8 and condition No. 9.

Conditions applicable to the relevant category and class of therapeutic goods as specified in the document "Standard Conditions Applying to Registered

or Listed Therapeutic Goods Under Section 28 of the Therapeutic Goods Act 1989" effective 1 July 1995, other than condition No.11

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. Nuora Infant Formulated Supplement 1

Product Type

Single Medicine Product

Effective date

30/01/2014

Warnings

No Warnings included on Record

Standard Indications

Specific Indications

DHA and ARA may assist in strong brain and eye development

Iron is important for carrying oxygen around the body

Prebiotic and Zinc may support a healthy immune system

Additional Product information

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Jar/Can

Not recorded

Not recorded

Not recorded

Not recorded

Not recorded

Pack Size/Poison information

Pack Size

Poison Schedule

Components

1.

Dosage Form

Powder, oral

Route of Administration

Oral

Visual Identification

White to off white powder

Active Ingredients

Ascorbic acid

.9773 mg

Biotin

.0002 mg

Calcium carbonate

1.8795 mg

calcium hydrogen phosphate dihydrate

2.3494 mg

Calcium pantothenate

.0417 mg

canola oil

36.1065 mg

Choline chloride

.9961 mg

Coconut Oil

42.4783 mg

Public Summary

Page 1 of

Produced at 26.11.2017 at 03:30:12 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

colecalciferol

0 mg

cupric sulfate

.0084 mg

Cyanocobalamin

0 mg

dibasic potassium phosphate

9.085 mg

dl-alpha-Tocopheryl acetate

.0845 mg

ferrous sulfate heptahydrate

.2357 mg

Folic acid

.0007 mg

Inositol

.314 mg

lactose monohydrate

212.6547 mg

liquid glucose

9.7562 mg

magnesium chloride hexahydrate

1.7565 mg

Manganese sulfate monohydrate

.0084 mg

natural fish oil

5.2738 mg

Nicotinamide

.0405 mg

nonfat dry milk

25.3742 mg

Oligofructose

23.11 mg

Phytomenadione

.0004 mg

potassium iodide

.0008 mg

pyridoxine hydrochloride

.0054 mg

retinol acetate

.0063 mg

Riboflavin

.0126 mg

sodium citrate dihydrate

5.0626 mg

sodium selenite

.0003 mg

Soya Oil

67.9653 mg

soy phosphatidylserine-enriched soy lecithin liquid

2.5486 mg

Sunflower Oil

63.2927 mg

Taurine

.3594 mg

Thiamine hydrochloride

.0074 mg

Whey powder

246.2239 mg

whey protein concentrate

93.0388 mg

whole dry milk

135.3291 mg

Zinc sulfate monohydrate

.1276 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 26.11.2017 at 03:30:12 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