Nuora

Main information

Documents

Localization

  • Available in:
  • Nuora Infant Formulated Supplement 2
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 219746
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

219746

Nuora Infant Formulated Supplement 2

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 2

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

.6314 mg

Biotin

.0003 mg

Calcium carbonate

1.8849 mg

Calcium pantothenate

.0273 mg

Choline chloride

1.2535 mg

Coconut Oil

19.4728 mg

colecalciferol

0 mg

cupric sulfate

.0074 mg

Public Summary

Page 1 of

Produced at 26.11.2017 at 03:29:42 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

Cyanocobalamin

0 mg

dibasic potassium phosphate

12.8462 mg

dl-alpha-Tocopheryl acetate

.0559 mg

ferrous sulfate heptahydrate

.2997 mg

Folic acid

.0006 mg

Inositol

.285 mg

lactose monohydrate

99.4143 mg

liquid glucose

9.3158 mg

magnesium chloride hexahydrate

1.9933 mg

Manganese sulfate monohydrate

.0022 mg

natural fish oil

5.0371 mg

Nicotinamide

.0362 mg

nonfat dry milk

75.8708 mg

Oligofructose

22.088 mg

Phytomenadione

.0003 mg

potassium iodide

.0013 mg

pyridoxine hydrochloride

.0041 mg

retinol acetate

.0068 mg

Riboflavin

.0138 mg

sodium citrate dihydrate

6.6917 mg

sodium selenite

.0003 mg

Soya Oil

82.9188 mg

soy phosphatidylserine-enriched soy lecithin liquid

1.8845 mg

Sunflower Oil

21.3578 mg

Taurine

.3605 mg

Thiamine hydrochloride

.0061 mg

Whey powder

278.036 mg

whey protein concentrate

93.4012 mg

whole dry milk

259.2803 mg

Zinc sulfate monohydrate

.0989 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 03:29:42 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