Alliaus HEALTHY MOTHER With Probiotics and Prebiotics

Australia - English - Department of Health (Therapeutic Goods Administration)

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Active ingredient:
Bifidobacterium lactis,fructooligosaccharides,Lactobacillus rhamnosus
Available from:
Health Sharing Group Pty Ltd
Authorization status:
Listed
Authorization number:
345966

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Public Summary

Summary for ARTG Entry:

345966

Alliaus HEALTHY MOTHER With Probiotics and Prebiotics

ARTG entry for

Medicine Listed

Sponsor

Health Sharing Group Pty Ltd

Postal Address

36 Amax Avenue, GIRRAWEEN, NSW, 2145

Australia

ARTG Start Date

15/10/2020

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.

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 . Alliaus HEALTHY MOTHER With Probiotics and Prebiotics

Product Type

Single Medicine Product

Effective Date

15/10/2020

Permitted Indications

Decrease/reduce/relieve diarrhoea

Relief of symptoms of medically diagnosed Irritable Bowel Syndrome

Maintain/support digestive system health

Maintain/support intestinal good/beneficial/friendly flora

Helps restore good/beneficial/friendly intestinal/gut/bowel flora

Nourish good/beneficial/friendly intestinal flora

Maintain/support gastrointestinal system health

Maintain/support immune system health

Maintain/support healthy immune system function

Maintain/support vaginal healthy flora/microflora

Maintain/support vaginal health

Indication Requirements

Product presentation must only refer to medically diagnosed IBS.

Label statement: Seek medical advice if diarrhoea persists for more than: 6 hours in infants under 6 months, 12 hours in children under 3 years, 24 hours in

children aged 3 to 6 years or 48 hours in adults and children over 6 years (or words to that effect).

Product presentation must not imply or refer to serious immunological diseases.

Label statement: If symptoms persist or worsen talk to your medical practitioner.

Standard Indications

No Standard Indications included on Record

Specific Indications

No Specific Indications included on Record

Warnings

No Warnings included on Record

Additional Product information

Public Summary

Page 1 of

Produced at 12.01.2021 at 12:45:18 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

Powder

Route of Administration

Oral

Visual Identification

Active Ingredients

Bifidobacterium lactis

2 billion CFU/g

fructooligosaccharides

10 mg/g

Lactobacillus rhamnosus

4 billion CFU/g

Other Ingredients (Excipients)

citric acid

colloidal anhydrous silica

Flavour

maltodextrin

sodium bicarbonate

Stevia rebaudiana

© 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 12.01.2021 at 12:45:18 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

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