Nature’s Way Restore Probiotic 30 Billion

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

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Active ingredient:
Bifidobacterium lactis,inulin,Lactobacillus rhamnosus
Available from:
Pharmacare Laboratories Pty Ltd
Authorization status:
Listed
Authorization number:
346631

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Public Summary

Summary for ARTG Entry:

346631

Nature's Way Restore Probiotic 30 Billion

ARTG entry for

Medicine Listed

Sponsor

Pharmacare Laboratories Pty Ltd

Postal Address

PO Box 384, MONA VALE, NSW, 1660

Australia

ARTG Start Date

27/10/2020

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 . Nature's Way Restore Probiotic 30 Billion

Product Type

Single Medicine Product

Effective Date

27/10/2020

Permitted Indications

Maintain/support general health and wellbeing in healthy adolescents

Maintain/support general health and wellbeing

Maintain/support bowel regularity

Maintain/support healthy bowel/colon function

Maintain/support healthy bowel/colon function in healthy adolescents

Decrease/reduce/relieve excess intestinal gas

Maintain/support healthy digestive system function

Maintain/support healthy digestive system function in healthy adolescents

Maintain/support healthy digestion in healthy adolescents

Maintain/support healthy digestion

Maintain/support digestive system health

Maintain/support digestive system health in healthy adolescents

Maintain/support good/beneficial/friendly bacteria adherence to intestinal mucosa in healthy adolescents

Maintain/support good/beneficial/friendly bacteria adherence to intestinal mucosa

Maintain/support intestinal good/beneficial/friendly flora

Maintain/support intestinal good/beneficial/friendly flora in healthy adolescents

Helps maintain/support good/beneficial/friendly gut flora during antibiotic use in healthy adolescents

Helps maintain/support good/beneficial/friendly gut flora during antibiotic use

Maintain/support healthy gastrointestinal function

Maintain/support healthy gastrointestinal function in healthy adolescents

Decrease/reduce/relieve abdominal bloating/distention

Relieve digestive discomfort

Maintain/support immune system health

Maintain/support immune system health in healthy adolescents

Maintain/support healthy immune system function in healthy adolescents

Maintain/support healthy immune system function

Public Summary

Page 1 of

Produced at 11.01.2021 at 11:57:37 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

Indication Requirements

Product presentation must not imply or refer to gastro oesophageal reflux disease.

Label statement: Do not use when abdominal pain, nausea or vomiting are present or if you develop diarrhoea. If you are pregnant or breastfeeding - seek

the advice of a healthcare professional before taking this product (or words to that effect).

Product presentation must not refer to or imply weight loss.

Label statement: If symptoms persist, talk to your health professional.

Label statement: Drink plenty of water (or words to that effect).

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

Label statement for stimulant laxatives: Prolonged use may cause serious bowel problems.

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

Pack Size/Poison information

Pack Size

Poison Schedule

Components

1 . Formulation 1

Dosage Form

Capsule, hard

Route of Administration

Oral

Visual Identification

Active Ingredients

Bifidobacterium lactis

2.5 billion CFU

Bifidobacterium lactis

2 billion CFU

inulin

30 mg

Lactobacillus rhamnosus

25.5 billion CFU

Other Ingredients (Excipients)

hypromellose

magnesium stearate

microcrystalline cellulose

silicon dioxide

titanium dioxide

© 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 11.01.2021 at 11:57:37 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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