Aunulife Probiotics Gastric Health Plus

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

Buy It Now

Active ingredient:
Bifidobacterium animalis ssp lactis,fructooligosaccharides,Lactobacillus acidophilus,Lactobacillus plantarum,Lactobacillus rhamnosus,Lactobacillus salivarius ssp salivarius
Available from:
Aunulife Pty Ltd
Authorization status:
Listed
Authorization number:
322402

Public Summary

Summary for ARTG Entry:

322402

Aunulife Probiotics Gastric Health Plus

ARTG entry for

Medicine Listed

Sponsor

Aunulife Pty Ltd

Postal Address

Unit 9 30 Middle Crescent,Brighton, VIC, 3186

Australia

ARTG Start Date

28/08/2019

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.

The sponsor of the listed medicine must not, by any means, intentionally or recklessly advertise the medicine for an indication other than those accepted

in relation to the inclusion of the medicine in the Register.

All reports of adverse reactions or similar experiences associated with the use or administration of the listed medicine shall be notified to the Head, Office

of Product Review, Therapeutic Goods Administration, as soon as practicable after the sponsor of the goods becomes aware of those reports. Sponsors

of listed medicines must retain records of such reports for a period of not less than 18 months from the day the Head, Office of Product Review is notified

of the report or reports.

The sponsor shall not supply the listed medicine after the expiry date of the goods.

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. Aunulife Probiotics Gastric Health Plus

Product Type

Single Medicine Product

Effective date

28/08/2019

Permitted Indications

Maintain/support intestinal health

Helps enhance/promote gastrointestinal system mucosa health

Maintain/support intestinal good/beneficial/friendly flora

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

Helps enhance/improve/promote/increase healthy digestive system flora/good bacteria growth

Helps enhance/improve/promote/increase intestinal good/beneficial/friendly bacteria growth

Nourish good/beneficial/friendly intestinal flora

Maintain/support gastrointestinal system health

Maintain/support gastrointestinal mucosal membrane health

Relieve excessive belching

Helps decrease/reduce/relieve symptoms of mild gastritis

Helps decrease/reduce/relieve mild gastrointestinal tract inflammation

Soothe gastro-intestinal tract mucous membranes

Decrease/reduce/relieve gastrointestinal pain

Decrease/reduce/relieve symptoms of stomach upsets

Indication Requirements

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

Product presentation must only refer to mild gastritis.

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

Public Summary

Page 1 of

Produced at 29.08.2019 at 04:00:18 AEST

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

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

Standard Indications

No Standard Indications included on Record

Specific Indications

Warnings

If symptoms persist consult your healthcare practitioner (or words to that effect).

Additional Product information

Pack Size/Poison information

Pack Size

Poison Schedule

Components

1. Formulation 1

Dosage Form

Powder, oral

Route of Administration

Oral

Visual Identification

Active Ingredients

Bifidobacterium animalis ssp lactis

.333 billion CFU/g

fructooligosaccharides

166.6 mg/g

Lactobacillus acidophilus

.333 billion CFU/g

Lactobacillus plantarum

1.7 billion CFU/g

Lactobacillus rhamnosus

2.189 billion CFU/g

Lactobacillus salivarius ssp salivarius

2.108 billion CFU/g

© 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 29.08.2019 at 04:00:18 AEST

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

Similar products

Search alerts related to this product

Share this information