35 Billion Probiotic 10

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

Buy It Now

Active ingredient:
Bifidobacterium breve,Bifidobacterium infantis,Bifidobacterium lactis,Bifidobacterium longum,Lactobacillus brevis,Lactobacillus paracasei,Lactobacillus plantarum,Lactobacillus reuteri,Lactobacillus rhamnosus,Lactobacillus salivarius ssp salivarius,Streptococcus thermophilus
Available from:
Evolution Health Pty Ltd
INN (International Name):
Bifidobacterium breve,Bifidobacterium infantis,Bifidobacterium lactis,Bifidobacterium longum,Lactobacillus brevis,Lactobacillus
Authorization status:
Listed
Authorization number:
292340

Read the complete document

Public Summary

Summary for ARTG Entry:

292340

35 Billion Probiotic 10

ARTG entry for

Medicine Listed

Sponsor

Evolution Health Pty Ltd

Postal Address

6 McArthur Street,WEST FOOTSCRAY, VIC, 3012

Australia

ARTG Start Date

2/08/2017

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. 35 Billion Probiotic 10

Product Type

Single Medicine Product

Effective date

2/08/2017

Warnings

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

Standard Indications

Aids, assists or helps in the maintenance of general well-being

Specific Indications

Healthy Essentials 35 Billion Probiotic 10 contains beneficial species of live bacteria all working to keep you healthy inside and out.

Supports general health and well-being.

Formulation provides beneficial bacteria to support immune health, intestinal (digestive) health and bowel health.

Supports Immune Health:

Helps support/assist/maintain immune health. Helps support/assist/maintain healthy immune function. Helps support/assist/maintain immune system

health/ a healthy immune system.

Supports Digestive (Intestinal) Health:

Helps maintain healthy populations of beneficial bacteria and healthy digestive function. Helps with the maintenance of a healthy digestive function.

Helps restore healthy digestive function that has been disrupted by antibiotic medications. May assist to restore healthy levels of beneficial intestinal flora

(friendly bacteria) that may have been disrupted by taking a course of antibiotics. Support the metabolism of food and absorption of nutrients.

Supports Bowel Health:

Helps support normal, healthy bowel movements.

Daily consumption of beneficial bacteria supports general health and well-being.

Each vege-capsule contains probiotic strains that provide a range of health benefits, supporting general health and well-being.

Probiotic supplementation may assist in maintaining healthy vaginal flora.

Additional Product information

Pack Size/Poison information

Pack Size

Poison Schedule

Components

Public Summary

Page 1 of

Produced at 24.11.2017 at 07:14:18 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

1. Formulation 1

Dosage Form

Capsule, hard

Route of Administration

Oral

Visual Identification

Active Ingredients

Bifidobacterium breve

1 billion CFU

Bifidobacterium infantis

1 billion CFU

Bifidobacterium lactis

6.2 billion CFU

Bifidobacterium longum

.9 billion CFU

Lactobacillus brevis

1.85 billion CFU

Lactobacillus paracasei

5 billion CFU

Lactobacillus plantarum

5 billion CFU

Lactobacillus reuteri

.3 billion CFU

Lactobacillus rhamnosus

12 billion CFU

Lactobacillus salivarius ssp salivarius

1.85 billion CFU

Streptococcus thermophilus

4.13 billion CFU

© 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 24.11.2017 at 07:14:18 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

Similar products

Search alerts related to this product

Share this information