Lifestream Advanced Probiotics Metabolise

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

Buy It Now

Active ingredient:
Bifidobacterium breve,Bifidobacterium longum,Lactobacillus acidophilus,Lactobacillus casei,Lactobacillus delbrueckii ssp bulgaricus,Lactobacillus rhamnosus,Streptococcus thermophilus
Available from:
Lifestream International Pty Ltd
INN (International Name):
Bifidobacterium breve,Bifidobacterium longum,Lactobacillus acidophilus,Lactobacillus casei,Lactobacillus delbrueckii ssp bulgari
Authorization status:
Listed
Authorization number:
293414

Read the complete document

Public Summary

Summary for ARTG Entry:

293414

Lifestream Advanced Probiotics Metabolise

ARTG entry for

Medicine Listed

Sponsor

Lifestream International Pty Ltd

Postal Address

Level 3 / 32 Martin Place,Sydney, NSW, 2000

Australia

ARTG Start Date

31/08/2017

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. Lifestream Advanced Probiotics Metabolise

Product Type

Single Medicine Product

Effective date

29/09/2017

Warnings

No Warnings included on Record

Standard Indications

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

Specific Indications

* Contains probiotics, which support the health and function of the immune system.

* Contains a source of probiotics, which support the health and function of the immune system.

* Supports normal immune system health.

* Contains Lactobacillus and Bifidobacteria probiotics, which support the health and function of the immune system.

* Contains probiotics, which help support the health and function of the gastrointestinal tract (GIT).

* Contains probiotics, which support gastrointestinal health.

* Contains probiotics, which support the health and function of the digestive tract.

* Contains probiotics, which support the integrity of the digestive tract.

* Contains Lactobacillus and Bifidobacteria probiotics, which may assist in supporting the health and function of the gastrointestinal tract (GIT) following

antibiotic therapy.

* Contains probiotics, which may assist in maintaining and stabilising healthy gut microflora.

* Contains probiotics/friendly bacteria, which may assist in maintaining healthy gut microflora.

* Contains probiotics, which may assist in maintaining healthy gut microflora.

* Contains probiotics, which assist with the digestion and absorption of nutrients.

* Contains Lactobacillus and Bifidobacteria probiotic species, which assist in the digestion and absorption of nutrients.

* Gastrointestinal microflora play an important role in nutrient metabolism.

* Probiotic supplementation supports gastrointestinal/gut health.

* Probiotic supplementation may support the health of the digestive system.

Additional Product information

Pack Size/Poison information

Pack Size

Poison Schedule

Components

Public Summary

Page 1 of

Produced at 03.11.2017 at 04:50:17 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

25 million CFU

Bifidobacterium longum

20 million CFU

Lactobacillus acidophilus

25 million CFU

Lactobacillus casei

200 million CFU

Lactobacillus delbrueckii ssp bulgaricus

5 million CFU

Lactobacillus rhamnosus

175 million CFU

Streptococcus thermophilus

50 million 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 03.11.2017 at 04:50:17 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