Oriental Botanicals GutBiotic 60 Billion

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

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Active ingredient:
Bifidobacterium breve,Bifidobacterium lactis,Bifidobacterium longum,Lactobacillus acidophilus,Lactobacillus casei,Lactobacillus delbrueckii ssp bulgaricus,Lactobacillus gasseri,Lactobacillus paracasei,Lactobacillus plantarum,Lactobacillus rhamnosus,Lactobacillus salivarius ssp salivarius,Streptococcus thermophilus
Available from:
McPherson's Consumer Products Pty Ltd
INN (International Name):
Bifidobacterium breve,Bifidobacterium lactis,Bifidobacterium longum,Lactobacillus acidophilus,Lactobacillus casei,Lactobacillus
Authorization status:
Listed
Authorization number:
293856

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Public Summary

Summary for ARTG Entry:

293856

Oriental Botanicals GutBiotic 60 Billion

ARTG entry for

Medicine Listed

Sponsor

Global Therapeutics Pty Ltd

Postal Address

Unit 1 Level 1,85 O'Riordan Street,Alexandria, NSW, 2015

Australia

ARTG Start Date

14/09/2017

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. Oriental Botanicals GutBiotic 60 Billion

Product Type

Single Medicine Product

Effective date

28/09/2017

Warnings

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

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

Standard Indications

Specific Indications

[01] May help to reduce/ relieve (symptoms of) flatulence

[02] May help to reduce/ relieve (symptoms of) bloating

[03] May help to reduce/ relieve (symptoms of) abdominal discomfort

[04]

(4a) May help to relieve irregular bowel movement

(4b) May help to relieve constipation

(4c) Helps to support a healthy gastrointestinal (GIT/ digestive) transit time

[05]

(5a) May help to maintain / restore intestinal / gut flora balance

(5b) May help to support a healthy balance of gastrointestinal / intestinal microflora / flora / colonisation of the GIT

(5c) Helps to support/ maintain healthy intestinal flora

(5d) May support a healthy microbial balance between harmful / bad bacteria and good bacteria in the GIT

(5d) May contribute to/ support the inhibition of growth / colonisation of harmful / bad bacteria (dysbiosis) in the gut

[06]

(6a) Helps support gastrointestinal / intestinal/ colonic / digestive health / function

(6b) Supports/maintains normal / healthy digestive / gastrointestinal / bowel function

(6c) Supports digestion

(6d) Helps maintain digestive function

[07]

(7a) Probiotics may help to restore healthy bacteria/ microflora balance in the digestive tract, which can be upset by certain medications such as

antibiotics and harmful / bad bacteria.

(7b) May help to restore healthy microbiota / microflora after antibiotic therapy

(7c) May help to restore normal faecal microbiota after disruption by antibiotics

[08] Supports healthy immune function

Public Summary

Page 1 of

Produced at 24.11.2017 at 06:00:56 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

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 breve

.5 billion CFU

Bifidobacterium lactis

14 billion CFU

Bifidobacterium lactis

4 billion CFU

Bifidobacterium longum

.5 billion CFU

Lactobacillus acidophilus

12 billion CFU

Lactobacillus casei

1.25 billion CFU

Lactobacillus delbrueckii ssp bulgaricus

.1 billion CFU

Lactobacillus gasseri

.1 billion CFU

Lactobacillus paracasei

14.8 billion CFU

Lactobacillus plantarum

7 billion CFU

Lactobacillus rhamnosus

2 billion CFU

Lactobacillus rhamnosus

2 billion CFU

Lactobacillus salivarius ssp salivarius

1.25 billion CFU

Streptococcus thermophilus

.5 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 06:00:56 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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