UltraBiotic 45

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

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Active ingredient:
Bifidobacterium animalis ssp lactis,Bifidobacterium bifidum,Bifidobacterium breve,Lactobacillus acidophilus,Lactobacillus casei,Lactobacillus fermentum,Lactobacillus plantarum,Lactobacillus rhamnosus,Streptococcus thermophilus
Available from:
FIT-BioCeuticals Limited
Authorization status:
Authorization number:

Public Summary

Summary for ARTG Entry:


UltraBiotic 45

ARTG entry for

Medicine Listed


FIT-BioCeuticals Limited

Postal Address

PO Box 6454,ALEXANDRIA, NSW, 2015


ARTG Start Date


Product category




Approval area

Listed Medicines


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


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.


1. UltraBiotic 45

Product Type

Single Medicine Product

Effective date


Permitted Indications

Relief of symptoms of medically diagnosed Irritable Bowel Syndrome

Linked indication - Helps reduce occurrence of constipation

Linked indication - Helps reduce occurrence of diarrhoea

Linked indication - Decrease/reduce/relieve abdominal pain/discomfort

Linked indication - Maintain/support general health and wellbeing

Maintain/support healthy digestive system function

Aid/assist digestion of lactose

Maintain/support digestive system health

Maintain/support intestinal good/beneficial/friendly flora

Maintain/support good/beneficial/friendly gut flora during antibiotic use

Help restore good/beneficial/friendly gut flora after antibiotic use

Decrease/reduce/relieve abdominal bloating/distention

Maintain/support immune system health

Maintain/support healthy immune system function

Indication Requirements

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

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

Product presentation must only refer to medically diagnosed IBS.

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

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

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

Public Summary

Page 1 of

Produced at 29.08.2019 at 05:53:17 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

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

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

Product presentation must not refer to or imply weight loss.

Label statement: Seek medical advice if diarrhoea persists for more than: 6 hours in infants under 6 months, 12 hours in children under 3 years, 24 hours

in children aged 3 to 6 years or 48 hours in a

Standard Indications

No Standard Indications included on Record

Specific Indications


No Warnings included on Record

Additional Product information

Pack Size/Poison information

Pack Size

Poison Schedule


1. Formulation 1

Dosage Form

Capsule, hard

Route of Administration


Visual Identification

Active Ingredients

Bifidobacterium animalis ssp lactis

4.275 billion CFU

Bifidobacterium bifidum

225 million CFU

Bifidobacterium breve

1.35 billion CFU

Lactobacillus acidophilus

7.4 billion CFU

Lactobacillus casei

9.45 billion CFU

Lactobacillus fermentum

1.35 billion CFU

Lactobacillus plantarum

3.15 billion CFU

Lactobacillus rhamnosus

15.55 billion CFU

Streptococcus thermophilus

2.25 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 29.08.2019 at 05:53:17 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

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