Prodophilus

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

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Active ingredient:
Bifidobacterium animalis ssp lactis,Bifidobacterium bifidum,Lactobacillus acidophilus,Lactobacillus casei,Lactobacillus rhamnosus
Available from:
FIT-BioCeuticals Limited
INN (International Name):
Bifidobacterium animalis ssp lactis,Bifidobacterium bifidum,Lactobacillus acidophilus,Lactobacillus casei,Lactobacillus rhamnosu
Authorization status:
Listed
Authorization number:
290662

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Public Summary

Summary for ARTG Entry:

290662

Prodophilus

ARTG entry for

Medicine Listed

Sponsor

FIT-BioCeuticals Limited

Postal Address

PO Box 6454,ALEXANDRIA, NSW, 2015

Australia

ARTG Start Date

26/06/2017

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. Prodophilus

Product Type

Single Medicine Product

Effective date

15/09/2017

Warnings

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 3-6 years or 48 hours

in adults and children over 6 years, seek medical advice (or words to that effect).

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

Standard Indications

Helps maintain healthy digestive function.

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

Aids digestion.

Specific Indications

[1]Lactobacillus acidophilus may aid in the relief of diarrhoea.

[2] May provide support for normal, healthy digestive function / Lactobacillus acidophilus may provide nutritional support for normal healthy digestive

function / Bifidobacterium longum inhabits the human intestinal mucosa, contributing to the maintenance of healthy digestive function.

[3] May provide nutritional support for normal healthy intestinal flora.

[4] May provide nutritional support for a normal healthy immune system.

[5] Lactobacillus rhamnosus has been found in the mucosal membrane of the female urogenital tract following oral use /Lactobacillus rhamnosus exists

in the female urogenital tract.

Additional Product information

Pack Size/Poison information

Pack Size

Poison Schedule

Components

1. Formulation 1

Dosage Form

Capsule, hard

Route of Administration

Oral

Public Summary

Page 1 of

Produced at 24.11.2017 at 08:37:01 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

Visual Identification

Active Ingredients

Bifidobacterium animalis ssp lactis

975 million CFU

Bifidobacterium bifidum

25 million CFU

Lactobacillus acidophilus

2 billion CFU

Lactobacillus casei

1 billion CFU

Lactobacillus rhamnosus

6 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 08:37:01 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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