MICROGENICS

Main information

Documents

Localization

  • Available in:
  • MICROGENICS PROBIOTIC 8
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 82536
  • Last update:
  • 01-12-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

82536

MICROGENICS PROBIOTIC 8

ARTG entry for

Medicine Listed

Sponsor

Optimum Healthcare Pty Ltd T/A Sanofi Consumer Healthcare

Postal Address

PO Box 403,VIRGINIA, QLD, 4014

Australia

ARTG Start Date

24/04/2002

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. MICROGENICS PROBIOTIC 8

Product Type

Single Medicine Product

Effective date

19/08/2016

Warnings

(If medicine contains one sugar) contains [insert name of sugar] OR (If medicine contains two or more sugars) Contains sugars [or words to that effect].

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

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).

Standard Indications

Specific Indications

Helps maintain healthy intestinal flora. Probiotics are useful for anyone suffering from the symptoms of bloating, gas or flatulence. May decrease the

duration of diarrhoea in children. May help restore healthy bacteria after a course of antibiotic has altered the normal gastrointestinal flora. Helps

maintain healthy urogenital flora. Probiotics help improve nutritional and microbial balance in the intestinal tract. Probiotics favour the growth of healthy

intestinal flora. May assist in relieving the symptoms of diarrhoea in children.

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 bifidum

333 thousand organisms

Lactobacillus acidophilus

3 billion organisms

Public Summary

Page 1 of

Produced at 01.12.2017 at 10:36:44 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

Lactobacillus brevis

333 thousand organisms

Lactobacillus casei

333 million organisms

Lactobacillus delbrueckii ssp bulgaricus

333 thousand organisms

Lactobacillus kefiri

333 thousand organisms

Lactobacillus plantarum

1.66 billion organisms

Lactobacillus rhamnosus

333 thousand organisms

© 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 01.12.2017 at 10:36:44 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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