Multi-Flora

Main information

Documents

Localization

  • Available in:
  • Multi-Flora Plus
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 216579
  • Last update:
  • 09-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

216579

Multi-Flora Plus

ARTG entry for

Medicine Listed

Sponsor

Evolution Health Pty Ltd

Postal Address

6 McArthur Street,WEST FOOTSCRAY, VIC, 3012

Australia

ARTG Start Date

25/10/2013

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. Multi-Flora Plus

Product Type

Single Medicine Product

Effective date

25/10/2013

Warnings

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

Standard Indications

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

Specific Indications

Contains 25 billion good bacteria per capsule.

Helps in the maintenance of a healthy digestive function.

Certain factors including stress, medications such as antibiotics, processed foods and alcohol can deplete our beneficial bacteria, and lead to a

disruption in the balance of good and bad intestinal bacteria.

Helpful in supporting mucosal immunity.

Contains a Prebiotic which feeds the beneficial bacteria and helps their survival and growth in the intestine.

Contains a high potency combination of 4 well-researched probiotic strains to provide optimum support for digestive function.

Helps provide support for healthy immune system function.

May help restore healthy digestive function during or following the use of antibiotics.

Is a source of beneficial intestinal micro-flora.

Digestive health support

Additional Product information

Pack Size/Poison information

Pack Size

Poison Schedule

Components

1. Formulation 1

Public Summary

Page 1 of

Produced at 26.11.2017 at 07:22:20 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

Dosage Form

Capsule, hard

Route of Administration

Oral

Visual Identification

Active Ingredients

Bifidobacterium bifidum

.625 billion organisms

Bifidobacterium lactis

11.88 billion organisms

Lactobacillus acidophilus

6.25 billion organisms

Lactobacillus casei

6.25 billion organisms

Oligofructose

100 mg

© 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 26.11.2017 at 07:22:20 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