Yomogi capsules

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

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Active ingredient:
Saccharomyces cerevisiae (Boulardii)
Available from:
Prinz Herget Pty Ltd T/A Natural Therapy Imports
Authorization status:
Listed
Authorization number:
321332

Public Summary

Summary for ARTG Entry:

321332

Yomogi capsules

ARTG entry for

Medicine Listed

Sponsor

Prinz Herget Pty Ltd T/A Natural Therapy Imports

Postal Address

PO Box 7302,WEST LAKES, SA, 5021

Australia

ARTG Start Date

6/08/2019

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. Yomogi capsules

Product Type

Single Medicine Product

Effective date

6/08/2019

Permitted Indications

Decrease/reduce/relieve diarrhoea in healthy children under 2 years of age

Decrease/reduce/relieve diarrhoea in children over 2 years of age

Decrease/reduce/relieve diarrhoea

Helps reduce occurrence of diarrhoea

Helps reduce occurrence of diarrhoea in children over 2 years of age

Helps decrease/reduce/relieve symptoms of traveller's diarrhoea

Linked indication - Maintain/support healthy gastrointestinal immune function

Helps decrease/reduce/relieve symptoms of traveller's diarrhoea in children over 2 years of age

Helps reduce occurrence of symptoms of traveller's diarrhoea

Helps reduce occurrence of symptoms of traveller's diarrhoea in children over 2 years of age

Maintain/support good/beneficial/friendly gut flora during antibiotic use in children over 2 years of age

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

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

Help restore good/beneficial/friendly gut flora after antibiotic use in children over 2 years of age

Maintain/support healthy immune system function

Maintain/support healthy gastrointestinal immune function

Indication Requirements

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

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

Public Summary

Page 1 of

Produced at 29.08.2019 at 05:29:58 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

Standard Indications

No Standard Indications included on Record

Specific Indications

Warnings

Contains lactose (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).

(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).

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

Saccharomyces cerevisiae (Boulardii)

250 million 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 05:29:58 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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