Allergy Relief & Immune Support

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

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Active ingredient:
Bifidobacterium longum,fructooligosaccharides,Lactobacillus acidophilus,Lactobacillus fermentum,Lactobacillus paracasei,Lactobacillus plantarum,Lactobacillus rhamnosus
Available from:
Biomonia Pty Ltd
Authorization status:
Listed
Authorization number:
345761

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Public Summary

Summary for ARTG Entry:

345761

Allergy Relief & Immune Support

ARTG entry for

Medicine Listed

Sponsor

Biomonia Pty Ltd

Postal Address

17 Mount Street, Glen Waverley, VIC, 3150

Australia

ARTG Start Date

12/10/2020

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.

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 . Allergy Relief & Immune Support

Product Type

Single Medicine Product

Effective Date

12/10/2020

Permitted Indications

Aids/assists with recovery from illness/convalescence

Helps enhance/improve/promote/increase healthy digestive system flora/good bacteria growth

Maintain/support gastrointestinal system health

Decrease/reduce/relieve post nasal drip

Decrease/reduce/relieve symptoms of hayfever

Helps decrease/reduce/relieve symptoms of mild allergies

Linked indication - Decrease/reduce/relieve watery eyes/excessive lacrimation

Linked indication - Relieve eye soreness

Linked indication - Relieve itchy eyes

Linked indication - Relieve eye discomfort

Decrease/reduce/relieve symptoms of allergic rhinitis

Helps decrease/reduce/relieve symptoms of seasonal allergies

Maintain/support immune system health

Maintain/support healthy immune system function

Maintain/support immune system to fight illness

Decrease/reduce/relieve sneezing

Helps decrease/reduce/relieve nasal itching

Relieve runny/dripping nose

Indication Requirements

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

Product presentation must not imply or refer to serious allergic conditions such as anaphylaxis.

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

Product presentation must not imply or refer to chronic fatigue syndrome.

Standard Indications

No Standard Indications included on Record

Specific Indications

Public Summary

Page 1 of

Produced at 12.01.2021 at 01:10:52 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

No Specific Indications included on Record

Warnings

No Warnings included on Record

Additional Product information

Pack Size/Poison information

Pack Size

Poison Schedule

Components

1 . Formulation 1

Dosage Form

Powder, oral

Route of Administration

Oral

Visual Identification

Active Ingredients

Bifidobacterium longum

.83 billion CFU/g

fructooligosaccharides

95 mg/g

Lactobacillus acidophilus

.83 billion CFU/g

Lactobacillus fermentum

3.3 billion CFU/g

Lactobacillus paracasei

3.3 billion CFU/g

Lactobacillus plantarum

.83 billion CFU/g

Lactobacillus rhamnosus

.83 billion CFU/g

Other Ingredients (Excipients)

Flavour

maltodextrin

Stevia rebaudiana

© 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 12.01.2021 at 01:10:52 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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