Histammune Clear

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

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Active ingredient:
ascorbic acid,bromelains,hesperidin,protease,pyridoxal 5-phosphate monohydrate,quercetin dihydrate,rutoside
Available from:
FIT-BioCeuticals Limited
INN (International Name):
Ascorbic acid,Bromelains,Hesperidin,pyridoxal 5-phosphate monohydrate,Protease,quercetin dihydrate,rutoside
Authorization status:
Listed
Authorization number:
290199

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Public Summary

Summary for ARTG Entry:

290199

Histammune Clear

ARTG entry for

Medicine Listed

Sponsor

FIT-BioCeuticals Limited

Postal Address

PO Box 6454,ALEXANDRIA, NSW, 2015

Australia

ARTG Start Date

15/06/2017

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. Histammune Clear

Product Type

Single Medicine Product

Effective date

15/06/2017

Warnings

Vitamins can only be of assistance if the dietary vitamin intake is inadequate. OR Vitamin supplements should not replace a balanced diet.

Standard Indications

Specific Indications

1. Vitamin C and citrus bioflavonoids including quercetin, hesperiden and rutin are antioxidants which may help to reduce the risk of cell damage

attributed to free radicals.

2. Vitamin C may provide nutritional support for a normal healthy immune system.

3. Vitamin C may provide nutritional support to help the body heal minor wounds (cuts, scratches, abrasions).

4. Vitamin C may support connective tissue formation.

5. Vitamin C may support the development and maintenance of healthy cartilage and bones.

6. Histammune Clear contains Vitamin C and B6/ P5P which may help to play a role in histamine metabolism.

7. Rutin and quercetin may help to protect healthy capillaries and blood vessels.

8. Bromelain may help to support anti-inflammatory pathways.

9. Bromelain and Protease assist in the digestion of protein.

Additional Product information

Pack Size/Poison information

Pack Size

Poison Schedule

Components

1. Formulation 1

Dosage Form

Tablet, film coated

Route of Administration

Oral

Visual Identification

Public Summary

Page 1 of

Produced at 24.11.2017 at 08:56:03 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

Active Ingredients

Ascorbic acid

166.66 mg

Bromelains

3.6 million PU

Hesperidin

100 mg

Protease

200 Thousand HUT

pyridoxal 5-phosphate monohydrate

7.84 mg

quercetin dihydrate

500 mg

rutoside

133.33 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 24.11.2017 at 08:56:03 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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