Glucosamine

Main information

Documents

Localization

  • Available in:
  • Glucosamine 1500 PLUS
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 219262
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

219262

Glucosamine 1500 PLUS

ARTG entry for

Medicine Listed

Sponsor

Bio Nourish Pty Ltd

Postal Address

PO Box 216,TERRIGAL, NSW, 2260

Australia

ARTG Start Date

15/01/2014

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'.

Sponsors with a product containing Potassium chloride must comply with the following condition of listing. All products must carry the label statement -

Contains [amount of potassium in milligrams] mg of potassium. If you have kidney disease or are taking heart or blood pressure medicines, consult your

doctor or pharmacist before use. Keep out of reach of children.

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. Glucosamine 1500 PLUS

Product Type

Single Medicine Product

Effective date

12/08/2015

Warnings

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

Contains [amount of potassium in milligrams] mg of potassium. If you have kidney disease or are taking heart or blood pressure medicines, consult your

doctor or pharmacist before use. Keep out of reach of children.

Derived from seafood.

Standard Indications

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

Helps maintain healthy digestive function.

Aids digestion.

Temporary relief of the pain of osteoarthritis (or) Temporary relief of osteoarthritic pain. [Warning S required]

May help increase joint mobility associated with arthritis.

May help reduce joint swelling associated with arthritis.

May help reduce joint inflammation associated with arthritis.

Symptomatic relief of osteoarthritis. [Warning S required]

Treatment of mild digestive disorders. [Warning S required]

May assist in the management of osteoarthritis. [Warning S required]

May assist in the management of osteoarthritic pain. [Warning S required]

Temporary relief of the pain of arthritis. (or) Temporary relief of arthritic pain. [Warning S required]

Specific Indications

* Glucosamine is produced naturally in the body and is an important/vital component of cartilage.

* Glucosamine assists in building and maintaining healthy cartilage, which is essential for healthy function of the joints.

Public Summary

Page 1 of

Produced at 26.11.2017 at 03:48:41 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

* Glucosamine helps to build and maintain the cartilage tendons, ligaments and synovial fluid in the joints.

* Glucosamine is necessary in the body for the structure and function of the articular cartilage.

* Helps maintain healthy joint function and provides structural support to the joints.

* Glucosamine is a naturally occurring compound that help maintain healthy cartilage.

* Assists in maintaining joint flexibility and function.

* Helps to maintain healthy joint cartilage.

* Helps to maintaining the health of the joints.

* Supports/maintains healthy joints.

* Glucosamine is produced naturally in the body and plays a necessary role in maintaining the health of the joints.

* Glucosamine is a building block of cartilage.

* Glucosamine is important for maintaining the elasticity, strength and resilience of cartilage in joints.

* Glucosamine is produced naturally in the body where it assists in maintaining the elasticity and the integrity of the connective tissue.

* May assist in the relief of symptoms of nausea and vomiting.

* Supports healthy digestive function.

* Contains ginger, which is a carminative herb and may aid healthy digestion.

* May assist in the relief of symptoms of motion sickness.

* May assist in the relief of gastrointestinal discomfort and/or nausea.

* Contains ginger, which decreases the tendency for nausea and vomiting associated with motion sickness.

* Ginger is traditionally used in herbal medicine to reduce inflammation associated with rheumatic conditions.

* Piperine aids the absorption of curcumin.

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

Active Ingredients

bovine sodium chondroitin sulfate

100 mg

Curcumin

129 mg

Dimethyl sulfone

200 mg

glucosamine sulfate potassium chloride

1.5 g

Piper nigrum

25 mg

Zingiber officinale

60 mg

Equivalent: Zingiber officinale (Dry)

1.2 g

© 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 03:48:41 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