Flexicare

Main information

Documents

Localization

  • Available in:
  • Flexicare Glucosamine and Chondroitin
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 217496
  • Last update:
  • 09-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

217496

Flexicare Glucosamine and Chondroitin

ARTG entry for

Medicine Listed

Sponsor

Australian Naturalcare Products Pty Ltd

Postal Address

PO Box 946,NORTH RYDE BC, NSW, 1670

Australia

ARTG Start Date

19/11/2013

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'.

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. Flexicare Glucosamine and Chondroitin

Product Type

Single Medicine Product

Effective date

2/09/2015

Warnings

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.

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

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

Standard Indications

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

Temporary relief of the pain of rheumatism. [or] Temporary relief of rheumatic pain. [Warning S required]

Symptomatic relief of osteoarthritis. [Warning S required]

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

May help increase joint mobility associated with arthritis.

Symptomatic relief or rheumatism. [Warning S required]

May help reduce joint swelling associated with arthritis.

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

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

May help reduce joint inflammation associated with arthritis.

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

Specific Indications

Glucosamine & chondroitin may help increase joint flexibility and mobility, plus provide temporary pain relief and help reduce the inflammation associated

with osteoarthritis.

Public Summary

Page 1 of

Produced at 26.11.2017 at 06:18:33 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 sulfate has been demonstrated in clinical trials to reduce the pain, tenderness, and swelling, and improve the mobility of knee osteoarthritis.

Flexicare contains glucosamine and chondroitin sulfate, two nutrients that are utilised by the body to maintain and rebuild healthy cartilage.

Glucosamine and chondroitin sulfate are both used by the body to support cartilage health.

Glucosamine and chondroitin sulfate are both used by the body to support the maintenance of the joint's natural shock-absorbing capacity.

Glucosamine sulfate and chondroitin sulfate both occur naturally in the body and are fundamental components of connective tissues such as cartilage.

They are both involved in the natural repair and formation/synthesis of healthy cartilage.

There is good evidence in the scientific literature to support the efficacy of both GS and CS for the symptomatic relief of osteoarthritis.

Glucosamine may help support joint health in athletes.

Glucosamine stimulates the production/synthesis proteoglycans, which in combination with water form the "cushioning" viscous property of synovial fluid

in the joint capsule.

Regular supplementation with glucosamine sulfate may have a significant effect on diminishing joint space narrowing which consequently helps reduce

the pain from changes to the joints associated with the natural "wear and tear" of osteoarthritis.

The pain relieving effects of glucosamine and chondroitin may take from 1 to 2 months to become apparent.

Manganese may help support healthy cartilage via its role in the synthesis of glycoproteins, which are building blocks needed for cartilage formation.

Vitamin C helps support connective tissue health/healthy connective tissue.

Adequate vitamin C is needed for the formation of healthy collagen, the major fibrous element of cartilage.

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

Ascorbic acid

50 mg

bovine chondroitin sulfate

400 mg

glucosamine sulfate potassium chloride

1000 mg

Manganese amino acid chelate

20 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 06:18:33 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

25-10-2018

Safety of zinc chelate of methionine sulfate for the target species

Safety of zinc chelate of methionine sulfate for the target species

Published on: Wed, 24 Oct 2018 00:00:00 +0200 Zinc chelate of methionine sulfate is intended to be used as a nutritional additive (functional group: compounds of trace elements). The additive is zinc chelated with methionine in a molar ratio 1:1. It is intended to supply zinc as a nutritional additive to all animal species/categories. In 2017, the EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) adopted an opinion on the safety and efficacy of zinc chelate of methionine su...

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EU/3/16/1714 (IQVIA RDS Ireland Limited)

EU/3/16/1714 (IQVIA RDS Ireland Limited)

EU/3/16/1714 (Active substance: 6'-(R)-methyl-5-O-(5-amino-5,6-dideoxy-a-L-talofuranosyl)-paromamine sulfate) - Transfer of orphan designation - Commission Decision (2018)1823 of Wed, 21 Mar 2018 European Medicines Agency (EMA) procedure number: EMA/OD/119/16/T/01

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