Swisse

Main information

  • Trade name:
  • Swisse Ultiboost Joint Repair
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • Swisse Ultiboost Joint Repair
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 220771
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

220771

Swisse Ultiboost Joint Repair

ARTG entry for

Medicine Listed

Sponsor

Swisse Wellness Pty Ltd

Postal Address

111 Cambridge Street,Collingwood, VIC, 3066

Australia

ARTG Start Date

6/03/2014

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'.

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. Swisse Ultiboost Joint Repair

Product Type

Single Medicine Product

Effective date

22/08/2017

Warnings

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

Derived from seafood.

The recommended daily dose of this medicine contains [state quantity and units] of sodium (or words to that effect).

Standard Indications

Specific Indications

Chondroitin, naturally occurring in the body, is found in joint cartilage and connective tissues.

Chondroitin absorbs water, adding to the thickness and elasticity of cartilage and its ability to absorb and distribute compressive forces.

Chondroitin assists with cartilage formation/formation of new cartilage.

Chondroitin helps improve/support joint mobility and relieve joint pain associated with osteoarthritis of the knee.

Chondroitin helps to relieve the symptoms of osteoarthritis of the knee.

Chondroitin supports the body's natural cartilage repair process.

Chondroitin supports formation of new cartilage matrix.

Glucosamine helps to maintain/support joint health/healthy cartilage.

Glucosamine helps support joint health /Maintenance of the structure and function of cartilage in joints of the body.

Glucosamine helps to maintain/support joint mobility and flexibilty, helping to maintain healthy joint function.

Glucosamine, which also occurs naturally in the body, plays a key role in the construction of cartilage/one of the 'building blocks' of cartilage (the tough

connective tissue that cushions the joints)/Glucosamine can be found naturally in the body and is used by the body as one of the building blocks of

cartilage.

Glucosamine assists with cartilage formation.

Osteoarthritis is characterised by cartilage loss.

Glucosamine helps to relieve joint pain associated with osteoarthritis of the knee/ helps to provide symptomatic relief of osteoarthritis of the knee.

Glucosamine helps in the management of osteoarthritis and helps relieve osteoarthritis symptoms.

Glucosamine helps to reduce joint swelling and inflammation associated with osteoarthritis.

Glucosamine helps to manage osteoarthritis and relieve osteoarthritis symptoms.

Contains glucosamine sulfate. Clinical trials demonstrate positive results for the symptomatic relief of osteoarthritis when using the sulfate form rather

than some other forms of glucosamine.

Glucosamine helps maintain the elasticity, strength and resilence of cartilage in joints.

Manganese contributes to/is important/essential for the maintenance of normal bones.

Manganese contributes to/is important/essential for the normal formation of connective tissue.

Manganese contributes to the protection of cells from oxidative stress.

Public Summary

Page 1 of

Produced at 26.11.2017 at 02:05:37 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

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

400 mg

glucosamine sulfate sodium chloride

942.92 mg

Manganese sulfate monohydrate

2.15 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 02:05:37 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

22-3-2019

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Published on: Thu, 21 Mar 2019 Following a request from the European Commission, the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on l‐lysine monohydrochloride and l‐lysine sulfate produced using Corynebacterium glutamicum CCTCC M 2015595 when used as nutritional additive in feed and water for drinking for all animal species. The active substance is l‐lysine and it is produced in two different forms (monohydrochloride or sulfate). O...

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FDA - U.S. Food and Drug Administration

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FDA - U.S. Food and Drug Administration

21-11-2018

Fresenius Kabi Issues Voluntary Nationwide Recall of Sodium Chloride Injection, USP, 0.9% Due to Product Labeling Incorrectly Stating Stoppers Do Not Contain Latex

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25-10-2018

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7-9-2018

SCA Pharmaceuticals LLC. Issues Voluntary Nationwide Recall of Furosemide 100 mg in 0.9% Sodium Chloride due to Presence of Precipitate

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FDA - U.S. Food and Drug Administration

2-7-2018

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18-3-2019


Orphan designation: Amikacin sulfate (liposomal), Treatment of Pseudomonas aeruginosa lung infection in cystic fibrosis, 25/07/2006, Positive

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Europe - EMA - European Medicines Agency

18-3-2019


Orphan designation: Amikacin sulfate, Treatment of nontuberculous mycobacterial lung disease, 08/04/2014, Positive

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Elmiron (bene-Arzneimittel GmbH)

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28-1-2019


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28-1-2019


Opinion/decision on a Paediatric investigation plan (PIP): Amikacin (sulfate), decision type: , therapeutic area: , PIP number: P/0346/2018

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18-12-2018


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3-12-2018


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22-11-2018


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