Swisse

Main information

  • Trade name:
  • Swisse Ultiboost Glucosamine +
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • Swisse Ultiboost Glucosamine +
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 218458
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

218458

Swisse Ultiboost Glucosamine +

ARTG entry for

Medicine Listed

Sponsor

Swisse Wellness Pty Ltd

Postal Address

111 Cambridge Street,Collingwood, VIC, 3066

Australia

ARTG Start Date

12/12/2013

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'.

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 Glucosamine +

Product Type

Single Medicine Product

Effective date

12/12/2013

Warnings

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

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

Derived from seafood.

Standard Indications

Specific Indications

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

Glucosamine sulfate helps to protect against the deterioration of cartilage/Helps support/assist joint health. Glucosamine sulfate is a factor in maintaining

good cartilage and joint health/Glucosamine supports healthy joints. Glucosamine, which also occurs naturally in the body, plays a key role in the

construction 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. Osteoarthritis is characterised by cartilage loss. Glucosamine sulfate helps to maintain/assist joint mobility and

flexibilty, helping to maintain/support healthy joint function. 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 sulfate helps to reduce joint swelling and

inflammation associated with osteoarthritis.

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

Public Summary

Page 1 of

Produced at 26.11.2017 at 04:46:22 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 sodium chloride

1.8858 g

Zingiber officinale

25 mg

Equivalent: Zingiber officinale (Fresh)

500 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 04:46:22 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

7-9-2018

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

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

, SCA Pharmaceuticals LLC (“SCA Pharma”) is voluntarily recalling 7 lots of the injectable product Furosemide 100 mg in 0.9% Sodium Chloride 100 mg bag to the consumer level. This product is being recalled for visible particulate matter believed to be furosemide precipitate.

FDA - U.S. Food and Drug Administration

There are no news related to this product.