Centrum MOVEMENT & MOBILITY

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

Buy It Now

Active ingredient:
bovine sodium chondroitin sulfate,copper gluconate,glucosamine sulfate sodium chloride,manganese gluconate
Available from:
GlaxoSmithKline Consumer Healthcare Australia Pty Ltd
Authorization status:
Listed
Authorization number:
347414

Read the complete document

Public Summary

Summary for ARTG Entry:

347414

Centrum MOVEMENT & MOBILITY

ARTG entry for

Medicine Listed

Sponsor

GlaxoSmithKline Consumer Healthcare Australia Pty Ltd

Postal Address

Locked Bag 3, Ermington, NSW, 2115

Australia

ARTG Start Date

5/11/2020

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.

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 . Centrum MOVEMENT & MOBILITY

Product Type

Single Medicine Product

Effective Date

5/11/2020

Permitted Indications

Maintain/support collagen formation

Maintain/support bone health

Decrease/reduce/relieve mild joint aches and pains

Decrease/reduce/relieve symptoms of mild arthritis/mild osteoarthritis

Helps maintain/supports healthy joint cartilage growth/development/production

Maintain/support joint health

Maintain/support joint mobility/flexibility

Decrease/reduce/relieve mild joint pain/soreness

Indication Requirements

Product presentation must not imply or refer to bone disease or disorders e.g. rheumatoid arthritis, juvenile arthritis, debilitating osteoarthritis, osteoporosis.

Label statement: If symptoms persist, talk to your health professional.

Product presentation must not imply or refer to bone disease or disorders e.g. rheumatoid arthritis, juvenile arthritis, debilitating osteoarthritis, osteoporosis.

Note: this requirement is not intended to apply where the indications referring to osteoporosis specified in column 2 of Table 2 of this instrument are also

used.

Product presentation must only refer to mild joint symptoms.

Product presentation must not imply or refer to any form of arthritis or osteoarthritis unless qualified as mild.

Standard Indications

No Standard Indications included on Record

Specific Indications

No Specific Indications included on Record

Warnings

Derived from seafood.

Additional Product information

Public Summary

Page 1 of

Produced at 11.01.2021 at 11:27:01 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

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

553.39 mg

Equivalent: chondroitin sulfate

400 mg

copper gluconate

1.79 mg

Equivalent: copper

.25 mg

glucosamine sulfate sodium chloride

942.02 mg

Equivalent: glucosamine sulfate

750 mg

manganese gluconate

7.09 mg

Equivalent: manganese

.875 mg

Other Ingredients (Excipients)

Carnauba Wax

crospovidone

iron oxide black

iron oxide yellow

lecithin

macrogol 3350

magnesium stearate

microcrystalline cellulose

polyvinyl alcohol

povidone

purified talc

titanium dioxide

© 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 11.01.2021 at 11:27:01 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

Similar products

Search alerts related to this product

Share this information