NUFLAM

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

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Active ingredient:
glucosamine sulfate potassium chloride,shark chondroitin sulfate
Available from:
Zifam Pinnacle Pty Ltd
Authorization status:
Listed
Authorization number:
352265

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Public Summary

Summary for ARTG Entry:

352265

NUFLAM

ARTG entry for

Medicine Listed

Sponsor

Zifam Pinnacle Pty Ltd

Postal Address

20-22 Long Street, SMITHFIELD, NSW, 2164

Australia

ARTG Start Date

24/12/2020

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 . NUFLAM

Product Type

Single Medicine Product

Effective Date

24/12/2020

Permitted Indications

Maintain/support general health and wellbeing

Decrease/reduce/relieve mild joint aches and pains

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

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

Maintain/support joint health

Maintain/support joint mobility/flexibility in adults

Indication Requirements

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.

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

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

Product presentation must only refer to mild joint symptoms.

Standard Indications

No Standard Indications included on Record

Specific Indications

No Specific Indications included on Record

Warnings

Contains 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.

Additional Product information

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Public Summary

Page 1 of

Produced at 11.01.2021 at 07:36:46 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

Multiple containers

Not recorded

Not recorded

Not recorded

Not recorded

Not recorded

Pack Size/Poison information

Pack Size

Poison Schedule

Components

1 . Formulation 1

Dosage Form

Capsule, hard

Route of Administration

Oral

Visual Identification

Active Ingredients

glucosamine sulfate potassium chloride

667 mg

Equivalent: potassium chloride

167 mg

Equivalent: glucosamine sulfate

500 mg

shark chondroitin sulfate

278 mg

Equivalent: chondroitin sulfate

250 mg

Other Ingredients (Excipients)

calcium hydrogen phosphate dihydrate

colloidal anhydrous silica

Gelatin

iron oxide yellow

magnesium stearate

microcrystalline cellulose

purified water

quinoline yellow

sodium lauryl sulfate

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 07:36:46 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

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