NZ Mussel

Main information

  • Trade name:
  • NZ Mussel Oil
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • NZ Mussel Oil
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 213402
  • Last update:
  • 09-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

213402

NZ Mussel Oil

ARTG entry for

Medicine Listed

Sponsor

Evolution Health Pty Ltd

Postal Address

6 McArthur Street,WEST FOOTSCRAY, VIC, 3012

Australia

ARTG Start Date

20/08/2013

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. NZ Mussel Oil

Product Type

Single Medicine Product

Effective date

20/08/2013

Warnings

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

Standard Indications

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

Specific Indications

May help reduce joint inflammation and pain associated with arthritis.

The biochemistry of Green Lipped Mussel includes a complex lipid profile of long chain fatty acids including DHA and EPA.

Contains omega 3 phospholipids, glucosamine and chondroitin.

Green Lipped Mussel is non-gastro toxic and does not affect platelet aggregation

Green Lipped Mussel Oil may disrupt the pro-inflammatory COX-2 pathway to reduce inflammation.

The mollusc Perna canaliculus is endemic to New Zealand where it is known as the "green lipped mussel".

Contains naturally present glycosaminoglycans which promote the growth of cartilage, collagen and elastin

Processed at low temperature to preserve the anti-inflammatory components of New Zealand Green Lipped Mussels.

Helps to maintain healthy knee joints.

Contains natural glucosamine ad chondroitin which may repair and rebuild cartilage.

May improve knee joint pain, stiffness and mobility.

For symptomatic relief of osteoarthritis of the knee joint.

Dual action formula.

Supports optimal health and wellbeing.

Additional Product information

Pack Size/Poison information

Public Summary

Page 1 of

Produced at 26.11.2017 at 11:08:27 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 Schedule

Components

1. Formulation 1

Dosage Form

Capsule, soft

Route of Administration

Oral

Visual Identification

Active Ingredients

Green lipped mussel dried

200 mg

Green lipped mussel oil

50 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 11:08:27 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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