NUTRIVITAL

Main information

  • Trade name:
  • NUTRIVITAL GREEN LIPPED MUSSEL 850MG
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • NUTRIVITAL GREEN LIPPED MUSSEL 850MG
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 212323
  • Last update:
  • 09-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

212323

NUTRIVITAL GREEN LIPPED MUSSEL 850MG

ARTG entry for

Medicine Listed

Sponsor

Nutrivital Pty Ltd

Postal Address

1056 Canley Vale Road,Wetherill Park,SYDNEY, NSW, 2164

Australia

ARTG Start Date

17/07/2013

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. NUTRIVITAL GREEN LIPPED MUSSEL 850MG

Product Type

Single Medicine Product

Effective date

17/07/2013

Warnings

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

Standard Indications

May assist in the management of rheumatism. [Warning S required]

Aids, assists or helps in the maintenance or improvement of general well-being.

May assist in the management of osteoarthritis. [Warning S required]

Symptomatic relief of osteoarthritis. [Warning S required]

Symptomatic relief or rheumatism. [Warning S required]

Specific Indications

* Supports connective tissue and cartilage function

* Helps to maintain healthy joints

* May assist in decreasing joint inflammation associated with osteoarthritis/rheumatoid arthritis

* Helps to relieve joint swelling associated with osteoarthritis/rheumatoid arthritis

* Studies have demonstrated that cold-extracted Green Lipped Mussel (GLM) powder has anti-inflammatory activity associated with the Omega-3

Essential Fatty Acids contained within its lipid fraction.

* Exhibits anti-inflammatory activity with osteo- and rheumatoid arthritis related inflammation.

* May assist in decreasing joint pain associated with osteoarthritis/rheumatoid arthritis.

* May assist in relief from osteo- and rheumatoid arthritis pain.

* Natural ingredient that may assist in the relief of pain associated with osteo- and rheumatoid arthritis.

* Clinically trialled to decrease joint pain associated with osteo- and rheumatoid arthritis.

* May help to increase joint mobility for osteoarthritic/rheumatoid arthritic joints

* May help to reduce stiffness of the joints associated with osteoarthritis/rheumatoid arthritis.

* May naturally assist in relieving the pain & reduced mobility caused by osteo- and rheumatoid arthritis.

* Prepared without heat using a special cold extraction process that preserves the anti-inflammatory and pain relieving components of New Zealand

Green Lipped Mussels.

* Ingredient from the sea

* 100% New Zealand Green Lipped Mussels

* Contains all 9 essential amino acids, naturally present

* Contains naturally present glycosaminoglycan (GAG)

Public Summary

Page 1 of

Produced at 27.11.2017 at 12:22:01 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

* Contains naturally present omega-3 fatty acids

* High in naturally present Vitamin B12, which is involved in the metabolism of lipids, protein and carbohydrate.

Additional Product information

Pack Size/Poison information

Pack Size

Poison Schedule

Components

1. Formulation 1

Dosage Form

Capsule, hard

Route of Administration

Oral

Visual Identification

Active Ingredients

Green lipped mussel dried

850 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 27.11.2017 at 12:22:01 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

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