EFA Krill

Main information

Documents

Localization

  • Available in:
  • EFA Krill
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 221771
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

221771

EFA Krill

ARTG entry for

Medicine Listed

Sponsor

Modere Australia Pty Ltd

Postal Address

Level 1/ 200 East Terrace,ADELAIDE, SA, 5000

Australia

ARTG Start Date

27/03/2014

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.

Preparations that contain the ingredient Euphasia superba oil are subject to the following condition: Must include the label warning (SFOOD) Derived

from seafood OR (SHELL) Contains crustacean shellfish.

Products

1. EFA Krill

Product Type

Single Medicine Product

Effective date

27/07/2017

Warnings

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

Standard Indications

May help reduce joint inflammation associated with arthritis.

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

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

May help increase joint mobility associated with arthritis.

Specific Indications

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

Helps to maintain a healthy heart and cardiovascular system in healthy individuals.

Supports joint health and mobility.

Omega-3 fatty acids are essential fatty acids that must be consumed in the diet.

Supports the body's natural anti-inflammatory and immune responses.

Supports brain and eye health and function.

Can assist in the management of dry skin.

Can assist in the management of dysmenorrhea and the emotional symptoms of premenstrual syndrome.

The EPA and DHA present in natural krill oil has been shown to be more bioavailable than standard fish oil.

ORAC antioxidant content of krill oil is 245micromol/g.

Chia ORAC value is 8,100 Vitamin E equivalents.

Cranberry seed oil contains omega 3, 6 and 9.

Additional Product information

Pack Size/Poison information

Pack Size

Poison Schedule

Public Summary

Page 1 of

Produced at 26.11.2017 at 12:35:24 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

Components

1. Formulation 1

Dosage Form

Capsule, soft

Route of Administration

Oral

Visual Identification

Active Ingredients

alpha lipoic acid

20 mg

euphausia superba oil

335 mg

Evening Primrose Oil

20 mg

Linum usitatissimum

20 mg

Salvia hispanica

100 mg

Vaccinium macrocarpon

65 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 12:35:24 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