Swisse

Main information

  • Trade name:
  • Swisse Ultiboost Absorb Well Co-Enzyme Q10
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • Swisse Ultiboost Absorb Well Co-Enzyme Q10
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 218376
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

218376

Swisse Ultiboost Absorb Well Co-Enzyme Q10

ARTG entry for

Medicine Listed

Sponsor

Swisse Wellness Pty Ltd

Postal Address

111 Cambridge Street,Collingwood, VIC, 3066

Australia

ARTG Start Date

11/12/2013

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. Swisse Ultiboost Absorb Well Co-Enzyme Q10

Product Type

Single Medicine Product

Effective date

11/12/2013

Warnings

Do not take while on warfarin therapy without medical advice.

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

Standard Indications

Specific Indications

Ubiquinol shows an increased level of absorption when compared to ubiquinone/Ubiquinol shows an increased level of bioavailability when compared to

ubiquinone/Ubiquinol shows an increased level of bioavailability, that is, plasma/blood co-enzyme Q10 levels are increased more so with ubiquinol, than

when compared to ubiquinone.

Ubiquinol is a bioavailable form of Co-enzyme Q10 for increased absorption.

Ubiquinol is known as the reduced or 'active' form of Co-enzyme Q10.

Supplementation with CoQ10 may support quality of life in elderly people. CoQ10 levels may be lower in elderly people. / There may be an increased

need for supplemental co-enzyme Q10 in the elderly due to levels decreasing with age.

Co-enzyme Q10 supports a healthy cardiovascular system/supports cardiovascular health/is important for heart health. Helps maintain cardiovascular

health.

CoQ10 acts as an antioxidant for the maintenance of good health/helps support healthy antioxidant activity/antioxidant to help protect cells from free

radical damage.

Co-enzyme Q10 acts as an antioxidant and helps to regenerate the antioxidant vitamin E . / Ubiquinol acts as an antioxidant, helping to regenerate the

antioxidant vitamin E. Provides antioxidant support. Has antioxidant properties.

Supports the maintenance of healthy ubiquinol levels.

Oxidative stress in the body increases the need for antioxidant support.

Co-enzyme Q10 is a vitamin-like compound occurring naturally in most cells of the body. It plays a vital role in the body's cellular energy production

processes.

The mitochondria, found within cells, contain high levels of co-enzyme Q10. Mitochondria provide the energy needed for basic cell function and are

considered to be the 'power centre' of the cell. Co-enzyme Q10 is found in cells which have high energy requirements such as the heart, brain, muscle

and liver cells.

Co-enzyme Q10 is a cofactor in the production of cellular energy/CoQ10 is well-known as a co-factor in several enzyme related systems related to

energy conversion in cells.

Co-enzyme Q10 plays a vital role in the body's cellular energy production processes.

Supports cellular energy production.

The antioxidant activity of CoQ10 helps to inhibit the oxidation of LDL cholesterol.

Co-enzyme Q10 helps maintain healthy/normal cholesterol levels in healthy people.

Public Summary

Page 1 of

Produced at 26.11.2017 at 04:57:47 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

Additional Product information

Pack Size/Poison information

Pack Size

Poison Schedule

Components

1. Formulation 1

Dosage Form

Capsule, soft

Route of Administration

Oral

Visual Identification

Active Ingredients

ubiquinol-10

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 04:57:47 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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