MediHerb

Main information

  • Trade name:
  • MediHerb Ubiquinol Forte
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • MediHerb Ubiquinol Forte
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 220957
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

220957

MediHerb Ubiquinol Forte

ARTG entry for

Medicine Listed

Sponsor

Integria Healthcare Australia Pty Ltd

Postal Address

PO Box 4854,EIGHT MILE PLAINS, QLD, 4113

Australia

ARTG Start Date

11/03/2014

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.

Products

1. MediHerb Ubiquinol Forte

Product Type

Single Medicine Product

Effective date

19/06/2014

Warnings

For practitioner dispensing only.

Do not take while on warfarin therapy without medical advice.

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

Standard Indications

May help reduce the oxidation of LDL cholesterol.

Specific Indications

Supports the maintenance of healthy ubiquinol levels

Supports (maintains) healthy Ubiquinol levels in the body

Helps raise Ubiquinol levels in the body

Ubiquinol may be of particular benefit to people experiencing increased oxidative stress as occurs with normal healthy ageing

Middle- and older-age individuals/ people experience more oxidative stress and hence benefit from Ubiquinol supplementation

Ubiquinol helps to counteract the increased oxidative stress that we experience / occurs with ageing / as we age

Ubiquinol supports ATP (energy) production in the mitochondria

Ubiquinol supports cellular energy production

Ubiquinol support energy production in the cell

Ubiquinol plays a key role in cellular energy production

Ubiquinol supports healthy antioxidant activity and helps regenerate other lipid-soluble antioxidants such as vitamin E and vitamin C

Ubiquinol is an important / powerful (fat-soluble) antioxidant

Ubiquinol helps to scavenge free radicals in the body

Ubiquinol helps to reduce free-radical damage in the body

Ubiquinol supports the body's antioxidant defences

Ubiquinol complements the antioxidant activity of Vitamin E

Ubiquinol helps to recycle and to regenerate Vitamin E and C

Helps to protect the oxidation of our 'bad' cholesterol

Increases total and reduced blood CoQ10

Ubiquinol serves as a potent and effective antioxidant in mitochondria, lipid membranes and plasma lipoproteins

Ubiquinol protects the body's cells from free radical damage

Ubiquinol is a powerful antioxidant of our body's cells

Ubiquinol protects the powerhouse of the cell and its membrane from oxidative (free-radical) damage

Public Summary

Page 1 of

Produced at 18.10.2017 at 09:11:06 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

CoQ10 helps to support the cardiovascular system / Helps maintain cardiovascular health

Coenzyme Q10 supports the cardiovascular system

CoQ10 is a potent antioxidant and free radical scavenger

Coenzyme Q10 may assist in the relief of symptoms / the sensation of fatigue

Coenzyme Q10 may help relieve the symptoms of fatigue

Coenzyme Q10 may help relieve the sensation of fatigue

Coenzyme Q10 may help support heart health

Coenzyme Q10 may help to support cellular / mitochondrial energy production

Coenzyme Q10 supports cellular energy production

Coenzyme Q10 support energy production in the cell

Coenzyme Q10 plays a key role in cellular energy production

MARKETING CLAIMS

Ubiquinol has superior absorption / has a statistically higher absorption rate / higher bioavailability / is more bioavailable than ubiquinone

Supplementation with Ubiquinol increases absorption and therefore the body's levels significantly / several-fold depending on dose and time

The absorption rate of Ubiquinol is several times that of normal Coenzyme Q10 depending on dose and time

A 150 mg dose of Ubiquinol has shown approximately twice the bioavailability of ubiquinone

Solubilised CoQ10 formulations show enhanced / superior bioavailability

Cholesterol-lowering medication lowers Coenzyme Q10 in the body, but this may be corrected by supplementing with Coenzyme Q10

Ubiquinol is the active and most common form of Coenzyme Q10 in the body

Supplementation with Coenzyme Q10 may help replenish reduced levels in those taking cholesterol-lowering medication

Cholesterol-lowering medication lowers Coenzyme Q10 in the body, but this may be corrected by supplementing with Coenzyme Q10

The body's Coenzyme Q10 levels decrease as we age

Ubiquinol is a lipid-soluble antioxidant

For Ubiquinol/ Coenzyme Q10 supplementation

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

150 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 18.10.2017 at 09:11:06 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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