X Power

Main information

Documents

Localization

  • Available in:
  • X Power Slim
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 210496
  • Last update:
  • 09-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

210496

X Power Slim

ARTG entry for

Medicine Listed

Sponsor

Golden Health Pty Ltd

Postal Address

542 Somerville Road,SUNSHINE WEST, VIC, 3020

Australia

ARTG Start Date

3/06/2013

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. X Power Slim

Product Type

Single Medicine Product

Effective date

31/01/2017

Warnings

Use in children under 12 years is not recommended.

Drink plenty of water (or words to that effect).

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

Vitamins can only be of assistance if the dietary vitamin intake is inadequate. OR Vitamin supplements should not replace a balanced diet.

Prolonged use may cause serious bowel problems.

Do not use when abdominal pain, nausea or vomiting are present, or if you develop diarrhoea. If you are pregnant or breast feeding, seek the advice of a

healthcare professional before taking this product (or words to that effect).

Standard Indications

May assist in the maintenance of normal/healthy cholesterol levels in healthy individuals.

Aids or assists in the relief of constipation. [Warnings S and LAX1 required / LAX2 required in certain circumstances]

May help reduce the oxidation of LDL cholesterol.

May assist in the management of constipation. [Warnings S and LAX1 required / LAX2 required in certain circumstances]

For the symptomatic relief of constipation. [Warnings S and LAX1 required / LAX2 required in certain circumstances]

May assist in the maintenance of cholesterol within the normal/healthy range in healthy individuals and improve the LDL:HDL ratio.

May assist in the maintenance of cholesterol within the normal range in healthy individuals.

May assist in the maintenance of a normal/healthy LDL:HDL cholesterol ratio.

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

Helps maintain normal blood/blood tonic (Note: These claims are appropriate for folic acid, vitamin B12 and iron, but must not imply anaemic conditions)

Aids or assists in the treatment of constipation. [Warnings S and LAX1 required / LAX2 required in certain circumstances]

Specific Indications

* Supports/helps to maintain a healthy cardiovascular system.

* Supports cardiovascular health.

* Supports/maintains the health of the blood vessels.

Public Summary

Page 1 of

Produced at 27.11.2017 at 09:46:55 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 Green tea, which has antioxidant activity and can therefore help to inhibit free radical damage.

* Has antioxidant activity and can therefore assist in decreasing cell damage attributed to free radicals.

* Supports healthy immune system function.

* Supports the health and function of the immune system.

* Contains nutrients that play important roles in the proper functioning of the immune system.

* Pyridoxine and cyanocobalamin are involved in immune system processes in the body.

* Contains nutrients that play an essential role in the production of energy in the body.

* Contains nutrients that play an essential role in the production of ATP/cellular energy.

* Thiamine and cyanocobalamin are involved in energy metabolism/the production of energy in the body.

* Contains nutrients that are essential for carbohydrate, protein and fat metabolism.

* Supports healthy metabolism of proteins, carbohydrates and fats in the body.

* Supports metabolism.

* Contains nutrients that are essential for healthy nervous system function.

* Supports the health and function of the nervous system.

* Contains nutrients that are required in the body for nerve cell function and muscle action.

* Supports healthy brain function.

* Contains nutrients necessary for healthy brain function.

* Contains senna, which is used in traditional Chinese medicine to relax the bowels.

* Facilitates the body's natural fat burning processes.

* Supports the burning of body fat/thermogenesis.

* Supports thermogenesis/fat burning.

* Supports healthy weight maintenance when used with a healthy diet and exercise program

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

Arctostaphylos uva-ursi

5 mg

Calcium carbonate

18.75 mg

Camellia sinensis

450 mg

Equivalent: Camellia sinensis (Dry)

11.25 g

Cyanocobalamin

6 microgram

Folic acid

95 microgram

Ganoderma lucidum

10 mg

Opuntia ficus-indica

156 mg

pyridoxine hydrochloride

3.525 mg

Senna alexandrina

75 mg

Equivalent: Senna alexandrina (Dry)

750 mg

Taraxacum officinale

5 mg

Thiamine hydrochloride

5 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 09:46:55 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