Weight

Main information

  • Trade name:
  • Weight Burn (Fusion Health)
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • Weight Burn (Fusion Health)
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 220236
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

220236

Weight Burn (Fusion Health)

ARTG entry for

Medicine Listed

Sponsor

Global Therapeutics Pty Ltd

Postal Address

Commercial 1 57-61 Rothschild Avenue,ROSEBERY, NSW, 2018

Australia

ARTG Start Date

18/02/2014

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. Weight Burn (Fusion Health)

Product Type

Single Medicine Product

Effective date

28/07/2016

Warnings

Contains caffeine [state quantity per dosage unit or per mL or per gram of product] [must be clear and legible].

Standard Indications

Specific Indications

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

levels in healthy individuals. May assist in the maintenance of cholesterol within the normal range in healthy individuals. May help reduce the oxidation of

LDL cholesterol and help maintain normal serum lipid levels in healthy individuals/people.

Aids, assists or helps in the maintenance or improvement of general well-being. Supports general health and wellbeing.

May help to support normal blood pressure in healthy individuals. May assist in the maintenance of normal blood pressure in healthy individuals.

Supports/assists healthy weight loss/management (in conjunction with a calorie controlled diet/eating plan and regular exercise). Provides thermogenic

effects. Activates/promotes thermogenesis (energy expenditure).

May help inhibit weight regain after weight loss.

Promotes/supports cardiovascular health.

Supports healthy ageing.

May enhance the body's own antioxidant defences. Works as an antioxidant. Provides antioxidant benefits.

Rich source of antioxidants/antioxidant polyphenols. Research shows that the body's antioxidant defences, which help fight cell damage, are reinforced

by taking antioxidant-rich foods or supplements.

Helps neutralise (scavenge) potentially damaging free radicals.

Enhances antioxidant levels.

Helps to support cellular energy production.

Helps maintain normal health of the liver.

Free radicals are produced during normal cellular metabolism (oxidation) and from exposure to a variety of external factors such as the sun, pollution,

and cigarette smoke.

Free radicals can attack cells in the body causing excessive oxidation (oxidative stress), which may produce cumulative damage contributing to the

ageing process

Public Summary

Page 1 of

Produced at 26.11.2017 at 02:42:13 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

Tablet, film coated

Route of Administration

Oral

Visual Identification

Active Ingredients

Camellia sinensis

312.5 mg

Equivalent: Camellia sinensis (Dry)

9.375 g

Coffea canephora

562.5 mg

Equivalent: Coffea canephora (Dry)

28.125 g

© 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 02:42:13 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

17-11-2018

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Europe - EFSA - European Food Safety Authority Publications

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Europe - EFSA - European Food Safety Authority Publications

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FDA - U.S. Food and Drug Administration

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FDA - U.S. Food and Drug Administration

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Health Canada

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FDA - U.S. Food and Drug Administration

31-8-2018

Public Notification: Slimming Capsule contains hidden drug ingredients

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FDA - U.S. Food and Drug Administration

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Public Notification: BodySlim Herbal contains hidden drug ingredient

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FDA - U.S. Food and Drug Administration

29-8-2018

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28-8-2018

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FDA - U.S. Food and Drug Administration

9-7-2018

Public Notification: Asunsa contains hidden drug ingredients

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FDA - U.S. Food and Drug Administration

9-7-2018

Public Notification: Lyn DTOX FS3 contains hidden drug ingredients

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FDA - U.S. Food and Drug Administration

3-7-2018

Public Notification: Adipotrim XT contains hidden drug ingredient

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FDA - U.S. Food and Drug Administration

3-7-2018

Public Notification: Row of Antibody Pil contains hidden drug ingredients

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FDA - U.S. Food and Drug Administration

3-7-2018

Public Notification: Body Shape Weight Loss System contains hidden drug ingredient

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FDA - U.S. Food and Drug Administration

20-6-2018

Public Notification: Adriana Balance S contains hidden drug ingredient

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FDA - U.S. Food and Drug Administration

20-6-2018

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FDA - U.S. Food and Drug Administration

7-6-2018

Public Notification: PAYA Dietary Supplement Product contains hidden drug ingredient

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FDA - U.S. Food and Drug Administration

5-6-2018

Camellia sinensis (green tea) extract

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Therapeutic Goods Administration - Australia

5-6-2018

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Health Canada

14-5-2018

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FDA - U.S. Food and Drug Administration

11-1-2018

Is My Dog or Cat a Healthy Weight? Important Questions to Ask the Vet

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FDA - U.S. Food and Drug Administration

9-3-2015

Warning against Slimex 15 and Slimex 15 New Formula

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Danish Medicines Agency

9-12-2009

Warning against the weight-loss product Super Slim

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Danish Medicines Agency

27-5-2008

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Danish Medicines Agency

30-1-2008

The Danish Medicines Agency and the Danish Veterinary and Food Administration warn against the weight loss product Therma Power

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Danish Medicines Agency

19-10-2007

Warning: Illegal sibutramine-containing weight-loss products sold on the internet

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Danish Medicines Agency

11-10-2018

October is #SIDSAwarenessMonth.  Smoking during pregnancy can lead to complications, premature delivery, low birth weight, stillbirth, and SIDS. Make sure your baby is #safetosleep at  https://women.smokefree.gov/  via @FDATobaccopic.twitter.com/i37QX61Bb

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October is #SIDSAwarenessMonth. Smoking during pregnancy can lead to complications, premature delivery, low birth weight, stillbirth, and SIDS. Make sure your baby is #safetosleep at https://women.smokefree.gov/  via @FDATobacco pic.twitter.com/i37QX61Bb7

FDA - U.S. Food and Drug Administration