VLC Diet

Main information

Documents

Localization

  • Available in:
  • VLC Diet Supreme
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 212467
  • Last update:
  • 09-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

212467

VLC Diet Supreme

ARTG entry for

Medicine Listed

Sponsor

Eagle Supreme Health Pty Ltd ATF Eagle Supreme Family Trust

Postal Address

PO Box 131,WANNEROO, WA, 6946

Australia

ARTG Start Date

22/07/2013

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. VLC Diet Supreme

Product Type

Single Medicine Product

Effective date

18/02/2016

Warnings

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

Standard Indications

May aid or assist weight loss by suppression of appetite in conjunction with (or as part of) a kilojoule/calorie controlled eating plan.

Specific Indications

Contains a combination of Amino Acids, Vitamins and Herbal extracts that form a powerful formulation to assist weight loss and weight management.

May help to promote/aid/assist weight loss.

This product assists with weight management when taken with a specific calorie controlled diet.

Contains the adaptogen Rhodiola. Adaptogens are a class of traditional herbal medicines that have been found to support and increase the body's

normal resistance to physical, chemical and biological stress. Rather than exerting a stimulatory effect, they assist the balancing of body system

functions and support recovery.

Rhodiola is a traditional herbal remedy used to assist / may help with Stamina and endurance, Energy and vitality, Relieving fatigue and exhaustion,

Mood and well-being, Mental and physical performance, Relieves stress and nervous tension and supports immune function.

Astragalus is a Traditional Chinese Medicine that promote the transformation of Qi from food to enhance vitality and boost energy levels.

Citrus aurantium (bitter orange) is used in traditional Chinese medicine (TCM) to reduce digestive sluggishness; restoring an efficient

flow/transit/movement/rhythm in the digestive system (qi). In traditional Chinese medicine Citrus aurantium (bitter orange) is a digestive cleansing herb.

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

Public Summary

Page 1 of

Produced at 27.11.2017 at 12:16:21 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

Active Ingredients

Alanine

43.5 mg

Astragalus membranaceus

43.5 mg

Equivalent: Astragalus membranaceus (Dry)

435 mg

citrus aurantium

43.5 mg

Equivalent: citrus aurantium (Dry)

5.22 g

cysteine hydrochloride

43.5 mg

Glutamine

43.5 mg

Histidine

43.5 mg

Leucine

43.5 mg

Levocarnitine

43.5 mg

Nicotinamide

94.5 mg

Ornithine monohydrochloride

43.5 mg

Rhodiola rosea

43.5 mg

Equivalent: Rhodiola rosea (Dry)

174 mg

Threonine

43.5 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 12:16:21 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

There are no safety alerts related to this product.

30-10-2018

EU/3/18/2076 (Orphan Europe S.A.R.L.)

EU/3/18/2076 (Orphan Europe S.A.R.L.)

EU/3/18/2076 (Active substance: Glycine, L-alanine, L-arginine, L-aspartic acid, L-cysteine, L-cystine, L-glutamic acid, L-histidine, L-lysine monohydrate, L-methionine, L-phenylalanine, L-proline, L-serine, L-threonine, L-tryptophan, L-tyrosine, taurine) - Orphan designation - Commission Decision (2018)7277 of Tue, 30 Oct 2018 European Medicines Agency (EMA) procedure number: EMA/OD/100/18

Europe -DG Health and Food Safety