Metabolism+

Australia - English - Department of Health (Therapeutic Goods Administration)

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Active ingredient:
caffeine,Camellia sinensis,Citrus maxima,hesperidin,Platycodon grandiflorus
Available from:
Usana Australia Pty Ltd
Authorization status:
Listed
Authorization number:
346492

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Public Summary

Summary for ARTG Entry:

346492

Metabolism+

ARTG entry for

Medicine Listed

Sponsor

Usana Australia Pty Ltd

Postal Address

PO Box 6744, BAULKHAM HILLS, NSW, 2153

Australia

ARTG Start Date

23/10/2020

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.

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 . Metabolism+

Product Type

Single Medicine Product

Effective Date

23/10/2020

Permitted Indications

Helps enhance/promote heat/energy production/thermogenesis

Maintain/support heat/energy production/thermogenesis

Helps enhance/promote general health and wellbeing

Maintain/support general health and wellbeing

Helps decrease/reduce body weight

Helps enhance/promote/increase body fat loss

Helps enhance/promote/increase weight loss

Aid/assist/helps in the management of food cravings

Aid/assist digestion/breakdown of dietary fat

Helps decrease/reduce dietary fat absorption in digestive system

Aid/assist/helps elimination of dietary fat

Helps reduce carbohydrate metabolism

Indication Requirements

If product is indicated for weight loss, label statement: When used in conjunction with a program of reduced intake of dietary calories and increased

physical activity.

Label statement: When used in conjunction with a program of reduced intake of dietary calories and increased physical activity.

Product presentation must not imply or refer to lowering or raising blood sugar/glucose levels from outside of the normal healthy range.

Standard Indications

No Standard Indications included on Record

Specific Indications

No Specific Indications included on Record

Warnings

Adults only (or words to that effect).

Additional Product information

Public Summary

Page 1 of

Produced at 12.01.2021 at 12:11:40 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

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

caffeine

25 mg

Camellia sinensis leaf Extract dry concentrate standardised

90 mg

Equivalent: Camellia sinensis (Dry)

2.7 g

Citrus maxima fruit Extract dry concentrate

106 mg

Equivalent: Citrus maxima (Dry)

1.06 g

hesperidin

100 mg

Platycodon grandiflorus root Extract dry concentrate

190.34 mg

Equivalent: Platycodon grandiflorus (Dry)

1.9 g

Other Ingredients (Excipients)

Acacia

croscarmellose sodium

dextrin

Flavour

glucose monohydrate

hyprolose

lecithin

microcrystalline cellulose

silicon dioxide

sodium citrate dihydrate

stearic acid

Stevia rebaudiana

© 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 12.01.2021 at 12:11:40 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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