Sugar Balance

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

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Active ingredient:
alpha lipoic acid,calcium pantothenate,chromium picolinate,cyanocobalamin,Cinnamomum cassia,folic acid,Gymnema sylvestre,Momordica charantia,nicotinamide,pyridoxine hydrochloride,riboflavin,thiamine hydrochloride
Available from:
Azure Health Products Pty Ltd
Authorization status:
Listed
Authorization number:
347835

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Public Summary

Summary for ARTG Entry:

347835

Sugar Balance

ARTG entry for

Medicine Listed

Sponsor

Azure Health Products Pty Ltd

Postal Address

4503 MLC Centre 19 Martin Place, Sydney, NSW, 2000

Australia

ARTG Start Date

10/11/2020

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 . Sugar Balance

Product Type

Single Medicine Product

Effective Date

10/11/2020

Permitted Indications

Maintain/support energy production

Helps enhance/promote general health and wellbeing

Maintain/support general health and wellbeing

Helps maintain/support healthy blood sugar/glucose

Aid/assist/helps in the management of sugar cravings

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.

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

No Warnings included on Record

Additional Product information

Pack Size/Poison information

Pack Size

Poison Schedule

Components

1 . Formulation 1

Dosage Form

Capsule, hard

Route of Administration

Oral

Public Summary

Page 1 of

Produced at 11.01.2021 at 11:09:09 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

Visual Identification

Active Ingredients

alpha lipoic acid

100 mg

calcium pantothenate

10 mg

Equivalent: pantothenic acid

9.2 mg

chromium picolinate

1.77 mg

Equivalent: chromium

.22 mg

Cinnamomum cassia stem bark Extract dry concentrate

50 mg

Equivalent: Cinnamomum cassia (Dry)

500 mg

cyanocobalamin

.02 mg

folic acid

.095 mg

Gymnema sylvestre leaf Extract dry concentrate

125 mg

Equivalent: Gymnema sylvestre (Dry)

Momordica charantia fruit Extract dry concentrate

100 mg

Equivalent: Momordica charantia (Dry)

nicotinamide

20 mg

pyridoxine hydrochloride

15 mg

Equivalent: pyridoxine

12.34 mg

riboflavin

7.5 mg

thiamine hydrochloride

5 mg

Other Ingredients (Excipients)

calcium hydrogen phosphate dihydrate

Gelatin

magnesium stearate

maltodextrin

microcrystalline cellulose

purified water

silicon dioxide

© 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 11.01.2021 at 11:09:09 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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