QUALITY HEALTH AUSTRALIA B COMPLETE

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

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Active ingredient:
Biotin,calcium pantothenate,choline bitartrate,folic acid,inositol,mecobalamin (co-methylcobalamin),nicotinamide,pyridoxine hydrochloride,riboflavin,thiamine hydrochloride
Available from:
Natural Bio Pty Limited
Authorization status:
Listed
Authorization number:
349292

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Public Summary

Summary for ARTG Entry:

349292

QUALITY HEALTH AUSTRALIA B COMPLETE

ARTG entry for

Medicine Listed

Sponsor

Natural Bio Pty Limited

Postal Address

PO Box 384, MONA VALE, NSW, 1660

Australia

ARTG Start Date

23/11/2020

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 . QUALITY HEALTH AUSTRALIA B COMPLETE

Product Type

Single Medicine Product

Effective Date

23/11/2020

Permitted Indications

Maintain/support energy levels

Helps convert (state food) into energy

Maintain/support energy production

Maintain/support general health and wellbeing

Maintain/support immune system health

Maintain/support healthy immune system function

Aid/assist/helps glucose/sugar/carbohydrate metabolism

Helps decrease/reduce homocysteine levels

Aid/assist/helps protein synthesis in the body

Support healthy stress response in the body

Decrease/reduce/relieve symptoms of stress

Maintain/support cognitive function/mental function

Aid/assist/helps synthesis of neurotransmitters

Maintain/support nervous system health

Maintain/support nervous system function

Indication Requirements

Product presentation must not imply or refer to mental illnesses, disorders or conditions.

Product presentation must not imply or refer to chronic fatigue syndrome.

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.

Product presentation must not imply or refer to serious immunological diseases.

Label statement: If symptoms persist, talk to your health professional.

Standard Indications

No Standard Indications included on Record

Public Summary

Page 1 of

Produced at 11.01.2021 at 10:24:47 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

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

Tablet, film coated

Route of Administration

Oral

Visual Identification

Active Ingredients

Biotin

.05 mg

calcium pantothenate

54.35 mg

Equivalent: pantothenic acid

50 mg

choline bitartrate

335.49 mg

Equivalent: choline

138 mg

folic acid

.4 mg

inositol

.06 mg

mecobalamin (co-methylcobalamin)

.15 mg

nicotinamide

100 mg

pyridoxine hydrochloride

60.78 mg

Equivalent: pyridoxine

50 mg

riboflavin

40 mg

thiamine hydrochloride

76.26 mg

Equivalent: thiamine

60 mg

Other Ingredients (Excipients)

calcium hydrogen phosphate dihydrate

Carnauba Wax

colloidal anhydrous silica

croscarmellose sodium

hypromellose

macrogol 400

magnesium stearate

microcrystalline cellulose

povidone

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 10:24:47 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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