B Complex Advanced

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

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Active ingredient:
alpha lipoic acid,Biotin,calcium pantothenate,choline bitartrate,cyanocobalamin,Camellia sinensis,folic acid,inositol,nicotinamide,pyridoxine hydrochloride,riboflavine,thiamine hydrochloride
Available from:
Global Therapeutics Pty Ltd
Authorization status:
Listed
Authorization number:
324145

Public Summary

Summary for ARTG Entry:

324145

B Complex Advanced

ARTG entry for

Medicine Listed

Sponsor

Global Therapeutics Pty Ltd

Postal Address

PO Box 1999,BYRON BAY, NSW, 2481

Australia

ARTG Start Date

27/09/2019

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. B Complex Advanced

Product Type

Single Medicine Product

Effective date

27/09/2019

Permitted Indications

Maintain/support energy levels

Maintain/support energy production

Maintain/support vitality

Relieve weariness/tiredness/fatigue/feeling of weakness

Relieve weariness/tiredness/fatigue/feeling of weakness when dietary intake is inadequate

Maintain/support general health and wellbeing

Aid/assist healthy red blood cell production

Helps maintain/support haemoglobin formation/synthesis

Aid/assist/helps metabolism of (state vitamin/mineral/nutrient)

Support healthy stress response in the body

Maintain/support cognitive function/mental function

Maintain/support brain function

Maintain/support brain health

Aid/assist/helps synthesis of neurotransmitters

Maintain/support nervous system function

Support healthy emotional/mood balance

Indication Requirements

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

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.

Public Summary

Page 1 of

Produced at 29.09.2019 at 03:59:49 AEST

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

Product presentation must not imply or refer to serious cardiovascular conditions.

If product is indicated for supplementation, Label statement: Vitamins and minerals can only be of assistance if dietary intake is inadequate OR Vitamin

and/or mineral supplements should not replace a

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

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

Standard Indications

No Standard Indications included on Record

Specific Indications

Warnings

The recommended dose of this medicine provides small amounts of caffeine

WARNING - Stop taking this medication if you experience tingling, burning or numbness and see your healthcare practitioner as soon as possible.

[Contains vitamin B6].

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

alpha lipoic acid

50 mg

Biotin

150 microgram

calcium pantothenate

110 mg

Camellia sinensis

113.75 mg

Equivalent: Camellia sinensis (Dry)

9.1 g

choline bitartrate

100 mg

cyanocobalamin

.15 mg

folic acid

150 microgram

inositol

100 mg

nicotinamide

150 mg

pyridoxine hydrochloride

75 mg

riboflavine

50 mg

thiamine hydrochloride

100 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 29.09.2019 at 03:59:49 AEST

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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