Mega B Complex

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

Buy It Now

Active ingredient:
Biotin,calcium pantothenate,cyanocobalamin,folic acid,nicotinamide,pyridoxine hydrochloride,riboflavin sodium phosphate,thiamine hydrochloride
Available from:
Vitaminhaus Pty Ltd
Authorization status:
Listed
Authorization number:
346336

Read the complete document

Public Summary

Summary for ARTG Entry:

346336

Mega B Complex

ARTG entry for

Medicine Listed

Sponsor

Vitaminhaus Pty Ltd

Postal Address

Suite 7/400 Canterbury Road, SURREY HILLS, VIC, 3127

Australia

ARTG Start Date

21/10/2020

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 . Mega B Complex

Product Type

Single Medicine Product

Effective Date

21/10/2020

Permitted Indications

Maintain/support heat/energy production/thermogenesis

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

Maintain/support red blood cell health

Maintain/support blood health

Maintain/support cognitive function/mental function

Maintain/support nervous system health

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 mental illnesses, disorders or conditions.

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

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

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

Standard Indications

No Standard Indications included on Record

Specific Indications

No Specific Indications included on Record

Warnings

The recommended daily dose of this medicine contains [state quantity and units] of sodium (or words to that effect).

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

If symptoms persist consult your healthcare practitioner (or words to that effect).

Adults only (or words to that effect).

Keep out of reach of children (or words to that effect).

Public Summary

Page 1 of

Produced at 12.01.2021 at 12:27:21 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

Additional Product information

Pack Size/Poison information

Pack Size

Poison Schedule

Components

1 . Formulation 1

Dosage Form

Tablet, effervescent

Route of Administration

Oral

Visual Identification

Active Ingredients

Biotin

50 microgram

calcium pantothenate

56.3 mg

Equivalent: pantothenic acid

50 mg

cyanocobalamin

50 microgram

folic acid

500 microgram

nicotinamide

100 mg

pyridoxine hydrochloride

55.53 mg

Equivalent: pyridoxine

45 mg

riboflavin sodium phosphate

28.4 mg

Equivalent: riboflavin

20 mg

thiamine hydrochloride

66.85 mg

Equivalent: thiamine

50 mg

Other Ingredients (Excipients)

beetroot

citric acid

Flavour

inulin

maltodextrin

mannitol

sodium bicarbonate

sucralose

© 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 12:27:21 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

Similar products

Search alerts related to this product

Share this information