Vitamin B12

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

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Active ingredient:
mecobalamin (co-methylcobalamin)
Available from:
Digital Services Australia II Pty Ltd
Authorization status:
Listed
Authorization number:
321395

Public Summary

Summary for ARTG Entry:

321395

Vitamin B12

ARTG entry for

Medicine Listed

Sponsor

Digital Services Australia II Pty Ltd

Postal Address

JustCo Level 16 175 Pitt Street,Sydney, NSW, 2000

Australia

ARTG Start Date

7/08/2019

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. Vitamin B12

Product Type

Single Medicine Product

Effective date

7/08/2019

Permitted Indications

Maintain/support energy levels

Maintain/support calorie burning

Helps convert (state food) into energy

Maintain/support energy production

Maintain/support general health and wellbeing

Aid/assist healthy red blood cell production

Maintain/support healthy immune system function

Aid/assist/helps glucose/sugar/carbohydrate metabolism

Maintain/support (state vitamin/mineral/nutrient) levels in the body

Helps prevent dietary (state vitamin/mineral/nutrient) deficiency

Maintain/support cognitive function/mental function

Maintain/support learning and information processing

Maintain/support brain function

Maintain/support brain health

Maintain/support nervous system health

Maintain/support nervous system function

Indication Requirements

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

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

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

Public Summary

Page 1 of

Produced at 29.08.2019 at 05:24:29 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

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

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: Vitamins and minerals can only be of assistance if dietary intake is inadequate OR Vitamin and/or mineral supplements should not

replace a balanced diet.

Standard Indications

No Standard Indications included on Record

Specific Indications

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

Visual Identification

Active Ingredients

mecobalamin (co-methylcobalamin)

250 microgram

© 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 29.08.2019 at 05:24:29 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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