Main information

  • Trade name:
  • Swisse Ultiboost High Strength Vitamin B12
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug



  • Available in:
  • Swisse Ultiboost High Strength Vitamin B12
  • Language:
  • English

Other information


  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 220754
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:


Swisse Ultiboost High Strength Vitamin B12

ARTG entry for

Medicine Listed


Swisse Wellness Pty Ltd

Postal Address

111 Cambridge Street,Collingwood, VIC, 3066


ARTG Start Date


Product category




Approval area

Listed Medicines


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


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.


1. Swisse Ultiboost High Strength Vitamin B12

Product Type

Single Medicine Product

Effective date



If symptoms persist consult your healthcare practitioner (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.

Standard Indications

Specific Indications

A factor in the maintenance of good health. / Helps support/maintain general health and wellbeing.

Helps/assists the body metabolise fats, carbohydrates and protein.

Vitamin B12 contributes to norma/healthy energy-yielding metabolism/energy production. Helps convert food into energy.

Contributes to the reduction of/helps reduce tiredness and fatigue.

May assist in/support the management of dietary vitamin B12 deficiency.

Vegetarians, vegans, and people who do not eat sufficient meat or dairy products may not be getting enough Vitamin B12 from their diet.

Older adults may have an increased need for vitamin B12 due to low stomach acid resulting in poor/reduced asbsorption of vitamin B12 from food/diet.

There is an increased/elevated requirement/need for Vitamin B12 in pregnancy.

Helps maintain/support normal/healthy homocysteine levels/contributes to normal homecysteine metabolism

Assists in the maintenance of/supports/maintains healthy/normal neurological function / brain function/brain health

Vitamin B12 is required for normal red blood cell formation/production.

Vitamin B12 has a role in the process of cell division. Supports DNA synthesis/production.

DNA contains all our genetic information and instructions for the development and function of all cells.

Individuals with digestive challengesmay have difficulty absorb/ing enough vitamin B12 from food sources.

Vitamin B12 contributes to normal/healthy functioning of the nervous system. / Helps maintain/support healthy nervous system function

Additional Product information

Pack Size/Poison information

Pack Size

Poison Schedule


1. Formulation 1

Dosage Form

Tablet, film coated

Public Summary

Page 1 of

Produced at 26.11.2017 at 02:08:30 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.

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Route of Administration


Visual Identification

Active Ingredients


1000 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

Public Summary

Page 2 of

Produced at 26.11.2017 at 02:08:30 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 for contact information