Swisse

Main information

Documents

Localization

  • Available in:
  • Swisse Ultiboost Immune
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 222356
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

222356

Swisse Ultiboost Immune

ARTG entry for

Medicine Listed

Sponsor

Swisse Wellness Pty Ltd

Postal Address

111 Cambridge Street,Collingwood, VIC, 3066

Australia

ARTG Start Date

10/04/2014

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. Swisse Ultiboost Immune

Product Type

Single Medicine Product

Effective date

28/10/2015

Warnings

Adults only. OR Not to be used in children under two years of age without medical advice (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.

Adults only. OR Not to be used in children under two years of age without medical advice (or words to that effect).

WARNING: May be dangerous if taken in large amounts or for a long period. OR WARNING: Contains zinc which may be dangerous if taken in large

amounts or for a long period (or words to that effect).

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

Standard Indications

Specific Indications

Aids, assists or helps in the maintenance or improvement of general health and well-being.

May help to reduce the duration and severity of symptoms associated with the common cold/May help to reduce the duration and severity common cold

symptoms

Zinc & Vitamin C help maintain/support a healthy immune system/healthy immune function/support immune health

The formula includes zinc and vitamin C to help support the body during immune-challenging conditions such as the common cold/colds/helps support

the body's natural immune defence

Symptoms associated with the common cold include blocked or runny nose, dry cough and mucous congestion

Vitamin C helps/supports/helps maintain good health/general wellbeing

The antioxidant properties of vitamin C help to maintain good health/general wellbeing.

As an antioxidant, vitamin C helps to protect cells from oxidative damage/oxidative stress/free radical damage. Provides antioxidant support / supports

healthy antioxidant activity

Vitamin C helps the body metabolise fats and proteins

Vitamin C is found in high concentrations in the adrenal glands. It is important for the synthesis of hormones involved in the stress response.

Vitamin C is water soluble, therefore is not stored in large amounts in the body. The human body is unable to synthesis it's own vitamin C therefore

regular/daily intake is desirable.

Vitamin C helps to regulate normal/healthy immune function./Vitamin C helps to support healthy immune function./Vitamin C is important/essential for

maintaining a healthy immune response.

Zinc plays a role in/is important for growth and development

Zinc plays a key role in/is important for the maintenance and functioning of a healthy immune system and is essential for good health

Adequate levels of zinc help to support/maintain healthy skin and support/assist minor wound healing

Zinc is essential for male reproductive health including healthy sperm production

Zinc is required for the production of hormones such as testosterone Zinc also plays a role in the maintenance of taste and smell and helps to support

Public Summary

Page 1 of

Produced at 26.11.2017 at 11:30:55 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

the metabolism of proteins, fats and carbohydrates.

Zinc plays a key role in the maintenance and functioning of a healthy immune system and is essential for good health

Adequate levels of zinc help to support healthy skin and minor wound healing Zinc also plays a role in the maintenance of taste and smell and helps to

support the metabolism of proteins, fats and carbohydrates.

Zinc is required/important/essential for female reproductive health.

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

calcium ascorbate

605.34 mg

Citrus bioflavonoids extract

20 mg

Cupric sulfate pentahydrate

3.93 mg

Magnesium aspartate dihydrate

250 mg

Olea europaea

55.56 mg

Equivalent: Olea europaea (Dry)

250 mg

Zinc sulfate monohydrate

68.61 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 26.11.2017 at 11:30:55 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