Swisse

Main information

Documents

Localization

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

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 222346
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

222346

Swisse Ultiboost Prostate

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 Prostate

Product Type

Single Medicine Product

Effective date

15/08/2016

Warnings

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).

This product contains selenium which is toxic in high doses. A daily dose of 150 micrograms for adults of selenium from dietary supplements should not

be exceeded.

Standard Indications

Specific Indications

Includes zinc, vitamin D, turmeric and selenium to aid/help/assist/support wellbeing/vitality/maintenance general well-being. Nettle and Saw palmetto

help in the/help provide symptomatic relief of medically diagnosed benign prostatic hypertrophy/May assist in the management of medically diagnosed

benign prostatic hypertrophy/Nettle and Saw palmetto may provide relief from the symptoms of medically diagnosed Benign Prostatic Hypertrophy (or

Hyperplasia, commonly known as prostate enlargement), including difficulties in micturition (urination), a hesitant interrupted weak stream, urinary

frequency, urgency and dribbling or leaking. Selenium and Lycopene assist/help/support/maintain normal/healthy prostate function/prostate health. Zinc

helps support immune health/healthy immune system/function. Zinc is essential/important for/helps support male reproductive health and healthy sperm

production. Lycopene is a free radical scavenger and antioxidant/has antioxidant properties, helping to protect against free radical damage/supports

healthy antioxidant activity.

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

Public Summary

Page 1 of

Produced at 26.11.2017 at 11:33:47 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

colecalciferol

1.25 microgram

Cucurbita pepo

25 mg

Equivalent: Cucurbita pepo (Dry)

500 mg

Curcuma longa

5 mg

Equivalent: Curcuma longa (Dry)

100 mg

Folic acid

250 microgram

Ganoderma lucidum

2.75 mg

Equivalent: Ganoderma lucidum (Dry)

55 mg

Glycyrrhiza glabra

13.75 mg

Equivalent: Glycyrrhiza glabra (Dry)

55 mg

Isatis tinctoria

11 mg

Equivalent: Isatis tinctoria (Dry)

55 mg

Lycopersicon esculentum

10 mg

Panax ginseng

5.5 mg

Equivalent: Panax ginseng (Dry)

55 mg

Selenomethionine

16.25 microgram

Serenoa repens

100 mg

Equivalent: Serenoa repens (Dry)

Serenoa repens

217.5 mg

Equivalent: Serenoa repens (Dry)

870 mg

Urtica dioica

62.5 mg

Equivalent: Urtica dioica (Dry)

zinc amino acid chelate

30 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 11:33:47 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