NutriVital

Main information

  • Trade name:
  • NutriVital Prostate Formula
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • NutriVital Prostate Formula
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 221966
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

221966

NutriVital Prostate Formula

ARTG entry for

Medicine Listed

Sponsor

Nutrivital Pty Ltd

Postal Address

1056 Canley Vale Road,Wetherill Park,SYDNEY, NSW, 2164

Australia

ARTG Start Date

3/04/2014

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. NutriVital Prostate Formula

Product Type

Single Medicine Product

Effective date

3/04/2014

Warnings

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

Aids, assists or helps in the maintenance of general well-being

For mineral (may state the mineral) supplementation.

Male support. May be beneficial to men in satisfying physiological requirements of the male body.

Male support. Balances and supports normal male physiology and function.

For the symptomatic relief of medically diagnosed benign prostatic hypertrophy.

May assist in the management of medically diagnosed benign prostatic hypertrophy.

Specific Indications

Zinc supports the health of the male reproductive system. Zinc is an important mineral for the formation and maturation of spermatozoa. Helps maintain

prostate health. Zinc is an important nutritional antioxidant that assists in protecting the body from the damaging effects of free radicals. Curcumin has

antioxidant actions and can therefore help to reduce damage associated with free radicals.

Selenium is required for the health of the reproductive system. Selenium supports normal sperm motility in healthy men. Selenium supports the health

and function of the male reproductive system. Selenium supports and maintains prostate health.

Saw palmetto has been traditionally used in herbal medicine for the relief of symptoms associated with benign prostatic hypertrophy.Saw palmetto has

been traditionally used in herbal medicine to support/maintain the health of the prostate. Saw palmetto is traditionally used in herbal medicine for urinary

complaints associated with benign prostatic enlargement.

Lycopene is an important antioxidant that assists in protecting the body from the damaging effects of free radicals.

Additional Product information

Pack Size/Poison information

Pack Size

Poison Schedule

Public Summary

Page 1 of

Produced at 26.11.2017 at 12:17:53 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

Components

1. Formulation 1

Dosage Form

Capsule, soft

Route of Administration

Oral

Visual Identification

Active Ingredients

conifer phytosterol complex

65 mg

Curcuma longa

5 mg

Equivalent: Curcuma longa (Dry)

100 mg

Lycopene

3.25 mg

Selenomethionine

124.19 microgram

Serenoa repens

160 mg

Equivalent: Serenoa repens (Dry)

1.6 g

zinc oxide

12.45 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 12:17:53 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