Microgenics Protech Complete Prostate Health

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

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Active ingredient:
Epilobium parviflorum,lycopene,selenomethionine,Serenoa repens,Turnera diffusa,zinc gluconate
Available from:
RF Six Pty Ltd
INN (International Name):
Epilobium parviflorum,Lycopene,Selenomethionine,Serenoa repens,Turnera diffusa,Zinc gluconate
Authorization status:
Listed
Authorization number:
291420

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Public Summary

Summary for ARTG Entry:

291420

Microgenics Protech Complete Prostate Health

ARTG entry for

Medicine Listed

Sponsor

Sanofi-Aventis Healthcare Pty Ltd T/A Sanofi Consumer Healthcare

Postal Address

PO Box 403,VIRGINIA, QLD, 4014

Australia

ARTG Start Date

12/07/2017

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. Microgenics Protech Complete Prostate Health

Product Type

Single Medicine Product

Effective date

12/07/2017

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

Specific Indications

Traditionally used in Western herbal medicine to help relieve urination problems such as frequent night time urination and weak urine flow associated

with prostate health.

Antioxidant, helps reduce free radical damage

Has antioxidant property and helps to protect against free radical damage.

Lycopene is the most prominent carotenoid in the prostate gland.

Zinc is more abundant in human prostate than in other tissues.

Zinc supports healthy prostate function.

Traditionally used in Western herbal medicine to help relieve symptoms of weak urine flow, incomplete voiding, frequent daytime and night time urination

associated with prostate health.

Traditionally used in Western herbal medicine to help relieve symptoms of incomplete voiding associated with prostate health.

Additional Product information

Pack Size/Poison information

Pack Size

Poison Schedule

Components

1. Formulation 1

Dosage Form

Capsule, soft

Route of Administration

Oral

Visual Identification

Public Summary

Page 1 of

Produced at 24.11.2017 at 08:04:38 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

Active Ingredients

Epilobium parviflorum

100 mg

Equivalent: Epilobium parviflorum (Dry)

400 mg

Lycopene

2 mg

Selenomethionine

64.5 microgram

Serenoa repens

356 mg

Equivalent: Serenoa repens (Dry)

3.56 g

Turnera diffusa

60 mg

Equivalent: Turnera diffusa (Dry)

300 mg

Zinc gluconate

115 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 24.11.2017 at 08:04:38 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

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