Caruso's Tribulus 30000

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

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Active ingredient:
Tribulus terrestris
Available from:
Caruso's Natural Health Pty Ltd
INN (International Name):
Tribulus terrestris
Authorization status:
Listed
Authorization number:
292331

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Public Summary

Summary for ARTG Entry:

292331

Caruso's Tribulus 30000

ARTG entry for

Medicine Listed

Sponsor

Caruso's Natural Health Pty Ltd

Postal Address

PO Box 310,HORSLEY PARK, NSW, 2175

Australia

ARTG Start Date

2/08/2017

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. Caruso's Tribulus 30000

Product Type

Single Medicine Product

Effective date

9/08/2017

Warnings

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

Standard Indications

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

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

Male support. Nutritional and herbal support designed to support and enhance masculine needs.

Specific Indications

Maintain/support healthy female sexual function

Helps enhance/improve/promote/increase healthy female libido

Maintain/support healthy female libido

Helps enhance/promote uterine health

Maintain/support uterine health

Uterine tonic

Maintain/support healthy uterine tone

Maintain/support healthy male sexual function

Help maintain/support healthy male libido

Helps enhance/improve/promote/increase healthy male libido

Maintain/support healthy male sexual performance

Maintain/support healthy male reproductive system function

Maintain/support healthy male physiological function

Aid/assist/helps male body physiological requirements/needs

Helps enhance/promote male health

Maintain/support male health

Maintain/support healthy nervous system function

Helps balance/calm/soothe the nervous system

Maintain/support a healthy nervous system health

Nourish the nervous system

Additional Product information

Public Summary

Page 1 of

Produced at 24.11.2017 at 07:16:27 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

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

Tribulus terrestris

300 mg

Equivalent: Tribulus terrestris (Dry)

15 g

Tribulus terrestris

300 mg

Equivalent: Tribulus terrestris (Dry)

15 g

© 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 07:16:27 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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