Neuro C

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

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Active ingredient:
Bacopa monnieri,d-alpha-tocopheryl acid succinate,Ginkgo biloba,soy phosphatidylserine-enriched soy lecithin powder
Available from:
Biomedica Nutraceuticals Pty Ltd
INN (International Name):
Bacopa monnieri,d-alpha-Tocopheryl acid succinate,Ginkgo biloba,soy phosphatidylserine-enriched soy lecithin powder
Authorization status:
Listed
Authorization number:
291984

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Public Summary

Summary for ARTG Entry:

291984

Neuro C

ARTG entry for

Medicine Listed

Sponsor

Biomedica Nutraceuticals Pty Ltd

Postal Address

PO Box 7052,ALEXANDRIA, NSW, 2015

Australia

ARTG Start Date

25/07/2017

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.

The Ginkgo biloba leaf extract used in the manufacture of this medicine must comply with the requirement of Identification Test B of the monograph

Powdered Ginkgo Extract in the United States Pharmacopeia 32 - National Formulary 27 (USP32-NF27) as in force or existing from time to time. This

condition does not apply to powdered or dried leaf.

Products

1. Neuro C

Product Type

Single Medicine Product

Effective date

25/07/2017

Warnings

If symptoms persist consult your healthcare practitioner (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.

Standard Indications

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

Specific Indications

* Contains Ginkgo biloba which may enhance cognitive function

* Contains Ginkgo biloba which may improve/enhance memory in healthy adults

* Contains Ginkgo biloba which may help maintain/support healthy peripheral circulation

* Contains Ginkgo biloba which may help support healthy cerebral vascular circulation

* Contains Bacopa monniera which may improve memory acquisition and retention

* A principal function of Vitamin E is as an antioxidant.

* The cell membranes of brain tissues are particularly susceptible to oxidation

* Contains Bacopa monniera which may improve/support healthy cognition

* Contains Phosphatidylserine which is naturally occurring in cell membranes, and is particularly concentrated in brain cells.

* Contains Ginkgo biloba which has antioxidant activity and may therefore assist in protecting the body from the damaging effects of free radicals

* Contains Ginkgo biloba which supports the health and function of the brain and nervous system

* Contains Ginkgo biloba which has neuroprotective effects

* Bacopa is traditionally used in Ayurvedic medicine as a nervine/nerve tonic

Additional Product information

Pack Size/Poison information

Pack Size

Poison Schedule

Public Summary

Page 1 of

Produced at 23.11.2017 at 02:18:56 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, hard

Route of Administration

Oral

Visual Identification

Active Ingredients

Bacopa monnieri

225 mg

d-alpha-Tocopheryl acid succinate

8.26 mg

Ginkgo biloba

60 mg

Equivalent: Ginkgo biloba (Dry)

soy phosphatidylserine-enriched soy lecithin powder

83.33 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 23.11.2017 at 02:18:56 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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