METAGENICS NEUROLIFT

Main information

Documents

Localization

  • Available in:
  • METAGENICS NEUROLIFT
    Australia
  • Language:
  • English

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization status:
  • Listed
  • Authorization number:
  • 192923
  • Last update:
  • 21-05-2019

Public Assessment Report

Public Summary

Summary for ARTG Entry:

192923

METAGENICS NEUROLIFT

ARTG entry for

Medicine Listed

Sponsor

Health World Ltd

Postal Address

PO Box 675,VIRGINIA BC, QLD, 4014

Australia

ARTG Start Date

12/12/2011

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. METAGENICS NEUROLIFT

Product Type

Single Medicine Product

Effective date

12/12/2011

Warnings

St John's Wort affects the way many prescription medicines work, including the oral contraceptive pill. Consult your doctor.

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

Individuals who are using prescription anti-depressants or suffer from bipolar depression should not use this product unless under the supervision of a

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.

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 or improvement of general well-being.

Non-vitamin active ingredients may improve stress adaptation.

Beneficial during times of stress. [Warning S required]

Non-vitamin active ingredients in this product may be beneficial during times of stress. [Warning S required]

Specific Indications

Rhodiola may reduce stress-induced physical and mental fatigue to provide support for stressed people.

Rhodiola may support mental performance in stressed individuals.

Rhodiola and withania are adaptogenic herbs which may enhance the body's ability to cope with stress.

St John's wort may help to support normal healthy mood.

Withania has been used to support stressed people who are both physically and mentally exhausted in traditional Ayurvedic medicine.

Coleus, iodine and selenium may support normal healthy thyroid function.

Contains nutrients essential for thyroid hormone production.

To support normal healthy mood, stress adaptation and thyroid hormone production.

Metagenics NeuroLift may assist normal healthy mood and thyroid function. Nutrients essential for thyroid hormone production are combined with coleus

and the well documented mood supporting herb, hypericum. NeuroLift may improve stress adaptation, reduce stress induced physical and mental fatigue

Public Summary

Page 1 of

Produced at 28.11.2017 at 07:55:48 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

as well as supporting normal healthy mood.

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

ademetionine disulfate tosylate

98.04 mg

Calcium folinate

270.3 microgram

colecalciferol

.005 mg

Hypericum perforatum

450 mg

Equivalent: Hypericum perforatum (Dry)

1.935 g

Plectranthus barbatus

16.67 mg

Equivalent: Plectranthus barbatus (Dry)

500 mg

potassium iodide

98 microgram

Rhodiola rosea

36 mg

Equivalent: Rhodiola rosea (Dry)

630 mg

Selenomethionine

125 microgram

Withania somnifera

150 mg

Equivalent: Withania somnifera (Dry)

1.5 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 28.11.2017 at 07:55:48 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