ETHICAL NUTRIENTS CLINICAL NERVALGESIC

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

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Active ingredient:
Crocus sativus,palmidrol,thiamine hydrochloride
Available from:
Metagenics (Aust) Pty Ltd
Authorization status:
Listed
Authorization number:
351119

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Public Summary

Summary for ARTG Entry:

351119

ETHICAL NUTRIENTS CLINICAL NERVALGESIC

ARTG entry for

Medicine Listed

Sponsor

Metagenics (Aust) Pty Ltd

Postal Address

PO Box 675, VIRGINIA BC, QLD, 4014

Australia

ARTG Start Date

8/12/2020

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.

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 . ETHICAL NUTRIENTS CLINICAL NERVALGESIC

Product Type

Single Medicine Product

Effective Date

8/12/2020

Permitted Indications

Anti-inflammatory/relieve inflammation

Analgesic/Anodyne/relieve pain

Aid/assist/helps synthesis of neurotransmitters

Maintain/support nervous system function

Decrease/reduce/relieve mild nerve pain/neuralgia

Indication Requirements

Product presentation must only refer to mild nerve pain/neuralgia.

Label statement: If symptoms persist, talk to your health professional.

Product presentation must not imply or refer to mental illnesses, disorders or conditions.

Standard Indications

No Standard Indications included on Record

Specific Indications

No Specific Indications included on Record

Warnings

Vitamins can only be of assistance if the dietary vitamin intake is inadequate. OR Vitamin supplements should not replace a balanced diet.

The medicine may interact with other prescription analgesic medicines, please consult your healthcare practitioner before use (or words to that effect)

Not to be used for more than 21 consecutive days (or words to that effect)

Adults only (or words to that effect).

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

Additional Product information

Pack Size/Poison information

Pack Size

Poison Schedule

Public Summary

Page 1 of

Produced at 11.01.2021 at 09:03:42 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

Crocus sativus stigma Extract dry concentrate

7.5 mg

Equivalent: Crocus sativus (Dry)

22.5 mg

palmidrol

299.9997 mg

thiamine hydrochloride

50 mg

Other Ingredients (Excipients)

calcium hydrogen phosphate dihydrate

colloidal anhydrous silica

disodium edetate

dl-alpha-tocopheryl acetate

gellan gum

hypromellose

lecithin

Lime Oil Coldpressed

magnesium stearate

medium chain triglycerides

microcrystalline cellulose

Olive Oil

PEG-35 castor oil

potable water

potassium acetate

silicon dioxide

© 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 11.01.2021 at 09:03:42 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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