Nature's Own Complete Sleep Advanced

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

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Active ingredient:
alpha casozepine enriched hydrolysed milk protein,Humulus lupulus,Ziziphus jujuba var. spinosa
Available from:
Sanofi-Aventis Healthcare Pty Ltd T/A Sanofi Consumer Healthcare
Authorization status:
Listed
Authorization number:
349778

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Public Summary

Summary for ARTG Entry:

349778

Nature's Own Complete Sleep Advanced

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

26/11/2020

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 . Nature's Own Complete Sleep Advanced

Product Type

Single Medicine Product

Effective Date

26/11/2020

Permitted Indications

Traditionally used in Chinese medicine to soothe/calm nerves

Decrease/reduce/relieve symptoms of stress

Traditionally used in Western herbal medicine to decrease/reduce/relieve sleeplessness

Traditionally used in Chinese medicine to decrease/reduce time to fall asleep

Traditionally used in Chinese medicine to decrease/reduce/relieve disturbed/restless sleep

Indication Requirements

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

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

Standard Indications

No Standard Indications included on Record

Specific Indications

No Specific Indications included on Record

Warnings

Derived from cow's milk.

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

Contains lactose (or words to that effect).

Not suitable for use in children under the age of 12 months, except on health professional advice.

Additional Product information

Pack Size/Poison information

Pack Size

Poison Schedule

Components

1 . Formulation 1

Public Summary

Page 1 of

Produced at 11.01.2021 at 10:02:34 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

Dosage Form

Tablet, film coated

Route of Administration

Oral

Visual Identification

Active Ingredients

alpha casozepine enriched hydrolysed milk protein

112.5 mg

Humulus lupulus flower Extract dry concentrate

66.67 mg

Equivalent: Humulus lupulus (Dry)

500 mg

Ziziphus jujuba var. spinosa seed Extract dry concentrate

450 mg

Equivalent: Ziziphus jujuba var. spinosa (Dry)

4.5 g

Other Ingredients (Excipients)

Acacia

calcium hydrogen phosphate dihydrate

colloidal anhydrous silica

croscarmellose sodium

crospovidone

hypromellose

lecithin

macrogol 3350

macrogol 400

magnesium stearate

maltodextrin

microcrystalline cellulose

polyvinyl alcohol

purified talc

silicon dioxide

titanium 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 10:02:34 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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