SEDASLEEP

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

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Active ingredient:
Humulus lupulus,Passiflora incarnata
Available from:
Bioplus Healthcare Pty Ltd
Authorization status:
Listed
Authorization number:
351619

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Public Summary

Summary for ARTG Entry:

351619

SEDASLEEP

ARTG entry for

Medicine Listed

Sponsor

Bioplus Healthcare Pty Ltd

Postal Address

1609 Botany Road, BOTANY, NSW, 2019

Australia

ARTG Start Date

11/12/2020

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 . SEDASLEEP

Product Type

Single Medicine Product

Effective Date

11/12/2020

Permitted Indications

Traditionally used in Western herbal medicine to decrease/reduce/relieve restlessness/excess nervous energy

Traditionally used in Western herbal medicine to decrease/reduce/relieve nervous tension/unrest

Traditionally used in Western herbal medicine to calmative/nervous system relaxant

Traditionally used in Western herbal medicine to nervine/support nervous system

Traditionally used in Western herbal medicine to soporific/induces sleep

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

Traditionally used in Western herbal 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

No Warnings included on Record

Additional Product information

Pack Size/Poison information

Pack Size

Poison Schedule

Components

1 . Formulation 1

Dosage Form

Tablet, uncoated

Public Summary

Page 1 of

Produced at 11.01.2021 at 08:38:40 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

Route of Administration

Oral

Visual Identification

Active Ingredients

Humulus lupulus fruit Extract dry concentrate

23.34 mg

Equivalent: Humulus lupulus (Dry)

175 mg

Passiflora incarnata herb top flowering Extract dry concentrate

125 mg

Equivalent: Passiflora incarnata (Dry)

500 mg

Other Ingredients (Excipients)

colloidal anhydrous silica

crospovidone

lecithin

magnesium stearate

maltodextrin

microcrystalline cellulose

© 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 08:38:40 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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