Anxiety and Stress Release

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

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Active ingredient:
Magnolia officinalis,Melissa officinalis
Available from:
Greenoia Healthcare
Authorization status:
Listed
Authorization number:
351362

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Public Summary

Summary for ARTG Entry:

351362

Anxiety and Stress Release

ARTG entry for

Medicine Listed

Sponsor

Greenoia Healthcare

Postal Address

1/5 George Street, North Strathfield, NSW, 2137

Australia

ARTG Start Date

9/12/2020

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 . Anxiety and Stress Release

Product Type

Single Medicine Product

Effective Date

9/12/2020

Permitted Indications

Decrease/reduce/relieve symptoms of stress

Decrease/reduce/relieve nervous tension/unrest

Decrease/reduce/relieve symptoms of mild anxiety

Helps reduce occurrence of symptoms of mild anxiety

Enhance/improve/promote/increase mental alertness/wakefulness

Indication Requirements

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

Product presentation must only refer to mild anxiety.

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

(If the medicine contains one sorbate) Contains [insert name of sorbate] OR (if medicine contains two or more sorbates) Contains sorbates [or words to that

effect].

Not suitable for infants under the age of twelve months (or words to that effect).

(If medicine contains one sugar) contains [insert name of sugar] OR (If medicine contains two or more sugars) Contains sugars [or words to that effect].

(If medicine contains one benzoate) Contains [insert name of benzoate] Or (If medicine contains two or more benzoates) Contains benzoates [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 08:49:59 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

Oral Liquid

Route of Administration

Oral

Visual Identification

Active Ingredients

Magnolia officinalis stem bark outer Extract dry concentrate

13.24 mg/mL

Equivalent: Magnolia officinalis (Dry)

529.66 mg/mL

Melissa officinalis leaf Extract dry concentrate

110.2 mg/mL

Equivalent: Melissa officinalis (Dry)

771.4 mg/mL

Other Ingredients (Excipients)

citric acid

Flavour

Honey

maltodextrin

potassium sorbate

purified water

sodium benzoate

sucralose

thaumatin

© 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 08:49:59 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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