Harmony

Main information

  • Trade name:
  • Harmony Restore
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • Harmony Restore
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 222601
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

222601

Harmony Restore

ARTG entry for

Medicine Listed

Sponsor

Martin & Pleasance Pty Ltd

Postal Address

PO Box 2007,SOUTH MELBOURNE, VIC, 3205

Australia

ARTG Start Date

16/04/2014

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. Harmony Restore

Product Type

Single Medicine Product

Effective date

6/07/2016

Warnings

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

Standard Indications

Non-vitamin active ingredients may improve stress adaptation.

Helps relieve nervous tension, stress and mild anxiety. [Warning S required]

Relief of sleeplessness. [Warning S required]

Help reduce effects of mild anxiety and nervous tension. [Warning S required]

Aids, assists or helps in the maintenance or improvement of general well-being.

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

Aids, assists or helps in the maintenance of general well-being

Herbal blend which helps relieve stress of study or work. [Warning S required]

Aids, assists or helps in the improvement of general well-being.

Non-vitamin active ingredients in this product help relieve nervous tension, stress and mild anxiety. [Warning S required]

Beneficial during times of stress. [Warning S required]

Specific Indications

Restore yourself.

Rejuvenate yourself.

Improved energy.

Stress relief.

Skin health.

Sleep quality.

Harmony Mum's Restore may assist with:

* Modulating the physical and emotional stress response.

* Improving the symptoms of general stress.

* Reducing the stress related symptom of frequently feeling exhausted.

* Reducing the stress related symptom of sleep problems.

Public Summary

Page 1 of

Produced at 26.11.2017 at 11:03:36 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

* Reducing the stress related symptom of forgetfulness.

* Reducing the symptoms of sexual problems of a recent origin.

* Supporting the health of sun exposed skin.

* Protective support for skin health.

* Antioxidant skin protection.

Harmony Mum's Restore shows:

* Anti stress properties.

* Antioxidant properties.

* Immunomodulation properties.

* Rejuvenating properties by supporting ageing issues.

* Adaptogenic effect.

* Anti inflammatory properties.

* Anti microbial activity.

* Heart health support.

* Longevity support.

* Studies indicate that Withania has anti stress properties.

* Studies indicate that Withania has antioxidant properties.

* Studies indicate that Withania has immunomodulation properties.

* Studies indicate that Withania has an adaptogenic effect.

* Studies indicate that Withania has an ability to modulate the physical and emotional stress response.

* Studies indicate that Withania has anti inflammatory properties.

* Octibest (R) (Holy Basil) has been clinically trialled and shown to improve the symptoms of general stress.

* Octibest (R) (Holy Basil) has been clinically trialled and shown to reduce the stress related symptom of frequently feeling exhausted.

* Octibest (R) (Holy Basil) has been clinically trialled and shown to reduce the stress related symptom of sleep problems.

* Octibest (R) (Holy Basil) has been clinically trialled and shown to reduce the stress related symptom of forgetfulness.

* Octibest (R) (Holy Basil) has been clinically trialled and shown to reduce the symptoms of sexual problems of a recent origin.

* Opextan (R) (Olive Fruit) has been clinically trialled and shown to support the health of sun exposed skin.

* Research with Opextan (R) (Olive Fruit) shows preventive properties for skin health.

* Research with Opextan (R) (Olive Fruit) shows antioxidant properties.

* Olive fruit supports anti inflammatory activity.

* Olive fruit supports anti microbial activity.

* Olive fruit supports heart health.

* Olive fruit supports longevity.

Harmony Mum's Restore is formulated with herbs which have been traditionally used to:

* Relieve pain (analgesic).

* Relieve lower back pain.

* Relieve abdominal pain.

* Relieve headache.

* Improve headache.

* Assist with muscle pain.

* Assist arthritis.

* Anti inflammatory.

* Relieve fatigue.

* Improve fatigue.

* Assist with a weak constitution.

* Assist with insomnia.

* Support convalescence from physical and emotional stress.

* Improve sleeplessness.

* Ease insomnia.

* Regulate menstruation.

* Assist with menstrual disorders.

* Assist with night sweats.

* Relieve bloating.

* Assist with women's disorders.

* Assist with Premenstrual Syndrome (PMS)

* Improve poor balance.

* Relieve dizziness.

* Assist with vertigo.

* Improve pale skin.

* Improve dull skin.

* Improve lustreless skin.

* Improve skin problems.

* Improve brittle nails.

* Improve dull nails.

* Anti ageing.

* Assist with atopic eczema.

* Assist with eczema.

* Improve skin health.

* Support sun exposed skin health.

* Relieve irritability.

* Ease bad temper.

* Stabilize mood.

* Ease restlessness.

* Have a calming effect.

* Ease nervous excitability.

* Ease nervous tension.

* Ease bad mood.

* Assist with nervous exhaustion.

* Assist with mild anxiety.

* Nourish the blood.

* Nourishment for the liver.

* Support a healthy liver.

* To tone, a tonic, has a tonifying action.

* Improve circulation.

* Support cardiovascular health.

* Assist the healthy functioning of the immune system.

Public Summary

Page 2 of

Produced at 26.11.2017 at 11:03:36 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

* Assist with respiratory infections.

* Can assist with normalizing bodily functions.

* Can assist with revitalizing bodily functions.

* Immunostimulant.

* Support immune function.

* Relieve allergies.

* Stimulate the immune system.

* Antioxidant.

* Anti microbial.

* Immune support.

* An adaptogen.

* Assist the body with resistance to physiological and emotional stress.

* Assist with modulating stress.

* Assist with stress.

* Improve stress.

* Ease stress.

* Improve physical energy.

* Relief from environmental stress.

* Protect against oxidative stress.

* Assist with exercise performance.

* An aphrodisiac.

* Assist with sexual enhancement.

* Sexual enhancer.

* Allow for the restoration of vitality.

* Assist with cognitive improvement.

* Improve concentration.

* Improve forgetfulness.

* Heighten mental clarity in times of stress.

* Improve overall health.

* Improve wellbeing.

* Improve quality of life.

* Promote longevity.

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

Ocimum tenuiflorum

600 mg

Olea europaea

80 mg

Paeonia lactiflora

150 mg

Equivalent: Paeonia lactiflora (Dry)

Withania somnifera

75 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 3 of

Produced at 26.11.2017 at 11:03:36 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