PMS Relief

Main information

Documents

Localization

  • Available in:
  • PMS Relief
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 219001
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

219001

PMS Relief

ARTG entry for

Medicine Listed

Sponsor

Tasman Pacific Holding Pty Ltd

Postal Address

4 Bridge Street,RYDALMERE, NSW, 2116

Australia

ARTG Start Date

8/01/2014

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. PMS Relief

Product Type

Single Medicine Product

Effective date

8/01/2014

Warnings

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

If fluid retention persists, seek medical advice (or words to that effect).

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

Standard Indications

For the symptomatic relief of dysmenorrhoea. [Warning S required]

May assist in the management of pre-menstrual tension/syndrome. [Warning S required]

Relief of pre-menstrual symptoms/syndrome. [Warning S required]

May assist in the management of irregular periods. [Warning S required]

For the symptomatic relief of irregular periods [Warning S required]

Non-vitamin active ingredients may improve stress adaptation.

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

For mineral (may state the mineral) supplementation.

For vitamin (may state the vitamin) supplementation.

May assist in the management of dysmenorrhoea. [Warning S required]

For the symptomatic relief of pre-menstrual tension/syndrome. [Warning S required]

Relief of pre-menstrual breast pain. [Warning S required]

Relief of menstrual symptoms. [Warning S required]

Relief of menstrual cramps. [Warning S required]

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

Relief of menstrual pain. [Warning S required]

Specific Indications

* Supports/maintains normal/healthy menstruation.

Public Summary

Page 1 of

Produced at 26.11.2017 at 04:10:13 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

* May assists in the relief of nervous tension, moodiness and/or irritability associated with pre-menstrual tension/syndrome.

* May assist in the relief of abdominal bloating and fluid retention associated with pre-menstrual tension/syndrome.

* May assist in the relief of headaches associated with pre-menstrual syndrome/tension.

* Rhodiola has adaptogenic activity and may therefore assist in improving the resistance of the body's various types of stress and anxiety.

* Rhodiola may assist the body to adapt to physically and mentally draining circumstances.

* Rhodiola is an adaptogenic herb and can therefore help to increase the capacity to adapt to stressful conditions.

* May be beneficial during times of stress.

* Helps perform in peak condition.

* Supports energy and endurance during training/exercise.

* Supports vitality and stamina and physical endurance.

* Rhodiola has been traditionally used in Russia and Asia as a tonic to increase physical endurance and concentration.

* Rhodiola has been traditionally used to enhance physical and cognitive performance.

* May help to reduce the effects of mental and physical fatigue during stressful situations.

* May provide support during times of fatigue support work capacity and concentration.

* Supports mental clarity and support cognitive function.

* May help to increase mental performance during stressful situations.

* Supports memory and learning.

· Rhodiola has a long history of use in traditional medical systems in Eastern Europe and Asia as a brain tonic and for supporting healthy mood, work

performance and energy.

* Supports/maintains the health of the cardiovascular system.

* Rhodiola is an antioxidant herb and may therefore assist in reducing the harmful effects of free radicals. * Contains vitamin B6, which is involved in

immune system processes.

* Contains nutrients, which play a role in the metabolism of proteins, fats and carbohydrates.

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

Chromium picolinate

241 microgram

Magnesium amino acid chelate

500 mg

pyridoxine hydrochloride

60.78 mg

Rhodiola rosea

250 mg

Equivalent: Rhodiola rosea (Dry)

Vitex agnus-castus

200 mg

Equivalent: Vitex agnus-castus (Dry)

© 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 26.11.2017 at 04:10:13 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