NATURE'S

Main information

Documents

Localization

  • Available in:
  • NATURE'S PATH EX-STRESS
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 65616
  • Last update:
  • 01-12-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

65616

NATURE'S PATH EX-STRESS Capsule - hard bottle

ARTG entry for

Medicine Listed

Sponsor

MMS International Health Products Pty Ltd

Postal Address

PO Box 2631,SYDNEY, NSW, 2001

Australia

ARTG Start Date

31/07/1998

Product category

Medicine

Status

Active

Approval area

Listed Medicines

Conditions

Except where the sponsor has been contracted by an overseas partry to manufacturer the goods and that party will be responsible for placing the goods

on the market in countries other than Australia, the sponsor must have and shall retain, while the goods remain listed, evidence necessary to

substantiate and support the accuracy of the indications in relation to the listed goods, and upon the request of the Head, Office of Prescription

Medicines Authorisation Branch, Therapeutic Goods Administration, shall produce such evidence to this officer.

A copy of a signed and dated certificate of analysis, which is not more than six months old, for the first batch of goods manufactured is to be provided to

the Head, Listing Treaties & Export Section, Chemical & Non Prescription Drug Branch within six months of the date of supply of the goods.

The conditions applying to these goods when they are exported from Australia are given below:

Conditions applicable to all therapeutic goods as specified in the document "Standard Conditions Applying to Registered or Listed Therapeutic Goods

Under Section 28 of the Therapeutic Goods Act 1989" effective 1 July 1995, other than condition No. 8 and condition No. 9.

Conditions applicable to the relevant category and class of therapeutic goods as specified in the document "Standard Conditions Applying to Registered

or Listed Therapeutic Goods Under Section 28 of the Therapeutic Goods Act 1989" effective 1 July 1995, other than condition No.11

Conditions applicable to all therapeutic goods as specified in the document "Standard Conditions Applying to Registered or Listed Therapeutic Goods

Under Section 28 of the Therapeutic Goods Act 1989" effective 1 July 1995.

Conditions applicable to the relevant category and class of therapeutic goods as specified in the document "Standard Conditions Applying to Registered

or Listed Therapeutic Goods Under Section 28 of the Therapeutic Goods Act 1989" effective 1 July 1995.

Products

1. NATURE'S PATH EX-STRESS

Product Type

Single Medicine Product

Effective date

3/07/2002

Warnings

No Warnings included on Record

Standard Indications

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

Relief of sleeplessness. [Warning S required]

Relief of insomnia. [Warning S required]

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

Beneficial during times of stress. [Warning S required]

Specific Indications

Has a calming effect and calms the nerves, stress and tension. Improves stress adaptation. Ex-Stress is a herbal blend which helps relieve stress of

study or work. Also for the relief of irritability, restlessness, nervous unrest. May reduce the effects of mild anxiety and nervous tension.

Additional Product information

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Bottle

Not recorded

5 Years

Store below 30

degrees Celsius

Not recorded

Not recorded

Pack Size/Poison information

Pack Size

Poison Schedule

Not scheduled. Not considered by committee

Components

1. COMPONENT ONE

Dosage Form

Capsule, hard

Route of Administration

Oral

Public Summary

Page 1 of

Produced at 01.12.2017 at 09:00:12 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

Visual Identification

Size 0 clear capsule, light green to green-tan powder

Active Ingredients

Black Cohosh Powder

68 mg

Capsicum Powder

22 mg

Hop Strobile Powder

68 mg

Scutellaria lateriflora

102 mg

Stachys officinalis

102 mg

Valerian Powder

68 mg

© 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 01.12.2017 at 09:00:12 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

15-2-2019

Safety of Yarrowia lipolytica yeast biomass as a novel food pursuant to Regulation (EU) 2015/2283

Safety of Yarrowia lipolytica yeast biomass as a novel food pursuant to Regulation (EU) 2015/2283

Published on: Thu, 14 Feb 2019 Following a request from the European Commission, the EFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA) was asked to deliver a scientific opinion on Yarrowia lipolytica yeast biomass as a novel food (NF) pursuant to Regulation (EU) 2015/2283. The NF is the dried and heat‐killed biomass of Yarrowia lipolytica, a yeast species that is widespread in nature and which can be found in the environment as well as in foods. The production process is sufficiently describ...

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Sun Pharmaceutical Industries, Inc. (SPII), a wholly owned subsidiary of Sun Pharmaceutical Industries, Ltd. is voluntarily recalling three lots of Vecuronium Bromide for Injection, 10 mg (lyophilized powder), and one lot of Vecuronium Bromide for Injection, 20 mg (lyophilized powder) to the hospital level. The Vecuronium Bromide for Injection has been found to contain particulate matter identified as glass.

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23-7-2018

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FDA - U.S. Food and Drug Administration

23-7-2018

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2-7-2018

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FDA - U.S. Food and Drug Administration