ETHICAL

Main information

  • Trade name:
  • ETHICAL NUTRIENTS ALLERGY CONTROL
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • ETHICAL NUTRIENTS ALLERGY CONTROL
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 217301
  • Last update:
  • 09-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

217301

ETHICAL NUTRIENTS ALLERGY CONTROL

ARTG entry for

Medicine Listed

Sponsor

Health World Ltd

Postal Address

PO Box 675,VIRGINIA BC, QLD, 4014

Australia

ARTG Start Date

14/11/2013

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. ETHICAL NUTRIENTS ALLERGY CONTROL

Product Type

Single Medicine Product

Effective date

14/11/2013

Warnings

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

Standard Indications

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

Relief of the symptoms of hayfever. [Warning S required]

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

Specific Indications

Lactobacillus paracasei LP33 helps reduce frequency and severity of symptoms of allergic rhinitis/hayfever, such as stuffy/blocked, runny itchy nose,

sneezing, itchy, watery, swollen/puffy, sore eyes, thirst, not feeling well all over, irritable, tired, headaches and scratchy/itchy throat.

Lactobacillus paracasei LP33 may help to relieve environmental allergies such as allergic rhinitis induced by the house dust-mite/reduce allergic

sensitivity and allergic rhinitis induced by the house dust-mite.

Lactobacillus paracasei LP33 for the symptomatic relief of allergic rhinitis.

Clinically trialled. May be beneficial for quality of life for people with hayfever/allergic rhinitis. Beneficial for hayfever/allergic rhinitis sufferers. Assists with

house dust-mite allergies (allergic rhinitis). Allergic rhinitis (also known as hayfever) affects around 15%-20% of people in Australia and New Zealand.

The house dust mite is a common causative factor of perennial allergic rhinitis. Matches clinical trial dose and strain. Live L.paracasei (LP33) organisms

showed efficacy in reducing the frequency of a greater number of allergic rhinitis sysmptoms than heat killed L. paracasei (LP33). Heat killed LP33 was

not effective in reducing the frequency or severity of eye allergy symptoms. Live LP33 was significantly effective in reducing the frequency of 5/6 allergy

symptoms measured as opposed to heat killed which was only effective in 3/6 symptoms.

Allergy Control contains the probiotic strain Lactobacillus paracasei (LP33) which has been clinically trialled in allergic rhinitis and shown to: reduce the

frequency and severity of allergy symptoms, assist with house dust mite allergies, relieve hay fever symptoms, relieve environmental allergies, reduce

allergic sensitivity, assist in the management of allergic rhinitis, relieve symptoms of allergies including a blocked, itchy, runny nose, sneezing, itchy and

watery eyes, puffy and sore eyes and an itchy throat.

Clinically Trialled to Reduce the Frequency of Allergic Rhinitis.

Additional Product information

Pack Size/Poison information

Public Summary

Page 1 of

Produced at 26.11.2017 at 06:24:29 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

Pack Size

Poison Schedule

Components

1. Formulation 1

Dosage Form

Capsule, hard

Route of Administration

Oral

Visual Identification

Active Ingredients

Lactobacillus paracasei

10 billion CFU

© 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 06:24:29 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

31-10-2018

Safety and efficacy of Lactobacillus hilgardii CNCM I‐4785 and Lactobacillus buchneri CNCM I‐4323/NCIMB 40788 as a silage additive for all animal species

Safety and efficacy of Lactobacillus hilgardii CNCM I‐4785 and Lactobacillus buchneri CNCM I‐4323/NCIMB 40788 as a silage additive for all animal species

Published on: Tue, 30 Oct 2018 00:00:00 +0100 Following a request from the European Commission, the Panel on Additives and Products or Substances used in Animal Feed was asked to deliver a scientific opinion on the safety and efficacy of a strain of Lactobacillus hilgardii and of Lactobacillus buchneri when used as a technological additive intended to improve ensiling at a proposed application rate of 3.0 x 108 colony forming units (CFU)/kg fresh material. The two bacterial species are considered by EFS...

Europe - EFSA - European Food Safety Authority Publications

27-7-2018

Scientific guideline:  Reflection paper on dose optimisation of established veterinary antibiotics in the context of summary of product characteristics (SPC) harmonisation, draft: consultation open

Scientific guideline: Reflection paper on dose optimisation of established veterinary antibiotics in the context of summary of product characteristics (SPC) harmonisation, draft: consultation open

Established veterinary antibiotics are not always used at the authorised dose, and the dose may need to be reviewed in order to maintain their effectiveness whilst limiting the risks of antimicrobial resistance. Before a new dose is introduced, the company would typically have to conduct new studies to ensure it does not negatively affect the safety of the target animal, the consumer of animal produce, or the environment. This may reduce product availability, which could have a negative impact on antimic...

Europe - EMA - European Medicines Agency