NUTRA-LIFE

Main information

Documents

Localization

  • Available in:
  • NUTRA-LIFE PROBIOTIC 50 BILLION
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 215861
  • Last update:
  • 09-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

215861

NUTRA-LIFE PROBIOTIC 50 BILLION

ARTG entry for

Medicine Listed

Sponsor

Vitaco Health Australia Pty Ltd

Postal Address

PO Box 399,NORTH RYDE BC, NSW, 1670

Australia

ARTG Start Date

10/10/2013

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. NUTRA-LIFE PROBIOTIC 50 BILLION

Product Type

Single Medicine Product

Effective date

25/10/2013

Warnings

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

Adults only. OR Not to be used in children under two years of age without medical advice (or words to that effect).

Standard Indications

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

Specific Indications

* Supports the immune system. * Supports healthy immune function. * Maintains a normal/healthy immune system. * Probiotics support the human

immune system and immune function. * Bifidobacterium lactis improves immune parameters in healthy people. * Aids, assists or helps in the

maintenance of general intestinal/gut health.* Supports/maintains the health of the gastrointestinal tract.* Assists in maintaining healthy gut microflora.*

May assist in maintaining healthy balance of microflora after antibiotic administration.* Supports healthy bowel habits and the health of the bowel * Helps

maintain healthy bowel habit.* Prenatal supplementation may assist healthy immune parameters in the newborn.* Supplementation during pregnancy

and whilst breastfeeding may support healthy immune function of the newborn after birth.* Supplementation by expectant mothers prior to birth may

assist in healthy gastrointestinal colonisation of the newborn for the first few months of life.* May assist in maintaining urinary & genital tract health.* Oral

probiotic supplementation supports healthy vaginal colonisation.* Oral probiotic supplementation supports healthy vaginal microflora. * May help to

reduce the risk/incidence of mild upper respiratory tract infections

Additional Product information

Pack Size/Poison information

Pack Size

Poison Schedule

Components

1. Formulation 1

Dosage Form

Capsule, modified release

Route of Administration

Oral

Visual Identification

Public Summary

Page 1 of

Produced at 26.11.2017 at 07:55:50 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

Active Ingredients

Bifidobacterium animalis ssp lactis

10 billion CFU

Bifidobacterium animalis ssp lactis

10 billion CFU

Bifidobacterium breve

2.5 billion CFU

Bifidobacterium longum

2.5 billion CFU

Lactobacillus acidophilus

20 billion CFU

Lactobacillus casei

1.25 billion CFU

Lactobacillus delbrueckii ssp bulgaricus

.25 billion CFU

Lactobacillus paracasei subsp. paracasei

1 billion CFU

Lactobacillus plantarum

1 billion CFU

Lactobacillus rhamnosus

.5 billion CFU

Lactobacillus salivarius ssp salivarius

1 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 07:55:50 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

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