Alliaus HEALTHY NATURAL PREGNANCY with Probiotics and Prebiotics

オーストラリア - 英語 - Department of Health (Therapeutic Goods Administration)

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公開評価報告書 公開評価報告書 (PAR)

11-01-2021

有効成分:
Bifidobacterium lactis,fructooligosaccharides,Lactobacillus rhamnosus
から入手可能:
Health Sharing Group Pty Ltd
認証ステータス:
Listed
承認番号:
351745

完全なドキュメントを読む

Public Summary

Summary for ARTG Entry:

351745

Alliaus HEALTHY NATURAL PREGNANCY with Probiotics and Prebiotics

ARTG entry for

Medicine Listed

Sponsor

Health Sharing Group Pty Ltd

Postal Address

36 Amax Avenue, GIRRAWEEN, NSW, 2145

Australia

ARTG Start Date

15/12/2020

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.

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 . Alliaus HEALTHY NATURAL PREGNANCY with Probiotics and Prebiotics

Product Type

Single Medicine Product

Effective Date

24/12/2020

Permitted Indications

Maintain/support healthy pregnancy

Maintain/support maternal health

Helps reduce occurrence of symptoms of eczema/dermatitis in infants

Indication Requirements

Label statement: If symptoms persist, talk to your health professional.

Label statement: If you are concerned about the health of yourself or your baby, talk to your health practitioner.

If directed to women, Label statement: Advise your doctor of any medicine you take during pregnancy, particularly in your first trimester.

Label statement: Advise your doctor of any medicine you take during pregnancy, particularly in your first trimester.

Standard Indications

No Standard Indications included on Record

Specific Indications

No Specific Indications included on Record

Warnings

Contains lactose (or words to that effect).

Additional Product information

Pack Size/Poison information

Pack Size

Poison Schedule

Components

1 . Formulation 1

Dosage Form

Powder, oral

Route of Administration

Oral

Visual Identification

Public Summary

Page 1 of

Produced at 11.01.2021 at 08:22:20 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 lactis

2 billion CFU/g

fructooligosaccharides

10 mg/g

Lactobacillus rhamnosus

4 billion CFU/g

Other Ingredients (Excipients)

Flavour

lecithin

maltodextrin

Stevia rebaudiana

whole dry milk

© 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 11.01.2021 at 08:22:20 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

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