Perdays Pregnancy Probiotic 360° & Vitamin D

Australia - English - Department of Health (Therapeutic Goods Administration)

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Active ingredient:
Bifidobacterium animalis ssp lactis,Bifidobacterium breve,Bifidobacterium infantis,Bifidobacterium lactis,Bifidobacterium longum,colecalciferol,fructooligosaccharides,Lactobacillus acidophilus,Lactobacillus delbrueckii ssp bulgaricus,Lactobacillus paracasei,Lactobacillus plantarum,Lactobacillus reuteri,Lactobacillus rhamnosus,Lactobacillus salivarius ssp salivarius
Available from:
PERDAY'S HEALTH FUNCTIONAL FOOD (AU) PTY LTD
Authorization status:
Listed
Authorization number:
347700

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Public Summary

Summary for ARTG Entry:

347700

Perdays Pregnancy Probiotic 360° & Vitamin D

ARTG entry for

Medicine Listed

Sponsor

PERDAY'S HEALTH FUNCTIONAL FOOD (AU) PTY LTD

Postal Address

Suite 505 Level 5 815 Pacific Highway, Chatswood, NSW, 2067

Australia

ARTG Start Date

9/11/2020

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 . Perdays Pregnancy Probiotic 360° & Vitamin D

Product Type

Single Medicine Product

Effective Date

9/11/2020

Permitted Indications

Maintain/support general health and wellbeing

Helps maintain/support healthy blood sugar/glucose

Support healthy emotional/mood balance

Maintain/support vaginal healthy flora/microflora

Helps reduce occurrence of symptoms of eczema/dermatitis in healthy children under 2 years of age

Indication Requirements

Product presentation must not imply or refer to mental illnesses, disorders or conditions.

Product presentation must not imply or refer to lowering or raising blood sugar/glucose levels from outside of the normal healthy range.

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

Standard Indications

No Standard Indications included on Record

Specific Indications

No Specific Indications included on Record

Warnings

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

Additional Product information

Pack Size/Poison information

Pack Size

Poison Schedule

Components

1 . Formulation 1

Dosage Form

Capsule, hard

Route of Administration

Oral

Public Summary

Page 1 of

Produced at 11.01.2021 at 11:12:22 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

Active Ingredients

Bifidobacterium animalis ssp lactis

100 million CFU

Bifidobacterium breve

100 million CFU

Bifidobacterium infantis

100 million CFU

Bifidobacterium lactis

100 million CFU

Bifidobacterium longum

100 million CFU

colecalciferol

.025 mg

fructooligosaccharides

10 mg

Lactobacillus acidophilus

9 billion CFU

Lactobacillus delbrueckii ssp bulgaricus

100 million CFU

Lactobacillus paracasei

100 million CFU

Lactobacillus plantarum

100 million CFU

Lactobacillus reuteri

100 million CFU

Lactobacillus rhamnosus

6 billion CFU

Lactobacillus salivarius ssp salivarius

100 million CFU

Other Ingredients (Excipients)

carrageenan

colloidal anhydrous silica

dl-alpha-tocopherol

hypromellose phthalate

hypromellose

magnesium stearate

maltodextrin

medium chain triglycerides

microcrystalline cellulose

potassium acetate

purified water

titanium dioxide

trehalose dihydrate

vegetable oil

© 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 11:12:22 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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