Bio CPro 1000

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

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Active ingredient:
ascorbic acid,Rosa canina
Available from:
Bio-Practica Pty Ltd
INN (International Name):
Ascorbic acid,Rosa canina
Authorization status:
Listed
Authorization number:
292184

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Public Summary

Summary for ARTG Entry:

292184

Bio CPro 1000

ARTG entry for

Medicine Listed

Sponsor

Bio-Practica Pty Ltd

Postal Address

651 Portrush Road,GLEN OSMOND, SA, 5064

Australia

ARTG Start Date

28/07/2017

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. Bio CPro 1000

Product Type

Single Medicine Product

Effective date

28/07/2017

Warnings

Vitamins can only be of assistance if the dietary vitamin intake is inadequate. OR Vitamin supplements should not replace a balanced diet.

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

Standard Indications

Protects capillaries.

Maintain health of capillaries.

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

May assist in the prevention of vitamin [XX] deficiency when dietary intake is inadequate

Specific Indications

* Contains Vitamin C, which is an important nutritional antioxidant/free radical scavenger.

* As an antioxidant, vitamin C assists in protecting the body from the damaging effects of free radicals.

* Vitamin C is a potent antioxidant that can reduce the risk of cellular damage from free radicals.

* Vitamin C can regenerate oxidised vitamin E in the body.

* Contains Vitamin C, which aids iron absorption.

* Contains Vitamin C, which assists in maintaining a normal/healthy cardiovascular system.

* Vitamin C is necessary for the manufacture of collagen in the body.

* Vitamin C plays a role in collagen formation.

* Vitamin C supports the development and maintenance of bones.

* Vitamin C supports the development and maintenance of teeth.

* Vitamin C supports the development and maintenance of cartilage.

* Vitamin C supports connective tissue formation.

* Vitamin C is essential for the proper function of the immune system.

* Contains Vitamin C, which supports a normal/healthy immune system.

* Contains Vitamin C, which plays a vital role in many immune mechanisms.

* Contains Vitamin C, which is involved in many immune mechanisms in the body and supports healthy immune function.

* Contains Vitamin C, which supports healthy functioning of the immune system.

* Vitamin C is involved in the normal breakdown of cholesterol into bile acids.

* Contains Vitamin C, which is involved in neurotransmitter synthesis.

* Contains Vitamin C, which contributes to normal neurological function.

Public Summary

Page 1 of

Produced at 24.11.2017 at 07:24:45 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

* Vitamin C is necessary for minor wound healing.

* Vitamin C is necessary for the maintenance of healthy skin.

* Vitamin C assists in the healing and repair of the skin.

* Contains Vitamin C, which aids in the metabolism and synthesis of fats and proteins.

* Regular Vitamin C supplementation may aid in decreasing the duration of colds.

* Vitamin C supplementation may aid in reducing the incidence of colds in people exposed to short-term physical stress.

* Regular Vitamin C supplementation may aid in reducing the duration of colds.

Additional Product information

Pack Size/Poison information

Pack Size

Poison Schedule

Components

1. Formulation 1

Dosage Form

Tablet, film coated

Route of Administration

Oral

Visual Identification

Active Ingredients

Ascorbic acid

1 g

Rosa canina

50 mg

Equivalent: Rosa canina (Dry)

500 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 24.11.2017 at 07:24:45 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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