Scivit Ultra Cranberry

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

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Active ingredient:
ascorbic acid,Vaccinium macrocarpon
Available from:
Bio-Health Group Pty Ltd
INN (International Name):
Ascorbic acid,Vaccinium macrocarpon
Authorization status:
Listed
Authorization number:
293506

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Public Summary

Summary for ARTG Entry:

293506

Scivit Ultra Cranberry

ARTG entry for

Medicine Listed

Sponsor

Bio-Health Group Pty Ltd

Postal Address

39 Rockgarden Drive,Truganina, VIC, 3029

Australia

ARTG Start Date

4/09/2017

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. Scivit Ultra Cranberry

Product Type

Single Medicine Product

Effective date

4/09/2017

Warnings

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

Standard Indications

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

Specific Indications

*Cranberry helps support healthy urinary tract function.

*Clinical research indicate that cranberry can assist in the maintenance of healthy urinary tract.

*Cranberry is a good source of antioxidants to assist in protecting the body from the damage effects of free radicals.

*Cranberry is rich in proanthocyanidins that helps maintain healthy cardiovascular system function and cholesterol health.

*Vitamin C helps maintain healthy immune system.

*Vitamin C is a powerful antioxidant which helps protect against free radical damage and maintain good health.

*Helps maintain / support healthy urinary tract.

*Helps maintain / support healthy urinary tract function.

Additional Product information

Pack Size/Poison information

Pack Size

Poison Schedule

Components

1. Formulation 1

Dosage Form

Capsule, hard

Route of Administration

Oral

Visual Identification

Active Ingredients

Public Summary

Page 1 of

Produced at 24.11.2017 at 06:21:32 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

Ascorbic acid

50 mg

Vaccinium macrocarpon

500 mg

Equivalent: Vaccinium macrocarpon (Dry)

50 g

© 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 06:21:32 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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