WAGNER

Main information

  • Trade name:
  • WAGNER BIO-CURCUMIN
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • WAGNER BIO-CURCUMIN
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 217651
  • Last update:
  • 09-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

217651

WAGNER BIO-CURCUMIN

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

22/11/2013

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. WAGNER BIO-CURCUMIN

Product Type

Single Medicine Product

Effective date

9/02/2015

Warnings

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

Standard Indications

Temporary relief of the pain of arthritis. (or) Temporary relief of arthritic pain. [Warning S required]

May assist in the maintenance of cholesterol within the normal range in healthy individuals.

For the symptomatic relief of medically diagnosed irritable bowel syndrome

May assist in the management of medically diagnosed irritable bowel syndrome

May assist in the maintenance of a normal/healthy LDL:HDL cholesterol ratio.

May assist in the management of osteoarthritic pain. [Warning S required]

May assist in the management of osteoarthritis. [Warning S required]

Symptomatic relief of osteoarthritis. [Warning S required]

Temporary relief of the pain of osteoarthritis (or) Temporary relief of osteoarthritic pain. [Warning S required]

May help increase joint mobility associated with arthritis.

May help reduce joint swelling associated with arthritis.

May help reduce joint inflammation associated with arthritis.

May help reduce the oxidation of LDL cholesterol.

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

May assist in the maintenance of cholesterol within the normal/healthy range in healthy individuals and improve the LDL:HDL ratio.

May assist in the maintenance of normal/healthy cholesterol levels in healthy individuals.

Specific Indications

* Has been shown in clinical trials to decrease pain and inflammation and assist in the management and symptomatic relief of osteoarthritis.

* Phytosomes of curcumin and lecithin, as found in Meriva, increases the bioavailability of curcumin.

* Meriva utilises a combination of curcumin with phosphatidylcholine to enhance intestinal absorption and tissue delivery of the curcumin.

* Meriva utilises a combination of curcumin with phosphatidylcholine to increase efficacy of curcumin through improved absorption.

Public Summary

Page 1 of

Produced at 26.11.2017 at 06:10:26 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

* Supports gastrointestinal health.

* Antioxidant or free radical scavenger.

* Has antioxidant activity and therefore assists in protecting the body from the damaging effects of free radicals.

* Helps to inhibit free radical cellular damage.

* Antioxidants are involved in inhibiting cellular damage attributed to free radicals.

* Antioxidants protect the body from the damaging effects of free radicals.

* Antioxidants reduce the risk of cell damage attributed to free radicals.

* Factors such as stress, alcohol, cigarettes and pollution may increase free radicals in the body and the potential for oxidative damage.

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

Curcumin

99 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 26.11.2017 at 06:10:26 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