NUTRA-LIFE

Main information

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

Documents

Localization

  • Available in:
  • NUTRA-LIFE BIO-CURCUMIN
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 217653
  • Last update:
  • 09-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

217653

NUTRA-LIFE 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. NUTRA-LIFE BIO-CURCUMIN

Product Type

Single Medicine Product

Effective date

24/03/2017

Warnings

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

Standard Indications

May help reduce the oxidation of LDL cholesterol.

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

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

May help reduce joint inflammation associated with arthritis.

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

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.

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

For the symptomatic relief of medically diagnosed irritable bowel syndrome

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

May assist in the management of medically diagnosed irritable bowel syndrome

May help reduce joint swelling associated with arthritis.

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

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 06:10:05 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 06:10:05 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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FDA - U.S. Food and Drug Administration

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FDA - U.S. Food and Drug Administration

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FDA - U.S. Food and Drug Administration

7-12-2018

Fine Land Corp Issues Allergy Alert on Undeclared Milk Allergens in “Meiqili Durian Candy”

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FDA - U.S. Food and Drug Administration

7-12-2018

Accra Super Market Issues Allergy Alert On Undeclared Peanuts In 'Suya Barbecue Seasoning'

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FDA - U.S. Food and Drug Administration

7-12-2018

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6-12-2018

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FDA - U.S. Food and Drug Administration

6-12-2018

Country Flavor Inc Issues Alert on Undeclared Sulfites In "Best Taste Brand Dried Bamboo Shoot"

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FDA - U.S. Food and Drug Administration

5-12-2018

Public health risks associated with food‐borne parasites

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Europe - EFSA - European Food Safety Authority Publications

5-12-2018

Chukar Cherries Expands Recall of Ultra Dark Chocolate Product Due to Undeclared Milk

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Chukar Cherries of Prosser, WA expands a recall on Ultra Dark Chocolate product because it may contain undeclared milk. People who have an allergy or severe sensitivity to milk run the risk of serious or life-threatening allergic reaction if they consume these products.

FDA - U.S. Food and Drug Administration

5-12-2018

Hiland Dairy Announces Voluntary Recall of Hiland Dairy Half-Gallon Whole Chocolate Milk

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Hiland Dairy is announcing a voluntary recall of half-gallon premium whole milk chocolate that is produced at the Kansas City, Missouri facility, over concerns the products may contain eggnog that could affect those individuals that have sensitivity to egg allergens. People who have an allergy or severe sensitivity to eggs run the risk of serious or life-threatening allergic reaction if they consume these products.

FDA - U.S. Food and Drug Administration

1-12-2018

Tres Hermanos Bakery Issues Allergy Alert on Undeclared Milk in Telera and Bolillo Breads

Tres Hermanos Bakery Issues Allergy Alert on Undeclared Milk in Telera and Bolillo Breads

Tres Hermanos Bakery of Wyoming, MI is recalling its white Telera and Bolillo Mexican salt breads because they may contain undeclared milk. People who have allergies to milk run the risk of serious or life-threatening allergic reaction if they consume these products.

FDA - U.S. Food and Drug Administration

30-11-2018

Data collection for the estimation of ecological data (specific focal species, time spent in treated areas collecting food, composition of diet), residue level and residue decline on food items to be used in the risk assessment for birds and mammals

Data collection for the estimation of ecological data (specific focal species, time spent in treated areas collecting food, composition of diet), residue level and residue decline on food items to be used in the risk assessment for birds and mammals

Published on: Thu, 29 Nov 2018 The study described in this report was conducted with the aim of developing an unified database of ecological data and residue data to be used for the risk assessment of plant protection products for birds and mammals. The main sources of data were the information submitted in the context of approval of active substances and authorization of products and and additional information retrieved through a systematic literature review. The data were screened and organised in thr...

Europe - EFSA - European Food Safety Authority Publications

24-11-2018

Ottogi America, Inc. Issues Allergy Alert on Undeclared Egg in Product

Ottogi America, Inc. Issues Allergy Alert on Undeclared Egg in Product

Ottogi America, Inc. of Gardena, California announced today it is recalling 1lb 5.16ounce of Jin Ramen Mild 5pk. (Best Before Aug. 19th 2019) and Jin Ramen Spicy 5pk. (Best Before Aug. 20th 2019) due to undeclared egg as an ingredient on the packages. People who have an allergy or severe sensitivity to eggs run the risk of serious or life-threatening allergic reaction if they consume these products.

FDA - U.S. Food and Drug Administration

23-11-2018

FDA Classifies Field Action Related to Fc 500™ And Epics® As Class 1 Recall Beckman Coulter Life Sciences Committed to Helping Customers Take Prompt, Appropriate Actions

FDA Classifies Field Action Related to Fc 500™ And Epics® As Class 1 Recall Beckman Coulter Life Sciences Committed to Helping Customers Take Prompt, Appropriate Actions

Beckman Coulter Life Sciences today announced the previously communicated global voluntary recall launched in January 2018 related to the FC 500™ Series Flow Cytometers (FC 500), COULTER® EPICS® XL™ and COULTER® EPICS® XL-MCL™ Flow Cytometer with System II Software (together referred to as the EPICS) has been classified as Class 1 by the U.S. Food and Drug Administration (FDA).

FDA - U.S. Food and Drug Administration

22-11-2018

Foreign Product Alert: Black Lion Pill, Help 100% & Pure Natural & Body Slim capsules, Herba Saraf, Horny Little Devil, Ja Dera Max capsules, Lida (Plus) capsules, Nutra Organics Green Tea Extract capsules, Papapa, Red Zone Xtreme 3000, Rhino 69 Extreme 5

Foreign Product Alert: Black Lion Pill, Help 100% & Pure Natural & Body Slim capsules, Herba Saraf, Horny Little Devil, Ja Dera Max capsules, Lida (Plus) capsules, Nutra Organics Green Tea Extract capsules, Papapa, Red Zone Xtreme 3000, Rhino 69 Extreme 5

These foreign health products have been found by regulators in other countries to contain undeclared drug ingredients and/or unacceptable contaminant(s).

Health Canada

21-11-2018

First Source Issues Allergy Alert on Undeclared Pecan and Cashew in Chocolate and Nut Tray

First Source Issues Allergy Alert on Undeclared Pecan and Cashew in Chocolate and Nut Tray

First Source of Tonawanda, NY, is voluntarily recalling Chocolate and Nut Tray because it contains undeclared tree nuts, pecan and cashew. People who have an allergy or sensitivity to tree nuts (Pecan & Cashew) run the risk of serious or life-threatening allergic reaction if they consume this product.

FDA - U.S. Food and Drug Administration

20-11-2018

FDA approves first treatment specifically for patients with rare and life-threatening type of immune disease

FDA approves first treatment specifically for patients with rare and life-threatening type of immune disease

The FDA approved Gamifant (emapalumab-lzsg) for the treatment of pediatric (newborn and above) and adult patients with primary hemophagocytic lymphohistiocytosis (HLH) who have refractory, recurrent or progressive disease or intolerance with conventional HLH therapy. This FDA approval is the first for a drug specifically for HLH.

FDA - U.S. Food and Drug Administration

19-11-2018

Jay Robb Enterprises Issues Allergy Alert on Undeclared Milk Allergen in Unflavored Egg White Protein

Jay Robb Enterprises Issues Allergy Alert on Undeclared Milk Allergen in Unflavored Egg White Protein

Jay Robb Enterprises is recalling Jay Robb Unflavored Egg White Protein Product, manufactured by Agropur MSI, LLC of La Crosse, Wisconsin, because it may contain undeclared milk allergen. People who have an allergy or severe sensitivity to milk run the risk of serious or life-threatening allergic reaction if they consume these products.

FDA - U.S. Food and Drug Administration

17-11-2018

Chukar Cherries Issues Allergy Alert on Undeclared Milk in 7.5 Oz Amaretto Rainier Chocolate Cherries Pouches

Chukar Cherries Issues Allergy Alert on Undeclared Milk in 7.5 Oz Amaretto Rainier Chocolate Cherries Pouches

Chukar Cherries of Prosser, WA is recalling 7.5oz Amaretto Rainier Chocolate Cherries because they may contain undeclared milk. People who have an allergy or severe sensitivity to milk run the risk of serious or life-threatening allergic reaction if they consume this product.

FDA - U.S. Food and Drug Administration

14-11-2018

Nor Cal Food Solutions, LLC ISSUES ALLERGY ALERT ON UNDECLARED Tree Nut – Walnut in The Purveyors Kitchen - Pumpkin Pesto Tapenade

Nor Cal Food Solutions, LLC ISSUES ALLERGY ALERT ON UNDECLARED Tree Nut – Walnut in The Purveyors Kitchen - Pumpkin Pesto Tapenade

Nor Cal Food Solutions, LLC of Auburn, CA is announcing a recall of 567 cases of Pumpkin Pesto Tapenade, manufactured by Purveyors Kitchen, because it contains an undeclared tree nut (walnut). People who have an allergy or severe sensitivity to tree nuts (walnuts) run the risk of serious or life-threatening allergic reaction if they consume this product.

FDA - U.S. Food and Drug Administration

15-3-2019

reviewers, compliance officers and other experts would work in teams responsible for device oversight throughout the product's development and  commercialization. This is known as a Total Product Life Cycle  approach or #TPLC.

reviewers, compliance officers and other experts would work in teams responsible for device oversight throughout the product's development and commercialization. This is known as a Total Product Life Cycle approach or #TPLC.

reviewers, compliance officers and other experts would work in teams responsible for device oversight throughout the product's development and commercialization. This is known as a Total Product Life Cycle approach or #TPLC.

FDA - U.S. Food and Drug Administration

6-3-2019

Today @US_FDA made an update to a Safety Communication on the Zoll LifeVest 4000 Wearable Cardioverter Defibrillator: Software Update for Potential Lack of Treatment (Shock) Delivery Due to Device Failure. Read more:  https://go.usa.gov/xEfkX  #MedicalDev

Today @US_FDA made an update to a Safety Communication on the Zoll LifeVest 4000 Wearable Cardioverter Defibrillator: Software Update for Potential Lack of Treatment (Shock) Delivery Due to Device Failure. Read more: https://go.usa.gov/xEfkX  #MedicalDev

Today @US_FDA made an update to a Safety Communication on the Zoll LifeVest 4000 Wearable Cardioverter Defibrillator: Software Update for Potential Lack of Treatment (Shock) Delivery Due to Device Failure. Read more: https://go.usa.gov/xEfkX  #MedicalDevice #FDA pic.twitter.com/WZZjTq0BMX

FDA - U.S. Food and Drug Administration

28-2-2019

If a person has cardiac arrest, rapid treatment with a #medicaldevice called an automated external defibrillator (AED) can be life-saving. Here's how. link:  https://go.usa.gov/xEpzJ?utm_source=CDRHTwitterD … #heartmonthpic.twitter.com/fmj3uU8yb7

If a person has cardiac arrest, rapid treatment with a #medicaldevice called an automated external defibrillator (AED) can be life-saving. Here's how. link: https://go.usa.gov/xEpzJ?utm_source=CDRHTwitterD … #heartmonthpic.twitter.com/fmj3uU8yb7

If a person has cardiac arrest, rapid treatment with a #medicaldevice called an automated external defibrillator (AED) can be life-saving. Here's how. link: https://go.usa.gov/xEpzJ?utm_source=CDRHTwitterD … #heartmonth pic.twitter.com/fmj3uU8yb7

FDA - U.S. Food and Drug Administration

20-2-2019


Solifenacin / tamsulosin: List of nationally authorised medicinal products - PSUSA/00010285/201807

Solifenacin / tamsulosin: List of nationally authorised medicinal products - PSUSA/00010285/201807

Solifenacin / tamsulosin: List of nationally authorised medicinal products - PSUSA/00010285/201807

Europe - EMA - European Medicines Agency

20-2-2019

Pixuvri (CTI Life Sciences Deutschland GmbH)

Pixuvri (CTI Life Sciences Deutschland GmbH)

Pixuvri (Active substance: pixantrone) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2019)1510 of Wed, 20 Feb 2019 European Medicines Agency (EMA) procedure number: EMEA/H/C/002055/T/0045

Europe -DG Health and Food Safety

14-2-2019

EU/3/16/1656 (Sellas Life Sciences Limited)

EU/3/16/1656 (Sellas Life Sciences Limited)

EU/3/16/1656 (Active substance: Tyr-Met-Phe-Pro-Asn-Ala-Pro-Tyr-Leu, Ser-Gly-Gln-Ala-Tyr-Met-Phe-Pro-Asn-Ala-Pro-Tyr-Leu-Pro-Ser-Cys-Leu-Glu-Ser, Arg-Ser-Asp-Glu-Leu-Val-Arg-His-His-Asn-Met-His-Gln-Arg-Asn-Met-Thr-Lys-Leu and Pro-Gly-Cys-Asn-Lys-Arg-Tyr-Phe-Lys-Leu-Ser-His-Leu-Gln-Met-His-Ser-Arg-Lys-His-Thr-Gly) - Transfer of orphan designation - Commission Decision (2019)1346 of Thu, 14 Feb 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000003557

Europe -DG Health and Food Safety

14-2-2019

EU/3/16/1655 (Sellas Life Sciences Limited)

EU/3/16/1655 (Sellas Life Sciences Limited)

EU/3/16/1655 (Active substance: Tyr-Met-Phe-Pro-Asn-Ala-Pro-Tyr-Leu, Ser-Gly-Gln-Ala-Tyr-Met-Phe-Pro-Asn-Ala-Pro-Tyr-Leu-Pro-Ser-Cys-Leu-Glu-Ser, Arg-Ser-Asp-Glu-Leu-Val-Arg-His-His-Asn-Met-His-Gln-Arg-Asn-Met-Thr-Lys-Leu and Pro-Gly-Cys-Asn-Lys-Arg-Tyr-Phe-Lys-Leu-Ser-His-Leu-Gln-Met-His-Ser-Arg-Lys-His-Thr-Gly) - Transfer of orphan designation - Commission Decision (2019)1345 of Thu, 14 Feb 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000003572

Europe -DG Health and Food Safety

23-1-2019


No new patients should start treatment with Lartruvo after study shows cancer medicine does not prolong life

No new patients should start treatment with Lartruvo after study shows cancer medicine does not prolong life

No new patients should start treatment with Lartruvo after study shows cancer medicine does not prolong life

Europe - EMA - European Medicines Agency

19-12-2018

The Breakthrough Devices Program’s goal is to provide patients and health care providers with timely access to devices that treat or diagnose a life-threatening or irreversibly debilitating condition.

The Breakthrough Devices Program’s goal is to provide patients and health care providers with timely access to devices that treat or diagnose a life-threatening or irreversibly debilitating condition.

The Breakthrough Devices Program’s goal is to provide patients and health care providers with timely access to devices that treat or diagnose a life-threatening or irreversibly debilitating condition.

FDA - U.S. Food and Drug Administration

22-11-2018

Neuraceq (Life Radiopharma Berlin GmbH)

Neuraceq (Life Radiopharma Berlin GmbH)

Neuraceq (Active substance: florbetaben (18F)) - Centralised - Renewal - Commission Decision (2018)7882 of Thu, 22 Nov 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2553/R/25

Europe -DG Health and Food Safety

20-11-2018

.@US_FDA issues Class I Medical Device Recall, the most serious type of recall: Beckman Coulter Life Sciences Beckman Coulter Life Sciences recalls the FC500 Series Flow Cytometers and EPICS XL Series Flow Cytometers. Find out more:  https://go.usa.gov/xP

.@US_FDA issues Class I Medical Device Recall, the most serious type of recall: Beckman Coulter Life Sciences Beckman Coulter Life Sciences recalls the FC500 Series Flow Cytometers and EPICS XL Series Flow Cytometers. Find out more: https://go.usa.gov/xP

. @US_FDA issues Class I Medical Device Recall, the most serious type of recall: Beckman Coulter Life Sciences Beckman Coulter Life Sciences recalls the FC500 Series Flow Cytometers and EPICS XL Series Flow Cytometers. Find out more: https://go.usa.gov/xPAtn  #MedicalDevice #FDA pic.twitter.com/6e064UQ2wg

FDA - U.S. Food and Drug Administration