Natures

Main information

  • Trade name:
  • Natures Family Policosanol
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • Natures Family Policosanol
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 218514
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

218514

Natures Family Policosanol

ARTG entry for

Medicine Listed

Sponsor

Nature's Family Australia Pty Ltd

Postal Address

1 Curban Street Balgowlah Heights NSW 2093,Sydney, NSW, 2093

Australia

ARTG Start Date

13/12/2013

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. Natures Family Policosanol

Product Type

Single Medicine Product

Effective date

13/12/2013

Warnings

Not recommended for use by pregnant and lactating women (or words to that effect).

Standard Indications

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

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

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 a normal/healthy LDL:HDL cholesterol ratio.

May help to reduce intestinal absorption of cholesterol from dietary sources.

May help reduce the oxidation of LDL cholesterol.

Specific Indications

Cholesterol is a waxy, fat-like substance that travels throughout the body in the blood. In human bloodstream, cholesterol exists in two forms as LDL

cholesterol which can build up atherosclerotic plaque in our arteries and HDL cholesterol which carries cholesterol away from the arteries and back to the

liver. Balance of LDL and HDL cholesterols is important and unhealthy cholesterol levels are linked to having a poor diet, lack of exercise, being

overweight, age, heredity, and other factors. Policosanol is natural mixture of high molecular weight alcohols present in some plant oils which has been

studied to assist in the maintenance of cholesterol level. Natures Family Policosanol is formulated with policosanol from sugar cane wax alcohols and

may help to maintain healthy cholesterol levels in healthy individuals when combined with proper diet and exercise.

Additional Product information

Pack Size/Poison information

Pack Size

Poison Schedule

Components

1. Formulation 1

Dosage Form

Tablet, uncoated

Route of Administration

Public Summary

Page 1 of

Produced at 26.11.2017 at 04:43:10 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

Oral

Visual Identification

Active Ingredients

sugar cane wax alcohols

12 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 04:43:10 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

20-11-2018

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Published on: Mon, 19 Nov 2018 In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant BASF SE submitted two requests to the competent national authority in Germany. The first one, to modify the existing maximum residue levels (MRL) for the active substance pyraclostrobin in various crops and to set import tolerances for sugar canes and American persimmons; the second one to set import tolerances for pineapples and passion fruits/maracujas. The data submitted in support of the request...

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31-10-2018

Peer review of the pesticide risk assessment of the active substance dimethoate

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Europe - EFSA - European Food Safety Authority Publications

25-10-2018

Xylitol and Your Dog: Danger, Paws Off

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17-10-2018

SLR Food Distribution Inc. Issues Alert on Undeclared Sulfites in Sugar Melon Candy

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SLR Food Distribution Inc. of New Hyde Park, NY is recalling its 7.04oz package of SUGAR MELON CANDY / WAX GOURD because it contains undeclared sulfites. Consumers who have severe sensitivity to sulfites run the risk of serious or life-threatening allergic reactions if they consume this product.

FDA - U.S. Food and Drug Administration

10-10-2018

Resources for Animal Food Producers in Flooded Areas of Gulf Coast

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As Hurricane Michael makes landfall along the Florida Gulf Coast, FDA’s Center for Veterinary Medicine reminds those who may be affected by weather events about resources available for animal food producers who may be harvesting, mixing, storing or distributing grains and other foods for animals.

FDA - U.S. Food and Drug Administration

5-10-2018

Working Cow Homemade, Inc. Recalls Product Because of Possible Health Risk

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FDA - U.S. Food and Drug Administration

26-9-2018

Modification of the existing maximum residue level for flonicamid in various crops

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26-9-2018

Technical Report on the notification of syrup from Sorghum bicolor (L.) Moench as a traditional food from a third country pursuant to Article 14 of Regulation (EU) 2015/2283

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Europe - EFSA - European Food Safety Authority Publications

21-9-2018

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Europe - EMA - European Medicines Agency

13-9-2018

Resources for Animal Food Producers in Flooded Areas

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FDA - U.S. Food and Drug Administration

12-9-2018

Natural Disaster Preparedness and Response (Drugs)

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FDA - U.S. Food and Drug Administration

11-9-2018

Preparation of Dutch food consumption data for risk assessment

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Europe - EFSA - European Food Safety Authority Publications

6-9-2018

Statement from FDA Commissioner Scott Gottlieb, M.D., on an updated approach for including added sugar information on the Nutrition Facts labels of pure maple syrup and honey

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FDA - U.S. Food and Drug Administration

29-8-2018

Outcome of the public consultation on a draft protocol for the Scientific Opinion on dietary sugars

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Europe - EFSA - European Food Safety Authority Publications

29-8-2018

Protocol for the scientific opinion on the Tolerable Upper Intake Level of dietary sugars

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20-7-2018

J2Labz recalls Sugar Shack Vaping Liquid

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Health Canada

10-7-2018

FDA updates warnings for fluoroquinolone antibiotics on risks of mental health and low blood sugar adverse reactions

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FDA - U.S. Food and Drug Administration

10-7-2018

Fluoroquinolone Antibiotics: FDA Requires Labeling Changes Due to Low Blood Sugar Levels and Mental Health Side Effects

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FDA - U.S. Food and Drug Administration

12-5-2018

Sugarfina, Inc.  Issues Allergen Labeling Alert for Undeclared Eggs in Sugar Cookies Product

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FDA - U.S. Food and Drug Administration

6-11-2018

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FDA - U.S. Food and Drug Administration

15-10-2018

We have created a rumor control page for Hurricane #Michael that will be updated regularly. Help us share this info and remember to always check with official sources like @FLSERT, @GeorgiaEMA and @femaregion4.

 http://fema.gov/hurricane-michael-rumor-co

We have created a rumor control page for Hurricane #Michael that will be updated regularly. Help us share this info and remember to always check with official sources like @FLSERT, @GeorgiaEMA and @femaregion4. http://fema.gov/hurricane-michael-rumor-co

We have created a rumor control page for Hurricane #Michael that will be updated regularly. Help us share this info and remember to always check with official sources like @FLSERT, @GeorgiaEMA and @femaregion4. http://fema.gov/hurricane-michael-rumor-control … pic.twitter.com/T3h7ZiFUrZ

FDA - U.S. Food and Drug Administration

10-10-2018

If you use a #MedicalDevice affected by a power outage caused by #HurricaneMichael, check out the #FDA’s tips for using a generator to restore power to your device:  https://go.usa.gov/xPjau pic.twitter.com/SLxGKzIIgc

If you use a #MedicalDevice affected by a power outage caused by #HurricaneMichael, check out the #FDA’s tips for using a generator to restore power to your device: https://go.usa.gov/xPjau pic.twitter.com/SLxGKzIIgc

If you use a #MedicalDevice affected by a power outage caused by #HurricaneMichael, check out the #FDA’s tips for using a generator to restore power to your device: https://go.usa.gov/xPjau  pic.twitter.com/SLxGKzIIgc

FDA - U.S. Food and Drug Administration

10-10-2018

#HurricaneMichael continues to move inland and remains a major hurricane. An extreme wind warning is in effect for portions of the Ern FL Panhandle & extreme SW GA for winds >115 MPH valid until 345 PM CT. If you are in the EWW, TAKE SHELTER NOW!!!pic.twi

#HurricaneMichael continues to move inland and remains a major hurricane. An extreme wind warning is in effect for portions of the Ern FL Panhandle & extreme SW GA for winds >115 MPH valid until 345 PM CT. If you are in the EWW, TAKE SHELTER NOW!!!pic.twi

#HurricaneMichael continues to move inland and remains a major hurricane. An extreme wind warning is in effect for portions of the Ern FL Panhandle & extreme SW GA for winds >115 MPH valid until 345 PM CT. If you are in the EWW, TAKE SHELTER NOW!!! pic.twitter.com/Mhx4LNoJCr

FDA - U.S. Food and Drug Administration

10-10-2018

As Hurricane #Michael nears land, take shelter & stay safe.

Follow weather updates on your phone or radio.

 In a tornado WARNING, go to an interior, windowless room.

 If water comes in, go to the highest floor that’s not flooded but do NOT enter a clos

As Hurricane #Michael nears land, take shelter & stay safe. Follow weather updates on your phone or radio. In a tornado WARNING, go to an interior, windowless room. If water comes in, go to the highest floor that’s not flooded but do NOT enter a clos

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FDA - U.S. Food and Drug Administration

9-10-2018

#FDA is closely tracking #Michael and has activated its Emergency Operations Center to support federal and state efforts in GA, FL, and AL. Additionally, we are taking steps to prevent any potential drug shortages and will share more over the coming days

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FDA - U.S. Food and Drug Administration

24-9-2018

If you use a #MedicalDevice affected by a power outage caused by #HurricaneFlorence, check out the #FDA’s tips for using a generator to restore power to your device:  https://go.usa.gov/xPjau pic.twitter.com/z8SW2mlb86

If you use a #MedicalDevice affected by a power outage caused by #HurricaneFlorence, check out the #FDA’s tips for using a generator to restore power to your device: https://go.usa.gov/xPjau pic.twitter.com/z8SW2mlb86

If you use a #MedicalDevice affected by a power outage caused by #HurricaneFlorence, check out the #FDA’s tips for using a generator to restore power to your device: https://go.usa.gov/xPjau  pic.twitter.com/z8SW2mlb86

FDA - U.S. Food and Drug Administration

21-9-2018

Click the link for a handy list of #FDA’s recommendations for using and  caring for your medical devices during a #hurricane.   https://go.usa.gov/xPbgc  #MedicalDevice

Click the link for a handy list of #FDA’s recommendations for using and caring for your medical devices during a #hurricane. https://go.usa.gov/xPbgc  #MedicalDevice

Click the link for a handy list of #FDA’s recommendations for using and caring for your medical devices during a #hurricane. https://go.usa.gov/xPbgc  #MedicalDevice

FDA - U.S. Food and Drug Administration

21-9-2018

#DYK #hurricane season is active through November. Be prepared & stay informed of #MedicalDevice safety. Click the link to find a useful planning booklet from the #FDA that can help u prepare & handle power outages for medical devices that use electricity

#DYK #hurricane season is active through November. Be prepared & stay informed of #MedicalDevice safety. Click the link to find a useful planning booklet from the #FDA that can help u prepare & handle power outages for medical devices that use electricity

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FDA - U.S. Food and Drug Administration

19-9-2018

As people return home and businesses begin to reopen, #FDA is committed to providing safety tips for the general public and technical assistance for businesses, such as advice on Restaurants and Grocers Reopening After Hurricanes and Flooding:  https://go

As people return home and businesses begin to reopen, #FDA is committed to providing safety tips for the general public and technical assistance for businesses, such as advice on Restaurants and Grocers Reopening After Hurricanes and Flooding: https://go

As people return home and businesses begin to reopen, #FDA is committed to providing safety tips for the general public and technical assistance for businesses, such as advice on Restaurants and Grocers Reopening After Hurricanes and Flooding: https://go.usa.gov/xP2y6  pic.twitter.com/r3c0i4pose

FDA - U.S. Food and Drug Administration

1-8-2018

Ucedane (Lucane Pharma)

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Europe -DG Health and Food Safety

21-3-2018

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Europe -DG Health and Food Safety