FRESH

Main information

  • Trade name:
  • FRESH and NATURAL PROPOLIS ALCOHOL FREE
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • FRESH and NATURAL PROPOLIS ALCOHOL FREE
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 212590
  • Last update:
  • 09-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

212590

FRESH and NATURAL PROPOLIS ALCOHOL FREE

ARTG entry for

Medicine Listed

Sponsor

Brisbane Trading Pty Ltd

Postal Address

79 Millers Road,Eight Mile Plains,Brisbane, QLD, 4113

Australia

ARTG Start Date

25/07/2013

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. FRESH and NATURAL PROPOLIS ALCOHOL FREE

Product Type

Single Medicine Product

Effective date

25/07/2013

Warnings

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

WARNING: Propolis may cause skin irritation. Test before use.

WARNING: Propolis may cause allergic reactions. If irritation or swelling of the mouth or throat occurs, discontinue use.

Standard Indications

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

May reduce the severity and duration of colds. [Warning COLD required]

Specific Indications

Propolis is collected by honeybees and contains high levels of bioflavonoids

including rutin.

Bioflavonoids are antioxidants beneficial for general wellbeing.

Assists the immune system.

Propolis and its active components have anti-inflammatory function.

Free radical scavenger.

Additional Product information

Pack Size/Poison information

Pack Size

Poison Schedule

Components

1. Formulation 1

Dosage Form

Liquid, multipurpose

Route of Administration

Oral Application

Topical

Oral

Public Summary

Page 1 of

Produced at 27.11.2017 at 12:11:17 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

Visual Identification

Active Ingredients

Propolis

600 mg/mL

© 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 27.11.2017 at 12:11:17 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

10-11-2018

Outcome of the consultation with Member States and EFSA on the basic substance application for propolis extract (admissibility accepted when named water‐soluble extract of propolis) for use in plant protection as fungicide and bactericide

Outcome of the consultation with Member States and EFSA on the basic substance application for propolis extract (admissibility accepted when named water‐soluble extract of propolis) for use in plant protection as fungicide and bactericide

Published on: Fri, 09 Nov 2018 00:00:00 +0100 The European Food Safety Authority (EFSA) was asked by the European Commission to provide scientific assistance with respect to the evaluation of applications received by the European Commission concerning basic substances. In this context, EFSA's scientific views on the specific points raised during the commenting phase conducted with Member States and EFSA on the basic substance application for propolis extract are presented. The context of the evaluation ...

Europe - EFSA - European Food Safety Authority Publications

9-11-2018

Safety assessment of the active substance polyacrylic acid, sodium salt, cross‐linked, for use in active food contact materials

Safety assessment of the active substance polyacrylic acid, sodium salt, cross‐linked, for use in active food contact materials

Published on: Thu, 08 Nov 2018 00:00:00 +0100 The EFSA Panel on Food Contact Materials, Enzymes and Processing Aids (CEP) assessed the safety of polyacrylic acid, sodium salt, cross‐linked, FCM substance No 1015, which is intended to be used as a liquid absorber in the packaging of fresh or frozen foods such as meat, poultry and seafood as well as fresh fruits and vegetables. Specific migration tests were not performed due to the high absorption of liquids by the substance. The Panel noted that if polya...

Europe - EFSA - European Food Safety Authority Publications

31-10-2018

Safety and efficacy of a super critical carbon dioxide extract of Humulus lupulus L. flos when used as a feed flavouring for all animal species

Safety and efficacy of a super critical carbon dioxide extract of Humulus lupulus L. flos when used as a feed flavouring for all animal species

Published on: Tue, 30 Oct 2018 00:00:00 +0100 Following a request from the European Commission, the EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on the safety and efficacy of a super critical carbon dioxide extract of Humulus lupulus L. flos (hop strobiles) when used as a sensory feed additive for all animal species. The additive is specified to containing 40% beta acids and less than 0.2% alpha acids. Known substances of conce...

Europe - EFSA - European Food Safety Authority Publications

31-10-2018

Safety and efficacy of Lactobacillus hilgardii CNCM I‐4785 and Lactobacillus buchneri CNCM I‐4323/NCIMB 40788 as a silage additive for all animal species

Safety and efficacy of Lactobacillus hilgardii CNCM I‐4785 and Lactobacillus buchneri CNCM I‐4323/NCIMB 40788 as a silage additive for all animal species

Published on: Tue, 30 Oct 2018 00:00:00 +0100 Following a request from the European Commission, the Panel on Additives and Products or Substances used in Animal Feed was asked to deliver a scientific opinion on the safety and efficacy of a strain of Lactobacillus hilgardii and of Lactobacillus buchneri when used as a technological additive intended to improve ensiling at a proposed application rate of 3.0 x 108 colony forming units (CFU)/kg fresh material. The two bacterial species are considered by EFS...

Europe - EFSA - European Food Safety Authority Publications

19-10-2018

Statement by FDA Commissioner Scott Gottlieb, M.D., on FDA’s new steps to help produce farmers, processors more effectively comply with food safety requirements

Statement by FDA Commissioner Scott Gottlieb, M.D., on FDA’s new steps to help produce farmers, processors more effectively comply with food safety requirements

Statement from FDA Commissioner Scott Gottlieb, M.D., on FDA’s new steps to help produce farmers, fresh-cut produce processors more effectively comply with food safety requirements

FDA - U.S. Food and Drug Administration

18-10-2018

Stewart’s Shops Issues Allergy Alert on Undeclared Milk in Cranberry Apple Refresher

Stewart’s Shops Issues Allergy Alert on Undeclared Milk in Cranberry Apple Refresher

Saratoga Springs, NY - Stewart’s Shops Corp. is recalling units of Stewart’s Shops brand Cranberry Apple Refresher 16 fluid oz. because the product may contain undeclared milk. People who have an allergy to milk run the risk of serious or life-threatening allergic reaction if they consume this product. Approximately 2,300 units of affected product were distributed in upstate New York and Southern Vermont.

FDA - U.S. Food and Drug Administration

16-10-2018

Assessment of low pathogenic avian influenza virus transmission via raw poultry meat and raw table eggs

Assessment of low pathogenic avian influenza virus transmission via raw poultry meat and raw table eggs

Published on: Mon, 15 Oct 2018 00:00:00 +0200 A rapid qualitative assessment has been done by performing a theoretical analysis on the transmission of low pathogenic avian influenza (LPAI) via fresh meat from poultry reared or kept in captivity for the production of meat (raw poultry meat) or raw table eggs. A predetermined transmission pathway followed a number of steps from a commercial or non‐commercial poultry establishment within the EU exposed to LPAI virus (LPAIV) to the onward virus transmission...

Europe - EFSA - European Food Safety Authority Publications

7-8-2018

Seaweed consumption: remain vigilant to the risk of excess iodine intake

Seaweed consumption: remain vigilant to the risk of excess iodine intake

Over the last few years, seaweed has become increasingly common on our plates. Fresh, dried or as a food supplement, its iodine content varies and can sometimes be high. ANSES assessed the risk of excess iodine intake from the consumption of seaweed-based products. In view of the non-negligible risk of exceeding the upper limit of safe intake for iodine, the Agency advises against the consumption of seaweed and seaweed-based food supplements by certain at-risk populations, and recommends that regular con...

France - Agence Nationale du Médicament Vétérinaire

28-7-2018

Lipari Foods Issues Voluntary Recall of Premo Brand & Fresh Grab Turkey & Swiss Submarine Sandwiches Due to Potential Contamination of Listeria Monocytogenes

Lipari Foods Issues Voluntary Recall of Premo Brand & Fresh Grab Turkey & Swiss Submarine Sandwiches Due to Potential Contamination of Listeria Monocytogenes

Lipari Foods, LLC has issued a voluntary recall of Premo Brand and Fresh Grab turkey and Swiss submarine sandwiches produced and packaged by sister company JLM due to potential contamination of Listeria monocytogenes. Listeria monocytogenes is an organism, which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Although healthy individuals may suffer only short-term symptoms such as high fever, severe headache, stiffness,...

FDA - U.S. Food and Drug Administration

25-7-2018

Pollen allergies and food supplements: ANSES reminds consumers of the precautions to be taken

Pollen allergies and food supplements: ANSES reminds consumers of the precautions to be taken

Cases of allergies associated with the consumption of food supplements are regularly reported to ANSES under its nutrivigilance scheme. Recently, severe allergies following the consumption of food supplements containing hive products (royal jelly, propolis) and pollen have been reported. ANSES reminds consumers that people who are allergic to pollen can potentially be at risk from allergies when consuming foods and food supplements containing products of the beehive.

France - Agence Nationale du Médicament Vétérinaire

23-7-2018

Flowers Foods Issues Voluntary Recall on Mrs. Freshley’s and Other Brands of Swiss Rolls and Captain John Derst’s Old Fashioned Bread

Flowers Foods Issues Voluntary Recall on Mrs. Freshley’s and Other Brands of Swiss Rolls and Captain John Derst’s Old Fashioned Bread

As a precautionary measure, Flowers Foods, Inc. (NYSE: FLO) is voluntarily recalling Swiss Rolls sold under the brand names Mrs. Freshley’s, Food Lion, H-E-B, Baker’s Treat, Market Square, and Great Value, distributed nationwide, and Captain John Derst’s Old Fashioned Bread distributed in Alabama, Florida, Georgia, North Carolina, and South Carolina, due to the potential presence of Salmonella in an ingredient, whey powder. The ingredient recall was initiated by a third-party whey powder manufacturer and...

FDA - U.S. Food and Drug Administration

14-7-2018

FDA Investigates Multistate Outbreak of Cyclospora Illnesses Linked to Fresh Express Salad Mix Served at McDonald’s

FDA Investigates Multistate Outbreak of Cyclospora Illnesses Linked to Fresh Express Salad Mix Served at McDonald’s

The FDA confirms the presence of Cyclospora in Fresh Express salad mix through new laboratory method; Fresh Express recalls expired products containing romaine lettuce.

FDA - U.S. Food and Drug Administration

10-7-2018

7 Tips for Cleaning Fruits, Vegetables

7 Tips for Cleaning Fruits, Vegetables

Fresh produce can become contaminated in many ways, but following these simple steps can help protect you and your family from foodborne illness.

FDA - U.S. Food and Drug Administration

16-6-2018

Del Monte Fresh Produce N.A., Inc. Voluntarily Recalls Limited Quantity of Vegetable Trays in a Multistate Outbreak of Cyclospora Illnesses in Select Retailers in Illinois, Indiana, Iowa, Michigan, Minnesota, and Wisconsin, Because of Possible Health Risk

Del Monte Fresh Produce N.A., Inc. Voluntarily Recalls Limited Quantity of Vegetable Trays in a Multistate Outbreak of Cyclospora Illnesses in Select Retailers in Illinois, Indiana, Iowa, Michigan, Minnesota, and Wisconsin, Because of Possible Health Risk

Del Monte Fresh Produce N.A., Inc. ("Del Monte Fresh") announced today, the voluntary recall of a limited quantity of 6 oz., 12 oz. and 28 oz. vegetable trays containing fresh broccoli, cauliflower, celery sticks, carrots, and dill dip sold to select retailers in Illinois, Indiana, Iowa, Michigan, Minnesota and Wisconsin. Del Monte was notified by state agencies of the outbreak and its potential involvement.

FDA - U.S. Food and Drug Administration

9-6-2018

Caito Foods, LLC Voluntarily Recalls Fresh Cut Melon Products Because of Possible Health Risk

Caito Foods, LLC Voluntarily Recalls Fresh Cut Melon Products Because of Possible Health Risk

Caito Foods is voluntarily recalling fresh cut watermelon, honeydew melon, cantaloupe and fresh-cut mixed fruit containing one of these melons, produced at the Caito Foods facility in Indianapolis, because these products have the potential to be contaminated with Salmonella.

FDA - U.S. Food and Drug Administration

24-9-2018

News and press releases:  EMA to launch new corporate website on 27 September 2018

News and press releases: EMA to launch new corporate website on 27 September 2018

Fresh design and improved features to provide better user experience

Europe - EMA - European Medicines Agency

8-8-2018

The FDA’s Fresh Empire campaign illustrates tobacco prevention messages to multicultural youth in a novel and attention-grabbing way. 

Watch the new ad encouraging teens to live tobacco free: https://www.youtube.com/watch?v=6iBAMnU96UY …

The FDA’s Fresh Empire campaign illustrates tobacco prevention messages to multicultural youth in a novel and attention-grabbing way. Watch the new ad encouraging teens to live tobacco free: https://www.youtube.com/watch?v=6iBAMnU96UY …

The FDA’s Fresh Empire campaign illustrates tobacco prevention messages to multicultural youth in a novel and attention-grabbing way. Watch the new ad encouraging teens to live tobacco free: https://www.youtube.com/watch?v=6iBAMnU96UY …

FDA - U.S. Food and Drug Administration

16-7-2018

Federal health officials estimate that nearly 48 million people are sickened by food contaminated with harmful germs each year. Fresh produce can become contaminated in many ways. Follow these 7 tips for cleaning fruits and vegetables  https://go.usa.gov/

Federal health officials estimate that nearly 48 million people are sickened by food contaminated with harmful germs each year. Fresh produce can become contaminated in many ways. Follow these 7 tips for cleaning fruits and vegetables https://go.usa.gov/

Federal health officials estimate that nearly 48 million people are sickened by food contaminated with harmful germs each year. Fresh produce can become contaminated in many ways. Follow these 7 tips for cleaning fruits and vegetables https://go.usa.gov/xU9VY  pic.twitter.com/ldh9OQWMWT

FDA - U.S. Food and Drug Administration