PROPOLIS

Main information

  • Trade name:
  • PROPOLIS 30% LIQUID
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • PROPOLIS 30% LIQUID
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 77213
  • Last update:
  • 01-12-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

77213

PROPOLIS 30% LIQUID Propolis 200mg/mL Liquid multipurpose bottle

ARTG entry for

Medicine Listed

Sponsor

Nature's Goodness Australia Pty Ltd

Postal Address

PO Box 428,NARELLAN, NSW, 2567

Australia

ARTG Start Date

20/12/2000

Product category

Medicine

Status

Active

Approval area

Listed Medicines

Conditions

Except where the sponsor has been contracted by an overseas partry to manufacturer the goods and that party will be responsible for placing the goods

on the market in countries other than Australia, the sponsor must have and shall retain, while the goods remain listed, evidence necessary to

substantiate and support the accuracy of the indications in relation to the listed goods, and upon the request of the Head, Office of Prescription

Medicines Authorisation Branch, Therapeutic Goods Administration, shall produce such evidence to this officer.

The conditions applying to these goods when they are exported from Australia are given below:

Conditions applicable to all therapeutic goods as specified in the document "Standard Conditions Applying to Registered or Listed Therapeutic Goods

Under Section 28 of the Therapeutic Goods Act 1989" effective 1 July 1995, other than condition No. 8 and condition No. 9.

Conditions applicable to the relevant category and class of therapeutic goods as specified in the document "Standard Conditions Applying to Registered

or Listed Therapeutic Goods Under Section 28 of the Therapeutic Goods Act 1989" effective 1 July 1995, other than condition No.11

Conditions applicable to all therapeutic goods as specified in the document "Standard Conditions Applying to Registered or Listed Therapeutic Goods

Under Section 28 of the Therapeutic Goods Act 1989" effective 1 July 1995.

Conditions applicable to the relevant category and class of therapeutic goods as specified in the document "Standard Conditions Applying to Registered

or Listed Therapeutic Goods Under Section 28 of the Therapeutic Goods Act 1989" effective 1 July 1995.

Products

1. PROPOLIS 30% LIQUID

Product Type

Single Medicine Product

Effective date

3/07/2002

Warnings

No Warnings included on Record

Standard Indications

Relief of the symptoms of cold sores. [Warning S required]

Relief of mouth ulcers. [Warning S required]

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

Specific Indications

Aids in repair of skin tissue and healing of minor cuts and abrasions

Additional Product information

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Bottle

Not recorded

3 Years

Store below 30

degrees Celsius

Not recorded

Not recorded

Pack Size/Poison information

Pack Size

Poison Schedule

15ml

Not scheduled. Not considered by committee

50ml

Not scheduled. Not considered by committee

25ml

Not scheduled. Not considered by committee

Components

1. COMPONENT ONE

Dosage Form

Liquid, multipurpose

Route of Administration

Oral

Visual Identification

Amber liquid

Active Ingredients

Public Summary

Page 1 of

Produced at 01.12.2017 at 08:36:29 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

Propolis

200 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 01.12.2017 at 08:36:29 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

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

There are no news related to this product.