Thursday

Main information

  • Trade name:
  • Thursday Plantation Bergamot Oil
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • Thursday Plantation Bergamot Oil
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 219202
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

219202

Thursday Plantation Bergamot Oil

ARTG entry for

Medicine Listed

Sponsor

Integria Healthcare Australia Pty Ltd

Postal Address

PO Box 4854,EIGHT MILE PLAINS, QLD, 4113

Australia

ARTG Start Date

14/01/2014

Product category

Medicine

Status

Active

Approval area

Listed Medicines

Conditions

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. Thursday Plantation Bergamot Oil

Product Type

Single Medicine Product

Effective date

14/01/2014

Warnings

Application to skin may increase sensitivity to sunlight (or words to that effect).

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

Standard Indications

Specific Indications

Used in traditional aromatherapy to lift mood and to relieve mild anxiety, stress and nervous tension.

Bergamot oil is used in traditional aromatherapy as a sedative to aid relaxation.

Additional Product information

Pack Size/Poison information

Pack Size

Poison Schedule

Components

1. Formulation 1

Dosage Form

Essential Oil

Route of Administration

Inhalation

Visual Identification

Active Ingredients

Bergamot oil coldpressed

1 mL/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 1 of

Produced at 26.11.2017 at 03:52:20 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

13-11-2018

Peer review of the pesticide risk assessment of the active substance napropamide‐M

Peer review of the pesticide risk assessment of the active substance napropamide‐M

Published on: Mon, 12 Nov 2018 00:00:00 +0100 The conclusions of EFSA following the peer review of the initial risk assessments carried out by the competent authority of the rapporteur Member State the United Kingdom for the pesticide active substance napropamide‐M are reported. The context of the peer review was that required by Regulation (EC) No 1107/2009 of the European Parliament and of the Council. The conclusions were reached on the basis of the evaluation of the representative uses of napropamid...

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10-11-2018

Pest categorisation of Popillia japonica

Pest categorisation of Popillia japonica

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Europe - EFSA - European Food Safety Authority Publications

5-11-2018

Products containing metam-sodium: ANSES announces the withdrawal of marketing authorisations

Products containing metam-sodium: ANSES announces the withdrawal of marketing authorisations

Plant protection products containing metam-sodium are used in market gardening and horticulture to disinfect the soil. Following the substance's approval at European level, ANSES reassessed the dossiers and notified the industrial companies concerned of its intention to withdraw all marketing authorisations for metam-sodium products. ANSES is also taking this opportunity to reiterate the importance of phytopharmacovigilance and the requirement for professionals to report any adverse effects on humans or ...

France - Agence Nationale du Médicament Vétérinaire

1-11-2018

Pest categorisation of Conotrachelus nenuphar

Pest categorisation of Conotrachelus nenuphar

Published on: Wed, 31 Oct 2018 00:00:00 +0100 The EFSA Panel on Plant Health performed a pest categorisation of Conotrachelus nenuphar (Herbst) (Coleoptera: Curculionidae), for the EU. C. nenuphar is a well‐defined species, recognised as a serious pest of stone and pome fruit in the USA and Canada where it also feeds on a range of other hosts including soft fruit (e.g. Ribes,Fragaria) and wild plants (e.g. Crataegus). Adults, which are not good flyers, feed on tender twigs, flower buds and leaves. Femal...

Europe - EFSA - European Food Safety Authority Publications

20-10-2018

Evaluation of confirmatory data following the Article 12 MRL review for pyraflufen‐ethyl

Evaluation of confirmatory data following the Article 12 MRL review for pyraflufen‐ethyl

Published on: Fri, 19 Oct 2018 00:00:00 +0200 The applicant, Nichino Europe Co. Ltd., submitted application request to the competent national authority in the Netherlands to evaluate confirmatory data that were identified for pyraflufen‐ethyl in the framework of the maximum residue level (MRL) review under Article 12 of Regulation (EC) No 396/2005 as not available. The submitted data were sufficient to confirm the MRLs for citrus fruits, tree nuts, pome fruits, stone fruits, table and wine grapes, curra...

Europe - EFSA - European Food Safety Authority Publications

18-10-2018

Hydrolevel Company recalls HydroStat 3000

Hydrolevel Company recalls HydroStat 3000

The controller may not shut down the boiler when it reaches the high temperature limit, potentially allowing it to overheat and posing a fire hazard.

Health Canada

17-10-2018

Pest categorisation of Stagonosporopsis andigena

Pest categorisation of Stagonosporopsis andigena

Published on: Tue, 16 Oct 2018 00:00:00 +0200 The Panel on Plant Health performed a pest categorisation of Stagonosporopsis andigena, the causal agent of black blight of potato, for the EU. The pest is a well‐defined fungal species and reliable methods exist for its detection and identification. S. andigena is present in Bolivia and Peru. The pest is not known to occur in the EU and is listed in Annex IAI of Directive 2000/29/EC as Phoma andina, meaning its introduction into the EU is prohibited. The ma...

Europe - EFSA - European Food Safety Authority Publications

11-10-2018

Re‐evaluation of oxidised soya bean oil interacted with mono‐ and diglycerides of fatty acids (E 479b) as a food additive

Re‐evaluation of oxidised soya bean oil interacted with mono‐ and diglycerides of fatty acids (E 479b) as a food additive

Published on: Wed, 10 Oct 2018 00:00:00 +0200 The EFSA Panel on Food Additives and Flavourings (FAF) provides a scientific opinion re‐evaluating the safety of thermally oxidised soya bean oil interacted with mono‐ and diglycerides of fatty acids (TOSOM) (E 479b) when used as a food additive. The Scientific Committee on Food (SCF) and the Joint FAO/WHO Expert Committee on Food Additives (JECFA) derived an acceptable daily intake (ADI) of 25 and 30 mg/kg body weight (bw) per day, respectively. There was n...

Europe - EFSA - European Food Safety Authority Publications

9-10-2018

Essity Professional Hygiene North America LLC recalls Tork Foam Soap Extra Mild SKU

Essity Professional Hygiene North America LLC recalls Tork Foam Soap Extra Mild SKU

The recalled product is potentially contaminated with the bacteria Burkholderia cepacia. B. cepacia is found in soil and water and poses little medical risk to healthy people.

Health Canada

3-10-2018

Enforcement Report for the Week of October 03, 2018

Enforcement Report for the Week of October 03, 2018

Recently Updated Records for the Week of October 03, 2018 Last Modified Date: Thursday, September 27, 2018

FDA - U.S. Food and Drug Administration

27-9-2018

Enforcement Report for the Week of November 02, 2016

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Recently Updated Records for the Week of November 02, 2016 Last Modified Date: Thursday, September 27, 2018

FDA - U.S. Food and Drug Administration

27-9-2018

General Finishes Recalls Outdoor Oil

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The recalled products do not have the proper consumer chemical hazard packaging and labelling required by the consumer Chemicals and Containers Regulations, 2001 under the Canada Consumer Product Safety Act.

Health Canada

11-9-2018

Prizer-Painter Stove Works, Inc. recalls BlueStar and Big Chill Brand Gas Ranges and Wall Ovens

Prizer-Painter Stove Works, Inc. recalls BlueStar and Big Chill Brand Gas Ranges and Wall Ovens

Use of the convection oven fan during pre-heating or broiling can cause accumulated gas to ignite, posing a burn hazard to consumers when oven door is opened.

Health Canada

11-9-2018

Peer review of the pesticide risk assessment of the active substance alpha‐cypermethrin

Peer review of the pesticide risk assessment of the active substance alpha‐cypermethrin

Published on: Mon, 10 Sep 2018 00:00:00 +0200 The conclusions of EFSA following the peer review of the initial risk assessments carried out by the competent authorities of the rapporteur Member State Belgium and co‐rapporteur Member State Greece for the pesticide active substance alpha‐cypermethrin are reported. The context of the peer review was that required by Commission Implementing Regulation (EU) No 844/2012. The conclusions were reached on the basis of the evaluation of the representative uses of...

Europe - EFSA - European Food Safety Authority Publications

31-8-2018

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

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Europe - EFSA - European Food Safety Authority Publications

30-8-2018

Anthrax

Anthrax

Anthrax is a zoonosis (i.e. a disease common to humans and animals) that primarily affects herbivores. It is caused by Bacillus anthracis, a bacterium that is unusual in that it persists in soil for decades as spores. ANSES is the National Reference Laboratory for this disease. Here we provide a presentation of the disease and the role played by ANSES.

France - Agence Nationale du Médicament Vétérinaire

29-8-2018

Scientific Opinion about the Guidance of the Chemical Regulation Directorate (UK) on how aged sorption studies for pesticides should be conducted, analysed and used in regulatory assessments

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Published on: Mon, 27 Aug 2018 00:00:00 +0200 The EFSA Panel on Plant Protection Products and their Residues reviewed the guidance on how aged sorption studies for pesticides should be conducted, analysed and used in regulatory assessment. The inclusion of aged sorption is a higher tier in the groundwater leaching assessment. The Panel based its review on a test with three substances taken from a data set provided by the European Crop Protection Association. Particular points of attention were the quali...

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

Modification of the existing maximum residue levels for prohexadione in various oilseeds

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Published on: Mon, 27 Aug 2018 00:00:00 +0200 In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant BASF SE submitted a request to the competent national authority in France to modify the existing maximum residue levels (MRL) for the active substance prohexadione in linseeds, poppy seeds, sunflower seeds, rape seeds, mustard seeds and gold of pleasure seeds. The data submitted in support of the request were found to be sufficient to derive MRL proposals for all oilseeds under consid...

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

Modification of the existing maximum residue levels for fluoxastrobin in oilseeds

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Published on: Mon, 13 Aug 2018 00:00:00 +0200 In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Arysta LifeSciences SAS submitted a request to the competent national authority in the United Kingdom to modify the existing maximum residue levels (MRL) for the active substance fluoxastrobin in certain oilseeds. The data submitted in support of the request were found to be sufficient to derive MRL proposals for the oilseeds for which a modification was requested. Adequate analytical...

Europe - EFSA - European Food Safety Authority Publications

22-8-2018

Enforcement Report for the Week of August 22, 2018

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Recently Updated Records for the Week of August 22, 2018 Last Modified Date: Thursday, August 16, 2018

FDA - U.S. Food and Drug Administration

16-8-2018

Enforcement Report for the Week of August 28, 2013

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Recently Updated Records for the Week of August 28, 2013 Last Modified Date: Thursday, August 16, 2018

FDA - U.S. Food and Drug Administration

25-7-2018

Kraft Heinz Voluntarily Recalls Taco Bell Salsa Con Queso Mild Cheese Dip Distributed to Retailers

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As a precaution, approximately 7,000 cases of Taco Bell Salsa Con Queso Mild Cheese Dip are being voluntarily recalled because the affected product is showing signs of product separation which can lead to a potential health hazard. This could create conditions that could allow for the growth of Clostridium botulinum (C. botulinum), a bacterium which can cause life-threatening illness or death. Consumers are warned not to use the product even if it does not look or smell spoiled.

FDA - U.S. Food and Drug Administration

11-7-2018

OCOOW LLC recalls Odie's Solvent-Free Super Penetrating Oil and Odie's Safer Solvent

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The recalled products do not have proper consumer chemical hazard packaging and labelling required by the Consumer Chemicals and Containers Regulations, 2001 under the Canada Consumer Product Safety Act.

Health Canada

25-5-2018

Brands Unlimited Trading Inc. recalls Laura Secord Mason Glass Mugs

Brands Unlimited Trading Inc. recalls Laura Secord Mason Glass Mugs

The glass mason mug may crack or break upon contact with hot or boiled liquid, posing a burn or laceration hazard to consumers.

Health Canada

9-5-2018

Fabius Anesthesia Machines by Dräger Medical: Class I Recall - Due to Production Step Error

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Dräger Medical is recalling the Fabius Anesthesia machines due to excessive oil that was not removed at the time of production. Such excess oil may interfere with the position detector of the ventilation motor during operation and may cause ventilation to fail. A halt in ventilation may lead to serious adverse health consequences, including patient injury or death.

FDA - U.S. Food and Drug Administration

8-5-2018

Neurovascular Stents Used for Stent-Assisted Coiling (SAC): Letter to Health Care Providers - Recommendations Associated With the Use of These Devices in the Treatment of Unruptured Brain Aneurysms

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The FDA has received reports associated with the use of these devices in the treatment of unruptured brain aneurysms that suggest some events of peri-procedural stroke and/or death may have been related to procedural risks or patient selection related factors. These factors include patients who had serious co-morbidities resulting in a reduced life expectancy, or who were intolerant to required anticoagulation or anti-platelet therapy.

FDA - U.S. Food and Drug Administration

2-3-2018

European top post for Thomas Senderovitz

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Director General of the Danish Medicines Agency, Thomas Senderovitz, was Thursday elected Chairperson of the HMA Management Group. HMA is an acronym for Heads of Medicines Agencies and is the network of the heads of the national drug regulatory authorities in Europe.

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8-6-2017

Extensive modernisation of our IT from 8 June to 13 June

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The Danish Medicines Agency will launch an extensive modernisation of our IT systems from Thursday 8 June 2017 at 6pm to Tuesday 13 June 2017 at 8am. During this period, you may experience longer response times and some of our IT systems and forms will not be available.

Danish Medicines Agency

15-4-2016

Promising prospects for cooperation with Mexico

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Thursday, the Danish Medicines Agency's new Director General Thomas Senderovitz signed a cooperation agreement between the Mexican drug regulatory authority and the Danish Medicines Agency.

Danish Medicines Agency

14-10-2015

The Icelandic Medicines Agency is closed due to Union strike

The Icelandic Medicines Agency is closed due to Union strike

From Thursday the 15th of October until Tuesday the 20th of October The Icelandic Medicines Agency is closed. The Agency will reopen Wednesday 21st of October.

IMA - Icelandic Medicines Agency

13-11-2018

Check out the #PEAC2018 agenda, webcast information, and meeting materials for Thursday’s Patient Engagement Advisory Committee meeting on  http://FDA.gov : https://go.usa.gov/xPf9n  #DigitalHealthpic.twitter.com/1DCieYB33v

Check out the #PEAC2018 agenda, webcast information, and meeting materials for Thursday’s Patient Engagement Advisory Committee meeting on http://FDA.gov : https://go.usa.gov/xPf9n  #DigitalHealthpic.twitter.com/1DCieYB33v

Check out the #PEAC2018 agenda, webcast information, and meeting materials for Thursday’s Patient Engagement Advisory Committee meeting on http://FDA.gov : https://go.usa.gov/xPf9n  #DigitalHealth pic.twitter.com/1DCieYB33v

FDA - U.S. Food and Drug Administration

24-5-2018

#ThrowBackThursday- May 24, 1977- Bureau of Medical Devices and Diagnostic Products renamed Bureau of Medical Devices and new Office of Small Manufacturers Assistance created, as required by law. #OnThisDay #FDAHistory

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FDA - U.S. Food and Drug Administration

17-5-2018

#ThrowBackThursday: May 17, 1971- The Public Health Service Bureau of Radiological Health transferred to FDA. It’s Mission: Protect against unnecessary human exposure to radiation from electronic products in the home and industry. #OnThisDay #FDAHistory

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FDA - U.S. Food and Drug Administration

15-5-2018

Claims about hemp and CBD oils misleading consumers

Claims about hemp and CBD oils misleading consumers

The TGA is aware of false and misleading claims by some companies supplying products containing cannabidiol

Therapeutic Goods Administration - Australia