CLAMPS, SURGICAL, ARTERY, GENERAL-PURPOSE

Informazioni principali

  • Nome commerciale:
  • CLAMPS, SURGICAL, ARTERY, GENERAL-PURPOSE
  • Utilizzare per:
  • Esseri umani
  • Tipo di medicina:
  • Dispositivo medico

Documenti

  • per il pubblico:
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  • per i professionisti:
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Localizzazione

  • Disponibile in:
  • CLAMPS, SURGICAL, ARTERY, GENERAL-PURPOSE
    Italia
  • Lingua:
  • italiano

Informazioni terapeutiche

  • Gruppo terapeutico:
  • ANGIOSTATI E PINZE PER CLAMPAGGIO VASCOLARE GENERICO

Altre informazioni

Status

  • Fonte:
  • Ministero della Salute - Italia
  • Stato dell'autorizzazione:
  • S
  • Data dell'autorizzazione:
  • 11-12-2009
  • Ultimo aggiornamento:
  • 09-08-2016
  • Il foglio illustrativo per questo prodotto non è al momento disponibile, é possibile inviare una richiesta al nostro Servizio Clienti ed essere avvisati nel momento in cui è disponibile sulla nostra piattaforma.

    Richiedi il foglio illustrativo per il pubblico.

4-1-2019

Modification of the existing maximum residue levels for lambda‐cyhalothrin in celeries, fennel and rice

Modification of the existing maximum residue levels for lambda‐cyhalothrin in celeries, fennel and rice

Published on: Thu, 03 Jan 2019 In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Syngenta Crop Protection AG submitted a request to the competent national authority in Greece to modify the existing maximum residue levels (MRLs) for lambda‐cyhalothrin in celeries, fennel and rice. The data submitted in support of the request were found to be sufficient to derive tentative MRL proposals for the concerned crops. They are tentative as formally the general data gap identified in the ...

Europe - EFSA - European Food Safety Authority EFSA Journal

21-12-2018

National Research Programme for Environmental and Occupational Health:  43 projects selected and €7.4 million mobilised  for the 2018 calls for projects

National Research Programme for Environmental and Occupational Health: 43 projects selected and €7.4 million mobilised for the 2018 calls for projects

Today, ANSES is publishing the list of projects selected as part of its two 2018 calls for research projects for the National Research Programme for Environmental and Occupational Health: the first for projects on a general theme, and the second on the theme of "radiofrequencies and health". Following the selection process, 43 projects were selected with funding amounting to a total of 7.4 million euros.

France - Agence Nationale du Médicament Vétérinaire

21-12-2018

One lot of Equate brand Lens Care System and Multi-Purpose Solution voluntarily recalled because of a labelling error

One lot of Equate brand Lens Care System and Multi-Purpose Solution voluntarily recalled because of a labelling error

Teva Canada is voluntarily recalling one lot (Lot 150261) of two products because of a labelling error. While the outer carton of Equate brand Lens Care System is correctly labelled, the bottle within the carton is mislabelled as Equate brand Multi-Purpose Solution. Because of the labelling error, the company is recalling both products labelled with Lot 150261. Bottles labelled as Equate Multi-Purpose Solution should contain a 0.0001% w/v polyhexanide based disinfecting solution for rinsing. The mislabel...

Health Canada

21-12-2018

Avian influenza overview August – November 2018

Avian influenza overview August – November 2018

Published on: Thu, 20 Dec 2018 Between 16 August and 15 November 2018, 14 highly pathogenic avian influenza (HPAI) A(H5N8) outbreaks in poultry establishments in Bulgaria and seven HPAI A(H5N6) outbreaks, one in captive birds in Germany and six in wild birds in Denmark and the Netherlands were reported in the European Union (EU). No human infection due to HPAI A(H5N8) and A(H5N6) viruses have been reported in Europe so far. Seroconversion of people exposed during outbreaks in Russia has been reported in...

Europe - EFSA - European Food Safety Authority EFSA Journal

20-12-2018

Fluoroquinolone Antibiotics: Safety Communication - Increased Risk of Ruptures or Tears in the Aorta Blood Vessel in Certain Patients

Fluoroquinolone Antibiotics: Safety Communication - Increased Risk of Ruptures or Tears in the Aorta Blood Vessel in Certain Patients

FDA review found that fluoroquinolone antibiotics can increase the occurrence of rare but serious events of ruptures or tears in the main artery of the body, called the aorta. These tears, called aortic dissections, or ruptures of an aortic aneurysm can lead to dangerous bleeding or even death. They can occur with fluoroquinolones for systemic use given by mouth or through an injection.

FDA - U.S. Food and Drug Administration

20-12-2018

Scientific assistance to assess the detoxification process for dioxins and PCBs in sunflower cake by hexane extraction

Scientific assistance to assess the detoxification process for dioxins and PCBs in sunflower cake by hexane extraction

Published on: Wed, 19 Dec 2018 EFSA was requested to provide scientific assistance to the European Commission on a detoxification process for dioxins and PCBs from sunflower cake by hexane extraction in an emergency situation, as specified in Article 7 of Commission Regulation (EU) 2015/786. The process entails hexane extraction of sunflower oil from the cake to remove dioxins (PCDDs and PCDFs) as well as DL- and NDL-PCBs. The data provided by the applicant were assessed with respect to the efficacy of ...

Europe - EFSA - European Food Safety Authority EFSA Journal

14-12-2018

Statement on the safety of d‐ribose

Statement on the safety of d‐ribose

Published on: Thu, 13 Dec 2018 In 2018, the EFSA NDA Panel adopted the Scientific Opinion on the safety of d‐ribose as a novel food pursuant to Regulation (EU) 2015/2283 when used in a variety of food, concluding that d‐ribose is safe for the general population at intake levels up to 36 mg/kg body weight (bw) per day, but that its safety at the intended uses and use levels as proposed by the applicant could not be established. Following a request from the European Commission, the EFSA NDA Panel was aske...

Europe - EFSA - European Food Safety Authority Publications

13-12-2018

FDA Works to Keep Injectable Opioids Available to Treat Animals’ Surgical and Trauma Pain During Ongoing Supply Shortage

FDA Works to Keep Injectable Opioids Available to Treat Animals’ Surgical and Trauma Pain During Ongoing Supply Shortage

In its continuing mission to protect animal health, the U.S. Food and Drug Administration announced that it has worked with Pfizer Inc to alleviate a shortage of injectable opioids available to treat pain in animals, by facilitating the availability of a limited amount of product labeled for humans.

FDA - U.S. Food and Drug Administration

13-12-2018

The European Union summary report on trends and sources of zoonoses, zoonotic agents and food-borne outbreaks in 2017

The European Union summary report on trends and sources of zoonoses, zoonotic agents and food-borne outbreaks in 2017

Published on: Wed, 12 Dec 2018 This report of the European Food Safety Authority and the European Centre for Disease Prevention and Control presents the results of zoonoses monitoring activities carried out in 2017 in 37 European countries (28 Member States (MS) and nine non-MS). Campylobacteriosis was the commonest reported zoonosis and its EU trend for confirmed human cases increasing since 2008 stabilised during 2013–2017. The decreasing EU trend for confirmed human salmonellosis cases since 2008 end...

Europe - EFSA - European Food Safety Authority Publications

9-12-2018

TachoSil

TachoSil

Product approval information is indicated for use with manual compression in adult and pediatric patients as an adjunct to hemostasis in cardiovascular and hepatic surgery, when control of bleeding by standard surgical techniques (such as suture, ligature or cautery) is ineffective or impractical.

FDA - U.S. Food and Drug Administration

7-12-2018

Magnesium citrate malate as a source of magnesium added for nutritional purposes to food supplements

Magnesium citrate malate as a source of magnesium added for nutritional purposes to food supplements

Published on: Thu, 06 Dec 2018 The present scientific opinion deals with the assessment of the bioavailability of magnesium, from the proposed nutrient source, magnesium citrate malate (MgCM), when added for nutritional purposes to food supplements. MgCM is a mixed salt consisting of magnesium cations and citrate and malate anions, and with a magnesium content of 12–15%. MgCM is proposed to be used in food supplements that are intended to provide up to 300–540 mg/day magnesium. The data provided demonst...

Europe - EFSA - European Food Safety Authority Publications

4-12-2018

Joint project on Benchmark Dose modelling with RIVM

Joint project on Benchmark Dose modelling with RIVM

Published on: Mon, 03 Dec 2018 A web application for PROAST, a software package for BMD modelling, was developed to make the use of the BMD approach significantly easier for toxicologists and risk assessors. In addition, model averaging was included in the software, for the most frequently occurring types of data in toxicological studies. The PROAST web application now allows for applying model averaging for the case of both quantal and continuous data, as well as for combined datasets (dose‐response da...

Europe - EFSA - European Food Safety Authority Publications

29-11-2018

ANSES and CEA join forces to strengthen technological innovation in order to safeguard health

ANSES and CEA join forces to strengthen technological innovation in order to safeguard health

During the symposium organised to mark the sixtieth anniversary of the creation of the ANSES Laboratory in Ploufragan (Côtes d'Armor), on Thursday 29 November 2018, Roger Genet, Director General of ANSES, and Stéphane Siebert, Director of Technological Research at the CEA, signed a framework partnership agreement aimed at strengthening their cooperation to develop innovative technological tools in order to improve responsiveness in the fields of animal and plant health and food safety.

France - Agence Nationale du Médicament Vétérinaire

24-11-2018

The EFSA‐funded collection of dietary and related data in the general population aged 10‐74 years in Greece

The EFSA‐funded collection of dietary and related data in the general population aged 10‐74 years in Greece

Published on: Fri, 23 Nov 2018 The Hellenic Health Foundation received support from the European Food Safety Authority in order to organise a national nutrition survey according to the methodology described in the EFSA Guidance document and to collect food consumption and related information among 780 adolescents, adults and elderly residing permanently in Greece. The EFSA‐funded data collection was largely based on the protocol of a large scale Greek national nutrition and health survey, called HYDRIA....

Europe - EFSA - European Food Safety Authority Publications

22-11-2018

National Research Programme on Environmental and Occupational Health:  calls for research projects issued for 2019

National Research Programme on Environmental and Occupational Health: calls for research projects issued for 2019

ANSES is today issuing its annual calls for research projects as part of the National Research Programme on Environmental and Occupational Health. The 2019 edition of this programme will include two calls for projects with total funding of 8 million euros: a general one on the themes of environmental health and occupational health, which includes a budget of 2 million euros devoted to the topic of endocrine disruptors, and a second specific one on the theme of radiofrequencies and health.

France - Agence Nationale du Médicament Vétérinaire

15-11-2018

Recommendations on the use of the proportionality approach in the framework of risk assessment for pesticide residues

Recommendations on the use of the proportionality approach in the framework of risk assessment for pesticide residues

Published on: Wed, 14 Nov 2018 The technical report reflects the outcome of the discussions and agreements that were reached in the pesticides peer review meeting on residues and maximum residue levels regarding the principles and guidance for application of the proportionality concept in the risk assessment methodologies used at European level for the estimation of the maximum residue levels for pesticides. In addition, practical experiences on the use of the proportionality approach gained by EFSA hav...

Europe - EFSA - European Food Safety Authority Publications

13-11-2018

The importance of vector abundance and seasonality

The importance of vector abundance and seasonality

Published on: Mon, 12 Nov 2018 00:00:00 +0100 This joint ECDC‐EFSA report assesses whether vector count data (abundance) and the way these change throughout the year (seasonality) can provide useful information about vector‐borne diseases epidemiological processes of interest, and therefore, whether resources should be devoted to collecting such data. The document also summarises what measures of abundance and seasonality can be collected for each vector group (mosquitoes, sandflies, midges and ticks), ...

Europe - EFSA - European Food Safety Authority Publications

9-11-2018

An increase in poisonings due to wild mushroom consumption: be vigilant!

An increase in poisonings due to wild mushroom consumption: be vigilant!

In response to an increase in the number of cases of poisonings due to wild mushroom consumption reported to the French Poison Control and Monitoring Centres (CAP-TVs), ANSES and the Directorate General for Health (DGS) are issuing a warning to wild mushroom gatherers and reminding them of the good practices to be observed.

France - Agence Nationale du Médicament Vétérinaire

9-11-2018

Sargassum seaweed: limit the exposure of residents and workers to hydrogen sulphide

Sargassum seaweed: limit the exposure of residents and workers to hydrogen sulphide

Since August 2014, the French Caribbean and French Guiana have been experiencing successive waves of Sargassum seaweed washing up on their coastlines. Despite the efforts made to clean it up, the seaweed decomposes in situ. This leads to the production of hydrogen sulphide (H2S), which can sometimes be detected at high concentrations. Doctors' reports concerning the health effects suffered by people exposed to H2S, and complaints from the general public relating to the problem of odours, have increased s...

France - Agence Nationale du Médicament Vétérinaire

9-11-2018

Safety assessment of the substance Ln 1,4‐benzene dicarboxylic acid (with Ln = La, Eu, Gd, Tb) for use in food contact materials

Safety assessment of the substance Ln 1,4‐benzene dicarboxylic acid (with Ln = La, Eu, Gd, Tb) for use in food contact materials

Published on: Wed, 07 Nov 2018 00:00:00 +0100 The EFSA Panel on Food Contact Materials, Enzymes and Processing Aids (CEP Panel) assessed the safety of the additive Ln 1,4‐benzene dicarboxylic acid (with Ln = La, Eu, Gd, Tb) for use in food contact materials. It is a family of mixtures combining the four lanthanides lanthanum (La), europium (Eu), gadolinium (Gd) and/or terbium (Tb) in different proportions as their 1,4‐benzene dicarboxylate complexes, used as a taggant in plastics for authentication and ...

Europe - EFSA - European Food Safety Authority Publications

31-10-2018

Guidance on the scientific requirements for health claims related to muscle function and physical performance

Guidance on the scientific requirements for health claims related to muscle function and physical performance

Published on: Tue, 30 Oct 2018 00:00:00 +0100 EFSA has asked the Panel on Nutrition, Novel Foods and Food Allergens (NDA) to update the guidance on the scientific requirements for health claims related to physical performance published in 2012. The update takes into account the experience gained by the NDA Panel with the evaluation of additional health claim applications, changes introduced to the general scientific guidance for stakeholders for health claims applications and information collected from ...

Europe - EFSA - European Food Safety Authority Publications

30-10-2018

Training courses on “Steering an Expert Knowledge Elicitation” and “Use of the Expert Knowledge Elicitation Guidance in Risk Assessments for EFSA Management” and “Conduct of the Sheffield protocol for an Expert Knowledge Elicitation”

Training courses on “Steering an Expert Knowledge Elicitation” and “Use of the Expert Knowledge Elicitation Guidance in Risk Assessments for EFSA Management” and “Conduct of the Sheffield protocol for an Expert Knowledge Elicitation”

Published on: Mon, 29 Oct 2018 00:00:00 +0100 This report presents the results from an exploratory study in 2016 on clear communication of scientific assessment results. It had a specific focus on the communication of scientific uncertainties in EFSA scientific opinions. Qualitative methods were applied to the design and communication of an opinion summary and uncertainty statements related to that opinion, and to collect evidence on how different stakeholder groups responded to them. The study tested t...

Europe - EFSA - European Food Safety Authority Publications

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

10-10-2018

Tanning booths: ANSES issues a reminder of the proven risk of skin cancer

Tanning booths: ANSES issues a reminder of the proven risk of skin cancer

The health risks associated with exposure to artificial UV radiation from tanning booths have been well established for many years now. ANSES points out that recent data on the subject support previous assessments: there is a proven cancer risk associated with UV radiation from artificial tanning equipment. The Agency therefore recommends that the public authorities take the necessary steps to prevent people from being exposed to artificial UV radiation from tanning booths used for cosmetic purposes.

France - Agence Nationale du Médicament Vétérinaire

2-10-2018

"The environment has a real impact on the risk of cancer, although it remains difficult to assess": three questions for Professor Gérard Lasfargues, Managing Director General of the Science for Expertise Division

"The environment has a real impact on the risk of cancer, although it remains difficult to assess": three questions for Professor Gérard Lasfargues, Managing Director General of the Science for Expertise Division

Despite medical advances, cancer remains the leading cause of death in France.  While active smoking, alcohol consumption and an unbalanced diet continue to be the main causes of cancer mortality, the environment has a real impact on the risk of cancer, although it remains difficult to assess.

France - Agence Nationale du Médicament Vétérinaire

28-9-2018

Avian influenza overview May – August 2018

Avian influenza overview May – August 2018

Published on: Thu, 27 Sep 2018 00:00:00 +0200 Between 16 May and 15 August 2018, three highly pathogenic avian influenza (HPAI) A(H5N8) outbreaks in poultry establishments and three HPAI A(H5N6) outbreaks in wild birds were reported in Europe. Three low pathogenic avian influenza (LPAI) outbreaks were reported in three Member States. Few HPAI and LPAI bird cases have been detected in this period of the year, in accordance with the seasonal expected pattern of LPAI and HPAI. There is no evidence to date ...

Europe - EFSA - European Food Safety Authority Publications

27-9-2018

General Finishes Recalls Outdoor Oil

General Finishes Recalls Outdoor Oil

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

21-9-2018

Scientific guideline:  Guideline on determination of withdrawal periods for edible tissues - Revision 1, adopted

Scientific guideline: Guideline on determination of withdrawal periods for edible tissues - Revision 1, adopted

This document provides a standard approach to be used across the European Union in the analysis of residue depletion data for the purpose of establishing withdrawal periods for edible tissues. Emphasis has been put on a statistical approach. As the method of first choice, a linear regression technique is recommended. A computerised version of the method described is available: Updated application software: withdrawal time calculation for tissues. Read together with the explanatory note on updated applica...

Europe - EFSA - European Food Safety Authority EFSA Journal

19-9-2018

National dietary survey in 2012‐2016 on the general population aged 1‐79 years in the Netherlands

National dietary survey in 2012‐2016 on the general population aged 1‐79 years in the Netherlands

Published on: Tue, 18 Sep 2018 00:00:00 +0200 During the years 2012‐2016, the Dutch National Food Consumption survey was conducted in the Netherlands. For the survey, a random sample was drawn from consumer panels stratified by age and gender and maintained representative to the population with regard to region, address density and educational level. Complete results were obtained for 4,313 persons (response rate 65%); including toddlers, children, adolescents, adults and elderly. Pregnant or lactating ...

Europe - EFSA - European Food Safety Authority Publications

18-9-2018

Les Distributions Orca Lite Inc. recalls FLEXI LIGHT multi-purpose utility lighters

Les Distributions Orca Lite Inc. recalls FLEXI LIGHT multi-purpose utility lighters

Health Canada's sampling and evaluation program has determined that these lighters do not meet the Lighters Regulations in Canada and may pose a fire or burn hazard. Specifically, the child-resistant mechanism may not work properly.

Health Canada

14-9-2018

FDA approves device for treatment of acute coronary artery perforations

FDA approves device for treatment of acute coronary artery perforations

FDA approves device for treatment of acute coronary artery perforations

FDA - U.S. Food and Drug Administration

11-9-2018

Risk ranking of chemical and microbiological hazards in food

Risk ranking of chemical and microbiological hazards in food

Published on: Mon, 27 Aug 2018 00:00:00 +0200 Risk ranking is a versatile tool used to prioritise activities performed by public health regulatory bodies. It also allows efficient communication between all stakeholders in the process of risk analysis. However, risk ranking methods are still not optimal. Because of the different approaches employed in the risk assessment of microbiological agents and chemicals, it is difficult to rank them together using the same metrics. In our work, we first discuss di...

Europe - EFSA - European Food Safety Authority Publications

11-9-2018

Identification and evaluation of potentially mutagenic and carcinogenic food contaminants

Identification and evaluation of potentially mutagenic and carcinogenic food contaminants

Published on: Mon, 27 Aug 2018 00:00:00 +0200 Heat processing of food gives rise to a plethora of chemical compounds whose toxicological effects are largely unknown. Due to a general lack of experimental toxicological data, assessing the risks associated with the consumption of these substances remains a challenge. Computer models that allow for an in silico prediction of physicochemical and toxicological characteristics, may be able to fill current data gaps and facilitate the risk assessment of toxico...

Europe - EFSA - European Food Safety Authority Publications

11-9-2018

Preparation of Dutch food consumption data for risk assessment

Preparation of Dutch food consumption data for risk assessment

Published on: Mon, 27 Aug 2018 00:00:00 +0200 The availability of detailed and high‐quality food consumption data collected at an individual level is essential for assessing the exposure to potential risks in the food chain. During the years 2012–2016, the Dutch National Food Consumption Survey was conducted in the Netherlands as part of the EU Menu survey, following the EFSA 2009 guidance on ‘General principles for the collection of national food consumption data in the view of a pan‐European dietary s...

Europe - EFSA - European Food Safety Authority Publications

5-9-2018

Outcome of the pesticides peer review meeting on general recurring issues in mammalian toxicology

Outcome of the pesticides peer review meeting on general recurring issues in mammalian toxicology

Published on: Tue, 04 Sep 2018 00:00:00 +0200 This technical report reflects the outcome of the mammalian toxicology experts meeting on general recurring issues noted during the EFSA peer reviews of pesticide active substances under Regulation (EC) No 1107/2009. The main issues identified were related to genotoxicity of products and principles of (Q)SAR and read‐across. General presentations on the different EFSA guidance and EFSA developmental activities related to human health risk assessment of pesti...

Europe - EFSA - European Food Safety Authority Publications

31-8-2018

Alcon Announces Voluntary Global Market Withdrawal of CyPass Micro-Stent for Surgical Glaucoma

Alcon Announces Voluntary Global Market Withdrawal of CyPass Micro-Stent for Surgical Glaucoma

Reflecting its uncompromising commitment to patient safety, Alcon today announced an immediate, voluntary market withdrawal of the CyPass Micro-Stent from the global market. In addition, Alcon advises surgeons to immediately cease further implantation with the CyPass Micro-Stent and to return any unused devices to Alcon. This decision and corresponding recommendation is based on an analysis of five-year post-surgery data from the COMPASS-XT long-term safety study. The US Food and Drug Administration (FD...

FDA - U.S. Food and Drug Administration

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

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

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

Scientific Opinion on the state of the art of Toxicokinetic/Toxicodynamic (TKTD) effect models for regulatory risk assessment of pesticides for aquatic organisms

Scientific Opinion on the state of the art of Toxicokinetic/Toxicodynamic (TKTD) effect models for regulatory risk assessment of pesticides for aquatic organisms

Published on: Thu, 23 Aug 2018 00:00:00 +0200 Following a request from EFSA, the Panel on Plant Protection Products and their Residues (PPR) developed an opinion on the state of the art of Toxicokinetic/Toxicodynamic (TKTD) models and their use in prospective environmental risk assessment (ERA) for pesticides and aquatic organisms. TKTD models are species‐ and compound‐specific and can be used to predict (sub)lethal effects of pesticides under untested (time‐variable) exposure conditions. Three differen...

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

Evaluation of data concerning the necessity of bromoxynil as herbicide to control a serious danger to plant health which cannot be contained by other available means, including non‐chemical methods

Evaluation of data concerning the necessity of bromoxynil as herbicide to control a serious danger to plant health which cannot be contained by other available means, including non‐chemical methods

Published on: Mon, 13 Aug 2018 00:00:00 +0200 EFSA was requested by the European Commission to provide scientific assistance under Article 31 of Regulation (EC) No 178/2002 regarding the evaluation of data concerning the necessity of bromoxynil as a herbicide to control a serious danger to plant health which cannot be contained by other available means including non‐chemical methods, in accordance with Article 4(7) of Regulation (EC) No 1107/2009. In this context, EFSA organised a commenting phase with ...

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

Safety assessment of the process ‘General Plastic’, based on Starlinger Decon technology, used to recycle post‐consumer PET into food contact materials

Safety assessment of the process ‘General Plastic’, based on Starlinger Decon technology, used to recycle post‐consumer PET into food contact materials

Published on: Fri, 10 Aug 2018 00:00:00 +0200 This scientific opinion of the EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF Panel) deals with the safety evaluation of the recycling process General Plastic (EU register No RECYC153), which is based on the Starlinger Decon technology. The decontamination efficiency of the process was demonstrated by a challenge test. The input of this process is hot caustic washed and dried poly(ethylene terephthalate) (PET) flakes orig...

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

Grant agreement for piloting the Framework Partnership Agreement between the National data provider organisations in Slovakia and EFSA – Final report

Grant agreement for piloting the Framework Partnership Agreement between the National data provider organisations in Slovakia and EFSA – Final report

Published on: Tue, 07 Aug 2018 00:00:00 +0200 Presented document is the final report of the project GA/EFSA/DATA/2017/01: “Strategic Partnership with Slovakia on Data Quality (Pilot project)”. The report describes national processes and tools in order to implement internal validation and quality control of collected data according to EFSA requirements. A description of the data transmission processes from the National Databases to the EFSA databases, terminology, data mapping and data transformations fo...

Europe - EFSA - European Food Safety Authority Publications

14-8-2018

Scientific guideline:  Procedure for the review and revision of European Union herbal monographs and European Union list entries - Revision 2, adopted

Scientific guideline: Procedure for the review and revision of European Union herbal monographs and European Union list entries - Revision 2, adopted

The purpose of this procedure is to enable a consistent and proportionate process in reviewing and revising all European Union herbal monographs and European Union list entries adopted by the HMPC. The aim of this document is to describe how to identify the criteria/reasons that trigger the revision of European Union herbal monographs and list entries and the associated procedure and timelines for both the review and the revision.

Europe - EFSA - European Food Safety Authority EFSA Journal

27-7-2018

Agathe Denéchère appointed Deputy Director General for General Affairs at ANSES

Agathe Denéchère appointed Deputy Director General for General Affairs at ANSES

France - Agence Nationale du Médicament Vétérinaire

18-7-2018

Sodium glucose co-transporter 2 inhibitors

Sodium glucose co-transporter 2 inhibitors

Safety advisory - diabetic ketoacidosis and surgical procedures

Therapeutic Goods Administration - Australia

26-6-2018

Home Hardware Stores Ltd. recalls Home Flexible Multi-Purpose Lighter

Home Hardware Stores Ltd. recalls Home Flexible Multi-Purpose Lighter

Health Canada's sampling and evaluation program has determined that these lighters do not meet the Lighters Regulations in Canada and may pose a fire or burn hazard. Specifically the lighters:

Health Canada

20-6-2018

Signature of the framework agreement for the ESA Platform: strengthening epidemiological surveillance in animal health

Signature of the framework agreement for the ESA Platform: strengthening epidemiological surveillance in animal health

The signing of the new framework agreement for the Epidemiological Surveillance Platform for Animal Health (ESA Platform) on 20 June 2018 by the Director General for Food in the presence of Roger Genet, Director General of ANSES, and eight other members, signals a new departure for this platform, which has demonstrated its usefulness and effectiveness ever since it was set up in October 2011.  

France - Agence Nationale du Médicament Vétérinaire

27-11-2018

Reclassification of surgical mesh medical devices

Reclassification of surgical mesh medical devices

New guidance to assist sponsors with the reclassification of surgical mesh devices

Therapeutic Goods Administration - Australia

26-11-2018

A stereotactic system used by neurosurgeons to more precisely determine where to perform their surgical procedure was intended to be MRI compatible but the older predicate it compared itself to was not, requiring additional performance testing.

A stereotactic system used by neurosurgeons to more precisely determine where to perform their surgical procedure was intended to be MRI compatible but the older predicate it compared itself to was not, requiring additional performance testing.

A stereotactic system used by neurosurgeons to more precisely determine where to perform their surgical procedure was intended to be MRI compatible but the older predicate it compared itself to was not, requiring additional performance testing.

FDA - U.S. Food and Drug Administration

20-11-2018

.@US_FDA has updated the webpage on Urogynecologic Surgical Mesh Implants. Read more:  https://go.usa.gov/xPAzD  #MedicalDevice

.@US_FDA has updated the webpage on Urogynecologic Surgical Mesh Implants. Read more: https://go.usa.gov/xPAzD  #MedicalDevice

. @US_FDA has updated the webpage on Urogynecologic Surgical Mesh Implants. Read more: https://go.usa.gov/xPAzD  #MedicalDevice

FDA - U.S. Food and Drug Administration

9-10-2018

#ICYMI - FDA issues recommendations to help prevent surgical fires and      related patient injury. Click the link to read the recommendations:  https://go.usa.gov/xQdwG   #FirePreventionWeek #MedicalDevice

#ICYMI - FDA issues recommendations to help prevent surgical fires and related patient injury. Click the link to read the recommendations: https://go.usa.gov/xQdwG  #FirePreventionWeek #MedicalDevice

#ICYMI - FDA issues recommendations to help prevent surgical fires and related patient injury. Click the link to read the recommendations: https://go.usa.gov/xQdwG  #FirePreventionWeek #MedicalDevice

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

14-9-2018

#FDA approves device for treatment of acute coronary artery perforations. Read more about the approval here:  https://go.usa.gov/xPgTA  #MedicalDevice

#FDA approves device for treatment of acute coronary artery perforations. Read more about the approval here: https://go.usa.gov/xPgTA  #MedicalDevice

#FDA approves device for treatment of acute coronary artery perforations. Read more about the approval here: https://go.usa.gov/xPgTA  #MedicalDevice

FDA - U.S. Food and Drug Administration

7-9-2018

 2018 Annual workshop of the European Network of Paediatric Research at the European Medicines Agency (Enpr-EMA), European Medicines Agency, London, UK, From: 07-Jun-2018, To: 07-Jun-2018

2018 Annual workshop of the European Network of Paediatric Research at the European Medicines Agency (Enpr-EMA), European Medicines Agency, London, UK, From: 07-Jun-2018, To: 07-Jun-2018

Enpr-EMA will hold its tenth annual workshop on 7-8 June 2018 at EMA. The workshop brings relevant stakeholders together to discuss requirements, barriers and opportunities for the conduct of high-quality clinical studies in children. The overall theme of this year’s workshop will be a ‘holistic approach to paediatric research’. Highlights of this year’s workshop include: i) short perspectives of the various stakeholders involved in paediatric research (patient/young people advisory groups, research netw...

Europe - EMA - European Medicines Agency

30-8-2018

About Australian recall actions

About Australian recall actions

Update to general information about product recalls

Therapeutic Goods Administration - Australia

17-8-2018

Scientific guideline:  Draft guideline on clinical investigation of medicinal products in the treatment of epileptic disorders - Revision 3, draft: consultation open

Scientific guideline: Draft guideline on clinical investigation of medicinal products in the treatment of epileptic disorders - Revision 3, draft: consultation open

The present document is a third revision of the existing guideline. It should be considered as general guidance on the development of medicinal products for the treatment of epileptic disorders and should be read in conjunction with other EMA and ICH guidelines, which may apply to these conditions and patient populations. The main changes to the existing guideline include incorporation of the new classification / definitions of seizure types and epilepsies, the acceptance of add-on studies in support o...

Europe - EMA - European Medicines Agency

15-8-2018

Scientific guideline:  Draft guideline on quality of herbal medicinal products/traditional herbal medicinal products - Revision 3 , draft: consultation open

Scientific guideline: Draft guideline on quality of herbal medicinal products/traditional herbal medicinal products - Revision 3 , draft: consultation open

This document intends to cover the general quality aspects of herbal medicinal products for human and veterinary use, including traditional herbal medicinal products for human use. It describes the special problems of herbal medicinal products and the differences between medicinal products containing chemically defined active substances.

Europe - EMA - European Medicines Agency

27-7-2018

General dossier requirements

General dossier requirements

Amendments to Part C to update the reference for dossier requirements for biologicals

Therapeutic Goods Administration - Australia

18-7-2018

#ICYMI - According to @PAPATIENTSAFETY June 2018 report, the number of reported surgical fires has decreased since 2011.  Read more about preventing surgical fires here:  https://go.usa.gov/xU5zs  #FDA #MedicalDevice

#ICYMI - According to @PAPATIENTSAFETY June 2018 report, the number of reported surgical fires has decreased since 2011. Read more about preventing surgical fires here: https://go.usa.gov/xU5zs  #FDA #MedicalDevice

#ICYMI - According to @PAPATIENTSAFETY June 2018 report, the number of reported surgical fires has decreased since 2011. Read more about preventing surgical fires here: https://go.usa.gov/xU5zs  #FDA #MedicalDevice

FDA - U.S. Food and Drug Administration

10-7-2018

Chiarimenti sulla Determinazione AIFA n. 821/2018 (10/07/2018)

Chiarimenti sulla Determinazione AIFA n. 821/2018 (10/07/2018)

L'Agenzia Italiana del Farmaco rende disponibili chiarimenti sulla Determinazione del Direttore Generale AIFA n. 821 del 2018 (Gazzetta Ufficiale Repubblica Italiana Serie Generale n. 133 del 11.06.2018) per l’applicazione delle disposizioni relative alla smaltimento delle scorte dei medicinali.

Italia - AIFA - Agenzia Italiana del Farmaco

5-7-2018

Commissione Tecnico Scientifica (CTS) (05/07/2018)

Commissione Tecnico Scientifica (CTS) (05/07/2018)

L'Agenzia Italiana del Farmaco rende disponibile l'ordine del giorno, parte generale, dei lavori della riunione della Commissione Tecnico Scientifica (CTS) dell'AIFA del 9-10-11 luglio 2018.

Italia - AIFA - Agenzia Italiana del Farmaco

3-7-2018

The Pediatric Medical Device Development public meeting is August 13-14 at #FDA White Oak Campus. Do you know how the FDA defines “pediatrics” for medical device purposes? Click the link for the answer and more info on #Pediatric #MedicalDevices  https://

The Pediatric Medical Device Development public meeting is August 13-14 at #FDA White Oak Campus. Do you know how the FDA defines “pediatrics” for medical device purposes? Click the link for the answer and more info on #Pediatric #MedicalDevices https://

The Pediatric Medical Device Development public meeting is August 13-14 at #FDA White Oak Campus. Do you know how the FDA defines “pediatrics” for medical device purposes? Click the link for the answer and more info on #Pediatric #MedicalDevices https://go.usa.gov/xU2e8 

FDA - U.S. Food and Drug Administration

27-6-2018

Regulatory and procedural guideline:  Quality Review of Documents general principles regarding the summary-of-product-characteristics information for a generic / hybrid / biosimilar product

Regulatory and procedural guideline: Quality Review of Documents general principles regarding the summary-of-product-characteristics information for a generic / hybrid / biosimilar product

This document outlines the general principles to follow for the preparation of the summary of product characteristics (SmPC) for a generic, hybrid or biosimilar medicinal product to be authorised via the centralised procedure using a reference medicinal product authorised either at national level or centrally.

Europe - EMA - European Medicines Agency

25-6-2018

 Save the date - Uso dei farmaci in Italia: AIFA presenta il Rapporto Nazionale 2017

Save the date - Uso dei farmaci in Italia: AIFA presenta il Rapporto Nazionale 2017

Giovedì 12 luglio alle ore 10.30, presso la sede dell’Agenzia Italiana del Farmaco, il Direttore Generale Mario Melazzini presenterà i dati del Rapporto Nazionale 2017 “L’Uso dei Farmaci in Italia”. Il Rapporto, realizzato dall’Osservatorio Nazionale sull’impiego dei Medicinali (OsMed) dell’AIFA, analizza le evidenze derivanti dai dati sul consumo dei medicinali e sulla spesa farmaceutica in Italia e fornisce approfondimenti sul consumo dei farmaci per età e genere, sulle differenze regionali e sulle cat...

Italia - AIFA - Agenzia Italiana del Farmaco