AVSᆴ 14 X 20 X 0ᄚ- 8 PL PROVA

Informazioni principali

  • Nome commerciale:
  • AVSᆴ 14 X 20 X 0ᄚ- 8 PL PROVA
  • 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:
  • AVSᆴ 14 X 20 X 0ᄚ- 8 PL PROVA
    Italia
  • Lingua:
  • italiano

Informazioni terapeutiche

  • Gruppo terapeutico:
  • DISPOSITIVI PER SIMULAZIONE DI PROCEDURE CLINICHE

Altre informazioni

Status

  • Fonte:
  • Ministero della Salute - Italia
  • Stato dell'autorizzazione:
  • N
  • Data dell'autorizzazione:
  • 18-11-2009
  • 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.

17-1-2019

Safety and efficacy of 8‐mercapto‐p‐menthan‐3‐one and p‐menth‐1‐ene‐8‐thiol belonging to chemical group 20 when used as flavourings for all animal species

Safety and efficacy of 8‐mercapto‐p‐menthan‐3‐one and p‐menth‐1‐ene‐8‐thiol belonging to chemical group 20 when used as flavourings for all animal species

Published on: Wed, 16 Jan 2019 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 two compounds belonging to chemical group 20 (aliphatic and aromatic mono‐ and di‐thiols and mono‐, di‐, tri‐, and polysulfides with or without additional oxygenated functional groups). 8‐Mercapto‐p‐menthan‐3‐one [12.038] and p‐menth‐1‐ene‐8‐thiol [12.085] are currently ...

Europe - EFSA - European Food Safety Authority EFSA Journal

16-1-2019

Safety and efficacy of B‐Act® (Bacillus licheniformis DSM 28710) as a feed additive for turkeys for fattening, turkeys reared for breeding and minor poultry species for fattening or raised for laying

Safety and efficacy of B‐Act® (Bacillus licheniformis DSM 28710) as a feed additive for turkeys for fattening, turkeys reared for breeding and minor poultry species for fattening or raised for laying

Published on: Mon, 14 Jan 2019 Following a request from the European Commission, the EFSA Panel on Additives and Products or Substances used in Animal Feed was asked to deliver a scientific opinion on the safety and efficacy of B‐Act® when used in feed for turkeys for fattening, reared for breeding and minor poultry species for fattening or raised for laying. B‐Act® is a preparation containing viable spores of a Bacillus licheniformis strain. This species is considered by EFSA to be suitable for the qua...

Europe - EFSA - European Food Safety Authority EFSA Journal

16-1-2019

Software for Benchmark Dose Modelling

Software for Benchmark Dose Modelling

Published on: Mon, 14 Jan 2019 In specific contract No 7 issued under the framework agreement OC/EFSA/AMU/2015/02, EFSA requested Open Analytics to extend the Web application for Benchmark Dose Modelling built under specific contracts No 3 and No 4. The Web application is further developed in R with focus on creating a graphical module to evaluate model fit and to modify specific plot settings, as specified in the Technical Annex to Specific Contract No 7. The web application includes the latest develop...

Europe - EFSA - European Food Safety Authority EFSA Journal

16-1-2019

Safety and efficacy of Deccox® (decoquinate) for chickens for fattening

Safety and efficacy of Deccox® (decoquinate) for chickens for fattening

Published on: Mon, 14 Jan 2019 Deccox®, containing decoquinate as the active substance, is a feed additive intended to be used for the prevention of coccidiosis in chickens for fattening at a dose range of 20–40 mg/kg complete feed. Decoquinate from Deccox® is safe for chickens for fattening at the highest applied concentration in complete feed of 40 mg/kg. No practically relevant interactions with other additives or veterinary drugs exist except with bentonite. Decoquinate does not have antibacterial a...

Europe - EFSA - European Food Safety Authority EFSA Journal

15-1-2019

Voorstelling van Zaken “GOED SCHEIDEN” in Internationaal Theater Amsterdam

Voorstelling van Zaken “GOED SCHEIDEN” in Internationaal Theater Amsterdam

De komende Voorstelling van Zaken GOED SCHEIDEN vindt plaats op dinsdag 26 februari 2019 van 14.00-17.15 uur in Internationaal Theater Amsterdam (voorheen Stadsschouwburg Amsterdam). De voorstelling is bedoeld voor professionals betrokken bij scheidingen. Phaedra Werkhoven, journalist en ervaringsdeskundige, leidt de gesprekken op het toneel. Acteurs Gijs Scholten van Aschat, Jacob Derwig en Hannah van Lunteren spelen scènes die de scheidingsproblematiek op unieke wijze zullen laten zien. Scheiden is pij...

Netherlands - Ministerie van Volksgezondheid, Welzijn en Sport

15-1-2019

Assessment of genetically modified maize MON 89034 × 1507 × MON 88017 × 59122 × DAS‐40278‐9 and subcombinations independently of their origin for food and feed uses, import and processing under Regulation (EC) No 1829/2003 (application EFSA‐GMO‐NL‐2013‐11

Assessment of genetically modified maize MON 89034 × 1507 × MON 88017 × 59122 × DAS‐40278‐9 and subcombinations independently of their origin for food and feed uses, import and processing under Regulation (EC) No 1829/2003 (application EFSA‐GMO‐NL‐2013‐11

Published on: Mon, 14 Jan 2019 Maize MON 89034 × 1507 × MON 88017 × 59122 × DAS‐40278‐9 (five‐event stack maize) was produced by conventional crossing to combine five single events: MON 89034, 1507, MON 88017, 59122 and DAS‐40278‐9. The GMO Panel previously assessed the 5 single maize events and 11 of their subcombinations and did not identify safety concerns. No new data on the single maize events or their 11 subcombinations that could modify the original conclusions on their safety were identified. Th...

Europe - EFSA - European Food Safety Authority EFSA Journal

15-1-2019

Review of the existing maximum residue levels for metam according to Article 12 of Regulation (EC) No 396/2005

Review of the existing maximum residue levels for metam according to Article 12 of Regulation (EC) No 396/2005

Published on: Mon, 14 Jan 2019 According to Article 12 of Regulation (EC) No 396/2005, EFSA has reviewed the maximum residue levels (MRLs) currently established at European level for the pesticide active substance metam. To assess the occurrence of metam residues in plants, processed commodities, rotational crops and livestock, EFSA considered the conclusions derived in the framework of Commission Regulation (EC) No 33/2008C as well as the European authorisations reported by Member States (including the...

Europe - EFSA - European Food Safety Authority EFSA Journal

15-1-2019

Setting of an import tolerance for spiromesifen in coffee beans

Setting of an import tolerance for spiromesifen in coffee beans

Published on: Mon, 14 Jan 2019 In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Bayer CropScience submitted a request to the competent national authority in Greece to set an import tolerance for the active substance spiromesifen in coffee beans. The data submitted in support of the request were found to be sufficient to derive a maximum residue level (MRL) proposal for coffee beans. Adequate analytical methods for enforcement are available to control the residues of spiromesife...

Europe - EFSA - European Food Safety Authority EFSA Journal

15-1-2019

Assessment of genetically modified soybean A2704‐12 for renewal of authorisation under Regulation (EC) No 1829/2003 (application EFSA‐GMO‐RX‐009)

Assessment of genetically modified soybean A2704‐12 for renewal of authorisation under Regulation (EC) No 1829/2003 (application EFSA‐GMO‐RX‐009)

Published on: Mon, 14 Jan 2019 Following the submission of application EFSA‐GMO‐RX‐009 under Regulation (EC) No 1829/2003 from Bayer CropScience N.V., the Panel on Genetically Modified Organisms of the European Food Safety Authority was asked to deliver a scientific risk assessment on the data submitted in the context of the renewal of authorisation application for the herbicide‐tolerant genetically modified soybean A2704‐12, for food and feed uses, import and processing, excluding cultivation within th...

Europe - EFSA - European Food Safety Authority EFSA Journal

15-1-2019

EFSA's activities on emerging risks in 2017

EFSA's activities on emerging risks in 2017

Published on: Mon, 14 Jan 2019 The main objectives of EFSA's activities on emerging risks are: (i) to carry out activities to identify emerging risks in the areas within the remit of EFSA; and (ii) to develop and improve emerging risk identification methodologies and approaches. The current technical report summarises the activities of all groups involved in the emerging risk identification procedure, the issues identified in the course of 2017, a description of methodologies being developed and collabo...

Europe - EFSA - European Food Safety Authority EFSA Journal

15-1-2019

Review of the existing maximum residue levels for fluometuron according to Article 12 of Regulation (EC) No 396/2005

Review of the existing maximum residue levels for fluometuron according to Article 12 of Regulation (EC) No 396/2005

Published on: Mon, 14 Jan 2019 According to Article 12 of Regulation (EC) No 396/2005, EFSA has reviewed the maximum residue levels (MRLs) currently established at European level for the pesticide active substance fluometuron. To assess the occurrence of fluometuron residues in plants, processed commodities, rotational crops and livestock, EFSA considered the conclusions derived in the framework of Commission Regulation (EC) No 33/2008 as well as the European authorisations reported by Member States (in...

Europe - EFSA - European Food Safety Authority EFSA Journal

15-1-2019

Safety assessment of the substance, montmorillonite clay modified with hexadecyltrimethylammonium bromide, for use in food contact materials

Safety assessment of the substance, montmorillonite clay modified with hexadecyltrimethylammonium bromide, for use in food contact materials

Published on: Mon, 14 Jan 2019 The EFSA Panel on Food Contact Materials, Enzymes and Processing Aids (CEP) assessed the safety of montmorillonite clay modified with hexadecyltrimethylammonium bromide (HDTA) when used as an additive at up to ■■■■■ in polylactic acid (PLA) bottles intended for contact with water for long‐term storage at ambient temperature or below. The modified clay, which 90% w/w of the particles have a dimension of 33.1 μm or less and the average size is 9 μm, has a layered structure w...

Europe - EFSA - European Food Safety Authority EFSA Journal

8-1-2019

Sun Pharmaceutical Industries, Inc. Issues Voluntary Nationwide Recall of Vecuronium Bromide for Injection Due to the Presence of Particulate Matter Identified as Glass

Sun Pharmaceutical Industries, Inc. Issues Voluntary Nationwide Recall of Vecuronium Bromide for Injection Due to the Presence of Particulate Matter Identified as Glass

Sun Pharmaceutical Industries, Inc. (SPII), a wholly owned subsidiary of Sun Pharmaceutical Industries, Ltd. is voluntarily recalling three lots of Vecuronium Bromide for Injection, 10 mg (lyophilized powder), and one lot of Vecuronium Bromide for Injection, 20 mg (lyophilized powder) to the hospital level. The Vecuronium Bromide for Injection has been found to contain particulate matter identified as glass.

FDA - U.S. Food and Drug Administration

24-12-2018

Bonify recalls 14 lots of dried cannabis products

Bonify recalls 14 lots of dried cannabis products

The recalled products have record keeping issues with production documents that may not meet the requirements under theCannabis Regulations. As a result, Bonify has issued a recall as a precautionary measure.

Health Canada

21-12-2018

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

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

Published on: Thu, 20 Dec 2018 The conclusions of EFSA following the peer review of the initial risk assessments carried out by the competent authority of the rapporteur Member State Italy for the pesticide active substance propanil and the assessment of applications for maximum residue levels (MRLs) 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 t...

Europe - EFSA - European Food Safety Authority EFSA Journal

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

Pest categorisation of Gymnosporangium spp. (non‐EU)

Pest categorisation of Gymnosporangium spp. (non‐EU)

Published on: Wed, 19 Dec 2018 Following a request from the European Commission, the EFSA Panel on Plant Health performed a pest categorisation of Gymnosporangium spp. (non‐EU), a well‐defined and distinguishable group of fungal plant pathogens of the family Pucciniaceae affecting woody species. Many different Gymnosporangium species are recognised, of which at least 14 species are considered not to be native in the European Union. All the non‐EU Gymnosporangium species are not known to be present in th...

Europe - EFSA - European Food Safety Authority EFSA Journal

18-12-2018


eXtended EudraVigilance Medicinal Product Dictionary face-to-face training course (Amsterdam), BCN Amsterdam Arena, Atlas Arena Complex Amsterdam, The Netherlands, from 14/02/2019 to 15/02/2019

eXtended EudraVigilance Medicinal Product Dictionary face-to-face training course (Amsterdam), BCN Amsterdam Arena, Atlas Arena Complex Amsterdam, The Netherlands, from 14/02/2019 to 15/02/2019

eXtended EudraVigilance Medicinal Product Dictionary face-to-face training course (Amsterdam), BCN Amsterdam Arena, Atlas Arena Complex Amsterdam, The Netherlands, from 14/02/2019 to 15/02/2019

Europe - EMA - European Medicines Agency

18-12-2018

Atherstone Foods Inc Issues Allergy Alert on Undeclared Soy in “Greens and Grains Hummus and Quinoa Tabouleh Wrap”

Atherstone Foods Inc Issues Allergy Alert on Undeclared Soy in “Greens and Grains Hummus and Quinoa Tabouleh Wrap”

ATHERSTONE FOODS INC of Richmond, CA is recalling 14.6 ounce (414g) Greens and Grains Hummus and Quinoa Tabouleh Wrap, because it may contain undeclared soy, people who have an allergy or severe sensitivity to soy run the risk of serious or life-threatening allergic reaction if they consume these products.

FDA - U.S. Food and Drug Administration

18-12-2018

Enovachem Pharmaceuticals Issues Voluntary Nationwide Recall of Dyural-40 and Dyural-80 Convenience Kits Containing Recalled Sodium Chloride Injection, USP, 0.9% Due to Latex Hazard

Enovachem Pharmaceuticals Issues Voluntary Nationwide Recall of Dyural-40 and Dyural-80 Convenience Kits Containing Recalled Sodium Chloride Injection, USP, 0.9% Due to Latex Hazard

Torrance, CA, Asclemed USA Inc is voluntarily recalling 20 lots of Dyural-40 and 61 lots of Dyural-80, to the user level. The products include recalled Sodium Chloride, USP, 0.9% manufactured by Fresenius Kabi, which has been recalled due to product labeling incorrectly stating stoppers do not contain latex.

FDA - U.S. Food and Drug Administration

17-12-2018


Draft cabozantinib tablet 20 mg, 40 mg and 60 mg, capsule 20 4 mg and 80 mg product-specific bioequivalence guidance

Draft cabozantinib tablet 20 mg, 40 mg and 60 mg, capsule 20 4 mg and 80 mg product-specific bioequivalence guidance

Draft cabozantinib tablet 20 mg, 40 mg and 60 mg, capsule 20 4 mg and 80 mg product-specific bioequivalence guidance

Europe - EMA - European Medicines Agency

16-12-2018

Apio, Inc. Voluntarily Recalls Five Skus of Eat Smart Single-Serve Salad Shake Ups™

Apio, Inc. Voluntarily Recalls Five Skus of Eat Smart Single-Serve Salad Shake Ups™

Apio, Inc. of Guadalupe, California is voluntarily recalling five SKUs of Eat Smart® Single-Serve Salad Shake Ups™ (bowls). The recall comes after the Canadian Food Inspection Agency (CFIA) informed the company that one random sample of Eat Smart Single-Serve Salad Shake Ups Sweet Kale/Chou Frise Doux 156 gr. (5.5oz) with Best Before of Dec 14, 2018 tested positive for Listeria Monocytogenes. As a precautionary measure, we are recalling all products produced on the same day, same production line, as the ...

FDA - U.S. Food and Drug Administration

15-12-2018

Annual report of the Scientific Network on Microbiological Risk Assessment 2018

Annual report of the Scientific Network on Microbiological Risk Assessment 2018

Published on: Fri, 14 Dec 2018 Among the tasks of EFSA, according to its founding regulation (Regulation (EC) No 178/2002), there is the establishment of a system of Networks of organisations operating in the fields within EFSA's mission, the objective being to facilitate a scientific cooperation framework by the coordination of activities, the exchange of information, the development and implementation of joint projects, the exchange of expertise and best practices. Additionally, the EFSA Science Strat...

Europe - EFSA - European Food Safety Authority Publications

15-12-2018

Annual Report of the Scientific Network on BSE‐TSE 2018

Annual Report of the Scientific Network on BSE‐TSE 2018

Published on: Fri, 14 Dec 2018 The EFSA Scientific Network on bovine spongiform encephalopathies and other transmissible spongiform encephalopathies (BSE‐TSE) held its 13th meeting on 15‐16 October 2018 in Parma. The meeting served as an opportunity to exchange scientific information on BSE‐TSE related issues among EU Member States, countries from the European Free Trade Association (EFTA), EFSA, the European Commission and ad hocparticipants. In this occasion, ad hoc representation included the World A...

Europe - EFSA - European Food Safety Authority Publications

14-12-2018

Risk to human health related to the presence of perfluorooctane sulfonic acid and perfluorooctanoic acid in food

Risk to human health related to the presence of perfluorooctane sulfonic acid and perfluorooctanoic acid in food

Published on: Thu, 13 Dec 2018 The European Commission asked EFSA for a scientific evaluation on the risks to human health related to the presence of perfluorooctane sulfonic acid (PFOS) and perfluorooctanoic acid (PFOA) in food. Regarding PFOS and PFOA occurrence, the final data set available for dietary exposure assessment contained a total of 20,019 analytical results (PFOS n = 10,191 and PFOA n = 9,828). There were large differences between upper and lower bound exposure due to analytical methods with i...

Europe - EFSA - European Food Safety Authority Publications

14-12-2018

Response to comments on the Scientific Opinion on the scientific substantiation of a health claim related to Symbiosal® and lowering of blood pressure and reduced risk of hypertension pursuant to Article 14 of Regulation (EC) No 1924/2006

Response to comments on the Scientific Opinion on the scientific substantiation of a health claim related to Symbiosal® and lowering of blood pressure and reduced risk of hypertension pursuant to Article 14 of Regulation (EC) No 1924/2006

Published on: Thu, 13 Dec 2018 Following a request from the European Commission, EFSA was asked to review the comments received on the Scientific Opinion of the EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA) on the scientific substantiation of a health claim related to Symbiosal® and lowering of blood pressure and reduced risk of hypertension pursuant to Article 14 of Regulation (EC) No 1924/2006. Comments originating from the applicant (Han‐Biotech GmbH) were submitted to EFSA via the E...

Europe - EFSA - European Food Safety Authority Publications

14-12-2018

Analysis of hunting statistics collection frameworks for wild boar across Europe and proposals for improving the harmonisation of data collection

Analysis of hunting statistics collection frameworks for wild boar across Europe and proposals for improving the harmonisation of data collection

Published on: Thu, 13 Dec 2018 Heterogeneities in the wild boar data collection frameworks across Europe were analysed using questionnaires to explore comparability of hunting data in the short term and propose a common framework for future collection. Fifty‐seven respondents representing 32 countries covering more than 95% of European territory participated to the questionnaire. The most frequently recorded information in the official statistics included the quantity of animals shot per hunting ground ...

Europe - EFSA - European Food Safety Authority Publications

11-12-2018


The new EudraVigilance system and the electronic reporting of individual case safety reports in the ISO/ICH E2B(R3) format: Hands-on training course, Madrid, Spain, from 20/05/2019 to 22/05/2019

The new EudraVigilance system and the electronic reporting of individual case safety reports in the ISO/ICH E2B(R3) format: Hands-on training course, Madrid, Spain, from 20/05/2019 to 22/05/2019

The new EudraVigilance system and the electronic reporting of individual case safety reports in the ISO/ICH E2B(R3) format: Hands-on training course, Madrid, Spain, from 20/05/2019 to 22/05/2019

Europe - EMA - European Medicines Agency

11-12-2018


The new EudraVigilance system and the electronic reporting of individual case safety reports in the ISO/ICH E2B(R3) format: Hands-on training course, London, United Kingdom, from 11/02/2019 to 20/02/2019

The new EudraVigilance system and the electronic reporting of individual case safety reports in the ISO/ICH E2B(R3) format: Hands-on training course, London, United Kingdom, from 11/02/2019 to 20/02/2019

The new EudraVigilance system and the electronic reporting of individual case safety reports in the ISO/ICH E2B(R3) format: Hands-on training course, London, United Kingdom, from 11/02/2019 to 20/02/2019

Europe - EMA - European Medicines Agency

11-12-2018


Agenda - PDCO agenda of the 11-14 December 2018 meeting

Agenda - PDCO agenda of the 11-14 December 2018 meeting

Agenda - PDCO agenda of the 11-14 December 2018 meeting

Europe - EMA - European Medicines Agency

29-11-2018

Glyphosate: ANSES launches a comparative assessment with the available alternatives

Glyphosate: ANSES launches a comparative assessment with the available alternatives

Following the five-year re-approval of this active substance at European level in December 2017, ANSES is reassessing marketing authorisations for products containing glyphosate. For products for which an application for authorisation or re-authorisation has been submitted, the Agency will carry out a comparative assessment with the available alternatives. For each glyphosate-based product, all uses for which there is an alternative that meets the substitution criteria will therefore be prohibited.

France - Agence Nationale du Médicament Vétérinaire

21-11-2018

Fresenius Kabi Issues Voluntary Nationwide Recall of Sodium Chloride Injection, USP, 0.9% Due to Product Labeling Incorrectly Stating Stoppers Do Not Contain Latex

Fresenius Kabi Issues Voluntary Nationwide Recall of Sodium Chloride Injection, USP, 0.9% Due to Product Labeling Incorrectly Stating Stoppers Do Not Contain Latex

Fresenius Kabi USA is voluntarily recalling 163 lots of Sodium Chloride Injection, USP, 0.9%, 10 mL fill in a 10 mL vial and Sodium Chloride Injection, USP, 0.9%, 20 mL fill in a 20 mL vial to the user level. The product insert states that stoppers for both the 10mL and the 20mL vials do not contain natural rubber latex; the tray label for the two vial sizes and the vial label for the 20mL vial also state that the stoppers do not contain latex. The product is being recalled because the stoppers contain n...

FDA - U.S. Food and Drug Administration

21-11-2018

Enforcement Report for the Week of November 21, 2018

Enforcement Report for the Week of November 21, 2018

Recently Updated Records for the Week of November 21, 2018 Last Modified Date: Tuesday, November 20, 2018

FDA - U.S. Food and Drug Administration

21-11-2018

Implementation and verification of PBPK modelling codes of TCDD in rats and humans into Berkeley Madonna

Implementation and verification of PBPK modelling codes of TCDD in rats and humans into Berkeley Madonna

Published on: Tue, 20 Nov 2018 The goal of the current work was to implement and verify previously published rat and human PBPK modelling codes for TCDD into Berkeley Madonna. The US‐EPA has used these PBPK models in the reassessment of TCDD. A procurement contract has been set up to explore the possibilities to adequately run the models and reproduce previously published results. The implementation of the available codes in Berkeley Madonna was carried out at RIKILT‐WUR under the framework agreement wi...

Europe - EFSA - European Food Safety Authority Publications

21-11-2018

Extensive Literature Search, Selection for Relevance and Data Extraction of Studies Related to the Toxicity of PCDD/Fs and DL‐PCBs in Experimental Animals

Extensive Literature Search, Selection for Relevance and Data Extraction of Studies Related to the Toxicity of PCDD/Fs and DL‐PCBs in Experimental Animals

Published on: Tue, 20 Nov 2018 Polychlorinated dibenzodioxins (PCDD), polychlorinated dibenzofurans (PCDFs) and dioxin‐like polychlorinated biphenyls (DL‐PCBs) are detected ubiquitously in the environment, diet and human tissues. The European Food Safety Authority (EFSA) CONTAM Panel received a mandate from the European Commission for a scientific opinion on the risks for human and animal health related to the presence of dioxins and DL‐PCBs in food and feed. To support preparatory work for the hazard i...

Europe - EFSA - European Food Safety Authority Publications

21-11-2018

Safety and efficacy of Monteban® G100 (narasin) for chickens for fattening

Safety and efficacy of Monteban® G100 (narasin) for chickens for fattening

Published on: Tue, 20 Nov 2018 The feed additive Monteban® G100, containing the active substance narasin, an ionophore anticoccidial, is intended to control coccidiosis in chickens for fattening at a dose of 60–70 mg/kg complete feed. Narasin is produced by fermentation. Limited data on the taxonomic identification of the production strain did not allow the proper identification of strain NRRL 8092 as Streptomyces aureofaciens. The FEEDAP Panel cannot conclude on the absence of genetic determinants for ...

Europe - EFSA - European Food Safety Authority Publications

21-11-2018

Extensive literature search, selection for relevance and data extraction of studies related to the toxicity of PCDD/Fs and DL‐PCBs in humans

Extensive literature search, selection for relevance and data extraction of studies related to the toxicity of PCDD/Fs and DL‐PCBs in humans

Published on: Tue, 20 Nov 2018 To enable the hazard identification and characterisation in the risk assessment for humans related to the seventeen 2,3,7,8‐substituted dioxins (PCCDs) and furans (PCDFs) and the twelve dioxin‐like polychlorinated biphenyls (DL‐PCBs), EFSA outsourced an extensive literature search (ELS), followed by selection for relevance and extraction of relevant data for consideration in the risk assessment. Two tailored search strategies for Web of Science (WoS) and PubMed for identif...

Europe - EFSA - European Food Safety Authority Publications

21-11-2018

Risk for animal and human health related to the presence of dioxins and dioxin-like PCBs in feed and food

Risk for animal and human health related to the presence of dioxins and dioxin-like PCBs in feed and food

Published on: Tue, 20 Nov 2018 The European Commission asked EFSA for a scientific opinion on the risks for animal and human health related to the presence of dioxins (PCDD/Fs) and DL‐PCBs in feed and food. The data from experimental animal and epidemiological studies were reviewed and it was decided to base the human risk assessment on effects observed in humans and to use animal data as supportive evidence. The critical effect was on semen quality, following pre‐ and postnatal exposure. The critical s...

Europe - EFSA - European Food Safety Authority Publications

21-11-2018

Setting of an import tolerance for mandipropamid in cocoa beans

Setting of an import tolerance for mandipropamid in cocoa beans

Published on: Tue, 20 Nov 2018 In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Syngenta Agro GmbH submitted a request to the competent national authority in Austria to set a maximum residue level (MRL) for the active substance mandipropamid in cocoa beans imported from Nigeria and Cameroon. The data submitted in support of the request were found to be sufficient to derive a MRL proposal of 0.06 mg/kg. Adequate analytical methods for enforcement are available to control the res...

Europe - EFSA - European Food Safety Authority Publications

20-11-2018

November 20, 2018: Rochester Man Pleads Guilty to Smuggling Counterfeit Cialis and Viagra into the United States

November 20, 2018: Rochester Man Pleads Guilty to Smuggling Counterfeit Cialis and Viagra into the United States

November 20, 2018: Rochester Man Pleads Guilty to Smuggling Counterfeit Cialis and Viagra into the United States

FDA - U.S. Food and Drug Administration

20-11-2018

Vijf winnaars van energieneutrale sportprojecten kunnen aan de slag

Vijf winnaars van energieneutrale sportprojecten kunnen aan de slag

Op 20 november zijn de vijf winnaars van de Innovation Challenge Energieneutrale Sportaccommodaties, vanuit het programma Sportinnovator, bekendgemaakt. De innovatieve ideeën voor energiebesparing bij sportaccommodaties hebben groen licht gekregen. Ze ontvangen hiervoor steun van het ministerie van Volksgezondheid, Welzijn en Sport om innovatie in de sport te bevorderen. Onderstaande initiatieven krijgen 100.000 euro om het idee in de praktijk door te voeren.

Netherlands - Ministerie van Volksgezondheid, Welzijn en Sport

18-1-2019


Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 14-17 January 2019

Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 14-17 January 2019

Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 14-17 January 2019

Europe - EMA - European Medicines Agency

14-1-2019

Paclitaxel Hetero and associated names

Paclitaxel Hetero and associated names

Paclitaxel Hetero and associated names (Active substance: paclitaxel) - Community Referrals - Art 29 - Commission Decision (2019)205 of Mon, 14 Jan 2019 European Medicines Agency (EMA) procedure number: EMEA/H//A-29(4)/1466

Europe -DG Health and Food Safety

24-12-2018

ACCM meeting statement, Meeting 20, 16 November 2018

ACCM meeting statement, Meeting 20, 16 November 2018

ACCM meeting statement for 16 November 2018 published

Therapeutic Goods Administration - Australia

21-12-2018

Consultation: Fees and charges proposal 2019-20

Consultation: Fees and charges proposal 2019-20

The TGA is seeking comments from interested parties on the proposed changes in fees and charges for 2019-2020. Closing date: 8 February 2018

Therapeutic Goods Administration - Australia

20-12-2018

Namuscla (Lupin Europe GmbH)

Namuscla (Lupin Europe GmbH)

Namuscla (Active substance: Mexiletine) - New authorisation - Commission Decision (2018)9133 of Thu, 20 Dec 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4584

Europe -DG Health and Food Safety

20-12-2018

Bevespi Aerosphere (AstraZeneca AB)

Bevespi Aerosphere (AstraZeneca AB)

Bevespi Aerosphere (Active substance: glycopyrronium bromide / formoterol) - New authorisation - Commission Decision (2018)9127 of Thu, 20 Dec 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4245

Europe -DG Health and Food Safety

19-12-2018

Consultation: Medical device cyber security

Consultation: Medical device cyber security

The TGA is seeking comments from interested parties on the applicability and usefulness of the content contained in the draft regulatory guidance and information materials. Closing date: 14 February 2019

Therapeutic Goods Administration - Australia

18-12-2018


Human medicines European public assessment report (EPAR): Vabomere, meropenem / vaborbactam, Urinary Tract Infections,Bacteremia,Bacterial Infections,Respiratory Tract Infections,Pneumonia,Pneumonia, Ventilator-Associated, Date of authorisation: 20/11/20

Human medicines European public assessment report (EPAR): Vabomere, meropenem / vaborbactam, Urinary Tract Infections,Bacteremia,Bacterial Infections,Respiratory Tract Infections,Pneumonia,Pneumonia, Ventilator-Associated, Date of authorisation: 20/11/20

Human medicines European public assessment report (EPAR): Vabomere, meropenem / vaborbactam, Urinary Tract Infections,Bacteremia,Bacterial Infections,Respiratory Tract Infections,Pneumonia,Pneumonia, Ventilator-Associated, Date of authorisation: 20/11/2018, Status: Authorised

Europe - EMA - European Medicines Agency

18-12-2018


Human medicines European public assessment report (EPAR): Buvidal, buprenorphine, Opioid-Related Disorders, Date of authorisation: 20/11/2018, Status: Authorised

Human medicines European public assessment report (EPAR): Buvidal, buprenorphine, Opioid-Related Disorders, Date of authorisation: 20/11/2018, Status: Authorised

Human medicines European public assessment report (EPAR): Buvidal, buprenorphine, Opioid-Related Disorders, Date of authorisation: 20/11/2018, Status: Authorised

Europe - EMA - European Medicines Agency

14-12-2018

Desloratadine Teva (Teva B.V.)

Desloratadine Teva (Teva B.V.)

Desloratadine Teva (Active substance: desloratadine) - Centralised - Yearly update - Commission Decision (2018)8912 of Fri, 14 Dec 2018

Europe -DG Health and Food Safety

14-12-2018

Revinty Ellipta (GlaxoSmithKline (Ireland) Limited)

Revinty Ellipta (GlaxoSmithKline (Ireland) Limited)

Revinty Ellipta (Active substance: fluticasone furoate / vilanterol) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)8927 of Fri, 14 Dec 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2745/T/38

Europe -DG Health and Food Safety

14-12-2018

Valdoxan (Les Laboratoires Servier)

Valdoxan (Les Laboratoires Servier)

Valdoxan (Active substance: agomelatine) - Centralised - Renewal - Commission Decision (2018)8932 of Fri, 14 Dec 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/915/R/42

Europe -DG Health and Food Safety

14-12-2018

Ogivri (Mylan S.A.S.)

Ogivri (Mylan S.A.S.)

Ogivri (Active substance: trastuzumab) - Centralised - Authorisation - Commission Decision (2018)8913 of Fri, 14 Dec 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4916

Europe -DG Health and Food Safety

14-12-2018

LONGRANGE (Merial)

LONGRANGE (Merial)

LONGRANGE (Active substance: eprinomectin) - Refusal of authorisation - Commission Decision (2018)8905 of Fri, 14 Dec 2018 European Medicines Agency (EMA) procedure number: EMEA/V/C/4291

Europe -DG Health and Food Safety

14-12-2018

Relvar Ellipta (GlaxoSmithKline (Ireland) Limited)

Relvar Ellipta (GlaxoSmithKline (Ireland) Limited)

Relvar Ellipta (Active substance: fluticasone furoate/vilanterol) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)8928 of Fri, 14 Dec 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2673/T/40

Europe -DG Health and Food Safety

14-12-2018

Dengvaxia (Sanofi Pasteur)

Dengvaxia (Sanofi Pasteur)

Dengvaxia (Active substance: dengue tetravalent vaccine (live, attenuated)) - Centralised - Authorisation - Commission Decision (2018)8933 of Fri, 14 Dec 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4171

Europe -DG Health and Food Safety

14-12-2018

Flucelvax Tetra (Seqirus Netherlands B.V.)

Flucelvax Tetra (Seqirus Netherlands B.V.)

Flucelvax Tetra (Active substance: influenza vaccine (surface antigen, inactivated, prepared in cell cultures)) - Centralised - Authorisation - Commission Decision (2018)8911 of Fri, 14 Dec 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4814

Europe -DG Health and Food Safety

14-12-2018

Pregabalin Pfizer (Pfizer Europe MA EEIG)

Pregabalin Pfizer (Pfizer Europe MA EEIG)

Pregabalin Pfizer (Active substance: pregabalin) - Centralised - Renewal - Commission Decision (2018)8908 of Fri, 14 Dec 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/3880/R/25

Europe -DG Health and Food Safety

12-12-2018


Human medicines European public assessment report (EPAR): Exondys, eteplirsen, Muscular Dystrophy, Duchenne, Date of refusal: 20/09/2018, Status: Refused

Human medicines European public assessment report (EPAR): Exondys, eteplirsen, Muscular Dystrophy, Duchenne, Date of refusal: 20/09/2018, Status: Refused

Human medicines European public assessment report (EPAR): Exondys, eteplirsen, Muscular Dystrophy, Duchenne, Date of refusal: 20/09/2018, Status: Refused

Europe - EMA - European Medicines Agency

5-12-2018

TGA presentation: Webinar: Advertising therapeutic goods in 2019: The Code basics – 20 November

TGA presentation: Webinar: Advertising therapeutic goods in 2019: The Code basics – 20 November

The slides from TGA's webinar on Advertising Code Basics have been published

Therapeutic Goods Administration - Australia

30-11-2018

Consultation: Proposal for the regulation of IVD companion diagnostics

Consultation: Proposal for the regulation of IVD companion diagnostics

Closing date extended to 14 December 2018

Therapeutic Goods Administration - Australia

28-11-2018

PHEBURANE (Eurocept International BV)

PHEBURANE (Eurocept International BV)

PHEBURANE (Active substance: Sodium Phenylbutyrate) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)8043 of Wed, 28 Nov 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2500/T/20

Europe -DG Health and Food Safety

26-11-2018

Data show that nearly 20% of current 510(k)s are cleared based on a predicate that’s more than 10 years old. That doesn’t mean the products are unsafe. But it does mean that some devices may not be continually improving, which is the hallmark of health te

Data show that nearly 20% of current 510(k)s are cleared based on a predicate that’s more than 10 years old. That doesn’t mean the products are unsafe. But it does mean that some devices may not be continually improving, which is the hallmark of health te

Data show that nearly 20% of current 510(k)s are cleared based on a predicate that’s more than 10 years old. That doesn’t mean the products are unsafe. But it does mean that some devices may not be continually improving, which is the hallmark of health technologies.

FDA - U.S. Food and Drug Administration