MYLAB FIVE

Informazioni principali

  • Nome commerciale:
  • MYLAB FIVE
  • 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:
  • MYLAB FIVE
    Italia
  • Lingua:
  • italiano

Informazioni terapeutiche

  • Gruppo terapeutico:
  • ECOTOMOGRAFI PORTATILI

Altre informazioni

Status

  • Fonte:
  • Ministero della Salute - Italia
  • Stato dell'autorizzazione:
  • N
  • Data dell'autorizzazione:
  • 24-11-2009
  • 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.

24-1-2019

General Mills Recalls Five Pound Bags of Gold Medal Unbleached Flour

General Mills Recalls Five Pound Bags of Gold Medal Unbleached Flour

General Mills announced today a voluntary national recall of five-pound bags of its Gold Medal Unbleached Flour with a better if used by date of April 20, 2020. The recall is being issued for the potential presence of Salmonella which was discovered during sampling of the five-pound bag product.

FDA - U.S. Food and Drug Administration

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

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

12-1-2019

Scientific Opinion on Flavouring Group Evaluation 208 Revision 3 (FGE.208Rev3): consideration of genotoxicity data on alicyclic aldehydes with α,β‐unsaturation in ring/side‐chain and precursors from chemical subgroup 2.2 of FGE.19

Scientific Opinion on Flavouring Group Evaluation 208 Revision 3 (FGE.208Rev3): consideration of genotoxicity data on alicyclic aldehydes with α,β‐unsaturation in ring/side‐chain and precursors from chemical subgroup 2.2 of FGE.19

Published on: Fri, 11 Jan 2019 The EFSA Panel on Food Additives and Flavourings was requested to evaluate the genotoxic potential of flavouring substances from subgroup 2.2 of FGE.19 in the Flavouring Group Evaluation 208 Revision 3 (FGE.208Rev3). In FGE.208Rev1, the Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF) evaluated genotoxicity studies on the representative substance p‐mentha‐1,8‐dien‐7‐al [FL‐no: 05.117], which was found to be genotoxic in vivo. The Panel conclu...

Europe - EFSA - European Food Safety Authority EFSA Journal

12-1-2019

Safety evaluation of the food enzyme endo‐1,4‐β‐xylanase from Bacillus subtilis (strain XAS)

Safety evaluation of the food enzyme endo‐1,4‐β‐xylanase from Bacillus subtilis (strain XAS)

Published on: Fri, 11 Jan 2019 The EFSA Panel on Food Additives and Flavourings was requested to evaluate the genotoxic potential of flavouring substances from subgroup 2.2 of FGE.19 in the Flavouring Group Evaluation 208 Revision 3 (FGE.208Rev3). In FGE.208Rev1, the Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF) evaluated genotoxicity studies on the representative substance p‐mentha‐1,8‐dien‐7‐al [FL‐no: 05.117], which was found to be genotoxic in vivo. The Panel conclu...

Europe - EFSA - European Food Safety Authority EFSA Journal

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

8-12-2018

Annual assessment of Echinococcus multilocularis surveillance reports submitted in 2018 in the context of Commission Regulation (EU) No 1152/2011

Annual assessment of Echinococcus multilocularis surveillance reports submitted in 2018 in the context of Commission Regulation (EU) No 1152/2011

Published on: Fri, 07 Dec 2018 This report is part of the `Echinococcus multilocularis surveillance’ scientific reports which are presented annually by EFSA to the European Commission and are intended to assess the sampling strategy, data collection and detection methods used by Finland, Ireland, Malta, the United Kingdom (UK) and Norway in their respective surveillance programmes. The surveillance programmes of these five countries were evaluated by checking the information submitted by each of them an...

Europe - EFSA - European Food Safety Authority Publications

7-12-2018

Strawberry-flavoured acetaminophen infant oral drops in 24 mL bottles recalled because of defective child-resistant safety caps

Strawberry-flavoured acetaminophen infant oral drops in 24 mL bottles recalled because of defective child-resistant safety caps

Laboratoire RivaInc. and Laboratoires Trianon Inc. are voluntarily recalling five over-the-counter strawberry-flavoured acetaminophen oral drops for infants. The products are labeled as Biomedic, Option, Personnelle, Selection, or Laboratoires Trianon Inc. The products are packaged in 24 mL bottles and are used for pain and fever relief. They are being recalled because the child-resistant safety cap may be defective. This recall is in addition to previous recalls of children’s acetaminophen syrups for th...

Health Canada

30-11-2018

The European Union summary report on surveillance for the presence of transmissible spongiform encephalopathies (TSEs) in 2017

The European Union summary report on surveillance for the presence of transmissible spongiform encephalopathies (TSEs) in 2017

Published on: Thu, 29 Nov 2018 This report presents the results of surveillance on transmissible spongiform encephalopathies (TSEs) in bovine animals, sheep, goats, cervids and other animal species, as well as genotyping in sheep, carried out in 2017 in the European Union (EU) according to Regulation (EC) 999/2001, and in Iceland, Norway and Switzerland. In total, 1,312,714 cattle were tested by the 28 EU Member States (MSs) which is a decrease of 3% compared with 2016; 18,526 were tested by the three n...

Europe - EFSA - European Food Safety Authority Publications

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

17-11-2018

The Quaker Oats Company Issues Voluntary Recall of a Small Quantity of Cap’n Crunch’s Peanut Butter Crunch Cereal Distributed to Five Target Stores Due to Possible Health Risk

The Quaker Oats Company Issues Voluntary Recall of a Small Quantity of Cap’n Crunch’s Peanut Butter Crunch Cereal Distributed to Five Target Stores Due to Possible Health Risk

The Quaker Oats Company, a subsidiary of PepsiCo, Inc., today announced a voluntary recall of a small quantity of Cap’n Crunch’s Peanut Butter Crunch cereal due to the potential presence of Salmonella. While the potentially affected product only reached five specific Target stores and is limited to 21 boxes of one variety with two Best Before Dates, Quaker is initiating the voluntary recall to protect public health.

FDA - U.S. Food and Drug Administration

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

14-9-2018

FDA Releases Five-Year Plan for Supporting Antimicrobial Stewardship in Veterinary Settings

FDA Releases Five-Year Plan for Supporting Antimicrobial Stewardship in Veterinary Settings

CVM’s five-year action plan for supporting antimicrobial stewardship in veterinary settings builds upon the important steps CVM has taken to eliminate production uses of medically important antimicrobials.

FDA - U.S. Food and Drug Administration

12-9-2018

FDA awards five grants to advance the development of pediatric medical devices

FDA awards five grants to advance the development of pediatric medical devices

FDA has awarded grants to five Pediatric Device Consortia that will provide advice to innovators of children's medical devices

FDA - U.S. Food and Drug Administration

1-9-2018

Spodoptera frugiperda partial risk assessment

Spodoptera frugiperda partial risk assessment

Published on: Fri, 31 Aug 2018 00:00:00 +0200 EFSA was asked for a partial risk assessment of Spodoptera frugiperda for the territory of the EU focussing on the main pathways for entry, factors affecting establishment, risk reduction options and pest management. As a polyphagous pest, five commodity pathways were examined in detail. Aggregating across these and other pathways, we estimate that tens of thousands to over a million individual larvae could enter the EU annually on host commodities. Instigat...

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

Protocol for the scientific opinion on the Tolerable Upper Intake Level of dietary sugars

Protocol for the scientific opinion on the Tolerable Upper Intake Level of dietary sugars

Published on: Fri, 10 Aug 2018 00:00:00 +0200 In June 2016, EFSA received a mandate from the national food competent authorities of five European countries (Denmark, Finland, Iceland, Norway and Sweden) to provide a dietary reference value (DRV) for sugars, with particular attention to added sugars. A draft protocol was developed with the aim of defining as much as possible beforehand the strategy that will be applied for collecting data, appraising the relevant evidence, and analysing and integrating t...

Europe - EFSA - European Food Safety Authority Publications

23-7-2018

FDA Awards Grants to Fund Studies for Drugs for Minor Uses/Minor Species

FDA Awards Grants to Fund Studies for Drugs for Minor Uses/Minor Species

FDA has awarded five grants totaling $650,000 to provide funding for studies to support the approval or conditional approval of three different products, including a cancer drug for dogs.

FDA - U.S. Food and Drug Administration

9-7-2018

Several drugs containing valsartan being recalled due to contamination with a potential carcinogen

Several drugs containing valsartan being recalled due to contamination with a potential carcinogen

Several drugs containing the ingredient valsartan are being recalled by their manufacturers. An impurity, N-nitrosodimethylamine (NDMA), was found in the valsartan used in these products. The valsartan was supplied by Zhejiang Huahai Pharmaceuticals. NDMA is a potential human carcinogen, which means that it could cause cancer with long-term exposure. Five companies have affected products, which are being recalled (identified in table below).

Health Canada

21-5-2018

5 Tips for a Healthy Vacation

5 Tips for a Healthy Vacation

As you plan your next beach vacation, make sure your trip is a healthy one. Consider these five tips on sun safety, medications, contact lenses, tattoos, and eating well.

FDA - U.S. Food and Drug Administration

17-4-2018

March 27, 2018: Compounding Pharmacy Owner Sentenced to Five Years in Prison for $10.5 Million Health Care Fraud

March 27, 2018: Compounding Pharmacy Owner Sentenced to Five Years in Prison for $10.5 Million Health Care Fraud

March 27, 2018: Compounding Pharmacy Owner Sentenced to Five Years in Prison for $10.5 Million Health Care Fraud

FDA - U.S. Food and Drug Administration

15-8-2016

An impact on the European agenda

An impact on the European agenda

In five short videos, we describe how we work with safety for Danish medicine users at the Danish Medicines Agency. The work extends far beyond the borders of Denmark when we assess whether to authorise new medicines and whether the side effects of a medicine are too serious in relation to its efficacy.

Danish Medicines Agency

4-2-2016

Updated list of biological medicinal products

Updated list of biological medicinal products

The Danish Medicines Agency has added five new medicinal products to the list of biological and biosimilar medicinal products.

Danish Medicines Agency

4-3-2015

The MMR vaccine is a safe vaccine

The MMR vaccine is a safe vaccine

We have reviewed the reported adverse reactions from the MMR vaccine during the past five years.

Danish Medicines Agency

2-12-2014

Danish Pharmacovigilance Update, November 2014

Danish Pharmacovigilance Update, November 2014

Five years ago, we issued Danish Pharmacovigilance Update for the first time. We are delighted to celebrate the newsletter's fifth anniversary with more than 3,000 subscribers to the Danish and the English version, and we hope the interest in Danish Pharmacovigilance Update will continue to grow. You can sign up for the newsletter on our website under News. Among the articles in this issue, you can read about how we have developed the pharmacovigilance activities in the recent years.

Danish Medicines Agency

26-9-2011

Danish Pharmacovigilance Update, 15 September 2011

Danish Pharmacovigilance Update, 15 September 2011

In this issue of Danish Pharmacovigilance Update, read about a significant increase in off-label use of AeroBec® in children under the age of five, and much more.

Danish Medicines Agency

27-11-2008

Reassessment of reimbursement status for 5 combination products in ATC groups C07, C08 and C09

Reassessment of reimbursement status for 5 combination products in ATC groups C07, C08 and C09

The Danish Medicines Agency has assessed the question of the future reimbursement status for five combination products in ATC groups C07, C08 and C09 on the basis of updated information about prices and consumption of these medicinal products.

Danish Medicines Agency

14-9-2018

#FDA awards five grants to advance the development of pediatric medical devices. Click the link to read more about the grants and the FDA's work to advance the development of pediatric #MedicalDevices:  http://go.usa.gov/xPg2A 

#FDA awards five grants to advance the development of pediatric medical devices. Click the link to read more about the grants and the FDA's work to advance the development of pediatric #MedicalDevices: http://go.usa.gov/xPg2A 

#FDA awards five grants to advance the development of pediatric medical devices. Click the link to read more about the grants and the FDA's work to advance the development of pediatric #MedicalDevices: http://go.usa.gov/xPg2A 

FDA - U.S. Food and Drug Administration

22-7-2018

The Medical Device Safety Action Plan focuses on five key areas: establishing a safety net, exploring regulatory options, spurring Innovation, advancing cybersecurity and advancing the Total Product Lifecycle approach to Device Safety. Let’s look at each

The Medical Device Safety Action Plan focuses on five key areas: establishing a safety net, exploring regulatory options, spurring Innovation, advancing cybersecurity and advancing the Total Product Lifecycle approach to Device Safety. Let’s look at each

The Medical Device Safety Action Plan focuses on five key areas: establishing a safety net, exploring regulatory options, spurring Innovation, advancing cybersecurity and advancing the Total Product Lifecycle approach to Device Safety. Let’s look at each area pic.twitter.com/aDwVxKGjyA

FDA - U.S. Food and Drug Administration

29-5-2018

EU/3/18/2026 (Alnylam UK Limited)

EU/3/18/2026 (Alnylam UK Limited)

EU/3/18/2026 (Active substance: Synthetic double-stranded siRNA oligonucleotide targeted against transthyretin mRNA, with six phosphorothioate linkages in the backbone, and nine 2'-fluoro and thirty-five 2'-O-methyl nucleoside residues in the sequence, which is covalently linked via a phosphodiester group to a ligand containing three N-acetylgalactosamine residues) - Orphan designation - Commission Decision (2018)3394 of Tue, 29 May 2018 European Medicines Agency (EMA) procedure number: EMA/OD/019/18

Europe -DG Health and Food Safety