KIT STYLO BASE MONOUSO DA POLSO

Informazioni principali

  • Nome commerciale:
  • KIT STYLO BASE MONOUSO DA POLSO
  • 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:
  • KIT STYLO BASE MONOUSO DA POLSO
    Italia
  • Lingua:
  • italiano

Informazioni terapeutiche

  • Gruppo terapeutico:
  • FISSATORI ESTERNI PER OSTEOSINTESI - ALTRI

Altre informazioni

Status

  • Fonte:
  • Ministero della Salute - Italia
  • Stato dell'autorizzazione:
  • S
  • Data dell'autorizzazione:
  • 06-03-2010
  • 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.

21-1-2019

John Deere recalls some Attachment Kits for Snow Blowers and 52 Inch Brooms that were sold without manuals

John Deere recalls some Attachment Kits for Snow Blowers and 52 Inch Brooms that were sold without manuals

Some of the attachment kits are missing the operator's manual.The operator's manual describes how to attach and safely operate the snow blowers and 52 inch brooms.Not following the operator's manual can result in important safety information being missed, posing an injury hazard.

Health Canada

20-12-2018

Navien Inc. recalls Propane Conversion Kit for Condensing Tankless Water Heater and Combination Boiler

Navien Inc. recalls Propane Conversion Kit for Condensing Tankless Water Heater and Combination Boiler

Navien has identified a non-conforming specification in the natural gas (NG) to propane gas (LP) conversion kit that is supplied as an accessory with each unit. If the kit is installed in order to use propane gas rather than natural gas to fuel the unit, and if not properly vented, it could pose a risk of exposure to carbon monoxide.

Health Canada

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

Michigan-based food manufacturer agrees to stop operations after repeated food safety violations

Michigan-based food manufacturer agrees to stop operations after repeated food safety violations

Saranac Brand Foods, Inc. specialized in a variety of 35 different ready-to-eat foods, including prepared salads, dips, and sauces.

FDA - U.S. Food and Drug Administration

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

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

28-11-2018

Allergen Alert: Kitchen Cravings Strawberry and Mixed Berry Parfaits with Trace Tree Nuts

Allergen Alert: Kitchen Cravings Strawberry and Mixed Berry Parfaits with Trace Tree Nuts

Kwik Trip, Inc. located in La Crosse, WI is recalling Kitchen Cravings Strawberry and Mixed Berry Parfaits in an 8.25 oz. cup because they may contain undeclared traces of cashews or almonds

FDA - U.S. Food and Drug Administration

21-11-2018

VaperBC recalls 100 mg Nicotine Base Liquid Nicotine

VaperBC recalls 100 mg Nicotine Base Liquid Nicotine

These vaping products do not meet requirements of the Consumer Chemicals and Containers Regulations, 2001 (CCCR, 2001) under the Canada Consumer Product Safety Act.

Health Canada

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

14-11-2018

Nor Cal Food Solutions, LLC ISSUES ALLERGY ALERT ON UNDECLARED Tree Nut – Walnut in The Purveyors Kitchen - Pumpkin Pesto Tapenade

Nor Cal Food Solutions, LLC ISSUES ALLERGY ALERT ON UNDECLARED Tree Nut – Walnut in The Purveyors Kitchen - Pumpkin Pesto Tapenade

Nor Cal Food Solutions, LLC of Auburn, CA is announcing a recall of 567 cases of Pumpkin Pesto Tapenade, manufactured by Purveyors Kitchen, because it contains an undeclared tree nut (walnut). People who have an allergy or severe sensitivity to tree nuts (walnuts) run the risk of serious or life-threatening allergic reaction if they consume this product.

FDA - U.S. Food and Drug Administration

13-11-2018

Registration Reminder: FDA Center for Veterinary Medicine Public Webinar about Genome Editing in Animals on Dec. 3

Registration Reminder: FDA Center for Veterinary Medicine Public Webinar about Genome Editing in Animals on Dec. 3

On Dec. 3, 2018, FDA’s Center for Veterinary Medicine (CVM) will hold a public webinar about genome editing in animals, focusing mainly on current scientific evidence, promising uses of this technology in animals, the potential risks & CVM’s flexible, risk-based approach to regulation.

FDA - U.S. Food and Drug Administration

9-11-2018

First Choice Vapor recalls Unflavoured 100 mg Nicotine Base E-Liquids

First Choice Vapor recalls Unflavoured 100 mg Nicotine Base E-Liquids

These vaping products do not meet requirements of the Consumer Chemicals and Containers Regulations, 2001 (CCCR, 2001) under the Canada Consumer Product Safety Act.

Health Canada

23-10-2018

Federal judge enters consent decree against Tennessee over-the-counter drug manufacturer

Federal judge enters consent decree against Tennessee over-the-counter drug manufacturer

A federal court orders a Tennessee-based company to stop selling over-the-counter (OTC) drug products

FDA - U.S. Food and Drug Administration

18-10-2018

Ryerson Canada and Vista Railings Systems Inc. recall Various ProBuilt Aluminum Deck Railing Posts

Ryerson Canada and Vista Railings Systems Inc. recall Various ProBuilt Aluminum Deck Railing Posts

Certain ProBuilt Aluminum Posts have an issue with the screws that affix the base plate to the post which may cause the post to separate from the base plate when forces over 334 pounds are applied horizontally to the top side of the post. As a result, the posts do not fully comply with local building code requirements and may pose a fall hazard.

Health Canada

28-9-2018

FDA authorizes first next generation sequencing-based test to detect very low levels of remaining cancer cells in patients with acute lymphoblastic leukemia or multiple myeloma

FDA authorizes first next generation sequencing-based test to detect very low levels of remaining cancer cells in patients with acute lymphoblastic leukemia or multiple myeloma

FDA authorizes first next generation sequencing-based test to detect very low levels of remaining cancer cells in patients with acute lymphoblastic leukemia or multiple myeloma

FDA - U.S. Food and Drug Administration

27-9-2018

Statement from FDA Commissioner Scott Gottlieb, M.D., on modernizing standards of identity and the use of dairy names for plant-based substitutes

Statement from FDA Commissioner Scott Gottlieb, M.D., on modernizing standards of identity and the use of dairy names for plant-based substitutes

FDA issues a request for information to solicit feedback on how consumers are using plant-based substitutes for milk, cheese and other dairy foods.

FDA - U.S. Food and Drug Administration

22-9-2018

Risk assessment of new sequencing information on genetically modified carnation FLO‐40689‐6

Risk assessment of new sequencing information on genetically modified carnation FLO‐40689‐6

Published on: Fri, 21 Sep 2018 00:00:00 +0200 The GMO Panel has previously assessed genetically modified (GM) carnation FLO‐40689‐6 and concluded that there is no scientific reason to consider that the import, distribution and retailing in the EU of carnation FLO‐40689‐6 cut flowers for ornamental use will cause any adverse effects on human health or the environment. On 27 October 2017, the European Commission requested EFSA to analyse new nucleic acid sequencing data and updated bioinformatics data for...

Europe - EFSA - European Food Safety Authority Publications

11-9-2018

Modelling of inactivation through heating for quantitative microbiological risk assessment (QMRA)

Modelling of inactivation through heating for quantitative microbiological risk assessment (QMRA)

Published on: Mon, 27 Aug 2018 00:00:00 +0200 EFSA regards the household as a stage in the food chain that is important for the final number of food‐borne infections. The fate of a pathogen in the private kitchen largely depends on consumer hygiene during preparation of food and on its proper cooking, especially in the case of meat. Unfortunately, detailed information on the microbiological survival in meat products after heating in the consumer kitchen is lacking. The aim of the study was to improve th...

Europe - EFSA - European Food Safety Authority Publications

16-8-2018

Statement from FDA Commissioner Scott Gottlieb, M.D., on advancing the science and regulation of live microbiome-based products used to prevent, treat, or cure diseases in humans

Statement from FDA Commissioner Scott Gottlieb, M.D., on advancing the science and regulation of live microbiome-based products used to prevent, treat, or cure diseases in humans

FDA announces workshop on advancing the science and regulation of live microbiome-based products used to prevent, treat, or cure diseases in humans.

FDA - U.S. Food and Drug Administration

14-8-2018

Genius Premium Craft Boxes recalls Do-It-Yourself Slime Kits

Genius Premium Craft Boxes recalls Do-It-Yourself Slime Kits

Health Canada’s sampling and evaluation program has determined the Do-It-Yourself Slime Kits do not meet the Canadian toy safety requirements related to boric acid content.

Health Canada

10-8-2018

FDA approves first-of-its kind targeted RNA-based therapy to treat a rare disease

FDA approves first-of-its kind targeted RNA-based therapy to treat a rare disease

FDA approves new drug for treatment of polyneuropathy caused by hereditary transthyretin-mediated amyloidosis (hATTR). This is the first FDA-approved treatment for this rare, debilitating and often fatal genetic disease and the first FDA approval of a new class of drugs called small interfering ribonucleic acid (siRNA) treatment.

FDA - U.S. Food and Drug Administration

9-8-2018

Vita-Mix Corporation recalls Ascent and Venturist Series 8-ounce and 20-ounce Blending Containers

Vita-Mix Corporation recalls Ascent and Venturist Series 8-ounce and 20-ounce Blending Containers

The container can separate from the blade base exposing the blades, posing a laceration hazard to consumers.

Health Canada

7-8-2018

Seaweed consumption: remain vigilant to the risk of excess iodine intake

Seaweed consumption: remain vigilant to the risk of excess iodine intake

Over the last few years, seaweed has become increasingly common on our plates. Fresh, dried or as a food supplement, its iodine content varies and can sometimes be high. ANSES assessed the risk of excess iodine intake from the consumption of seaweed-based products. In view of the non-negligible risk of exceeding the upper limit of safe intake for iodine, the Agency advises against the consumption of seaweed and seaweed-based food supplements by certain at-risk populations, and recommends that regular con...

France - Agence Nationale du Médicament Vétérinaire

26-7-2018

Medical Devices Safety Update Volume 6, Number 4, July 2018

Medical Devices Safety Update Volume 6, Number 4, July 2018

Be aware of cross-reactivity with home-use self-test ovulation kits, TGA undertakes product safety review into intragastric balloon systems

Therapeutic Goods Administration - Australia

19-7-2018

Makita Canada Inc. recalls Makita and Dolmar Chainsaws

Makita Canada Inc. recalls Makita and Dolmar Chainsaws

The automatic chain brake does not easily engage when the saw kicks back, possibly exposing the user to contact with the chain while it is still moving, posing a laceration hazard.

Health Canada

17-7-2018

ALDI Voluntarily Recalls AnnaSea Wasabi Ahi Poke Hawaiian Poke Kits and Limu Ahi Poke Hawaiian Poke Kits Due to Storage at Incorrect Temperature in Area Store

ALDI Voluntarily Recalls AnnaSea Wasabi Ahi Poke Hawaiian Poke Kits and Limu Ahi Poke Hawaiian Poke Kits Due to Storage at Incorrect Temperature in Area Store

Batavia, Ill. Uuly 14, 2018) -ALDI has voluntarily recalled AnnaSea Wasabi Ahi Poke Hawaiian Poke Kits and Limu Ahi Poke Hawaiian Poke Kits sold at one retail store location in North Carolina. While the products are required to remain at frozen temperatures to ensure safety, this store location displayed and sold the products from the cooler section. Because storing the products at temperatures above freezing prior to consumption can render the products unsafe for consumption, ALDI is recalling these items.

FDA - U.S. Food and Drug Administration

13-7-2018

Water Pik, Inc. Recalls Sonic-Fusion® Flossing Toothbrush Product for Possible Health Risk

Water Pik, Inc. Recalls Sonic-Fusion® Flossing Toothbrush Product for Possible Health Risk

Water Pik, Inc. is voluntarily recalling its Sonic-Fusion® flossing toothbrush because the charging base may overheat with localized melting and sparking, possibly causing fire, shock or burns. Water Pik, Inc. has received consumer reports of product malfunctioning in the U.S. The recall is applicable only to Sonic-Fusion® products. All other Waterpik® brand flossers and toothbrushes are not affected.

FDA - U.S. Food and Drug Administration

13-7-2018

AZ Firm Issues Voluntary Product Recall Due to Undeclared Peanuts in Superfood Salad

AZ Firm Issues Voluntary Product Recall Due to Undeclared Peanuts in Superfood Salad

Papa John’s Salads and Produce of Tolleson, AZ is voluntarily recalling 148 units of the Superfood Salads due to misbranding and undeclared peanuts. The product contains peanuts which are not declared on the product label as packages of peanuts were mistakenly included in the kits instead of cashews.

FDA - U.S. Food and Drug Administration

6-7-2018

Pseudomonas Aeruginosa Bacteria Found In Saje Splish Splash Gentle Baby Wash

Pseudomonas Aeruginosa Bacteria Found In Saje Splish Splash Gentle Baby Wash

Saje Natural Wellness is warning customers not to use Splish Splash Gentle Baby Wash, 8.5 fl. oz. and 1.7 fl. oz. (found in the Wee and Well Gentle Baby Care Kit) as it may contain the bacteria Pseudomonas aeruginosa. Pseudomonas aeruginosa is an opportunistic pathogen that causes infection and results in bacteria in the blood, particularly in individuals with compromised immune systems.

FDA - U.S. Food and Drug Administration

28-6-2018

Minister Bruno Bruins verbetert transparantie zorgverzekeringen

Minister Bruno Bruins verbetert transparantie zorgverzekeringen

Er zijn in Nederland 55 verschillende standaard basisverzekeringen. In de praktijk worden verzekeringen onder allerlei namen en in verschillende verpakkingen aangeboden. Een van de verpakkingsvormen zijn de ongeveer 51.000 verschillende collectieve zorgverzekeringen. Hierdoor is de zorgverzekeringsmarkt ondoorzichtig geworden en is goed vergelijken een haast onmogelijke opgave. Minister Bruno Bruins (Medische Zorg) wil daarom dat zorgverzekeraars zorgen voor meer transparantie, onder andere door precies ...

Netherlands - Ministerie van Volksgezondheid, Welzijn en Sport

14-6-2018

FDA Releases FSMA Draft Guidance on the Supply-Chain Program Preventive Control for Animal Food

FDA Releases FSMA Draft Guidance on the Supply-Chain Program Preventive Control for Animal Food

FDA issued draft guidance to help animal food facilities needing a supply-chain program meet those requirements under the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals rule.

FDA - U.S. Food and Drug Administration

12-6-2018

Statement from FDA Commissioner Scott Gottlieb, M.D., on new efforts to advance medical product communications to support drug competition and value-based health care

Statement from FDA Commissioner Scott Gottlieb, M.D., on new efforts to advance medical product communications to support drug competition and value-based health care

Statement from FDA Commissioner Scott Gottlieb, M.D., on new efforts to advance medical product communications to support drug competition and value-based health care

FDA - U.S. Food and Drug Administration

26-5-2018

Shadow Holdings, LLC Issues Voluntary Nationwide Recall of X-Jow and Acne Shave products due to Possible Bacterial Contamination

Shadow Holdings, LLC Issues Voluntary Nationwide Recall of X-Jow and Acne Shave products due to Possible Bacterial Contamination

Shadow Holdings is voluntarily recalling all lots, within expiry, of Herb-X Solutions X-Jow Pain Gel, and United Exchange Acne Shave Moisturizer, Acne Shave Shave Cream with Acne Shield, and Acne Shave Shave Kit to the retail level. The products may be contaminated with bacteria.

FDA - U.S. Food and Drug Administration

17-5-2018

The Michaels Companies, Inc. recalls Creatology Pottery Wheel Kit and Creatology Spin Art Kit

The Michaels Companies, Inc. recalls Creatology Pottery Wheel Kit and Creatology Spin Art Kit

Internal wiring within the product may overheat posing a risk of burns or fire.

Health Canada

11-5-2018

Vyaire Medical AirLife Resuscitation Device & Broselow Convenience Kit by Vyaire Medical: Class I Recall - Due to Risk of Malfunction Caused by Error in Product Design

Vyaire Medical AirLife Resuscitation Device & Broselow Convenience Kit by Vyaire Medical: Class I Recall - Due to Risk of Malfunction Caused by Error in Product Design

Vyaire Medical is recalling the AirLife Resuscitation Device & Broselow Convenience Kit due to an error in its product design that may result in difficultly or the inability to disconnect the mask from the elbow of the resuscitator.

FDA - U.S. Food and Drug Administration

10-5-2018

Nota Informativa Importante su forniture di LYMPHOSEEK (15/05/2018)

Nota Informativa Importante su forniture di LYMPHOSEEK (15/05/2018)

A causa di problemi produttivi, non saranno disponibili nuove forniture di LYMPHOSEEK (tilmanocept, 50 microgrammi kit per preparazione radio farmaceutica) per il mercato Europeo fino al terzo o quarto trimestre del 2018.

Italia - AIFA - Agenzia Italiana del Farmaco

7-5-2018

Viibryd Starter Kit (10 & 20 mg)

Viibryd Starter Kit (10 & 20 mg)

Health Canada

4-5-2018

 Slime: a very popular toy putty that is not without risk

Slime: a very popular toy putty that is not without risk

ANSES and the DGCCRF are alerting consumers to the risks associated with making and handling "slime". Slime, a sticky and elastic putty for kneading, is currently very popular with children and adolescents. It is commercially available in ready-to-use form or in kits. It can also be made at home, in order to vary its appearance and texture (by adding colour, glitter, etc.). Tutorials on how to make slime have proliferated on the Internet and offer many recipes, based on ingredients such as paper glue and...

France - Agence Nationale du Médicament Vétérinaire

3-5-2018

FDA Approves Application for AquaBounty Salmon Facility in Indiana

FDA Approves Application for AquaBounty Salmon Facility in Indiana

FDA approved a supplemental New Animal Drug Application submitted by AquaBounty Technologies, Inc. The supplemental NADA requested FDA approval to raise AquAdvantage Salmon at a land-based contained facility near Albany, Indiana.

FDA - U.S. Food and Drug Administration

30-4-2018

Stonewall Kitchen Voluntarily Recalls a Limited Amount of Basil Pesto Aioli due to Mislabeling and Undeclared Presence of the Dairy Allergen, Egg

Stonewall Kitchen Voluntarily Recalls a Limited Amount of Basil Pesto Aioli due to Mislabeling and Undeclared Presence of the Dairy Allergen, Egg

Stonewall Kitchen is voluntarily recalling a limited amount of 10.25oz Basil Pesto Aioli with an Enjoy By date of 28 Sep 2019 which may contain the undeclared allergen egg, as we may have inadvertently placed the label for our Basil Pesto on a small portion of our most recent production run.

FDA - U.S. Food and Drug Administration

22-1-2018

Flawless Beauty, LLC Issues Voluntary Recall of Unapproved Drugs

Flawless Beauty, LLC Issues Voluntary Recall of Unapproved Drugs

Ocean Township, NJ. In accordance with a Consent Decree of Permanent Injunction ordered in the United States District Court for the District of New Jersey, Flawless Beauty, LLC is voluntarily recalling all lots of nineteen different products sold individually or as part of multi-unit kits alleged by the U.S. Food and Drug Administration ("FDA") to be misbranded or unapproved new drugs pursuant to the Federal Food, Drug, and Cosmetic Act. The FDA believes that these drugs present serious public health risks.

FDA - U.S. Food and Drug Administration

21-1-2019

St John Ambulance Tiny Tots First Aid Kit - electronic thermometer

St John Ambulance Tiny Tots First Aid Kit - electronic thermometer

Recall - potential risk of harm for children who access the button battery

Therapeutic Goods Administration - Australia

2-12-2018

As a science-based agency we rely on evidence generated from data to inform regulatory decisions. #FDA's #SundayTweetorial discusses how we use data from real-world settings to enhance what we know about medical products. This week we'll announce policies

As a science-based agency we rely on evidence generated from data to inform regulatory decisions. #FDA's #SundayTweetorial discusses how we use data from real-world settings to enhance what we know about medical products. This week we'll announce policies

As a science-based agency we rely on evidence generated from data to inform regulatory decisions. #FDA's #SundayTweetorial discusses how we use data from real-world settings to enhance what we know about medical products. This week we'll announce policies to advance these efforts pic.twitter.com/2co2Hz4jUt

FDA - U.S. Food and Drug Administration

24-9-2018

#FDA announces the release of the Collaborative Communities Toolkit for interested stakeholder organizations to work together on healthcare challenges. Learn about the program, download the Toolkit, and submit comments:  https://go.usa.gov/xPjKX pic.twitt

#FDA announces the release of the Collaborative Communities Toolkit for interested stakeholder organizations to work together on healthcare challenges. Learn about the program, download the Toolkit, and submit comments: https://go.usa.gov/xPjKX pic.twitt

#FDA announces the release of the Collaborative Communities Toolkit for interested stakeholder organizations to work together on healthcare challenges. Learn about the program, download the Toolkit, and submit comments: https://go.usa.gov/xPjKX  pic.twitter.com/iQsKIAAQTn

FDA - U.S. Food and Drug Administration

27-8-2018

Yescarta (Kite Pharma EU B.V.)

Yescarta (Kite Pharma EU B.V.)

Yescarta (Active substance: axicabtagene ciloleucel) - Centralised - Authorisation - Commission Decision (2018)5718 of Mon, 27 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4480

Europe -DG Health and Food Safety

1-8-2018

Cyanokit (SERB S.A.)

Cyanokit (SERB S.A.)

Cyanokit (Active substance: hydroxocobalamin) - Centralised - Yearly update - Commission Decision (2018)5229 of Wed, 01 Aug 2018

Europe -DG Health and Food Safety

17-7-2018

Comunicazione EMA su medicinali contenenti il principio attivo valsartan (17/07/2018)

Comunicazione EMA su medicinali contenenti il principio attivo valsartan (17/07/2018)

E’ attualmente in corso la revisione da parte dell’ Agenzia Europea dei Medicinali (EMA) dei medicinali a base di valsartan in relazione a un'impurezza riscontrata nella sostanza attiva prodotta da Zhejiang Huahai Pharmaceuticals. L'impurezza - N-nitrosodimetilammina (NDMA) - è classificata come probabile cancerogeno per l'uomo, in base ai risultati di test di laboratorio, e potrebbe causare il cancro nell’uso a lungo termine. Nelle ultime due settimane, le autorità sanitarie nazionali hanno richiamato i...

Italia - AIFA - Agenzia Italiana del Farmaco

29-6-2018

EU/3/18/2033 (Real Regulatory Limited)

EU/3/18/2033 (Real Regulatory Limited)

EU/3/18/2033 (Active substance: Codon-optimised human ornithine transcarbamylase mRNA complexed with lipid-based nanoparticles) - Orphan designation - Commission Decision (2018)4178 of Fri, 29 Jun 2018 European Medicines Agency (EMA) procedure number: EMA/OD/022/18

Europe -DG Health and Food Safety

19-6-2018

Comunicazione EMA sui medicinali a base di lisati batterici (02/07/2018)

Comunicazione EMA sui medicinali a base di lisati batterici (02/07/2018)

L’EMA avvia una revisione sui medicinali a base di lisati batterici a seguito della pubblicazione di recenti studi che hanno sollevato dubbi sull’efficacia dei lisati batterici nella riduzione del numero e della gravità delle infezioni respiratorie negli adulti e nei bambini che soffrono di infezioni ripetute.

Italia - AIFA - Agenzia Italiana del Farmaco

19-6-2018

Comunicazione EMA sui medicinali a base di amido idrossietilico (HES) (02/07/2018)

Comunicazione EMA sui medicinali a base di amido idrossietilico (HES) (02/07/2018)

Il CMDh  ha stabilito che le soluzioni per infusione a base di amido idrossietilico (HES) debbano rimanere sul mercato a condizione che sia implementata una combinazione di misure aggiuntive per proteggere i pazienti.

Italia - AIFA - Agenzia Italiana del Farmaco

15-6-2018

Comparable overseas regulators (CORs) for prescription medicines

Comparable overseas regulators (CORs) for prescription medicines

Minor clarifications to the prescription medicines COR report-based process and the list of CORs for work-sharing.

Therapeutic Goods Administration - Australia

11-6-2018

SomaKit TOC (Advanced Accelerator Applications)

SomaKit TOC (Advanced Accelerator Applications)

SomaKit TOC (Active substance: edotreotide) - Centralised - Yearly update - Commission Decision (2018)3762 of Mon, 11 Jun 2018

Europe -DG Health and Food Safety

18-5-2018

Comunicazione EMA sulle soluzioni per infusione contenenti amido idrossietilico (18/05/2018)

Comunicazione EMA sulle soluzioni per infusione contenenti amido idrossietilico (18/05/2018)

A seguito di una richiesta della Commissione Europea di esaminare alcuni aspetti relativi alla sospensione delle autorizzazioni all'immissione in commercio per le soluzioni per infusione a base di amidi idrossietilici (HES), il PRAC ha confermato la raccomandazione di sospendere questi prodotti in tutta l'Unione Europea.

Italia - AIFA - Agenzia Italiana del Farmaco

10-5-2018

Richiesta di modifica stampati dei medicinale a base di Corticosteroidi (01/06/2018)

Richiesta di modifica stampati dei medicinale a base di Corticosteroidi (01/06/2018)

AIFA ricorda alle Aziende di aggiornare gli stampati di tutti i medicinali a base di Corticosteroidi autorizzati con procedure nazionali o per le quali l’Italia agisca come RMS, in accordo alle “Conclusioni scientifiche e motivazioni per la variazione dei termini dell’autorizzazione/delle autorizzazioni all’immissione in commercio.

Italia - AIFA - Agenzia Italiana del Farmaco

22-3-2018

Comunicazione EMA medicinali a base retinoidi (23/03/2018)

Comunicazione EMA medicinali a base retinoidi (23/03/2018)

L'Agenzia europea per i medicinali (EMA) ha completato la revisione dei medicinali a base  retinoidi e ha confermato che è necessario l’aggiornamento delle misure di prevenzione della gravidanza. Inoltre, un’avvertenza sul possibile rischio di disordini neuropsichiatrici (quali depressione, ansia e cambiamenti di umore) sarà inserita negli stampati dei retinoidi orali.

Italia - AIFA - Agenzia Italiana del Farmaco

22-3-2018

Comunicazione EMA su medicinali a base di acidi grassi omega-3 (23/03/2018)

Comunicazione EMA su medicinali a base di acidi grassi omega-3 (23/03/2018)

L’Agenzia Europea dei Medicinali (EMA) sta rivalutando l’uso dei medicinali a base di acidi grassi omega-3 in pazienti che hanno avuto  un infarto, come seguito di indagini che mostrano che questi medicinali, da assumere per via orale, potrebbero non prevenire la ricorrenza di malattie cardiache o ictus.

Italia - AIFA - Agenzia Italiana del Farmaco

22-3-2018

Comunicazione EMA su valproato (23/03/2018)

Comunicazione EMA su valproato (23/03/2018)

Il CMDh ha approvato nuove misure per evitare l'esposizione dei bambini ai medicinali a base di valproato in utero, perché i bambini esposti sono ad alto rischio di malformazioni e problemi di sviluppo.

Italia - AIFA - Agenzia Italiana del Farmaco