Tarivid 200

Informazioni principali

  • Nome commerciale:
  • Tarivid 200 compresse rivestite con film
  • Forma farmaceutica:
  • compresse rivestite con film
  • Composizione:
  • ofloxacinum 200 mg, excipiens pro compresso obducto.
  • Utilizzare per:
  • Esseri umani
  • Tipo di medicina:
  • Farmaco biologico

Documenti

  • per i professionisti:
  • 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 i professionisti.

Localizzazione

  • Disponibile in:
  • Tarivid 200 compresse rivestite con film
    Svizzera
  • Lingua:
  • italiano

Informazioni terapeutiche

  • Gruppo terapeutico:
  • Synthetika
  • Area terapeutica:
  • Malattie infettive

Altre informazioni

Status

  • Fonte:
  • Swissmedic - Swiss Agency for Therapeutic Products
  • Numero dell'autorizzazione:
  • 47386
  • Data dell'autorizzazione:
  • 25-06-1987
  • Ultimo aggiornamento:
  • 19-10-2018

Foglio illustrativo: composizione, posologia, indicazioni, interazioni, gravidanza, allattamento, effetti indesiderati, controindicazioni

Patienteninformation

Tarivid®

Sanofi-Aventis (Suisse) SA

Che cos’è Tarivid e quando si usa?

Tarivid è un medicamento per il trattamento di malattie infettive provocate da batteri. Tarivid è un

antibiotico appartenente al gruppo dei fluorochinoloni ed è efficace contro numerose specie di

batteri.

Tarivid è indicato per il trattamento di malattie infettive, quali:

·infezioni dei reni,

·infezioni degli organi genitali maschili,

·infezioni del piccolo bacino (pelvi).

Tarivid è indicato come trattamento di seconda linea, per le malattie infettive dell'adulto, quali:

·infezioni della pelle e delle parti molli,

·infezioni delle ossa e delle articolazioni,

·infezioni delle vie respiratorie,

·infezioni delle vie urinarie,

·prevenzione delle infezioni nei pazienti che soffrono di neutropenia (riduzione numerica di

determinati globuli bianchi).

Tarivid deve essere usato esclusivamente su prescrizione medica.

Di che cosa occorre inoltre tener conto durante il trattamento?

Questo medicamento le è stato prescritto dal medico per curare la sua malattia attuale.

L'antibiotico Tarivid non è efficace contro tutti i microrganismi che provocano malattie infettive.

L'uso di un antibiotico mal scelto o non correttamente dosato può causare complicazioni. Quindi non

lo utilizzi mai di sua iniziativa per curare altre malattie o altre persone.

Quando non si può assumere Tarivid?

I pazienti ipersensibili nei confronti di Tarivid o di medicamenti analoghi (consulti il suo medico)

non devono assumere Tarivid.

I pazienti in cui si sono manifestati dolori dei tendini durante una terapia precedente con antibiotici

della classe dei fluorochinoloni non dovrebbero assumere Tarivid, poiché con l'assunzione di Tarivid

c'è lo stesso rischio (compresa la lacerazione del tendine).

Tarivid non deve essere usato dai pazienti che soffrono di epilessia e nei casi con precedente danno

del sistema nervoso centrale (ad es. dopo trauma del cranio e del cervello, processi infiammatori a

carico del cervello, ictus). Nei pazienti che soffrono di miastenia (debolezza e affaticabilità dei

muscoli), Tarivid non deve essere impiegato.

Tarivid non deve essere somministrato ai bambini e agli adolescenti in fase di crescita (età inferiore a

18 anni) o durante la gravidanza o l'allattamento.

Quando è richiesta prudenza nella somministrazione di Tarivid?

Questo medicamento può ridurre la capacità di reazione, la capacità di condurre un veicolo e la

capacità di utilizzare attrezzi o macchine.

In alcuni pazienti sono stati riportati casi di reazioni cutanee gravi. Se manifesta reazioni a livello

della pelle e/o delle mucose, contatti immediatamente il suo medico prima di proseguire il

trattamento.

In caso di reazioni di ipersensibilità e di allergia, interrompa il trattamento e contatti il suo medico.

I fluorochinoloni, compreso Tarivid, possono provocare effetti collaterali gravi potenzialmente

irreversibili e invalidanti che possono interessare, isolatamente o simultaneamente, diversi organi nel

medesimo paziente. Tali effetti collaterali possono comprendere tendinite, rottura del tendine, dolore

alle articolazioni (artralgia), dolore muscolare (mialgia), neuropatia periferica, effetti sul sistema

nervoso centrale (allucinazioni, ansia, depressione, insonnia, mal di testa e confusione). Queste

reazioni possono verificarsi nelle ore o nelle settimane successive all'assunzione di Tarivid. Tali

effetti collaterali si sono sviluppati in pazienti di qualsiasi età o che non presentavano fattori di

rischio preesistenti.

Tarivid può provocare infiammazioni dei tendini fino alla rottura del tendine d'Achille soprattutto nei

pazienti di età superiore a 60 anni, nei pazienti che assumono contemporaneamente corticosteroidi

(ad es. prednisone o sostanze simili) o anche nei pazienti trapiantati. Tale effetto collaterale può

manifestarsi sia entro 48 ore dall'inizio del trattamento che parecchi mesi dopo l'interruzione del

trattamento. In questi casi, contatti immediatamente il medico e tenga l'arto interessato a riposo, al

fine di evitare una lesione al tendine.

Durante il trattamento a base di fluorochinoloni, compresa l'ofloxacina, sono stati riportati casi di

danno nervoso periferico; questi sintomi clinici variano da un caso all'altro e comprendono deficit

neurologici sensomotori o sensoriali (ad es. dolori, sensazione di bruciore, intorpidimento o

sensazione di debolezza, formicolio, perdita della sensibilità al tatto, alla temperatura e al dolore

negli arti o, al contrario, un'ipersensibilità). La comparsa di tali lesioni può essere rapida e, in questi

casi, l'assunzione di Tarivid deve essere interrotta. In tali casi, è necessario contattare

immediatamente il medico e interrompere il trattamento. In questo modo, il potenziale rischio di

comparsa di un danno neurologico irreversibile può essere ridotto. I fluorochinoloni devono essere

evitati nei pazienti con precedenti di neuropatia periferica.

Reazioni psichiatriche (ad es. nervosismo, agitazione, insonnia, angoscia, incubi, pensieri paranoici,

confusione, tremori, allucinazioni e depressione) possono manifestarsi anche sin dalla prima

assunzione di fluorochinoloni, come l'ofloxacina. In casi molto rari, è stato osservato un

peggioramento della depressione o delle reazioni psicotiche, il quale ha indotto idee suicide o

comportamenti a rischio, come tentativi di suicidio. Deve prestare particolare attenzione se ha

manifestato o manifesta disturbi psichici o soffre di una malattia mentale. In caso di comparsa di tali

sintomi, interrompa immediatamente il trattamento e si rivolga al suo medico.

I fluorochinoloni, compreso Tarivid, possono provocare convulsioni o abbassare la soglia

convulsiva. In caso di convulsioni, interrompa immediatamente il trattamento. Consulti il suo medico

se soffre di epilessia o presenta altri disturbi del sistema nervoso centrale come un abbassamento

della soglia convulsiva, precedenti di convulsioni, una diminuzione della circolazione cerebrale,

un'alterazione della struttura cerebrale o un accidente cerebrovascolare.

Interrompa il trattamento ai primi segni o sintomi di un effetto collaterale grave.

L'assunzione di Tarivid nei pazienti con un'alterazione della funzionalità epatica può provocare

lesioni al fegato fino a un'insufficienza epatica. Se constata segni di malattia epatica (ad es.

anoressia, ittero, colorazione scura delle urine, addome dolente alla palpazione), interrompa il

trattamento e contatti il suo medico.

Se la sua funzione renale è ridotta (insufficienza renale), il suo medico adatterà il dosaggio

giornaliero.

Nelle persone che hanno un fattore di rischio noto di allungamento del ritmo cardiaco (persone

anziane, malattie cardiache) o quando si usano di sostanze che prolungano notoriamente l'intervallo

QT (antiaritmici, antidepressivi triciclici, macrolidi, antipsicotici), i fluorochinoloni devono essere

usati con cautela e il dosaggio dovrebbe essere adattato di conseguenza.

La contemporanea assunzione di medicamenti contro l'iperacidità dello stomaco e di preparati a base

di ferro va evitata, poiché l'effetto di Tarivid può venire diminuito. Pertanto Tarivid per via orale va

assunto circa 2 ore prima di tali medicamenti.

Certi chinoloni scatenano reazioni di fotosensibilità nei pazienti che espongono troppo la pelle al

sole. Durante il trattamento bisogna, quindi, evitare di stare troppo tempo al sole e di esporsi ai raggi

ultravioletti in un solarium. Se si manifestano reazioni di ipersensibilità, la terapia va interrotta.

Come per tutti i chinoloni, sono stati riportati disturbi della glicemia (ipoglicemia e iperglicemia)

generalmente in caso di diabete trattato con un agente ipoglicemizzante orale (ad es. la

glibenclamide) o con l'insulina. In questo caso, si raccomanda una stretta sorveglianza della glicemia.

Tarivid non è indicato nei pazienti con precedenti di miastenia (malattia dei muscoli) poiché può

aggravare la debolezza muscolare.

In caso di trattamento contemporaneo con un antagonista della vitamina K (ad es. Warfarina) e

Tarivid, potrebbe verificarsi un aumento dei valori dei suoi test della coagulazione (PT/INR) e

sanguinamenti. Informi il suo medico o il suo farmacista se assume un antagonista della vitamina K.

Se soffre di carenza di glucosio-6-fosfato deidrogenasi (G6PDH) latente o diagnosticata, è a rischio

di sviluppare reazioni emolitiche sotto trattamento con chinoloni. Per questo motivo, Tarivid deve

essere somministrato con cautela nei pazienti con una carenza di G6PDH.

Informi il suo medico o farmacista se sta già assumendo altri medicamenti fra cui i farmaci

epilettogeni (ad es. teofillina, fenbufene o antinfiammatori non steroidei), il probenecid (per il

trattamento dell'artrite gottosa: livello elevato di acido urico nel sangue), la cimetidina (per il

trattamento del reflusso esofageo), il furosemide (per il trattamento dell'accumulo di acqua: edema),

il metotrexato (per il trattamento ad esempio della poliartrite o della psoriasi) oppure i medicamenti

potenzialmente ipotensivi.

Informi il suo medico o il suo farmacista se

·soffre di altre malattie,

·soffre di allergie o

·assume o applica esternamente altri medicamenti (anche se acquistati di sua iniziativa!).

Ciò vale, tra l'altro, per i medicamenti contro l'ipertensione, l'iperglicemia, l'iperacidità dello

stomaco, la diarrea e preparati che contenengono ferro, medicamenti antinfiammatori e la teofillina

(un antiasmatico).

Si può assumere Tarivid durante la gravidanza o l’allattamento?

Tarivid non deve essere assunto durante la gravidanza o l'allattamento.

Come usare Tarivid?

Come per tutti gli antibiotici, è necessario attenersi rigorosamente alla posologia e alla durata del

trattamento prescritti dal suo medico. Soltanto così si potrà ottenere il massimo beneficio possibile da

Tarivid. Siccome i sintomi della malattia spesso scompaiono prima che l'infezione sia completamente

guarita, non interrompa la terapia, anche se si sente meglio.

Tarivid può essere assunto a digiuno o durante pasti. Le compresse vanno ingerite con una quantità

sufficiente di liquido (½ bicchiere d'acqua).

Il dosaggio di Tarivid dipende dalla sensibilità dell'agente patogeno e dalla localizzazione

dell'infezione.

Adulti

Il suo medico può prescrivere i seguenti dosaggi:

Infezioni delle vie urinarie

2× 100 fino a 200 mg al giorno

Sinusite acuta

2× 200 mg al giorno

Polmonite

2× 200 fino a 400 mg al giorno

Infezioni della pelle e delle parti molli

2× 200 mg al giorno

Infezioni degli organi genitali maschili

2× 100 fino a 200 mg al giorno

Infezioni delle ossa e delle articolazioni

2× 200 mg al giorno

Prevenzione delle infezioni nei pazienti con

neutropenia

da 400 a 600 mg al giorno

Peggioramento di una bronchite cronica o recidivante

2× 200 fino a 400 mg al giorno

Infezione del piccolo bacino (pelvi)

2× 400 mg al giorno

Il medico può aumentare il dosaggio fino a 400 mg 2 volte al giorno.

Nelle infezioni acute, è sufficiente generalmente un trattamento di 7-10 giorni.

Non modifichi di propria iniziativa la posologia prescritta. Se ritiene che l'azione del medicamento

sia troppo debole o troppo forte ne parli al suo medico o al suo farmacista.

Bambini e adolescenti

Tarivid non deve essere somministrato ai bambini e agli adolescenti in fase di crescita (età inferiore a

18 anni).

Se dimentica un'assunzione di Tarivid, prenda la compressa non appena possibile, sempre che non

sia già il momento di prendere la dose successiva. In questo caso, prenda la dose prescritta e non il

doppio della dose, cioè la compressa o le compresse dimenticate non saranno più assunte.

Se ha preso inavvertitamente una compressa di troppo, non tema effetti collaterali. Tuttavia, se ha

involontariamente preso molte compresse in più, si rivolga al suo medico o al suo farmacista.

Quali effetti collaterali può avere Tarivid?

I possibili effetti collaterali sono i seguenti: disturbi gastrointestinali, come difficoltà di deglutizione,

secchezza della bocca, mal di stomaco, dolori addominali, inappetenza, nausea, vomito, flatulenze,

stitichezza o diarrea. Se compare diarrea abbondante e persistente (talvolta con presenza di sangue)

durante o dopo il trattamento, consulti immediatamente il suo medico. Non cerchi di curare da solo

questo tipo di diarrea, ad esempio con medicamenti che riducono le contrazioni dell'intestino. Sono

stati riportati casi isolati di infiammazione del pancreas o dello stomaco.

Possono manifestarsi reazioni allergiche, soprattutto reazioni di ipersensibilità della pelle sotto forma

di eczemi, prurito, arrossamento cutaneo, anche correlati a una forte esposizione al sole, orticaria,

bruciore agli occhi, tosse non produttiva e raffreddore , aumento della pressione arteriosa,

infiammazione allergica dei polmoni o dei reni e febbre. Molto raramente sono state osservate

reazioni allergiche che provocano gonfiore del viso, della lingua o della laringe, in casi isolati gravi,

con difficoltà respiratorie e shock. In questi casi, bisogna sospendere immediatamente Tarivid e

avvisare il medico, che avvierà il necessario trattamento (ad es. terapia dello shock).

Occasionalmente possono insorgere disturbi del sonno o persino insonnia. Molto rari sono gli effetti

collaterali come mal di testa, vertigini, agitazione, eccitazione, palpitazioni cardiache, stati ansiosi,

stato confusionale, stordimento, allucinazioni, depressione fino al punto da mettere in pericolo sé

stessi, inclusi idee suicide, tentativo di suicidio, sogni intensi fino all'incubo, insicurezza

dell'andatura, tremori, convulsioni, alterazioni della sensibilità degli arti, alterazioni della vista,

dell'udito, del gusto, dell'odorato o dell'equilibrio, debolezza muscolare. Sono stati osservati casi

isolati di infiammazione dell'occhio o di una parte dell'occhio (uveite) e alterazioni del ritmo

cardiaco.

Si possono riscontrare effetti respiratori secondari in seguito all'assunzione di Tarivid. I pazienti

possono presentare occasionalmente tosse o rinofaringite e raramente difficoltà respiratorie oppure

oppressione toracica.

In casi molto rari, la funzione del fegato e quella dei reni rischiano di essere compromesse.

Se queste reazioni si manifestano, cosa che è possibile fin dalla prima assunzione del medicamento,

bisogna sospendere immediatamente il trattamento e consultare il medico.

Molto raramente, si sono osservati casi di lesione nervosa periferica.

Raramente sono stati segnalati dolori articolari e muscolari, nonché dolori ai tendini, strappo

muscolare, rottura muscolare, rottura dei legamenti, artrite. (vedi sezione «Quando è richiesta

prudenza nella somministrazione di Tarivid?»).

In casi isolati, possono verificarsi un abbassamento o un aumento eccessivi della glicemia, in

particolare nei pazienti diabetici. Inoltre, sono stati riportati casi isolati di coma ipoglicemico.

In casi molto rari si sono osservati disturbi della circolazione, quali una riduzione del numero dei

globuli rossi o di alcuni globuli bianchi (anemia, leucopenia).

Salvo casi molto rari di disturbi dell'olfatto, dell'udito e del gusto, gli effetti collaterali osservati

durante il trattamento con Tarivid di norma sono scomparsi dopo la sospensione del medicamento.

Se osserva effetti collaterali qui non descritti dovrebbe informare il suo medico o il suo farmacista.

Di che altro occorre tener conto?

Conservare il medicamento fuori dalla portata dei bambini.

Conservare Tarivid nella sua confezione originale a temperatura ambiente (15-25 °C) e al riparo

dalla luce.

Il medicamento non dev'essere utilizzato oltre la data indicata con «EXP» sul contenitore.

Terminato il trattamento, riportare le compresse non utilizzate al medico o al farmacista che le ha

fornite, affinché vengano eliminate in modo corretto.

Il medico o il farmacista, che sono in possesso di un'informazione professionale dettagliata, possono

darle ulteriori informazioni.

Cosa contiene Tarivid?

1 compressa pellicolata di Tarivid contiene 200 mg di ofloxacina e degli eccipienti.

Numero dell’omologazione

47'386 (Swissmedic)

Dov’è ottenibile Tarivid? Quali confezioni sono disponibili?

In farmacia, dietro presentazione della prescrizione medica non rinnovabile.

Confezioni da 10 e 20 compresse pellicolate.

Titolare dell’omologazione

sanofi-aventis (svizzera) sa, 1214 Vernier/GE

Questo foglietto illustrativo è stato controllato l'ultima volta nel settembre 2017 dall'autorità

competente in materia di medicamenti (Swissmedic).

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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

28-12-2018

The red palm weevil

The red palm weevil

What is the red palm weevil? The red palm weevil (Rhynchophorus ferrugineus) is a beetle that is a particular menace to palm trees. Originally from South and South-east Asia, it is now found in more than 60 countries, where it threatens date palms, ornamental palms and coconut palms. It has been present in France since 2006; it was first detected in the Provence-Alpes-Côte d'Azur region (French Riviera) and has now become established in the Occitanie region and Corsica.

France - Agence Nationale du Médicament Vétérinaire

22-12-2018

Modification of the existing maximum residue level for captan in hops

Modification of the existing maximum residue level for captan in hops

Published on: Fri, 21 Dec 2018 In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant ADAMA Agriculture BV on behalf of ADAMA Makhteshim Ltd. submitted a request to the competent national authority in the Netherlands to modify the existing maximum residue level for the active substance captan in hops. The data submitted in support of the request were found to be insufficient to conclude whether the existing residue definitions are appropriate for hops. Although the number of residue ...

Europe - EFSA - European Food Safety Authority EFSA Journal

22-12-2018

Modification of the existing maximum residue level for captan in cranberries

Modification of the existing maximum residue level for captan in cranberries

Published on: Fri, 21 Dec 2018 In accordance with Article 6 of Regulation (EC) No 396/2005, the Belgian Federal Public Service (FPS) for Health, Food chain safety and Environment, submitted an application as the competent national authority in Belgium to modify the existing maximum residue level (MRL) for the active substance captan in cranberries. The data submitted in support of the request were found to be sufficient to derive MRL proposal for cranberries. Adequate analytical methods for enforcement ...

Europe - EFSA - European Food Safety Authority EFSA Journal

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

20-12-2018

Outcome of the consultation with Member States, the applicant and EFSA on the pesticide risk assessment for mesotrione in light of confirmatory data

Outcome of the consultation with Member States, the applicant and EFSA on the pesticide risk assessment for mesotrione in light of confirmatory data

Published on: Wed, 19 Dec 2018 The European Food Safety Authority (EFSA) was asked by the European Commission to provide scientific assistance with respect to the risk assessment for an active substance in light of confirmatory data requested following approval in accordance with Article 6(1) of Directive 91/414/EEC and Article 6(f) of Regulation (EC) No 1107/2009. In this context EFSA's scientific views on the specific points raised during the commenting phase conducted with Member States, the applican...

Europe - EFSA - European Food Safety Authority EFSA Journal

19-12-2018

The red palm weevil:  combating the loss of palm trees on the Mediterranean coast

The red palm weevil: combating the loss of palm trees on the Mediterranean coast

The palm weevil is one of the most damaging insect pests of palm trees, and is a threat to plant biodiversity in many countries. This insect has spread rapidly along the Mediterranean coast in the last ten years or more, and is classified as a regulated quarantine pest and a major danger to plant health in France. It is therefore subject to compulsory control measures. In order to curb the spread of the pest, which was introduced into the country in 2006, control strategies are being implemented at local...

France - Agence Nationale du Médicament Vétérinaire

18-12-2018

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

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

Published on: Mon, 17 Dec 2018 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 pencycuron. To assess the occurrence of pencycuron 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 (incl...

Europe - EFSA - European Food Safety Authority Publications

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

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

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

27-11-2018

Risk assessment of new sequencing information for genetically modified soybean A2704‐12

Risk assessment of new sequencing information for genetically modified soybean A2704‐12

Published on: Mon, 26 Nov 2018 The GMO Panel has previously assessed genetically modified (GM) soybean A2704‐12. This soybean was found to be as safe and nutritious as its conventional counterpart with respect to potential effects on human and animal health and the environment in the context of its intended uses. On 5 June 2018, the European Commission requested EFSA to analyse new nucleic acid sequencing data and updated bioinformatics data for GM soybean A2704‐12 and to indicate whether the previous c...

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

Modification of the existing maximum residue levels for pyraclostrobin in soyabean

Modification of the existing maximum residue levels for pyraclostrobin in soyabean

Published on: Mon, 19 Nov 2018 In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant BASF SE submitted a request to the competent national authority in France to modify the existing maximum residue level (MRL) for the active substance pyraclostrobin in soyabean. The data submitted in support of the request were found to be sufficient to derive MRL proposals for soyabean. The applicant provided a new validated analytical method to control residues of pyraclostrobin on the commodity u...

Europe - EFSA - European Food Safety Authority Publications

20-11-2018

Modification of the existing maximum residue levels and setting of import tolerances for pyraclostrobin in various crops

Modification of the existing maximum residue levels and setting of import tolerances for pyraclostrobin in various crops

Published on: Mon, 19 Nov 2018 In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant BASF SE submitted two requests to the competent national authority in Germany. The first one, to modify the existing maximum residue levels (MRL) for the active substance pyraclostrobin in various crops and to set import tolerances for sugar canes and American persimmons; the second one to set import tolerances for pineapples and passion fruits/maracujas. The data submitted in support of the request...

Europe - EFSA - European Food Safety Authority Publications

20-11-2018

Peer review of the pesticide risk assessment of the active substance (EZ)‐1,3‐dichloropropene

Peer review of the pesticide risk assessment of the active substance (EZ)‐1,3‐dichloropropene

Published on: Mon, 19 Nov 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, Spain, for the pesticide active substance (EZ)‐1,3‐dichloropropene are reported. The context of the peer review was that required by Regulation (EC) No 1107/2009 of the European Parliament and of the Council. The conclusions were reached on the basis of the evaluation of the representative uses of (EZ)‐1,3‐dichloropropene ...

Europe - EFSA - European Food Safety Authority Publications

17-11-2018

Assessment of genetically modified soybean MON 89788 for renewal of authorisation under Regulation (EC) No 1829/2003 (application EFSA‐GMO‐RX‐011)

Assessment of genetically modified soybean MON 89788 for renewal of authorisation under Regulation (EC) No 1829/2003 (application EFSA‐GMO‐RX‐011)

Published on: Fri, 16 Nov 2018 Following the submission of application EFSA‐GMO‐RX‐011 under Regulation (EC) No 1829/2003 from Monsanto Europe, the Panel on Genetically Modified Organisms of the European Food Safety Authority (GMO Panel) 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 MON 89788, for food and feed uses, excluding cultivation within the European Union....

Europe - EFSA - European Food Safety Authority Publications

17-11-2018

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

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

Published on: Fri, 16 Nov 2018 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 tau‐fluvalinate. To assess the occurrence of tau‐fluvalinate 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 St...

Europe - EFSA - European Food Safety Authority Publications

17-11-2018

Evaluation of confirmatory data following the Article 12 MRL review for picolinafen

Evaluation of confirmatory data following the Article 12 MRL review for picolinafen

Published on: Fri, 16 Nov 2018 The applicant BASF Agro B.V. submitted a request to the competent national authority in Germany to evaluate the confirmatory data that were identified for picolinafen in the framework of the maximum residue level (MRL) review under Article 12 of Regulation (EC) No 396/2005 as not available. To address the data gaps, a new validated analytical method for enforcement of the residue in dry/high starch‐, high water content‐, high acid content‐ and high oil content commodities ...

Europe - EFSA - European Food Safety Authority Publications

16-11-2018

Setting of an import tolerance for pyraclostrobin in rice

Setting of an import tolerance for pyraclostrobin in rice

Published on: Thu, 15 Nov 2018 In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant BASF SE submitted a request to the competent national authority in Germany to set an import tolerance for the active substance pyraclostrobin in rice. The data submitted in support of the request were found to be sufficient to derive a maximum residue level (MRL) proposal for rice. Based on the risk assessment results, EFSA concluded that the short‐term intake of residues resulting from the use of p...

Europe - EFSA - European Food Safety Authority Publications

16-11-2018

Evaluation of confirmatory data following the Article 12 MRL review for pyraclostrobin

Evaluation of confirmatory data following the Article 12 MRL review for pyraclostrobin

Published on: Thu, 15 Nov 2018 The applicant BASF SE submitted a request to the competent national authority in Germany to evaluate the confirmatory data that were identified for pyraclostrobin in the framework of the MRL review under Article 12 of Regulation (EC) No 396/2005 as not available. To address the data gaps, residues trials supporting the existing use of pyraclostrobin on table grapes authorised in southern EU Member States and an analytical method for analysing residues of pyraclostrobin in ...

Europe - EFSA - European Food Safety Authority Publications

15-11-2018

Assessment of genetically modified LLCotton25 for renewal of authorisation under Regulation (EC) No 1829/2003 (application EFSA‐GMO‐RX‐010)

Assessment of genetically modified LLCotton25 for renewal of authorisation under Regulation (EC) No 1829/2003 (application EFSA‐GMO‐RX‐010)

Published on: Wed, 14 Nov 2018 Following the submission of application EFSA‐GMO‐RX‐010 under Regulation (EC) No 1829/2003 from Bayer, the Panel on Genetically Modified Organisms of the European Food Safety Authority (GMO Panel) 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 LLCotton25, for food and feed uses, import and processing, excluding cultivation within the EU. The d...

Europe - EFSA - European Food Safety Authority Publications

15-11-2018

Assessment of genetically modified maize MZHG0JG for food and feed uses, import and processing under Regulation (EC) No 1829/2003 (application EFSA‐GMO‐DE‐2016‐133)

Assessment of genetically modified maize MZHG0JG for food and feed uses, import and processing under Regulation (EC) No 1829/2003 (application EFSA‐GMO‐DE‐2016‐133)

Published on: Wed, 14 Nov 2018 The scope of application EFSA‐GMO‐DE‐2016‐133 is for food and feed uses, import and processing of genetically modified (GM) maize MZHG0JG in the European Union. Maize MZHG0JG was developed to confer tolerance to the herbicidal active substances glyphosate and glufosinate‐ammonium. The molecular characterisation data and bioinformatic analyses do not identify issues requiring food/feed safety assessment. None of the identified differences in the agronomic/phenotypic and com...

Europe - EFSA - European Food Safety Authority Publications

14-11-2018

Evaluation of confirmatory data following the Article 12 MRL review for cyazofamid

Evaluation of confirmatory data following the Article 12 MRL review for cyazofamid

Published on: Tue, 13 Nov 2018 The applicant ISK Biosciences Europe N.V. submitted a request to the competent national authority in France to evaluate the confirmatory data that were identified in the framework of the MRL review under Article 12 of Regulation (EC) No 396/2005 as not available. The data gap which was related to information on freezer storage conditions for the residue trials reported on potatoes, tomatoes and cucurbits with edible and inedible peel was considered satisfactorily addressed...

Europe - EFSA - European Food Safety Authority Publications

13-11-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

13-11-2018

Setting of import tolerances for teflubenzuron in grapefruits, mandarins and broccoli

Setting of import tolerances for teflubenzuron in grapefruits, mandarins and broccoli

Published on: Mon, 12 Nov 2018 00:00:00 +0100 In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant BASF Agro BV submitted a request to the competent national authority in the United Kingdom to set import tolerances for the active substance teflubenzuron in grapefruits and mandarins imported from Brazil and for broccoli imported from Paraguay. The data submitted were found to be sufficient to derive maximum residue level (MRL) proposals for grapefruits and broccoli. The MRL derived ...

Europe - EFSA - European Food Safety Authority Publications

10-11-2018

Outcome of the consultation with Member States and EFSA on the basic substance application for propolis extract (admissibility accepted when named water‐soluble extract of propolis) for use in plant protection as fungicide and bactericide

Outcome of the consultation with Member States and EFSA on the basic substance application for propolis extract (admissibility accepted when named water‐soluble extract of propolis) for use in plant protection as fungicide and bactericide

Published on: Fri, 09 Nov 2018 00:00:00 +0100 The European Food Safety Authority (EFSA) was asked by the European Commission to provide scientific assistance with respect to the evaluation of applications received by the European Commission concerning basic substances. In this context, EFSA's scientific views on the specific points raised during the commenting phase conducted with Member States and EFSA on the basic substance application for propolis extract are presented. The context of the evaluation ...

Europe - EFSA - European Food Safety Authority Publications

9-11-2018

Influenza A (H1N1) 2009 Monovalent Vaccines Composition and Lot Release

Influenza A (H1N1) 2009 Monovalent Vaccines Composition and Lot Release

Vaccine lot release information updated on 3/3/2010.

FDA - U.S. Food and Drug Administration

6-11-2018

Evaluation of confirmatory data following the Article 12 MRL review for kresoxim‐methyl

Evaluation of confirmatory data following the Article 12 MRL review for kresoxim‐methyl

Published on: Fri, 02 Nov 2018 00:00:00 +0100 The applicant BASF SE submitted a request to the competent national authority in Belgium to evaluate the confirmatory data that were identified for kresoxim‐methyl in the framework of the maximum residue level (MRL) review under Article 12 of Regulation (EC) No 396/2005 as not available. To address the confirmatory data requirement, a new study on the storage stability of kresoxim‐methyl residues in animal matrices was submitted. The data gap was considered ...

Europe - EFSA - European Food Safety Authority Publications

6-11-2018

Setting of import tolerances for haloxyfop‐P in linseed and rapeseed

Setting of import tolerances for haloxyfop‐P in linseed and rapeseed

Published on: Fri, 02 Nov 2018 00:00:00 +0100 In accordance with Article 6 of Regulation (EC) No 396/2005, the Australian Government Department of Agriculture and Water Resources submitted two requests to the competent national authority in Denmark to set import tolerances for the active substance haloxyfop‐P in linseed and rapeseed. The data submitted in support of the request were found to be sufficient to derive maximum residue level (MRL) proposals for linseed and rapeseed. Adequate analytical metho...

Europe - EFSA - European Food Safety Authority Publications

31-10-2018

Updated review of the existing maximum residue levels for imazalil according to Article 12 of Regulation (EC) No 396/2005 following new toxicological information

Updated review of the existing maximum residue levels for imazalil according to Article 12 of Regulation (EC) No 396/2005 following new toxicological information

Published on: Tue, 30 Oct 2018 00:00:00 +0100 In compliance with Article 43 of Regulation (EC) No 396/2005, EFSA received a mandate from the European Commission to provide an update of the reasoned opinion on the review of existing maximum residue levels (MRLs) for imazalil published on 5 September 2017, taking into account the additional information provided on the toxicity of the metabolites R014821, FK‐772 and FK‐284. EFSA did not derive MRL proposals from the post‐harvest uses reported on citrus fru...

Europe - EFSA - European Food Safety Authority Publications

23-10-2018

Evaluation of confirmatory data following the Article 12 MRL review for pendimethalin

Evaluation of confirmatory data following the Article 12 MRL review for pendimethalin

Published on: Mon, 22 Oct 2018 00:00:00 +0200 The applicant BASF Agro BV submitted a request to the competent national authority in the Netherlands to evaluate the confirmatory data that were identified in the framework of the maximum residue level (MRL) review under Article 12 of Regulation (EC) No 396/2005 as not available. To address the data gaps, residue trials on strawberries, onions, garlic, tomatoes, peppers, cucumbers, artichokes, leeks and rape seeds were submitted. The data gaps are considere...

Europe - EFSA - European Food Safety Authority Publications

20-10-2018

Evaluation of confirmatory data following the Article 12 MRL review for dimethomorph

Evaluation of confirmatory data following the Article 12 MRL review for dimethomorph

Published on: Fri, 19 Oct 2018 00:00:00 +0200 The applicant BASF SE submitted a request to the competent national authority in Germany to evaluate the confirmatory data that were identified for dimethomorph in the framework of the maximum residue level (MRL) review under Article 12 of Regulation (EC) No 396/2005 as not available. The submitted residue data on raspberries were satisfactorily addressing the data gaps on raspberries and blackberries. Considering the new information provided, it is appropri...

Europe - EFSA - European Food Safety Authority Publications

20-10-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

20-10-2018

Scientific Opinion of Flavouring Group Evaluation 411 (FGE.411): 2‐(4‐methylphenoxy)‐N‐(1H‐pyrazol‐3‐yl)‐N‐(thiophen‐2‐ylmethyl)acetamide from chemical group 30 (miscellaneous substances)

Scientific Opinion of Flavouring Group Evaluation 411 (FGE.411): 2‐(4‐methylphenoxy)‐N‐(1H‐pyrazol‐3‐yl)‐N‐(thiophen‐2‐ylmethyl)acetamide from chemical group 30 (miscellaneous substances)

Published on: Fri, 19 Oct 2018 00:00:00 +0200 EFSA was requested to deliver a scientific opinion on the implications for human health of the flavouring substance 2‐(4‐methylphenoxy)‐N‐(1H‐pyrazol‐3‐yl)‐N‐(thiophen‐2‐ylmethyl)acetamide [FL‐no: 16.133], in the Flavouring Group Evaluation 411 (FGE.411), according to Regulation (EC) No 1331/2008 of the European Parliament and of the Council. The substance has not been reported to occur in natural source materials of botanical or animal origin. It is intende...

Europe - EFSA - European Food Safety Authority Publications

20-10-2018

Scientific Opinion on Flavouring Group Evaluation 200, Revision 1 (FGE.200 Rev.1): 74 α,β‐unsaturated aliphatic aldehydes and precursors from chemical subgroup 1.1.1 of FGE.19

Scientific Opinion on Flavouring Group Evaluation 200, Revision 1 (FGE.200 Rev.1): 74 α,β‐unsaturated aliphatic aldehydes and precursors from chemical subgroup 1.1.1 of FGE.19

Published on: Fri, 19 Oct 2018 00:00:00 +0200 The Panel on Food Additives and Flavourings of the European Food Safety Authority was requested to evaluate the genotoxic potential of 74 flavouring substances from subgroup 1.1.1 of FGE.19 in the Flavouring Group Evaluation 200 Revision 1 (FGE.200 Rev1). In FGE.200, genotoxicity studies were provided for one representative substance, namely hex‐2(trans)‐enal [FL‐no: 05.073], and for other two substances in the same subgroup, namely 2‐dodecenal [FL‐no: 05.03...

Europe - EFSA - European Food Safety Authority Publications

16-10-2018

Modification of the existing maximum residue levels for mepiquat in cotton seeds and animal commodities

Modification of the existing maximum residue levels for mepiquat in cotton seeds and animal commodities

Published on: Mon, 15 Oct 2018 00:00:00 +0200 In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant, BASF SE, submitted an application to the competent national authority in Greece to modify the existing maximum residue level (MRL) for the active substance mepiquat in cotton seeds. The data submitted in support of the application were found to be sufficient to derive a MRL proposal for cotton seeds and the previously derived MRL proposals for animal commodities were found to be stil...

Europe - EFSA - European Food Safety Authority Publications

16-10-2018

Evaluation of confirmatory data following the Article 12 MRL review for teflubenzuron

Evaluation of confirmatory data following the Article 12 MRL review for teflubenzuron

Published on: Mon, 15 Oct 2018 00:00:00 +0200 The applicant BASF Agro BV submitted a request to the competent national authority in United Kingdom to evaluate the confirmatory data that were identified for teflubenzuron in the framework of the maximum residue level (MRL) review under Article 12 of Regulation (EC) No 396/2005 as not available. To address the data gaps, a new metabolism study on leafy crops, a study investigating the nature of residues under standard hydrolytic conditions and a validated ...

Europe - EFSA - European Food Safety Authority Publications

6-10-2018

Modification of the existing maximum residue level for epoxiconazole in beetroots

Modification of the existing maximum residue level for epoxiconazole in beetroots

Published on: Fri, 05 Oct 2018 00:00:00 +0200 In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Agriculture & Horticulture Development Board submitted a request to the competent national authority in the United Kingdom to modify the existing maximum residue level (MRL) for the active substance epoxiconazole in beetroots. The data submitted in support of the request were found to be sufficient to derive a MRL proposal for beetroots. Adequate analytical methods for enforcement are...

Europe - EFSA - European Food Safety Authority Publications

2-10-2018

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

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

Published on: Mon, 01 Oct 2018 00:00:00 +0200 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 cyflufenamid. To assess the occurrence of cyflufenamid residues in plants, processed commodities, rotational crops and livestock, EFSA considered the conclusions derived in the framework of Directive 91/414/EEC as well as the European authorisations reported by Member States (in...

Europe - EFSA - European Food Safety Authority Publications

28-9-2018

Peer review of the pesticide risk assessment of the active substance ABE‐IT 56 (components of lysate of Saccharomyces cerevisiae strain DDSF623)

Peer review of the pesticide risk assessment of the active substance ABE‐IT 56 (components of lysate of Saccharomyces cerevisiae strain DDSF623)

Published on: Thu, 27 Sep 2018 00:00:00 +0200 The conclusions of EFSA following the peer review of the initial risk assessments carried out by the competent authority of the rapporteur Member State, France, for the pesticide active substance ABE‐IT 56 (components of lysate of Saccharomyces cerevisiae strain DDSF623) 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...

Europe - EFSA - European Food Safety Authority Publications

27-9-2018

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

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

Published on: Wed, 26 Sep 2018 00:00:00 +0200 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 tembotrione. To assess the occurrence of tembotrione residues in plants, processed commodities, rotational crops and livestock, EFSA considered the conclusions derived in the framework of Commission Regulation (EU) No 188/2011 as well as the import tolerances and European author...

Europe - EFSA - European Food Safety Authority Publications

27-9-2018

Outcome of the consultation on confirmatory data used in risk assessment for the active substance  copper (I), copper (II) variants

Outcome of the consultation on confirmatory data used in risk assessment for the active substance copper (I), copper (II) variants

Published on: Wed, 26 Sep 2018 00:00:00 +0200 The European Food Safety Authority (EFSA) was asked by the European Commission to provide scientific assistance with respect to the risk assessment for an active substance in light of confirmatory data requested following the first approval in accordance with Article 6(1) of Directive 91/414/EEC and Article 6(f) of Regulation (EC) No 1107/2009. In this context EFSA's scientific views on the specific points raised during the commenting phase conducted with Me...

Europe - EFSA - European Food Safety Authority Publications

26-9-2018

Modification of the existing maximum residue level for flonicamid in various crops

Modification of the existing maximum residue level for flonicamid in various crops

Published on: Tue, 25 Sep 2018 00:00:00 +0200 In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Dienstleistungszentrum Ländlicher Raum submitted a request to the competent national authority in Germany to modify the existing maximum residue level (MRL) for the active substance flonicamid in radishes. Furthermore, in accordance with Article 6 of Regulation (EC) No 396/2005, the applicant ISK Biosciences Europe N.V. submitted a request to the competent national authority in the Ne...

Europe - EFSA - European Food Safety Authority Publications

21-9-2018

Outcome of the consultation with Member States, the applicant and EFSA on the pesticide risk assessment for sulfoxaflor in light of confirmatory data

Outcome of the consultation with Member States, the applicant and EFSA on the pesticide risk assessment for sulfoxaflor in light of confirmatory data

Published on: Thu, 20 Sep 2018 00:00:00 +0200 The European Food Safety Authority (EFSA) was asked by the European Commission to provide scientific assistance with respect to the risk assessment for an active substance in light of confirmatory data requested following approval in accordance with Article 6(1) of Directive 91/414/EEC and Article 6(f) of Regulation (EC) No 1107/2009. In this context EFSA's scientific views on the specific points raised during the commenting phase conducted with Member State...

Europe - EFSA - European Food Safety Authority Publications

21-9-2018

Modification of the existing maximum residue level for clothianidin in potatoes

Modification of the existing maximum residue level for clothianidin in potatoes

Published on: Thu, 20 Sep 2018 00:00:00 +0200 In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Bayer CropScience AG submitted a request to the competent national authority in Germany to modify the existing maximum residue level (MRL) for the active substance clothianidin to accommodate the use on potatoes imported from Canada. The data submitted in support of the request were found to be sufficient to derive a MRL proposal. Adequate analytical methods for enforcement are availa...

Europe - EFSA - European Food Safety Authority Publications

20-9-2018

Getinge Issues Worldwide Voluntary Correction of Maquet/Getinge Cardiosave Intra-Aortic Balloon Pump (IABP) For Interruption and/or Inability to Start Therapy at Altitudes above 3,200 Feet/975 Meters

Getinge Issues Worldwide Voluntary Correction of Maquet/Getinge Cardiosave Intra-Aortic Balloon Pump (IABP) For Interruption and/or Inability to Start Therapy at Altitudes above 3,200 Feet/975 Meters

Getinge is voluntarily initiating a Worldwide recall involving a field correction of approximately 5,223 Maquet/Getinge Cardiosave Intra-Aortic Balloon Pumps (IABP) sold by Datascope Corp., for a potential interruption and/or inability to start therapy to the patient regarding the use of certain Intra-Aortic Balloons (IABs) prior to or during the use with Cardiosave IABP for users who are at altitudes above 3200 feet/975 meters. This condition could potentially lead to patient hemodynamic instability.

FDA - U.S. Food and Drug Administration

18-12-2018


Orphan designation: Mercaptopurine (oral suspension), Treatment of acute lymphoblastic leukaemia, 30/04/2009, Positive

Orphan designation: Mercaptopurine (oral suspension), Treatment of acute lymphoblastic leukaemia, 30/04/2009, Positive

Orphan designation: Mercaptopurine (oral suspension), Treatment of acute lymphoblastic leukaemia, 30/04/2009, Positive

Europe - EMA - European Medicines Agency

5-12-2018


Orphan designation: Paclitaxel (micellar), Treatment of ovarian cancer, 17/12/2006, Positive

Orphan designation: Paclitaxel (micellar), Treatment of ovarian cancer, 17/12/2006, Positive

Orphan designation: Paclitaxel (micellar), Treatment of ovarian cancer, 17/12/2006, Positive

Europe - EMA - European Medicines Agency

4-12-2018


Overview of comments received on Ibuprofen 200 – 800 mg oral use, immediate release formulations product-specific bioequivalence guidance

Overview of comments received on Ibuprofen 200 – 800 mg oral use, immediate release formulations product-specific bioequivalence guidance

Overview of comments received on Ibuprofen 200 – 800 mg oral use, immediate release formulations product-specific bioequivalence guidance

Europe - EMA - European Medicines Agency

26-11-2018

Today’s statement highlights increased expectations for information required in 510(k) submissions; each averages 1,185 pages, compared to 475 pages in 2009. Reviewers spend more time reviewing applications, but time to decision has become more efficient

Today’s statement highlights increased expectations for information required in 510(k) submissions; each averages 1,185 pages, compared to 475 pages in 2009. Reviewers spend more time reviewing applications, but time to decision has become more efficient

Today’s statement highlights increased expectations for information required in 510(k) submissions; each averages 1,185 pages, compared to 475 pages in 2009. Reviewers spend more time reviewing applications, but time to decision has become more efficient https://go.usa.gov/xPHdE 

FDA - U.S. Food and Drug Administration

26-11-2018

Today, #FDA’s device center also posted performance report highlighting measures taken to increase predictability, transparency of 510(k) review process, incl. 50 final guidance documents on important medical device policy issues issued since 2009.  https

Today, #FDA’s device center also posted performance report highlighting measures taken to increase predictability, transparency of 510(k) review process, incl. 50 final guidance documents on important medical device policy issues issued since 2009. https

Today, #FDA’s device center also posted performance report highlighting measures taken to increase predictability, transparency of 510(k) review process, incl. 50 final guidance documents on important medical device policy issues issued since 2009. https://go.usa.gov/xPHdn 

FDA - U.S. Food and Drug Administration