MST Continus 200 mg

Informazioni principali

  • Nome commerciale:
  • MST Continus 200 mg Tabletten ritardo
  • Forma farmaceutica:
  • Tabletten ritardo
  • Composizione:
  • morphini zolfo pentahydricus 200 mg corrisp. morphinum 150 mg, colore.: Di E 104, E-133, 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:
  • MST Continus 200 mg Tabletten ritardo
    Svizzera
  • Lingua:
  • italiano

Informazioni terapeutiche

  • Gruppo terapeutico:
  • Synthetika
  • Area terapeutica:
  • Analgetikum

Altre informazioni

Status

  • Fonte:
  • Swissmedic - Swiss Agency for Therapeutic Products
  • Numero dell'autorizzazione:
  • 44246
  • Data dell'autorizzazione:
  • 29-03-1982
  • Ultimo aggiornamento:
  • 19-10-2018

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

Patienteninformation

MST® Continus®

Mundipharma Medical Company

Che cos'è MST Continus e quando si usa?

MST Continus è un antidolorifico per il trattamento di dolori persistenti di intensità media o forte.

Contiene il principio attivo morfina. Dopo I'assunzione di MST Continus, la morfina viene rilasciata

lentamente nel tratto gastrointestinale ed assorbita nella circolazione sanguigna.

MST Continus deve essere usato esclusivamente su prescrizione medica e sotto regolare controllo

medico.

Quando non si può assumere MST Continus?

·Se è ipersensibile (allergico) al principio attivo morfina o a una delle sostanze ausiliarie,

·se soffre di gravi disturbi respiratori, cioè se il suo respiro è superficiale e rallentato (depressione

respiratoria grave),

·se soffre di una malattia cronica grave dei polmoni che comporta un restringimento delle vie

respiratorie (broncopneumopatia cronica ostruttiva (BPCO) grave),

·in caso di dolori addominali acuti,

·in presenza di paralisi dell'attività intestinale (ileo paralitico).

Quando è richiesta prudenza nella somministrazione di MST Continus?

·In presenza di grave aumento della pressione nel cuore destro in seguito a ipertensione polmonare

(cuore polmonare grave), asma bronchiale grave o disturbi respiratori,

·in caso di insufficienza epatica grave o insufficienza renale,

·in caso di insufficienza della tiroide (ipotiroidismo),

·in caso di insufficienza delle ghiandole surrenali (malattia di Addison),

·in caso di disturbi psichici causati dall'alcool o da intossicazioni, alcolismo o reazioni gravi a una

disintossicazione dall'alcool,

·in presenza di calcoli biliari o altre malattie delle vie biliari,

·in caso di infiammazione del pancreas (pancreatite),

·in presenza di malattie intestinali ostruttive o infiammatorie,

·in caso di ipertrofia prostatica con difficoltà a urinare,

·in presenza di pressione bassa o alta o di malattie cardiocircolatorie preesistenti,

·in caso di lesioni al capo, epilessia o tendenza a convulsioni,

·in caso di assunzione di medicamenti del gruppo degli inibitori delle monoaminossidasi (IMAO);

l'assunzione di MST Continus non è indicata in concomitanza con una terapia a base di IMAO o nei

14 giorni successivi all'interruzione di una terapia di questo tipo,

·se sta allattando.

Se lei è in età avanzata o è fisicamente debole, è più probabile che possa manifestare effetti

collaterali. Sia quindi particolarmente prudente.

Con l'impiego prolungato di MST Continus può svilupparsi assuefazione. In tal caso è possibile che

per ottenere l'effetto analgesico desiderato, lei abbia bisogno di una dose maggiore.

L'assunzione prolungata di MST Continus può inoltre causare una dipendenza fisica. In caso di

interruzione improvvisa del trattamento, possono verificarsi sintomi da astinenza, come

irrequietezza, attacchi di sudorazione e dolori muscolari. Se non necessita più della terapia, deve

ridurre gradualmente la dose quotidiana d'intesa con il suo medico.

Il principio attivo morfina ha un potenziale di abuso simile a quello di tutti gli altri analgesici forti

simili alla morfina. Esiste la possibilità di sviluppare una dipendenza psichica. In caso di abuso di

alcolici, droghe o medicamenti, attuale o pregresso, l'assunzione di MST Continus va evitata.

Nel caso dovesse sottoporsi a un intervento chirurgico, informi i medici che sta assumendo MST

Continus.

Un’assunzione prolungata di antidolorifici morfinosimili come MST Continus può determinare

variazioni ormonali reversibili come ad esempio una diminuita funzionalità della corteccia surrenale

con sintomi quali nausea, vomito, perdita di appetito, affaticamento, debolezza, capogiri o

ipotensione arteriosa o una diminuita funzionalità degli organi sessuali con sintomi quali calo della

libido, disfunzioni erettili o amenorrea.

Alcuni medicamenti possono aumentare la probabilità che si manifestino effetti collaterali (in

particolare compromissione della funzionalità respiratoria, ipotensione, sonnolenza e/o riduzione

dell'attenzione), che nei casi più gravi possono determinare un profondo obnubilamento, il coma e la

morte:

·altri analgesici simili alla morfina (oppioidi),

·sonniferi e tranquillanti (come ad es. le benzodiazepine),

·alcuni medicamenti contro allergie, mal d'auto o nausea,

·alcuni medicamenti contro la depressione e le psicosi,

·alcuni medicamenti per il trattamento delle convulsioni e di alcuni tipi di dolore (ad es. fenitoina,

gabapentin o pregabalin),

·medicamenti per il rilassamento muscolare (miorilassanti).

Informi immediatamente il suo medico o il suo farmacista in caso di utilizzo di uno di questi

medicamenti.

Non beva alcol durante il trattamento con MST Continus. L’assunzione di alcol durante il

trattamento con MST Continus può portare a sonnolenza eccessiva e aumentare il rischio che si

manifestino gravi effetti collaterali quali la respirazione superficiale e il conseguente rischio di

arresto respiratorio e perdita di coscienza, il che in casi gravi può portare al coma e alla morte.

I medicamenti contro l'iperacidità gastrica (antiacidi) vanno assunti con un intervallo di almeno 2 ore

dall'assunzione di MST Continus sospensione retard.

L'uso di MST Continus può portare a risultati positivi ai controlli anti-doping.

MST Continus può ridurre la capacità di reazione, la capacità di condurre un veicolo e la capacità di

utilizzare attrezzi o macchine. Chieda quindi al suo medico se può guidare l'auto, utilizzare macchine

o eseguire lavori pericolosi.

MST Continus compresse retard da 10 mg, 30 mg e 60 mg contengono lattosio. Pertanto se soffre di

intolleranza a determinati zuccheri, le raccomandiamo di consultare il suo medico prima di assumere

questi dosaggi di MST Continus.

I pazienti ipersensibili alle sostanze coloranti azoiche, agli acidi acetilsalicilici nonché agli

antireumatici ed analgesici (inibitori della prostaglandina), devono astenersi dall'uso di MST

Continus 30 mg e 60 mg compresse retard e di MST Continus sospensione retard.

Informi il suo medico o il suo farmacista nel caso in cui soffre di altre malattie, soffre di allergie o

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

Si può assumere MST Continus durante la gravidanza o l'allattamento?

Gravidanza

Un'assunzione prolungata di MST Continus durante la gravidanza può provocare l'insorgenza di

sintomi da astinenza nel neonato. Se MST Continus viene utilizzato durante il parto, può causare un

rallentamento e appiattimento del respiro (depressione respiratoria) nel neonato. MST Continus non

dev'essere somministrato durante la gravidanza. Il suo medico può tuttavia fare delle eccezioni.

Allattamento

Se sta allattando, deve assumere MST Continus solo se il suo medico lo ritiene assolutamente

necessario.

Come usare MST Continus?

Assuma MST Continus sempre esattamente secondo le indicazioni del medico. In caso di dubbio, si

rivolga al suo medico o al suo farmacista. Il dosaggio dipende da quanto sono forti i dolori e dalla

sua sensibilità individuale e viene definito dal suo medico.

MST Continus compresse retard vanno assunte due volte al giorno, all'incirca alla stessa ora, durante

o fra un pasto e l'altro, con una sufficiente quantità di liquido. Le compresse retard non devono essere

divise, masticate o frantumate.

Mescolare il contenuto della bustina della sospensione retard di MST Continus 20 mg, 30 mg o

60 mg con almeno 10 ml (2 cucchiaini) di acqua. Mescolare il contenuto delle bustine da 100 mg con

almeno 20 ml e delle bustine da 200 mg con almeno 30 ml di acqua. Mescolare bene per circa 10

secondi e bere subito. Se nel bicchiere rimane ancora del granulato, riempirlo nuovamente con acqua

e bere il contenuto rimasto.

Il contenuto della bustina si può prendere dopo averlo cosparso su alimenti freddi di consistenza

morbida (p.es. yogurt, gelato, pappe). Abbia cura di assumere subito l'intero contenuto della bustina

(p.es. cosparso su un cucchiaio di alimento di consistenza morbida).

In caso di peso corporeo sotto i 70 kg, età avanzata o debolezza fisica, la dose normale all'inizio della

terapia è di due compresse retard da 10 mg o il contenuto di una bustina da 20 mg ogni 12 ore. Se il

peso supera i 70 kg, la dose è di una compressa retard o il contenuto di una bustina da 30 mg ogni 12

ore. In caso di necessità, il medico aumenterà gradualmente la dose.

Per i bambini il medico stabilirà individualmente lo schema posologico a seconda dell'età e delle

circostanze.

Informi il suo medico se dovessero comparire dolori fra le assunzioni di MST Continus. Il medico le

potrà prescrivere un antidolorifico a rilascio rapido (analgesico di riserva) per la terapia di questi

dolori episodici.

Se ha assunto più MST Continus di quanto prescritto, informi immediatamente il suo medico.

Si attenga scrupolosamente ai tempi di assunzione prescritti dal medico. Per avere una protezione

ottimale contro i dolori o la loro ricomparsa è importante assumere le compresse retard o la

sospensione retard ad intervalli regolari stabiliti dal medico. Non aspetti a prendere il preparato fino

a quando comincia a sentire nuovamente dolore.

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.

Quali effetti collaterali può avere MST Continus?

Molto spesso l'assunzione di MST Continus può causare stitichezza. Si può combattere questo

disturbo con un'alimentazione ricca di fibre e con l'assunzione di sufficienti quantità di liquidi, ma

spesso sarà necessario che il medico prescriva, in aggiunta, un lassativo.

Soprattutto all'inizio della terapia possono verificarsi molto frequentemente nausea e frequentemente

vomito. Se ha nausea o le viene il vomito, informi il suo medico, che le può prescrivere un

trattamento.

Con l'assunzione di MST Continus possono inoltre manifestarsi i seguenti effetti collaterali:

Frequenti: diminuzione o perdita dell'appetito, confusione, insonnia, vertigini, mal di testa, spasmi

muscolari involontari, grave sonnolenza o stordimento (sedazione), dolori addominali, secchezza

delle fauci, sudorazione, eruzioni cutanee, prurito, debolezza, stanchezza, malessere.

Occasionali: reazioni da ipersensibilità, eccitazione, euforia, allucinazioni, alterazioni dell'umore,

convulsioni, contratture muscolari, parestesie, disturbi della vista, vertigini, palpitazioni,

arrossamento del volto, calo di pressione, svenimento (sincope), accumulo di fluidi nei polmoni

(dopo un repentino aumento del dosaggio), rallentamento e appiattimento della respirazione

(depressione respiratoria), compromissione della funzione respiratoria, affanno, occlusione

intestinale, alterazioni del gusto, disturbi digestivi, aumento dei valori epatici, eruzioni cutanee

pruriginose (orticaria), ritenzione urinaria, ritenzione idrica (edemi).

Possono inoltre verificarsi reazioni allergiche generali acute, disturbi del pensiero, disforia,

farmacodipendenza, eccessiva sensibilità al dolore (iperalgesia), restringimento delle pupille,

rallentamento della frequenza cardiaca, diminuzione dello stimolo della tosse, alterazioni dell'olfatto,

dolori alla cistifellea (coliche biliari), assenza di mestruazioni (amenorrea), disturbi erettili, riduzione

della libido, assuefazione in caso di utilizzo prolungato o sintomi da astinenza.

MST Continus compresse retard da 30 mg e 60 mg e MST Continus sospensione retard possono

provocare reazioni di ipersensibilità della pelle e del sistema respiratorio, in particolare nei pazienti

affetti da asma, orticaria, ipersensibilità agli acidi acetilsalicilici e ad altri antireumatici o analgesici.

Tenga conto che, nonostante l'assenza di mestruazioni, è possibile che insorga una gravidanza e

quindi, anche in assenza di mestruazioni, è necessario utilizzare un contraccettivo efficace durante la

terapia con MST Continus.

In caso di presunto sovradosaggio informare immediatamente il medico che adotterà le contromisure

adeguate. Segni di sovradosaggio sono: restringimento delle pupille, estremo rallentamento della

respirazione, pressione bassa, stato simile alla narcosi.

La paralisi respiratoria è il pericolo più grave correlato al sovradosaggio.

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

Di che altro occorre tener conto?

Conservare a temperatura ambiente (15–25 °C) e in luogo inaccessibile ai bambini.

A cura ultimata portare il medicamento residuo presso un luogo di raccolta (studio medico, farmacia)

per il corretto smaltimento.

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

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

darle ulteriori informazioni.

Cosa contiene MST Continus?

MST Continus 10 mg contiene 10 mg di morfina solfato pentaidrato (corrispondenti a 7,5 mg di

morfina) nonché sostanze ausiliarie (compressa retard: tra cui lattosio; sospensione retard: tra

cui aromatizzanti, colorante Ponceau 4R (E 124)).

MST Continus 20 mg contiene 20 mg di morfina solfato pentaidrato (corrispondenti a 15 mg di

morfina) nonché sostanze ausiliarie (sospensione retard: tra cui aromatizzanti, colorante Ponceau 4R

(E 124)).

MST Continus 30 mg contiene 30 mg di morfina solfato pentaidrato (corrispondenti a 22,5 mg di

morfina) nonché sostanze ausiliarie (compressa retard: tra cui lattosio, coloranti giallo arancio S

(E 110), eritrosina (E 127), indigotina (E 132); sospensione retard: tra cui aromatizzanti, colorante

Ponceau 4R (E 124)).

MST Continus 60 mg contiene 60 mg di morfina solfato pentaidrato (corrispondenti a 45 mg di

morfina) nonché sostanze ausiliarie (compressa retard: tra cui lattosio, coloranti giallo di chinolina

(E 104), giallo arancio S (E 110), eritrosina (E 127); sospensione retard: tra cui aromatizzanti,

colorante Ponceau 4R (E 124)).

MST Continus 100 mg contiene 100 mg di morfina solfato pentaidrato (corrispondenti a 75 mg di

morfina) nonché sostanze ausiliarie (compressa retard: tra cui colorante indigotina (E 132);

sospensione retard: tra cui aromatizzanti, colorante Ponceau 4R (E 124)).

MST Continus 200 mg contiene 200 mg di morfina solfato pentaidrato (corrispondenti a 150 mg di

morfina) nonché sostanze ausiliarie (compressa retard: tra cui coloranti giallo di chinolina (E 104),

blu brillante FCF (E133); sospensione retard: tra cui aromatizzanti, colorante Ponceau 4R (E 124)).

Numero dell’omologazione

44246 (compresse retard), 51697 (sospensione retard) (Swissmedic).

Dove è ottenibile MST Continus? Quali confezioni sono disponibili?

In farmacia, dietro presentazione della prescrizione medica non rinnovabile.

MST Continus è sottoposto alla legge federale sugli stupefacenti e sulle sostanze psicotrope.

MST Continus compresse retard

MST Continus 10 mg, 30 mg: confezioni da 60 compresse retard.

MST Continus 60 mg, 100 mg, 200 mg: confezioni da 30 compresse retard.

MST Continus sospensione retard

Confezioni da 30 bustine.

Titolare dell'omologazione

Mundipharma Medical Company, Hamilton/Bermuda, filiale di Basilea.

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

competente in materia di medicamenti (Swissmedic).

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Minister Bruno Bruins verwelkomt EMA in Nederland

Minister Bruno Bruins verwelkomt EMA in Nederland

De tijdelijke huisvesting voor het Europees Geneesmiddelen Agentschap (EMA) is klaar voor gebruik. Dit is een belangrijke stap in de verhuizing van het EMA naar Nederland. Het EMA brengt jaarlijks 36.000 bezoekers naar Nederland en zorgt voor de komst van vele bedrijven. Vandaag heeft minister Bruins de sleutel van het Spark-gebouw overgedragen aan EMA.

Netherlands - Ministerie van Volksgezondheid, Welzijn en Sport

9-1-2019

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

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

Published on: Tue, 08 Jan 2019 According to Article 12 of Regulation (EC) No 396/2005, EFSA has reviewed the maximum residue levels (MRLs) currently established at European level for the pesticide active substance sedaxane. To assess the occurrence of sedaxane residues in plants, processed commodities, rotational crops and livestock, EFSA considered the conclusions derived in the framework of Commission Regulation (EU) No 188/2011, the MRLs established by the Codex Alimentarius Commission as well as the...

Europe - EFSA - European Food Safety Authority EFSA Journal

9-1-2019

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

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

Published on: Tue, 08 Jan 2019 According to Article 12 of Regulation (EC) No 396/2005, EFSA has reviewed the maximum residue levels (MRLs) currently established at European level for the pesticide active substance triazoxide. To assess the occurrence of triazoxide 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. Bas...

Europe - EFSA - European Food Safety Authority EFSA Journal

9-1-2019

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

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

Published on: Tue, 08 Jan 2019 According to Article 12 of Regulation (EC) No 396/2005, EFSA has reviewed the maximum residue levels (MRLs) currently established at European level for the pesticide active substance chromafenozide. Considering the information provided by Member States, neither EU uses nor import tolerances are currently authorised for chromafenozide within the EU. Furthermore, no MRLs are established by the Codex Alimentarius Commission (codex maximum residue limits) for this active subst...

Europe - EFSA - European Food Safety Authority EFSA Journal

4-1-2019

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

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

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

Europe - EFSA - European Food Safety Authority EFSA Journal

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

Meer nodig voor toekomst huisartsenzorg

Meer nodig voor toekomst huisartsenzorg

Minister Bruno Bruins voor Medische Zorg en Sport gaat begin 2019 met de Landelijke Huisartsen Vereniging (LHV) bespreken hoe het vak van huisarts aantrekkelijker kan worden gemaakt. Uit een gezamenlijk onderzoek blijkt dat de komende jaren knelpunten zijn te verwachten tussen vraag een aanbod van deze zorg in verschillende regio’s.

Netherlands - Ministerie van Volksgezondheid, Welzijn en Sport

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


Agenda and registration form - eXtended EudraVigilance Medicinal Product Dictionary face-to-face training course (Amsterdam)

Agenda and registration form - eXtended EudraVigilance Medicinal Product Dictionary face-to-face training course (Amsterdam)

Agenda and registration form - eXtended EudraVigilance Medicinal Product Dictionary face-to-face training course (Amsterdam)

Europe - EMA - European Medicines Agency

18-12-2018


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

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

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

Europe - EMA - European Medicines Agency

18-12-2018

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

11-12-2018


The new EudraVigilance system and the electronic reporting of individual case safety reports in the ISO/ICH E2B(R3) format: Hands-on training course, Amsterdam, The Netherlands, from 17/06/2019 to 19/06/2019

The new EudraVigilance system and the electronic reporting of individual case safety reports in the ISO/ICH E2B(R3) format: Hands-on training course, Amsterdam, The Netherlands, from 17/06/2019 to 19/06/2019

The new EudraVigilance system and the electronic reporting of individual case safety reports in the ISO/ICH E2B(R3) format: Hands-on training course, Amsterdam, The Netherlands, from 17/06/2019 to 19/06/2019

Europe - EMA - European Medicines Agency

11-12-2018


The new EudraVigilance system and the electronic reporting of individual case safety reports in the ISO/ICH E2B(R3) format: Hands-on training course, Amsterdam, The Netherlands, from 08/04/2019 to 10/04/2019

The new EudraVigilance system and the electronic reporting of individual case safety reports in the ISO/ICH E2B(R3) format: Hands-on training course, Amsterdam, The Netherlands, from 08/04/2019 to 10/04/2019

The new EudraVigilance system and the electronic reporting of individual case safety reports in the ISO/ICH E2B(R3) format: Hands-on training course, Amsterdam, The Netherlands, from 08/04/2019 to 10/04/2019

Europe - EMA - European Medicines Agency

11-12-2018


The new EudraVigilance system and the electronic reporting of individual case safety reports in the ISO/ICH E2B(R3) format: Hands-on training course, Amsterdam, The Netherlands, from 25/03/2019 to 27/03/2019

The new EudraVigilance system and the electronic reporting of individual case safety reports in the ISO/ICH E2B(R3) format: Hands-on training course, Amsterdam, The Netherlands, from 25/03/2019 to 27/03/2019

The new EudraVigilance system and the electronic reporting of individual case safety reports in the ISO/ICH E2B(R3) format: Hands-on training course, Amsterdam, The Netherlands, from 25/03/2019 to 27/03/2019

Europe - EMA - European Medicines Agency

11-12-2018


The new EudraVigilance system and the electronic reporting of individual case safety reports in the ISO/ICH E2B(R3) format: Hands-on training course, Amsterdam, The Netherlands, from 11/02/2019 to 13/02/2019

The new EudraVigilance system and the electronic reporting of individual case safety reports in the ISO/ICH E2B(R3) format: Hands-on training course, Amsterdam, The Netherlands, from 11/02/2019 to 13/02/2019

The new EudraVigilance system and the electronic reporting of individual case safety reports in the ISO/ICH E2B(R3) format: Hands-on training course, Amsterdam, The Netherlands, from 11/02/2019 to 13/02/2019

Europe - EMA - European Medicines Agency

27-11-2018


15th Joint European Medicines Agency/European network for Health Technology Assessment dialogue meeting, Amsterdam, The Netherlands, from 05/07/2018 to 05/07/2018

15th Joint European Medicines Agency/European network for Health Technology Assessment dialogue meeting, Amsterdam, The Netherlands, from 05/07/2018 to 05/07/2018

15th Joint European Medicines Agency/European network for Health Technology Assessment dialogue meeting, Amsterdam, The Netherlands, from 05/07/2018 to 05/07/2018

Europe - EMA - European Medicines Agency

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

2-11-2018

Afspraken over beheerste afbouw Slotervaart Ziekenhuis Amsterdam

Afspraken over beheerste afbouw Slotervaart Ziekenhuis Amsterdam

Vandaag, vrijdag 2 november, zijn alle betrokken partijen op uitnodiging van minister Bruins van Medische Zorg en Sport bij elkaar geweest om nadere afspraken te maken over een beheerste afbouw van het Slotervaartziekenhuis met het oog op de veilige overdracht van patiënten.

Netherlands - Ministerie van Volksgezondheid, Welzijn en Sport

2-11-2018

Commissie buigt zich over de zorg voor ouderen thuis in 2030

Commissie buigt zich over de zorg voor ouderen thuis in 2030

Wat is er nodig om de zorg voor thuiswonende ouderen ook in de toekomst op peil te houden? Om die vraag te beantwoorden stelt het kabinet een commissie in die wordt voorgezeten door Leon van Halder, bestuursvoorzitter van het Radboudumc te Nijmegen. De commissie zal uiterlijk eind 2019 advies uitbrengen. 

Netherlands - Ministerie van Volksgezondheid, Welzijn en Sport

1-11-2018

Publiekscampagne Ik Zorg van start

Publiekscampagne Ik Zorg van start

Vandaag gaven minister Hugo de Jonge, minister Bruno Bruins en staatssecretaris Paul Blokhuis het startsein voor de publiekscampagne Ik Zorg. Hiermee willen de sector Zorg en Welzijn en de overheid nieuwe werknemers aantrekken. Dat is hard nodig, om ook in de toekomst iedereen goede zorg te kunnen blijven bieden. Als we nu niks doen, hebben we in 2022 een tekort van 125.000 mensen.

Netherlands - Ministerie van Volksgezondheid, Welzijn en Sport

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

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