Odefsey 200/25/25 mg

Informazioni principali

  • Nome commerciale:
  • Odefsey 200/25/25 mg Filmtabletten
  • Forma farmaceutica:
  • Filmtabletten
  • Composizione:
  • rilpivirinum 25 mg ut rilpivirini hydrochloridum, tenofovirum 25 mg ut tenofovirum alafenamidum hemifumaras, emtricitabinum 200 mg, excipiens pro compresso obducto.
  • Utilizzare per:
  • Esseri umani
  • Tipo di medicina:
  • Farmaco biologico

Documenti

  • per i professionisti:
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Localizzazione

  • Disponibile in:
  • Odefsey 200/25/25 mg Filmtabletten
    Svizzera
  • Lingua:
  • italiano

Informazioni terapeutiche

  • Gruppo terapeutico:
  • Synthetika
  • Area terapeutica:
  • HIV-Infektion

Altre informazioni

Status

  • Fonte:
  • Swissmedic - Swiss Agency for Therapeutic Products
  • Numero dell'autorizzazione:
  • 66031
  • Data dell'autorizzazione:
  • 22-05-2018
  • Ultimo aggiornamento:
  • 19-10-2018

Foglio illustrativo

Patienteninformation

Odefsey®, compresse rivestite con film

Gilead Sciences Switzerland Sàrl

Che cos'è Odefsey e quando si usa?

Odefsey è un medicamento antiretrovirale per il trattamento dell'infezione da virus

dell'immunodeficienza umana 1 (HIV-1). È una monocompressa rivestita con film contenente una

combinazione di tre principi attivi: emtricitabina, rilpivirina e tenofovir alafenamide. Ciascuno di

questi principi attivi interferisce con l'attività di un enzima chiamato «trascrittasi inversa», che è

responsabile della replicazione del virus dell'HIV.

Odefsey è un trattamento per l'infezione da HIV indicato:

·negli adulti che non sono mai stati trattati in precedenza con medicamenti anti-HIV.

·in quegli adulti che all'inizio del trattamento con Odefsey presentano una carica virale (quantità di

HIV nel sangue) inferiore a 50 copie/ml, in sostituzione dei medicamenti anti-HIV da loro

attualmente assunti.

Odefsey riduce la quantità di HIV nel suo corpo. In questo modo, migliora il suo sistema

immunitario e riduce il rischio di sviluppare malattie correlate all'infezione da HIV.

Odefsey è ottenibile solo su prescrizione medica.

Di che cosa occorre inoltre tener conto durante il trattamento?

Durante il trattamento con Odefsey è necessario essere seguiti da un medico.

Lei può ancora trasmettere l'HIV mentre sta prendendo questo medicamento, sebbene il rischio sia

ridotto dall'effetto della terapia antiretrovirale. Discuta con il suo medico delle precauzioni necessarie

per evitare di trasmettere l'infezione ad altre persone. Questo medicamento non guarisce

dall'infezione da HIV. Mentre prende Odefsey lei può comunque sviluppare infezioni o altre malattie

associate all'infezione da HIV. Il suo medico la monitorerà a questo riguardo.

Quando non si può assumere Odefsey?

Odefsey non deve essere preso:

·Se è allergico (ipersensibile) a emtricitabina, rilpivirina, tenofovir alafenamide o a una delle

sostanze ausiliarie di questo medicamento.

·Se attualmente prende uno di questi medicamenti:

·carbamazepina, oxcarbazepina, fenobarbital e fenitoina (medicamenti per il trattamento

dell'epilessia e per la prevenzione delle convulsioni)

·rifabutina, rifampicina e rifapentina (medicamenti per il trattamento di alcune infezioni batteriche

come la tubercolosi)

·omeprazolo, dexlansoprazolo, lansoprazolo, rabeprazolo, pantoprazolo ed esomeprazolo

(medicamenti per la prevenzione e il trattamento di ulcere gastriche, bruciore di stomaco e malattia

da reflusso)

·desametasone (un medicamento corticosteroide indicato per il trattamento di infiammazioni e la

soppressione del sistema immunitario) se ingerito o iniettato (tranne che per una singola assunzione)

·prodotti che contengono l'erba di San Giovanni (Hypericum perforatum), un rimedio a base di erbe

contro la depressione e l'ansia.

Quando è richiesta prudenza nella somministrazione di Odefsey?

Informi il suo medico:

·se ha o ha avuto in passato problemi al fegato, inclusa l'epatite (infiammazione del fegato). I

pazienti con malattie del fegato come un'epatite cronica B o C, sottoposti a trattamento con

medicamenti antiretrovirali, presentano un rischio maggiore di complicazioni al fegato gravi e

potenzialmente fatali. Se è affetto da epatite B, il suo medico valuterà il miglior trattamento per lei.

Se è affetto da epatite B, i problemi al fegato possono peggiorare quando interrompe il trattamento

con Odefsey. È importante che non interrompa il trattamento con Odefsey senza parlarne con il suo

medico (vedere «Come usare Odefsey?»).

·Se soffre o ha sofferto di malattie renali o nel caso in cui le analisi del sangue o delle urine abbiano

evidenziato risultati indicanti problemi a livello renale e. L'uso a lungo termine d'Odefsey potrebbe

portare a problemi renali.

·Se sta assumendo medicamenti che possono causare un battito cardiaco irregolare potenzialmente

letale (torsione di punta).

Odefsey non è stato studiato in bambini e adolescenti di età inferiore ai 18 anni e non deve essere

usato per questi pazienti.

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

capacità di utilizzare attrezzi o macchine. Odefsey può causare affaticamento, vertigini e sonnolenza.

Se compaiono vertigini durante l'assunzione d'Odefsey non guidi e non usi attrezzi o macchine.

Odefsey contiene lattosio monoidrato. Prima di prendere questo medicamento, parli con il suo

medico nel caso in cui sia a conoscenza del fatto che lei non tolleri il lattosio o che le sia stato detto

che lei ha un'intolleranza nei confronti di alcuni zuccheri.

Assunzione di Odefsey con altri medicamenti

Odefsey può interagire con altri medicamenti. Di conseguenza, le quantità d'Odefsey o di altri

medicamenti nel sangue possono risultare alterate. Ciò potrebbe impedire ai medicamenti di agire nel

modo corretto o potrebbe peggiorare gli effetti collaterali. In alcuni casi, il suo medico dovrà

modificare la dose o controllare i livelli ematici.

Per questo motivo informi il suo medico se assume uno dei seguenti medicamenti:

·medicamenti per il trattamento dell'HIV

·medicamenti contenenti uno dei seguenti principi attivi:

·tenofovir alafenamide

·tenofovir disoproxil

·lamivudina

·adefovir dipivoxil

·didanosina

·antibiotici per il trattamento di infezioni batteriche contenenti uno dei seguenti principi attivi:

·claritromicina

·eritromicina

·antimicotici per il trattamento di infezioni fungine:

·ketoconazolo

·fluconazolo

·itraconazolo

·posaconazolo

·voriconazolo

·medicamenti per il trattamento di ulcere gastriche, bruciore di stomaco o malattia da reflusso, come

ad esempio:

·antiacidi (idrossido d’alluminio/magnesio o carbonato di calcio)

·antagonisti del recettore H2 (famotidina, cimetidina, nizatidina o ranitidina)

·ciclosporina, un medicamento per ridurre l'azione del sistema immunitario del corpo

·metadone, un medicamento per il trattamento della dipendenza da oppiacei, poiché il medico

probabilmente dovrà variare il dosaggio di metadone.

·dabigatran etexilato, un medicamento per il trattamento di malattie cardiache, poiché il medico

probabilmente dovrà controllare i livelli di questo medicamento nel sangue.

Informi il suo medico se sta assumendo questi o altri medicamenti. Non interrompa il trattamento

senza contattare il suo medico.

Informi il suo medico o il suo farmacista nel caso in cui

·soffre di altre malattie,

·soffre di allergie o

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

Si può somministrare Odefsey durante la gravidanza o l'allattamento?

Dovrebbe chiedere consiglio al suo medico o al suo farmacista prima di prendere qualsiasi

medicamento durante la gravidanza.

·Durante il trattamento con Odefsey prenda le dovute precauzioni per evitare gravidanze. Deve usare

un metodo contraccettivo efficace durante il trattamento con Odefsey.

·Informi immediatamente il suo medico se è in stato di gravidanza. Se è in corso una gravidanza, non

prenda Odefsey a meno che lei e il suo medico decidiate che ciò è assolutamente necessario. Il suo

medico discuterà assieme a lei i potenziali benefici e i rischi per lei e il suo bambino se prende

Odefsey durante la gravidanza.

Se assume Odefsey durante la gravidanza, il suo medico potrà sottoporla ad esami del sangue

periodici e ad altre analisi diagnostiche per monitorare lo sviluppo del bambino.

Non deve in nessun caso allattare durante il trattamento con Odefsey. Sia l'HIV, per lo meno, uno dei

principi attivi d'Odefsey passano nel latte materno.

Come usare Odefsey?

Assuma sempre questo medicamento seguendo esattamente la prescrizione del suo medico per

assicurare che Odefsey abbia piena efficacia e per ridurre il rischio di sviluppo di farmacoresistenza

al trattamento.

La dose consigliata è:

Adulti: 1 compressa rivestita con film una volta al giorno da assumere con del cibo.

Non mastichi, frantumi o spezzi la compressa rivestita con film.

Se assume un antiacido come l'idrossido d'alluminio/magnesio o il carbonato di calcio, lo assuma

almeno 2 ore prima o dopo almeno 4 ore dall'assunzione d'Odefsey.

Se assume antagonisti del recettore H2 come famotidina, cimetidina, nizatidina o ranitidina, deve

assumerli almeno 12 ore prima o dopo almeno 4 ore dall'assunzione d'Odefsey. Se sta assumendo

Odefsey, può assumere un antagonista del recettore H2 solo una volta al giorno. Gli antagonisti del

recettore H2 non possono essere assunti due volte al giorno. Discuta con il suo medico altre opzioni

di trattamento.

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.

Se prende più Odefsey di quanto deve

Se accidentalmente prende una dose d'Odefsey superiore a quella raccomandata potrebbe avere un

rischio aumentato di manifestare i possibili effetti collaterali di questo medicamento (vedere «Quali

effetti collaterali può avere Odefsey»).

Contatti immediatamente il suo medico o il più vicino pronto soccorso. Porti con sé il flacone di

compresse in modo da poter descrivere facilmente cosa ha assunto.

Se dimentica l'assunzione di una dose di Odefsey

È importante che non si dimentichi alcuna dose d'Odefsey.

Se salta l'assunzione di una dose:

·se se ne accorge entro le prime 12 ore dall'ora abituale di assunzione, deve prendere la compressa

rivestita con film d'Odefsey quanto prima possibile. Quindi prenda la successiva compressa all'ora

prevista.

·se se ne accorge solo dopo 12 ore o più tardi dall'ora abituale di assunzione non prenda più la

compressa. Attenda e prenda la dose successiva all'ora prevista.

In caso di vomito entro 4 ore dall'assunzione di Odefsey, deve assumere un'altra compressa rivestita

con film con del cibo. In caso di vomito dopo più di 4 ore dall'assunzione d'Odefsey, non sarà

necessario assumere un'altra compressa fino alla compressa successiva.

Non interrompa il trattamento con Odefsey

Non interrompa il trattamento con Odefsey senza parlarne al suo medico. L'interruzione del

trattamento con Odefsey può influenzare seriamente la sua risposta al trattamento successivo. Se il

trattamento con Odefsey viene interrotto per qualsiasi motivo, ne parli con il suo medico prima di

iniziare nuovamente a prendere le compresse rivestite con film d'Odefsey.

Se ha sia un'infezione da HIV che da epatite B, è particolarmente importante non interrompere il

trattamento con Odefsey senza aver contattato prima il suo medico. Può essere necessario eseguire

analisi del sangue per diversi mesi dopo l'interruzione del trattamento. In alcuni pazienti con malattia

epatica avanzata o cirrosi, non è raccomandato interrompere il trattamento in quanto ciò può portare

a un peggioramento dell'epatite, che potrebbe essere fatale.

Informi subito il suo medico di qualsiasi sintomo nuovo o insolito osservato dopo l'interruzione del

trattamento, in particolare dei sintomi normalmente associati all'infezione da epatite B.

Provveda sempre ad avere una scorta sufficiente di compresse rivestite con film d'Odefsey. Questo è

molto importante perché se smette di prendere il medicamento anche per breve tempo, il virus può

cominciare a moltiplicarsi e, in questo caso, potrebbe diventare più difficile combatterlo.

Quali effetti collaterali può avere Odefsey?

Durante una terapia anti-HIV può verificarsi un aumento di peso e un aumento dei livelli dei lipidi e

del glucosio nel sangue. Ciò è in parte dovuto al miglioramento della salute e dello stile di vita;

mentre i lipidi possono dipendere dagli stessi medicamenti anti-HIV. Il suo medico analizzerà questi

cambiamenti.

Come tutti i medicamenti, anche questo medicamento può causare effetti collaterali, sebbene non

tutte le persone li manifestino.

Durante l'assunzione d'Odefsey possono manifestarsi i seguenti effetti collaterali:

Possibili effetti collaterali gravi: informi immediatamente il suo medico

·Tutti i segni di infiammazione o infezione. In alcuni pazienti con infezione avanzata da HIV (AIDS)

e storia di precedenti infezioni opportunistiche (infezioni che si verificano soltanto in persone con un

sistema immunitario debole), subito dopo l'inizio di un trattamento anti-HIV possono verificarsi

segni e sintomi di infiammazione da infezioni precedenti. Si pensa che questi sintomi siano dovuti a

un miglioramento della risposta immunitaria del corpo, che permette di combattere le infezioni che

possono essere presenti senza sintomi evidenti. Oltre alle infezioni opportunistiche, possono

verificarsi anche disturbi autoimmuni (una condizione che accade quando il sistema immunitario

attacca il tessuto sano del corpo) dopo che ha iniziato l'assunzione dei medicamenti per il trattamento

dell'infezione da HIV. I disturbi autoimmuni possono verificarsi molti mesi dopo l'inizio del

trattamento. Se nota qualsiasi sintomo di infezione o altri sintomi quali debolezza muscolare,

debolezza iniziale a mani e piedi che risale verso il tronco del corpo, palpitazioni, tremore o

iperattività, informi immediatamente il suo medico per richiedere il trattamento necessario.

Se nota segni d'infiammazione o d'infezione, informi subito il suo medico.

Effetti collaterali molto frequenti

·disturbi del sonno (insonnia)

·cefalea

·vertigini

·sensazione di malessere (nausea)

Le analisi di laboratorio possono dare anche i seguenti risultati:

·livelli elevati di colesterolo e/o amilasi pancreatica (un enzima digestivo) nel sangue

·aumento dei livelli degli enzimi epatici nel sangue

Effetti collaterali frequenti

·riduzione dell'appetito

·aumento di peso

·depressione

·sogni anomali

·disturbi del sonno

·umore depressivo

·sonnolenza

·astenia

·disturbi e dolori addominali

·vomito

·sensazione di gonfiore

·bocca secca

·gas intestinali (flatulenza)

·diarrea

·eruzione cutanea

Le analisi di laboratorio possono dare anche i seguenti risultati:

·bassa conta di globuli bianchi (la diminuzione del numero di globuli bianchi potrebbe renderla più

suscettibile a infezioni)

·bassa conta di piastrine (cellule del sangue coinvolte nella coagulazione del sangue)

·diminuzione dei livelli di emoglobina nel sangue

·livelli elevati di trigliceridi (acidi grassi), bilirubina (pigmento biliare) o lipasi nel sangue

Effetti collaterali occasionali

·segni o sintomi di infiammazione o infezione

·bassa conta di globuli rossi (anemia)

·reazioni cutanee gravi, comprese eruzioni cutanee con febbre, gonfiore e problemi al fegato

·problemi digestivi che portano a malessere dopo i pasti

·gonfiore del viso, delle labbra, della lingua o della gola (angioedema)

·prurito

·dolore articolare (artralgia)

→ Se uno qualsiasi degli effetti collaterali la debilita in modo significativo, informi il suo medico.

Altri possibili effetti collaterali osservati durante il trattamento dell'HIV

La frequenza dei seguenti effetti collaterali non è nota (la frequenza non può essere definita sulla

base dei dati disponibili).

·Problemi ossei. Alcuni pazienti che assumono terapia antiretrovirale di combinazione come Odefsey

possono sviluppare una malattia dell'osso chiamata osteonecrosi (morte del tessuto osseo causata da

un mancato afflusso di sangue all'osso). La durata della terapia antiretrovirale di combinazione,

l'impiego di corticosteroidi, il consumo di alcol, una grave immunosoppressione o sovrappeso, tra gli

altri, possono essere alcuni dei numerosi fattori di rischio per lo sviluppo di questa malattia. Segni di

osteonecrosi sono:

·rigidità delle articolazioni

·fastidio e dolore alle articolazioni (specialmente alle anche, alle ginocchia e alle spalle)

·difficoltà nei movimenti

→ Se nota uno di questi segni, informi il suo medico.

Informi il suo medico se nota uno di questi effetti collaterali.

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

Di che altro occorre tener conto?

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

Tenere fuori dalla portata dei bambini.

Non conservare a temperatura superiore ai 30 °C.

Conservare nella confezione originale per tenere il contenuto al riparo dall'umidità. Il flacone ha una

chiusura a prova di bambino e contiene un essiccante. Tenere il flacone ben chiuso.

Restituisca al suo farmacista il medicamento non più utilizzato per lo smaltimento.

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

possono darle ulteriori informazioni.

Cosa contiene Odefsey?

1 compressa rivestita con film d'Odefsey contiene:

Principi attivi: 200 mg di emtricitabina, 25 mg di rilpivirina (equivalente a 27,5 mg di rilpivirina

cloridrato) e 25 mg di tenofovir alafenamide (equivalente a 28 mg di tenofovir alafenamide

fumarato).

Sostanze ausiliarie: lattosio monoidrato e altre sostanze ausiliarie utilizzate nella produzione di una

compressa rivestita con film.

Numero dell'omologazione

66031 (Swissmedic).

Dove è ottenibile Odefsey? Quali confezioni sono disponibili?

In farmacia, dietro presentazione della prescrizione medica non rinnovabile.

Confezioni da 1× 30 compresse rivestite con film.

Titolare dell'omologazione

Gilead Sciences Switzerland Sàrl, Steinhausen.

Questo foglietto illustrativo è stato controllato l'ultima volta nell'aprile 2018 dall'autorità competente

in materia di medicamenti (Swissmedic).

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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

10-11-2018

Pest categorisation of Popillia japonica

Pest categorisation of Popillia japonica

Published on: Thu, 08 Nov 2018 00:00:00 +0100 The Panel on Plant Health performed a pest categorisation of Popillia japonica(Coleoptera: Scarabaeidae) for the EU. P. japonica is a distinguishable species listed in Annex IAII of Council Directive 2000/29/EC. It is native to Japan but established in the USA in the early 20th century. It spreads from New Jersey to most US states east of the Mississippi, some to the west and north into Canada. P. japonica feeds on over 700 plant species. Adults attack folia...

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

9-11-2018

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

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

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

Health Canada

7-11-2018

Nature's Ultimate recalls NuWrench and NuStainless Products

Nature's Ultimate recalls NuWrench and NuStainless Products

The recalled products are not provided with the required child-resistant containers required by the Consumer Chemicals and Containers Regulations, 2001 under the Canada Consumer Product Safety Act.

Health Canada

7-11-2018

Murray Wholesale Cash & Carry recalls King Universal Butane Fuel

Murray Wholesale Cash & Carry recalls King Universal Butane Fuel

The recalled products do not have proper hazard labelling as required by the Consumer Chemicals and Containers Regulations, 2001 under the Canada Consumer Product Safety Act.

Health Canada

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

5-11-2018

Vanpak Limited recalls David Ross Extra purified Butane gas

Vanpak Limited recalls David Ross Extra purified Butane gas

The recalled products do not have proper hazard labelling as required by the Consumer Chemicals and Containers Regulations, 2001 under the Canada Consumer Product Safety Act. Improper labelling could result in unintentional exposure to these products and lead to serious illness, injury or death.

Health Canada

1-11-2018

Pest categorisation of Conotrachelus nenuphar

Pest categorisation of Conotrachelus nenuphar

Published on: Wed, 31 Oct 2018 00:00:00 +0100 The EFSA Panel on Plant Health performed a pest categorisation of Conotrachelus nenuphar (Herbst) (Coleoptera: Curculionidae), for the EU. C. nenuphar is a well‐defined species, recognised as a serious pest of stone and pome fruit in the USA and Canada where it also feeds on a range of other hosts including soft fruit (e.g. Ribes,Fragaria) and wild plants (e.g. Crataegus). Adults, which are not good flyers, feed on tender twigs, flower buds and leaves. Femal...

Europe - EFSA - European Food Safety Authority Publications

1-11-2018

Pest categorisation of Acrobasis pirivorella

Pest categorisation of Acrobasis pirivorella

Published on: Wed, 31 Oct 2018 00:00:00 +0100 The European Commission requested EFSA to conduct a pest categorisation of Acrobasis pirivorella (Lepidoptera: Pyralidae), a monophagous moth whose larvae exclusively feed on developing buds, flowers, and fruits of cultivated and wild Pyrus spp. A. pirivorella is a species with reliable methods available for identification. A. pirivorellaoccurs in north‐east Asia only, causing significant damage in cultivated pears. It is regulated in the EU by Council Direc...

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

30-10-2018

Pest categorisation of Sternochetus mangiferae

Pest categorisation of Sternochetus mangiferae

Published on: Mon, 29 Oct 2018 00:00:00 +0100 The European Commission requested EFSA to conduct a pest categorisation of Sternochetus mangiferae (Coleoptera: Curculionidae), a monophagous pest weevil whose larvae exclusively feed on mango seeds, whereas adults feed on mango foliage. S. mangiferae is a species with reliable methods available for identification. It is regulated in the EU by Council Directive 2000/29/EC where it is listed in Annex IIB as a harmful organism whose introduction into EU Protec...

Europe - EFSA - European Food Safety Authority Publications

30-10-2018

Pest categorisation of Aleurocanthus spp.

Pest categorisation of Aleurocanthus spp.

Published on: Mon, 29 Oct 2018 00:00:00 +0100 The Panel on Plant Health performed a pest categorisation of Aleurocanthus spp., a well‐defined insect genus of the whitefly family Aleyrodidae (Arthropoda: Hemiptera). Difficulties within the taxonomy of the genus give doubt about the ability to accurately identify some members to species level. Nevertheless, the genus is thought to currently include about ninety species mainly reported from tropical and subtropical areas. The genus is listed in Council Dir...

Europe - EFSA - European Food Safety Authority Publications

25-10-2018

BLL Enterprises Inc. recalls Fluid Film Rust & Corrosion Protection Aerosol

BLL Enterprises Inc. recalls Fluid Film Rust & Corrosion Protection Aerosol

The recalled products do not have proper hazard labelling required by the Consumer Chemicals and Containers Regulations, 2001 under the Canada Consumer Product Safety Act.

Health Canada

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

17-10-2018

Pest categorisation of Stagonosporopsis andigena

Pest categorisation of Stagonosporopsis andigena

Published on: Tue, 16 Oct 2018 00:00:00 +0200 The Panel on Plant Health performed a pest categorisation of Stagonosporopsis andigena, the causal agent of black blight of potato, for the EU. The pest is a well‐defined fungal species and reliable methods exist for its detection and identification. S. andigena is present in Bolivia and Peru. The pest is not known to occur in the EU and is listed in Annex IAI of Directive 2000/29/EC as Phoma andina, meaning its introduction into the EU is prohibited. The ma...

Europe - EFSA - European Food Safety Authority Publications

17-10-2018

Pest categorisation of Thecaphora solani

Pest categorisation of Thecaphora solani

Published on: Tue, 16 Oct 2018 00:00:00 +0200 The Panel on Plant Health performed a pest categorisation of the fungus Thecaphora solani, the causal agent of smut of potato, for the EU. The identity of the pest is well established and reliable methods exist for its detection and identification. T. solaniis present in Bolivia, Chile, Colombia, Ecuador, Mexico, Panama, Peru and Venezuela. The pathogen is not known to occur in the EU and is listed in Annex IAI of Directive 2000/29/EC, meaning its introducti...

Europe - EFSA - European Food Safety Authority Publications

16-10-2018

Pest categorisation of Cronartium harknessii, Cronartium kurilense and Cronartium sahoanum

Pest categorisation of Cronartium harknessii, Cronartium kurilense and Cronartium sahoanum

Published on: Mon, 15 Oct 2018 00:00:00 +0200 Following a request from the European Commission, the EFSA Panel on Plant Health performed a pest categorisation of Cronartium harknessii, Cronartium kurilense and Cronartium sahoanum, which are well‐defined and distinguishable tree fungal pathogens of the family Cronartiaceae. In 2018, these species were moved from the genus Endocronartium to the genus Cronartium. These pathogens are not known to be present in the EU and are regulated in Council Directive 2...

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

Pest categorisation of Melampsora farlowii

Pest categorisation of Melampsora farlowii

Published on: Mon, 15 Oct 2018 00:00:00 +0200 Following a request from the European Commission, the EFSA Panel on Plant Health performed a pest categorisation of Melampsora farlowii, a well‐defined and distinguishable fungus of the family Melampsoraceae. M. farlowii is the causal agent of a leaf and twig rust of hemlocks (Tsuga spp.) in eastern North America. The pathogen is regulated in Council Directive 2000/29/EC (Annex IAI) as a harmful organism whose introduction into the EU is banned. M. farlowii ...

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

General Finishes Recalls Outdoor Oil

General Finishes Recalls Outdoor Oil

The recalled products do not have the proper consumer chemical hazard packaging and labelling required by the consumer Chemicals and Containers Regulations, 2001 under the Canada Consumer Product Safety Act.

Health Canada

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

25-9-2018

Daiso Holdings Ltd. recalls Daiso Brand Consumer Chemical Products

Daiso Holdings Ltd. recalls Daiso Brand Consumer Chemical Products

The recalled products have not been properly classified according to the Consumer Chemicals and Containers Regulations, 2001, in order to ensure appropriate hazard labelling. These regulations are empowered by the Canada Consumer Product Safety Act. Improper labelling could result in unintentional exposure to these products and lead to serious illness, injury or death.

Health Canada

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

19-9-2018

Modification of the existing maximum residue levels for potassium phosphonates in certain berries and small fruits

Modification of the existing maximum residue levels for potassium phosphonates in certain berries and small fruits

Published on: Tue, 18 Sep 2018 00:00:00 +0200 In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant LTZ Augustenberg submitted a request to the competent national authority in Germany to modify the existing maximum residue levels (MRLs) for the active substance potassium phosphonates in raspberries, blackberries, currants, blueberries, gooseberries and elderberries. The data submitted in support of the request were found to be sufficient to derive MRL proposals for all crops under c...

Europe - EFSA - European Food Safety Authority Publications

19-9-2018

Modification of the existing maximum residue levels for flonicamid in various root crops

Modification of the existing maximum residue levels for flonicamid in various root crops

Published on: Tue, 18 Sep 2018 00:00:00 +0200 In accordance with Article 6 of Regulation (EC) No 396/2005, the Agriculture and Horticulture Development Council submitted a request to the competent national authority in the United Kingdom to modify the existing maximum residue levels (MRL) for the active substance flonicamid in beetroots, carrots, celeriacs/turnip rooted celeries, horseradishes, Jerusalem artichokes, parsnips, parsley roots/Hamburg roots parsley, radishes, salsifies, swedes/rutabagas, tu...

Europe - EFSA - European Food Safety Authority Publications

19-9-2018

National dietary survey in 2012‐2016 on the general population aged 1‐79 years in the Netherlands

National dietary survey in 2012‐2016 on the general population aged 1‐79 years in the Netherlands

Published on: Tue, 18 Sep 2018 00:00:00 +0200 During the years 2012‐2016, the Dutch National Food Consumption survey was conducted in the Netherlands. For the survey, a random sample was drawn from consumer panels stratified by age and gender and maintained representative to the population with regard to region, address density and educational level. Complete results were obtained for 4,313 persons (response rate 65%); including toddlers, children, adolescents, adults and elderly. Pregnant or lactating ...

Europe - EFSA - European Food Safety Authority Publications

18-9-2018

Xtava recalls Allure and Allure Pro 2200W ionic ceramic hair dryers

Xtava recalls Allure and Allure Pro 2200W ionic ceramic hair dryers

The hair dryer and power cord can overheat and catch on fire, posing fire, burn and electrical shock hazards.

Health Canada

18-9-2018

Peer review of the pesticide risk assessment of the active substance sodium hydrogen carbonate

Peer review of the pesticide risk assessment of the active substance sodium hydrogen carbonate

Published on: Fri, 14 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 Austria for the pesticide active substance sodium hydrogen carbonate 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 use of sodium hyd...

Europe - EFSA - European Food Safety Authority Publications

14-9-2018

Peer review of the pesticide risk assessment of the active substance azadirachtin (Margosa extract)

Peer review of the pesticide risk assessment of the active substance azadirachtin (Margosa extract)

Published on: Thu, 13 Sep 2018 00:00:00 +0200 The conclusions of the EFSA following the peer review of the initial risk assessments carried out by the competent authority of the rapporteur Member State, Germany, for the pesticide active substance azadirachtin 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 additional representative use of azadir...

Europe - EFSA - European Food Safety Authority Publications

13-9-2018

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

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

Published on: Wed, 12 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 fluquinconazole. Considering the information provided by Member States, neither EU uses nor import tolerances are currently authorised for fluquinconazole within the European Union. Furthermore, no MRLs are established by the Codex Alimentarius Commission (codex maximum residue ...

Europe - EFSA - European Food Safety Authority Publications

11-9-2018

Preparation of Dutch food consumption data for risk assessment

Preparation of Dutch food consumption data for risk assessment

Published on: Mon, 27 Aug 2018 00:00:00 +0200 The availability of detailed and high‐quality food consumption data collected at an individual level is essential for assessing the exposure to potential risks in the food chain. During the years 2012–2016, the Dutch National Food Consumption Survey was conducted in the Netherlands as part of the EU Menu survey, following the EFSA 2009 guidance on ‘General principles for the collection of national food consumption data in the view of a pan‐European dietary s...

Europe - EFSA - European Food Safety Authority Publications

5-9-2018

Outcome of the pesticides peer review meeting on general recurring issues in mammalian toxicology

Outcome of the pesticides peer review meeting on general recurring issues in mammalian toxicology

Published on: Tue, 04 Sep 2018 00:00:00 +0200 This technical report reflects the outcome of the mammalian toxicology experts meeting on general recurring issues noted during the EFSA peer reviews of pesticide active substances under Regulation (EC) No 1107/2009. The main issues identified were related to genotoxicity of products and principles of (Q)SAR and read‐across. General presentations on the different EFSA guidance and EFSA developmental activities related to human health risk assessment of pesti...

Europe - EFSA - European Food Safety Authority Publications

4-9-2018

Osmo Wood and Colour Canada Ltd. recalls Various Wood Finishing Products

Osmo Wood and Colour Canada Ltd. recalls Various Wood Finishing Products

The recalled products do not have the proper consumer chemical hazard packaging and labelling required by the consumer Chemicals and Containers Regulations, 2001 under the Canada Consumer Product Safety Act.

Health Canada

4-9-2018

Outcome of the consultation with Member States and EFSA on the basic substance application for milk for use in plant protection as fungicide

Outcome of the consultation with Member States and EFSA on the basic substance application for milk for use in plant protection as fungicide

Published on: Mon, 03 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 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 milk are presented. The context of the evaluation was that req...

Europe - EFSA - European Food Safety Authority Publications

1-9-2018

Acknowledgement:EFSA  wishes  to  thank  the  rapporteur  Member  State  Denmark  for  thepreparatory work on this scientific output.Suggested citation:EFSA (European Food Safety Authority), Brancato A, Brocca D, Carrasco Cabrera L,De Lentdecker C, Erdos

Acknowledgement:EFSA wishes to thank the rapporteur Member State Denmark for thepreparatory work on this scientific output.Suggested citation:EFSA (European Food Safety Authority), Brancato A, Brocca D, Carrasco Cabrera L,De Lentdecker C, Erdos

Published on: Fri, 31 Aug 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 napropamide. To assess the occurrence of napropamide 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 (incl...

Europe - EFSA - European Food Safety Authority Publications

1-9-2018

Review of the existing MRLs for fenbuconazole

Review of the existing MRLs for fenbuconazole

Published on: Fri, 31 Aug 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 fenbuconazole. To assess the occurrence of fenbuconazole residues in plants, processed commodities, rotational crops and livestock, EFSA considered the conclusions derived in the framework of Directive 91/414/EEC, the MRLs established by the Codex Alimentarius Commission as well...

Europe - EFSA - European Food Safety Authority Publications

30-8-2018

National summary reports on pesticide residue analysis performed in 2016

National summary reports on pesticide residue analysis performed in 2016

Published on: Tue, 07 Aug 2018 00:00:00 +0200 In accordance with Article 31 of Regulation (EC) No 396/2005, European Union (EU) Member States have to communicate to the European Food Safety Authority (EFSA) the results of their official controls on pesticide residues in food. In the framework of this communication, the EU Member States, Iceland and Norway provided a short summary report outlining the main findings of the control activities during the reference year. This technical report is the compilat...

Europe - EFSA - European Food Safety Authority Publications

17-9-2018

Scientific guideline:  Concept paper on the need for revision of the guideline on the investigation of medicinal products in the term and preterm neonate - Revision 1, draft: consultation open

Scientific guideline: Concept paper on the need for revision of the guideline on the investigation of medicinal products in the term and preterm neonate - Revision 1, draft: consultation open

The Guideline on the investigation of medicinal products in the term and preterm neonates was prepared during the period from 2007 to 2009 and came into effect in 2010 (EMEA/536810/2008). Considerable experience of assessing PIP applications covering neonatal age subset has been gained since then and it has become apparent that some essential questions arise repeatedly during the assessment of Paediatric Investigation Plans (PIP) applications for products intended to be investigated and used in neonates....

Europe - EMA - European Medicines Agency