Fluconazol "Accord"

Primær information

  • Handelsnavn:
  • Fluconazol "Accord" 50 mg kapsler, hårde
  • Dosering:
  • 50 mg
  • Lægemiddelform:
  • kapsler, hårde
  • Brugt til:
  • Mennesker
  • Medicin typen:
  • Allopatiske stof

Dokumenter

Lokation

  • Fås i:
  • Fluconazol "Accord" 50 mg kapsler, hårde
    Danmark
  • Sprog:
  • dansk

Andre oplysninger

Status

  • Kilde:
  • Lægemiddelstyrelsen - Danish Medicines Agency
  • Autorisation status:
  • Markedsført
  • Autorisationsnummer:
  • 48497
  • Sidste ændring:
  • 22-02-2018

Indlægsseddel

Indlægsseddel: Information til brugeren

Fluconazol Accord 50 mg hårde kapsler

Fluconazol Accord 150 mg hårde kapsler

Fluconazol Accord 200 mg hårde kapsler

(fluconazol)

Læs denne indlægsseddel grundigt, inden du begynder at tage dette lægemiddel, da den

indeholder vigtige oplysninger.

Gem indlægssedlen. Du kan få brug for at læse den igen.

Spørg lægen eller apoteketspersonalet, hvis der er mere, du vil vide.

Lægen har ordineret dette lægemiddel til dig personligt. Lad derfor være med at give det til

andre. Det kan være skadeligt for andre, selvom de har de samme symptomer, som du har.

Tal med lægen eller apotekspersonalet, hvis en bivirkning bliver værre, eller du får

bivirkninger, som ikke er nævnt her. Se punkt 4.

Den nyeste indlægsseddel kan findes på www.indlaegsseddel.dk

Oversigt over indlægssedlen:

Virkning og anvendelse

Det skal du vide, før du begynder at tage Fluconazol Accord

Sådan skal du tage Fluconazol Accord

Bivirkninger

Opbevaring

Pakningsstørrelser og yderligere oplysninger

1.

Virkning og anvendelse

Fluconazol Accord tilhører en gruppe lægemidler, der betegnes som svampemidler. Det aktive stof

er fluconazol. Fluconazol Accord anvendes til behandling af infektioner forårsaget af svampe og

kan også anvendes til at forhindre, at du får en infektion med gærsvampen

Candida

Candida

den mest almindelig årsag til svampeinfektioner.

Voksne

Din læge kan have ordineret Fluconazol Accord til behandling af følgende svampeinfektioner:

Kryptokokmeningitis – en svampeinfektion i hjernen.

Kokcidioidomykose – en sygdom i luftrørene/lungerne.

Infektioner forårsaget af

Candida

i blodet, organer (f.eks. hjerte og lunger) eller urinvejene.

Mukøs

candidiasis

infektion,

påvirker

slimhinderne

mund

hals,

tandprotesesvamp

Genital candidiasis - infektion i skeden eller penis

Hudinfektioner - f.eks. fodsvamp, ringorm, svamp i lysken, negleinfektioner

Du kan også have fået Fluconazol Accord for:

at forhindrer at kryptokokmeningitis vender tilbage

at forhindrer at mukøs candidiasis vender tilbage

at reducere tilbagevenden af skedesvamp

at forhindre, at du får infektioner forårsaget af

Candida

(hvis dit immunsystem er

svækket og ikke fungerer tilstrækkeligt)

Børn og unge (0 til 17 år)

Lægen kan have ordineret Fluconazol Accord til behandling af følgende svampeinfektioner:

Mukøs candidiasis – infektion, der påvirker slimhinderne i mund og hals

Infektioner forårsaget af

Candida

i blodet, organer (f.eks. hjerte og lunger) eller

urinvejene

Kryptokokmeningitis – en svampeinfektion i hjernen

Lægen kan også have ordineret Fluconazol Accord for:

at forhindre infektioner forårsaget af

Candida

(hvis immunsystemet er svækket og ikke

fungerer tilstrækkeligt)

at forhindrer, at kryptokokmeningitis vender tilbage

2.

Det skal du vide, før du begynder at tage Fluconazol Accord

Lægen kan have foreskrevet anden anvendelse eller dosering end angivet i denne information. Følg

altid lægens anvisning og oplysningerne på doseringsetiketten.

Tag ikke Fluconazol Accord:

hvis du er allergisk over for fluconazol, over for anden medicin, som du har taget mod

svampeinfektioner, eller over for et af de øvrige indholdsstoffer i Fluconazol Accord

(angivet i pkt. 6). Symptomerne kan være kløe, hudrødmen eller vejrtrækningsbesvær.

hvis du tager astemizol eller terfenadin (antihistamin-lægemidler mod allergi)

hvis du tager cisaprid (anvendes mod maveproblemer)

hvis du tager pimozid (anvendes til behandling af psykisk sygdom)

hvis du tager quinidin (anvendes til behandling af uregelmæssig hjerterytme)

hvis du tager erythromycin (et antibiotikum til behandling af infektioner)

Advarsler og forsigtighedsregler

Kontakt lægen eller apoteket, før du tager Fluconazol Accord:

hvis du har lever- eller nyreproblemer

hvis du lider af hjertesygdom, herunder hjerterytmeproblemer

hvis du har unormale mængder kalium, kalcium eller magnesium i blodet.

hvis du får alvorlige hudreaktioner (kløe, hudrødmen eller vejrtrækningsbesvær).

hvis du får tegn på binyresvigt, hvor binyrerne ikke producerer tilstrækkelige mængder af

visse steroidhormoner, såsom kortisol (kronisk eller langvarig udmattelse, muskelsvaghed,

tab af appetit, vægttab, mavesmerter).

Brug af anden medicin sammen med Fluconazol Accord

Fortæl det

straks

til din læge, hvis du tager astemizol eller terfenadin (antihistamin-lægemidler

mod allergi), cisaprid (anvendes mod maveproblemer), pimozid (anvendes til behandling af psykisk

sygdom), quinidin (anvendes til behandling af uregelmæssig hjerterytme) eller erythromycin (et

antibiotikum til behandling af infektioner), da disse lægemidler ikke bør tages sammen med

Fluconazol Accord (se afsnittet "Tag ikke Fluconazol Accord").

Der er nogle lægemidler, der kan påvirke Fluconazol Accord, eller hvis virkning kan blive påvirket

af Fluconazol Accord. Fortæl det til din læge, hvis du tager et af følgende lægemidler:

rifampicin eller rifabutin (antibiotika til behandling af infektioner)

alfentanil, fentanyl (anvendes til bedøvelse)

amitriptylin, nortriptylin (anvendes mod depression)

amphotericin B, voriconazol (midler mod svamp)

medicin, der fortynder blodet og skal forhindre blodpropper (warfarin, indanedione eller

lignende lægemidler)

såkaldte benzodiazepiner (midazolam, triazolam eller lignende lægemidler), der anvendes

mod søvnproblemer eller angst

carbamazepin og phenytoin (mod epilepsi)

amiodaron (anvendes til behandling af uregelmæssig hjerterytme (hjertearytmi))

hydrochlorothiazid (anvendes som vanddrivende middel)

nifedipin, isradipin, amlodipin, felodipin og losartan (mod for højt blodtryk)

ciclosporin,

everolimus,

sirolimus

eller

tacrolimus

(anvendes

afstødning

efter

transplantation)

cyclosphosphamid og vinkaalkaloider (vincristin, vinblastin eller lignende lægemidler) -

anvendes mod kræft

halofantrin (anvendes til behandling af malaria)

statins (atorvastatin, simvastatin og fluvastatin eller lignende lægemidler) – anvendes mod

for højt kolesterolindhold i blodet

methadon (anvendes mod smerte)

celecoxib, flurbiprofen, naproxen, ibuprofen, lornoxicam, meloxicam, diclofenac (svage

smertestillende lægemidler, såkaldte non-steroide antiinflammatoriske midler (NSAID))

orale kontraceptiver (prævention)

prednison (steroid)

zidovudin, også kendt som AZT, eller saquinavir (anvendes til HIV-inficerede patienter)

medicin mod sukkersyge, såsom chlorpropamid, glibenclamid, glipizid eller tolbutamid

theophyllin (anvendes til at kontrollere astma)

vitamin A (kosttilskud)

Fortæl altid lægen eller på apoteket, hvis du tager anden medicin eller har gjort det for nylig. Dette

gælder også medicin, som ikke er købt på recept, f.eks. naturlægemidler og vitaminer og mineraler

Brug af Fluconazol Accord sammen med mad og drikke

Dette lægemiddel kan tages med eller uden mad.

Graviditet, amning og fertilitet

Hvis du er gravid eller ammer, har mistanke om, at du er gravid, eller planlægger at blive gravid,

skal du spørge din læge eller apoteket til råds, før du tager dette lægemiddel.

Du må ikke tage Fluconazol Accord, mens du er gravid eller ammer, medmindre din læge har sagt,

at du skal gøre det.

Trafik- og arbejdssikkerhed

Hvis du fører motorkøretøj eller betjener maskiner, skal du tage i betragtning, at der kan forekomme

svimmelhed eller krampeanfald.

Fluconazol Accord indeholder lactosemonohydrat

Dette lægemiddel indeholder lactosemonohydrat (en sukkertype). Hvis din læge har fortalt dig, at

du ikke kan tåle visse sukkerarter, skal du kontakte din læge, inden du tager dette lægemiddel.

3.

Sådan skal du tage Fluconazol Accord

Tag altid dette lægemiddel nøjagtigt efter lægens eller apotekspersonalets anvisning. Er du i tvivl,

så spørg lægen eller på apoteket.

Synk kapslen hel og drik et glas vand til. Det er bedst, at du tager kapslen på samme tidspunkt hver

dag.

Den anbefalede dosis til forskellige infektioner er angivet nedenfor:

Voksne

Tilstand

Dosis

Til behandling af kryptokokmeningitis

400 mg den første dag og derefter 200 mg til

400 mg én gang dagligt i 6 til 8 uger eller om

nødvendigt længere. Nogle gange forøges

dosis op til 800 mg.

For at forhindre, at kryptokokmeningitis

vender tilbage

200 mg én gang dagligt, indtil du får at vide,

at du skal stoppe

Til behandling af kokcidioidomykose

200 mg to 400 mg én gang dagligt fra 11

måneder i op til 24 måneder eller om

nødvendigt længere. Nogle gange forøges

dosis op til 800 mg.

Til behandling af svampeinfektioner i kroppen

forårsaget af gærsvampen

Candida

800 mg den første dag og derefter 400 mg én

gang dagligt, indtil du får at vide, at du skal

stoppe

Til behandling af infektioner i slimhinderne i

mund og hals og til behandling af

tandprotesesvamp

200 mg til 400 mg den første dag og derefter

100 mg til 200 mg, indtil du får at vide, at du

skal stoppe

Til behandling af mukøs candidiasis - dosis

afhænger af, hvor infektionen er lokaliseret

50 mg til 400 mg én gang dagligt i 7 til 30

dage, indtil du får at vide, at du skal stoppe

For at stoppe infektioner i slimhinderne i

mund og hals

100 mg til 200 mg én gang dagligt eller 200

mg 3 gange om ugen, mens du stadig har

risiko for at få en infektion

Til behandling af genital candidiasis

150 mg som én enkelt dosis

For at forhindre tilbagevenden af skedesvamp

150 mg hver tredje dag tre gange (i alt 3 doser

(dag 1, 4 og 7)), og derefter én gang om ugen

i 6 måneder, mens du stadig har risiko for at

få en infektion

Til behandling af svampeinfektioner i hud og

negle

Afhængig af infektionsstedet 50 mg én gang

dagligt, 150 mg én gang ugentligt, 300 til 400

mg én gang ugentligt i 1 til 4 uger (måske op

til 6 uger ved fodsvamp, ved negleinfektioner

indtil den inficerede negl er erstattet).

For at forhindre, at du får en infektion

forårsaget af gærsvampen

Candida

(hvis dit

immunsystem er svækket og ikke fungerer

tilstrækkeligt)

200 mg til 400 mg én gang dagligt, mens du

stadig har risiko for at få en infektion

Anvendelse til børn og unge

Kapslerne er ikke tilpasset til anvendelse til spædbørn og små børn. Andre former af lægemidlet

kan være bedre eget. Spørg lægen eller apotekspersonalet.

Unge fra 12 til 17 år

Tag den dosis, som lægen har ordineret (enten voksendosis eller børnedosis).

Børn op til 11 år

Den maksimale dosis for børn er 400 mg dagligt.

Dosis vil være baseret på barnets vægt i kilo.

Tilstand

Daglig dosis

Mukøs candidiasis og halsinfektioner

forårsaget af gærsvampen

Candida

- dosis og

varighed afhænger af, hvor alvorlig

infektionen er, og hvor den er lokaliseret

3 mg pr. kg kropsvægt (måske 6 mg pr. kg

kropsvægt den første dag)

Kryptokokmeningitis eller svampeinfektioner

i kroppen forårsaget af gærsvampen

Candida

6 mg til 12 mg pr. kg kropsvægt

For at forhindre, at børn får en infektion

forårsaget af

Candida

(hvis deres

immunsystem ikke fungerer tilstrækkeligt)

3 mg til 12 mg pr. kg kropsvægt

Anvendelse til børn i alderen 0 til 4 uger

Anvendelse til børn i alderen 3 til 4 uger:

Samme dosis som ovenfor, men dosis gives én gang hver anden dag. Den maksimale dosis er 12

mg pr. kg kropsvægt hver 48. time.

Anvendelse til børn, der er under 2 uger gamle:

Samme dosis som ovenfor, men dosis gives én gang hver tredje dag. Den maksimale dosis er 12

mg pr. kg kropsvægt hver 72. time.

Ældre

Den sædvanlige dosis bør anvendes, medmindre du har nyreproblemer.

Patienter med nyreproblemer

Lægen kan ændre din dosis afhængig af din nyrefunktion.

Hvis du har taget for meget Fluconazol Accord

Hvis du tager for mange kapsler på én gang, kan du blive utilpas. Kontakt straks din læge eller den

nærmeste skadestue. Symptomerne på mulig overdosering kan være, at man hører, ser, føler eller

tænker ting, der ikke er virkelige (hallucinationer og paranoid adfærd). Behandling af symptomerne

(med understøttende tiltag og om nødvendigt maveskylning) kan være tilstrækkeligt.

Hvis du har glemt at tage Fluconazol Accord

Du må ikke tage en dobbeltdosis som erstatning for den glemte dosis. Hvis du glemmer at tage en

dosis, skal du tage den, så snart du kommer i tanke om det. Hvis det næsten er tid til at tage næste

dosis, skal du ikke tage den dosis, du har glemt at tage.

Spørg lægen eller på apoteket, hvis der er noget, du er i tvivl om.

4.

Bivirkninger

Dette lægemiddel kan som al anden medicin give bivirkninger, men ikke alle får bivirkninger.

Nogle

mennesker

udvikler

overfølsomhedsreaktioner

alvorlige

overfølsomhedsreaktioner sjældne. Hvis du får bivirkninger, skal du tale med din læge eller

apotekspersonalet. Dette gælder også bivirkninger, som ikke er nævnt i denne indlægsseddel. Hvis

du får et eller flere af følgende symptomer,

skal du straks kontakte din læge.

pludselig hvæsen, vejrtrækningsbesvær eller trykken for brystet

hævede øjenlåg, ansigt eller læber

kløe over hele kroppen, hudrødmen eller kløende røde pletter

hududslæt

alvorlige hudreaktioner såsom udslæt, der giver vabler (dette kan ramme mund og tunge).

Fluconazol Accord kan påvirke din lever. Tegn på leverproblemer er bl.a. følgende:

træthed

tab af appetit

opkastning

gulfarvning af huden eller den hvide del af øjnene (gulsot)

Hvis du får en eller flere af disse bivirkninger, skal du straks holde op med at tage Fluconazol

Accord og

straks kontakte din læge

Andre bivirkninger:

Hvis en eller flere af de følgende bivirkninger bliver alvorlig(e), eller du får bivirkninger, som ikke

er nævnt her, skal du straks kontakte lægen eller apotekspersonalet.

Almindelige bivirkninger (kan forekomme hos op til 1 ud af 10 patienter):

hovedpine

ubehag i maven, diarré, følelse af at være syg, opkastning

stigninger i visse blodprøve-værdier, der vedrører leverfunktionen

udslæt

Ikke almindelige bivirkninger (kan forekomme hos op til 1 ud af 100 patienter):

fald i antallet af røde blodceller, hvilket gør huden bleg og medfører svaghed og

stakåndethed

nedsat appetit

manglende evne til at sove, døsighed

anfald, svimmelhed, snurrende, svidende eller prikkende fornemmelse eller

følelsesløshed, ændringer i smagssansen

forstoppelse, fordøjelsesbesvær, øget luft i maven, tør mund

muskelsmerter

leverskader og gulfarvning af hud og øjne (gulsot)

udslæt (nældefeber), kløe, øget svedtendens

træthed, generel følelse af utilpashed, feber

Sjældne bivirkninger (kan forekomme hos op til 1 ud af 1.000 patienter):

lavere antal af hvide blodceller, som hjælper med at bekæmpe infektioner, og af blodceller,

der hjælper med at stoppe blødning

røde eller lilla misfarvninger af huden, der kan være forårsaget af lavt antal blodplader,

andre blodcelleforandringer

ændringer i blodkemien (højt indhold af kolesterol og fedt)

lavt indhold af kalium i blodet

rysten

unormale resultater ved EKG-scanning, ændringer i den hastighed, hvormed hjertet slår,

eller hjerterytmen

leversvigt

overfølsomhedsreaktioner (nogle gange alvorlige), herunder udbredt udslæt med vabler og

hudafskalning, alvorlige hudreaktioner, hævelser i læber eller ansigt

hårtab

Indberetning af bivirkninger

Hvis du oplever bivirkninger, bør du tale med din læge, sygeplejerske eller apoteket. Dette gælder

også mulige bivirkninger, som ikke er medtaget i denne indlægsseddel. Du eller dine pårørende

kan også indberette bivirkninger direkte til Lægemiddelstyrelsen via

Lægemiddelstyrelsen

Axel Heides Gade 1

DK-2300 København S

Websted: www.meldenbivirkning.dk

E-mail: dkma@dkma.dk

Ved at indrapportere bivirkninger kan du hjælpe med at fremskaffe mere information om

sikkerheden af dette lægemiddel.

5.

Opbevaring

Opbevar dette lægemiddel utilgængeligt for børn.

Brug ikke dette lægemiddel efter den udløbsdato, der står på pakningen efter Exp.

Udløbsdatoen er den sidste dag i den nævnte måned.

Opbevares ved temperaturer under 30 °C. Opbevares i den originale yderpakning for at

beskytte mod fugt.

Spørg på apoteket, hvordan du skal bortskaffe medicinrester. Af hensyn til miljøet må du

ikke smide medicinrester i afløbet eller toilettet eller skraldespanden.

6.

Pakningsstørrelser og yderligere oplysninger

Fluconazol Accord indeholder

Aktivt stof: fluconazol. Hver hårde kapsel indeholder 50 mg, 150 mg eller 200 mg fluconazol.

Øvrige indholdsstoffer: lactosemonohydrat, majsstivelse, natriumlaurilsulfat, kolloid vandfri silica

og magnesiumstearat.

Kapselskal:

50 mg:

Gelatine

Titandioxid (E171)

Indigo Carmine (E132)

Gul jernoxid (E172)

150 mg:

Gelatine

Titandioxid (E171)

Patent blue V (E131)

200 mg:

Gelatine

Titandioxid (E171)

Udseende og pakningsstørrelser

50 mg: kapselskal: størrelse 4, hvid krop og grøn hætte.

150 mg: kapselskal: størrelse 1, blå krop og blå hætte.

200 mg: kapselskal: størrelse 0, hvid krop og hvid hætte.

Fluconazol Accord hårde kapsler fås i PVC-aluminium-blisterpakninger.

50 mg og 200 mg kapsler

Pakningsstørrelser med 7, 14, 20, 28, 50 og 100 hårde kapsler

150 mg kapsler

Pakningsstørrelser med 1, 2, 4, 6 og 10 hårde kapsler

Ikke alle pakningsstørrelser er nødvendigvis markedsført.

Indehaver af markedsføringstilladelsen og fremstiller

Indehaver af markedsføringstilladelsen

Accord Healthcare Limited

Sage House, 319 Pinner Road,

North Harrow, Middlesex,

HA1 4HF, Storbritannien

Fremstiller

Accord Healthcare Limited

Sage House, 319 Pinner Road,

North Harrow, Middlesex,

HA1 4HF, Storbritannien

Dette lægemiddel er godkendt i EEA’s medlemslande under følgende navne:

Medlemslandets navn

Lægemidlets navn

Danmark

Fluconazol Accord

Tyskland

Fluconazol Accord 50/100/150/200 mg Hartkapseln

Irland

Fluconazole 50/150/200 mg Hard capsules

Italien

Fluconazolo Accord 50/100/150/200 mg capsule rigide

Holland

Fluconazol Accord 50/150/200 mg capsules, hard

Sverige

Fluconazole Accord

Denne indlægsseddel blev senest ændret 02/2018.

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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

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

13-11-2018

The importance of vector abundance and seasonality

The importance of vector abundance and seasonality

Published on: Mon, 12 Nov 2018 00:00:00 +0100 This joint ECDC‐EFSA report assesses whether vector count data (abundance) and the way these change throughout the year (seasonality) can provide useful information about vector‐borne diseases epidemiological processes of interest, and therefore, whether resources should be devoted to collecting such data. The document also summarises what measures of abundance and seasonality can be collected for each vector group (mosquitoes, sandflies, midges and ticks), ...

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

6-11-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

31-10-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

23-10-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

20-10-2018

Evaluation of confirmatory data following the Article 12 MRL review for 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

17-10-2018

Lumpy skin disease: scientific and technical assistance on control and surveillance activities

Lumpy skin disease: scientific and technical assistance on control and surveillance activities

Published on: Tue, 16 Oct 2018 00:00:00 +0200 The duration of the vaccination campaign sufficient to eliminate lumpy skin disease (LSD) mainly depends on the vaccination effectiveness and coverage achieved. By using a spread epidemiological model, assuming a vaccination effectiveness of 65%, with 50% and 90% coverage, 3 and 4 years campaigns, respectively, are needed to eliminate LSD. When vaccination effectiveness is 80% to 95%, 2 years of vaccination at coverage of 90% is sufficient to eliminate LSD vir...

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

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

Avian influenza overview May – August 2018

Avian influenza overview May – August 2018

Published on: Thu, 27 Sep 2018 00:00:00 +0200 Between 16 May and 15 August 2018, three highly pathogenic avian influenza (HPAI) A(H5N8) outbreaks in poultry establishments and three HPAI A(H5N6) outbreaks in wild birds were reported in Europe. Three low pathogenic avian influenza (LPAI) outbreaks were reported in three Member States. Few HPAI and LPAI bird cases have been detected in this period of the year, in accordance with the seasonal expected pattern of LPAI and HPAI. There is no evidence to date ...

Europe - EFSA - European Food Safety Authority Publications

27-9-2018

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

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

Published on: Wed, 26 Sep 2018 00:00:00 +0200 According to Article 12 of Regulation (EC) No 396/2005, EFSA has reviewed the maximum residue levels (MRLs) currently established at European level for the pesticide active substance tembotrione. To assess the occurrence of tembotrione residues in plants, processed commodities, rotational crops and livestock, EFSA considered the conclusions derived in the framework of Commission Regulation (EU) No 188/2011 as well as the import tolerances and European author...

Europe - EFSA - European Food Safety Authority Publications

27-9-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

26-9-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

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

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

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

Risk assessment of substances used in food supplements: the example of the botanical Gymnema sylvestre

Risk assessment of substances used in food supplements: the example of the botanical Gymnema sylvestre

Published on: Tue, 28 Aug 2018 00:00:00 +0200 Botanicals and preparations derived from these are among the substances frequently added to foods and food supplements, yet the safety of many botanicals has not been systematically assessed. In the context of the EU‐FORA fellowship programme, the fellow performed an assessment on the safety of the botanical Gymnema sylvestre, in accordance with EFSA's guidance on the assessment of safety of botanicals. Although preparations of G. sylvestre are marketed as f...

Europe - EFSA - European Food Safety Authority Publications

11-9-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

11-9-2018

Assessment of occupational and dietary exposure to pesticide residues

Assessment of occupational and dietary exposure to pesticide residues

Published on: Mon, 27 Aug 2018 00:00:00 +0200 Plant protection products (PPPs) are pesticides containing at least one active substance that drives specific actions against pests (diseases). PPPs are regulated in the EU and cannot be placed on the market or used without prior authorisation. EFSA assesses the possible risks of the use of active substances to humans and environment. Member States decide whether or not to approve their use at EU level. Furthermore, Member States decide at national level on ...

Europe - EFSA - European Food Safety Authority Publications

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

Multiple “Dr. King’s” homeopathic and “Natural Pet” veterinary products recalled due to potential microbial contamination

Multiple “Dr. King’s” homeopathic and “Natural Pet” veterinary products recalled due to potential microbial contamination

Health Canada is advising consumers and pet owners not to use homeopathic and veterinary products made by King Bio Inc. and labeled as "Dr. King's," "Dr King's Natural Pet" or "Natural Pet." These products may pose a health risk to people and pets, especially children, pregnant women and those with compromised immune systems, because of potential microbial contamination. According to the United States Food and Drug Administration, high levels of microbial contamination were identified at the manufacturin...

Health Canada

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

29-8-2018

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

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

Published on: Tue, 28 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 sintofen. To assess the occurrence of sintofen 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 ...

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

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

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

Published on: Mon, 27 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 prochloraz. To assess the occurrence of prochloraz 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 as th...

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

Modification of the existing maximum residue levels for prohexadione in various oilseeds

Modification of the existing maximum residue levels for prohexadione in various oilseeds

Published on: Mon, 27 Aug 2018 00:00:00 +0200 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 levels (MRL) for the active substance prohexadione in linseeds, poppy seeds, sunflower seeds, rape seeds, mustard seeds and gold of pleasure seeds. The data submitted in support of the request were found to be sufficient to derive MRL proposals for all oilseeds under consid...

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

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

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

Published on: Fri, 24 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

29-8-2018

Explanatory note on the determination of newly expressed protein levels in the context of genetically modified plant applications for EU market authorisation

Explanatory note on the determination of newly expressed protein levels in the context of genetically modified plant applications for EU market authorisation

Published on: Mon, 20 Aug 2018 00:00:00 +0200 Genetically modified organisms are subject to a risk assessment and regulatory approval before entering the European market. According to legislation (Directive 2001/18/EC, Regulation (EC) No 1829/2003 and Regulation (EU) No 503/2013) and the EFSA guidance documents on the risk assessment of food and feed from genetically modified (GM) plants and on the environmental risk assessment of GM plants, applicants need to perform a molecular characterisation of any...

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

Setting of import tolerances for mandestrobin in strawberries and table and wine grapes

Setting of import tolerances for mandestrobin in strawberries and table and wine grapes

Published on: Thu, 16 Aug 2018 00:00:00 +0200 In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Sumitomo Chemical Agro Europe SAS submitted a request to the competent national authority in Austria to set an import tolerance for the active substance mandestrobin in strawberries, table grapes and wine grapes. The data submitted in support of the request were found to be sufficient to derive maximum residue level (MRL) proposals for the crops under consideration. Adequate analytica...

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

Modification of the existing maximum residue levels for fluoxastrobin in oilseeds

Modification of the existing maximum residue levels for fluoxastrobin in oilseeds

Published on: Mon, 13 Aug 2018 00:00:00 +0200 In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Arysta LifeSciences SAS submitted a request to the competent national authority in the United Kingdom to modify the existing maximum residue levels (MRL) for the active substance fluoxastrobin in certain oilseeds. The data submitted in support of the request were found to be sufficient to derive MRL proposals for the oilseeds for which a modification was requested. Adequate analytical...

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

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

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

Published on: Mon, 13 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 myclobutanil. To assess the occurrence of myclobutanil residues in plants, processed commodities, rotational crops and livestock, EFSA considered the conclusions derived in the framework of Commission Regulation (EC) No 33/2008, the MRLs established by the Codex Alimentarius Com...

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

Evaluation of data concerning the necessity of bromoxynil as herbicide to control a serious danger to plant health which cannot be contained by other available means, including non‐chemical methods

Evaluation of data concerning the necessity of bromoxynil as herbicide to control a serious danger to plant health which cannot be contained by other available means, including non‐chemical methods

Published on: Mon, 13 Aug 2018 00:00:00 +0200 EFSA was requested by the European Commission to provide scientific assistance under Article 31 of Regulation (EC) No 178/2002 regarding the evaluation of data concerning the necessity of bromoxynil as a herbicide to control a serious danger to plant health which cannot be contained by other available means including non‐chemical methods, in accordance with Article 4(7) of Regulation (EC) No 1107/2009. In this context, EFSA organised a commenting phase with ...

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

Grant agreement for piloting the Framework Partnership Agreement between the National data provider organisations in Slovakia and EFSA – Final report

Grant agreement for piloting the Framework Partnership Agreement between the National data provider organisations in Slovakia and EFSA – Final report

Published on: Tue, 07 Aug 2018 00:00:00 +0200 Presented document is the final report of the project GA/EFSA/DATA/2017/01: “Strategic Partnership with Slovakia on Data Quality (Pilot project)”. The report describes national processes and tools in order to implement internal validation and quality control of collected data according to EFSA requirements. A description of the data transmission processes from the National Databases to the EFSA databases, terminology, data mapping and data transformations fo...

Europe - EFSA - European Food Safety Authority Publications

28-8-2018

Accord Healthcare Inc. Issues Voluntary Nationwide Recall of Hydrochlorothiazide Tablets USP 12.5 Mg Due to Labeling Mix-up

Accord Healthcare Inc. Issues Voluntary Nationwide Recall of Hydrochlorothiazide Tablets USP 12.5 Mg Due to Labeling Mix-up

A 100 count bottle of Hydrochlorothiazide Tablets USP 12.5 mg has been found to contain 100 Spironolactone Tablets USP 25 mg. Since the individual lot, PW05264, of the product is involved in a potential mix-up of labeling, Accord is recalling this individual lot from the market.

FDA - U.S. Food and Drug Administration

2-8-2018

"Jian Pai Natural Skin Care Cream" contains antifungal drugs not listed on the label, which may pose serious health risks

"Jian Pai Natural Skin Care Cream" contains antifungal drugs not listed on the label, which may pose serious health risks

Health Canada testing of “Jian Pai Natural Skin Care Cream,” also called ‘’Yikangshuang,” found that it contains two antifungal drugs (fluconazole and miconazole) that are not listed on the product label, and may pose serious health risks.

Health Canada

2-7-2018

Blissful Remedies Issues Voluntary Nationwide Recall of Certain Kratom Powder Capsule

Blissful Remedies Issues Voluntary Nationwide Recall of Certain Kratom Powder Capsule

Blissful Remedies., is voluntarily recalling only Lot No.: 112710 with expiration 03/2019 found embedded on the top of package of kratom ( mitragyn a speciosa) powder products, it manufactured, processed, packed, and/or held, between “March 1, 2018” to “April 30, 2018” to the consumer level. The products have been found by the U.S. Food and Drug Administration (“FDA”) via sample testing to have salmonella contamination. Blissful Remedies has not received reports of adverse events related to this recall. ...

FDA - U.S. Food and Drug Administration

22-6-2018

Kratom (mitragyna speciosa) Powder Products by Gaia Ethnobotanical: Recall - Due to Potential Salmonella Contamination

Kratom (mitragyna speciosa) Powder Products by Gaia Ethnobotanical: Recall - Due to Potential Salmonella Contamination

The products have been found by the FDA via sample testing and finding to have salmonella contamination. In lieu of such FDA findings the company has implemented standard operating procedures and sterilization processes in accordance to FDA guidelines

FDA - U.S. Food and Drug Administration

21-6-2018

Gaia Ethnobotanical, LLC., Voluntarily Recalls Kratom Products Due to Potential Salmonella Contamination

Gaia Ethnobotanical, LLC., Voluntarily Recalls Kratom Products Due to Potential Salmonella Contamination

Gaia Ethnobotanical, LLC., is voluntarily recalling all kratom (mitragyna speciosa) powder products, with Lot No.: 0102031800 it manufactured, processed, packed, and/or held, between March 18, 2018 to March 30, 2018 to the consumer level. The products have been found by the U.S. Food and Drug Administration (“FDA”) via sample testing and finding to have salmonella contamination. In lieu of such FDA findings the company has implemented standard operating procedures and sterilization processes in accordanc...

FDA - U.S. Food and Drug Administration

25-9-2018

Pelgraz (Accord Healthcare Limited)

Pelgraz (Accord Healthcare Limited)

Pelgraz (Active substance: pegfilgrastim) - Centralised - Authorisation - Commission Decision (2018)6288 of Tue, 25 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/003961/0000

Europe -DG Health and Food Safety

24-9-2018

Lenalidomide Accord (Accord Healthcare Limited)

Lenalidomide Accord (Accord Healthcare Limited)

Lenalidomide Accord (Active substance: lenalidomide) - Centralised - Authorisation - Commission Decision (2018)6237 of Mon, 24 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4857

Europe -DG Health and Food Safety

7-8-2018

Accofil (Accord Healthcare Limited)

Accofil (Accord Healthcare Limited)

Accofil (Active substance: Filgrastim) - Centralised - Yearly update - Commission Decision (2018)5428 of Tue, 07 Aug 2018

Europe -DG Health and Food Safety

7-8-2018

Memantine Accord (Accord Healthcare Limited)

Memantine Accord (Accord Healthcare Limited)

Memantine Accord (Active substance: memantine) - Centralised - Renewal - Commission Decision (2018)5421 of Tue, 07 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2766/R/10

Europe -DG Health and Food Safety

6-8-2018

Zoledronic acid Accord (Accord Healthcare Limited)

Zoledronic acid Accord (Accord Healthcare Limited)

Zoledronic acid Accord (Active substance: zoledronic acid) - Centralised - Yearly update - Commission Decision (2018)5386 of Mon, 06 Aug 2018

Europe -DG Health and Food Safety

18-7-2018

#ICYMI - According to @PAPATIENTSAFETY June 2018 report, the number of reported surgical fires has decreased since 2011.  Read more about preventing surgical fires here:  https://go.usa.gov/xU5zs  #FDA #MedicalDevice

#ICYMI - According to @PAPATIENTSAFETY June 2018 report, the number of reported surgical fires has decreased since 2011. Read more about preventing surgical fires here: https://go.usa.gov/xU5zs  #FDA #MedicalDevice

#ICYMI - According to @PAPATIENTSAFETY June 2018 report, the number of reported surgical fires has decreased since 2011. Read more about preventing surgical fires here: https://go.usa.gov/xU5zs  #FDA #MedicalDevice

FDA - U.S. Food and Drug Administration

4-7-2018

Docetaxel Accord (Accord Healthcare Limited)

Docetaxel Accord (Accord Healthcare Limited)

Docetaxel Accord (Active substance: Docetaxel) - Centralised - Yearly update - Commission Decision (2018)4341 of Wed, 04 Jul 2018

Europe -DG Health and Food Safety

3-7-2018

Temozolomide Accord (Accord Healthcare Limited)

Temozolomide Accord (Accord Healthcare Limited)

Temozolomide Accord (Active substance: temozolomide) - Centralised - Yearly update - Commission Decision (2018) 4240 of Tue, 03 Jul 2018

Europe -DG Health and Food Safety

11-6-2018

Pemetrexed Accord (Accord Healthcare Limited)

Pemetrexed Accord (Accord Healthcare Limited)

Pemetrexed Accord (Active substance: pemetrexed) - Centralised - Yearly update - Commission Decision (2018)3761 of Mon, 11 Jun 2018

Europe -DG Health and Food Safety