Sumatriptan "Accord"

Primær information

  • Handelsnavn:
  • Sumatriptan "Accord" 50 mg filmovertrukne tabletter
  • Dosering:
  • 50 mg
  • Lægemiddelform:
  • filmovertrukne tabletter
  • Brugt til:
  • Mennesker
  • Medicin typen:
  • Allopatiske stof

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Lokation

  • Fås i:
  • Sumatriptan "Accord" 50 mg filmovertrukne tabletter
    Danmark
  • Sprog:
  • dansk

Andre oplysninger

Status

  • Kilde:
  • Lægemiddelstyrelsen - Danish Medicines Agency
  • Autorisationsnummer:
  • 52079
  • Sidste ændring:
  • 22-02-2018

Produktresumé: dosering, interaktioner, bivirkninger

19. marts 2018

PRODUKTRESUMÉ

for

Sumatriptan ”Accord”, filmovertrukne tabletter

0.

D.SP.NR.

28693

1.

LÆGEMIDLETS NAVN

Sumatriptan ”Accord”

2.

KVALITATIV OG KVANTITATIV SAMMENSÆTNING

Hver 50 mg filmovertrukket tablet indeholder 70 mg sumatriptansuccinat svarende til 50

mg sumatriptan.

Hjælpestof: 72 mg laktosemonohydrat.

Hver 100 mg filmovertrukket tablet indeholder 140 mg sumatriptansuccinat svarende til

100 mg sumatriptan.

Hjælpestof: 143 mg laktosemonohydrat.

Alle hjælpestoffer er anført under pkt. 6.1.

3.

LÆGEMIDDELFORM

Filmovertrukne tabletter.

50 mg: Lyserøde, kapselformede, bikonvekse filmovertrukne tabletter, jævn på begge

sider.

100 mg: Hvide til offwhite, kapselformede, bikonvekse filmovertrukne tabletter, jævn på

begge sider.

4.

KLINISKE OPLYSNINGER

4.1

Terapeutiske indikationer

Akut behandling af migræneanfald med eller uden aura. Sumatriptan må kun anvendes,

hvis der foreligger en sikker migrænediagnose.

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Side 1 af 10

4.2

Dosering og indgivelsesmåde

Dosering

Voksne

Sumatriptan er indiceret til behandling af akut, periodisk tilbagevendende migræne.

Sumatriptan bør ikke anvendes profylaktisk. Den anbefalede dosis sumatriptan bør ikke

overskrides.

Det tilrådes, at sumatriptan gives så tidligt som muligt efter indtræden af migræneanfald,

men det er lige effektivt, uanset hvilket stadie af migræneanfaldet det indtages på.

De følgende anbefalede doser bør ikke overskrides.

Den anbefalede dosis oral sumatriptan er en enkelt 50 mg tablet. Nogle patienter kan have

behov for 100 mg.

Hvis patienten har responderet på den første dosis, men symptomerne recidiverer, kan en

yderligere dosis gives,forudsat, at der minimum er et interval på to timer mellem de to

doser. Der må ikke tages mere end 300 mg inden for 24 timer.

Patienter som ikke responderer på den ordinerede dosis sumatriptan, bør ikke tage endnu

en dosis til samme anfald. I disse tilfælde kan anfaldet behandles med paracetamol,

acetylsalicylsyre eller non-steroid-antiinflammatoriske lægemidler. Sumatriptan kan tages

til efterfølgende anfald.

Sumatriptan anbefales som monoterapi ved akut behandling af migræneanfald og bør ikke

gives samtidig med ergotamin eller ergotaminderivater (herunder methysergid) (se pkt.

4.3).

Sumatriptan ”Accord” fås i styrkerne 50 og 100 mg.

Pædiatrisk population

Virkning og sikkerhed af sumatriptan-tabletter til børn under 10 år er ikke blevet fastslået.

Der foreligger ingen kliniske data vedrørende denne aldersgruppe.

Virkning og sikkerhed af sumatriptan-tabletter til børn i alderen 10 til 17 år er ikke

demonstreret i de kliniske forsøg, der er udført i denne aldersgruppe. Derfor frarådes brug

af sumatriptan-tabletter til børn i alderen 10 til 17 år (se pkt. 5.1).

Ældre (over 65 år)

Erfaringerne med anvendelse af sumatriptan til patienter over 65 år er begrænsede.

Farmakokinetikken adskiller sig ikke væsentligt fra en yngre population, men indtil der

foreligger yderligere kliniske data, frarådes brug af sumatriptan til patienter over 65 år.

Nedsat leverfunktion

Til patienter med mildt til moderat nedsat leverfunktion bør lave doser på 25-50 mg

sumatriptan overvejes.

Nedsat nyrefunktion

Sumatriptan skal anvendes med forsigtighed til patienter med nedsat nyrefunktion.

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Side 2 af 10

Administration

Tabletterne skal synkes hele sammen med vand.

4.3

Kontraindikationer

Overfølsomhed over for sumatriptan eller over for et eller flere af hjælpestofferne i

pkt. 6.1.

Sumatriptan bør ikke gives til patienter, der har haft myokardieinfarkt eller har

iskæmisk hjertesygdom, koronar vasospasme (Prinzmetals angina), perifer vaskulær

sygdom eller til patienter, der har symptomer eller tegn på iskæmisk hjertesygdom.

Sumatriptan må ikke administreres til patienter med stroke (CVA) eller transitorisk

iskæmisk anfald (TIA) i anamnesen.

Sumatriptan må ikke administreres til patienter med svært nedsat leverfunktion.

Brug af sumatriptan til patienter med moderat til svær hypertension eller ukontrolleret

mild hypertension er kontraindiceret.

Samtidig administration af ergotamin, ergotaminderivater (inklusive methysergid)

eller andre triptaner/5-hydroxytryptamin

(5-HT

) receptoragonister er kontraindiceret

(se pkt. 4.5).

Samtidig administration af reversible (f.eks. moclobemid) eller irreversible (f.eks.

selegilin) monoaminoxidase-hæmmere (MAOI’er) og sumatriptan er kontraindiceret.

Sumatriptan må ikke bruges inden for 2 uger efter seponering af behandling med

monoaminoxidase-hæmmere.

4.4

Særlige advarsler og forsigtighedsregler vedrørende brugen

Sumatriptan bør kun anvendes, hvis der foreligger en sikker migrænediagnose.

Sumatriptan er ikke indiceret til brug ved hemiplegisk migræne, basilarisk migræne eller

oftalmoplegisk migræne.

Før påbegyndelse af behandling med sumatriptan skal potentielle alvorlige neurologiske

lidelser (f.eks. CVA, TIA) omhyggeligt udelukkes, hvis patienten udviser atypiske

symptomer eller ikke er diagnosticeret til anvendelse af sumatriptan.

Sumatriptan kan være forbundet med forbigående symptomer som brystsmerter og trykken

for brystet, som kan være intense og også omfatte halsen (se pkt. 4.8). Hvis disse

symptomer kan tænkes at skyldes iskæmisk hjertesygdom, må der ikke gives yderligere

doser af sumatriptan, og nærmere undersøgelser skal foretages.

Sumatriptan bør ikke administreres til patienter med risikofaktorer for iskæmisk

hjertesygdom, herunder patienter, der er storrygere eller brugere af nikotin-

substitutionsbehandling, uden forudgående kardiovaskulær evaluering (se pkt. 4.3). Særlig

opmærksomhed kræves ved postmenopausale kvinder og mænd over 40 år med disse

risikofaktorer. Det er dog ikke sikkert, at alle patienter med hjertesygdom kan identificeres

ved sådanne evalueringer, og i meget sjældne tilfælde er der forekommet alvorlige

hjertehændelser hos patienter uden underliggende hjertesygdom.

Sumatriptan bør administreres med forsigtighed hos patienter med mild, kontrolleret

hypertension, eftersom forbigående stigninger i blodtryk og perifer vaskulær modstand er

observeret hos en lille andel af patienterne (se pkt. 4.3).

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Side 3 af 10

I rapporter efter markedsføringen er der i sjældne tilfælde beskrevet patienter med

serotonin-syndrom (inklusive ændret psykisk tilstand, autonom ustabilitet og

neuromuskulære abnormaliteter) efter brug af selektive serotonin-reuptake-hæmmere

(SSRI'er) og sumatriptan. Der er rapporteret serotoninsyndrom efter samtidig behandling

med triptaner og serotonin-noradrenalin-reuptake-hæmmere (SNRI'er).

Hvis samtidig behandling med sumatriptan og en SSRI eller SNRI er klinisk indiceret,

tilrådes passende observation af patienten (se pkt. 4.5).

Sumatriptan bør administreres med forsigtighed til patienter med sygdomme, der kan

påvirke absorptionen, metabolismen eller udskillelsen af lægemidlerne, f.eks. nedsat

leverfunktion (Child-Pugh-klasse A eller B, se pkt. 4.2 & 5.2) eller nedsat nyrefunktion.

Sumatriptan bør anvendes med forsigtighed til patienter med krampeanfald eller andre

risikofaktorer, som kan nedsætte deres krampetærskel, i anamnesen, da krampeanfald er

rapporteret i forbindelse med behandling med sumatriptan (se pkt. 4.8).

Patienter med kendt overfølsomhed over for sulfonamider kan få en allergisk reaktion efter

administration af sumatriptan. Reaktionerne kan spænde fra hudreaktioner til anafylaksi.

Sandsynligheden for krydsallergi er begrænset. Dog skal der udvises forsigtighed ved brug

af sumatriptan til disse patienter.

Bivirkninger kan forekomme hyppigere ved samtidig brug af triptaner og naturmedicin

indeholdende prikbladet perikon (Hypericum perforatum).

Længere tids brug af et smertestillende middel mod hovedpine kan gøre hovedpinen værre.

Hvis patienten oplever dette eller har mistanke om det, bør patienten søge læge, og

behandlingen bør seponeres. Diagnosen medicinoverforbrugshovedpine (MOH) bør

overvejes hos patienter, som har hyppig eller daglig hovedpine på trods af (eller på grund

af) regelmæssig brug af midler mod hovedpine.

Patienter med sjældne arvelige problemer med galactose-intolerans, Lapp-lactase-mangel

eller glucose-galactose-malabsorption må ikke tage dette lægemiddel, da det indeholder

lactose.

4.5

Interaktion med andre lægemidler og andre former for interaktion

Studier med raske forsøgspersoner har vist, at sumatriptan ikke interagerer med

propranolol, flunarizin, pizotifen eller alkohol.

Der foreligger begrænsede data om interaktion med præparater, der indeholder ergotamin

eller en anden triptan-/5-HT

-receptoragonist. Øget risiko for koronar vasospasme er en

teoretisk mulighed, og samtidig administration er kontraindiceret (se pkt. 4.3).

Det vides ikke, hvor længe der skal gå mellem brug af sumatriptan og ergotaminholdige

præparater eller en anden triptan-/5-HT

-receptoragonist. Dette vil også afhænge af

dosisstørrelserne og den produkttype, der anvendes. Effekten kan være additiv. Det

anbefales at vente mindst 24 timer efter brugen af ergotaminholdige præparater eller en

anden triptan-/5-HT

-receptoragonist, før der administreres sumatriptan. Omvendt

anbefales det at vente mindst 6 timer efter brug af sumatriptan, før der administreres et

ergotaminholdigt produkt, og mindst 24 timer, før der administreres en anden triptan-/5-

-receptoragonist (se pkt. 4.3).

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Side 4 af 10

Der kan forekomme interaktion mellem sumatriptan og monoaminoxidase-hæmmere

(MAO-hæmmere), og samtidig administration er kontraindiceret (se pkt. 4.3).

I rapporter efter markedsføringen er der i sjældne tilfælde beskrevet patienter med

serotonin-syndrom (inklusive ændret psykisk tilstand, autonom ustabilitet og

neuromuskulære abnormaliteter) efter brug af selektive serotonin-reuptake-hæmmere

(SSRI'er) og sumatriptan. Der er også rapporteret serotoninsyndrom efter samtidig

behandling med triptaner og serotonin-noradrenalin-reuptake-hæmmere (SNRI'er) (se pkt.

4.4).

4.6

Graviditet og amning

Graviditet

Efter markedsføringen er der indsamlet data fra over 1.000 kvinder om brug af sumatriptan

i første trimester af graviditeten. Selv om disse data indeholder utilstrækkelige information

til at drage endelige konklusioner, tyder de ikke på en øget risiko for medfødte

misdannelser. Erfaringen med brug af sumatriptan i andet og tredje trimester er begrænset.

Evaluering af dyreforsøg indikerer ikke direkte teratogene eller skadelige påvirkninger af

den peri- og postnatale udvikling. Embryoføtal levedygtighed kan dog være påvirket hos

kaniner (se pkt. 5.3).

Administration af sumatriptan bør kun overvejes, hvis den forventede fordel for moderen

er større end den mulige risiko for fosteret.

Amning

Det er påvist, at sumatriptan udskilles i modermælk efter subkutan administration.

Eksponeringen af spædbarnet kan minimeres ved at undgå amning undgås i 12 timer efter

behandlingen. Modermælk, der malkes ud i disse 12 timer, skal kasseres.

4.7

Virkninger på evnen til at føre motorkøretøj eller betjene maskiner

Ikke mærkning.

Der er ikke udført studier af evnen til at føre motorkøretøj eller betjene maskiner.

Døsighed kan forekomme som følge af migræne eller behandlingen med sumatriptan.

Dette kan påvirke evnen til at køre bil eller betjene maskiner.

4.8

Bivirkninger

Bivirkningerne er opført i henhold til organklasse og hyppighed.

Hyppighederne er defineret som følger: meget almindelig (≥1/10), almindelig (≥1/100,

<1/10), ikke almindelig (≥1/1000, <1/100), sjælden (≥1/10.000, <1/1.000), meget sjælden

(<1/10.000) og ikke kendt (kan ikke estimeres ud fra de forhåndenværende data).

Nogle af de symptomer, som er rapporteret som bivirkninger, kan være migrænerelaterede

symptomer.

Immunsystemet

Ikke kendt:

Overfølsomhedsreaktioner, der kan spænde fra hudreaktioner (såsom

urticaria) til anafylaksi.

Psykiske forstyrrelser

Ikke kendt:

Angst.

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Side 5 af 10

Nerve systemet

Almindelig:

Svimmelhed, døsighed, sensoriske forstyrrelser inklusive paræstesi og

hypoæstesi.

Ikke kendt:

Krampeanfald, selv om nogle af disse er forekommet hos patienter med

krampeanfald i anamnesen eller samtidige lidelser, der disponerer for

krampeanfald. Der er også rapporter om krampeanfald hos patienter

uden åbenlyse disponerende faktorer. Tremor, dystoni, nystagmus,

skotom.

Øjne

Ikke kendt:

Flimren for øjnene, diplopi, nedsat syn. Synstab, herunder permanente

skader. Der kan dog også opstå synsforstyrrelser under selve

migræneanfaldet.

Hjerte

Ikke kendt:

Bradykardi, takykardi, palpitationer, hjertearytmier, forbigående

iskæmiske EKG-forandringer, koronar vasospasme, angina,

myokardieinfarkt (se pkt. 4.3 og 4.4).

Vaskulære sygdomme

Almindelig:

Forbigående stigning i blodtryk kort tid efter behandling. Rødmen.

Ikke kendt:

Hypotension, Raynauds syndrom.

Luftveje, thorax og mediastinum

Almindelig:

Dyspnø.

Mave-tarmkanalen

Almindelig:

Hos nogle patienter forekom kvalme og opkastning, men det er uklart,

om dette skyldtes sumatriptan eller den underliggende sygdom.

Ikke kendt:

Iskæmisk colitis, diarré.

Hud og subkutane væv

Ikke kendt:

Hyperhidrose.

Knogler, led, muskler og bindevæv

Almindelig:

Tyngdefornemmelse (som regel forbigående, men kan være intens og

påvirke alle dele af kroppen, inklusive bryst og hals). Myalgi.

Ikke kendt:

Nakkestivhed, artralgi.

Almene symptomer og reaktioner på administrationsstedet

Almindelig:

Smerte, fornemmelse af varme eller kulde, tryk eller sammensnøring

(disse hændelser er som regel forbigående, men kan være intense og

påvirke alle dele af kroppen, inklusive bryst og hals). Følelse af svaghed,

træthed (begge bivirkninger er som regel lette til moderate i intensitet og

forbigående).

Undersøgelser

Meget sjælden:

Der er i enkelte tilfælde observeret mindre afvigelser i

leverfunktionsprøver.

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Side 6 af 10

Indberetning af mistænkte bivirkninger

Når lægemidlet er godkendt, er indberetning af mistænkte bivirkninger vigtig. Det muliggør

løbende overvågning af benefit/risk-forholdet for lægemidlet. Læger og sundhedspersonale

anmodes om at indberette alle mistænkte bivirkninger via:

Lægemiddelstyrelsen

Axel Heides Gade 1

DK-2300 København S

Websted: www.meldenbivirkning.dk

E-mail: dkma@dkma.dk

4.9

Overdosering

Der er rapporteret tilfælde af overdosering af sumatriptan-tabletter.

Symptomer

Doser over 400 mg oralt og 16 mg subkutant har ikke været forbundet med andre

bivirkninger end de nævnte. Patienter har modtaget op til 12 mg sumatriptan som en enkelt

subkutan injektion uden signifikante bivirkninger.

Håndtering

Hvis der forekommer overdosering, skal patienten monitoreres i mindst 10 timer, og der

skal iværksættes almindelig støttende behandling efter behov. Det er uvist, hvilken effekt

hæmodialyse eller peritonealdialyse har på plasmakoncentrationerne af sumatriptan.

4.10

Udlevering

5.

FARMAKOLOGISKE EGENSKABER

5.0

Terapeutisk klassifikation

ATC-kode: N02CC01. Midler mod migræne, selektive serotonin (5-HT

) agonister.

5.1

Farmakodynamiske egenskaber

Virkningsmekanisme

Det er påvist, at sumatriptan er en specifik og selektiv 5-hydroxytryptamin 1D

(5HT

receptoragonist, der ikke har effekt på andre 5HT-receptor (5HT

-5HT

) undertyper.

Den vaskulære 5HT

-receptor findes hovedsagelig i kranielle blodkar og medierer

vasokonstriktion. Hos dyr forårsager sumatriptan selektive konstriktioner i den

karotisarterielle cirkulation, men ændrer ikke den cerebrale blodforsyning. Den

karotisarterielle cirkulation sørger for blodforsyning til de ekstrakranielle og intrakranielle

væv, såsom meninges, og det menes, at dilatation og/eller ødemdannelse i disse blodkar er

den mekanisme, der ligger til grund for migræneanfald hos mennesker.

Evidens fra dyrestudier tyder desuden på, at sumatriptan hæmmer trigeminusnervens

aktivitet. Begge disse virkninger (kraniel vasokonstriktion og hæmning af trigeminus-

nervens aktivitet) kan bidrage til sumatriptans migrænehæmmende virkning hos

mennesker.

Sumatriptan er effektivt i behandlingen af menstruationsmigræne, dvs. migræne uden aura,

som forekommer mellem 3 dage før og op til 5 dage efter første menstruationsdag.

Sumatriptan bør tages så hurtigt så muligt efter et anfald.

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Side 7 af 10

Klinisk respons ses ca. 30 minutter efter en oral dosis på 100 mg.

Selv om den anbefalede orale dosis af sumatriptan er 50 mg, kan migræneanfald variere i

sværhedsgraden både hos den enkelte patient og mellem patienter. I kliniske studier har

doser på 25-100 mg vist sig at have større effekt end placebo, men 25 mg er statistisk set

signifikant mindre effektivt end både 50 og 100 mg.

Pædiatrisk population

Der er udført en række placebokontrollerede kliniske forsøg, der vurderede sikkerheden og

effekten af orale sumatriptanstandardtabletter hos ca. 650 børn og unge i alderen 10-17 år

med migræne. I disse forsøg kunne der ikke påvises nogen statistisk signifikant forskel

med hensyn til hovedpinelindring efter to timer mellem placebo og sumatriptan, uanset

dosis. Oral sumatriptans bivirkningsprofil hos børn og unge i alderen 10-17 år var

sammenlignelig med den bivirkningsprofil, som er set i forsøg med voksne patienter.

5.2

Farmakokinetiske egenskaber

Det ser ikke ud til, at oral sumatriptans farmakokinetik påvirkes i signifikant grad af

migræneanfald.

Absorption

Efter oral administration absorberes sumatriptan hurtigt, og 70 % af den maksimale

koncentration indtræffer efter 45 minutter. Efter en dosis på 100 mg er den maksimale

koncentration i plasma 54 ng/ml, og den nås inden for to timer. Den gennemsnitlige

absolutte orale biotilgængelighed er 14 %, hvilket dels skyldes præsystemisk metabolisme

og dels skyldes ufuldstændig absorption.

Distribution

Plasmaproteinbindingen er lav (14-21 %), og den gennemsnitlige fordelingsvolumen er

170 liter.

Biotransformation

Hovedmetabolitten, indoleddikesyreanalogen af sumatriptan, udskilles primært i urinen,

hvor den forekommer som en fri syre og glukuronidkonjugatet. Metabolitten har ingen

kendt 5HT

- eller 5HT

-aktivitet. Der er ikke identificeret mindre betydende metabolitter.

Elimination

Eliminationshalveringstiden er ca. to timer. Den gennemsnitlige totale plasmaclearance er

ca. 1160 ml/min, og den gennemsnitlige renale clearance er ca. 260 ml/min. Non-renal

clearance udgør ca. 80 % af den totale clearance, hvilket tyder på, at sumatriptan primært

elimineres gennem oxidativ metabolisme medieret af monoaminoxidase A.

Ældre

I et pilotstudie blev der ikke fundet signifikante forskelle med hensyn til de

farmakokinetiske parametre mellem ældre og yngre raske frivillige forsøgspersoner.

Særlige patientpopulationer

Nedsat leverfunktion

Sumatriptans farmakokinetik efter administration af en oral dosis (50 mg) og en subkutan

dosis (6 mg) blev undersøgt hos 8 patienter med mild til moderat nedsat leverfunktion,

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Side 8 af 10

parret efter køn, alder og vægt med 8 raske forsøgspersoner. Efter en oral dosis blev

eksponeringen af sumatriptan i plasma (AUC og Cmax) næsten fordoblet (forøget med ca.

80 %) hos patienter med mild til moderat nedsat leverfunktion sammenlignet med

kontrolgruppen med normal leverfunktion. Der var ingen forskel mellem patienter med

nedsat leverfunktion og kontrolgruppen efter den subkutane dosis. Dette indikerer, at mild

til moderat nedsat leverfunktion nedsætter den præsystemiske clearance og øger

biotilgængeligheden og eksponeringen for sumatriptan sammenlignet med raske

forsøgspersoner.

Efter oral administration er den præsystemiske clearance reduceret hos patienter med mild

til moderat nedsat leverfunktion, og den systemiske eksponering er næsten fordoblet.

Farmakokinetikken hos patienter med svært nedsat leverfunktion er ikke blevet undersøgt

(se pkt. 4.3, ”Kontraindikationer”, og pkt. 4.4, ”Særlige advarsler og forsigtighedsregler

vedrørende brugen”).

5.3

Prækliniske sikkerhedsdata

Sumatriptan udviste ingen genotoksiske eller carcinogene virkninger i in vitro-systemer

eller dyrestudier.

I et fertilitetsstudie med rotter sås nedsat succes af insemination ved koncentrationer langt

over den maksimale koncentration hos mennesker.

Hos kaniner blev der set fosterdød uden udprægede teratogene effekter. Det vides ikke, om

disse fund har relevans for mennesker.

6.

FARMACEUTISKE OPLYSNINGER

6.1

Hjælpestoffer

Tabletkerne:

Lactosemonohydrat

Hypromellose

Mikrokrystallinsk cellulose

Croscarmellosenatrium

Magnesiumstearat

Filmovertræk

Hypromellose

Titandioxid (E 171)

Rød jernoxid (E 172) (50 mg tablet)

Triacetin (50 mg tablet)

6.2

Uforligeligheder

Ikke relevant.

6.3

Opbevaringstid

2 år.

6.4

Særlige opbevaringsforhold

Dette lægemiddel kræver ingen særlige forholdsregler vedrørende opbevaringen.

52079_spc.docx

Side 9 af 10

6.5

Emballagetyper og pakningsstørrelser

De enkelte tabletter er pakket i blistere (Al/al).

For 50 mg: 4, 6, 12 og 18 tabletter.

For 100 mg: 4, 6, 12 og 18 tabletter.

Ikke alle pakningsstørrelser er nødvendigvis markedsført.

6.6

Regler for destruktion og anden håndtering

Ikke anvendt lægemiddel samt affald heraf skal bortskaffes i henhold til lokale

retningslinjer.

Ingen særlige forholdsregler.

7.

INDEHAVER AF MARKEDSFØRINGSTILLADELSEN

Accord Healthcare Limited

Sage House, 319 Pinner Road

North Harrow, Middlesex, HA1 4HF

Storbritannien

8.

MARKEDSFØRINGSTILLADELSESNUMMER (NUMRE)

50 mg:

52079

100 mg:

52080

9.

DATO FOR FØRSTE MARKEDSFØRINGSTILLADELSE

22. oktober 2013

10.

DATO FOR ÆNDRING AF TEKSTEN

19. marts 2018

52079_spc.docx

Side 10 af 10

  • Oplysningerne indlægssedlen for dette produkt er i øjeblikket ikke tilgængelig, kan du sende en anmodning til vores kundeservice, og vi vil give dig besked, så snart vi er i stand til at opnå det.

    Anmode informationsbrochure for offentligheden.



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Modification of the existing maximum residue levels for mandipropamid in various crops

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Published on: Wed, 13 Feb 2019 In accordance with Article 6 of Regulation (EC) No 396/2005, the applicants Syngenta Crop Protection B.V. and Agriculture and Horticulture Development Board (AHDB) submitted, respectively, a request to the competent national authorities in the Netherlands and United Kingdom to modify the existing maximum residue levels (MRLs) for the active substance mandipropamid in various crops. The data submitted in support of the request were found to be sufficient to derive MRL propo...

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13-2-2019

Pesticide active substances that do not require a review of the existing maximum residue levels under Article 12 of Regulation (EC) No 396/2005

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Published on: Tue, 12 Feb 2019 According to Article 12(1) of Regulation (EC) No 396/2005, EFSA shall provide within 12 months from the date of the inclusion or non‐inclusion of an active substance in Annex I to Directive 91/414/EEC a reasoned opinion on the review of the existing maximum residue levels (MRLs) for that active substance. Among the active substances that need to be reviewed under Article 12(1) of Regulation (EC) No 396/2005, EFSA identified 13 active substances for which a review of MRLs i...

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1-2-2019

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

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Published on: Thu, 31 Jan 2019 According to Article 12 of Regulation (EC) No 396/2005, EFSA has reviewed the maximum residue levels (MRLs) currently established at European level for the pesticide active substance imidacloprid. To assess the occurrence of imidacloprid 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 the import to...

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Modification of the existing maximum residue levels for sulfoxaflor in various crops

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Published on: Thu, 31 Jan 2019 In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Dow AgroSciences submitted a request to the competent national authority in Ireland to modify the existing maximum residue levels (MRLs) for the active substance sulfoxaflor in various crops, including limes imported from Australia. The data submitted in support of the request were found to be sufficient to derive MRL proposals for limes, cauliflowers, Brussels sprouts, kales, spinaches and similar ...

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

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Published on: Thu, 31 Jan 2019 According to Article 12 of Regulation (EC) No 396/2005, EFSA has reviewed the maximum residue levels (MRLs) currently established at European level for the pesticide active substance hexythiazox. To assess the occurrence of hexythiazox 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 Commission as well a...

Europe - EFSA - European Food Safety Authority EFSA Journal

31-1-2019

Guidelines for reporting 2018 prevalence sample‐based data in accordance with SSD2 data model

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Published on: Wed, 30 Jan 2019 Prevalence sample‐based data should be transmitted from Member States to the European Food Safety Authority (EFSA) using the EFSA Standard Sample Description version 2 (SSD2) standard. To support reporting countries in data submission using eXtensible Markup Language (XML) data transfer, specific guidelines are given in this report covering the reporting of sample‐based zoonoses and zoonotic agent data. These guidelines are specifically aimed at guiding the reporting of in...

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31-1-2019

User manual for mapping Member State zoonoses standard terminology to EFSA standard terminology for information derived from the year 2018

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Published on: Wed, 30 Jan 2019 The European Food Safety Authority (EFSA) is tasked with coordinating the reporting of zoonoses, zoonotic agents, animal populations, antimicrobial resistance and food‐borne outbreaks in the European Union (EU) under Directive 2003/99/EC, as well as analysing and summarising the data collected. For data transmission purposes, EFSA created a simple Microsoft Office Excel‐based mapping tool to allow Member States to map their standard terminology to EFSA's standard terminolo...

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26-1-2019

Guidelines for reporting molecular typing data through EFSA's Data Collection Framework

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26-1-2019

Scientific Opinion on Flavouring Group Evaluation 217 Revision 2 (FGE.217Rev2), consideration of genotoxic potential for α,β‐unsaturated ketones and precursors from chemical subgroup 4.1 of FGE.19: lactones

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26-1-2019

Literature review in support of adjuvanticity/immunogenicity assessment of proteins

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25-1-2019

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

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Published on: Wed, 23 Jan 2019 According to Article 12 of Regulation (EC) No 396/2005, EFSA has reviewed the maximum residue levels (MRLs) currently established at European level for the pesticide active substance spiromesifen. To assess the occurrence of spiromesifen residues in plants, processed commodities, rotational crops and livestock, EFSA considered the conclusions derived in the framework of Regulation (EC) No 1107/2009, the MRLs established by the Codex Alimentarius Commission, as well as the ...

Europe - EFSA - European Food Safety Authority EFSA Journal

22-1-2019

Modification of the existing maximum residue level for trifloxystrobin in broccoli

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Published on: Mon, 21 Jan 2019 In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Bayer Hellas AG submitted a request to the competent national authority in Greece to modify the existing maximum residue level (MRL) for the active substance trifloxystrobin in broccoli. The data submitted in support of the request were found to be sufficient to derive an MRL proposal for broccoli. Adequate analytical methods for enforcement are available to control the residues of trifloxystrobin o...

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Modification of the existing maximum residue levels for aclonifen in celeriacs and certain fresh herbs

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Published on: Mon, 21 Jan 2019 In accordance with Article 6 of Regulation (EC) No 396/2005, the applicants Landesanstalt für Landwirtschaft und Gartenbau Sachsen‐Anhalt (LSA) and Dienstleistungszentrum Ländlicher Raum Rheinpfalz (DLR), respectively, submitted a request to the competent national authority in Germany to modify the existing maximum residue levels (MRL) for the active substance aclonifen in chives, parsley, celery leaves/dill leaves, thyme/savoury and in celeriacs/turnip‐rooted celery. The ...

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22-1-2019

Modification of the existing maximum residue levels for tetraconazole in kaki/Japanese persimmon, linseeds and poppy seeds

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Published on: Mon, 21 Jan 2019 In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Isagro S.p.A submitted a request to the competent national authority in Italy to modify the existing maximum residue levels (MRLs) for the active substance tetraconazole in various crops and animal commodities. The data submitted in support of the request were found to be sufficient to derive MRL proposals for tetraconazole in kaki/Japanese persimmon, linseeds and poppy seeds. Adequate analytical me...

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22-1-2019

Modification of the existing maximum residue levels for aminopyralid in certain cereals

Modification of the existing maximum residue levels for aminopyralid in certain cereals

Published on: Mon, 21 Jan 2019 In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Dow AgroSciences Denmark submitted a request to the competent national authority in the United Kingdom to modify the existing maximum residue levels (MRLs) for the active substance aminopyralid in cereals. The data submitted in support of the request were found to be sufficient to derive MRL proposals for barley, rye, sorghum, millet and oats. A modification of the existing MRL of aminopyralid in wh...

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21-1-2019

Succinate dehydrogenase inhibitor (SDHI) fungicides: ANSES presents the results of its expert appraisal

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France - Agence Nationale du Médicament Vétérinaire

19-1-2019

Modification of the existing maximum residue levels for spirotetramat in various crops

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Published on: Fri, 18 Jan 2019 In accordance with Article 6 of Regulation (EC) No 396/2005, the competent national authority in Belgium prepared a request to modify the existing maximum residue levels (MRLs) for the active substance spirotetramat in Florence fennels and rhubarbs. Furthermore, in accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Bayer SAS submitted a request to the competent national authority in Austria to modify the existing MRLs for spirotetramat in the group of ...

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18-1-2019

Publication of scientific data from EU-coordinated monitoring programmes and surveys

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17-1-2019

Genotoxicity assessment of chemical mixtures

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Published on: Wed, 16 Jan 2019 This document provides guidance for communicators on how to communicate the various expressions of uncertainty described in EFSA's document: ‘Guidance on uncertainty analysis in scientific assessments’. It also contains specific guidance for assessors on how best to report the various expressions of uncertainty. The document provides a template for identifying expressions of uncertainty in scientific assessments and locating the specific guidance for each expression. The g...

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17-1-2019

Guidance on Communication of Uncertainty in Scientific Assessments

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Published on: Wed, 16 Jan 2019 This document provides guidance for communicators on how to communicate the various expressions of uncertainty described in EFSA's document: ‘Guidance on uncertainty analysis in scientific assessments’. It also contains specific guidance for assessors on how best to report the various expressions of uncertainty. The document provides a template for identifying expressions of uncertainty in scientific assessments and locating the specific guidance for each expression. The g...

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16-1-2019

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

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

Published on: Tue, 15 Jan 2019 According to Article 12 of Regulation (EC) No 396/2005, EFSA has reviewed the maximum residue levels (MRLs) currently established at European level for the pesticide active substance dazomet. To assess the occurrence of dazomet 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 (including the supporting re...

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15-1-2019

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

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

Published on: Mon, 14 Jan 2019 According to Article 12 of Regulation (EC) No 396/2005, EFSA has reviewed the maximum residue levels (MRLs) currently established at European level for the pesticide active substance metam. To assess the occurrence of metam residues in plants, processed commodities, rotational crops and livestock, EFSA considered the conclusions derived in the framework of Commission Regulation (EC) No 33/2008C as well as the European authorisations reported by Member States (including the...

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15-1-2019

Setting of an import tolerance for spiromesifen in coffee beans

Setting of an import tolerance for spiromesifen in coffee beans

Published on: Mon, 14 Jan 2019 In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Bayer CropScience submitted a request to the competent national authority in Greece to set an import tolerance for the active substance spiromesifen in coffee beans. The data submitted in support of the request were found to be sufficient to derive a maximum residue level (MRL) proposal for coffee beans. Adequate analytical methods for enforcement are available to control the residues of spiromesife...

Europe - EFSA - European Food Safety Authority EFSA Journal

15-1-2019

EFSA's activities on emerging risks in 2017

EFSA's activities on emerging risks in 2017

Published on: Mon, 14 Jan 2019 The main objectives of EFSA's activities on emerging risks are: (i) to carry out activities to identify emerging risks in the areas within the remit of EFSA; and (ii) to develop and improve emerging risk identification methodologies and approaches. The current technical report summarises the activities of all groups involved in the emerging risk identification procedure, the issues identified in the course of 2017, a description of methodologies being developed and collabo...

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15-1-2019

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

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

Published on: Mon, 14 Jan 2019 According to Article 12 of Regulation (EC) No 396/2005, EFSA has reviewed the maximum residue levels (MRLs) currently established at European level for the pesticide active substance fluometuron. To assess the occurrence of fluometuron residues in plants, processed commodities, rotational crops and livestock, EFSA considered the conclusions derived in the framework of Commission Regulation (EC) No 33/2008 as well as the European authorisations reported by Member States (in...

Europe - EFSA - European Food Safety Authority EFSA Journal

9-1-2019

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

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

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

Europe - EFSA - European Food Safety Authority EFSA Journal

9-1-2019

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

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

Published on: Tue, 08 Jan 2019 According to Article 12 of Regulation (EC) No 396/2005, EFSA has reviewed the maximum residue levels (MRLs) currently established at European level for the pesticide active substance triazoxide. To assess the occurrence of triazoxide residues in plants, processed commodities, rotational crops and livestock, EFSA considered the conclusions derived in the framework of Commission Regulation (EC) No 33/2008, as well as the European authorisations reported by Member States. Bas...

Europe - EFSA - European Food Safety Authority EFSA Journal

9-1-2019

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

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

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

Europe - EFSA - European Food Safety Authority EFSA Journal

8-1-2019

Resapath

Resapath

The development of antimicrobial resistance in animal and human bacteria is a major public health issue requiring an integrated approach across all types of medicine, according to the "One Health" concept covering both humans and animals. ANSES has mobilised significant resources to combat antimicrobial resistance, in particular by coordinating the French Surveillance Network for Antimicrobial Resistance in Pathogenic Bacteria of Animal Origin (Resapath), which is devoted to monitoring resistance in bact...

France - Agence Nationale du Médicament Vétérinaire

8-1-2019

Antimicrobial resistance

Antimicrobial resistance

Antimicrobial resistance is a major international human and animal health issue, because the emergence and spread of drug-resistant strains of bacteria call into question the efficacy of these treatments in humans and animals alike. Preserving the effectiveness of antibiotics is therefore a genuine public health challenge requiring an integrated approach across all types of medicine, according to the "One Health" concept covering both humans and animals. ANSES has mobilised significant resources to addr...

France - Agence Nationale du Médicament Vétérinaire

4-1-2019

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

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

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

Europe - EFSA - European Food Safety Authority EFSA Journal

22-12-2018

Modification of the existing maximum residue level for captan in hops

Modification of the existing maximum residue level for captan in hops

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

Europe - EFSA - European Food Safety Authority EFSA Journal

22-12-2018

Modification of the existing maximum residue level for captan in cranberries

Modification of the existing maximum residue level for captan in cranberries

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

Europe - EFSA - European Food Safety Authority EFSA Journal

20-12-2018

Scientific assistance to assess the detoxification process for dioxins and PCBs in sunflower cake by hexane extraction

Scientific assistance to assess the detoxification process for dioxins and PCBs in sunflower cake by hexane extraction

Published on: Wed, 19 Dec 2018 EFSA was requested to provide scientific assistance to the European Commission on a detoxification process for dioxins and PCBs from sunflower cake by hexane extraction in an emergency situation, as specified in Article 7 of Commission Regulation (EU) 2015/786. The process entails hexane extraction of sunflower oil from the cake to remove dioxins (PCDDs and PCDFs) as well as DL- and NDL-PCBs. The data provided by the applicant were assessed with respect to the efficacy of ...

Europe - EFSA - European Food Safety Authority EFSA Journal

20-12-2018

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

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

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

Europe - EFSA - European Food Safety Authority EFSA Journal

18-12-2018

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

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

Published on: Mon, 17 Dec 2018 According to Article 12 of Regulation (EC) No 396/2005, EFSA has reviewed the maximum residue levels (MRLs) currently established at European level for the pesticide active substance pencycuron. To assess the occurrence of pencycuron residues in plants, processed commodities, rotational crops and livestock, EFSA considered the conclusions derived in the framework of Commission Regulation (EC) No 33/2008 as well as the European authorisations reported by Member States (incl...

Europe - EFSA - European Food Safety Authority Publications

15-12-2018

Annual report of the Scientific Network on Microbiological Risk Assessment 2018

Annual report of the Scientific Network on Microbiological Risk Assessment 2018

Published on: Fri, 14 Dec 2018 Among the tasks of EFSA, according to its founding regulation (Regulation (EC) No 178/2002), there is the establishment of a system of Networks of organisations operating in the fields within EFSA's mission, the objective being to facilitate a scientific cooperation framework by the coordination of activities, the exchange of information, the development and implementation of joint projects, the exchange of expertise and best practices. Additionally, the EFSA Science Strat...

Europe - EFSA - European Food Safety Authority Publications

30-11-2018

The European Union summary report on surveillance for the presence of transmissible spongiform encephalopathies (TSEs) in 2017

The European Union summary report on surveillance for the presence of transmissible spongiform encephalopathies (TSEs) in 2017

Published on: Thu, 29 Nov 2018 This report presents the results of surveillance on transmissible spongiform encephalopathies (TSEs) in bovine animals, sheep, goats, cervids and other animal species, as well as genotyping in sheep, carried out in 2017 in the European Union (EU) according to Regulation (EC) 999/2001, and in Iceland, Norway and Switzerland. In total, 1,312,714 cattle were tested by the 28 EU Member States (MSs) which is a decrease of 3% compared with 2016; 18,526 were tested by the three n...

Europe - EFSA - European Food Safety Authority Publications

27-11-2018

Database of processing techniques and processing factors compatible with the EFSA food classification and description system FoodEx 2 Objective 3: European database of processing factors for pesticides in food

Database of processing techniques and processing factors compatible with the EFSA food classification and description system FoodEx 2 Objective 3: European database of processing factors for pesticides in food

Published on: Mon, 26 Nov 2018 EFSA is conducting pan‐European dietary exposure and risk assessments related to actual levels of pesticide residues in food commodities. These assessments use the pesticide occurrence data generated under the official monitoring programs of Member States, the consumption data from EFSA's comprehensive food consumption database and pesticide‐specific information such as processing factors. Currently no harmonised list of processing factors is available within Europe and wo...

Europe - EFSA - European Food Safety Authority Publications

24-11-2018

The EFSA‐funded collection of dietary and related data in the general population aged 10‐74 years in Greece

The EFSA‐funded collection of dietary and related data in the general population aged 10‐74 years in Greece

Published on: Fri, 23 Nov 2018 The Hellenic Health Foundation received support from the European Food Safety Authority in order to organise a national nutrition survey according to the methodology described in the EFSA Guidance document and to collect food consumption and related information among 780 adolescents, adults and elderly residing permanently in Greece. The EFSA‐funded data collection was largely based on the protocol of a large scale Greek national nutrition and health survey, called HYDRIA....

Europe - EFSA - European Food Safety Authority Publications

24-11-2018

Hazard identification and ranking for poultry at slaughter

Hazard identification and ranking for poultry at slaughter

Published on: Fri, 23 Nov 2018 The Hellenic Health Foundation received support from the European Food Safety Authority in order to organise a national nutrition survey according to the methodology described in the EFSA Guidance document and to collect food consumption and related information among 780 adolescents, adults and elderly residing permanently in Greece. The EFSA‐funded data collection was largely based on the protocol of a large scale Greek national nutrition and health survey, called HYDRIA....

Europe - EFSA - European Food Safety Authority Publications

21-11-2018

Mylan Initiates Voluntary Nationwide Recall of 15 Lots of Valsartan Tablets, USP, Amlodipine and Valsartan Tablets, USP, and Valsartan and Hydrochlorothiazide Tablets, USP, Due to the Detection of Trace Amounts of NDEA (N-Nitrosodiethylamine) Impurity Fou

Mylan Initiates Voluntary Nationwide Recall of 15 Lots of Valsartan Tablets, USP, Amlodipine and Valsartan Tablets, USP, and Valsartan and Hydrochlorothiazide Tablets, USP, Due to the Detection of Trace Amounts of NDEA (N-Nitrosodiethylamine) Impurity Fou

Mylan N.V. (NASDAQ: MYL) today announced that its U.S. based Mylan Pharmaceuticals business is conducting a voluntary nationwide recall to the consumer level of select lots of Valsartan-containing products, including six lots of Amlodipine and Valsartan Tablets, USP (including the 5mg/160mg, 10mg/160mg, and 10mg/320mg strengths), seven lots of Valsartan Tablets, USP (including 40 mg, 80 mg, 160 mg, and 320 mg strengths), and two lots of Valsartan and Hydrochlorothiazide Tablets, USP 320mg/25mg strength. ...

FDA - U.S. Food and Drug Administration

21-11-2018

Setting of an import tolerance for mandipropamid in cocoa beans

Setting of an import tolerance for mandipropamid in cocoa beans

Published on: Tue, 20 Nov 2018 In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Syngenta Agro GmbH submitted a request to the competent national authority in Austria to set a maximum residue level (MRL) for the active substance mandipropamid in cocoa beans imported from Nigeria and Cameroon. The data submitted in support of the request were found to be sufficient to derive a MRL proposal of 0.06 mg/kg. Adequate analytical methods for enforcement are available to control the res...

Europe - EFSA - European Food Safety Authority Publications

20-11-2018

Modification of the existing maximum residue levels for pyraclostrobin in soyabean

Modification of the existing maximum residue levels for pyraclostrobin in soyabean

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

Europe - EFSA - European Food Safety Authority Publications

20-11-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

17-11-2018

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

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

Published on: Fri, 16 Nov 2018 According to Article 12 of Regulation (EC) No 396/2005, EFSA has reviewed the maximum residue levels (MRLs) currently established at European level for the pesticide active substance tau‐fluvalinate. To assess the occurrence of tau‐fluvalinate residues in plants, processed commodities, rotational crops and livestock, EFSA considered the conclusions derived in the framework of Commission Regulation (EC) No 33/2008 as well as the European authorisations reported by Member St...

Europe - EFSA - European Food Safety Authority Publications

16-11-2018

Setting of an import tolerance for pyraclostrobin in rice

Setting of an import tolerance for pyraclostrobin in rice

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

Europe - EFSA - European Food Safety Authority Publications

15-11-2018

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

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

Published on: Wed, 14 Nov 2018 Following the submission of application EFSA‐GMO‐RX‐010 under Regulation (EC) No 1829/2003 from Bayer, the Panel on Genetically Modified Organisms of the European Food Safety Authority (GMO Panel) was asked to deliver a scientific risk assessment on the data submitted in the context of the renewal of authorisation application for the herbicide‐tolerant genetically modified LLCotton25, for food and feed uses, import and processing, excluding cultivation within the EU. The d...

Europe - EFSA - European Food Safety Authority Publications

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

8-2-2019

Accofil (Accord Healthcare S.L.U.)

Accofil (Accord Healthcare S.L.U.)

Accofil (Active substance: Filgrastim) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2019)1033 of Fri, 08 Feb 2019 European Medicines Agency (EMA) procedure number: EMEA/H/C/3956/T/27

Europe -DG Health and Food Safety

8-2-2019

Eptifibatide Accord (Accord Healthcare S.L.U.)

Eptifibatide Accord (Accord Healthcare S.L.U.)

Eptifibatide Accord (Active substance: eptifibatide) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2019)1036 of Fri, 08 Feb 2019 European Medicines Agency (EMA) procedure number: EMEA/H/C/4104/T/05

Europe -DG Health and Food Safety

8-2-2019

Ivabradine Accord (Accord Healthcare S.L.U.)

Ivabradine Accord (Accord Healthcare S.L.U.)

Ivabradine Accord (Active substance: ivabradine) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2019)1034 of Fri, 08 Feb 2019 European Medicines Agency (EMA) procedure number: EMEA/H/C/4241/T/03

Europe -DG Health and Food Safety

4-2-2019

Memantine Accord (Accord Healthcare S.L.U.)

Memantine Accord (Accord Healthcare S.L.U.)

Memantine Accord (Active substance: memantine) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2019)844 of Mon, 04 Feb 2019 European Medicines Agency (EMA) procedure number: EMEA/H/C/2766/T/12

Europe -DG Health and Food Safety

4-2-2019

Aripiprazole Accord (Accord Healthcare Limited)

Aripiprazole Accord (Accord Healthcare Limited)

Aripiprazole Accord (Active substance: aripiprazole) - Centralised - Yearly update - Commission Decision (2019)854 of Mon, 04 Feb 2019

Europe -DG Health and Food Safety

25-1-2019

Pregabalin Accord (Accord Healthcare Limited)

Pregabalin Accord (Accord Healthcare Limited)

Pregabalin Accord (Active substance: pregabalin) - Centralised - Yearly update - Commission Decision (2019)683 of Fri, 25 Jan 2019

Europe -DG Health and Food Safety