Quetiapin "Accord"

Primær information

  • Handelsnavn:
  • Quetiapin "Accord" 200 mg depottabletter
  • Dosering:
  • 200 mg
  • Lægemiddelform:
  • depottabletter
  • Brugt til:
  • Mennesker
  • Medicin typen:
  • Allopatiske stof

Dokumenter

Lokation

  • Fås i:
  • Quetiapin "Accord" 200 mg depottabletter
    Danmark
  • Sprog:
  • dansk

Andre oplysninger

Status

  • Kilde:
  • Lægemiddelstyrelsen - Danish Medicines Agency
  • Autorisation status:
  • Markedsført
  • Autorisationsnummer:
  • 46349
  • Sidste ændring:
  • 22-02-2018

Indlægsseddel

Page 1 of 4

Indlægsseddel: Information til brugeren

Quetiapin Accord 50 mg depottabletter

Quetiapin Accord 200 mg depottabletter

Quetiapin Accord 300 mg depottabletter

Quetiapin Accord 400 mg depottabletter

quetiapin

Læs denne indlægsseddel grundigt, inden De begynder at tage medicinen, da den indeholder vigtige

oplysninger.

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

Spørg lægen, apotekspersonalet eller sundhedspersonalet, hvis der er mere, De vil vide.

Lægen har ordineret Quetiapin Accord til Dem personligt. Lad derfor være med at give medicinen til andre.

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

Kontakt lægen, apotekspersonalet eller sundhedspersonalet, hvis en bivirkning bliver værre, eller De får

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

Oversigt over indlægssedlen:

Virkning og anvendelse

Det skal De vide, før De begynder at tage Quetiapin Accord

Sådan skal De tage Quetiapin Accord

Bivirkninger

Opbevaring

Pakningsstørrelser og yderligere oplysninger

1.

Virkning og anvendelse

Quetiapin Accord indeholder et stof, der hedder quetiapin. Det tilhører en gruppe af lægemidler, som kaldes

antipsykotika. Quetiapin Accord kan anvendes til behandling af forskellige sygdomme, f.eks.:

• Skizofreni: De hører eller fornemmer ting, der ikke er der, tror på ting, der ikke er sande, eller føler Dem

usædvanligt mistroisk, ængstelig, forvirret, har skyldfølelse, er anspændt eller deprimeret.

• Mani: De føler Dem måske meget opstemt, opløftet, ophidset, begejstret eller hyperaktiv eller har dårlig

dømmekraft, er aggressiv eller destruktiv.

• Bipolar depression og alvorlige depressive anfald ved unipolar depression: De føler Dem måske ked af det

eller deprimeret, har skyldfølelse, mangler energi, har ingen appetit eller kan ikke sove.

Når Quetiapin Accord anvendes til behandling af alvorlige depressive anfald ved unipolar depression, vil det

blive anvendt som supplement til et andet lægemiddel, der bruges til behandling af sygdommen.

Deres læge vil muligvis fortsat ordinere Quetiapin Accord, selvom De får det bedre.

2.

Det skal De vide, før de begynder at tage Quetiapin Accord

Tag ikke Quetiapin Accord:

Hvis De er allergisk over for quetiapin eller et af de øvrige indholdsstoffer angivet i punkt 6.

Hvis De tager et af følgende lægemidler:

visse lægemidler mod HIV

medicin, der indeholder azoler (mod svampeinfektioner)

erythromycin eller clarithromycin (mod infektioner)

nefazodon (mod depression).

Tag ikke Quetiapin Accord, hvis ovenstående gælder for Dem. Hvis De er usikker, så tal altid med Deres læge

eller apoteket, inden De tager Quetiapin Accord.

Advarsler og forsigtighedsregler

Kontakt lægen, apoteketspersonalet eller sundhedspersonalet, før De tager Quetiapin Accord.

Hvis De eller nogen i Deres familie har eller har haft hjerteproblemer, f.eks. hjerterytmeproblemer

eller svækket hjertemuskel eller betændelse i hjertet, eller hvis De tager medicin, som kan have

påvirket måden, hvorpå Deres hjerte slår.

Hvis De har lavt blodtryk.

Hvis De har haft et slagtilfælde, specielt hvis De er ældre.

Hvis De har problemer med leveren.

Hvis De har haft krampeanfald.

Hvis De har sukkersyge eller har risiko for at få sukkersyge. Hvis dette er tilfældet, kan det være, at

Deres læge måler Deres blodsukkerniveau, mens De tager Quetiapin Accord.

Hvis De ved, at De tidligere har haft et lavt antal hvide blodceller (som måske eller måske ikke har

været forårsaget af anden medicin).

Hvis De er ældre og lider af demens (tab af hjernefunktion). I så fald må De ikke tage Quetiapin

Accord, fordi den gruppe lægemidler, som Quetiapin Accord tilhører, kan forøge risikoen for

slagtilfælde og i nogle tilfælde dødsfald, hos ældre demente.

Hvis De eller nogen i Deres familie har haft blodpropper, da denne type lægemidler har været

forbundet med dannelsen af blodpropper.

Hvis De har eller har haft en tilstand, hvor De holder op med at trække vejret i korte perioder i løbet

af Deres normale nattesøvn (kaldet "søvnapnø"), og tager medicin, der bremser den normale

aktivitet i hjernen ("depressiva").

Hvis De har eller har haft en tilstand, hvor De ikke kan tømme blæren helt (urinretention), har

forstørret prostata, en blokering i tarmene, eller øget tryk i øjet. Disse tilstande skyldes sommetider

lægemidler (kaldet "antikolinergika"), der påvirker den måde nerveceller fungerer med henblik på

at behandle visse medicinske tilstande.

Hvis De tidligere har haft et alkohol- eller stofmisbrug.

Fortæl det straks til Deres læge, hvis De oplever følgende efter at have taget Quetiapin Accord:

En kombination af feber, alvorlig muskelstivhed, svedtendens eller nedsat bevidsthedsniveau (en

lidelse, der kaldes “malignt neuroleptikasyndrom”). Omgående medicinsk behandling kan være

nødvendig.

Ufrivillige bevægelser, primært i ansigtet eller tungen.

Svimmelhed eller en følelse af at være søvnig. Dette kan forøge risikoen for ulykker (fald) for ældre

mennesker.

Krampeanfald.

Langvarig og smertefuld erektion (priapismus).

Disse tilstande kan skyldes denne type medicin.

Fortæl det til lægen så hurtigt som muligt, hvis De har:

- feber, influenzalignende symptomer, ondt i halsen, eller enhver anden infektion, da dette kan være på

grund af et meget lavt antal hvide blodlegemer, som kan kræve ophør med Quetiapin Accord og/eller

yderligere behandling.

- forstoppelse sammen med vedvarende mavesmerter, eller forstoppelse, der ikke reagerer på behandling,

da dette kan føre til en mere alvorlig blokering af tarmen.

Selvmordstanker og forværring af Deres depression

Hvis De er deprimeret, tænker De måske nogle gange på at skade Dem selv eller begå selvmord. Disse tanker

kan forstærkes, når De begynder at tage Deres medicin, da der går noget tid, inden denne type lægemidler

virker, normalt omkring to uger, men nogle gange længere tid. Disse tanker kan også blive forstærket, hvis De

pludselig stopper med at tage Deres medicin. Det er mere sandsynligt, at De vil have sådanne tanker, hvis De er

en yngre voksen. Information fra kliniske forsøg viser, at der er en øget risiko for selvmordstanker og/eller

selvmordsadfærd hos yngre voksne under 25 år med depression.

Hvis De på noget tidspunkt tænker på at skade Dem selv eller begå selvmord, skal De straks kontakte Deres

læge eller tage på hospitalet. Det kan være en hjælp at fortælle en slægtning eller en god ven, at De er

deprimeret, og bede dem læse denne indlægsseddel. De kan bede dem fortælle Dem, hvis de mener, at Deres

depression bliver værre, eller hvis de er bekymrede over en ændring i Deres opførsel.

Vægtøgning

Der er set vægtøgning hos patienter, der tager Quetiapin Accord. De og Deres læge bør tjekke Deres vægt

regelmæssigt.

Børn og unge

Quetiapin Accord er ikke til brug hos børn og unge under 18 år.

Brug af anden medicin sammen med Quetiapin Accord:

Fortæl det altid til lægen eller apotekspersonalet, hvis De tager anden medicin eller har gjort det for nylig.

Tag ikke Quetiapin Accord, hvis De tager et eller flere af følgende lægemidler:

Visse lægemidler mod HIV.

Medicin, der indeholder azoler (mod svampeinfektioner).

Erythromycin eller clarithromycin (mod infektioner).

Nefazodon (mod depression).

Fortæl det til lægen, hvis De tager et af følgende lægemidler:

Medicin mod epilepsi (såsom phenytoin eller carbamazepin).

Lægemidler mod forhøjet blodtryk.

Barbiturater (mod søvnbesvær).

Thioridazin eller litium (andre antipsykotika).

Medicin, som påvirker Deres hjerteslag, f.eks. lægemidler, der kan forårsage ubalance i elektrolytterne (lave

niveauer af kalium eller magnesium), f.eks. diuretika (vanddrivende lægemidler) eller bestemte typer

antibiotika (medicin mod infektioner).

Lægemidler, der kan forårsage forstoppelse,

Lægemidler (kaldet "antikolinergika"), der påvirker den måde nerveceller fungerer for at kunne behandle

visse medicinske tilstande

Tal altid med Deres læge, før De stopper med at tage Deres medicin.

Brug af Quetiapin Accord sammen med mad og drikke:

Quetiapin Accords virkning kan påvirkes af mad, og De bør derfor tage Deres tabletter mindst en time før et

måltid eller umiddelbart inden, De går i seng.

Vær forsigtig med, hvor meget alkohol De indtager. Dette skyldes, at virkningen af Quetiapin Accord

sammen med alkohol kan gøre Dem søvnig.

Drik ikke grapefrugtjuice, mens De er i behandling med Quetiapin Accord. Det kan påvirke den måde,

medicinen virker på.

Graviditet, amning og frugtbarhed

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

spørge Deres læge eller apotekspersonalet til råds, før De tager dette lægemiddel. De bør ikke tage Quetiapin

Accord under graviditet, medmindre det sker efter aftale med Deres læge. De må ikke tage Quetiapin Accord,

hvis De ammer.

De følgende abstinenssymptomer kan forekomme hos nyfødte børn, hvis mødre har taget Quetiapin Accord i

det sidste trimester (de sidste tre måneder af deres graviditet): rysten, muskelstivhed og/eller –svaghed,

søvnighed, ophidselse, vejrtrækningsproblemer og problemer med at sutte. Hvis Deres spædbarn udvikler nogen

af disse symptomer, kan det være nødvendigt, at De kontakter Deres læge.

Trafik- og arbejdssikkerhed

Deres tabletter kan gøre Dem søvnig. De må ikke køre bil eller betjene maskiner, før De ved, hvordan

tabletterne påvirker Dem.

Quetiapin Accord indeholder lactose, hvor advarsel er påkrævet

Quetiapin Accord indeholder lactose, der er en sukkerart. Hvis lægen har fortalt Dem, at De ikke tåler visse

sukkerarter, skal De tale med lægen, inden De tager dette lægemiddel.

Påvirkning af narkotikatestning af urin

Hvis De får taget en urinprøve til narkotikatestning, mens De tager Quetiapin Accord, kan prøven vise et

positivt resultat for metadon eller nogle stoffer mod depression, som kaldes tricykliske antidepressiva (TCA),

når visse typer drugtest anvendes, selv om De ikke tager metadon eller TCA. Hvis dette sker, kan man tage en

mere nøjagtig test.

3.

Sådan skal De tage Quetiapin Accord

Tag altid lægemidlet nøjagtigt efter lægens eller apotekspersonalets anvisning. Er De i tvivl, så spørg lægen

eller på apoteket. Deres læge vil bestemme, hvilken dosis De skal begynde med.

Deres læge vil beslutte hvilken dosering De skal starte med. Vedligeholdelsesdosis (daglig dosis) vil afhænge af

Deres sygdom og behov, men vil normalt være mellem 150 mg og 800 mg.

De skal tage én tablet en gang om dagen.

Undlad at dele, tygge eller knuse tabletten.

Synk tabletten hel og drik et glas vand til.

Tag tabletten uden mad (mindst én time inden et måltid eller umiddelbart inden, De går i seng –

Deres læge vil fortælle hvornår).

De må ikke drikke grapefrugtjuice, når De tager Quetiapin Accord. Det kan påvirke den måde,

medicinen virker på.

Selv om De føler Dem bedre, må De ikke stoppe med at tage tabletterne, medmindre det sker efter

aftale med Deres læge.

Leverproblemer

Deres læge vil muligvis ændre Deres dosis, hvis De har leverproblemer.

Ældre

Deres læge vil muligvis ændre Deres dosis, hvis De er en ældre person.

Brug til børn og unge

Quetiapin Accord må ikke anvendes af børn og unge under 18 år.

Hvis De har taget for mange Quetiapin Accord

Hvis De tager flere Quetiapin Accord, end lægen har ordineret, kan De føle Dem søvnig, svimmel og få

uregelmæssig hjertebanken. Kontakt straks Deres læge eller tag til nærmeste hospital. Tag depottabletterne med

Dem.

Hvis De har glemt at tage Quetiapin Accord

Hvis De glemmer at tage en dosis, så tag den, så snart De kommer i tanke om det. Hvis det næsten er tid til den

næste dosis, skal De bare vente indtil da. De må ikke tage en dobbeltdosis som erstatning for den glemte tablet.

Hvis De holder op med at tage Quetiapin Accord

Hvis De pludselig stopper med at tage Quetiapin Accord, kan De måske ikke falde i søvn, eller De kan få

kvalme eller hovedpine, diarré, opkastning, blive svimmel eller irritabel. Deres læge vil muligvis foreslå, at De

nedsætter Deres dosis gradvist, inden De stopper behandlingen.

Spørg lægen, apotekspersonalet eller sundhedspersonalet, hvis der er noget, De er i tvivl om

.

4.

Bivirkninger

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

Meget almindelige bivirkninger (kan forekomme hos flere end 1 ud af 10 patienter):

Svimmelhed (kan føre til fald), hovedpine, tør mund.

Søvnighed (forsvinder muligvis med tiden, når De fortsætter med at tage Quetiapin Accord) (kan føre til

fald).

Seponeringssymptomer (symptomer, der forekommer, når De stopper med at tage quetiapin), inkluderer

søvnløshed, kvalme, hovedpine, diarré, opkastning, svimmelhed og irritabilitet. Gradvis nedtrapning over

en periode på mindst 1 til 2 uger anbefales.

Vægtforøgelse.

Unormale muskelbevægelser. Dette kan omfatte problemer med at starte muskelbevægelser, rysten,

rastløshed eller stivhed i musklerne uden smerter.

Ændringer i mængden af visse fedtstoffer (trigylcerider og totalkolesterol).

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

Hurtig hjertebanken.

Følelse af at hjertet slår meget kraftigt, meget hurtigt eller springer slag over.

Forstoppelse, maveproblemer (fordøjelsesbesvær).

Følelse af at være svag

Hævede arme eller ben.

Lavt blodtryk, når De rejser Dem op. De kan føle Dem svimmel eller besvime (kan føre til fald).

Forhøjet blodsukkerniveau.

Sløret syn.

Abnorme drømme og mareridt.

Øget sultfornemmelse.

Irritation.

Tale- og sprogforstyrrelser.

Selvmordstanker og forværring af Deres depression.

Stakåndethed.

Opkastning (primært hos ældre).

Feber.

Ændringer i indholdet af skjoldbruskkirtelhormoner i blodet.

Fald i antallet af visse typer blodceller.

Stigninger i indholdet af leverenzymer i blodet.

Stigninger i indholdet af hormonet prolaktin i blodet. Stigninger i hormonet prolaktin kan i sjældne

tilfælde medføre:

Brysthævelse og uventet dannelse af brystmælk hos mænd og kvinder.

Udebleven eller uregelmæssig menstruation hos kvinder.

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

Krampeanfald.

Overfølsomhedsreaktioner, der kan omfatte hævede knuder (kvadler), hævelse af huden og omkring

munden.

Ubehagelig følelse i benene (uro i benene).

Synkebesvær.

Ukontrollable bevægelser, primært i ansigt og tunge.

Nedsat seksualfunktion.

Sukkersyge.

Ændringer i den elektriske aktivitet i hjertet, hvilket kan ses på EKG (kaldet forlængelse af QT-interval).

Langsommere hjerterytme end normalt, hvilket kan forekomme, når behandlingen påbegyndes, og kan

være forbundet med lavt blodtryk og besvimelse.

Vandladningsbesvær.

Besvimelse (kan medføre fald).

Tilstoppet næse.

Nedsat antal røde blodlegemer.

Nedsat indhold af natrium (salt) i blodet.

Forværring af allerede eksisterende sukkersyge.

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

En kombination af forhøjet temperatur (feber), øget svedtendens, muskelstivhed, følelse af stærk

døsighed eller besvimelse (en lidelse, der kaldes ”malignt neuroleptikasyndrom”).

Gulfarvning af huden og øjnene (gulsot).

Leverbetændelse.

Langvarig og smertefuld erektion (priapismus).

Hævede bryster og uventet produktion af brystmælk (galaktoré).

Menstruationsforstyrrelser.

Blodpropper i venerne, særligt i benene (symptomer på dette inkluderer hævelse, smerte og rødmen af

benet), som gennem blodårerne kan transporteres til lungerne og forårsage smerter i brystet og problemer

med at trække vejret. Hvis De får nogle af disse symptomer, skal De straks søge læge.Gåen i søvne, talen

i søvne og søvnrelateret spiseforstyrrelse.

Nedsat legemstemperatur (hypotermi).

Betændelse i bugspytkirtlen.

En tilstand (kaldet “metabolisk syndrom”), hvor De oplever en kombination af tre eller flere af følgende

forhold: øget mængde fedt omkring maven, et fald i mængden af det “gode kolesterol” (HDL-C), en

stigning i en type fedt i Deres blod, som kaldes triglycerider, for højt blodtryk og en stigning i Deres

blodsukker.

Kombination af feber, influenzalignende symptomer, ondt i halsen, eller enhver anden infektion med

meget lavt antal hvide blodceller, en tilstand kaldet agranulocytose.

Forstoppelse.

Forhøjet blodkreatinkinase (et stof fra muskler).

Meget sjældne bivirkninger (kan forekomme hos op til 1 ud af 10.000 patienter):

Alvorligt udslæt, blærer eller røde pletter på huden.

En alvorlig allergisk reaktion (kaldet anafylaksi), der kan forårsage åndedrætsbesvær eller shock.

Pludselig hævelse af huden, som regel omkring øjne, læber og hals (angioødem).

En alvorlig hudlidelse med blære i mund, øjne og på kønsorganer (Stevens-Johnsons syndrom).

Unormal udskillelse af et hormon, der kontrollerer urinmængden.

Nedbrydning af muskelfibre og muskelsmerter (rhabdomyolyse).

Ikke kendt (hyppigheden kan ikke vurderes ud fra de tilgængelige data)

Hududslæt med uregelmæssige, røde pletter (etythema multiforme)

Alvorlig allergisk reaktion med symptomer såsom feber og blæredannelse i huden og hudafskalning

(toksisk epidermal nekrolyse).

Abstinenssymptomer kan forekomme hos nyfødte, hvor mødrene har brugt Quetiapin Accord under

graviditeten.

Den gruppe lægemidler, som Quetiapin Accord tilhører, kan forårsage hjerterytmeproblemer, der kan være

alvorlige, og som i værste fald kan medføre døden.

Nogle bivirkninger kan kun ses, når der tages en blodprøve. Det kan dreje sig om ændringer i mængden af visse

fedttyper (triglycerider og total kolesterol) eller sukker i blodet, ændringer af mængden af skjoldbruskkirtel-

hormoner i blodet, øget antal leverenzymer, fald i mængden af visse typer blodceller, fald i mængden af røde

blodceller, stigning i blodkreatinfosfokinase (et stof i musklerne), fald i mængden af natrium i blodet og

stigninger i mængden af hormonet prolaktin i blodet. Stigninger i hormonet prolaktin kan i sjældne tilfælde føre

til følgende:

Mænd og kvinder kan få hævede bryster og uventet produktion af brystmælk.

Kvinders menstruation kan udeblive, eller de kan have uregelmæssig menstruation.

Det kan være, at Deres læge med mellemrum vil tage blodprøver.

Bivirkninger hos børn og unge:

De bivirkninger, som forekommer hos voksne, kan også forekomme hos børn og unge.

Følgende bivirkning er ses oftere hos børn og unge eller er ikke set hos voksne:

Meget almindelige bivirkninger (kan forekomme hos flere end 1 ud af 10 patienter):

Stigninger i mængden af et hormon, der hedder prolaktin, i blodet. Stigninger i mængden af hormonet

prolaktin kan i sjældne tilfælde medføre følgende:

Drenge og piger kan få hævede bryster og uventet produktion af brystmælk.

Pigers menstruation kan udeblive, eller de kan have uregelmæssig menstruation.

Øget appetit.

Opkastning.

Unormale muskelbevægelser. Disse omfatter vanskeligheder med at starte muskelbevægelser, rysten,

følelse af rastløshed eller muskelstivhed uden smerte.

Blodtryksstigning.

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

-

Følelse af svaghed, besvimelse (kan føre til fald).

Tilstoppet næse.

Følelse af at være irriteret.

Indberetning af bivirkninger

Hvis De oplever bivirkninger, bør De tale med Deres læge, sygeplejerske eller apoteket. Dette gælder også

mulige bivirkninger, som ikke er medtaget i denne indlægsseddel. De eller Deres pårørende kan også indberette

bivirkninger direkte til Sundhedsstyrelsen via

Danmark

Lægemiddelstyrelsen

Axel Heides Gade 1

DK-2300 København S

Websted: www.meldenbivirkning.dk

E-mail: dkma@dkma.dk

Ved at indrapportere bivirkninger kan De hjælpe med at fremskaffe mere information om sikkerheden af dette

lægemiddel.

5.

Opbevaring

Opbevar lægemidlet utilgængeligt for børn.

Brug ikke lægemidlet efter den udløbsdato, der står på pakningen efter Exp. Udløbsdatoen er den

sidste dag i den nævnte måned.

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

smide medicinrester i afløbet, toilettet eller skraldespanden.

Dette lægemiddel kræver ingen særlige forholdsregler vedrørende opbevaringen.

6.

Pakningsstørrelser og yderligere oplysninger

Quetiapin Accord indeholder:

Aktivt stof: quetiapin (som hemifumarat). Hver Quetiapin depottablet indeholder enten 50 mg, 200 mg,

300 mg eller 400 mg quetiapin (som quetiapinhemifumarat).

Øvrige indholdsstoffer:

Tabletkerne: Lactosemonohydrat, hypromellose, natriumklorid, povidon K-30, talkum og

magnesiumstearat. 50 mg tabletter indeholder også silicificeret mikrokrystallinsk cellulose

(siliciumdioxid og mikrokrystallinsk cellulose).

Tabletovertræk: Titaniumdioxid (E171) og macrogol 400 (E1521). 50 mg tabletter indeholder også

poly(vinylalkohol) (E1203), talkum (E553b) og rød jernoxid (E172). 50 mg, 200 mg og 300 mg

tabletter indeholder også gul jernoxid (E172). 200 mg, 300 mg og 400 mg tabletter indeholder også

hypromellose 6 cP (E464).

Udseende og pakningsstørrelser

Quetiapin Accord 50 mg er ferskenfarvede, runde, bikonvekse, depottabletter, præget med ‘Q50’ på den ene side,

jævne på den anden side.

Quetiapin Accord 200 mg er gule, runde, bikonvekse, depottabletter, præget med ‘I2’ på den ene side, jævne på

den anden side. 200 mg diameter tablet er cirka 9,6 mm.

Quetiapin Accord 300 mg er lysegule, runde, bikonvekse depottabletter, præget med ‘Q300’ på den ene side,

jævne på den anden. 300 mg diameter tablet er ca. 11,2 mm.

Quetiapin Accord 400 mg er hvide, runde, bikonvekse, depottabletter, præget med ‘I4’ på den ene side, jævne på

den anden. 400 mg diameter tablet er ca. 12,8 mm.

PVC/PVDC-alu-blisterpakning. Pakningsstørrelser med 10, 30, 50, 60 og 100 tabletter pr. pakke er registreret for

Quetiapin Accord 200 mg, 300 mg og 400 mg depottabletter.

PVC/PVDC-alu-blisterpakning eller OPA/alu/PVC-alu-blisterpakning. Pakningsstørrelser med 6, 10, 20, 28, 30,

50, 60, 90 og 100 tabletter pr. pakker er registeret for Quetiapin Accord 50 mg depottabletter.

Ikke alle pakningsstørrelser er nødvendigvis markedsført.

Indehaver af markedsføringstilladelsen og fremstiller:

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

Pharmacare Premium Ltd

HHF 003, Hal Far Industrial Estate, Birzebbugia, BBG 3000

Malta

GAP S.A.,

46, Agissilaou str.

Agios Dimitrios, Athens

Post Code:17341

Grækenland

Quetiapin Accord 50 mg depottabletter

ARROW GENERIQUES- LYON,

26 avenue Tony Garnier, LYON, 69007,

Frankrig

Denne indlægsseddel blev senest ændret 02/2017.

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

2-7-2018

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

29-8-2018

Rasilez HCT (Noden Pharma DAC)

Rasilez HCT (Noden Pharma DAC)

Rasilez HCT (Active substance: aliskiren hemifumarate / hydrochlorothiazide) - Centralised - Renewal - Commission Decision (2018)5769 of Wed, 29 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/964/R/87

Europe -DG Health and Food Safety

28-8-2018

EU/3/18/2057 (Pharm Research Associates (UK) Limited)

EU/3/18/2057 (Pharm Research Associates (UK) Limited)

EU/3/18/2057 (Active substance: 1-(2-hydroxyethyl)-8-{[5-(4-methylpiperazin-1-yl)-2-(trifluoromethoxy) phenyl]amino}-4,5-dihydro-1H-pyrazolo[4,3-h]quinazoline-3-carboxamide fumarate salt) - Orphan designation - Commission Decision (2018)5729 of Tue, 28 Aug 2018 European Medicines Agency (EMA) procedure number: EMA/OD/051/18

Europe -DG Health and Food Safety

28-8-2018

EU/3/18/2055 (IQVIA RDS Ireland Limited)

EU/3/18/2055 (IQVIA RDS Ireland Limited)

EU/3/18/2055 (Active substance: (3R,3aS,9R,9aS,9bS)-3-((dimethylamino)methyl)-9-hydroxy-6,9-dimethyl-3,3a,4,5,7,8,9,9a-octahydroazuleno[4,5-b]furan-2(9bH)-one fumarate) - Orphan designation - Commission Decision (2018)5727 of Tue, 28 Aug 2018 European Medicines Agency (EMA) procedure number: EMA/OD/060/18

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

7-8-2018

Duaklir Genuair (AstraZeneca AB)

Duaklir Genuair (AstraZeneca AB)

Duaklir Genuair (Active substance: aclidinium bromide / formoterol fumarate dihydrate) - Centralised - Yearly update - Commission Decision (2018)5419 of Tue, 07 Aug 2018

Europe -DG Health and Food Safety

7-8-2018

Brimica Genuair (AstraZeneca AB)

Brimica Genuair (AstraZeneca AB)

Brimica Genuair (Active substance: aclidinium bromide / formoterol fumarate dihydrate) - Centralised - Yearly update - Commission Decision (2018)5420 of Tue, 07 Aug 2018

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

25-7-2018

Viread (Gilead Sciences Ireland UC)

Viread (Gilead Sciences Ireland UC)

Viread (Active substance: tenofovir disoproxil fumarate) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)4980 of Wed, 25 Jul 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/419/T/187

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