Escitalopram "Accord"

Primær information

  • Handelsnavn:
  • Escitalopram "Accord" 20 mg filmovertrukne tabletter
  • Dosering:
  • 20 mg
  • Lægemiddelform:
  • filmovertrukne tabletter
  • Brugt til:
  • Mennesker
  • Medicin typen:
  • Allopatiske stof

Dokumenter

Lokation

  • Fås i:
  • Escitalopram "Accord" 20 mg filmovertrukne tabletter
    Danmark
  • Sprog:
  • dansk

Andre oplysninger

Status

  • Kilde:
  • Lægemiddelstyrelsen - Danish Medicines Agency
  • Autorisation status:
  • Markedsført
  • Autorisationsnummer:
  • 47468
  • Sidste ændring:
  • 17-07-2018

Indlægsseddel

Indlægsseddel: Information til brugeren

Escitalopram Accord 5 mg filmovertrukne tabletter

Escitalopram Accord 10 mg filmovertrukne tabletter

Escitalopram Accord 20 mg filmovertrukne tabletter

Escitalopram (som oxalat)

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

indeholder vigtige oplysninger.

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

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

Lægen har ordineret Escitalopram Accord til dig personligt. Lad derfor være med at give

medicinen til andre. Det kan være skadeligt for andre, selv om de har de samme symptomer,

som du har.

lægen

eller

apotekspersonalet,

hvis

bivirkning

bliver

værre,

eller

får

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

Den nyeste indlægsseddel kan findes på www.indlaegsseddel.dk

Oversigt over indlægssedlen

Virkning og anvendelse

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

Sådan skal du tage Escitalopram Accord

Bivirkninger

Opbevaring

Pakningsstørrelser og yderligere oplysninger

1. Virkning og anvendelse

Escitalopram Accord tilhører en gruppe af lægemidler mod depression, som kaldes selektive

serotoningenoptagshæmmere (SSRI’er). Disse lægemidler påvirker serotoninsystemet i hjernen

ved at øge serotoninniveauet. Forstyrrelser i serotoninsystemet anses for at være en vigtig faktor i

udviklingen af depression og beslægtede sygdomme.

Escitalopram Accord indeholder escitalopram og anvendes til behandling af depression (svære

depressive episoder) og angst, såsom panikangst med eller uden agorafobi (angst for at befinde

sig på åbne steder eller i situationer med mange mennesker), socialfobi, generaliseret angst og

obsessiv-kompulsiv tilstand (tilbagevendende tvangstanker eller tvangshandlinger også kaldet

OCD).

Der kan gå nogle uger, før du begynder at få det bedre. Fortsæt med at tage Escitalopram Accord,

selv hvis der går noget tid, inden du kan mærke, at din tilstand forbedres.

Tal med lægen, hvis du ikke får det bedre, eller hvis du får det værre.

2. Det skal du vide, før du begynder at tage Escitalopram Accord

Tag ikke Escitalopram Accord

hvis du er allergisk over for escitalopram eller et af de øvrige indholdsstoffer i Escitalopram

Accord (angivet i punkt 6).

hvis du tager anden medicin, som tilhører en gruppe af lægemidler, der kaldes MAO-

hæmmere og omfatter selegilin (bruges til behandling af Parkinsons sygdom), moclobemid

(mod depression) og linezolid (et antibiotikum).

hvis du er født med eller oplever en episode med unormal hjerterytme (målt ved EKG, en

undersøgelse af, hvordan hjertet fungerer).

hvis

tager

medicin

hjerterytmeproblemer

eller

medicin,

påvirke

hjertetrytmen (se pkt. 2).

Advarsler og forsigtighedsregler

Fortæl det til lægen, hvis du har andre sygdomme eller lidelser, så lægen kan tage højde for dette.

Det er især vigtigt, at du fortæller det til lægen:

hvis du lider af epilepsi. Behandling med Escitalopram Accord bør stoppes, hvis du får

anfald

første

gang,

eller

hvis

hyppigheden

anfaldene

stiger

også

pkt.

"Bivirkninger").

hvis du har nedsat lever- eller nyrefunktion. Lægen skal måske ændre din dosis.

hvis du lider af diabetes. Behandling med Escitalopram Accord kan påvirke dit blodsukker.

derfor

være

nødvendigt

ændre

doseringen

insulin

og/eller

tabletter

behandling af diabetes.

hvis du har nedsat indhold af natrium i blodet.

hvis du let kommer til at bløde eller let får blå mærker.

hvis du får elektrochok-behandling (elektrokonvulsiv behandling).

hvis du har en hjertesygdom, som berører en af kranspulsårerne.

hvis du har eller har haft hjerteproblemer eller for nylig har haft et hjerteanfald.

hvis

hvilepuls,

og/eller

ved,

lider

saltmangel

følge

længerevarende, alvorlig diarré og opkastning (sygdom) eller brug af vanddrivende midler

(diuretika).

hvis du har hurtig eller uregelmæssig hjerterytme, besvimer, kollapser eller bliver svimmel,

når du rejser dig op. Dette kan være tegn på, at hjertet ikke fungerer normalt.

hvis du har øjenproblemer, såsom visse typer grøn stær (øget tryk i øjet).

Bemærk venligst

Nogle patienter med maniodepressiv sygdom kan få en manisk periode. En manisk periode er

karakteriseret af usædvanlige og hurtigt skiftende idéer, umotiveret glæde og overdreven fysisk

aktivitet. Hvis du oplever dette, skal du kontakte din læge.

Symptomer såsom rastløshed eller besvær med at sidde eller stå stille kan forekomme i de første

uger af behandlingen. Fortæl det straks til din læge, hvis du oplever disse symptomer.

Selvmordstanker og forværring af din depression eller angst

Hvis du er deprimeret og/eller lider af angst, kan du sommetider have tanker om at gøre skade på

dig selv eller tage dit eget liv. Disse tanker kan blive forstærket, når du starter på at tage medicin

mod depression, fordi medicinen er et stykke tid om a virke, ofte omkring 14 dage, men nogle

gange længere tid.

Du kan have øget risiko for sådanne tanker:

Hvis du tidligere har haft tanker om at tage dit eget liv eller gøre skade på dig selv.

Hvis du er ung. Information fra kliniske forsøg har vist, at der er en øget risiko for

selvmordsadfærd hos voksne under 25 år med psykiatriske lidelser, som blev behandlet med

antidepressiv medicin.

Hvis du har eller på noget tidspunkt får tanker om at gøre skade på dig selv eller tage dit eget liv,

skal du straks kontakte din læge eller tage på hospitalet.

Det kan måske være en hjælp at tale med en pårørende eller en nær ven om

, at du er

deprimeret eller angst, og bede dem om at læse denne indlægsseddel. Du kan eventuelt bede dem

om at fortælle dig, hvis de synes, at din depression eller angst bliver værre, eller hvis de er

bekymrede over ændringer i din adfærd.

Børn og unge under 18 år

Escitalopram Accord bør normalt ikke anvendes til børn og unge under 18 år. Du bør også være

opmærksom på, at patienter under 18 år har øget risiko for bivirkninger såsom selvmordsforsøg,

selvmordstanker og fjendtlighed (især aggressivitet, trodsighed og vrede), når de tager denne

slags medicin. På trods af dette kan lægen vælge at ordinere Escitalopram Accord til patienter

under 18 år, hvis lægen vurderer, at det vil være det bedste for dem. Hvis din læge har ordineret

Escitalopram Accord til en patient under 18 år, og du ønsker at drøfte dette, skal du kontakte din

læge. Du bør informere lægen, hvis nogle af de ovenfor omtalte symptomer opstår eller tager til

hos en patient under 18 år, der tager escitalopram. Desuden foreligger der endnu ikke data om

den langsigtede sikkerhed med hensyn til vækst, modning og udvikling af åndsevner og adfærd,

når Escitalopram Accord gives til denne aldersgruppe.

Brug af anden medicin sammen med Escitalopram Accord

Fortæl det altid til lægen eller apotekspersonalet, hvis du bruger anden medicin eller har gjort det

for nylig. Dette gælder også medicin, som ikke er købt på recept.

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

Såkaldte

non-selektive

monoaminoxidasehæmmere

(MAO-hæmmere),

indeholder

phenelzin, iproniazid, isocarboxazid, nialamid eller tranylcypromin som det aktive stof. Hvis

du har taget et af disse lægemidler, skal der gå 14 dage, før du begynder at tage Escitalopram

Accord. Når behandlingen med Escitalopram Accord er ophørt, skal der gå 7 dage, før du må

begynde at tage et af disse midler.

Såkaldte reversible, selektive MAO-A-hæmmere, der indeholder moclobemid (anvendes

mod depression).

Såkaldte irreversible MAO-B-hæmmere, der indeholder selegilin (mod Parkinsons sygdom).

Medicin af denne type øger risikoen for bivirkninger.

Linezolid (et anitibiotikum).

Lithium (bruges til behandling af maniodepressivitet) og tryptophan.

Imipramin og desipramin (begge bruges til behandling af depression).

Sumatriptan og lignende lægemidler (til behandling af migræne) og tramadol (anvendes mod

kraftige smerter). Medicin af denne type øger risikoen for bivirkninger.

Cimetidin,

lansoprazol

omeprazol

(til

behandling

mavesår),

fluvoxamin

(mod

depression)

ticlopidin

(nedsætter

risikoen

slagtilfælde).

Disse

midler

øge

mængden af Escitalopram Accord i blodet.

Prikbladet perikon (

Hypericum perforatum

) - et naturlægemiddel mod depression.

Acetylsalicylsyre og NSAID (nonsteroide antiinflammatoriske midler) (medicin til at lindre

smerter

eller

fortynde

blodet,

såkaldte

antikoagulanter).

Disse

medføre

øget

blødningstendens.

Warfarin,

dipyridamol

phenprocoumon

(medicin,

bruges

fortynde

blodet,

såkaldte anti-koagulanter). Din læge vil sikkert undersøge, hvor længe dit blod er om at

størkne

(koagulationstiden)

påbegyndelse

afslutning

behandlingen

Escitalopram

Accord

sikre,

stadig

får

tilstrækkelig

dosis

blodfortyndende middel.

Mefloquin (til behandling af malaria), bupropion (anvendes til behandling af depression) og

tramadol (til behandling af svære smerter) på grund af øget risiko for, at du får kramper.

Neuroleptika (medicin til behandling af skizofreni og andre psykoser) og midler mod

depression (tricykliske antidepressiva og SSRI’er) på grund af øget risiko for, at du får

kramper.

Flecainid,

propafenon

metoprolol

(mod

hjerte-

karsygdomme),

clomipramin

nortriptylin (mod depression) og risperidon, thioridazin og haloperidol (antipsykotika). Det

kan være nødvendigt at ændre din dosis af Escitalopram Accord.

IKKE

DETTE

LÆGEMIDDEL,

hvis

tager

medicin

behandling

hjerterytmeproblemer eller medicin, der kan påvirke hjertetrytmen, såsom antiarytmika (medicin

mod hjerterytmeforstyrrelser) af klasse IA og III, medicin mod psykoser (antipsykotika) (f.eks.

såkaldte phenothiazin-derivater, pimozid, haloperidol), såkaldte tricykliske antidepressiva, visse

antimikrobielle

stoffer

(stoffer,

anvendes

mikroorganismer)

(f.eks.

sparfloxacin,

moxifloxacin, intravenøs erythromycin, pentamidin, anti-malaria-behandling, især halofantrin),

visse antihistaminer (f.eks. astemizol, mizolastin). Tal med din læge, hvis du har yderligere

spørgsmål.

Brug af Escitalopram Accord sammen med mad, drikke og alkohol

Escitalopram Accord kan tages i forbindelse med et måltid, men det er ikke nødvendigt (se pkt.

3: "Sådan skal du tage escitalopram").

Som tilfældet er med en række lægemidler bør Escitalopram Accord ikke kombineres med

alkohol, selvom Escitalopram Accord ikke forventes at reagere med alkohol.

Graviditet, amning og frugtbarhed

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

skal du spørge din læge eller apotekspersonalet til råds, før du tager dette lægemiddel. Hvis du er

gravid eller ammer, må du kun tage Escitalopram Accord, hvis du har drøftet fordele og risici

med lægen. Hvis du tager Escitalopram Accord i de sidste 3 måneder af graviditeten, skal du

være opmærksom på, at det kan have følgende virkninger på den nyfødte: vejrtrækningsbesvær,

blålig hud, anfald, forandringer i kropstemperatur, problemer med madning, opkastning, lavt

blodsukker, stive eller slappe muskler, voldsomme reflekser, skælven, nervøsitet, irritabilitet,

sløvhed, konstant gråd, søvnighed og søvnbesvær. Kontakt omgående lægen, hvis dit nyfødte

barn har nogen af disse symptomer.

Fortæl din jordemoder og/eller læge, at du tager Escitalopram Accord. Når lægemidler som

Escitalopram Accord tages under graviditeten, især i de sidste 3 måneder af graviditeten, kan det

øge risikoen for en alvorlig tilstand med forhøjet tryk i lungekredsløbet hos den nyfødte (såkaldt

persisterende pulmonal hypertension hos den nyfødte (PPHN)). Dette medfører, at barnet trækker

vejret hurtigere og bliver blåligt. Disse symptomer begynder normalt i løbet af det første døgn

efter fødslen. Hvis dette sker for dit barn, skal du straks kontakte din jordemoder eller læge.

Hvis du tager Escitalopram Accord, mens du er gravid, må du ikke stoppe behandlingen brat.

Det forventes, at escitalopram udskilles i modermælk.

Tag ikke Escitalopram Accord, mens du ammer, medmindre du har drøftet de risici og fordele,

som dette indebærer med din læge.

I dyreforsøg har citalopram, et lægemiddel, der minder om escitalopram, vist sig at nedsætte

sædkvaliteten. Teoretisk set kan det betyde, at menneskers fertilitet påvirkes, men der er indtil

videre ikke observeret nogen indflydelse på fertiliteten hos mennesker.

Spørg din læge eller apoteket til råds, før du tager nogen form for medicin.

Trafik- og arbejdssikkerhed

Det anbefales, at du ikke færdes i trafikken eller betjener maskiner, før du ved, hvordan

Escitalopram Accord påvirker dig.

3. Sådan skal du tage Escitalopram Accord

Tag altid Escitalopram Accord nøjagtigt efter lægens anvisning. Er du i tvivl, så spørg lægen

eller på apoteket.

Voksne

Depression

Den anbefalede dosis Escitalopram Accord er 10 mg taget som én daglig dosis. Din læge kan øge

denne dosis op til højst 20 mg dagligt.

Panikangst

Startdosis af Escitalopram Accord er 5 mg taget som én daglig dosis i den første uge, hvorefter

dosis øges til 10 mg pr. dag. Lægen kan øge denne dosis yderligere op til højst 20 mg pr. dag.

Socialangst

Den anbefalede dosis af Escitalopram Accord er 10 mg taget som én daglig dosis. Lægen kan

enten nedsætte dosis til 5 mg dagligt eller øge dosis op til højst 20 mg dagligt afhængig af,

hvordan du reagerer på medicinen.

Generaliseret angst

Den anbefalede dosis af Escitalopram Accord er 10 mg taget som én daglig dosis. Din læge kan

øge denne dosis op til højst 20 mg dagligt.

Obsessiv-kompulsiv tilstand

Den anbefalede dosis af Escitalopram Accord er 10 mg taget som én daglig dosis. Din læge kan

øge denne dosis op til højst 20 mg dagligt.

Ældre (over 65 år)

Den anbefalede startdosis af Escitalopram Accord er 5 mg taget som én daglig dosis. Din læge

kan forøge din dosis til 10 mg pr. dag.

Børn og unge (under 18 år)

Børn under 18 år må normalt ikke få Escitalopram Accord. For yderligere oplysninger, se afsnit

Du kan tage Escitalopram Accord med eller uden mad. Synk tabletten med noget vand. Lad være

med at tygge den, da smagen er bitter.

Om nødvendigt kan tabletterne deles, ved at du først anbringer tabletten på en plan overflade

med delekærven opad. Derefter kan tabletten knækkes ved at der trykkes

nedad med en

pegefinger i hver ende med fingerspidserne placeret som vist på tegningen.

Kun 10 mg og 20 mg tabletter kan deles i to lige store doser.

Behandlingens varighed

Der kan gå et par uger, før du begynder at få det bedre. Fortsæt med at tage Escitalopram

Accord, selvom der går nogen tid, før du kan mærke en bedring af din tilstand.

Du må ikke ændre din dosis af lægemidlet uden først at have talt med din læge.

Fortsæt med at tage Escitalopram Accord i den periode, som din læge har anbefalet. Hvis du

stopper behandlingen for tidligt, kan symptomerne vende tilbage. Det anbefales at fortsætte

behandlingen i mindst 6 måneder, efter at du har fået det godt igen.

Hvis du har taget for mange Escitalopram Accord-tabletter

Kontakt omgående lægen eller skadestuen på det nærmeste hospital, hvis du har taget flere

tabletter, end lægen har foreskrevet, også selvom du ikke føler dig utilpas. Tegn på en overdosis

kan være svimmelhed, skælven, ophidselse, krampe, koma, kvalme, opkastning, forandringer i

hjerterytmen,

fald

blodtryk

eller

forandringer

kroppens

salt-/væskebalance.

æsken/beholderen med Escitalopram Accord med, når du tager til lægen eller på hospitalet.

Hvis du har glemt at tage

Escitalopram Accord

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

en dosis, og du kommer i tanke om det, før du går i seng, skal du tage den med det samme.

Fortsæt med den sædvanlige dosis næste dag. Hvis du først kommer i tanke om det i løbet af

natten eller næste dag, skal du springe den glemte dosis over og fortsætte som sædvanligt.

Hvis du holder op med at tage

Escitalopram Accord

Stop ikke behandlingen med Escitalopram Accord, medmindre din læge siger, du skal gøre det.

Når

gennemført

planlagte

behandling,

anbefales

normalt

stoppe

Escitalopram Accord ved at nedtrappe dosis over nogle uger.

Når du holder op med at tage Escitalopram Accord, og især hvis det sker brat, kan du få

seponeringssymptomer. Dette er almindeligt ved ophør af behandlingen med Escitalopram

Accord. Risikoen er større, når Escitalopram Accord er blevet anvendt i længere tid eller i store

doser, eller når dosis nedtrappes for hurtigt. De fleste oplever, at symptomerne er milde og

aftager af sig selv i løbet af to uger. Imidlertid kan de hos nogle patienter være svære eller

langvarige

(2-3

måneder

eller

længere).

Kontakt

lægen,

hvis

får

svære

seponeringssymptomer, når du holder op med at tage Escitalopram Accord. Din læge kan foreslå,

at du begynder at tage tabletterne igen og derefter nedtrapper dem over en længere periode.

Seponeringssymptomer omfatter: svimmelhed (usikker på benene eller dårlig balance), prikken

eller stikken, svie og (mindre almindeligt) fornemmelse af at få elektrisk stød, også i hovedet,

søvnforstyrrelser (voldsomme drømme, mareridt, søvnløshed), angst, hovedpine, følelse af at

være syg (kvalme), øget svedtendens (også om natten), rastløshed eller ophidselse, skælven

(rysten), forvirring eller desorientering, letpåvirkelighed eller irritabilitet, diarré (tynd afføring),

synsforstyrrelser, hjertebanken (palpitationer).

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

4. Bivirkninger

Escitalopram Accord kan som al anden medicin give bivirkninger, men ikke alle får bivirkninger.

Bivirkningerne forsvinder som regel efter nogle ugers behandling. Vær opmærksom på, at mange

af disse bivirkninger også kan være symptomer på sygdommen og derfor vil aftage, når du

begynder at få det bedre.

Hvis du får nogle af følgende symptomer, skal du straks søge læge eller tage på hospitalet:

Ikke almindelig

(kan forekomme hos op til 1 ud af 100 patienter)

Usædvanlige blødninger, herunder mave-tarm-blødninger

Sjælden

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

Hævelser i huden, tungen, læberne eller ansigtet eller har besvær med at trække vejret eller

synke (allergisk reaktion)

Høj

feber

eller

lider

ophidselse,

forvirring,

skælven

pludselige

muskel-

sammentrækninger,

være

tegn

sjælden

tilstand,

kaldes

serotonergt

syndrom.

Ikke kendt

(hyppigheden kan ikke anslås ud fra de foreliggende data)

Besvær med at lade vandet

Hurtig, uregelmæssig hjerterytme og/eller besvimelse, der kan være symptomer på en

livstruende tilstand, der kaldes torsades de pointes.

Kramper (anfald), se også afsnit 2 "Advarsler og forsigtighedsregler”

Gulfarvning

huden

hvide

øjnene

være

tegn

nedsat

lever-

funktion/leverbetændelse

Tanker om at gøre skade på sig selv eller tage sit eget liv. Se også punktet: “Vær ekstra

forsigtig med at tage escitalopram”.

Desuden er følgende bivirkninger indberettet:

Meget almindelig

(kan forekomme hos flere end 1 ud af 10 patienter)

Følelse af at være syg (kvalme)

Hovedpine

Almindelig

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

Tilstoppet eller løbende næse (sinuitis)

Nedsat eller øget appetit

Angst,

rastløshed,

unormale

drømme,

problemer

falde

søvn,

søvnighed,

svimmelhed, gaben, skælven, prikken i huden

Diarré, forstoppelse, opkastning, tør mund

Øget svedtendens

Smerter i muskler og led (artralgi og myalgi)

Seksuelle forstyrrelser (forsinket sædafgang, rejsningsproblemer, nedsat lyst til sex samt hos

kvinder problemer med at få orgasme)

Træthed, feber

Øget vægt

Ikke almindelig

(kan forekomme hos op til 1 ud af 100 patienter)

Nældefeber (urticaria), udslæt, kløe (pruritus)

Tænderskæren, ophidselse, nervøsitet, panikanfald, forvirring

Søvnforstyrrelser, smagsforstyrrelser, besvimelse (synkope)

Forstørrede pupiller (mydriase), synsforstyrrelser, ringen for ørene (tinnitus)

Hårtab

Abnorm menstruationsblødning

Uregelmæssig menstruation

Vægttab

Hurtig puls

Hævelser i arme eller ben

Næseblod

Sjælden

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

Aggression, depersonalisering, hallucinationer

Langsom puls

Ikke kendt (kan ikke anslås ud fra de foreliggende data):

Nedsat

indhold

natrium

blodet

(symptomerne

kvalme

utilpashed

muskelsvækkelse eller forvirring)

Ændringer i hjerterytmen (kaldet “forlængelse af QT-intervallet”, der kan måles ved EKG-

scanning af hjertets elektriske aktivitet).

Svimmelhed på grund af fald i blodtryk, når man rejser sig (ortostatisk hypotension)

Unormale leverfunktionsprøver ((øgede mængder leverenzymer i blodet)

Bevægelsesforstyrrelser (ufrivillige muskelbevægelser)

Smertefulde erektioner (priapisme)

Tegn på øget blødning, f.eks. fra hud og slimhinder (ekkymose).

Pludselige hævelser i huden eller slimhinderne (angioødemer)

Stigning i mængden af urin ved vandladning (uhensigtsmæssig produktion af antidiuretika-

hormon)

Mælkeflåd hos mænd og kvinder, som ikke ammer

Mani

Der er set øget risiko for knoglebrud hos patienter, der tager denne type medicin

Desuden har man kendskab til en række bivirkninger ved lægemidler, som virker på samme

måde som escitalopram (det aktive stof i Escitalopram Accord). Det drejer sig om:

Motorisk rastløshed (akatisi)

Tab af appetit

Indberetning af bivirkninger

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

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

pårørende kan også indberette bivirkninger direkte til Lægemiddelstyrelsen via

Lægemiddelstyrelsen Axel Heides Gade 1

DK-2300 København S

Websted: www.meldenbivirkning.dk

E-mail: dkma@dkma.dk

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

sikkerheden af dette lægemiddel.

5. Opbevaring

Opbevar 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.

Må ikke opbevares ved temperaturer over 30 °C.

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

smide medicinrester i afløbet, toilettet eller skraldespanden.

6. Pakningsstørrelser og yderligere oplysninger

Escitalopram Accord indeholder

Aktivt stof: escitalopram.

Hver Escitalopram Accord 5 mg filmovertrukne tablet indeholder 5 mg escitalopram (som

oxalat).

Hver Escitalopram Accord 10 mg filmovertrukne tablet indeholder 10 mg escitalopram (som

oxalat).

Hver Escitalopram Accord 20 mg filmovertrukne tablet indeholder 20 mg escitalopram (som

oxalat).

Øvrige indholdsstoffer:

Kerne:

mikrokrystallinsk

cellulose

101)

(E460),

croscarmellosenatrium

(E468),

hypromellose E5 (E464), talkum (E553b), vandfri kolloid silica (E551), magnesiumstearat

(E470b).

Overtræk: hypromellose E-15 (E464), titandioxid (E171), macrogol 400

Udseende og pakningsstørrelser

Escitalopram Accord filmovertrukne tabletter fås som 5 mg, 10 mg and 20 mg filmovertrukne

tabletter. Tabletterne er beskrevet nedenfor.

5 mg:

Hvide til offwhite, runde, bikonvekse, filmovertrukne tabletter med en diameter på ca.

5,65 mm, jævne på begge sider.

10 mg: Hvide til offwhite, ovale, bikonvekse, filmovertrukne tabletter, ca. 8,10 mm lange og

5,60 mm brede, med inskriptionen ‘1’ og ‘0’ på hver side af delekærven på den ene

side og jævne på den anden side.

20 mg: Hvide til offwhite, ovale, bikonvekse, filmovertrukne tabletter, ca. 11,60 mm lange og

7,10 mm brede, med delekærv på den ene side, jævne på den anden side.

10 mg og 20 mg tabletter kan deles i to lige store doser.

Escitalopram Accord fås i følgende pakningsstørrelser:

Blister(e) i ydre karton:

5 mg, 10 mg og 20 mg: 14, 28, 56 og 98 tabletter

HDPE-flaskepakninger med 100 tabletter.

Ikke alle pakningsstørrelser er nødvendigvis markedsført.

Indehaver af markedsføringstilladelsen

Accord Healthcare Limited, Sage House, 319 Pinner Road, North Harrow Middlesex,

HA1 4HF, Storbritannien

Fremstiller

Accord Healthcare Limited, Sage House, 319, Pinner Road, North Harrow, Middlesex,

HA1 4HF, Storbritannien

Pharmacare Premium Ltd.,

HHF 003, Hal Far Industrial Estate, Birzebbugia,

BBG 3000,

Malta.

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

Østrig

Escitalopram Accord 5 mg/10mg/20mg filmtabletten

Tjekkiet

Escitalopram Accord 5 mg /10mg/20mg potahované tablety

Danmark

Escitalopram Accord Healthcare

Estland

Escitalopram Accord 10 mg/20mg

Irland

Escitalopram 5 mg/10mg/20mg film-coated tablets

Letland

Escitalopram Accord 10 mg/20mg apvalkotās tabletes

Portugal:

Escitalopram Accord

Spanien

Escitalopram Accord 5 mg /10mg/20mg comprimidos recubiertos

con película

Bulgarien

Escitalopram Accord 10 mg филмирани таблетки

Finland

Escitalopram Accord 10/20 mg Tabletti, kalvopäällysteinen

Italien

Escitalopram Accord

Holland

Escitalopram Accord 5 mg/10 mg /20 mg Filmomhulde tabletten

Sverige

Escitalopram Accord 5 mg /10 mg /20 mg Filmdragerade tabletter

Slovakiet

Escitalopram Accord 10 mg /20 mg filmom obalené tablety

Storbritannien

Escitalopram 5 mg/10 mg /20 mg Film-coated tablets

Denne indlægsseddel blev senest revideret: 03/2016

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

6-4-2018

"Organic Traditions Shatavari Powder" sold at Choices Markets Yaletown in Vancouver, B.C., contaminated with Salmonella

"Organic Traditions Shatavari Powder" sold at Choices Markets Yaletown in Vancouver, B.C., contaminated with Salmonella

Health Canada is advising Canadians that one lot of “Organic Traditions Shatavari Powder” is being voluntarily recalled by Advantage Health Matters Inc. Company testing found Salmonella bacteria contamination, which may pose serious health risks. According to Advantage Health Matters Inc., 13 units from the affected lot were distributed. Of the 13 units, only 2 packages, sold at Choices Markets Yaletown (1202 Richards Street) in Vancouver, B.C., have not been recovered.

Health Canada

23-1-2018

Overview of changes requiring an inspection in the GMP area

Overview of changes requiring an inspection in the GMP area

Companies that manufacture medicines must be authorised to perform manufacturing activities by the Danish Medicines Agency according to section 39 of the Danish Medicines Act. They must comply with the rules on good manufacturing practice (GMP) and will be inspected regularly by our GMP inspectors.

Danish Medicines Agency

22-1-2018

Flawless Beauty, LLC Issues Voluntary Recall of Unapproved Drugs

Flawless Beauty, LLC Issues Voluntary Recall of Unapproved Drugs

Ocean Township, NJ. In accordance with a Consent Decree of Permanent Injunction ordered in the United States District Court for the District of New Jersey, Flawless Beauty, LLC is voluntarily recalling all lots of nineteen different products sold individually or as part of multi-unit kits alleged by the U.S. Food and Drug Administration ("FDA") to be misbranded or unapproved new drugs pursuant to the Federal Food, Drug, and Cosmetic Act. The FDA believes that these drugs present serious public health risks.

FDA - U.S. Food and Drug Administration

11-2-2015

MIA format updated according to EMA's community procedures

MIA format updated according to EMA's community procedures

We have updated our IT systems and are now able to transfer Manufacturing and Importation Authorisations (MIA) to EudraGMDP via EMA's latest XML form. This implies some changes to how we will issue MIAs in future.

Danish Medicines Agency

5-1-2015

Fees for medical devices in 2015

Fees for medical devices in 2015

The fees for medical devices have been adjusted in accordance with Danish Government regulations, including the fees for registration of manufacturers and devices, importers and distributors, assessment of applications for the authorisation for clinical investigation of medical devices, and amendments to investigations, as well as supervision and control of notified bodies in Denmark.

Danish Medicines Agency

3-7-2014

More clinical trials to Denmark

More clinical trials to Denmark

The number of clinical trial applications increased by 35 trials (14%) from 2012 to 2013, which is the highest level in seven years. The increase covers both companies and researchers according to the Danish Health and Medicines Authority's annual report 2013 on clinical trials of medicines in humans.

Danish Medicines Agency

25-9-2018

Pelgraz (Accord Healthcare Limited)

Pelgraz (Accord Healthcare Limited)

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

Europe -DG Health and Food Safety

24-9-2018

Lenalidomide Accord (Accord Healthcare Limited)

Lenalidomide Accord (Accord Healthcare Limited)

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

Europe -DG Health and Food Safety

7-8-2018

Accofil (Accord Healthcare Limited)

Accofil (Accord Healthcare Limited)

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

Europe -DG Health and Food Safety

7-8-2018

Memantine Accord (Accord Healthcare Limited)

Memantine Accord (Accord Healthcare Limited)

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

Europe -DG Health and Food Safety

6-8-2018

Zoledronic acid Accord (Accord Healthcare Limited)

Zoledronic acid Accord (Accord Healthcare Limited)

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

Europe -DG Health and Food Safety

18-7-2018

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

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

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

FDA - U.S. Food and Drug Administration

4-7-2018

Docetaxel Accord (Accord Healthcare Limited)

Docetaxel Accord (Accord Healthcare Limited)

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

Europe -DG Health and Food Safety

3-7-2018

Temozolomide Accord (Accord Healthcare Limited)

Temozolomide Accord (Accord Healthcare Limited)

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

Europe -DG Health and Food Safety

11-6-2018

Pemetrexed Accord (Accord Healthcare Limited)

Pemetrexed Accord (Accord Healthcare Limited)

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

Europe -DG Health and Food Safety

30-5-2018

Bortezomib Accord (Accord Healthcare Limited)

Bortezomib Accord (Accord Healthcare Limited)

Bortezomib Accord (Active substance: bortezomib) - Centralised - Variation - Commission Decision (2018)3460 of Wed, 30 May 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/3984/X/8

Europe -DG Health and Food Safety

23-5-2018

Scientific guideline:  Draft guideline on the responsibilities of the sponsor with regard to handling and shipping of investigational medicinal products for human use in accordance with good clinical practice and good manufacturing practice, draft: consul

Scientific guideline: Draft guideline on the responsibilities of the sponsor with regard to handling and shipping of investigational medicinal products for human use in accordance with good clinical practice and good manufacturing practice, draft: consul

The guideline lays down the principles for the two-step release and shipping of the investigational medicinal products by the qualified person and the sponsor. The guideline also describes the areas of interface between the manufacturer and the sponsor and the required contractual agreements.

Europe - EMA - European Medicines Agency

15-5-2018

Pramipexole Accord (Accord Healthcare Limited)

Pramipexole Accord (Accord Healthcare Limited)

Pramipexole Accord (Active substance: pramipexole) - Centralised - Yearly update - Commission Decision (2018)2995 of Tue, 15 May 2018

Europe -DG Health and Food Safety