Imatinib Accord

Primær information

  • Handelsnavn:
  • Imatinib Accord
  • Brugt til:
  • Mennesker
  • Medicin typen:
  • Allopatiske stof

Dokumenter

Lokation

  • Fås i:
  • Imatinib Accord
    Den Europæiske Union
  • Sprog:
  • dansk

Terapeutisk information

  • Terapeutisk gruppe:
  • Proteinkinasehæmmere
  • Terapeutisk område:
  • Leukæmi, myelogen, kronisk, BCR-ABL positiv
  • Terapeutiske indikationer:
  • Imatinib Accord er indiceret til behandling af:.

Andre oplysninger

Status

  • Kilde:
  • EMA - European Medicines Agency
  • Autorisation status:
  • autoriseret
  • Autorisationsnummer:
  • EMEA/H/C/002681
  • Autorisation dato:
  • 01-07-2013
  • EMEA kode:
  • EMEA/H/C/002681
  • Sidste ændring:
  • 28-02-2018

Offentlige vurderingsrapport

EMA/393159/2017

EMEA/H/C/002681

EPAR - sammendrag for offentligheden

Imatinib Accord

imatinib

Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Imatinib

Accord. Det forklarer, hvordan agenturet vurderede lægemidlet for at kunne anbefale udstedelse af en

markedsføringstilladelse i EU og fastlægge anvendelsesbetingelserne. Det er ikke en praktisk

vejledning i, hvordan Imatinib Accord bør anvendes.

Hvis du ønsker praktisk vejledning om anvendelsen af Imatinib Accord, kan du læse indlægssedlen

eller kontakte din læge eller dit apotek.

Hvad er Imatinib Accord, og hvad anvendes det til?

Imatinib Accord er et lægemiddel mod kræft, som anvendes til at behandle følgende sygdomme:

kronisk myeloid leukæmi (CML), en form for kræft, som angriber de hvide blodlegemer, hvori der

er granulocytter (en form for hvide blodlegemer), som begynder at vokse ukontrolleret. Imatinib

Accord anvendes, når patienten er "Philadelphiakromosompositiv" (Ph+). Det betyder, at nogle af

patientens gener har omarrangeret sig, så de danner et specielt kromosom, der kaldes

Philadelphiakromosomet. Imatinib Accord anvendes til voksne og børn, som for nylig har fået

diagnosticeret Ph+ CML og ikke er egnede til en knoglemarvstransplantation. Det anvendes også til

voksne og børn i den "kroniske fase" af sygdommen, hvis den ikke reagerer på interferon alfa (et

andet lægemiddel mod kræft), og i de mere fremskredne faser af sygdommen ("accelereret fase"

og "blastkrise")

Ph+ akut lymfoblastisk leukæmi (ALL), en kræftform, hvor lymfocytterne (en anden form for hvide

blodlegemer) formerer sig for hurtigt. Imatinib Accord anvendes i kombination med andre

kræftlægemidler til voksne og børn, som for nylig har fået diagnosticeret Ph+ ALL. Det anvendes

desuden alene hos voksne til behandling af Ph+ ALL ved tilbagefald af sygdommen efter

forudgående behandling eller når sygdommen ikke reagerer på andre lægemidler

myelodysplastiske eller myeloproliferative sygdomme (MD/MPD), som er en gruppe af sygdomme,

hvor kroppen producerer et stort antal unormale blodlegemer. Imatinib Accord anvendes til

Imatinib Accord

EMA/393159/2017

Side 2/3

behandling af voksne med MD/MPD, hos hvem genet for blodpladederiveret vækstfaktorreceptor

(PDGFR) har omarrangeret sig

fremskredent hypereosinofilt syndrom (HES) eller kronisk eosinofil leukæmi (CEL), som er

sygdomme, hvor eosinofiler (en anden form for hvide blodlegemer) begynder at vokse

ukontrolleret. Imatinib Accord anvendes til behandling af voksne med HES eller CEL, hos hvem der

forekommer en særlig-omarrangering af de to gener FIP1L1 og PDGFRα

dermatofibrosarcoma protuberans (DFSP), en form for kræft (sarkom), hvor cellerne i vævet under

huden begynder at dele sig ukontrolleret. Imatinib Accord anvendes til behandling af voksne med

DFSP, der ikke kan fjernes ved operation, og til voksne, som er uegnede til operation, når der er

tilbagefald af kræften efter behandling, eller når den har bredt sig til andre dele af kroppen.

Imatinib Accord indeholder det aktive stof imatinib. Det er et "generisk lægemiddel". Det betyder, at

Imatinib Accord er identisk med et "referencelægemiddel", som allerede er godkendt i Den Europæiske

Union (EU), og som hedder Glivec. Der kan indhentes yderligere oplysninger om generiske lægemidler

i dokumentet med spørgsmål og svar her.

Hvordan anvendes Imatinib Accord?

Imatinib Accord leveres som tabletter (100 og 400 mg). Det udleveres kun efter recept, og

behandlingen bør ordineres og iværksættes af en læge med erfaring i behandling af patienter med

blodkræft eller faste svulster. Imatinib Accord gives gennem munden sammen med et måltid og et

stort glas vand for at mindske risikoen for irritation af mave-tarmkanalen. Dosis afhænger af den

behandlede sygdom, patientens alder og tilstand samt reaktionen på behandlingen, men den bør ikke

overstige 800 mg dagligt. De nærmere oplysninger fremgår af indlægssedlen.

Hvordan virker Imatinib Accord?

Det aktive indholdsstof i Imatinib Accord, imatinib, er en protein-tyrosinkinasehæmmer. Det vil sige, at

stoffet blokerer enzymer af typen tyrosinkinaser. Disse enzymer findes i visse receptorer på

kræftcellernes overflade, herunder de receptorer, der medvirker til at stimulere cellerne til at dele sig

ukontrolleret. Ved at blokere disse receptorer er Imatinib Accord med til at begrænse celledelingen.

Hvordan blev Imatinib Accord undersøgt?

Der er allerede gennemført undersøgelser af fordelene og risiciene ved det aktive stof i de godkendte

anvendelser med referencelægemidlet, Glivec, og det er ikke nødvendigt at gentage disse med

Imatinib Accord.

Som for alle lægemidler fremlagde virksomheden undersøgelser af kvaliteten af Imatinib Accord.

Virksomheden gennemførte også undersøgelser, der viste, at lægemidlet er "bioækvivalent" med

referencelægemidlet, Glivec. To lægemidler er bioækvivalente, når de danner den samme mængde af

det aktive stof i kroppen og derfor forventes at have samme virkning.

Hvilken fordel og risiko er der forbundet med Imatinib Accord?

Da Imatinib Accord er et generisk lægemiddel, som er bioækvivalent med referencelægemidlet, anses

benefit/risk-forholdet for at være det samme som for referencelægemidlet.

Imatinib Accord

EMA/393159/2017

Side 3/3

Hvorfor blev Imatinib Accord godkendt?

Det Europæiske Lægemiddelagentur konkluderede, at det i overensstemmelse med EU's krav er blevet

påvist, at Imatinib Accord er af sammenlignelig kvalitet og er bioækvivalent med Glivec. Agenturet

fandt derfor, at fordelene er større end risiciene, ligesom for Glivec. Agenturet anbefalede, at Imatinib

Accord godkendes til anvendelse i EU.

Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv

anvendelse af Imatinib Accord?

I produktresuméet og indlægssedlen er der indført anbefalinger og forholdsregler, som

sundhedspersonale og patienter skal følge med henblik på sikker og effektiv anvendelse af Imatinib

Accord.

Andre oplysninger om Imatinib Accord

Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske

Union for Imatinib Accord den 1. juli 2013.

Den fuldstændige EPAR for Imatinib Accord findes på agenturets websted under:

ema.europa.eu/Find

medicine/Human medicines/European public assessment reports. Hvis du ønsker yderligere

oplysninger om behandling med Imatinib Accord, kan du læse indlægssedlen (også en del af denne

EPAR) eller kontakte din læge eller dit apotek.

Den fuldstændige EPAR for referencelægemidlet findes også på agenturets websted.

Dette sammendrag blev sidst ajourført i 06-2017.

Indlægsseddel

B. INDLÆGSSEDDEL

Indlægsseddel: Information til brugeren

Imatinib Accord 100 mg filmovertrukne tabletter

Imatinib Accord 400 mg filmovertrukne tabletter

Imatinib

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, apotekspersonalet eller sundhedspersonalet, hvis der er mere, du vil vide.

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

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

Kontakt lægen, apotekspersonalet eller sundhedspersonalet, hvis du får bivirkninger, herunder

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

Se den nyeste indlægsseddel på www.indlaegsseddel.dk

Oversigt over indlægssedlen

Virkning og anvendelse

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

Sådan skal du tage Imitanib Accord

Bivirkninger

Opbevaring

Pakningsstørrelser og yderligere oplysninger

1.

Virkning og anvendelse

Imitanib Accord er et lægemiddel, der indeholder et aktivt stof kaldet imatinib. Dette lægemiddel

virker ved at hæmme væksten af unormale celler ved de sygdomme, der er nævnt nedenfor. Disse

omfatter nogle former for kræft.

Imitanib Accord er en behandling til voksne og børn mod:

Kronisk myeloid leukæmi (CML). Leukæmi er kræft i de hvide blodlegemer. Hvide

blodlegemer hjælper som regel kroppen med at bekæmpe infektioner. Kronisk myeloid leukæmi

er en type leukæmi, hvor nogle bestemte unormale hvide blodlegemer (der kaldes myeloide

celler) vokser ukontrolleret.

Philadelphia kromosom positiv akut lymfoblast leukæmi (Ph-positiv ALL). Leukæmi er

kræft i de hvide blodlegemer. Hvide blodlegemer hjælper som regel kroppen med at bekæmpe

infektioner. Akut lymfoblast leukæmi er en form af leukæmi, hvor visse abnorme hvide

blodlegemer (kaldet lymfoblaster) vokser ukontrolleret. Imatinib Accord hæmmer væksten af

disse celler.

Imitanib Accord anvendes til behandling af voksne med:

Myelodysplastiske/myeloproliferative sygdomme (MDS/MDP). Disse er en gruppe af

sygdomme i blodet, hvor nogle blodlegemer begynder at vokse ukontrolleret. Imatinib Accord

hæmmer væksten af disse blodlegemer i en vis undergruppe af disse sygdomme.

Hypereosinofil syndrom (HES) og/eller kronisk eosinofil leukæmi (CEL). Disse er

sygdomme i blodet, i hvilke visse blodlegemer (kaldet eosinofile celler) begynder at vokse

ukontrolleret. Imatinib Accord hæmmer væksten af disse celler i en vis undergruppe af disse

sygdomme.

Dermatofibrosarkom protuberans (DFSP). DFSP er en kræftform i vævet under huden, hvor

visse celler vokser ukontrolleret. Imatinib Accord hæmmer væksten af disse celler.

I resten af denne indlægsseddel vil vi bruge forkortelserne, når vi omtaler disse sygdomme.

Hvis du har spørgsmål om, hvordan Imatinib Accord virker, eller hvorfor du har fået ordineret dette

lægemiddel, kontakt din læge.

2.

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

Imatinib Accord vil kun blive ordineret til dig af en læge med erfaring i behandlingen af kræft i blodet

eller kræftknuder.

Følg omhyggeligt din læges anvisninger, selvom de er forskellige fra den generelle information i

denne indlægsseddel.

Tag ikke Imatinib Accord:

hvis du er allergisk over for imatinib eller et af de øvrige indholdsstoffer i Imatinib Accord

(angivet i afsnit 6).

Hvis dette gælder for dig, skal du fortælle din læge det, før du tager

Imatinib Accord.

Hvis du tror, du er allergisk, men ikke er sikker, skal du kontakte din læge for at få rådgivning.

Advarsler og forsigtighedsregler

Kontakt lægen, før du tager Imatinib Accord:

hvis du har eller har haft lever-, nyre- eller hjerteproblemer.

hvis du tager medicin indeholdende levothyroxin, fordi din skjoldbruskkirtel er blevet fjernet.

hvis du nogensinde har været eller måske er smittet med hepatitis B-virus. Dette skyldes, at

Imatinib Accord kan forårsage, at hepatitis B-infektionen bliver aktiv igen, hvilket undertiden

kan være dødeligt. Lægen vil omhyggeligt kontrolleres dig for tegn på denne infektion, før

behandlingen påbegyndes.

Hvis noget af det ovenstående gælder for dig, skal du fortælle din læge det, før du tager Imatinib

Accord.

Du skal straks fortælle din læge, hvis du meget hurtigt tager på i vægt, mens du er i behandling

med Imatinib Accord. kan forårsage, at din krop begynder at ophobe væske (svær væskeretention).

Mens du tager Imatinib Accord, vil din læge regelmæssigt kontrollere, om lægemidlet virker. Du vil

også få taget blodprøver og blive vejet regelmæssigt.

Børn og unge

Imatinib Accord bruges også til behandling af børn med CML. Der er ingen erfaring med behandling

af CML hos børn under 2 år. Der er begrænset erfaring hos børn og Ph-positiv ALL og meget

begrænset erfaring med børn med MDS/MPD, DFSP og HEL/CEL.

Nogle børn og unge, der får Imatinib Accord, kan vokse langsommere end normalt. Lægen vil

kontrollere væksten ved regelmæssige besøg.

Brug af anden medicin sammen med Imatinib Accord

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

Dette gælder også medicin, som ikke er købt på recept (såsom paracetamol), inklusive

naturlægemidler (såsom perikon). Nogle lægemidler kan påvirke virkningen af Imatinib Accord, når

de bruges samtidigt. De kan enten øge eller nedsætte virkningen af Imatinib Accord, hvilket kan

resultere i enten flere bivirkninger, eller de kan gøre Imatinib Accord mindre virksomt. Imatinib

Accord kan gøre det samme ved andre lægemidler.

Fortæl din læge hvis du tager medicin, der forebygger dannelsen af blodpropper.

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 til råds, før du tager dette lægemiddel.

Imatinib Accord anbefales ikke under graviditeten, medmindre det er strengt nødvendigt, da det

kan skade din baby. Din læge vil fortælle dig om de mulige risici, der er forbundet med brug af

Imatinib Accord under graviditeten.

Under behandlingen anbefales det, at kvinder som kan blive gravide, anvender effektiv

beskyttelse mod graviditet.

Du må ikke amme, mens du er i behandling med Imatinib Accord.

Hvis du er bekymret for din frugtbarhed, mens du tager Imatinib Accord, skal du kontakte din

læge.

Trafik- og arbejdssikkerhed

Du kan blive svimmel eller søvnig eller få sløret syn, mens du tager dette lægemiddel. Hvis dette sker,

bør du ikke køre bil eller bruge værktøj og maskiner, før du føler dig godt tilpas igen.

3.

Sådan skal du tage Imatinib Accord

Din læge har udskrevet Imatinib Accord, fordi du lider af en alvorlig sygdom. Imatinib Accord kan

hjælpe dig med at bekæmpe denne tilstand.

Tag altid lægemidlet nøjagtigt efter lægens eller apotekspersonalets anvisning. Det er vigtigt, at du

tager det så længe, lægen eller apotekspersonalet fortæller dig, at du skal. Er du i tvivl, så spørg lægen

eller apotekspersonalet.

Du må ikke stoppe med at tage Imatinib Accord, medmindre din læge fortæller dig det. Hvis du ikke

er i stand til at tage medicinen, som din læge har foreskrevet, eller hvis du føler, at du ikke længere

behøver den, skal du kontakte din læge med det samme.

Den sædvanlige dosis af Imatinib Accord er

Brug til voksne

Din læge vil fortælle dig, præcis hvor mange Imatinib Accord-tabletter, du skal tage.

Hvis du er i behandling for CML:

Afhængigt af din tilstand er den almindelige startdosis enten 400 mg eller 600 mg:

400 mg som skal tages som 4 tabletter à 100 mg eller én tablet af 400 mg én gang daglig.

600 mg som skal tages som 6 tabletter à 100 mg eller én tablet à 400 mg plus to tabletter

à 100 mg én gang daglig.

Ved CML kan din læge foreskrive højere eller lavere dosis afhængigt af, hvordan du reagerer på

behandlingen. Hvis din daglige dosis er 800 mg (8 tabletter à 100 mg eller to tabletter à 400 mg), skal

du tage 4 tabletter à 100 mg eller én tablet à 400 mg om morgenen og 4 tabletter à 100 mg eller én

tablet à 400 mg om aftenen.

Hvis du behandles for Ph-positiv ALL:

Startdosis er 600 mg, som skal tages som 6 tabletter à 100 mg eller én tablet à 400 mg plus to

tabletter à 100 mg én gang daglig.

Hvis du behandles for MDS/MPD:

Startdosis er 400 mg, som skal tages som 4 tabletter à 100 mg eller én tablet à 400 mg én gang

daglig.

Hvis du behandles for HES/CEL:

Startdosis er 100 mg, som skal tages som én tablet à 100 mg én gang daglig. Din læge kan

beslutte at øge dosis til 400 mg, som skal tages som 4 tabletter à 100 mg eller én tablet à 400 mg

én gang daglig afhængig af, hvordan du responderer på behandlingen.

Hvis du behandles for DSFP:

Dosis er 800 mg pr. dag, som skal tages som 4 tabletter à 100 mg eller én tablet à 400 mg om

morgenen og 4 tabletter à 100 mg eller én tablet à 400 mg om aftenen.

Brug til børn og unge

Lægen vil fortælle dig, hvor mange Imatinib Accord-tabletter, du skal give dit barn. Antallet af

Imatinib Accord-tabletter afhænger af barnets tilstand, kropsvægt og højde. Den totale daglige dosis til

børn må ikke overstige 800 mg for CML-patienter og 600 mg for Ph+ALL-patienter. Behandlingen

kan enten gives til dit barn som én daglig dosis, eller alternativt kan den daglige dosis deles og gives

to gange (halvdelen om morgenen og den anden halvdel om aftenen).

Hvornår og hvordan skal du tage Imatinib Accord

Tag Imatinib Accord sammen med et måltid. Dette vil hjælpe med at beskytte dig mod

maveproblemer, når du tager Imatinib Accord.

Synk tabletterne hele med et stort glas vand.

Hvis du ikke er i stand til at synke tabletterne, kan du opløse dem i et glas almindeligt vand eller

æblejuice:

Anvend ca. 50 ml til en 100 mg tablet og 200 ml til en 400 mg tablet

Omrør med en ske, indtil tabletten/tabletterne er fuldstændig opløst.

Når tabletten/tabletterne er opløst, skal opløsningen drikkes med det samme. Der kan være spor

af de opløste tabletter tilbage i glasset.

Hvor længe skal du tage Imatinib Accord

Bliv ved med at tage Imatinib Accord hver dag, så længe som din læge har foreskevet det.

Hvis du har taget for meget Imatinib Accord

Hvis du ved et uheld har indtaget for mange tabletter, skal du kontakte din læge med det samme.

Lægebehandling kan være nødvendig. Tag pakningen med dig.

Hvis du har glemt at tage Imatinib Accord

Hvis du glemmer at tage en dosis, så tag den, så snart du kommer i tanker om det. Men hvis det

næsten er tid til at tage den næste dosis, skal du springe den glemte dosis over.

Fortsæt derefter med den planlagte dosering.

Du må ikke tage en dobbeltdosis som erstatning for den glemte dosis.

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

4.

Bivirkninger

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

som regel lette til moderate.

Nogle bivirkninger kan være alvorlige. Kontakt din læge med det samme, hvis du oplever nogle

af de følgende bivirkninger:

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

forekomme hos op til 1 ud af 10 patienter):

Hurtig vægtøgning. Imatinib Accord kan føre til, at din krop kan begynde at ophobe væske

(svære ødemer).

Symptomer på infektioner såsom feber, kraftige kulderystelser, ondt i halsen eller sår i munden.

Imatinib Accord kan nedsætte antallet af hvide blodlegemer, så du lettere kan få infektioner.

Hvis du oplever uventede blødninger eller blå mærker (når du ikke er kommet til skade).

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

hos op til 1 ud af 1.000 patienter):

Brystsmerter, uregelmæssig hjerterytme (tegn på hjerteproblemer).

Hoste, åndedrætsbesvær eller smerter ved vejrtrækning (tegn på lungeproblemer).

Føle sig svimmel eller besvime (tegn på lavt blodtryk).

Have kvalme med tab af appetitten, mørk urin, gul hud eller øjne (tegn på leverproblemer).

Udslæt, rød hud med små blærer på læber, øjne, hud eller mund, afskallet hud, feber, hævede

røde eller lilla hudområder, kløe, brændende fornemmelse, pustuløst udslæt (tegn på

hudproblemer).

Kraftige mavesmerter, blod i opkast, afføring eller urin, sortfarvet afføring (tegn på mave-tarm-

sygdomme).

Kraftigt nedsat urinmængde, følelse af tørst (tegn på nyreproblemer).

Have kvalme med diarré og opkastning, mavesmerter eller feber (tegn på tarmproblemer).

Kraftig hovedpine, svækkelse eller lammelser af lemmer eller ansigt, talebesvær, pludseligt

bevidsthedstab (tegn på problemer med nervesystemet såsom blødning eller hævelse i

kranie/hjerne).

Bleghed, føle sig træt og stakåndet og have mørk urin (tegn på lavt antal røde blodceller).

Øjensmerter eller svækkelse af dit syn, blødning i øjnene.

Smerte i hoften eller svært ved at gå.

Følelsesløse eller kolde tæer og fingre (tegn på Raynaud´s syndrom).

Pludselig hævelse og rødme af huden (tegn på en hudinfektion kaldet cellulitis).

Hørebesvær.

Muskelsvaghed, kramper og en unormal hjerterytme (tegn på ændringer i mængden af kalium i

dit blod).

Let ved at få blå mærker.

Mavesmerter med kvalme.

Muskelkramper med feber, rød-brun urin, smerter eller svaghed i dine muskler (tegn på

muskelproblemer).

Bækkensmerter, nogle gange med kvalme og opkastninger med uventet vaginalblødning, føle

sig svimmel eller besvime pga. nedsat blodtryk (tegn på problemer med dine æggestokke eller

livmoder).

Kvalme, åndenød, uregelmæssig hjerterytme (puls), uklar urin, træthed og/eller ubehag

forbundet med abnorme resultater af laboratorieprøver (f.eks. højt indhold af kalium-, urinsyre-

og calcium i blodet og lavt indhold af fosfor i blodet).

Ikke kendt (kan ikke vurderes ud fra tilgængelige data):

Kombination af omfattende svært udslæt, følelse af at være syg, feber, højt indhold af visse hvide

blodlegemer eller gul hud eller øjne (tegn på gulsot) med stakåndethed, brystsmerter/ubehag,

svært nedsat urinproduktion og tørst osv. (tegn på en behandlingsrelateret allergisk reaktion).

Kronisk nyresvigt.

Genopblussen (reaktivering) af hepatitis B-infektion, hvis du tidligere har haft hepatitis B

(leverbetændelse type B).

Kontakt din læge med det samme, hvis du oplever en af ovenstående bivirkninger.

Andre bivirkninger kan omfatte:

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

Hovedpine eller følelse af træthed.

Kvalme opkastninger, diarré eller fordøjelsesbesvær.

Udslæt.

Muskelkramper eller led-, muskel- eller knoglesmerter mens du er i behandling med Imatinib

Accord, eller efter du er stopped med at tage Imatinib Accord.

Hævelse, som fx af anklerne eller omkring øjnene.

Vægtøgning.

Fortæl din læge, hvis du er meget påvirket af nogle af ovenstående symptomer.

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

Appetitløshed, vægttab eller smagsforstyrrelser.

Føle sig svimmel eller svag.

Svært ved at sove (søvnløshed).

Flåd fra øjet med kløe, rødme og hævelse (betændelse af øjets bindehinde), øget tåreflåd eller

sløret syn.

Næseblod.

Smerte eller oppustning af maven, luft i maven, halsbrand eller forstoppelse.

Kløe.

Usædvanligt hårtab eller udtyndning af håret.

Følelsesløshed i hænder eller fødder.

Sår i munden.

Hævede led og ledsmerter

Mundtørhed, tør hud eller tørre øjne.

Nedsat eller øget følsomhed i huden.

Hedeture, kulderystelser eller natlig svedtendens.

Fortæl din læge, hvis du er meget påvirket af nogle af ovenstående symptomer.

Ikke kendt (kan ikke vurderes ud fra tilgængelige data):

Rødmen og/eller hævelse af håndflader eller fodsåler, hvilket kan være ledsaget af en prikkende

følelse eller brændende smerte.

Langsommere vækst hos børn og unge.

Fortæl din læge, hvis du er meget påvirket af nogle af ovenstående symptomer.

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 det nationale rapporteringssystem

anført i Appendiks V. 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.

PVC/PVdC/alu-blister:

Må ikke opbevares ved temperaturer over 30°C.

Alu/alu-blister:

Dette lægemiddel kræver ingen særlige forholdsregler vedrørende opbevaringen.

Pakningen må ikke anvendes, hvis den er beskadiget, eller der er tegn på, at pakningen har

været åbnet.

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

Imatinib Accord indeholder:

Aktivt stof: imatinibmesilat.

Hver Imatinib Accord 100 mg tablet indeholder 100 mg imatinib (som mesilat).

Hver Imatinib Accord 400 mg tablet indeholder 400 mg imatinib (som mesilat).

Øvrige indholdsstoffer: mikrokrystallinsk cellulose, crospovidon, hypromellose 6 cps (E464),

magnesiumstearat og vandfri kolloid silica.Tabletovertrækket består af hypromellose 6 cps

(E464), talkum (E553b), polyethylenglycol, gul jernoxid (E172) og rød jernoxid (E172).

Udseende og pakningsstørrelser

Imatinib Accord 100 mg filmovertrukne tabletter er brun-orange, runde, bikonvekse filmovertrukne

tabletter, præget med ‘IM’ og ‘T1’ på hver sin side af delekærven på den ene side, jævne på den

anden side.

Imatinib Accord 400 mg filmovertrukne tabletter er brun-orange, ovale, bikonvekse filmovertrukne

tabletter, præget med ‘IM’ og ‘T2’ på hver sin side af delekærven på den ene side, jævne på den

anden.

Imatinib Accord 100 mg filmovertrukne tabletter leveres i pakker, der indeholder 20, 60, 120 eller 180

tabletter, men ikke alle pakningsstørrelser fås nødvendigvis i dit land.

Desuden kan Imatinib Accord 100 mg tabletter fås i perforeret enhedsdosis-blister af PVC/PVdC/alu i

pakningsstørrelser med 30 x 1, 60 x 1, 90 x 1, 120 x 1 eller 180 x 1 filmovertrukne tabletter.

Imatinib Accord 400 mg filmovertrukne tabletter leveres i pakker, der indeholder 10, 30 eller 90

tabletter, men ikke alle pakningsstørrelser fås nødvendigvis i dit land.

Desuden kan Imatinib Accord 400 mg tabletter fås i perforeret enhedsdosis-blister af PVC/PVdC/alu i

pakningsstørrelser med 30 x 1, 60 x 1 eller 90 x 1 filmovertrukne tabletter.

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

eller

Pharmacare Premium Ltd

HHF 003, Hal Far Industrial Estet,

Birzebbugia,BBG 3000, Malta

Denne indlægsseddel blev senest ændret

Du kan finde yderligere oplysninger om dette lægemiddel på Det Europæiske Lægemiddelagenturs

hjemmeside http://www.ema.europa.eu

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

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

27-6-2018

Glivec (Novartis Europharm Limited)

Glivec (Novartis Europharm Limited)

Glivec (Active substance: Imatinib) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)4087 of Wed, 27 Jun 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/406/T/110

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

Imatinib Teva B.V. (Teva B.V.)

Imatinib Teva B.V. (Teva B.V.)

Imatinib Teva B.V. (Active substance: imatinib) - Centralised - Withdrawal - Commission Decision (2018)3008 of Tue, 15 May 2018

Europe -DG Health and Food Safety

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