Voriconazole Accord

Primær information

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

Dokumenter

Lokation

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

Terapeutisk information

  • Terapeutisk gruppe:
  • voriconazol
  • Terapeutisk område:
  • aspergillose
  • Terapeutiske indikationer:
  • Voriconazol er et bredspektret, triazol-antisvampemiddel og er indiceret hos voksne og børn i alderen to år og derover som følger:.

Andre oplysninger

Status

  • Kilde:
  • EMA - European Medicines Agency
  • Autorisation status:
  • autoriseret
  • Autorisationsnummer:
  • EMEA/H/C/002669
  • Autorisation dato:
  • 16-05-2013
  • EMEA kode:
  • EMEA/H/C/002669
  • Sidste ændring:
  • 05-03-2018

Offentlige vurderingsrapport

© European Medicines Agency, 2016. Reproduction is authorised provided the source is acknowledged.

EMA/831772/2015

EMEA/H/C/002669

EPAR - sammendrag for offentligheden

Voriconazole Accord

voriconazol

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

Voriconazole 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 Voriconazole Accord bør anvendes.

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

eller kontakte din læge eller dit apotek.

Hvad er Voriconazole Accord, og hvad anvendes det til?

Voriconazole Accord er et lægemiddel mod svamp, som indeholder det aktive stof voriconazol. Det

anvendes til behandling af voksne og børn over 2 år med:

invasiv aspergillose (en svampeinfektion forårsaget af Aspergillus)

candidæmi (en anden type svampeinfektion forårsaget af Candida) hos ikke-neutropene patienter

(patienter med et normalt antal hvide blodlegemer)

alvorlige invasive Candida-infektioner, hvor svampen er resistent over for fluconazol (et andet

svampemiddel)

alvorlige svampeinfektioner forårsaget af Scedosporium eller Fusarium (to forskellige

svampearter).

Til behandling af svampeinfektioner er Voriconazole Accord hovedsagelig beregnet til patienter med

fremadskridende og muligt livstruende svampeinfektioner.

Voriconazole Accord anvendes desuden til forebyggelse af svampeinfektioner hos patienter, der har

fået foretaget en hæmatopoietisk (blod)stamcelletransplantation (transplantation af en type

stamceller, der kan udvikle sig til blodlegemer), og som har høj risiko for infektion.

Voriconazole Accord

EMA/831772/2015

Side 2/3

Voriconazole Accord er et "generisk lægemiddel". Det betyder, at Voriconazole Accord er identisk med

et "referencelægemiddel", der allerede er godkendt i Den Europæiske Union (EU), og som hedder

Vfend. Der kan indhentes yderligere oplysninger om generiske lægemidler i dokumentet med

spørgsmål og svar her.

Hvordan anvendes Voriconazole Accord?

Voriconazole Accord fås som tabletter (50 mg eller 200 mg). Det indgives to gange dagligt. Doseringen

af Voriconazole Accord afhænger af patientens vægt. Patienter skal have en højere begyndelsesdosis

på behandlingens første dag. Formålet med begyndelsesdosen er hurtigt at opnå et stabilt blodniveau.

Støddosen efterfølges af en vedligeholdelsesdosis, der kan tilpasses efter, hvordan lægemidlet virker

hos patienten. Dosen kan øges eller sættes ned afhængigt af, hvordan patienten reagerer.

Tabletterne skal tages mindst én time før eller efter et måltid. Yderligere oplysninger fremgår af

indlægssedlen. Lægemidlet udleveres kun efter recept.

Hvordan virker Voriconazole Accord?

Det aktive stof i Voriconazole Accord, voriconazol, er et svampemiddel i triazolgruppen. Det virker ved

at forhindre dannelsen af ergosterol, som er en vigtig del af svampecellemembranerne. Svampen dør

eller forhindres i at sprede sig uden ergosterol. En liste over de svampearter, som Voriconazole Accord

virker mod, fremgår af produktresuméet, der også er en del af denne EPAR.

Hvordan blev Voriconazole Accord undersøgt?

Da Voriconazole Accord er et generisk lægemiddel, har patientundersøgelserne været begrænset til

tests for at påvise, at det er bioækvivalent med referencelægemidlet Vfend. To lægemidler er

bioækvivalente, når de danner den samme mængde af det aktive stof i kroppen.

Hvilke fordele og risici er der forbundet med Voriconazole Accord?

Da Voriconazole Accord er et generisk lægemiddel, som er bioækvivalent med referencelægemidlet,

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

Hvorfor blev Voriconazole Accord godkendt?

Agenturets Udvalg for Lægemidler til Mennesker (CHMP) konkluderede, at det i overensstemmelse med

EU’s krav er blevet påvist, at Voriconazole Accord er af sammenlignelig kvalitet og er bioækvivalent

med Vfend. CHMP var derfor af den opfattelse, at fordelene opvejer de identificerede risici som for

Vfend. Udvalget anbefalede, at Voriconazole Accord godkendes til anvendelse i EU.

Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv

anvendelse af Voriconazole Accord?

Der er udarbejdet en risikostyringsplan for at sikre, at Voriconazole Accord anvendes så sikkert som

muligt. På baggrund af denne er der anført sikkerhedsoplysninger i produktresuméet og indlægssedlen

for Voriconazole Accord, herunder passende forholdsregler, som patienter og sundhedspersonale bør

følge.

Voriconazole Accord

EMA/831772/2015

Side 3/3

Andre oplysninger om Voriconazole Accord

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

Union for Voriconazole Accord den 16. maj 2013.

Den fuldstændige EPAR for Voriconazole 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 Voriconazole Accord, kan du læse indlægssedlen (også en

del af denne EPAR) eller kontakte din læge eller dit apotek.

Den fuldstændige EPAR for referencelægemidlet kan ligeledes findes på EMA's websted.

Dette sammendrag blev sidst ajourført i 12-2015.

Indlægsseddel

B. INDLÆGSSEDDEL

Indlægsseddel: Information til brugeren

Voriconazole Accord 50 mg filmovertrukne tabletter

Voriconazole Accord 200 mg filmovertrukne tabletter

voriconazol

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

indeholder vigtige oplysninger.

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

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

Lægen har ordineret Voriconazole Accord til Dem personligt. Lad derfor være med at give det

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

Tal med lægen, apotekspersonalet eller sundhedspersonalet, hvis en bivirkning bliver værre,

eller De 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 De vide, før De begynder at tage Voriconazole Accord

Sådan skal De tage Voriconazole Accord

Bivirkninger

Opbevaring

Pakningsstørrelser og yderligere oplysninger

1.

Virkning og anvendelse

Voriconazole Accord indeholder det aktive stof voriconazol og er et middel mod svampeinfektioner.

Det virker ved at dræbe eller stoppe væksten af de svampe, som forårsager infektioner.

Det bruges til behandling af patienter (voksne og børn over 2 år) med:

invasiv aspergillose (en infektion forårsaget af

Aspergillus

-arter)

infektion i blodet af

Candida

-arter (candidæmi) hos patienter, der ikke har et lavt antal hvide

blodlegemer

alvorlige invasive infektioner med

Candida

-arter, når svampen er resistent over for fluconazol

(et andet middel mod svampeinfektion)

alvorlige svampeinfektioner forårsaget af

Scedosporium

- eller

Fusarium

-arter (to andre typer

svamp).

Voriconazole Accord er beregnet til patienter med forværrede og potentielt livstruende

svampeinfektioner.

Forebyggelse af svampeinfektioner hos højrisikopatienter, der har fået en knoglemarvstransplantation.

Denne medicin bør kun bruges under tilsyn af en læge.

2.

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

Tag ikke Voriconazole Accord

Hvis De er overfølsom (allergisk) over for voriconazol eller et af de øvrige indholdsstoffer (angivet i

punkt 6).

Fortæl det altid til lægen eller apoteket, hvis De bruger anden medicin eller har brugt det for nylig.

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

mineraler.

Følgende typer medicin må ikke indtages under behandlingen med Voriconazole Accord:

Terfenadin (medicin mod allergi)

Astemizol (medicin mod allergi)

Cisaprid (medicin mod maveproblemer)

Pimozid (medicin mod psykiske sygdomme)

Quinidin (medicin mod uregelmæssig puls)

Rifampicin (medicin mod tuberkulose)

Efavirenz (til behandling af hiv) i doser på 400 mg en gang daglig og derover

Carbamazepin (medicin mod epilepsi og kramper)

Phenobarbital (medicin mod alvorlig søvnløshed og krampeanfald)

Sekalealkaloider (f.eks. ergotamin, dihydroergotamin, som bruges mod migræne)

Sirolimus (anvendes hos transplanterede patienter)

Ritonavir (medicin mod hiv) i doser på 400 mg og derover 2 gange dagligt

Perikon (naturmedicin).

Advarsler og forsigtighedsregler

Kontakt lægen, apotekspersonalet eller sundhedspersonalet, før De tager Voriconazole Accord, hvis

De har haft en allergisk reaktion over for andre azoler.

De lider af eller har lidt af en leversygdom. Hvis De har en leversygdom, kan Deres læge

ordinere en lavere dosis af Voriconazole Accord. Deres læge vil også kontrollere Deres

leverfunktion under behandling med Voriconazole Accord ved at tage blodprøver.

De ved, at De har problemer i hjertemuskulaturen (kardiomyopati), uregelmæssig puls, langsom

puls eller et unormalt elektrokardiogram (ekg), et såkaldt ”forlænget QTc-syndrom”.

De bør helt undgå sollys og ophold i solen under behandlingen. Det er vigtigt at tildække huden og

bruge solcreme med høj solbeskyttelsesfaktor (SPF), da De kan være særlig følsom for solens UV

stråler. Disse forsigtighedsregler gælder også for børn.

Mens De er i behandling med Voriconazole Accord:

Fortæl straks Deres læge, hvis De får

solskoldning

alvorligt hududslæt eller blærer

knoglesmerter.

Hvis De får skader på huden, som beskrevet ovenfor, vil lægen måske henvise Dem til en hudlæge,

som efter en undersøgelse muligvis beslutter, at det er vigtigt, at De går til regelmæssig kontrol. Der er

en lille risiko for, at langvarig brug af Voriconazole Accord kan forårsage hudkræft.

Deres læge vil tage blodprøver til vurdering af Deres lever- og nyrefunktion.

Børn og unge

Voriconazole Accord må ikke anvendes til børn under 2 år.

Brug af anden medicin sammen med Voriconazole Accord

Fortæl det altid til lægen eller apoteket, hvis De bruger, har brugt for nylig eller overvejer at tage

anden medicin. Dette gælder også medicin, som ikke er købt på recept, f.eks. naturlægemidler og

vitaminer og mineraler.

Visse typer medicin kan påvirke virkningen af Voriconazole Accord, eller Voriconazole Accord kan

påvirke virkningen af anden medicin, når den tages samtidig med Voriconazole Accord.

Fortæl det til lægen, hvis De tager følgende medicin, da behandling samtidig med Voriconazole

Accord bør undgås, hvis det er muligt:

Ritonavir (medicin mod hiv) i doser på 100 mg 2 gange dagligt

Fortæl det til lægen, hvis De tager følgende medicin, da behandling samtidig med Voriconazole

Accord bør undgås, hvis det er muligt. Det kan være nødvendigt at justere voriconazoldosis:

Rifabutin (medicin mod tuberkulose). Hvis De allerede er i behandling med rifabutin er det

nødvendigt, at tage blodprøver samt være opmærksom på bivirkninger forbundet med rifabutin.

Phenytoin (medicin mod epilepsi). Hvis De allerede er i behandling med phenytoin er det

nødvendigt at måle mængden af phenytoin i Deres blod under Deres behandling med

Voriconazole Accord og det kan være nødvendigt at justere dosis.

Fortæl det til lægen, hvis De tager følgende medicin, da det kan være nødvendigt at justere dosis og

kontrollere, om medicinen og/eller Voriconazole Accord stadig har den ønskede virkning:

Warfarin og anden blodfortyndende medicin (f.eks. phenprocoumon, acenocoumarol; bruges til

at nedsætte blodets evne til at størkne)

Ciclosporin (anvendes hos transplanterede patienter)

Tacrolimus (anvendes hos transplanterede patienter)

Sulfonylurinstoffer (f.eks. tolbutamid, glipizid og glyburid) (medicin mod diabetes)

Statiner (f.eks. atorvastatin, simvastatin) (kolesterolsænkende medicin)

Benzodiazepiner (f.eks. midazolam, triazolam) (medicin mod alvorlig søvnløshed og stress)

Omeprazol (medicin mod mavesår)

Oral svangerskabsforebyggende medicin (hvis De tager Voriconazole Accord sammen med oral

svangerskabsforebyggende medicin, kan De få bivirkninger, såsom kvalme og

menstruationsforstyrrelser)

Vinkaalkaloider (f.eks. vincristin og vinblastin) (medicin mod cancer)

Indinavir og andre HIV-proteasehæmmere (medicin mod hiv)

Non-nucleosid reverse transcriptase-hæmmere (f.eks. efavirenz, delavirdin, nevirapin) (medicin

mod hiv) (nogle doser af efavirenc kan IKKE tages på samme tid som Voriconazole Accord)

Methadon (medicin mod heroinmisbrug)

Alfentanil og fentanyl samt andre korttidsvirkende opiater, såsom sufentanil (smertestillende

medicin, der bruges ved operationer)

Oxycodon og andre langtidsvirkende opiater, såsom hydrocodon (bruges mod moderate og

stærke smerter)

Non-steroide anti-inflammatoriske lægemidler (f.eks. ibuprofen og diclofenac) (bruges til

behandling af smerter og betændelsestilstande)

Fluconazol (bruges mod svampeinfektioner)

Everolimus (bruges til behandling af fremskreden nyrekræft og hos patienter, der er blevet

transplanteret)

Graviditet og amning

De må ikke tage Voriconazole Accord under graviditet, medmindre det er foreskrevet af Deres læge.

Hvis De er i den fødedygtige alder, skal De bruge sikker prævention. Kontakt straks Deres læge, hvis

De bliver gravid, mens De tager Voriconazole Accord.

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

De spørge Deres læge eller apotekspersonalet til råds, før De tager dette lægemiddel.

Trafik- og arbejdssikkerhed

Voriconazole Accord kan forårsage sløring af synet eller ubehagelig lysfølsomhed. Hvis dette sker,

bør De ikke køre bil eller betjene maskiner. Kontakt Deres læge, hvis De oplever dette.

Voriconazole Accord indeholder lactose

Sig det til lægen før De tager denne medicin, hvis lægen har fortalt Dem, at De ikke tåler visse

sukkerarter.

3.

Sådan skal De tage Voriconazole Accord

Tag altid Voriconazole Accord nøjagtigt efter lægens anvisning. Er De i tvivl så spørg lægen eller

apoteket.

Lægen fastlægger dosis for hver enkelt patient afhængig af vægt og infektionstype.

Den anbefalede dosis til voksne (også ældre patienter) er:

Tabletter

Patienter 40 kg og derover

Patienter under 40 kg

Dosis i de første 24 timer

(Initialdosis)

400 mg hver 12. time i de første

24 timer

200 mg hver 12. time i de

første 24 timer

Dosis efter de første 24 timer

(Vedligeholdelsesdosis)

200 mg 2 gange dagligt

100 mg 2 gange dagligt

Afhængigt af hvordan behandlingen virker, vil lægen måske øge dosis til 300 mg 2 gange dagligt.

Lægen kan beslutte, at dosis skal nedsættes, hvis De har mild til moderat skrumpelever.

Børn og unge

Den anbefalede dosis til børn og teenagere:

Tabletter

Børn fra 2 år til under 12 år

samt teenagere fra 12 til 14 år,

der vejer mindre end 50 kg

Teenagere fra 12 til 14 år, der vejer

mere end 50 kg samt alle teenagere

over 14 år

Dosis i de første 24 timer

(Initialdosis)

Behandlingen af barnet vil

blive startet som en

indsprøjtning.

400 mg hver 12. time i de første 24

timer

Dosis efter de første 24

timer

(Vedligeholdelsesdosis)

9 mg/kg 2 gange dagligt

(højst 350 mg 2 gange

dagligt)

200 mg 2 gange dagligt

Afhængigt af hvordan behandlingen virker, vil lægen måske øge dosis.

Tabletterne må kun gives, hvis barnet er i stand til at sluge tabletterne.

De skal tage tabletten mindst én time før eller én time efter et måltid. Tabletterne synkes hele sammen

med vand.

Hvis De eller Deres barn tager Voriconazole Accord til forebyggelse af svampeinfektioner, kan

lægen stoppe behandlingen med Voriconazole Accord, hvis De eller Deres barn får

behandlingsrelaterede bivirkninger.

Hvis De har taget for mange Voriconazole Accord-tabletter

Kontakt lægen eller skadestuen, hvis De har taget flere tabletter, end De har fået foreskrevet (eller hvis

andre tager Deres tabletter). Tag æsken med Voriconazole Accord tabletter med. Hvis De har taget for

mange Voriconazole Accord kan De opleve abnorm intolerans over for lys.

Hvis De har glemt at tage Voriconazole Accord

Det er vigtigt, at De tager Voriconazole Accord-tabletter regelmæssigt på samme tidspunkt hver dag.

Hvis De glemmer at tage en dosis, så tag næste dosis, når det er tid. De må ikke tage en dobbeltdosis

som erstatning for den glemte dosis.

Hvis De holder op med at tage Voriconazole Accord

Det er blevet påvist, at når man tager alle doser regelmæssigt, forhøjes medicinens virkning. Derfor er

det vigtigt, at De fortsætter med at tage Voriconazole Accord som beskrevet ovenfor, medmindre

Deres læge beder Dem stoppe behandlingen.

Fortsæt med at tage Voriconazole Accord indtil Deres læge siger, De skal stoppe. Stop ikke

behandlingen i utide, da Deres infektion muligvis ikke er kureret. Patienter med et nedsat

immunsystem eller med svære infektioner kan have behov for langvarig behandling for at undgå, at

infektionen kommer igen.

Når Deres læge stopper Voriconazole Accord-behandlingen, bør De ikke kunne mærke det.

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

4.

Bivirkninger

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

fleste bivirkninger er milde og forbigående. Dog kan der forekomme alvorligere bivirkninger, hvor

lægehjælp er påkrævet.

Alvorlige bivirkninger – stop med at tage Voriconazole Accord og søg læge øjeblikkeligt

Udslæt

Gulsot, ofte med hudkløe; ændringer i blodprøver for leverfunktion

Voldsomme mavesmerter og feber pga. betændelse i bugspytkirtlen.

Andre bivirkninger

Meget almindelige: Kan forekomme hos flere end 1 ud af 10 patienter

Nedsat syn (ændring i synet såsom sløret syn, ændringer i farvesyn, unormal manglende

tolerance ved synsopfattelse af lys, farveblindhed, øjensygdom, lyscirkler, natteblindhed,

gyngende syn, gnister, synsaura, nedsat sysnskarphed, synsklarhed, tab af dele af det

sædvanlige synsfelt, pletter for øjnene)

Feber

Udslæt

Kvalme, opkastning, diarré

Hovedpine

Hævelse af arme og ben

Mavesmerter

Vejrtrækningsbesvær

Forhøjede leverenzymer.

Almindelige: Kan forekomme hos op til 1 ud af 10 patienter

Bihulebetændelse, betændelse i gummerne, kulderystelser, svaghed

Lavt antal, herunder alvorligt, af visse typer røde (sommetider immunrelateret) og/eller hvide

blodlegemer (sommetider med feber), lavt antal celler, som kaldes blodplader (trombocytter),

der hjælper blodet med at størkne

Lavt blodsukker, lavt indhold af kalium i blodet, lavt indhold af natrium i blodet

Angst, depression, forvirring, uro, søvnløshed, hallucinationer

Krampeanfald, rysten eller ukontrollerede muskelbevægelser, prikken eller unormal

hudfornemmelse, øget muskelspænding, søvnighed, svimmelhed

Blødning i øjet

Forstyrrelser i hjerterytmen, herunder meget hurtig puls, meget langsom puls, besvimelse

Lavt blodtryk, betændelsestilstand i en vene (som kan forbindes med dannelse af blodpropper)

Akut vejrtrækningsbesvær, brystsmerter, hævelser i ansigtet (mund, læber og omkring øjnene),

ophobning af væske i lungerne

Forstoppelse, fordøjelsesbesvær, betændelse i læber

Gulsot, leverbetændelse og leverskade

Hududslæt, der kan medføre udbredt blæredannelse og afskalning af huden, og som er

kendetegnet ved et fladt, rødt område på huden, der er dækket af små sammenflydende

ujævnheder, hudrødme

Kløe

Hårtab

Rygsmerter

Nyresvigt, blod i urinen, ændringer i prøver for nyrefunktionen.

Ikke almindelige: Kan forekomme hos op til 1 ud af 100 patienter

Influenzalignende symptomer, irritation og betændelse i mave-tarm-kanalen, betændelse i

mave-tarm-kanalen, der forårsager diarré i forbindelse med antibiotika, betændelse i lymfekar

Betændelse i den tynde hinde på indersiden af bugvæggen (bughinden)

Forstørrede lymfekirtler (undertiden smertefuldt), knoglemarvssvigt, øget antal eosinofiler

Hæmning af binyrefunktionen, nedsat funktion af skjoldbruskkirtlen

Unormal hjernefunktion, Parkinson-lignende symptomer, nerveskade, som giver følelsesløshed,

smerter, prikkende eller brændende fornemmelse i hænder eller fødder

Balance- eller koordinationsproblemer

Hjerneødem

Dobbeltsyn, alvorlige øjentilstande, herunder smerter og betændelsestilstand i øjne og øjenlåg,

unormale øjenbevægelser, beskadigelse af synsnerven, der medfører nedsat syn, hævelse af

synsnervepapillen

Nedsat berøringsfølelse

Smagsforstyrrelser

Problemer med hørelsen, ringen for ørerne, fornemmelse af, at alting drejer rundt

Betændelse i visse indre organer, bugspytkirtlen og tolvfingertarmen, hævelse og

betændelsestilstand i tungen

Forstørret lever, leversvigt, problemer med galdeblæren, galdesten

Ledbetændelse, betændelse i årerne under huden (som kan forbindes med dannelse af

blodpropper)

Betændelsestilstand i nyrerne, proteiner i urinen, nyreskader

Meget hurtig puls eller uregelmæssig hjerterytme, sommetider med uregelmæssige elektriske

impulser

Unormalt elektrokardiogram (EKG)

Forhøjet kolesterol i blodet, forhøjet urinstof i blodet

Allergiske hudreaktioner (undertiden alvorlige), herunder livstruende hudsygdom, der giver

smertende blærer og sår på hud og slimhinder, især i mundenu, betændelse i huden, nældefeber,

solskoldning eller kraftige hudreaktioner pga. lys eller solens stråler, hudrødme og hudirritation,

rød eller violet misfarvning af huden, som kan være forårsaget af et lavt antal blodplader, eksem

Reaktioner på infusionsstedet

Overfølsomhedsreaktion eller overdreven immunreaktion.

Sjældne: Kan forekomme hos op til 1 ud af 1.000 patienter

Øget funktion af skjoldbruskkirtlen

Nedsat hjernefunktion, der er en alvorlig komplikation i forbindelse med leversygdom

Tab af de fleste fibre i synsnerven, uklar hornhinde, ufrivillige øjenbevægelser

Blæreformet eksem pga. lysfølsomhed

Lidelse, hvor kroppens immunsystem angriber dele af det perifere nervesystem

Problemer med hjerterytmen eller -ledning (sommetider livstruende)

Livstruende allergisk reaktion

Sygdom i blodets størkningssystem

Allergiske hudreaktioner (sommetider svære), herunder hurtig hævelse (ødem) i huden,

underhuden, slimhinder og vævet under slimhinden, kløende eller ømme pletter af tyk, rød hud

med sølvfarvede hudskæl, irritation i hud og slimhinder, livstruende hudtilstand, der får store

dele af overhuden, det yderste hudlag, til at løsnes fra hudlagene nedenunder.

Små, tørre, skællede hudpletter, af og til fortykket med hård eller forhornet hud.

Bivirkninger med ikke kendt hyppighed:

Fregner og pigmentpletter.

Andre betydelige bivirkninger, hvis hyppighed ikke er kendt, men som De øjeblikkeligt skal fortælle

til lægen:

Hudkræft

Betændelse i vævet omkring knoglen

Røde, skællede pletter eller ringformede hudlæsioner, der kan være symptomer på den

autoimmune sygdom, som kaldes kutan lupus erythematosus.

Da Voriconazole Accord påvirker lever og nyrer, vil Deres læge tage blodprøver for at kontrollere

lever- og nyrefunktionen. De skal kontakte lægen, hvis De får mavesmerter, eller hvis Deres afføring

får en anden konsistens.

Der er set tilfælde af hudkræft hos patienter, der blev behandlet med Voriconazole Accord i gennem

længere tid.

Solskoldning eller kraftig hudreaktion pga. lys eller solens stråler ses hyppigere hos børn. Hvis De

eller Deres barn udvikler hudlidelser, kan lægen henvise Dem til en hudspecialist, som efter

konsultation kan beslutte, at det er vigtigt, at De eller Deres barn tilses regelmæssigt. Forhøjede

leverenzymer er også set oftere hos børn.

Hvis bivirkningerne fortsætter eller er generende, skal De kontakte lægen.

Tal med lægen, apoteket eller sundhedspersonalet, hvis De får bivirkninger, herunder bivirkninger,

som ikke fremgår af denne indlægsseddel.

Indberetning af bivirkninger

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

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

også indberette bivirkninger direkte til Lægemiddelstyrelsen via det nationale rapporteringssystem

anført i Appendix V.Ved at indrapportere bivirkninger kan De hjælpe med at fremskaffe mere

information om sikkerheden af dette lægemiddel.

5.

Opbevaring

Opbevar Voriconazole Accord utilgængeligt for børn.

Brug ikke Voriconazole Accord efter den udløbsdato, der står på pakningen. Udløbsdatoen er den

sidste i den nævnte måned.

Dette lægemiddel kræver ingen særlige forholdsregler vedrørende opbevaringen.

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

medicinrester i afløbet, toilettet eller skraldespanden.

6.

Pakningsstørrelser og yderligere oplysninger

Voriconazole Accord indeholder:

Aktivt stof: voriconazol. Hver tablet indeholder enten 50 mg voriconazol (Voriconazole Accord

50 mg filmovertrukne tabletter) eller 200 mg voriconazol (Voriconazole Accord 200 mg

filmovertrukne tabletter).

Øvrige indholdsstoffer:

Tabletkerne: Lactosemonohydrat, pregelatineret stivelse, croscarmellosenatrium, povidon og

magnesiumstearat.

Filmovertræk: Hypromellose, titandioxid (E171), lactosemonohydrat og triacetin.

Udseende og pakningsstørrelser

Voriconazole Accord 50 mg filmovertrukne tabletter er hvide til offwhite, runde, filmovertrukne

tabletter, ca. 7,0 mm i diameter, præget med ”V50” på den ene side og jævne på den anden side.

Voriconazole Accord 200 mg filmovertrukne tabletter er hvide til offwhite, ovale, filmovertrukne

tabletter, ca. 15,6 mm lange og 7.8 mm brede, præget med ”V200” på den ene side og jævne på den

anden side.

Voriconazole Accord 50 mg filmovertrukne tabletter og Voriconazole Accord 200 mg filmovertrukne

tabletter fås i pakninger med 2, 10, 14, 20, 28, 30, 50, 56 og 100 stk. eller i

enhedsdosisblisterpakninger (PVC/aluminium) indeholdende 10 x 1, 14 x 1, 28 x 1, 30 x 1, 56 x 1

eller 100 x 1 filmovertrukne 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

Denne indlægsseddel blev senest godkendt i {MM/ÅÅÅÅ}.

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

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

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

Voriconazole Hikma (Hikma FarmacEutica (Portugal), S.A.)

Voriconazole Hikma (Hikma FarmacEutica (Portugal), S.A.)

Voriconazole Hikma (Active substance: voriconazole) - Centralised - Yearly update - Commission Decision (2018)6286 of Tue, 25 Sep 2018

Europe -DG Health and Food Safety

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