Fluorouracil "Accord"

Primær information

  • Handelsnavn:
  • Fluorouracil "Accord" 50 mg/ml injektions-/infusionsvæske, opløsning
  • Dosering:
  • 50 mg/ml
  • Lægemiddelform:
  • injektions-/infusionsvæske, opløsning
  • Brugt til:
  • Mennesker
  • Medicin typen:
  • Allopatiske stof

Dokumenter

Lokation

  • Fås i:
  • Fluorouracil "Accord" 50 mg/ml injektions-/infusionsvæske, opløsning
    Danmark
  • Sprog:
  • dansk

Andre oplysninger

Status

  • Kilde:
  • Lægemiddelstyrelsen - Danish Medicines Agency
  • Autorisation status:
  • Markedsført
  • Autorisationsnummer:
  • 41876
  • Sidste ændring:
  • 17-07-2018

Indlægsseddel

INDLÆGSSEDDEL: INFORMATION TIL BRUGEREN

Fluorouracil Accord 50 mg/ml injektions- og infusionsvæske, opløsning

Fluorouracil

Læs hele denne indlægsseddel grundigt, inden du begynder at tage medicinen.

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

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

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

Accord til andre. Det kan være skadeligt for andre, selv om de har de samme symptomer, som du har.

Tal med lægen eller apoteket, hvis en bivirkning bliver værre, eller du får bivirkninger, som ikke er

nævnt her.

Oversigt over indlægssedlen:

1. Fluorouracil Accord virkning og hvad du skal bruge det til

2. Det skal du vide, før du begynder at bruge Fluorouracil Accord

3. Sådan skal du bruge Fluorouracil Accord

4. Bivirkninger

5. Sådan opbevarer du Fluorouracil Accord

6. Yderligere information

1. FLUOROURACIL ACCORD VIRKNING OG HVAD DU SKAL BRUGE DET TIL

Navnet på dette lægemiddel er Fluorouracil Accord 50 mg/ml, opløsning til injektion eller infusion’, men i

resten af denne indlægsseddel vil det blive omtalt som ‘Fluorouracil Accord’.

Hvad Fluorouracil Accord er

Fluorouracil Accord indeholder det aktive stof fluorouracil. Det er et anti-cancer-lægemiddel.

Hvad Fluorouracil Accord bruges til

Fluorouracil Accord bruges til behandling af mange almindelige kræftformer, særligt kræft i tyktarm og

endetarm

brystkræft.

bruges

kombination

andre

anti-cancer-lægemidler

strålebehandling.

Lægen kan have foreskrevet anden anvendelse eller dosering end angivet i denne information. Følg altid

lægens anvisning og oplysningerne på doseringsetiketten.

2. DET SKAL DU VIDE, FØR DU BEGYNDER AT BRUGE FLUOROURACIL ACCORD

Brug ikke Fluorouracil Accord

hvis du er overfølsom (allergisk) over for fluorouracil eller et af de øvrige indholdsstoffer i Fluorouracil

Accord.

hvis du har alvorlige infektioner (f.eks. herpes zoster, skoldkopper).

hvis din tumor er godartet.

hvis du er svækket af langvarig sygdom.

hvis din knoglemarv er beskadiget af anden behandling (inklusive strålebehandling).

hvis du tager brivudin, sorivudin og analogpræparater (lægemidler mod virus).

hvis du er gravid eller ammer.

Vær ekstra forsigtig med at bruge Fluorouracil Accord:

hvis antallet af blodceller i dit blod bliver for lavt (der vil blive taget blodprøver med henblik på at

kontrollere dette).

hvis du har nyreproblemer.

hvis du har leverproblemer, herunder gulsot (gulfarvning af huden).

hvis du har hjerteproblemer. Fortæl det til din læge, hvis du får brystsmerter under behandlingen.

hvis du har nedsat aktivitet af/mangel på enzymet DPD (dihydropyrimidin-dehydrogenase).

hvis du har modtaget højdosis-strålebehandling i bækkenet.

Brug af anden medicin:

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

gælder også medicin, som ikke er købt på recept.

Methotrexat (et anti-cancer-lægemiddel)

Metronidazol (et antibiotikum)

Calcium-leucovorin (kaldes også calcium-folinat – bruges til at mindske den skadelige virkning af anti-

cancer-lægemidler)

Allopurinol (bruges til behandling af gigt)

Cimetidin (bruges til behandling af mavesår)

Warfarin (mod blodpropper)

Interferon alfa 2a; brivudin, sorivudin og analogpræparater (mod virus)

Cisplatin (et anti-cancer-lægemiddel)

Phenytoin (bruges til at kontrollere epilepsi/anfald og uregelmæssig hjerterytme)

Vacciner

Ovenstående lægemidler påvirker fluorouracils virkning.

Graviditet og amning:

Fødedygtige kvinder skal bruge effektiv kontraception, mens de er i behandling med Fluorouracil Accord og

i mindst 6 måneder efter behandlingens ophør. Hvis du bliver gravid under behandlingsforløbet, skal du

fortælle det til din læge, og du bør søge genetisk rådgivning.

Eftersom det ikke vides, om Fluorouracil udskilles i modermælk, må kvinder ikke amme, hvis de behandles

med Fluorouracil Accord.

Mænd skal undgå at blive far til et barn under behandlingen med Flourouracil Injektion og op til seks

måneder

efter

behandlingens

ophør.

anbefales

søge

rådgivning

opbevaring

sæd

før

behandlingen pga. risikoen for uoprettelig ufrugtbarhed efter behandling med Fluorouracil Accord.

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

Trafik- og arbejdssikkerhed:

Da Fluorouracil Accord kan give bivirkninger såsom kvalme og opkastning, bør du ikke køre bil eller

betjene maskiner. Fluorouracil Accord kan også have uønskede virkninger på dit nervesystem og medføre

synsændringer. Hvis du oplever disse bivirkninger, bør du ikke bruge værktøj eller maskiner.

3. SÅDAN SKAL DU BRUGE FLUOROURACIL ACCORD

Den dosis Fluorouracil Accord, du får, vil afhænge af din sundhedstilstand, din kropsvægt, din lever- og

nyrefunktion og af, om du for nylig har fået foretaget operationer. Den vil også afhænge af resultaterne af

dine blodprøver. Dosen bør ikke være mere end 1 g per dag. De første behandlinger kan gives dagligt eller

med ugentlige intervaller. Yderligere behandlinger vil afhænge af, hvordan du reagerer på behandlingen. I

nogle tilfælde vil du modtage behandlingen sammen med strålebehandling.

Lægemidlet fortyndes med glukoseopløsning, natriumkloridopløsning eller vand til injektionsvæske før

behandlingen. Lægemidlet sprøjtes enten ind i en vene eller en arterie. Hvis det gives i en vene, kan det

enten være som en almindelig indsprøjtning eller som en langsom indsprøjtning via et drop (infusion). Hvis

det gives i en arterie, vil det blive givet som en infusion.

Hvis du har taget for meget Fluorouracil Accord:

Kontakt lægen, skadestuen eller apoteket, hvis De/du har taget mere af ”Fluorouracil Accord”, end der står i

denne information, eller mere end lægen har foreskrevet (og De/du føler Dem/dig utilpas).

Eftersom behandlingen med Fluorouracil Accord vil blive givet på et hospital, er det det usandsynligt, at du

vil få for lidt eller for meget. Tal med din læge, hvis du er bekymret for, at du har fået for meget medicin.

Der vil blive foretaget blodprøver under og efter behandlingen med Fluorouracil Accord for at kontrollere

antallet af blodceller i dit blod. Behandlingen kan blive indstillet, hvis antallet af hvide blodceller er for lavt.

Kvalme, opkastning, diarré, alvorlig mucositis og sår og blødning i mave-tarmkanalen kan forekomme, hvis

du får for meget Fluorouracil Accord. Kontakt din læge, hvis du har yderligere spørgsmål vedrørende

brugen af lægemidlet.

4. Bivirkninger

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

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

Iskæmiske EKG-

abnormaliteter (utilstrækkelig

blodtilførsel til et organ, som

regel på grund af en blokeret

arterie)

Neutropeni (et unormalt lavt

antal neutrofiler i blodet)

Leukopeni (et unormalt lavt antal

hvide blodceller i cirkulation i

blodet)

Anæmi (en tilstand, hvor

antallet af cirkulerende røde

blodceller er utilstrækkeligt)

Pancytopeni (en tilstand, hvor

knoglemarvens produktion af

blodceller falder markant eller

ophører)

Fald i produktionen af blodceller

Høj feber og et stærkt fald i

antallet af cirkulerende

granulære

hvide blodceller

Betændelse i slimhinderne i

munden og fordøjelseskanalen

Faryngitis (betændelse i

slimhinderne i svælget)

Betændelse i endetarm eller

anus

Tab af appetit

Vandig diarré

Kvalme

Opkastning

Hårtab

Forsinket sårheling

Blødning fra næsen

Hånd-fod-syndrom (en

hudreaktion på forgiftning)

Generel svaghed

Træthed

Afkræftelse

Betændelse i slimhinderne i

munden

Betændelse i spiserøret

Mangel på energi

Øget mængde urinsyre i

blodet

Almindelige bivirkninger (optræder hos færre end 1 ud af 10 patienter):

Angina pectoris (stærke smerter i brystet på grund af utilstrækkelig blodtilførsel til hjertet)

Ikke almindelige bivirkninger (optræder hos færre end 1 ud af 100 patienter):

Unormal hjerterytme

Hjertestop

Myokardial iskæmi (manglende

ilt til hjertemusklen)

Myocarditis (betændelse i

hjertemusklen)

Hjertesvigt

Dilateret kardiomyopati (en

hjertesygdom, hvor hjertemusklen

er unormalt stor, tyk eller stiv)

Kardiogent chok

Lavt blodtryk

Søvnighed

Dehydrering

Bakterieinfektion i blodet eller

kropsvævet

Sår og blødning i mave-

tarmkanalen, afstødning af hud

Rytmiske øjenbevægelser

Hovedpine

Følelse af usikkerhed og

manglende balance

Symptomer på Parkinsons

sygdom (en

bevægelsessygdom

kendetegnet ved rysten,

stivhed, langsomme

bevægelser)

Pyramidale symptomer

En følelse af at være syg

Betændelse i huden

Hudændringer, f.eks. tør hud,

revner, nedbrydning,

hudrødme, kløende makulo-

papuløst udslæt (udslæt, der er

begyndt på de nedre

ekstremiteter og har bevæget

sig op til armene og derefter til

brystet)

Hududslæt i forbindelse med visse

infektionssygdomme

Forekomst af kløende,

hævede striber på huden

Fotosensitivitet

Hyperpigmentering af huden

Stribet hyperpigmentering

eller depigmentering nær

blodårer

Negleændringer (f.eks. spredt

overfladisk blåfarvning,

hyperpigmentering,

negledystrofi, smerter og

fortykkelse af neglelejet)

Paronychia (betændelse i vævet

omkring en fingernegl)

Betændelse i neglematrix med

dannelsen af pus og tab af

neglen

Forstyrrelser af sperm- og

ægdannelsen

Levercelleskader

Øget tåreflåd

Sløret syn

Betændelse eller rødmen i

slimhinderne i den hvide del af

øjet og undersiden af øjenlåget

Forstyrrelser i

øjenbevægelserne

Optisk neuritis (betændelse i

synsnerven)

Dobbeltsyn

Nedsat synsskarphed

Stærkt øget følsomhed over for

lys og ubehag ved sollys eller

stærkt oplyste steder

Øjensygdom med kronisk

betændelse i øjenlågenes

yderkanter

Udkrængning af den nederste

del af øjenlåget

Blokerede tårekanaler

Et lag eller en ansamling af dødt

væv adskilt fra det omgivende

levende væv, som ved sår eller

betændelse

Sjældne bivirkninger (optræder hos flere end 1 ud af 10.000, men hos færre end 1 af 1.000 patienter):

Utilstrækkelig blodtilførsel til

hjernen, tarmene og andre

organer

Misfarvning af fingre, tæer og

nogle gange andre områder

Generaliserede allergiske

reaktioner

Hævelse (betændelse) af en

blodåre på grund af en

blodprop

Alvorlige

overfølsomhedsreaktioner på

hele kroppen (anafylaksi)

Udvikling af en blodprop i arterier

eller blodårer

Systemisk vasolidation

(udvidelse af blodkar), der

resulterer i lavt blodtryk

Forvirring

Øget mængde af hormonerne T4

(thyroxin) og T3 (trijodthyronin)

Meget sjældne bivirkninger (optræder hos færre end 1 ud af 10.000 patienter):

Hjertestop (pludseligt ophør af

hjerteslag og hjertefunktion)

Pludselig hjertedød (uventet

død på grund af

hjerteproblemer)

Symptomer på leukoencefalopati

(sygdomme, der påvirker hjernens

hvide substans), herunder ataksi

(tab af evnen til at koordinere

muskelbevægelser

Akut cerebellært syndrom

Besvær med at udtale ord

Konfusion (forvirring)

Mental forvirring eller

nedsat bevidsthed, især med

hensyn til tid, sted og

identitet

Delvis eller fuldstændig

mangel af evnen til at

kommunikere verbalt eller

skriftligt

Unormal muskelsvaghed eller

afkræftelse

Krampeanfald eller koma

hos patienter, der får høje

doser af 5-fluorouracil, og

hos patienter med såkaldt

dihydropyrimidin-

dehydrogenase-mangel

Nyresvigt

Levercelleskader (der er

forekommet tilfælde med

dødelig udgang)

Betændelse i galdeblæren

Langsom, fremadskridende

ødelæggelse af de små

galdeveje

Tal med lægen eller apoteket, hvis en bivirkning er generende eller bliver værre, eller du får bivirkninger,

som ikke er nævnt her.

Bivirkningerne kan dermed blive indberettet til Lægemiddelstyrelsen, og viden om bivirkninger kan blive

bedre. Patienter eller pårørende kan også indberette bivirkninger direkte til Lægemiddelstyrelsen. De/du

finder skema og vejledning under Bivirkninger på Lægemiddelstyrelsens netsted

http://www.laegemiddelstyrelsen.dk

5. SÅDAN OPBEVARER DU FLUOROURACIL ACCORD

Opbevares utilgængeligt for børn.

Brug ikke Fluorouracil Accord efter den udløbsdato, der står på pakningen. Udløbsdatoen (Exp) er den

sidste dag i den nævnte måned.

Opbevares ved temperaturer under 25° C. Må ikke opbevares i køleskab eller nedfryses.

Opbevar i den ydre karton for at beskytte mod lys.

Kun til engangsbrug. Eventuelt tiloversblevet lægemiddel skal kasseres.

Opbevaringstid og fortynding

Kemisk og fysisk brugsstabilitet er blevet påvist i 24 timer ved 25° C med 5 % glukose eller 0,9 %

natriumklorid eller vand til injektionsvæsker til en koncentration på 0,98 mg/ml

fluorouracil. Fra et

mikrobiologisk synspunkt bør produktet anvendes straks. Hvis det ikke anvendes straks, er opbevaringstid

og -forhold før anvendelse brugerens ansvar og vil normalt ikke overstige 24 timer ved 2-8° C, medmindre

fortyndingen er foretaget under kontrollerede aseptiske forhold.

Produktet skal kasseres, hvis opløsningen er brun eller mørkegul.

Må ikke anvendes, hvis emballagen er beskadiget, eller der er synlige partikler/krystaller.

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

medicinrester i afløbet, toilettet eller skraldespanden.

6. YDERLIGERE OPLYSNINGER

Fluorouracil Accord indeholder:

Det aktive stof i Fluorouracil Accord er fluorouracil.

De andre indholdsstoffer er vand til injektionsvæske, natriumklorid og saltsyre.

Fluorouracil Accord udseende og pakningsstørrelser:

1 ml opløsning indeholder 50 mg fluorouracil (som natriumsalt dannet in situ).

Fluorouracil opløsning til injektion eller infusion er en klar, næsten farveløs opløsning i et klart type I

(Ph.Eur) hætteglas med gummilukke.

Hvert hætteglas med 5 ml indeholder 250 mg fluorouracil

Hvert hætteglas med 10 ml indeholder 500 mg fluorouracil

Hvert hætteglas med 20 ml indeholder 1 g fluorouracil

Hvert hætteglas med 50 ml indeholder 2,5 g fluorouracil

Hvert hætteglas med 100 ml indeholder 5 g fluorouracil

Ikke alle pakningsstørrelser er nødvendigvis markedsført.

Indehaver af markedsføringstilladelsen og fremstiller:

Accord Healthcare Limited,

Sage House, 319 Pinner Road,

North Harrow, Middlesex, HA1 4HF,

Storbritannien

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

Medlemslandets

navn

Lægemidlets navn

Østrig

Fluorouracil Accord 50 mg/ml, Lösung zur Injektion oder Infusion

Belgien

Fluorouracil Accord Healthcare 50 mg/ml, solution pour injection ou perfusion/

oplossing voor injectie of infusie/ Lösung zur Injektion oder Infusion

Republikken

Tjekkiet

Fluorouracil Accord 50 mg/ml, injekční roztok nebo infuzi

Danmark

Fluorouracil Accord, injektions og infusionsvæske, opløsning

Estland

Fluorouracil Accord 50 mg/ml, süste- või infusioonilahus

Finland

Fluorouracil Accord 50 mg/ml, injektio- tai infuusioneste/ Lösning för injektion

och infusion

Irland

Fluorouracil 50 mg/ml, Solution for Injection or Infusion

Italien

Fluorouracil Accord 50 mg/ml, Soluzione per Iniezione o Infusione

Spanien

Fluorouracil Accord 50 mg/ml, para inyección o infusión EFG

Sverige

Fluorouracil Accord 50 mg/ml, Lösning för injektion och infusion

Letland

Fluorouracil Accord 50 mg/ml, šķīdums injekcijām vai infūzijām

Litauen

Fluorouracil Accord 50 mg/ml, injekcinis/infuzinis tirpalas

Polen

Fluorouracil Accord

Portugal

Fluorouracilo Accord

Republikken

Slovakiet

Fluorouracil Accord 50 mg/ml, injekčný alebo infúzny roztok

Holland

Fluorouracil Accord 50 mg/ml, oplossing voor injectie of infusie

Storbritannien

Fluorouracil 50 mg/ml, Solution for Injection or Infusion

Denne indlægsseddel blev senest godkendt 08/2011.

Følgende oplysninger er tiltænkt læger og sundhedspersonale:

INSTRUKTIONER VEDRØRENDE BRUG, HÅNDTERING, PRÆPARERING OG

BORTSKAFFELSE AF FLUOROURACIL ACCORD

Retningslinjer for håndtering af cytotoksika

Fluorouracil bør kun administreres af eller under tilsyn af en specialuddannet læge, der har erfaring med

brugen af kemoterapeutiske lægemidler til behandling af cancer.

Retningslinjer for præparering:

Kontaminering

I tilfælde af kontakt med hud eller øjne skal det berørte område vaskes med rigelige mængder vand eller

steril saltvandsopløsning. Hydrocortisoncreme 1 % kan bruges til at behandle den forbigående svie i huden.

Der bør søges lægehjælp, hvis øjnene er påvirket, eller hvis præpareringen inhaleres eller indtages.

tilfælde

spild

skal

personale,

foretager

rengøringen,

iføre

handsker,

ansigtsmaske,

øjenbeskyttelse og engangsforklæde og tørre det spildte materiale op med et absorberende materiale, der

opbevares i et område til dette formål. Området skal derefter rengøres, og alt forurenet materiale skal

kommes i en pose eller affaldsspand til cytotoksisk affald og forsegles, før det sendes til forbrænding.

Førstehjælp

Øjenkontakt: Skyld omgående med vand og søg lægehjælp.

Hudkontakt: Vask grundigt med sæbe og vand og fjern kontamineret tøj.

Inhalering, indtagelse: Søg lægehjælp.

Destruktion

Sprøjter, beholdere, absorberende materialer, opløsning og andet kontamineret materiale skal kommes i

kraftige plasticposer eller anden tæt emballage, mærkes som cytotoksisk affald og brændes ved minimum

700° C.

Kemisk inaktivering kan opnås med 5 % natriumhypoklorit over 24 timer.

a) Kemoterapeutiske stoffer bør kun præpareres til administration af fagfolk, der er uddannet i sikker brug af

præpareringen.

b) Procedurer såsom rekonstitution af pulver og overførsel til sprøjter bør kun udføres i dertil indrettede

områder.

c) Personale, der udføres disse procedurer, skal være tilstrækkeligt beskyttede med specialtøj, to par

handsker, det ene af latex, det andet af PVC (latex-handskerne skal bæres under PVC-handskerne), da dette

beskytter bedst mod de forskellige antineoplastiske stoffers varierende gennemtrængskraft, og desuden

øjenbeskyttelse. Der skal altid bruges luerlock-sprøjter og -fittings ved præparering og administration af

cytotoksika.

d) Det frarådes, at gravide kvinder håndterer kemoterapeutiske stoffer.

e) Der henvises desuden til lokale retningslinjer.

Instruktioner vedrørende brug

Fluorouracil Accord kan gives som intravenøs injektion eller intravenøs eller intraarteriel infusion.

Uforligeligheder

Fluorouracil er uforligeligt med Calciumfolinat, Carboplatin, Cisplatin, Cytarabin, Diazepam, Doxorubicin,

Droperidol,

Filgrastim,

Gallium-nitrat,

Methotrexat,

Metoclopramid,

morfin,

Ondansetron,

parenteral

ernæring, Vinorelbin, andre antracykliner.

Formulerede opløsninger er alkaliske, og det anbefales, at blanding med syreholdige lægemidler eller

opløsninger undgås.

Da der ikke foreligger undersøgelser vedrørende eventuelle uforligeligheder, bør dette præparat ikke blandes

med andre præparater.

Opbevaringstid

Opbevaringstid for uåbnet hætteglas:

2 år. Kun til engangsbrug. Kasser eventuelt ubrugt lægemiddel.

Opbevares ved temperaturer under 25° C. Må ikke opbevares i køleskab eller nedfryses. Opbevar i den ydre

karton for at beskytte mod lys.

Hvis der er dannet bundfald som følge af eksponering for lave temperaturer, opløses dette ved opvarmning

til 60 °C efterfulgt af kraftig omrysten. Afkøles til kropstemperatur inden anvendelse. Produktet skal

kasseres, hvis opløsningen er brun eller mørkegul.

Opbevaringstid efter fortynding

I brug: Kemisk og fysisk brugsstabilitet er blevet påvist i 24 timer ved 25° C med 5 % glukose eller 0,9 %

natriumklorid eller vand til injektionsvæsker til en koncentration på 0,98 mg/ml fluorouracil.

mikrobiologisk

synspunkt

bør

produktet

anvendes

straks.

Hvis

ikke

anvendes

straks,

opbevaringstid og -forhold før anvendelse brugerens ansvar og vil normalt ikke overstige 24 timer ved

2-8° C, med mindre fortyndingen er foretaget under kontrollerede aseptiske forhold.

16-10-2018

Modification of the existing maximum residue levels for mepiquat in cotton seeds and animal commodities

Modification of the existing maximum residue levels for mepiquat in cotton seeds and animal commodities

Published on: Mon, 15 Oct 2018 00:00:00 +0200 In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant, BASF SE, submitted an application to the competent national authority in Greece to modify the existing maximum residue level (MRL) for the active substance mepiquat in cotton seeds. The data submitted in support of the application were found to be sufficient to derive a MRL proposal for cotton seeds and the previously derived MRL proposals for animal commodities were found to be stil...

Europe - EFSA - European Food Safety Authority Publications

6-10-2018

Modification of the existing maximum residue level for epoxiconazole in beetroots

Modification of the existing maximum residue level for epoxiconazole in beetroots

Published on: Fri, 05 Oct 2018 00:00:00 +0200 In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Agriculture & Horticulture Development Board submitted a request to the competent national authority in the United Kingdom to modify the existing maximum residue level (MRL) for the active substance epoxiconazole in beetroots. The data submitted in support of the request were found to be sufficient to derive a MRL proposal for beetroots. Adequate analytical methods for enforcement are...

Europe - EFSA - European Food Safety Authority Publications

2-10-2018

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

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

Published on: Mon, 01 Oct 2018 00:00:00 +0200 According to Article 12 of Regulation (EC) No 396/2005, EFSA has reviewed the maximum residue levels (MRLs) currently established at European level for the pesticide active substance cyflufenamid. To assess the occurrence of cyflufenamid residues in plants, processed commodities, rotational crops and livestock, EFSA considered the conclusions derived in the framework of Directive 91/414/EEC as well as the European authorisations reported by Member States (in...

Europe - EFSA - European Food Safety Authority Publications

28-9-2018

Avian influenza overview May – August 2018

Avian influenza overview May – August 2018

Published on: Thu, 27 Sep 2018 00:00:00 +0200 Between 16 May and 15 August 2018, three highly pathogenic avian influenza (HPAI) A(H5N8) outbreaks in poultry establishments and three HPAI A(H5N6) outbreaks in wild birds were reported in Europe. Three low pathogenic avian influenza (LPAI) outbreaks were reported in three Member States. Few HPAI and LPAI bird cases have been detected in this period of the year, in accordance with the seasonal expected pattern of LPAI and HPAI. There is no evidence to date ...

Europe - EFSA - European Food Safety Authority Publications

27-9-2018

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

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

Published on: Wed, 26 Sep 2018 00:00:00 +0200 According to Article 12 of Regulation (EC) No 396/2005, EFSA has reviewed the maximum residue levels (MRLs) currently established at European level for the pesticide active substance tembotrione. To assess the occurrence of tembotrione residues in plants, processed commodities, rotational crops and livestock, EFSA considered the conclusions derived in the framework of Commission Regulation (EU) No 188/2011 as well as the import tolerances and European author...

Europe - EFSA - European Food Safety Authority Publications

27-9-2018

Outcome of the consultation on confirmatory data used in risk assessment for the active substance  copper (I), copper (II) variants

Outcome of the consultation on confirmatory data used in risk assessment for the active substance copper (I), copper (II) variants

Published on: Wed, 26 Sep 2018 00:00:00 +0200 The European Food Safety Authority (EFSA) was asked by the European Commission to provide scientific assistance with respect to the risk assessment for an active substance in light of confirmatory data requested following the first approval in accordance with Article 6(1) of Directive 91/414/EEC and Article 6(f) of Regulation (EC) No 1107/2009. In this context EFSA's scientific views on the specific points raised during the commenting phase conducted with Me...

Europe - EFSA - European Food Safety Authority Publications

26-9-2018

Modification of the existing maximum residue level for flonicamid in various crops

Modification of the existing maximum residue level for flonicamid in various crops

Published on: Tue, 25 Sep 2018 00:00:00 +0200 In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Dienstleistungszentrum Ländlicher Raum submitted a request to the competent national authority in Germany to modify the existing maximum residue level (MRL) for the active substance flonicamid in radishes. Furthermore, in accordance with Article 6 of Regulation (EC) No 396/2005, the applicant ISK Biosciences Europe N.V. submitted a request to the competent national authority in the Ne...

Europe - EFSA - European Food Safety Authority Publications

25-9-2018

Daiso Holdings Ltd. recalls Daiso Brand Consumer Chemical Products

Daiso Holdings Ltd. recalls Daiso Brand Consumer Chemical Products

The recalled products have not been properly classified according to the Consumer Chemicals and Containers Regulations, 2001, in order to ensure appropriate hazard labelling. These regulations are empowered by the Canada Consumer Product Safety Act. Improper labelling could result in unintentional exposure to these products and lead to serious illness, injury or death.

Health Canada

21-9-2018

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

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

Published on: Thu, 20 Sep 2018 00:00:00 +0200 The European Food Safety Authority (EFSA) was asked by the European Commission to provide scientific assistance with respect to the risk assessment for an active substance in light of confirmatory data requested following approval in accordance with Article 6(1) of Directive 91/414/EEC and Article 6(f) of Regulation (EC) No 1107/2009. In this context EFSA's scientific views on the specific points raised during the commenting phase conducted with Member State...

Europe - EFSA - European Food Safety Authority Publications

21-9-2018

Modification of the existing maximum residue level for clothianidin in potatoes

Modification of the existing maximum residue level for clothianidin in potatoes

Published on: Thu, 20 Sep 2018 00:00:00 +0200 In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Bayer CropScience AG submitted a request to the competent national authority in Germany to modify the existing maximum residue level (MRL) for the active substance clothianidin to accommodate the use on potatoes imported from Canada. The data submitted in support of the request were found to be sufficient to derive a MRL proposal. Adequate analytical methods for enforcement are availa...

Europe - EFSA - European Food Safety Authority Publications

19-9-2018

Modification of the existing maximum residue levels for potassium phosphonates in certain berries and small fruits

Modification of the existing maximum residue levels for potassium phosphonates in certain berries and small fruits

Published on: Tue, 18 Sep 2018 00:00:00 +0200 In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant LTZ Augustenberg submitted a request to the competent national authority in Germany to modify the existing maximum residue levels (MRLs) for the active substance potassium phosphonates in raspberries, blackberries, currants, blueberries, gooseberries and elderberries. The data submitted in support of the request were found to be sufficient to derive MRL proposals for all crops under c...

Europe - EFSA - European Food Safety Authority Publications

19-9-2018

Modification of the existing maximum residue levels for flonicamid in various root crops

Modification of the existing maximum residue levels for flonicamid in various root crops

Published on: Tue, 18 Sep 2018 00:00:00 +0200 In accordance with Article 6 of Regulation (EC) No 396/2005, the Agriculture and Horticulture Development Council submitted a request to the competent national authority in the United Kingdom to modify the existing maximum residue levels (MRL) for the active substance flonicamid in beetroots, carrots, celeriacs/turnip rooted celeries, horseradishes, Jerusalem artichokes, parsnips, parsley roots/Hamburg roots parsley, radishes, salsifies, swedes/rutabagas, tu...

Europe - EFSA - European Food Safety Authority Publications

13-9-2018

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

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

Published on: Wed, 12 Sep 2018 00:00:00 +0200 According to Article 12 of Regulation (EC) No 396/2005, EFSA has reviewed the maximum residue levels (MRLs) currently established at European level for the pesticide active substance fluquinconazole. Considering the information provided by Member States, neither EU uses nor import tolerances are currently authorised for fluquinconazole within the European Union. Furthermore, no MRLs are established by the Codex Alimentarius Commission (codex maximum residue ...

Europe - EFSA - European Food Safety Authority Publications

11-9-2018

Risk assessment of substances used in food supplements: the example of the botanical Gymnema sylvestre

Risk assessment of substances used in food supplements: the example of the botanical Gymnema sylvestre

Published on: Tue, 28 Aug 2018 00:00:00 +0200 Botanicals and preparations derived from these are among the substances frequently added to foods and food supplements, yet the safety of many botanicals has not been systematically assessed. In the context of the EU‐FORA fellowship programme, the fellow performed an assessment on the safety of the botanical Gymnema sylvestre, in accordance with EFSA's guidance on the assessment of safety of botanicals. Although preparations of G. sylvestre are marketed as f...

Europe - EFSA - European Food Safety Authority Publications

11-9-2018

Modelling of inactivation through heating for quantitative microbiological risk assessment (QMRA)

Modelling of inactivation through heating for quantitative microbiological risk assessment (QMRA)

Published on: Mon, 27 Aug 2018 00:00:00 +0200 EFSA regards the household as a stage in the food chain that is important for the final number of food‐borne infections. The fate of a pathogen in the private kitchen largely depends on consumer hygiene during preparation of food and on its proper cooking, especially in the case of meat. Unfortunately, detailed information on the microbiological survival in meat products after heating in the consumer kitchen is lacking. The aim of the study was to improve th...

Europe - EFSA - European Food Safety Authority Publications

11-9-2018

Assessment of occupational and dietary exposure to pesticide residues

Assessment of occupational and dietary exposure to pesticide residues

Published on: Mon, 27 Aug 2018 00:00:00 +0200 Plant protection products (PPPs) are pesticides containing at least one active substance that drives specific actions against pests (diseases). PPPs are regulated in the EU and cannot be placed on the market or used without prior authorisation. EFSA assesses the possible risks of the use of active substances to humans and environment. Member States decide whether or not to approve their use at EU level. Furthermore, Member States decide at national level on ...

Europe - EFSA - European Food Safety Authority Publications

4-9-2018

Outcome of the consultation with Member States and EFSA on the basic substance application for milk for use in plant protection as fungicide

Outcome of the consultation with Member States and EFSA on the basic substance application for milk for use in plant protection as fungicide

Published on: Mon, 03 Sep 2018 00:00:00 +0200 The European Food Safety Authority (EFSA) was asked by the European Commission to provide scientific assistance with respect to the evaluation of applications received by the European Commission concerning basic substances. In this context, EFSA's scientific views on the specific points raised during the commenting phase conducted with Member States and EFSA on the basic substance application for milk are presented. The context of the evaluation was that req...

Europe - EFSA - European Food Safety Authority Publications

1-9-2018

Multiple “Dr. King’s” homeopathic and “Natural Pet” veterinary products recalled due to potential microbial contamination

Multiple “Dr. King’s” homeopathic and “Natural Pet” veterinary products recalled due to potential microbial contamination

Health Canada is advising consumers and pet owners not to use homeopathic and veterinary products made by King Bio Inc. and labeled as "Dr. King's," "Dr King's Natural Pet" or "Natural Pet." These products may pose a health risk to people and pets, especially children, pregnant women and those with compromised immune systems, because of potential microbial contamination. According to the United States Food and Drug Administration, high levels of microbial contamination were identified at the manufacturin...

Health Canada

1-9-2018

Acknowledgement:EFSA  wishes  to  thank  the  rapporteur  Member  State  Denmark  for  thepreparatory work on this scientific output.Suggested citation:EFSA (European Food Safety Authority), Brancato A, Brocca D, Carrasco Cabrera L,De Lentdecker C, Erdos

Acknowledgement:EFSA wishes to thank the rapporteur Member State Denmark for thepreparatory work on this scientific output.Suggested citation:EFSA (European Food Safety Authority), Brancato A, Brocca D, Carrasco Cabrera L,De Lentdecker C, Erdos

Published on: Fri, 31 Aug 2018 00:00:00 +0200 According to Article 12 of Regulation (EC) No 396/2005, EFSA has reviewed the maximum residue levels (MRLs) currently established at European level for the pesticide active substance napropamide. To assess the occurrence of napropamide residues in plants, processed commodities, rotational crops and livestock, EFSA considered the conclusions derived in the framework of Directive 91/414/EEC as well as the European authorisations reported by Member States (incl...

Europe - EFSA - European Food Safety Authority Publications

1-9-2018

Review of the existing MRLs for fenbuconazole

Review of the existing MRLs for fenbuconazole

Published on: Fri, 31 Aug 2018 00:00:00 +0200 According to Article 12 of Regulation (EC) No 396/2005, EFSA has reviewed the maximum residue levels (MRLs) currently established at European level for the pesticide active substance fenbuconazole. To assess the occurrence of fenbuconazole residues in plants, processed commodities, rotational crops and livestock, EFSA considered the conclusions derived in the framework of Directive 91/414/EEC, the MRLs established by the Codex Alimentarius Commission as well...

Europe - EFSA - European Food Safety Authority Publications

30-8-2018

National summary reports on pesticide residue analysis performed in 2016

National summary reports on pesticide residue analysis performed in 2016

Published on: Tue, 07 Aug 2018 00:00:00 +0200 In accordance with Article 31 of Regulation (EC) No 396/2005, European Union (EU) Member States have to communicate to the European Food Safety Authority (EFSA) the results of their official controls on pesticide residues in food. In the framework of this communication, the EU Member States, Iceland and Norway provided a short summary report outlining the main findings of the control activities during the reference year. This technical report is the compilat...

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

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

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

Published on: Tue, 28 Aug 2018 00:00:00 +0200 According to Article 12 of Regulation (EC) No 396/2005, EFSA has reviewed the maximum residue levels (MRLs) currently established at European level for the pesticide active substance sintofen. To assess the occurrence of sintofen residues in plants, processed commodities, rotational crops and livestock, EFSA considered the conclusions derived in the framework of Commission Regulation (EC) No 33/2008, as well as the European authorisations reported by Member ...

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

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

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

Published on: Mon, 27 Aug 2018 00:00:00 +0200 According to Article 12 of Regulation (EC) No 396/2005, EFSA has reviewed the maximum residue levels (MRLs) currently established at European level for the pesticide active substance prochloraz. To assess the occurrence of prochloraz residues in plants, processed commodities, rotational crops and livestock, EFSA considered the conclusions derived in the framework of Directive 91/414/EEC, the MRLs established by the Codex Alimentarius Commission as well as th...

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

Modification of the existing maximum residue levels for prohexadione in various oilseeds

Modification of the existing maximum residue levels for prohexadione in various oilseeds

Published on: Mon, 27 Aug 2018 00:00:00 +0200 In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant BASF SE submitted a request to the competent national authority in France to modify the existing maximum residue levels (MRL) for the active substance prohexadione in linseeds, poppy seeds, sunflower seeds, rape seeds, mustard seeds and gold of pleasure seeds. The data submitted in support of the request were found to be sufficient to derive MRL proposals for all oilseeds under consid...

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

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

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

Published on: Fri, 24 Aug 2018 00:00:00 +0200 According to Article 12 of Regulation (EC) No 396/2005, EFSA has reviewed the maximum residue levels (MRLs) currently established at European level for the pesticide active substance napropamide. To assess the occurrence of napropamide residues in plants, processed commodities, rotational crops and livestock, EFSA considered the conclusions derived in the framework of Directive 91/414/EEC as well as the European authorisations reported by Member States (incl...

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

Explanatory note on the determination of newly expressed protein levels in the context of genetically modified plant applications for EU market authorisation

Explanatory note on the determination of newly expressed protein levels in the context of genetically modified plant applications for EU market authorisation

Published on: Mon, 20 Aug 2018 00:00:00 +0200 Genetically modified organisms are subject to a risk assessment and regulatory approval before entering the European market. According to legislation (Directive 2001/18/EC, Regulation (EC) No 1829/2003 and Regulation (EU) No 503/2013) and the EFSA guidance documents on the risk assessment of food and feed from genetically modified (GM) plants and on the environmental risk assessment of GM plants, applicants need to perform a molecular characterisation of any...

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

Setting of import tolerances for mandestrobin in strawberries and table and wine grapes

Setting of import tolerances for mandestrobin in strawberries and table and wine grapes

Published on: Thu, 16 Aug 2018 00:00:00 +0200 In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Sumitomo Chemical Agro Europe SAS submitted a request to the competent national authority in Austria to set an import tolerance for the active substance mandestrobin in strawberries, table grapes and wine grapes. The data submitted in support of the request were found to be sufficient to derive maximum residue level (MRL) proposals for the crops under consideration. Adequate analytica...

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

Modification of the existing maximum residue levels for fluoxastrobin in oilseeds

Modification of the existing maximum residue levels for fluoxastrobin in oilseeds

Published on: Mon, 13 Aug 2018 00:00:00 +0200 In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Arysta LifeSciences SAS submitted a request to the competent national authority in the United Kingdom to modify the existing maximum residue levels (MRL) for the active substance fluoxastrobin in certain oilseeds. The data submitted in support of the request were found to be sufficient to derive MRL proposals for the oilseeds for which a modification was requested. Adequate analytical...

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

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

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

Published on: Mon, 13 Aug 2018 00:00:00 +0200 According to Article 12 of Regulation (EC) No 396/2005, EFSA has reviewed the maximum residue levels (MRLs) currently established at European level for the pesticide active substance myclobutanil. To assess the occurrence of myclobutanil residues in plants, processed commodities, rotational crops and livestock, EFSA considered the conclusions derived in the framework of Commission Regulation (EC) No 33/2008, the MRLs established by the Codex Alimentarius Com...

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

Evaluation of data concerning the necessity of bromoxynil as herbicide to control a serious danger to plant health which cannot be contained by other available means, including non‐chemical methods

Evaluation of data concerning the necessity of bromoxynil as herbicide to control a serious danger to plant health which cannot be contained by other available means, including non‐chemical methods

Published on: Mon, 13 Aug 2018 00:00:00 +0200 EFSA was requested by the European Commission to provide scientific assistance under Article 31 of Regulation (EC) No 178/2002 regarding the evaluation of data concerning the necessity of bromoxynil as a herbicide to control a serious danger to plant health which cannot be contained by other available means including non‐chemical methods, in accordance with Article 4(7) of Regulation (EC) No 1107/2009. In this context, EFSA organised a commenting phase with ...

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

Grant agreement for piloting the Framework Partnership Agreement between the National data provider organisations in Slovakia and EFSA – Final report

Grant agreement for piloting the Framework Partnership Agreement between the National data provider organisations in Slovakia and EFSA – Final report

Published on: Tue, 07 Aug 2018 00:00:00 +0200 Presented document is the final report of the project GA/EFSA/DATA/2017/01: “Strategic Partnership with Slovakia on Data Quality (Pilot project)”. The report describes national processes and tools in order to implement internal validation and quality control of collected data according to EFSA requirements. A description of the data transmission processes from the National Databases to the EFSA databases, terminology, data mapping and data transformations fo...

Europe - EFSA - European Food Safety Authority Publications

28-8-2018

Accord Healthcare Inc. Issues Voluntary Nationwide Recall of Hydrochlorothiazide Tablets USP 12.5 Mg Due to Labeling Mix-up

Accord Healthcare Inc. Issues Voluntary Nationwide Recall of Hydrochlorothiazide Tablets USP 12.5 Mg Due to Labeling Mix-up

A 100 count bottle of Hydrochlorothiazide Tablets USP 12.5 mg has been found to contain 100 Spironolactone Tablets USP 25 mg. Since the individual lot, PW05264, of the product is involved in a potential mix-up of labeling, Accord is recalling this individual lot from the market.

FDA - U.S. Food and Drug Administration

2-7-2018

Blissful Remedies Issues Voluntary Nationwide Recall of Certain Kratom Powder Capsule

Blissful Remedies Issues Voluntary Nationwide Recall of Certain Kratom Powder Capsule

Blissful Remedies., is voluntarily recalling only Lot No.: 112710 with expiration 03/2019 found embedded on the top of package of kratom ( mitragyn a speciosa) powder products, it manufactured, processed, packed, and/or held, between “March 1, 2018” to “April 30, 2018” to the consumer level. The products have been found by the U.S. Food and Drug Administration (“FDA”) via sample testing to have salmonella contamination. Blissful Remedies has not received reports of adverse events related to this recall. ...

FDA - U.S. Food and Drug Administration

22-6-2018

Kratom (mitragyna speciosa) Powder Products by Gaia Ethnobotanical: Recall - Due to Potential Salmonella Contamination

Kratom (mitragyna speciosa) Powder Products by Gaia Ethnobotanical: Recall - Due to Potential Salmonella Contamination

The products have been found by the FDA via sample testing and finding to have salmonella contamination. In lieu of such FDA findings the company has implemented standard operating procedures and sterilization processes in accordance to FDA guidelines

FDA - U.S. Food and Drug Administration

21-6-2018

Gaia Ethnobotanical, LLC., Voluntarily Recalls Kratom Products Due to Potential Salmonella Contamination

Gaia Ethnobotanical, LLC., Voluntarily Recalls Kratom Products Due to Potential Salmonella Contamination

Gaia Ethnobotanical, LLC., is voluntarily recalling all kratom (mitragyna speciosa) powder products, with Lot No.: 0102031800 it manufactured, processed, packed, and/or held, between March 18, 2018 to March 30, 2018 to the consumer level. The products have been found by the U.S. Food and Drug Administration (“FDA”) via sample testing and finding to have salmonella contamination. In lieu of such FDA findings the company has implemented standard operating procedures and sterilization processes in accordanc...

FDA - U.S. Food and Drug Administration

6-4-2018

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

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

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

Health Canada

23-1-2018

Overview of changes requiring an inspection in the GMP area

Overview of changes requiring an inspection in the GMP area

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

Danish Medicines Agency

22-1-2018

Flawless Beauty, LLC Issues Voluntary Recall of Unapproved Drugs

Flawless Beauty, LLC Issues Voluntary Recall of Unapproved Drugs

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

FDA - U.S. Food and Drug Administration

11-2-2015

MIA format updated according to EMA's community procedures

MIA format updated according to EMA's community procedures

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

Danish Medicines Agency

5-1-2015

Fees for medical devices in 2015

Fees for medical devices in 2015

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

Danish Medicines Agency

3-7-2014

More clinical trials to Denmark

More clinical trials to Denmark

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

Danish Medicines Agency

25-9-2018

Pelgraz (Accord Healthcare Limited)

Pelgraz (Accord Healthcare Limited)

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

Europe -DG Health and Food Safety

24-9-2018

Lenalidomide Accord (Accord Healthcare Limited)

Lenalidomide Accord (Accord Healthcare Limited)

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

Europe -DG Health and Food Safety

7-8-2018

Accofil (Accord Healthcare Limited)

Accofil (Accord Healthcare Limited)

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

Europe -DG Health and Food Safety

7-8-2018

Memantine Accord (Accord Healthcare Limited)

Memantine Accord (Accord Healthcare Limited)

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

Europe -DG Health and Food Safety

6-8-2018

Zoledronic acid Accord (Accord Healthcare Limited)

Zoledronic acid Accord (Accord Healthcare Limited)

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

Europe -DG Health and Food Safety

18-7-2018

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

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

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

FDA - U.S. Food and Drug Administration

4-7-2018

Docetaxel Accord (Accord Healthcare Limited)

Docetaxel Accord (Accord Healthcare Limited)

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

Europe -DG Health and Food Safety

3-7-2018

Temozolomide Accord (Accord Healthcare Limited)

Temozolomide Accord (Accord Healthcare Limited)

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

Europe -DG Health and Food Safety

11-6-2018

Pemetrexed Accord (Accord Healthcare Limited)

Pemetrexed Accord (Accord Healthcare Limited)

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

Europe -DG Health and Food Safety

30-5-2018

Bortezomib Accord (Accord Healthcare Limited)

Bortezomib Accord (Accord Healthcare Limited)

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

Europe -DG Health and Food Safety

23-5-2018

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

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

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

Europe - EMA - European Medicines Agency

15-5-2018

Pramipexole Accord (Accord Healthcare Limited)

Pramipexole Accord (Accord Healthcare Limited)

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

Europe -DG Health and Food Safety