Linezolid "Accord"

Primær information

  • Handelsnavn:
  • Linezolid "Accord" 600 mg filmovertrukne tabletter
  • Dosering:
  • 600 mg
  • Lægemiddelform:
  • filmovertrukne tabletter
  • Brugt til:
  • Mennesker
  • Medicin typen:
  • Allopatiske stof

Dokumenter

Lokation

  • Fås i:
  • Linezolid "Accord" 600 mg filmovertrukne tabletter
    Danmark
  • Sprog:
  • dansk

Andre oplysninger

Status

  • Kilde:
  • Lægemiddelstyrelsen - Danish Medicines Agency
  • Autorisation status:
  • Markedsført
  • Autorisationsnummer:
  • 54073
  • Sidste ændring:
  • 22-02-2018

Indlægsseddel

Indlægsseddel: Information til brugeren

Linezolid Accord 600 mg filmovertrukne tabletter

linezolid

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

vigtige oplysninger.

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

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

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

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

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

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

Den nyeste indlægsseddel kan findes på www.indlaegsseddel.dk

Oversigt over indlægssedlen:

Virkning og anvendelse

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

Sådan skal du tage Linezolid Accord

Bivirkninger

Opbevaring

Pakningsstørrelser og yderligere oplysninger

1.

Virkning og anvendelse

Linezolid Accord er et antibiotikum af typen oxazolidinon, der virker ved at stoppe væksten af visse bakterier,

der forårsager infektioner. Det anvendes til behandling af lungebetændelse og visse infektioner i huden eller

under huden. Din læge har besluttet, at Linezolid Accord er velegnet til at behandle din infektion.

2.

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

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

lægens anvisning og oplysningerne på doseringsetiketten.

Tag ikke

Linezolid Accord:

hvis du er er overfølsom over for linezolid eller et af de øvrige indholdsstoffer i dette lægemiddel (se

punkt 6).

hvis du tager eller inden for de sidste 2 uger har taget eventuelle lægemidler kaldet

monoaminooxidasehæmmere (MAO-hæmmere, f.eks phenelzin, isocarboxazid, selegilin,

moclobemid). Disse lægemidler kan anvendes til behandling af depression eller Parkinsons sygdom.

hvis du ammer, da det udskilles i modermælken og kan påvirke barnet.

Advarsler og forsigtighedsregler

Kontakt lægen, apotekspersonalet eller sundhedspersonalet, før du bruger Linezolid Accord.

Linezolid Accord er måske ikke velegnet til dig, hvis du kan svare

ja

til nogen af de følgende spørgsmål. I så

tilfælde skal du kontakte din læge, da han/hun bliver nødt til at tjekke din almene sundhedstilstand og dit

blodtryk før og under behandlingen, eller kan beslutte, at en anden behandling er bedre for dig.

Spørg lægen, hvis du ikke er sikker på, om disse kategorier gælder for dig.

Har du forhøjet blodtryk, uanset om du bliver behandlet for det eller ej?

Er du blevet diagnosticeret med en overaktiv skjoldbruskkirtel?

Har du en tumor på binyrerne (fæokromocytom) eller carcinoid syndrom (forårsaget af tumorer i

hormonsystemet med symptomer på diarré, rødmen af huden, hiven efter vejret)?

Lider du af manisk depression, skizoaffektiv lidelse, mental forvirring eller andre psykiske

problemer?

Tager du nogen af følgende lægemidler?

- slimløsnende mod forkølelse eller influenza, der indeholder pseudoefedrin eller fenylpropanolamin

- lægemidler til behandling af astma, såsom salbutamol, terbutalin, fenoterol

- antidepressiver kendt som tricykliske eller SSRI (selektive serotonin reuptake hæmmere) for

eksempel amitriptylin, citalopram, clomipramin, dosulepin, doxepin, fluoxetin, fluvoxamin, imipramin,

lofepramin, paroxetin, sertralin

- lægemidler til behandling af migræne f.eks. sumatriptan og zolmitriptan.

- lægemidler til behandling af pludselige, alvorlige allergiske reaktioner, f.eks. adrenalin (epinefrin)

- lægemidler der øger dit blodtryk, såsom noradrenalin (norepinefrin), dopamin og dobutamin

- lægemidler til behandling af moderate til svære smerter, såsom petidin

- lægemidler til behandling af angst, såsom buspiron

- et antibiotikum kaldet rifampicin

Vær ekstra forsigtig med Linezolid Accord

Tal med din læge, før du tager dette lægemiddel, hvis du:

let bløder eller får blå mærker

er anæmisk (har blodmangel/lavt antal røde blodlegemer)

er tilbøjelig til at få infektioner

tidligere har haft krampeanfald

har leverproblemer eller nyreproblemer, især hvis du er i dialyse

har diarré.

Kontakt straks lægen, hvis du under behandling lider af:

problemer med dit syn, såsom sløret syn, ændringer i farvesyn, svært ved at se detaljer eller hvis dit

synsfelt bliver indskrænket.

tab af følelse i dine arme eller ben eller en følelse af snurren eller prikken i dine arme eller ben.

Du kan få diarré, mens du tager eller efter du har taget antibiotika, herunder Linezolid Accord. Hvis

dette bliver alvorligt eller vedvarende eller du bemærker, at din afføring indeholder blod eller slim,

skal du straks stoppe med at tage Linezolid Accord og kontakte lægen. I denne situation bør du ikke

tage lægemidler, der virker stoppende.

tilbagevendende kvalme eller opkastning, mavesmerter eller hurtig vejrtrækning.

Brug af anden medicin sammen med Linezolid Accord

Der er risiko for, at Linezolid Accord sommetider kan interagere med visse andre lægemidler, hvilket

kan medføre bivirkninger såsom ændringer i blodtryk, temperatur eller puls.

Fortæl det altid til lægen, hvis du bruger eller inden for de sidste 2 uger har brugt følgende

lægemidler,

da Linezolid Accord

ikke må

tages, hvis du allerede tager disse lægemidler, eller har

taget dem for nylig. (Se også punkt 2 herover 'Tag ikke Linezolid Accord')

monoaminooxidasehæmmere (MAO, for eksempel phenelzin, isocarboxazid, selegilin, moclobemid).

Disse kan anvendes til behandling af depression eller Parkinsons sygdom.

Sig det især til lægen, hvis du tager følgende lægemidler. Din læge kan stadig beslutte sig for at give dig

Linezolid Accord, men bliver nødt til at tjekke din almene sundhedstilstand og dit blodtryk før og under

din behandling. I andre tilfælde kan din læge beslutte, at en anden behandling er bedre for dig.

Slimløsnende mod forkølelse eller influenza, der indeholder pseudoefedrin eller fenylpropanolamin

Nogle lægemidler til behandling af astma, såsom salbutamol, terbutalin, fenoterol

Visse antidepressiva kendt som tricykliske eller SSRI (selektive serotonin reuptake hæmmere). Der

er mange af disse, herunder amitriptylin, citalopram, clomipramin, dosulepin, doxepin, fluoxetin,

fluvoxamin, imipramin, lofepramin, paroxetin, sertralin.

Lægemidler til behandling af migræne f.eks. sumatriptan og zolmitriptan.

Lægemidler til behandling af pludselige, alvorlige allergiske reaktioner, f.eks. adrenalin

(epinefrin)

Lægemidler der øger dit blodtryk, såsom noradrenalin (norepinefrin), dopamin og dobutamin

Lægemidler til behandling af moderate til svære smerter, såsom petidin

Lægemidler til behandling af angst, såsom buspiron

Lægemidler, der hindrer blodpropper, såsom warfarin.

Fortæl altid lægen, apotekspersonalet eller sundhedspersonalet, hvis du bruger anden medicin eller har

gjort det for nylig. Dette gælder også for medicin, der er købt uden recept.

Brug af Linezolid Accord sammen med mad, drikke og alkohol

Du kan tage Linezolid Accord før, under eller efter et måltid.

Undgå at spise store mængder af lagret og mellemlagret ost, gærekstrakter eller sojabønneekstrakter

f.eks. sojasovs og drikke alkohol, især fadøl og vin. Dette skyldes, at dette lægemiddel kan reagere

med et stof kaldet tyramin, som er naturligt til stede i visse fødevarer. Denne interaktion kan forårsage

en stigning i blodtrykket.

Kontakt straks lægen, apotekspersonalet eller sundhedspersonalet, hvis du får dunkende hovedpine efter

at have spist og drukket.

Graviditet, amning og frugtbarhed

Det vides ikke, hvordan dette lægemiddel påvirker graviditeten. Det bør derfor ikke tages under graviditet

medmindre lægen anbefaler dette. Hvis du er gravid eller ammer, har mistanke om, at du er gravid, eller

planlægger at blive gravid, skal du spørge din læge eller apotekspersonalet til råds, før du bruger dette

lægemiddel.

Du bør ikke amme, mens du tager Linezolid Accord, da det udskilles i modermælken og kan påvirke

barnet.

Trafik- og arbejdssikkerhed

Linezolid Accord kan gøre dig svimmel eller påvirke dit syn. Hvis dette sker, må du ikke køre bil eller betjene

maskiner. Husk, at hvis du er utilpas, så kan din evne til at køre eller betjene maskiner blive påvirket.

Linezolidtabletter indeholder sojalecitin. Hvis du er allergisk over for soja, så må du ikke tage dette

lægemiddel.

3.

Sådan skal du tage Linezolid Accord

Voksne

Tag altid lægemidlet nøjagtigt som beskrevet i denne indlægsseddel eller efter lægens, apotekspersonalets

eller sundhedspersonalets anvisning. Er du i tvivl, så spørg lægen, apotekspersonalet eller

sundhedspersonalet. Den sædvanlige dosis er én tablet (600 mg linezolid) to gange dagligt (hver tolvte

time). Synk tabletten hel med lidt vand.

Hvis du er i dialyse, bør du tage linezolid efter dialysebehandlingen.

En behandling varer normalt 10 til 14 dage, men kan vare op til 28 dage. Sikkerheden og effektiviteten af

dette lægemiddel er ikke fastlagt for behandlingsperioder af mere end 28 dages varighed. Din læge vil

bestemme, hvor længe du behandles.

Mens du tager Linezolid Accord, så vil din læge tage regelmæssige blodprøver for at overvåge din

blodprocent. Din læge bør kontrollere dit syn, hvis du tager Linezolid Accord i mere end 28 dage.

Brug til børn og unge

Linezolid Accord anvendes normalt ikke til behandling af børn og unge (under 18 år).

Hvis du har taget for meget Linezolid Accord

Fortæl det straks til lægen eller apotekspersonalet.

Kontakt lægen, skadestuen eller apoteket, hvis

du har taget mere af Linezolid Accord, end der står i denne information, eller mere end lægen har

foreskrevet (og du føler dig utilpas).

Hvis du har glemt at tage Linezolid Accord

Tag den glemte tablet, så snart du husker det. Tag den næste tablet 12 timer efter dette, og fortsæt med at

tage tabletterne hver 12. time.

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

Hvis du holder med at tage Linezolid Accord

Medmindre din læge beder dig om at stoppe behandlingen, er det vigtigt at du fortsætter med at tage

linezolid.

Hvis du stopper og dine oprindelige symptomer kommer tilbage, så sig det til lægen eller

apotekspersonalet med det samme. Hvis du har yderligere spørgsmål om brugen af dette lægemiddel, så

spørg din læge, apotekspersonalet eller sundhedspersonalet.

4.

Bivirkninger

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

Fortæl det straks til lægen, sygeplejersken eller apotekspersonalet

, hvis du bemærker nogen af disse

bivirkninger under behandlingen med Linezolid Accord:

hudreaktioner såsom rød øm hud og afskalning (dermatitis), udslæt, kløe, eller hævelse, især omkring

ansigtet og på halsen. Dette kan være tegn på en allergisk reaktion, og det kan være nødvendigt for

dig at stoppe med at tage Linezolid Accord.

problemer med dit syn, såsom sløret syn, ændringer i farvesyn, svært ved at se detaljer eller hvis dit

synsfelt bliver indskrænket.

svær diarré indeholdende blod og/eller slim (antibiotika-associeret colitis inklusive pseudomembranøs

colitis), som i sjældne tilfælde kan udvikle sig til komplikationer, der er livstruende.

tilbagevendende kvalme eller opkastning, mavesmerter eller hurtig vejrtrækning.

Der er rapporteret om kramper og krampeanfald i forbindelse med Linezolid Accord. Du skal sige

det til lægen, hvis du oplever ophidselse, forvirring, delirium, stivhed, rysten, manglende

koordination og krampeanfald, hvis du samtidig tager antidepressiva kendt som SSRI (se punkt 2).

Der er rapporteret om følelsesløshed, prikken eller sløret syn hos patienter, der har fået Linezolid Accord i

mere end 28 dage. Hvis du oplever problemer med dit syn, bør du kontakte din læge så hurtigt som

muligt.

Andre bivirkninger omfatter:

Almindelige

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

Svampeinfektioner især vaginal eller oral ”trøske”

Hovedpine

Metallisk smag i munden

Diarré, kvalme eller opkastning

Ændringer i nogle blodprøver herunder tal for din nyre- eller leverfunktion eller blodsukker

Uforklarlig blødning eller blå mærker, hvilket kan skyldes ændringer i antallet af visse celler i blodet,

der kan påvirke blodets evne til at størkne eller føre til blodmangel

Søvnbesvær

Forhøjet blodtryk

Anæmi (lavt antal røde blodlegemer)

Ændringer i antallet af visse celler i blodet, der kan påvirke din evne til at bekæmpe infektion

Hududslæt

Kløende hud

Svimmelhed

Lokaliserede eller generelle mavesmerter

Forstoppelse

Dårlig fordøjelse

Lokaliseret smerte

Feber

Ikke almindelige

(kan forekomme hos up till 1 ud af 100 patienter):

Betændelse i vagina eller kønsområde hos kvinder

Fornemmelser såsom prikken eller følelsesløshed

Sløret syn

”Ringen” i ørerne (tinnitus)

Årebetændelse (kun ved indsprøjtning)

Tør mund eller ondt i munden, hævet, øm eller misfarvet tunge

Øget tissetrang

Kuldegysninger

Følelse af træthed eller tørst

Luftrørsbetændelse

Øget svedtendens

Ændringer i proteiner, salte eller enzymer i blodet, der måler nyre- eller leverfunktion.

Kramper

Hyponatriæmi (lavt natriumindhold i blodet)

Nyresvigt

Nedsat antal blodlegemer

Oppustet mave

Transient iskæmisk anfald (TIA/midlertidig forstyrrelse af blodtilførslen til hjernen, der forårsager

kortsigtede symptomer såsom tab af synet, svaghed i ben og arm, slørret af tale og bevidsthedstab).

Smerte på injektionsstedet

Betændelse i huden

Forhøjet kreatinin

Mavesmerter

Ændringer i hjerterytme (f.eks. hjertebanken)

Sjældne

(kan forekomme hos up til 1 ud af 1000 patienter):

Begrænset synsfelt.

Overfladisk misfarvning af tænder, kan fjernes med professionel tandrensning (manuel

afkalkning)

Følgende bivirkninger er også set

(hyppigheden kendes ikke):

Serotoninsyndrom (symptomerne omfatter hurtig puls, forvirring, unormal svedtendens,

hallucinationer, ufrivillige bevægelser, kulderystelser og kuldegysninger)

Laktatacidose (symptomerne omfatter tilbagevendende kvalme og opkastning, mavesmerter, hurtig

vejrtrækning)

Alvorlige hudlidelser

Sideroblastisk anæmi [en type anæmi (lavt antal røde blodlegemer)]

Alopecia (hårtab)

Ændringer i farvesyn eller svært ved at se detaljer

Nedsat blodprocent

Svaghed og/eller sensoriske ændringer

Indberetning af bivirkninger

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

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

indberette bivirkninger direkte til Lægemiddelstyrelsen via:

Lægemiddelstyrelsen

Axel Heides Gade 1

DK-2300 København S

Websted: www.meldenbivirkning.dk

E-mail: dkma@dkma.dk.

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

dette lægemiddel.

5.

Opbevaring

Opbevar Linezolid Accord utilgængeligt for børn.

Brug ikke lægemidlet efter den udløbsdato, der står på kartonen eller blisterkortet efter utl.dato. eller EXP.

Udløbsdatoen er den sidste dag i den nævnte måned.

Dette lægemiddel kræver ingen særlige forholdsregler vedrørende opbevaringen.

HDPE-beholderen bør anvendes inden for 90 dage efter første åbning.

Bortskaf ikke medicinrester via afløbet eller husholdningsaffald. Spørg på apoteket, hvordan du skal

bortskaffe medicinrester, som du ikke længere bruger. Disse foranstaltninger vil bidrage til at beskytte

miljøet.

6.

Pakningsstørrelser og yderligere oplysninger

Linezolid Accord filmovertrukne tabletter indeholder

- Aktivt stof: linezolid. Hver tablet indeholder 600 mg linezolid.

-Øvrige indholdsstoffer: mikrokrystallinsk cellulose, hydroxypropylcellulose -L,

natriumstivelsesglycolat (type A) og magnesiumstearat.

Filmovertræk: polyvinylalkohol del. hydrolyseret, titandioxid (E171), talcum, lecitin (soja) og

xanthangummi.

Udseende og pakningsstørrelser

Linezolid Accord 600 mg filmovertrukne tabletter er hvide til off-white, ovale bikonveks og præget med

"EQ1" på den ene side og glat på den anden side.

Tabletter fås som Alu-Alu blister, pakket i en karton eller HDPE-beholdere.

HDPE-beholdere er udstyret med hvid uigennemsigtig børnesikret polypropylenlukning (med

induktionsforseglet foring i åbning) og en tørremiddelbeholder.

Hver karton med Alu-Alu blister indeholder 1, 10, 20, 30, 50, 60 eller 100 tabletter.

Hver HDPE-beholdere indeholder 10, 30 eller 100 tabletter.

Ikke alle pakningsstørelser er nødvendigvis markedsført.

Indehaver af markedsføringstilladelsen og fremstiller

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

Wessling Hungary Kft.

Fóti út 56., Budapest 1047, Ungarn

Dette lægemiddel er godkendt i EEAs medlemslande under følgende navne:

Storbirtannien

Linezolid 600 mg Film-coated Tablets

Østrig

Linezolid Accord 600 mg Filmtabletten

Cypern

Linezolid Accord 600 mg Film-coated Tablets

Tjekkiet

Linezolid 600 mg Film-coated Tablets

Tyskland

Linezolid Accord 600 mg Filmtabletten

Danmark

Linezolid Accord

Estland

Linezolid Accord 600 mg potahované tablet

Spanien

Linezolid Accord 600 mg comprimidos recubiertos con pelicula

Finland

Linezolid Accord 600 mg tabletti, kalvopäällysteinen

Frankrig

Linezolid Accord 600 mg comprimés pelliculés

Ungarn

Linezolid Accord 600 mg Filmom obložene tablete

Irland

Linezolid 600 mg Film-coated Tablets

Italien

Linezolid Accord

Litauen

Linezolid Accord 600 mg plėvele dengtos tabletės

Letland

Linezolid Accord 600 mg apvalkotās tablets

Malta

Linezolid 600 mg Film-coated Tablets

Nederlandene

Linezolid Accord 600 mg filmomhulde tabletten

Norge

Linezolid Accord

Polen

Linezolid Accord

Portugal

Linezolida Accord

Sverige

Linezolid Accord 600 mg filmdragerade tabletter

Slovenien

Linezolid Accord 600 mg filmsko obložene tablete

Slovakiet

Linezolid Accord 600 mg filmom obalené tablety

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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