Epirubicin "Accord"

Primær information

  • Handelsnavn:
  • Epirubicin "Accord" 2 mg/ml injektions-/infusionsvæske, opløsning
  • Dosering:
  • 2 mg/ml
  • Lægemiddelform:
  • injektions-/infusionsvæske, opløsning
  • Brugt til:
  • Mennesker
  • Medicin typen:
  • Allopatiske stof

Dokumenter

Lokation

  • Fås i:
  • Epirubicin "Accord" 2 mg/ml injektions-/infusionsvæske, opløsning
    Danmark
  • Sprog:
  • dansk

Andre oplysninger

Status

  • Kilde:
  • Lægemiddelstyrelsen - Danish Medicines Agency
  • Autorisation status:
  • Markedsført
  • Autorisationsnummer:
  • 41338
  • Sidste ændring:
  • 22-02-2018

Indlægsseddel

INDLÆGSSEDDEL: INFORMATION TIL BRUGEREN

Epirubicin Accord 2 mg/ml, injektions og infusionsvæske, opløsning

e

pirubicinhydrochlorid

Læs hele denne indlægsseddel grundigt, inden du begynder at bruge 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 Epirubicin Accord til dig personligt. Lad derfor være med at give Epirubicin

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. Virkning og anvendelse

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

3. Sådan skal du bruge Epirubicin Accord

4. Bivirkninger

5. Opbevaring

6. Yderligere oplysninger

1. Virkning og anvendelse

Navnet på dette lægemiddel er ‘Epirubicin Accord 2 mg/ml, injektions og infusionsvæske, opløsning’, men i resten af

denne indlægsseddel vil det blive omtalt som ‘Epirubicin Accord’.

Hvad Epirubicin Accord er

Epirubicin Accord er et anti-cancer-lægemiddel. Behandling med anti-cancer-lægemidler kaldes nogle gange cancer-

kemoterapi. Epirubicin Accord tilhører en gruppe lægemidler kaldet antracykliner. Disse påvirker celler, der vokser

aktivt, og forsinker eller stopper cellernes vækst og øger chancen for, at cellerne dør.

Hvad Epirubicin Accord bruges til

Epirubicin Accord bruges til behandling af en række kræftformer, enten alene eller i kombination med andre

lægemidler. Den måde, det bruges på, afhænger af, hvilken type kræft der behandles.

Epirubicin Accord bruges til behandling af brystkræft og mavekræft.

Når Epirubicin Accord sprøjtes ind i blæren gennem et rør, bruges det til behandling af abnormale celler eller kræft i

blærevæggen. Det kan også bruges efter andre behandlinger til at forebygge, at sådanne celler vokser igen.

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

Brug ikke Epirubicin Accord

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

Accord (en liste over indholdsstoffer findes under pkt. 6).

hvis du ved, at dit blodtal er lavt, da Epirubicin Accord kan nedsætte det yderligere.

hvis du lide af eller tidligere har lidt af alvorligt hjertesvigt eller stadig modtager behandling for dette.

hvis du tidligere er blevet behandlet med epirubicinhydrochlorid eller lignende kemoterapeutiske lægemidler, da

tidligere behandling med disse lægemidler kan øge risikoen for bivirkninger.

hvis du lider af akut alvorlig infektion.

hvis du har alvorlig betændelse i munden, svælget, spiserøret eller mave-tarmkanalen.

hvis du ammer.

hvis du har alvorlige leverproblemer

Fortæl det til din læge, hvis et eller flere af ovenstående forhold gælder for dig.

Hvis et eller flere af ovenstående forhold gælder for dig, bør du ikke modtage Epirubicin Accord.

Epirubicin Accord bør ikke indsprøjtes i blæren, hvis:

du lider af urinvejsinfektion

der er tumorer, der gennemtrænger blærevæggen

lægen har problemer med at indsætte et kateter (rør) i din blære

du har blærebetændelse

du har en stor mængde urin tilbage i din blære efter forsøg på at tømme den

din blære er sammentrukket.

Vær ekstra forsigtig med at tage Epirubicin Accord, hvis du:

Fortæl det til din læge, hvis:

har nyre- eller leverproblemer. Du skal give din læge besked om dette, da han/hun skal tage særligt hensyn til det.

du har fået eller skal have vaccinationer.

Din læge vil foretage regelmæssige prøver,

så dit blodcelletal ikke er for lavt

for at kontrollere urinsyreniveauet i blodet

for at kontrollere, at dit hjerte og din lever fungerer normalt

hvis du modtager eller skal modtage radioterapi i området omkring hjertet.

Du skal give din læge besked, hvis du oplever hævelse eller smerte i munde eller slimhinde.

Det er muligt, at urinen vil være rødlig i en til to dage efter indgivelse af lægemidlet.

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. Specielt:

Cimetidin (et lægemiddel, der anvendes til at reducere syreindholdet i maven og mod halsbrand). Cimetidin kan

forstærke virkningen af Epirubicin Accord.

Paclitaxel og docetaxel (bruges mod visse kræfttyper).

Såkaldte kalciumkanalblokkere (hjertemedicin).

Interferon alfa-2b (bruges mod visse cancertyper og lymfomer og mod nogle tilfælde af gul feber).

Kinin (bruges til behandling af malaria og mod benkramper).

Antibiotika såsom sulfonamid og kloramfenikol.

Antiretrovirale lægemidler (lægemidler til behandling af infektion ved HIV).

Phenytoin (et lægemiddel til behandling af epilepsi).

Smertestillende lægemidler såsom amidopyrinderivatier.

Dexrazoxan (bruges nogle gange sammen med doxorubicin for at mindske risikoen for hjerteproblemer).

Dexverapamil (bruges til behandling af nogle hjertesygdomme).

Andre lægemidler, der kan påvirke din lever og/eller dit hjerte.

Graviditet og amning

Epirubicin Accord kan forårsage fosterskader, hvis det bruges under graviditet. Fortæl det til din læge, hvis du prøver

at blive gravid, allerede er gravid eller ammer, før du behandles med Epirubicin Accord. Du må ikke modtage

behandling med Epirubicin Accord under graviditet, medmindre det sker på din læges anvisning.

Hvis du eller din partner behandles med Epirubicin Accord, tilrådes effektiv prævention for at forhindre graviditet

under og i seks måneder efter behandlingen. Hvis du bliver gravid, anbefales genetisk rådgivning.

Der er risiko for sterilitet ved behandling med Epirubicin Accord, og mandlige patienter bør overveje nedfrysning af

sæd før behandling.

Epirubicin Accord kan skade diende børn. Derfor bør du ophøre med at amme, inden du påbegynder behandling med

Epirubicin Accord.

Trafik- og arbejdssikkerhed

Epirubicin Accord kan forårsage kvalme og opkastning, hvilket kan medføre en midlertidig forringelse af evnen til at

føre motorkøretøj eller betjene maskineri.

Vigtig information om nogle af indholdsstofferne i Epirubicin Accord

Dette lægemiddel indeholder mindre end 1 mmol natrium (23 mg) per ml, hvilket i praksis svarer til ‘natrium-fri’.

3. Sådan skal du bruge Epirubicin Accord

Indsprøjtningen af Epirubicin Accord vil blive foretaget af en læge eller sygeplejerske, enten i en vene eller direkte

ind i din blære.

Din læge vil bestemme den dosis, der passer bedst til dig, og det antal dage, du skal modtage behandlingen. Dette vil

afhænge af, hvilken type cancer du har, dit helbred, din højde, vægt, hvor godt din lever fungerer, og om du modtager

anden behandling.

Ved indsprøjtning eller infusion i en vene

Epirubicin Accord kan gives som en indsprøjtning i en vene over 3-5 minutter. Det vil måske blive fortyndet før det

langsomt infunderes, som regel gennem et drop i en vene over 30 minutter.

Ved indsprøjtning i blæren

Hvis indsprøjtningen gives i blæren, må du ikke drikke væske 12 timer før behandlingen, så din urin ikke fortynder

lægemidlet for meget. Opløsningen skal forblive i din blære i 1-2 timer efter indsprøjtningen. Du skal vende dig et

antal gange for at sikre, at alle områder af blæren udsættes for lægemidlet.

Når blæren tømmes, må indholdet ikke komme i kontakt med huden. I tilfælde af hudkontakt, skal de påvirkede

områder vaskes grundigt med sæbe og vand. Undlad at skrubbe.

Din læge vil regelmæssigt tage blodprøver med henblik på bivirkninger. For at opdage evt. skade på hjertet vil din

læge monitorere dit hjerte i adskillige uger efter behandlingen.

Regelmæssig kontrol hos lægen under behandling med Epirubicin Accord

Under behandlingen vil din læge foretage regelmæssig kontrol af:

Dit blod – for at kontrollere, om blodcelletallet er for lavt, hvilket kan nødvendiggøre behandling.

Din hjertefunktion – hjertet kan blive beskadiget ved brug af høje doser af Epirubicin Accord. Der kan gå

adskillige uger, inden dette viser sig, så regelmæssige prøver kan være påkrævet i en periode.

Din lever – ved hjælp af blodprøver kontrolleres det, at lægemidlet ikke skader din leverfunktion.

Indholdet af urinsyre i dit blod – Epirubicin Accord kan forøge urinsyreniveauet i blodet, hvilket kan

forårsage gigt. Måske skal du anvende et andet lægemiddel, hvis dit urinsyreniveau er for højt.

Hvis du har taget for meget Epirubicin Accord:

Høje doser kan forværre bivirkninger såsom sår i munden eller føre til et fald i antallet af hvide blodceller (der

bekæmper infektioner) og blodplader (der hjælper blodet med at størkne). Hvis disse bivirkninger forekommer, skal

du måske have antibiotika eller blodtransfusioner. Sår i munden kan behandles, hvilket kan nedsætte generne ved

dem, mens de heler.

Du bør tale med din læge, hvis du er bekymret for, at du har fået for meget medicin.

4. Bivirkninger

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

Hvis du får en eller flere af følgende bivirkninger, efter at du har fået epirubicin ved infusion i en vene, kontakt da

straks din læge, da det er meget alvorlige bivirkninger. Du har måske brug for øjeblikkelig behandling:

rødme, smerte eller hævelse på injektionsstedet; vævsskade kan forekomme, hvis indsprøjtningen ved et uheld

gives uden for en vene.

- symptomer på hjerteproblemer såsom smerter i brystet, stakåndethed, hævede ankler (disse bivirkninger kan

optræde op til flere uger efter afslutningen af behandlingen med epirubicin).

alvorlige allergiske reaktioner, symptomer som afkræftelse, hududslæt, ansigtshævelser og besvær med at trække

vejret eller hvæsen. I nogle tilfælde kan kollaps forekomme.

Kontakt din læge, hvis du har en eller flere af følgende bivirkninger:

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

Antallet af hvide blodceller (der bekæmper infektioner) kan falde, hvilket kan øge risikoen for infektioner og

feber.

Et lavt antal røde blodceller (anæmi), hvilket kan medføre træthed og sløvhed.

Hårtab – i nogle tilfælde ret omfattende. Mænds skægvækst kan ophøre. Håret vokser som regl ud, når

behandlingen stopper.

Rødfarvning af urinen (dette er normalt og hænger sammen med medicinens farve). Du bør sige det til din

læge, hvis det ikke ophører i løbet af nogle dage, eller hvis du tror, der er urin i blodet.

Almindelig (optræder hos mellem 1 og 10 ud af 100 patienter):

Infektioner

Allergiske reaktioner

Følelse af at være syg (kvalme eller opkastning)

Diarré (der kan resultere i dehydrering)

Tørst (dehydrering)

Tab af appetit

Mavesmerter

Halsbrand

Betændelse i spiserøret (øsofagitis)

Højt niveau af pigment i munden

Hævelser og smerte i munden

Sår på læberne og/eller tungen og/eller under tungen (viser sig i nogle tilfælde først 3-10 dage efter behandling)

Hedeture

Blodcelleændringer, der kan forårsage blødning

Feber

Smerter, rødmen, brændende eller stikkende følelse på injektionsstedet

Irriteret blære eller skader på blærevæggen (kaldes nekrose)

Ikke almindelig (optræder hos mellem 1 og 100 ud af 10.000 patienter):

Påvirkning af blodplader (celler, der hjælper blodet med at størkne), der kan medføre, at man nemmere får blå

mærker eller bløder. Det er vigtigt at søge læge, hvis dette forekommer.

Hævelser, rødme, smerter i benene, der kan være forbundet med blodpropper.

Venebetændelse inklusive blodpropper (tromboflebitis).

Sjælden (optræder hos mellem 1 og 1.000 ud af 10.000 patienter):

Efter kombinationsbehandling med andre lægemidler mod kræft har nogle patienter udviklet en sjælden form

for leukæmi (kræft i de hvide blodceller) efter gennemførelse af behandlingen.

Træthed, svaghed og følelse af at være kold

Hiven efter vejret, stakåndethed, hævelser i mave, ben eller ankler, væske i lungerne (tegn på såkaldt kongestivt

hjertesvigt).

Abnormaliteter ved EKG-scanninger, uregelmæssig hjerterytme, sygdom i hjertemusklen.

Nældefeber (urticaria)

Feber og/eller kuldegysninger

Svimmelhed

Udebleven menstruation (amenorré)

Lavt antal sædceller.

Øget mængde urinsyre i blodet, hvilket kan forårsage gigt

Ændringer i hjerte- eller leverfunktion.

Feber med stærk forhøjelse af kropstemperaturen (hyperpyreksi)

Følelse af generelt ubehag eller ængstelse (utilpashed)

Ikke kendt (kan ikke fastslås ud fra de foreliggende data)

Betændelse i blodet

Lungebetændelse

Indre blødninger

Øjenbetændelse (konjunktivitis og keratitis)

Shock

Misfarvning af hud og negle

Øget følsomhed over for lys

Blodpropper, herunder blodpropper i lungerne, der forårsager brystsmerter og stakåndethed

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

nævnt her.

5. Opbevaring

Opbevar hætteglasset i den ydre karton for at beskytte mod lys.

Opbevar altid Epirubicin Accord et sikkert sted. Opbevares utilgængeligt for børn.

Brug ikke Epirubicin Accord efter den udløbsdato, der står på pakningen. Udløbsdatoen (Exp) er den sidste dag i den

nævnte måned.

Anvend ikke Epirubicin Accord, hvis der er synlige tegn på forringelse af lægemidlet.

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

Epirubicin Accord indeholder:

Det aktive stof i Epirubicin Accord er epirubicinhydrochlorid. 1 ml indeholder 2 mg epirubicinhydrochlorid.

Andre indholdsstoffer er natriumchlorid, saltsyre og vand til injektionvæske.

Epirubicin Accord s udseende og pakningsstørrelse:

Epirubicin Accord er en klar, rødlig opløsning.

Pakningsstørrelser:

1 x 5 ml hætteglas (10 mg/5 ml)

1 x 10 ml hætteglas (20 mg/10 ml)

1 x 25 ml hætteglas (50 mg/25 ml)

1 x 100 ml hætteglas (200 mg/100 ml)

Pakningsstørrelse: 1 hætteglas.

Ikke alle pakningsstørrelser er nødvendigvis markedsført.

Indehaver af markedsføringstilladelsen:

Accord Healthcare Limited,

Sage House,

319, Pinner Road,

Opbevares i køleskab (2

C -8

C). Må ikke nedfryses.

5 og 10 ml hætteglas: rørtrukket type I-hætteglas med 20 mm chlorobutyl-RTS-gummiprop og hvid ”flip-off”-

aluminiumforsegling.

25 ml hætteglas: rørtrukket type I-hætteglas med 20 mm chlorobutyl-RTS-gummiprop og hvid/kongeblå ”flip-off”-

aluminiumforsegling.

50 ml hætteglas: klart, støbt type I-hætteglas med 20 mm chlorobutyl-RTS-gummiprop og kongeblå ”flip-off”-

aluminiumforsegling.

100 ml hætteglas: klart, støbt type I-hætteglas med 20 mm chlorobutyl-RTS-gummiprop hvid/kongeblå ”flip-off”-

aluminiumforsegling.

North Harrow, Middlesex, HA1 4HF,

Storbritannien

Fremstiller:

Laboratori FUNDACIO DAU,

C/ De la letra C, 12-14,

Poligono Industrial de la Zona Franca,

08040 Barcelona,

Spanien

eller

Accord Healthcare Limited,

Sage House,

319, Pinner Road,

North Harrow, Middlesex, HA1 4HF,

Storbritannien

Denne indlægsseddel blev senest godkendt 04/2016.

Følgende oplysninger er tiltænkt læger og sundhedspersonale:

Uforligeligheder

Lægemidlet bør ikke komme i kontakt med basiske opløsninger (inklusive natriumbikarbonatopløsninger) over

længere tid: Dette vil resultere i hydrolyse (nedbrydelse) af det aktive lægemiddelstof. Dette lægemiddel må ikke

blandes med andre lægemidler end dem, der er anført under ‘Instruktioner vedrørende brug’.

Hverken injektionsvæsken eller den fortyndede opløsning må blandes med andre lægemidler. Der er rapporteret

fysisk inkompatibilitet med heparin.

Epirubicin bør ikke blandes med andre lægemidler.

Instruktioner vedrørende brug

Intravenøs administration:

Det anbefales at administrere Epirubicin Accord via en sonde med fritløbende intravenøs

infusion

(0,9

natriumchlorid).

minimere

risikoen

trombose

eller

perivenøs

ekstravasation

infusionstiden i reglen mellem 3 og 20 minutter afhængig af dosis og volume af infusionsopløsningen. En ‘direct

push’-injektion anbefales ikke pga. risikoen for ekstravasation, der kan forekomme selv ved tilstedeværelse af

adækvat blodreturnering efter nåleaspiration.

Intravesikal administration:

Epirubicin Accord bør fortyndes med sterilt vand til injektion eller 0,9 % steril

saltvandsopløsning før administration. Epirubicin bør instilleres ved brug af et kateter og opbevares intravesikalt i 1-2

timer. Under instillering bør patienten dreje sig for at sikre, at den vesikale slimhinde i pelvis har længst kontakt med

opløsningen. For at undgå unødig fortynding med urin skal patienten instrueres om ikke at indtage væske i 12 timer

før instilleringen. Patienten skal instrueres om at tømme blæren efter endt instillering.

Injektionsvæsken indeholder ingen konserveringsmidler, og ikke anvendt lægemiddel i hætteglasset skal omgående

bortskaffes.

Retningslinjer for sikker håndtering og bortskaffelse af antineoplastiske stoffer:

Tilberedning af en infusionsopløsning skal udføres af uddannet personale under aseptiske betingelser.

Tilberedning af en infusionsopløsning skal ske på et dertil indrettet aseptisk område.

Der skal bæres egnet beskyttelsesudstyr i form af engangshandsker, briller, kittel og maske.

Der skal træffes foranstaltninger til at udgå, at lægemidlet kommer i kontakt med øjnene. Hvis det alligevel sker,

skal der skylles med store mængder vand og/eller 0,9 % natriumchloridopløsning, hvorefter der skal søges lægelig

vurdering.

tilfælde

hudkontakt

vaskes

berørte

område

omhyggeligt

vand

sæbe

eller

natriumbikaronatopløsning. Huden må ikke skrubbes med en børste. Vask altid hænder, når handskerne tages af.

Spild eller lækage skal behandles med fortyndet natriumhypochloritopløsning (1 % tilgængeligt chlor), helst ved

iblødsætning, og derefter vand. Alle rengøringsmaterialer skal bortskaffes som beskrevet nedenfor.

Gravide medarbejdere må ikke håndtere cytostatika.

Der skal udvises tilstrækkelig forsigtighed og træffes passende foranstaltninger ved bortskaffelse af genstande

(sprøjter,

kanyler

osv.),

anvendt

rekonstitution

og/eller

fortynding

cytostatika.

Ikke

anvendt

lægemiddel samt affald heraf skal bortskaffes i henhold til lokale retningslinjer.

Opbevaring

Opbevaring af lægemidlet i salgspakningen:

Opbevares i køleskab (2

C – 8

C). Må ikke nedfryses.

Opbevar hætteglasset i den ydre karton for at beskytte mod lys.

Opbevaringstid for lægemidlet i salgspakningen:

Hætteglassene er udelukkende til engangsbrug, og ubrugt lægemiddel skal bortskaffes efter brug. Fra et

mikrobiologisk synspunkt bør produktet bruges umiddelbart efter første penetreation af gummiproppen. Hvis det ikke

anvendes umiddelbart, er opbevaringstid og opbevaringsbetingelser før anvendelse brugerens ansvar.

Opbevaringstid efter fortynding af injektionsopløsningen:

Lægemidlet kan, under aseptiske forhold, fortyndes yderligere ved brug af glucose 5 % eller natriumchlorid 0,9 % og

administreres som intravenøs infusion. Ud fra et mikrobiologisk synspunkt bør præparatet bruges med det samme.

Anvendes præparatet ikke med det samme, er opbevaringstiden og opbevaringsbetingelserne brugerens ansvar, og

opbevaringstiden

ikke

overstige

timer

2°C-8°C,

medmindre

fortyndingen

fundet

sted

under

kontrollerede og validerede aseptiske forhold.

Destruktion

Medicin bør ikke skylles ud via spildevand eller bortskaffes som almindeligt affald. Alle materialer, der er brugt til

præparation eller administration, eller som på anden måde har været i kontakt med Epirubicin, skal destrueres i

overensstemmelse med lokale retningslinjer for håndtering af cytotoksiske stoffer.

Der

henvises

til

Prokuktresuméet

for

yderligere

information

om

Epirubicin

Accord

2

mg/ml

injektionsopløsning.

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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

26-9-2018

Sileo (Orion Corporation)

Sileo (Orion Corporation)

Sileo (Active substance: Dexmedetomidine hydrochloride) - Centralised - Yearly update - Commission Decision (2018)6325 of Wed, 26 Sep 2018

Europe -DG Health and Food Safety

25-9-2018

Pelgraz (Accord Healthcare Limited)

Pelgraz (Accord Healthcare Limited)

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

Europe -DG Health and Food Safety

24-9-2018

Lenalidomide Accord (Accord Healthcare Limited)

Lenalidomide Accord (Accord Healthcare Limited)

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

Europe -DG Health and Food Safety

10-8-2018

Brinavess (Correvio)

Brinavess (Correvio)

Brinavess (Active substance: vernakalant hydrochloride) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)5523 of Fri, 10 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/1215/T/31

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

30-7-2018

Segluromet (Merck Sharp and Dohme B.V.)

Segluromet (Merck Sharp and Dohme B.V.)

Segluromet (Active substance: ertugliflozin / metformin hydrochloride) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)5103 of Mon, 30 Jul 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4314/T/2

Europe -DG Health and Food Safety

30-7-2018

Ceplene (Noventia Pharma Srl)

Ceplene (Noventia Pharma Srl)

Ceplene (Active substance: Histamine dihydrochloride) - Centralised - Renewal - Commission Decision (2018)5116 of Mon, 30 Jul 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/796/R/36

Europe -DG Health and Food Safety

23-7-2018

Optruma (Eli Lilly Nederland B.V.)

Optruma (Eli Lilly Nederland B.V.)

Optruma (Active substance: Raloxifene hydrochloride) - Centralised - Yearly update - Commission Decision (2018)4893 of Mon, 23 Jul 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

12-7-2018

Econor (Elanco Europe Ltd)

Econor (Elanco Europe Ltd)

Econor (Active substance: Valnemulin hydrochloride) - Centralised - Yearly update - Commission Decision (2018)4580 of Thu, 12 Jul 2018

Europe -DG Health and Food Safety

11-7-2018

Ariclaim (Eli Lilly Nederland B.V.)

Ariclaim (Eli Lilly Nederland B.V.)

Ariclaim (Active substance: duloxetine hydrochloride) - Centralised - Withdrawal - Commission Decision (2018)4515 of Wed, 11 Jul 2018

Europe -DG Health and Food Safety

5-7-2018

Scientific guideline:  Draft pegylated liposomal doxorubicin hydrochloride concentrate for solution 2 mg/ml product-specific bioequivalence guidance, draft: consultation open

Scientific guideline: Draft pegylated liposomal doxorubicin hydrochloride concentrate for solution 2 mg/ml product-specific bioequivalence guidance, draft: consultation open

This document provides product-specific guidance on the demonstration of the bioequivalence of pegylated liposomal doxorubicin hydrochloride concentrate for solution 2 mg/ml.

Europe - EMA - European Medicines Agency

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