Spironolactone "Accord"

Primær information

  • Handelsnavn:
  • Spironolactone "Accord" 100 mg filmovertrukne tabletter
  • Dosering:
  • 100 mg
  • Lægemiddelform:
  • filmovertrukne tabletter
  • Brugt til:
  • Mennesker
  • Medicin typen:
  • Allopatiske stof

Dokumenter

Lokation

  • Fås i:
  • Spironolactone "Accord" 100 mg filmovertrukne tabletter
    Danmark
  • Sprog:
  • dansk

Andre oplysninger

Status

  • Kilde:
  • Lægemiddelstyrelsen - Danish Medicines Agency
  • Autorisation status:
  • Markedsført
  • Autorisationsnummer:
  • 56377
  • Sidste ændring:
  • 22-02-2018

Indlægsseddel

Indlægsseddel: Information til patienten

Spironolactone Accord 25 mg filmovertrukne tabletter

Spironolactone Accord 50 mg filmovertrukne tabletter

Spironolactone Accord 100 mg filmovertrukne tabletter

spironolacton

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

indeholder vigtige oplysninger.

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

Spørg lægen eller apotekspersonalet, 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 Spironolactone Accord

Sådan skal du tage Spironolactone Accord

Bivirkninger

Opbevaring

Pakningsstørrelser og yderligere oplysninger

1.

Virkning og anvendelse

Det aktive stof i tabletterne er spironolacton. Spironolacton tilhører en særlig gruppe af lægemidler, kendt

som aldosteronantagonister, der hæmmer virkningen af hormonet aldosteron. En af aldosterons funktioner

er at sikre, at kroppen tilbageholder natrium. Det indgår i et system, der regulerer væske- og saltbalancen i

kroppen (’RAAS’, renin-angiotensin-aldosteron-system). Spironolacton fremmer udskillelse af urin hos

patienter, hvor der er en ophobning af væske i væv (ødem) eller i bughulen (ascites) ved at øge mængden

af natrium (salt), der udskilles i urinen. Kaliumtab, som en mulig konsekvens af at bruge visse

vanddrivende midler, nedsættes. Den blodtrykssænkende virkning beror på udskillelsen af vand og salt.

Spironolactone Accord kan udskrives af din læge til behandling af:

ophobning af væske i væv som følge af hjertelidelser;

alvorligt hjertesvigt (NYHA III-IV)

forhøjet blodtryk som et supplement til en salt-fri kost og vanddrivende middel;

visse nyrelidelser;

ophobning af væske i vævet i bughulen.

Spironolactone Accord kan også anvendes:

under medicinske undersøgelser (diagnostik) for at bekræfte tilstedeværelsen af lidelser, hvor et for højt

niveau af aldosteron er produceret i binyrebarken (kendt som Conn sygdom) og behandling.

Børn bør kun behandles under vejledning af en pædiatrisk specialist.

2.

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

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

lægens anvisning og oplysningerne på doseringsetiketten.

Tag ikke Spironolactone Accord

hvis du er allergisk over for spironolacton eller et af de øvrige indholdsstoffer i Spironolactone

Accord (angivet i punkt 6).

hvis du lider af svært nedsat nyrefunktion eller fra en pludselig eller hastigt forværret nyresygdom,

herunder tilfælde, hvor der ikke urin, eller der produceres meget lidt urin.

hvis dit natriumindhold i blodet er for lavt (hyponatriæmi)

hvis du har hyperkaliæmi (forhøjet kaliumindhold i blodet) eller andre tilstande i forbindelse med

hyperkaliæmi

hvis du tager kaliumbesparende diuretika (herunder eplerenon) eller kalium-kosttilskud, eller dual-

RAAS blokade i kombination med et angiotensin-konverterende enzym (ACE)-hæmmer og en

angiotensin-receptor-blokker (ARB)

Børn

Børn med moderat til svær nyresygdom må ikke tage Spironolactone Accord.

Vær ekstra forsigtig med Spironolactone Accord

hvis du lider af en nyresygdom, især børn med hypertension. Din læge vil rutinemæssigt vurdere

dig.

Advarsler og forsigtighedsregler

Kontakt lægen eller apotekspersonalet, før du tager Spironolactone Accord

hvis du skal bruge Spironolactone Accord i lang tid. Lægen bør udføre regelmæssige opfølgende

kontrol (for eksempel indhold af kalium og natrium i blodet), især hvis du er ældre.

hvis du har en leversygdom. Lægen bør udvise forsigtighed ved behandling af dig;

hvis du har en nyresygdom. Lægen bør udvise forsigtighed ved behandling af dig;

hvis du har et forhøjet kaliumniveau i blodet eller nedsat nyrefunktion, så anbefales Spironactone

Accord ikke (se også "Tag ikke Spironolactone Accord");

hvis du har svært nedsat nyrefunktion, der samtidigt bliver behandlet med kaliumtilskud, da der kan

forekomme alvorlig hyperkaliæmi, som kan resultere i hjertestop (undertiden fatal).

hvis du bruger visse vanddrivende midler, kaldet kaliumbesparende diuretika (såsom amilorid og

triamteren). Samtidig brug med Spironolactone Accord er kontraindiceret, fordi risikoen øges for alt

for høje niveauer af kalium i blodet (hyperkaliæmi).

i tilfælde af langtidsbehandling af unge patienter med Spironolactone Accord, bør din læge afveje

fordele omhyggeligt mod de langsigtede ulemper.

samtidig indtagelse af Spironolactone Accord og visse lægemidler, kaliumtilskud og mad, der er rig

på kalium, kan føre til alvorlig hyperkaliæmi (forhøjede kaliumniveauer i blodet). Symptomerne på

alvorlig hyperkaliæmi kan bl.a. være muskelkramper, uregelmæssig hjerterytme, diarré, kvalme,

svimmelhed og hovedpine.

Fortæl din læge, hvis en af ovennævnte advarsler gælder for dig, eller har været gældende tidligere.

Brug af anden medicin sammen med Spironolactone Accord

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

gælder også håndkøbsmedicin. Din læge vil muligvis ændre din dosis af Spironolactone Accord, hvis du

tager noget af følgende.

medicin mod forhøjet blodtryk, herunder ACE-hæmmere, ganglion-blokerende lægemidler

andre vanddrivende midler

non-steroid anti-inflammatorisk lægemiddel (NSAID), såsom aspirin eller ibuprofen

kaliumtilskud

heparin eller lavmolekylært heparin (medicin til forebyggelse af blodpropper)

lægemidler, der hæmmer blodets koagulation (antikoagulanter, 'blodfortyndingsmidler’), noradrenalin

(et middel med en stimulerende virkning på en bestemt del af nervesystemet (sympatomimetiske))

lithium (til behandling af depression)

digoxin (anvendes til behandling af forskellige hjertelidelser)

alkohol, barbiturater eller narkotika

medicin kendt for at forårsage hyperkaliæmi (forhøjet kalium i blodet)

colestyramin (bruges til at nedsætte kolesterol i blodet)

kortikosteroider, ACTH (udskrives til forskellige epileptiske tilstande)

ammoniumchlorid (f.eks. i lakrids)

ciclosporin

trimethoprim og trimethoprim-sulfamethoxazol

Spironolactone Accord med mad

Virkningen af spironolacton påvirkes ikke af mad.

Graviditet, amning og frugtbarhed

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

spørge din læge eller apotekspersonalet til råds, før du bruger dette lægemiddel.

Spironolacton bør ikke anvendes under graviditet.

Spironolacton bør kun anvendes under amning ved klart behov.

Du bør diskutere brugen af Sprinonolactone Accord med din læge, som vil råde dig til at overveje en

alternativ metode til at ernære dit spædbarn, mens du tager denne medicin.

Spironolacton kan fremkalde impotens og uregelmæssig menstruation.

Trafik- og arbejdssikkerhed

Bivirkninger såsom svimmelhed, hovedpine og forvirring kan undertiden forekomme, mens du bruger

Spironolactone Accord. I dette tilfælde skal du ikke køre bil eller betjene maskiner.

Spironolactone Accord indeholder lactose

Dette lægemiddel indeholder lactose. Hvis din læge har fortalt dig, at du ikke kan tåle visse sukkerarter,

skal du kontakte din læge, inden du tager denne medicin.

3.

Sådan skal du tage Spironolactone Accord

Tag altid lægemidlet nøjagtigt efter lægens eller apotekspersonalets anvisning. Er du i tvivl, så spørg

lægen eller apotekspersonalet.

Den anbefalede dosis er:

Voksne

Den anbefalede dosis er 100 mg dagligt, indtaget som en eller flere doser. Den voksne dosis varierer fra

25 mg til 400 mg spironolacton dagligt. Hvis du ikke er sikker på, hvor meget du skal tage, så spørg din

læge eller apotekspersonalet.

Du bør tage tabletterne med måltider. Hvis den totale dosis er mere end 100 mg om dagen, skal dosis

indtages i opdelte doser fordelt over dagen.

Brug til børn

Den anbefalede dosis er 3 mg pr. kg legemsvægt dagligt i flere opdelte doser. For at gøre det lettere for

børn at tage tabletterne, kan disse først formales eller knuses og derefter opløses i et glas vand ved

omrøring.

Ældre

Det anbefales, at ældre patienter bør starte med den lavest mulige dosis, som øges gradvist, indtil den

ønskede virkning er opnået. Det tilrådes at udvise opmærksomhed og få regelmæssig lægekontrol, især i

tilfælde af nedsat nyrefunktion.

Husk at tage din medicin. At tage tabletterne på samme tidspunkt hver dag, giver den bedste virkning. Det

gør det også lettere for dig at huske, hvornår du skal tage tabletterne.

Hvis du har taget for meget Spironolactone Accord

Kontakt lægen, skadestuen eller apoteket, hvis du har taget mere af Spironolactone Accord, end der står i

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

Hvis du har taget for meget Spironolactone Accord, skal du straks kontakte din læge eller

apotekspersonalet. Tag pakningen med dig, så lægen kan se, hvilken medicin du har taget.

Symptomer på overdosering kan omfatte kvalme og opkastning, og (sjældnere) døsighed, forvirring,

hududslæt eller diarré. Der kan forekomme forstyrrelse af væske- og saltbalancen og dehydrering.

Hvis du har glemt at tage Spironolactone Accord

Hvis du har glemt at tage en dosis, så tag den så hurtigt som muligt, medmindre det næsten er tid til at

tage den næste dosis, i hvilket tilfælde du ikke bør tage den glemte dosis, men fortsætte i henhold til den

foreskrevne tidsplan. Du må ikke tage en dobbeltdosis som erstatning for den glemte dosis. Er du i tvivl,

så spørg lægen eller apotekspersonalet.

Hvis du holder op med at tage Spironolactone Accord

Hvis du holder op med Spironolactone Accord, kan de oprindelige symptomer vende tilbage. Kontakt

altid din læge, hvis du ønsker at stoppe med at bruge medicinen.

Hvis du har yderligere spørgsmål om brugen af dette lægemiddel, så spørg din læge eller

apotekspersonalet.

4.

Bivirkninger

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

Bivirkningerne afhænger af dosis og behandlingsvarighed.

De mest almindelige bivirkninger er hyperkaliæmi, i det reproduktive system og brystlidelser, herunder

gynækomasti. Gynækomasti synes at være relateret til både doseringsniveau og behandlingsvarighed og er

sædvanligvis reversibel, så snart behandlingen afbrydes. Andre meget almindelige bivirkninger er

hovedpine, forstyrrelser i fordøjelsessystemet, diarré, træthed og døsighed.

Meget almindelige (kan påvirke flere end 1 ud af 10 personer)

Hyperkaliæmi hos patienter med svært nedsat nyrefunktion, der får samtidig behandling med

kaliumtilskud

Hovedpine

Fordøjelsesbesvær, diarré

Mænd: nedsat libido, erektil dysfunktion, impotens, vækst af brystvævet (gynækomasti);

Kvinder: brystlidelser, ømhed i brysterne, menstruationsforstyrrelser, dybere stemme (i mange

tilfælde irreversibel)

Træthed, døsighed

Almindelige: kan påvirke op til 1 ud af 10 personer

Hyponatriæmi (navnlig under kombineret intensiv behandling med thiaziddiuretika), hyperkaliæmi

hos (1) patienter med svært nedsat nyrefunktion, (2) patienter, der fik behandling med ACE-hæmmere

eller kaliumklorid, (3) ældre patienter, og (4) diabetiske patienter

Kvalme og opkastning

Kvinder: ændringer i vaginalsekret, nedsat libido, manglende menstruationer (amenorré),

postmenopausal blødning

Svaghed, somnolens (sløvhed) hos patienter med cirrose, fornemmelser af kildren, kløe eller prikken

uden nogen årsag (paræstesi)

Generel svaghed

Ikke almindelig: kan påvirke op til 1 ud af 100 personer

Acidose hos patienter med leverproblemer

Forvirring

Hududslæt, urticaria, erytem, chloasma, generaliseret kløe

Muskelkramper

Lægkramper

Forhøjede serumkreatininniveauer

Sjældne: kan påvirke op til 1 ud af 1.000 personer

Meget alvorlige blodabnormiteter (mangel på hvide blodlegemer) ledsaget af pludselig høj feber,

meget ondt i halsen og sår i munden (agranulocytose), blodabnormitet (blodplademangel) ledsaget af

blå mærker og tendens til blødning (trombocytopeni),

Allergiske reaktioner

Utilstrækkelig væske i vævene (dehydrering), porfyri, midlertidig stigning i kvælstof i blodet og

urinen, forhøjet urinsyre i blodet (hyperurikæmi). Dette kan forårsage gigtangreb hos modtagelige

patienter.

Lammelse, paraplegi af lemmer på grund af hyperkaliæmi

Meget sjældne: kan påvirke op til 1 ud af 10.000 personer

Brystkræft

Betændelse i karvæggene (vaskulitis)

Gastrisk inflammation, mavesår, tarmblødning, kramper

Hepatitis

Alopeci, eksem, erytem annulare centrifugum (EAC)

Systemisk lupus erythematosus (SLE)

Akut nyresvigt

Overdreven hårvækst (hypertrikose)

Knogleblødgøring (osteomalaci)

Hyppigheden er ikke kendt (hyppigheden kan ikke vurderes ud fra tilgængelige data):

Mindre androgene virkninger, herunder hirsutisme.

Der er rapporteret reversibel hyperchloræmisk metabolisk acidose - som regel ledsaget af

hyperkaliæmi - hos nogle patienter med dekompenseret levercirrose, selv når nyrefunktionen var

normal.

Svimmelhed, ataksi

Let hypotension

Kløe og blærer på huden omkring læberne og resten af kroppen (Stevens-Johnsons syndrom)

Frigørelse af det øverste lag af huden fra de lavere lag af huden over hele kroppen (toksisk epidermal

nekrolyse)

Hududslæt, feber og hævelse (som kunne være symptomer på noget mere alvorligt, lægemiddeludslæt

og eosinofili og systemiske symptomer)

Pemfigoid (tilstand med væskefyldte blærer på huden)

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:

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

Opbevares utilgængeligt for børn.

Dette lægemiddel kræver ingen særlige forholdsregler vedrørende opbevaringen. Opbevar i

originalemballagen for at beskytte mod lys.

Brug ikke lægemidlet efter den udløbsdato, der står på pakning og blister efter EXP. Udløbsdatoen

er den sidste dag i den nævnte måned.

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

Spironolactone Accord indeholder:

- Aktivt stof: spironolacton

Spironolactone Accord indeholder 25 mg, 50 mg eller 100 mg spironolacton.

- Øvrige indholdsstoffer:

Tabletkernen

Lactosemonohydrat, prægelatineret majsstivelse, calciumhydrogenphosphat, vandfrit, povidon K25,

pebermynteolie, renset talcum, silica, kolloid vandfri, magnesiumstearat (E470b).

Filmovertræk

Hypromellose, macrogol, titandioxid (E171).

Udseende og pakningsstørrelser

Spironolactone Accord 25 mg filmovertrukne tabletter er hvide eller råhvide, runde, bikonvekse tabletter

præget med ’AD’ på den ene side og uden prægning på den anden side. 25 mg-tablettens diameter er ca.

8,1 mm.

Spironolactone Accord 50 mg filmovertrukne tabletter er hvide eller råhvide, runde, bikonvekse tabletter

præget med ’AE’ på den ene side og uden prægning på den anden side. 50 mg-tablettens diameter er ca.

10,1 mm.

Spironolactone Accord 100 mg filmovertrukne tabletter er hvide eller råhvide, runde, bikonvekse tabletter

præget med ’AF’ på den ene side og uden prægning på den anden side. 100 mg- tablettens diameter

11,2 mm.

Tabletterne er pakket i PVC / aluminiumfolieblistere og HDPE-beholdere.

Pakningsstørrelser:

Blisterpakning: 20, 28, 30, 50, 60, 90 og 100 tabletter.

HDPE-beholdere: 250, 500 og 1000 tabletter (kun til hospitalsbrug eller dosisdispensering).

Ikke alle pakningsstørrelser er nødvendigvis markedsført.

Indehaver af markedsføringstilladelsen og fremstiller

Accord Healthcare Limited

Sage House, 319 Pinner Road, North Harrow,

Middlesex, HA1 4HF,

Storbritannien

Denne indlægsseddel blev senest revideret i 02/2018.

17-11-2018

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

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

Published on: Fri, 16 Nov 2018 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 tau‐fluvalinate. To assess the occurrence of tau‐fluvalinate 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 St...

Europe - EFSA - European Food Safety Authority Publications

16-11-2018

Setting of an import tolerance for pyraclostrobin in rice

Setting of an import tolerance for pyraclostrobin in rice

Published on: Thu, 15 Nov 2018 In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant BASF SE submitted a request to the competent national authority in Germany to set an import tolerance for the active substance pyraclostrobin in rice. The data submitted in support of the request were found to be sufficient to derive a maximum residue level (MRL) proposal for rice. Based on the risk assessment results, EFSA concluded that the short‐term intake of residues resulting from the use of p...

Europe - EFSA - European Food Safety Authority Publications

15-11-2018

Assessment of genetically modified LLCotton25 for renewal of authorisation under Regulation (EC) No 1829/2003 (application EFSA‐GMO‐RX‐010)

Assessment of genetically modified LLCotton25 for renewal of authorisation under Regulation (EC) No 1829/2003 (application EFSA‐GMO‐RX‐010)

Published on: Wed, 14 Nov 2018 Following the submission of application EFSA‐GMO‐RX‐010 under Regulation (EC) No 1829/2003 from Bayer, the Panel on Genetically Modified Organisms of the European Food Safety Authority (GMO Panel) was asked to deliver a scientific risk assessment on the data submitted in the context of the renewal of authorisation application for the herbicide‐tolerant genetically modified LLCotton25, for food and feed uses, import and processing, excluding cultivation within the EU. The d...

Europe - EFSA - European Food Safety Authority Publications

13-11-2018

Setting of import tolerances for teflubenzuron in grapefruits, mandarins and broccoli

Setting of import tolerances for teflubenzuron in grapefruits, mandarins and broccoli

Published on: Mon, 12 Nov 2018 00:00:00 +0100 In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant BASF Agro BV submitted a request to the competent national authority in the United Kingdom to set import tolerances for the active substance teflubenzuron in grapefruits and mandarins imported from Brazil and for broccoli imported from Paraguay. The data submitted were found to be sufficient to derive maximum residue level (MRL) proposals for grapefruits and broccoli. The MRL derived ...

Europe - EFSA - European Food Safety Authority Publications

13-11-2018

The importance of vector abundance and seasonality

The importance of vector abundance and seasonality

Published on: Mon, 12 Nov 2018 00:00:00 +0100 This joint ECDC‐EFSA report assesses whether vector count data (abundance) and the way these change throughout the year (seasonality) can provide useful information about vector‐borne diseases epidemiological processes of interest, and therefore, whether resources should be devoted to collecting such data. The document also summarises what measures of abundance and seasonality can be collected for each vector group (mosquitoes, sandflies, midges and ticks), ...

Europe - EFSA - European Food Safety Authority Publications

10-11-2018

Outcome of the consultation with Member States and EFSA on the basic substance application for propolis extract (admissibility accepted when named water‐soluble extract of propolis) for use in plant protection as fungicide and bactericide

Outcome of the consultation with Member States and EFSA on the basic substance application for propolis extract (admissibility accepted when named water‐soluble extract of propolis) for use in plant protection as fungicide and bactericide

Published on: Fri, 09 Nov 2018 00:00:00 +0100 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 propolis extract are presented. The context of the evaluation ...

Europe - EFSA - European Food Safety Authority Publications

6-11-2018

Setting of import tolerances for haloxyfop‐P in linseed and rapeseed

Setting of import tolerances for haloxyfop‐P in linseed and rapeseed

Published on: Fri, 02 Nov 2018 00:00:00 +0100 In accordance with Article 6 of Regulation (EC) No 396/2005, the Australian Government Department of Agriculture and Water Resources submitted two requests to the competent national authority in Denmark to set import tolerances for the active substance haloxyfop‐P in linseed and rapeseed. The data submitted in support of the request were found to be sufficient to derive maximum residue level (MRL) proposals for linseed and rapeseed. Adequate analytical metho...

Europe - EFSA - European Food Safety Authority Publications

31-10-2018

Updated review of the existing maximum residue levels for imazalil according to Article 12 of Regulation (EC) No 396/2005 following new toxicological information

Updated review of the existing maximum residue levels for imazalil according to Article 12 of Regulation (EC) No 396/2005 following new toxicological information

Published on: Tue, 30 Oct 2018 00:00:00 +0100 In compliance with Article 43 of Regulation (EC) No 396/2005, EFSA received a mandate from the European Commission to provide an update of the reasoned opinion on the review of existing maximum residue levels (MRLs) for imazalil published on 5 September 2017, taking into account the additional information provided on the toxicity of the metabolites R014821, FK‐772 and FK‐284. EFSA did not derive MRL proposals from the post‐harvest uses reported on citrus fru...

Europe - EFSA - European Food Safety Authority Publications

23-10-2018

Evaluation of confirmatory data following the Article 12 MRL review for pendimethalin

Evaluation of confirmatory data following the Article 12 MRL review for pendimethalin

Published on: Mon, 22 Oct 2018 00:00:00 +0200 The applicant BASF Agro BV submitted a request to the competent national authority in the Netherlands to evaluate the confirmatory data that were identified in the framework of the maximum residue level (MRL) review under Article 12 of Regulation (EC) No 396/2005 as not available. To address the data gaps, residue trials on strawberries, onions, garlic, tomatoes, peppers, cucumbers, artichokes, leeks and rape seeds were submitted. The data gaps are considere...

Europe - EFSA - European Food Safety Authority Publications

20-10-2018

Evaluation of confirmatory data following the Article 12 MRL review for pyraflufen‐ethyl

Evaluation of confirmatory data following the Article 12 MRL review for pyraflufen‐ethyl

Published on: Fri, 19 Oct 2018 00:00:00 +0200 The applicant, Nichino Europe Co. Ltd., submitted application request to the competent national authority in the Netherlands to evaluate confirmatory data that were identified for pyraflufen‐ethyl in the framework of the maximum residue level (MRL) review under Article 12 of Regulation (EC) No 396/2005 as not available. The submitted data were sufficient to confirm the MRLs for citrus fruits, tree nuts, pome fruits, stone fruits, table and wine grapes, curra...

Europe - EFSA - European Food Safety Authority Publications

20-10-2018

Scientific Opinion of Flavouring Group Evaluation 411 (FGE.411): 2‐(4‐methylphenoxy)‐N‐(1H‐pyrazol‐3‐yl)‐N‐(thiophen‐2‐ylmethyl)acetamide from chemical group 30 (miscellaneous substances)

Scientific Opinion of Flavouring Group Evaluation 411 (FGE.411): 2‐(4‐methylphenoxy)‐N‐(1H‐pyrazol‐3‐yl)‐N‐(thiophen‐2‐ylmethyl)acetamide from chemical group 30 (miscellaneous substances)

Published on: Fri, 19 Oct 2018 00:00:00 +0200 EFSA was requested to deliver a scientific opinion on the implications for human health of the flavouring substance 2‐(4‐methylphenoxy)‐N‐(1H‐pyrazol‐3‐yl)‐N‐(thiophen‐2‐ylmethyl)acetamide [FL‐no: 16.133], in the Flavouring Group Evaluation 411 (FGE.411), according to Regulation (EC) No 1331/2008 of the European Parliament and of the Council. The substance has not been reported to occur in natural source materials of botanical or animal origin. It is intende...

Europe - EFSA - European Food Safety Authority Publications

17-10-2018

Lumpy skin disease: scientific and technical assistance on control and surveillance activities

Lumpy skin disease: scientific and technical assistance on control and surveillance activities

Published on: Tue, 16 Oct 2018 00:00:00 +0200 The duration of the vaccination campaign sufficient to eliminate lumpy skin disease (LSD) mainly depends on the vaccination effectiveness and coverage achieved. By using a spread epidemiological model, assuming a vaccination effectiveness of 65%, with 50% and 90% coverage, 3 and 4 years campaigns, respectively, are needed to eliminate LSD. When vaccination effectiveness is 80% to 95%, 2 years of vaccination at coverage of 90% is sufficient to eliminate LSD vir...

Europe - EFSA - European Food Safety Authority Publications

16-10-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

6-10-2018

Modification of the existing maximum residue level for epoxiconazole in beetroots

Modification of the existing maximum residue level for epoxiconazole in beetroots

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

Europe - EFSA - European Food Safety Authority Publications

2-10-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

28-9-2018

Avian influenza overview May – August 2018

Avian influenza overview May – August 2018

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

Europe - EFSA - European Food Safety Authority Publications

27-9-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

27-9-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

26-9-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

25-9-2018

Daiso Holdings Ltd. recalls Daiso Brand Consumer Chemical Products

Daiso Holdings Ltd. recalls Daiso Brand Consumer Chemical Products

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

Health Canada

21-9-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

21-9-2018

Modification of the existing maximum residue level for clothianidin in potatoes

Modification of the existing maximum residue level for clothianidin in potatoes

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

Europe - EFSA - European Food Safety Authority Publications

19-9-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

19-9-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

13-9-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

11-9-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

11-9-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

11-9-2018

Assessment of occupational and dietary exposure to pesticide residues

Assessment of occupational and dietary exposure to pesticide residues

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

Europe - EFSA - European Food Safety Authority Publications

4-9-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

1-9-2018

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

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

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

Health Canada

1-9-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

1-9-2018

Review of the existing MRLs for fenbuconazole

Review of the existing MRLs for fenbuconazole

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

Europe - EFSA - European Food Safety Authority Publications

30-8-2018

National summary reports on pesticide residue analysis performed in 2016

National summary reports on pesticide residue analysis performed in 2016

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

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

Modification of the existing maximum residue levels for fluoxastrobin in oilseeds

Modification of the existing maximum residue levels for fluoxastrobin in oilseeds

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

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

28-8-2018

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

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

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

FDA - U.S. Food and Drug Administration

2-7-2018

Blissful Remedies Issues Voluntary Nationwide Recall of Certain Kratom Powder Capsule

Blissful Remedies Issues Voluntary Nationwide Recall of Certain Kratom Powder Capsule

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

FDA - U.S. Food and Drug Administration

22-6-2018

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

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

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

FDA - U.S. Food and Drug Administration

21-6-2018

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

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

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

FDA - U.S. Food and Drug Administration

25-9-2018

Pelgraz (Accord Healthcare Limited)

Pelgraz (Accord Healthcare Limited)

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

Europe -DG Health and Food Safety

24-9-2018

Lenalidomide Accord (Accord Healthcare Limited)

Lenalidomide Accord (Accord Healthcare Limited)

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

Europe -DG Health and Food Safety

7-8-2018

Accofil (Accord Healthcare Limited)

Accofil (Accord Healthcare Limited)

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

Europe -DG Health and Food Safety

7-8-2018

Memantine Accord (Accord Healthcare Limited)

Memantine Accord (Accord Healthcare Limited)

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

Europe -DG Health and Food Safety

6-8-2018

Zoledronic acid Accord (Accord Healthcare Limited)

Zoledronic acid Accord (Accord Healthcare Limited)

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

Europe -DG Health and Food Safety

18-7-2018

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

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

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

FDA - U.S. Food and Drug Administration

4-7-2018

Docetaxel Accord (Accord Healthcare Limited)

Docetaxel Accord (Accord Healthcare Limited)

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

Europe -DG Health and Food Safety

3-7-2018

Temozolomide Accord (Accord Healthcare Limited)

Temozolomide Accord (Accord Healthcare Limited)

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

Europe -DG Health and Food Safety

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