Naltrexon "Accord"

Primær information

  • Handelsnavn:
  • Naltrexon "Accord" 50 mg filmovertrukne tabletter
  • Dosering:
  • 50 mg
  • Lægemiddelform:
  • filmovertrukne tabletter
  • Brugt til:
  • Mennesker
  • Medicin typen:
  • Allopatiske stof

Dokumenter

Lokation

  • Fås i:
  • Naltrexon "Accord" 50 mg filmovertrukne tabletter
    Danmark
  • Sprog:
  • dansk

Andre oplysninger

Status

  • Kilde:
  • Lægemiddelstyrelsen - Danish Medicines Agency
  • Autorisation status:
  • Markedsført
  • Autorisationsnummer:
  • 43589
  • Sidste ændring:
  • 17-07-2018

Indlægsseddel

Indlægsseddel: Information til brugeren

Naltrexon Accord 50 mg filmovertrukne tabletter

Naltrexonhydrochlorid

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

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 Naltrexon Accord 50 mg filmovertrukne tabletter 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 eller apotekspersonalet, 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 tage Naltrexon Accord

3. Sådan skal du tage Naltrexon Accord

4. Bivirkninger

5. Opbevaring

6. Pakningsstørrelser og yderligere oplysninger

1. Virkning og anvendelse

Det aktive stof, naltrexonhydrochlorid, tilhører en gruppe af lægemidler kaldet anden nervemedicin, som bruges

til behandling af afhængighedslidelser.

Hvad Naltrexon Accord bruges til

Naltrexonhydrochlorid bruges i kombination med andre lægemidler eller anden behandling til at hjælpe

personer, der er afhængige af stoffer såsom heroin (opioider), med at komme ud af deres afhængighed.

Naltrexonhydrochlorid

indiceret

støttende

behandling

opretholdelse

afholdenhed

alkoholafhængige patienter.

Naltrexon virker ved at blokere receptorer i hjernen og dermed blokere opioidernes virkning. Personen vil ikke

længere opleve den eufori, der tidligere fulgte efter indtagelse af opioider.

2. Det skal du vide, før du begynder at tage Naltrexon Accord

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

anvisning og oplysningerne på doseringsetiketten.

Tag ikke Naltrexon Accord

hvis du er allergisk over for naltrexonhydrochlorid eller et af de øvrige indholdsstoffer (angivet i punkt

hvis

afhængig

opiater

eller

modtager

abstinensbehandling

(ved

afholdenhed),

eftersom

abstinenssyndrom eller en forværring af abstinenssyndrom kan forekommer.

hvis du tager medicin, der indeholder opioider, for eksempel visse midler mod hoste, medicin til

behandling af diarré (såsom kaolin og morfin) og analgetika (smertestillende midler).

Note: Naltrexonhydrochlorid har ikke en blokerende virkning på smertestillende midler, der ikke

indeholder opioider (såsom ibuprofen, paracetamol og acetylsalicylsyre).

hvis du har en akut leverinfektion eller din lever fungerer dårligt.

hvis du har abstinenssymptomer efter indtagelse af naloxonhydrochlorid.

hvis du tager metadon.

Hvis du mener, at ovenstående gælder for dig, må du ikke tage tabletterne. Tal med din læge og følg dennes råd.

Advarsler og forsigtighedsregler

Kontakt lægen eller apoteketspersonalet, før du tager Naltrexon Accord.

Det er vigtigt, at du fortæller det til din læge, inden du begynder at tage Naltrexon Accord

Hvis

lever-

eller

nyrelidelser.

Patienter,

taget

Naltrexon

Accord

stadig

overfølsomhedsreaktioner, når de tager medicin, der indeholder opiater, selv efter, at de er holdt op med

at tage Naltrexon Accord .

Før behandlingen begynder, vil din læge måske tage en blodprøve. Blodprøver er også nødvendige under

behandlingen, fordi Naltrexon Accord bearbejdes af leveren, og blodprøverne kan vise, hvor godt din

lever fungerer.

Hvis

patienter

brug

tage

lægemidler,

indeholder

opioider,

f.eks.

visse

analgetika

(smertestillende midler) eller anæstetika (bedøvelsesmidler) i nødsituationer, kræver det en højere

opioid-dosis at opnå den terapeutiske virkning. I sådanne tilfælde vil vejrtrækningsbesvær og påvirkning

af kredsløbet være mere udtalt og vare længere.

Behandling med naltrexon må først påbegyndes, når du ikke har taget opioidet i en tilstrækkeligt lang

periode (cirka 5 til 7 dage for heroin og mindst 10 dage for metadon).

Der er indberettet unormale resultater af leverfunktionsprøver hos overvægtige og ældre patienter, som

fik naltrexon, og som ikke var stofmisbrugere. Der bør foretages leverfunktionsprøver både før og under

behandlingen.

Det er vigtigt at holde op med at tage Naltrexon Accord med det samme og fortælle det til din læge,

hvis du får følgende symptomer: vedvarende mavesmerter, hvid afføring, mørk urin, eller hvis dine øjne

blive gule og/eller din hud blive gul.

Fortæl det til din læge, hvis ovenstående gælder dig.

Børn og unge

Naltrexon bør ikke bruges af børn og unge under 18 år, da der mangler forsøgsdata for denne aldersgruppe. Det

er ikke blevet fastslået, at børn kan bruge naltrexon uden risiko.

Ældre

Der foreligger ikke tilstrækkelige data mht. sikkerhed og virkning ved brug af naltrexon til ældre patienter.

Brug af anden medicin sammen med Naltrexon Accord

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

Samtidig brug af Naltrexon Accord og medicin, der indeholder opiater, bør undgås. Hvis du prøver at

overvinde naltrexons blokerende virkning med store mængder opioider, kan du få store problemer. Dette

kan føre til åndedrætsbesvær, koma og endda resultere i døden.

Samtidig brug af Naltrexon Accord og thioridazin kan medføre døsighed. Der kendes ikke andre

skadelige virkninger af interaktion mellem Naltrexon Accord og andre lægemidler.

Lægemidler kan påvirke hinanden gensidigt.

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

gælder også medicin, som ikke er købt på recept.

Brug af Naltrexon Accord sammen med mad og drikke

Indtagelse af mad og drikke har ingen indflydelse på virkningen af Naltrexon Accord .

Graviditet og amning

Det er ikke blevet fastslået, at Naltrexon Accord kan bruges uden risiko under graviditet. Hvis du er gravid eller

planlægger at blive gravid, bør du fortælle det til din læge, der vil beslutte, om du kan tage naltrexon.

Det vides ikke, om naltrexon uskilles i modermælk. Da det ikke er fastslået, at naltrexon er uskadeligt for

nyfødte og børn, må man ikke tage Naltrexon Accord , mens man ammer.

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 tager dette lægemiddel.

Trafik- og arbejdssikkerhed

Naltrexon kan nedsætte de mentale og/eller fysiske evner, der kræves ved udførelse af potentielt farlige

aktiviteter såsom at køre bil eller betjene maskiner.

Naltrexon Accord indeholder laktosemonohydrat

Dette lægemiddel indeholder 192,85 mg laktose. Den anbefalede dosis kan indeholde op til 192,85 mg laktose.

Kontakt lægen, før du tager denne medicin, hvis lægen har fortalt dig, at du ikke tåler visse sukkerarter.

3. Sådan skal du tage Naltrexon Accord

Tag altid Naltrexon Accord nøjagtigt efter lægens anvisning. Er du i tvivl, så spørg lægen eller på apoteket.

Den sædvanlige dosis er 1 tablet pr. dag, medmindre din læge har ordineret en anden dosis.

Naltrexon Accord tages gennem munden med lidt væske.

Når du begynder at tage Naltrexon Accord , må du ikke have taget opiater i mindst 7-10 dage. Din læge

kan foretage en test for at se, om du er fri for disse stoffer, før du påbegynder behandlingen. Almindeligvis

begynder behandlingen med en dosis på 1/2 tablet per dag (25 mg). Senere øges dosis til 1 tablet per dag

(50 mg).

Naltrexon Accord må kun bruges til behandling af den tilstand, som er grunden til, at din læge har

ordineret Naltrexon Accord .

Det er vigtigt, at du nøje følger din læges anvisninger mht. dosering.

Det er vigtigt, at du tager Naltrexon Accord i så lang tid, som din læge har sagt, du skal tage dem i.

Behandlingen kan vare i tre måneder eller længere, afhængig af din læges vurdering. Naltrexon Accord

bør kombineres med andre former for behandling.

Hvis du mærker, at virkningen af Naltrexon Accord er for stærk eller ikke er stærk nok, bør du sige det til din

læge eller på apoteket.

Hvis du har taget for meget Naltrexon Accord

Hvis du har taget flere tabletter, end din læge har foreskrevet, skal du straks underrette din læge.

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

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

Hvis du har glemt at tage Naltrexon Accord

Du skal fortsætte med at tage Naltrexon Accord , når du kommer i tanke om det.

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

Hvis du holder op med at tage Naltrexon Accord

Hvis du overvejer at holde op med at tage Naltrexon Accord før det aftalte sluttidspunkt for behandlingen, skal

du drøfte det med din læge.

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

4. Bivirkninger

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

Naltrexon Accord kan påvirke din leverfunktion. Din læge vil måske tage blodprøver før påbegyndelse af

behandlingen og i løbet af behandlingen for at overvåge din leverfunktion.

Hvis du får en eller flere af følgende bivirkninger, skal du stoppe med at tage Naltrexon Accord og straks

kontakte din læge:

Mavesmerter, der varer i mere end et par dage

Hvid afføring

Mørk urin

Gulfarvning af dine øjne

Ovenstående kan være tegn på, at din lever ikke fungerer så godt.

Hvis du få en eller flere af følgende bivirkninger, skal du straks kontakte din læge:

Hævelser i ansigt, læber eller tunge

Hududslæt

Vejrtrækningsbesvær

Ovenstående kan være tegn på en allergisk reaktion.

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

Søvnproblemer

Angst eller nervøsitet

Mavekramper og mavesmerter

At være syg eller føle, man er syg

Mangel på energi eller styrke

Led- og muskelsmerter

Hovedpine

Hurtig eller uregelmæssig hjerterytme

Rastløshed

Almindelige bivirkninger (forekommer hos op til 1 ud af 10 patienter)

Irritabilitet

Humørsvingninger

Øget energi

Fortvivlelse

Svimmelhed

Rysten

Øget svedtendens

Vertigo (fornemmelse af at snurre rundt)

Øget tåreflåd

Hurtig hjerterytme

Hjertebanken

Ændringer i EKG-resultater

Brystsmerter

Diarré

Forstoppelse

Udslæt

Besvær med at tømme blæren

Forsinket sædafgang

Impotens

Appetitmangel

Tørst

Øget energi

Kulderystelser

Ikke almindelige bivirkninger (forekommer hos op til 1 ud af 100 patienter)

Visse infektioner (f.eks. herpes i munden, fodsvamp)

Hævede/forstørrede lymfeknuder

Hallucinationer

Forvirring

Depression

Paranoia

Disorientering

Mareridt

Ophidselse

Nedsat seksualdrift

Unormale drømme

Rysten (tremor)

Døsighed

Sløret syn

Øjenirritation

Unormalt høj lysfølsomhed

Hævede øjne

Øjensmerter

Anstrengte øjne

Øreubehag

Øresmerter

Ringen for ørerne

Svimmelhed (vertigo)

Udsving i blodtryk

Rødmen

Tilstoppet næse og ubehag i næsen

Nysen

Øget spytproduktion

Bihuleproblemer

Stemmeforstyrrelser

Stakåndethed/vejrtrækningsbesvær

Hoste

Gaben

Løbende næse

Øget dannelse og afgang af tarmluft

Hæmorider

Indre sår (ulcus)

Mundtørhed

Leverforstyrrelser (herunder leverbetændelse)

Øget mængde leverenzymer

Fedtet hud

Analkløe (pruritus)

Akne

Hårtab

Lyskesmerter

Øget vandladning

Urinblærebetændelse

Øget appetit

Vægttab

Vægtforøgelse

Feber

Smerter

Kolde hænder eller fødder

Hedeture

Sjældne bivirkninger (forekommer hos op til 1 ud af 1.000 patienter)

Selvmordstanker

Selvmordsforsøg

Blødningsforstyrrelser

Taleforstyrrelser

Meget sjældne bivirkninger (forekommer hos op til 1 ud af 10.000 patienter)

Stærkt opstemthed (eufori)

Hududslæt

Beskadiget muskelvæv

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 Sundhedsstyrelsen via nedenstående kontaktoplysninger

Sundhedsstyrelsen

Axel Heides Gade 1

DK-2300 København S

Websted: www.meldenbivirkning.dk

E-mail: sst@sst.dk

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

dette lægemiddel.

5. Opbevaring

Opbevar lægemidlet utilgængeligt for børn.

Brug ikke lægemidlet efter den udløbsdato, der står på pakningen efter Exp. Udløbsdatoen er den sidste

dag i den nævnte måned.

Dette lægemiddel kræver ingen særlige forholdsregler vedrørende opbevaringen.

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

medicinrester i afløbet, toilettet eller skraldespanden.

6. Pakningsstørrelser og yderligere oplysninger

Naltrexon Accord indeholder

Det aktive stof er naltrexonhydrochlorid.

Hver filmovertrukne tablet indeholder 50 mg naltrexonhydrochlorid.

De øvrige indholdsstoffer er:

Tabletkerne: lactosemonohydrat, mikrokrystallinsk cellulose, crospovidon, silica kolloid vandfri ,

magnesiumstearat

Filmovertræk: hypromellose (E464), macrogol 400, polysorbat 80 (E433), gul jernoxid (E172), rød jernoxid

(E172), titanidioxid (E171)

Udseende og pakningsstørrelse

Naltrexon Accord fås som gule, ovale, bikonvekse filmovertrukne tabletter med delekærv på den ene side, flade

på den anden side.

Tabletten kan deles i to lige store dele.

Naltrexon

Accord

fås

hvide,

uigennemsigtige

PVC/PE/Aclar-alu-blister-

alu-alu-blisterpakninger

indeholdende 7, 14, 28, 30, 50 og 56 tabletter.

Ikke alle pakningsstørrelser er nødvendigvis markedsført.

Indehaver af markedsføringstilladelsen og fremstiller:

Accord Healthcare Limited, Sage House, 319, Pinner Road, North Harrow, Middlesex, HA1 4HF,

Storbritannien

Dette lægemiddel er godkent i EØS under folgende navne:

Medlemslandets

navn

Lægemidlets navn

Belgien

Naltrexone Accord 50 mg comprimes pellicules/ filmomhulde

tabletten/ Filmtabletten

Danmark

Naltrexon Accord 50 mg filmovertrukne tabletter

Estland

Naltrexone Accord 50 mg õhukese polümeerikattega tabletid

Finland

Naltrexon

Accord

kalvopäällysteinen

tabletti/

filmdragerade tabletter

Tyskland

Naltrexonhydrochlorid Accord 50 mg Filmtabletten

Irland

Naltrexone Hydrochloride 50 mg Film-coated Tablets

Italien

Naltrexone Accord Healthcare 50 mg compresse rivestite con

film

Letland

Naltrexone Accord 50 mg apvalkotās tabletes

Litauen

Naltrexone Accord 50 mg plėvele dengtos tabletės

Norge

Naltrexon Accord 50 mg Filmdrasjert tablett

Polen

Naltrexone Hydrochloride Accord 50 mg tabletki powlekane

Portugal

Naltrexona

Hydrochloride

Accord

comprimidos

revestidos por película

Spanien

Naltrexone

Hydrochloride

Accord

comprimidos

recubiertos con pelicula EFG

Holland

Naltrexon hydrochloride Accord 50 mg filmomhulde tabletten

Storbritannien

Naltrexone Hydrochloride 50 mg Film-coated Tablets

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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

Mysimba (Orexigen Therapeutics Ireland Limited)

Mysimba (Orexigen Therapeutics Ireland Limited)

Mysimba (Active substance: naltrexone / bupropion) - PSUSA - Modification - Commission Decision (2018) 4347 of Wed, 04 Jul 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/3687/PSUSA/10366/201709

Europe -DG Health and Food Safety

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