Naltrexone Accord

Hauptinformation

  • Handelsname:
  • Naltrexone Accord Filmtablette 50 mg
  • Dosierung:
  • 50 mg
  • Darreichungsform:
  • Filmtablette
  • Verwenden für:
  • Menschen
  • Art der Medizin:
  • allopathic Droge

Dokumenten

  • Information für medizinisches Fachpersonal:
  • Das Informationsblatt für dieses Produkt ist derzeit nicht verfügbar, können Sie eine Anfrage an unseren Kundendienst zu senden und wir werden Sie benachrichtigen, sobald wir in der Lage, um es zu erhalten.


    Fordern Sie die Packungsbeilage für medizinisches Fachpersonal.

Lokalisierung

  • Erhältlich in:
  • Naltrexone Accord Filmtablette 50 mg
    Belgien
  • Sprache:
  • Deutsch

Therapeutische Informationen

  • Therapiegruppe:
  • andere Medikamente für das Nervensystem Arzneimittel für Süchte.

Weitere Informationen

Status

  • Quelle:
  • AFMPS - Agence Fédérale des Médicaments et des Produits de Santé - Belgium
  • Zulassungsnummer:
  • BE374674
  • Letzte Änderung:
  • 12-04-2018

Packungsbeilage

GEBRAUCHSINFORMATION: INFORMATION FÜR DEN ANWENDER

Naltrexone Accord 50 mg Filmtabletten

Naltrexonhydrochlorid

Lesen Sie die gesamte Packungsbeilage sorgfältig durch, bevor Sie mit der Einnahme dieses

Arzneimittels beginnen, denn sie enthält wichtige Informationen.

Heben Sie die Packungsbeilage auf. Vielleicht möchten Sie diese später nochmals lesen.

Wenn Sie weitere Fragen haben, wenden Sie sich an Ihren Arzt oder Apotheker.

Dieses Arzneimittel wurde Ihnen persönlich verschrieben. Geben Sie es nicht an Dritte weiter. Es kann

anderen Menschen schaden, auch wenn diese die gleichen Beschwerden haben wie Sie.

Wenn Sie Nebenwirkungen bemerken, wenden Sie sich an Ihren Arzt oder Apotheker. Dies gilt auch für

Nebenwirkungen, die nicht in dieser Packungsbeilage angegeben sind. Siehe Abschnitt 4.

Was in dieser Packungsbeilage steht:

1. Was sind Naltrexone Accord 50 mg Filmtabletten und wofür werden sie angewendet?

2. Was müssen Sie vor der Einnahme von Naltrexone Accord 50 mg Filmtabletten beachten?

3. Wie sind Naltrexone Accord 50 mg Filmtabletten einzunehmen?

4. Welche Nebenwirkungen sind möglich?

5. Wie sind Naltrexone Accord 50 mg Filmtabletten aufzubewahren?

6. Inhalt der Packung und weitere Informationen

1. Was sind Naltrexone Accord 50 mg Filmtabletten und wofür werden sie angewendet?

Der Wirkstoff Naltrexonhydrochlorid gehört zu einer Gruppe von Arzneimitteln mit der Bezeichnung „Andere

Mittel für das Nervensystem; medikamentöse Unterstützung der Entzugsbehandlung“.

Was sind Naltrexone Accord 50 mg Filmtabletten und wofür werden sie angewendet?

Naltrexonhydrochlorid wird in Kombination mit weiteren Arzneimitteln oder Therapien angewendet, um

Personen mit einer Abhängigkeit von Substanzen wie Heroin (Opioide) bei der Entwöhnung zu unterstützen.

Es wird bei alkoholabhängigen Patienten als unterstützende Behandlung zum Aufrechterhalten der

Enthaltsamkeit (willentlicher Verzicht) angewendet.

Naltrexon übt seine Wirkung dadurch aus, dass es Rezeptoren im Gehirn blockiert, so dass sie die Wirkung von

Opioiden stoppen. Personen werden nicht mehr die Euphorie empfinden, die sich vorher nach der Anwendung

von Opioiden einstellte.

2. Was müssen Sie vor der Einnahme von Naltrexone Accord 50 mg Filmtabletten beachten?

Naltrexone Accord 50 mg Filmtabletten dürfen nicht eingenommen werden,

wenn Sie allergisch gegen Naltrexonhydrochlorid oder einen der in Abschnitt 6. genannten sonstigen

Bestandteile des Arzneimittels sind;

wenn Sie von Opiaten abhängig sein oder eine Therapie zum Erreichen der Abstinenz (Enthaltsamkeit)

erhalten, weil es zu einem Abstinenzsyndrom (Entzugssyndrom) oder zu einer Verschlimmerung des

Abstinenzsyndroms kommen kann;

wenn Sie kontinuierlich ein Arzneimittel einnehmen, das ein Opioid enthält, wie z. B. bestimmte

Hustenpräparate, Arzneimittel zur Behandlung von Durchfallerkrankungen (wie Kaolin und Morphin)

und Schmerzmittel (Analgetika).

Hinweis: Naltrexonhydrochlorid blockiert nicht die schmerzstillende Wirkung von Analgetika, die keine

Opioide enthalten (wie z. B. Ibuprofen, Paracetamol und Acetylsalicylsäure);

wenn Sie an einer akuten Infektion der Leber erkrankt sind oder eine schlechte Leberfunktion haben.

wenn bei Patienten Entzugssymptome nach der Gabe von Naltrexonhydrochlorid auftreten;

wenn Sie Methadon einnehmen.

Wenn Sie der Ansicht sind, dass einer dieser Gründe auf Sie zutrifft, dürfen Sie Naltrexonhydrochlorid 50 mg

Filmtabletten nicht einnehmen. Sprechen Sie zuerst mit Ihrem Arzt und befolgen Sie seinen Rat.

Warnhinweise und Vorsichtsmaßnahmen

Bitte sprechen Sie mit Ihrem Arzt oder Apotheker, bevor Sie Naltrexone Accord 50 mg Filmtabletten

einnehmen:

Wenn bei Ihnen Leber- oder Nierenerkrankungen bestehen. Patienten, die Naltrexone Accord 50 mg

Filmtabletten eingenommen haben, können immer noch eine Überempfindlichkeitsreaktion auf

Arzneimittel haben, die Opiate enthalten. Dies trifft sogar auf die Zeit nach der Anwendung zu.

Bevor Sie mit der Behandlung beginnen: Ihr Arzt wird möglicherweise eine Blutuntersuchung

durchführen. Auch während der Behandlung sind Blutuntersuchungen erforderlich, weil Naltrexone

Accord 50 mg Filmtabletten von der Leber verarbeitet werden und weil diese Tests zeigen, wie gut Ihre

Leber ihre Aufgabe erfüllt.

Sollte ein Patient in einer Notfallsituation dennoch eine Therapie mit Opioiden benötigen, z. B.

Opioidanalgesie oder -anästhesie, dann ist die benötigte Dosis größer als üblich, um die schmerzstillende

Wirkung zu erreichen. In diesen Fällen werden Atemdepression und Kreislaufstörungen ausgeprägter

sein und länger andauern.

Die Behandlung mit Naltrexon darf erst eingeleitet werden, nachdem das Opioid über einen ausreichend

langen Zeitpunkt abgesetzt wurde (ca. 5 bis 7 Tage bei Heroin und mindestens 10 Tage für Methadon).

Abnorme Werte in Leberfunktionstests wurden bei adipösen und älteren Patienten berichtet, die mit

Naltrexon behandelt wurden und bei denen kein Medikamentenmissbrauch in der Vorgeschichte vorlag.

Es ist wichtig, dass Sie die Einnahme von Naltrexone Accord 50 mg Filmtabletten sofort abbrechen und

Ihren Arzt unterrichten, falls die folgenden Symptome auftreten: anhaltende Bauchschmerzen, weiß

gefärbter Stuhl, dunkel gefärbter Harn oder wenn sich Ihre Augen und/oder Haut gelb verfärben.

Sprechen Sie mit Ihrem Arzt, falls einer der oben genannten Warnhinweise auf Sie zutrifft oder dies in der

Vergangenheit der Fall war.

Kinder und Jugendliche (<18 Jahre)

Naltrexon sollte nicht bei Kindern und Jugendlichen unter 18 Jahren angewendet werden, da klinische Daten für

diese Altersgruppe fehlen. Eine sichere Anwendung bei Kindern steht nicht fest.

Ältere Patienten

Es gibt nur ungenügend Daten über die Sicherheit und Wirksamkeit von Naltrexon in dieser Indikation bei

älteren Patienten.

Einnahme von Naltrexone Accord 50 mg Filmtabletten zusammen mit anderen Arzneimitteln

Bitte informieren Sie Ihren Arzt oder Apotheker, wenn Sie andere Arzneimittel einnehmen/anwenden,

kürzlich andere Arzneimittel eingenommen/angewendet haben oder beabsichtigen, andere Arzneimittel

einzunehmen/anzuwenden.

Die gleichzeitige Einnahme von Naltrexone Accord 50 mg Filmtabletten und Arzneimitteln, die Opiate

enthalten, muss vermieden werden. Wenn Sie versuchen, die blockierende Wirkung von Naltrexone

Accord 50 mg Filmtabletten durch große Mengen an Opioiden zu beseitigen, werden Sie ernsthafte

Probleme bekommen. Ein solches Vorgehen kann zu Atemlosigkeit, Koma und sogar zum Tod führen.

Die gleichzeitige Einnahme von Naltrexone Accord

50 mg Filmtabletten und Thioridazin kann

Benommenheit verursachen. Es sind keine weiteren schädlichen Wirkungen bekannt, die durch

Wechselwirkungen zwischen Naltrexone Accord 50 mg Filmtabletten und anderen Arzneimittel bedingt

sind.

Arzneimittel können eine wechselseitige Wirkung aufeinander ausüben.

Einnahme von Naltrexone Accord 50 mg Filmtabletten zusammen mit Nahrungsmitteln und Getränken

Die Einnahme von Naltrexone Accord 50 mg Filmtabletten zusammen mit Nahrungsmitteln und Getränken hat

keinen Einfluss auf Ihre Behandlung.

Schwangerschaft und Stillzeit

Die Sicherheit der Einnahme von Naltrexone Accord 50 mg Filmtabletten während der Schwangerschaft wurde

nicht nachgewiesen.

Es ist nicht bekannt, ob Naltrexon in die Muttermilch übertritt. Weil bei Neugeborenen und Kindern die

Sicherheit von Naltrexon nicht nachgewiesen wurde, wird das Stillen während der Einnahme von Naltrexone

Accord 50 mg Filmtabletten nicht empfohlen.

Wenn Sie schwanger sind oder stillen, oder wenn Sie vermuten, schwanger zu sein oder beabsichtigen,

schwanger zu werden, fragen Sie vor der Einnahme dieses Arzneimittels Ihren Arzt oder Apotheker um Rat.

Verkehrstüchtigkeit und das Bedienen von Maschinen

Naltrexon kann physische und psychische Fähigkeiten beeinflussen, weswegen von gefährlichen Aufgaben, wie

Lenken von Fahrzeugen oder Bedienen von Maschinen, abgesehen werden soll.

Naltrexone Accord 50 mg Filmtabletten enthalten Lactosemonohydrat

Dieses Arzneimittel enthält 192,85 mg Lactose. Nach den Dosierungsempfehlungen werden mit jeder Dosis bis

zu 192,85 mg Lactose zugeführt. Wenn Sie von Ihrem Arzt darüber unterrichtet wurden, dass Sie eine

Unverträglichkeit gegen bestimmte Zucker haben, sprechen Sie vor der Anwendung dieses Arzneimittels mit

Ihrem Arzt.

3. Wie sind Naltrexone Accord 50 mg Filmtabletten einzunehmen?

Nehmen Sie Naltrexone Accord 50 mg Filmtabletten immer dieses Arzneimittel immer nach Absprache mit

Ihrem Arzt oder Apotheker ein. Bitte fragen Sie bei Ihrem Arzt oder Apotheker nach, wenn Sie sich nicht sicher

sind.

Die empfohlene Dosis beträgt 1 Tablette pro Tag, sofern Ihnen vom Arzt keine andere Dosierung verordnet

wurde.

Naltrexone Accord 50 mg Filmtabletten werden mit einer kleinen Menge Flüssigkeit eingenommen.

Bevor Sie mit der Einnahme Naltrexone Accord 50 mg Filmtabletten beginnen, müssen Sie mindestens 7-

10 Tage lang keinerlei anderen Opiate genutzt haben. Ihr Arzt kann einen Test darauf machen, dass diese

Stoffe vor Beginn Ihrer Behandlung nicht mehr in Ihrem Körper vorhanden sind. Im Allgemeinen beginnt

die Behandlung mit einer halben Tablette pro Tag (25 mg) und die Dosis wird später auf 1 Tablette pro Tag

(50 mg) erhöht.

Naltrexone Accord 50 mg Filmtabletten müssen ausschließlich für die Erkrankung genutzt werden, für die

sie von Ihrem Arzt verschrieben wurden.

Sie müssen im Hinblick auf die Dosierung genau die Anweisungen Ihres Arztes befolgen.

Es ist sehr wichtig, dass Sie Naltrexone Accord 50 mg Filmtabletten für den Zeitraum einnehmen, der

Ihnen von Ihrem Arzt verordnet wurde. Die Behandlung kann drei Monate oder länger dauern – die

Entscheidung wird von Ihrem Arzt getroffen. Naltrexone Accord 50 mg Filmtabletten sollten zusammen

mit anderen Therapieformen angewendet werden.

Falls Sie feststellen, dass die Wirkung von Naltrexone Accord 50 mg Filmtabletten zu stark oder nicht stark

genug ist, sprechen Sie bitte mit Ihrem Apotheker.

Wenn Sie eine größere Menge von Naltrexone Accord 50 mg Filmtabletten eingenommen haben, als Sie

sollten

Wenn Sie mehr als die verordnete Anzahl an Tabletten eingenommen haben, müssen Sie sofort Ihren Arzt

verständigen.

Wenn Sie zu viel Naltrexone Accord 50 mg Filmtabletten eingenommen haben, setzen Sie sich umgehend mit

Ihrem Arzt, Ihrem Apotheker oder dem “Antigifcentrum“ (070/245.245) in Verbindung

Wenn Sie die Einnahme von Naltrexone Accord 50 mg Filmtabletten vergessen haben

Sie können Naltrexone Accord 50 mg Filmtabletten immer noch einnehmen, wenn Sie sich daran erinnern.

Nehmen Sie keine doppelte Dosis ein, um eine vergessene Einzeldosis nachzuholen.

Wenn Sie die Einnahme von Naltrexone Accord 50 mg Filmtabletten abbrechen

Falls Sie sich überlegen, die Einnahme vor Abschluss der vereinbarten Behandlungszeit abzubrechen, müssen

Sie dies immer mit Ihrem Arzt besprechen.

Wenn Sie weitere Frage zur Anwendung dieses Arzneimittels haben, fragen Sie Ihren Arzt oder Apotheker.

4. Welche Nebenwirkungen sind möglich?

Wie alle Arzneimittel auch dieses Arzneimittel Nebenwirkungen haben, die aber nicht bei jedem auftreten

müssen.

Naltrexone Accord 50 mg Filmtabletten können Ihre Leberfunktion beeinträchtigen. Zur Überwachung der

Leberfunktion wird Ihr Arzt vor Beginn der Behandlung und zu verschiedenen Zeitpunkten während der

Behandlung möglicherweise Blutuntersuchungen vornehmen.

Wenn Sie eine der folgenden Nebenwirkungen bemerken, beenden Sie sofort die Einnahme von Naltrexone

Accord 50 mg Filmtabletten und wenden Sie sich unverzüglich an Ihren Arzt:

Bauchschmerzen, die länger als ein paar Tage anhalten

Weiß gefärbter Stuhl

Dunkel gefärbter Harn

Gelbfärbung der Augen

Dies können Anzeichen einer Funktionsstörung der Leber sein.

Wenn Sie eine der folgenden Nebenwirkungen bemerken, wenden Sie sich unverzüglich an einen Arzt:

Anschwellen von Gesicht, Lippen oder Zunge

Hautausschlag

Atemnot

Dies können Anzeichen einer allergischen Reaktion sein

Sehr häufig (betrifft mehr als 1 von 10 Patienten)

Schlafstörungen

Angstzustände oder Nervosität

Bauchkrämpfe und -schmerzen

Brechreiz und/oder Erbrechen

Mangel an Energie oder Kraftlosigkeit

Gelenk- und/oder Muskelschmerzen

Kopfschmerzen

Beschleunigter oder unregelmäßiger Herzschlag

Unruhe

Häufig (betrifft 1 von 10 Patienten)

Reizbarkeit

Stimmungsschwankungen

Gesteigerte Energie

Niedergeschlagenheit

Benommenheit

Schüttelfrost

Vermehrtes oder übermäßiges Schwitzen

Schwindel

Vermehrte Tränenproduktion

Beschleunigter Herzschlag

Herzklopfen

Abweichungen im EKG

Schmerzen in der Brust

Diarrhoe

Verstopfung

Hautausschlag

Harnverhalt

Verzögerte Ejakulation

Potenzstörungen

Appetitmangel

Durst

Gesteigerte Energie

Schüttelfrost

Gelegentlich (betrifft 1 von 100 Patienten)

Bestimmte Infektionen (z. B. Herpes im Mund, Fußpilz)

Geschwollene/vergrößerte Lymphknoten

Halluzinationen

Verwirrtheit

Depression

Paranoia

Desorientierung

Albträume

Unruhe

Verminderte Libido

Ungewöhnliche Träume

Zittern

Schläfrigkeit

Verschwommenes Sehen

Augenreizung

Überempfindlichkeit der Augen gegenüber Lichteinwirkung

Schwellung der Augen

Augenschmerzen

Augenermüdung

Ohrenbeschwerden

Ohrenschmerzen

Ohrgeräusche

Schwindel

Blutdruckschwankungen

Erröten

Verstopfte Nase und Nasenbeschwerden

Niesen

Vermehrtes Sputum

Sinusprobleme

Stimmstörungen

Kurzatmigkeit/Atembeschwerden

Husten

Gähnen

Laufende Nase

Wind

Hämorrhoiden

Geschwüre

Mundtrockenheit

Leberstörungen (einschließlich Entzündung der Leber)

Erhöhte Leberenzyme

Fettige Haut

Juckreiz

Akne

Haarausfall

Leistenschmerzen

Vermehrte Harnausscheidung

Entzündung der Harnblase

Gesteigerter Appetit

Gewichtsabnahme

Gewichtszunahme

Fieber

Schmerzen

Kalte Hände oder Füße

Hitzegefühl

Selten (betrifft 1 von 1.000 Patienten)

Selbstmordgedanken

Selbstmordversuch

Blutungsstörungen

Sprachstörungen

Sehr selten (betrifft 1 von 10.000 Patienten)

Euphorie

Hautausschlag/-eruptionen

Schädigung der Skelettmuskulatur

Meldung von Nebenwirkungen

Wenn Sie Nebenwirkungen bemerken, wenden Sie sich bitte an Ihren Arzt, Apotheker oder das medizinische

Fachpersonal. Dies gilt auch für Nebenwirkungen, die nicht in dieser Packungsbeilage angegeben sind. Sie

können Nebenwirkungen außerdem direkt über das in Anhang V genannte nationale Meldesystem melden.

Indem Sie Nebenwirkungen melden, können Sie dazu beitragen, dass mehr Informationen über die Sicherheit

dieses Arzneimittels zur Verfügung gestellt werden.

5. Wie sind Naltrexone Accord 50 mg Filmtabletten aufzubewahren?

Arzneimittel für Kinder unzugänglich aufbewahren.

Sie dürfen dieses Arzneimittel nach dem auf dem Etikett angegebenen Verfalldatum (Verw. bis:) nicht

mehr anwenden. Das Verfalldatum bezieht sich auf den letzten Tag des Monats.

Für dieses Arzneimittel sind keine besonderen Lagerungsbedingungen erforderlich.

Entsorgen Sie Arzneimittel nicht im Abwasser oder Haushaltsabfall. Fragen Sie Ihren Apotheker, wie das

Arzneimittel zu entsorgen ist, wenn Sie es nicht mehr verwenden. Sie tragen damit zum Schutz der

Umwelt bei.

6. Inhalt der Packung und weitere Informationen

Was Naltrexone Accord 50 mg Filmtabletten enthalten

Der Wirkstoff ist Naltrexonhydrochlorid.

Jede Filmtablette enthält 50 mg Naltrexonhydrochlorid.

Die sonstigen Bestandteile sind:

Tablettenkern: Lactose-Monohydrat, mikrokristalline Cellulose, Crospovidon, kolloidales Siliziumdioxid,

Magnesiumstearat.

Filmüberzug: Hypromellose (E464), Macrogol 400, Polysorbat 80 (E 433), Eisenoxid, gelb (E 172), Eisenoxid,

rot (E 172), Titandioxid (E 171).

Wie Naltrexone Accord 50 mg Filmtabletten aussehen und Inhalt der Packung

Naltrexone Accord 50 mg Filmtabletten sind gelbe, ovale, bikonvexe Filmtabletten mit einer Bruchrille auf einer

Seite und ohne Prägung auf der anderen Seite.

Die Tablette kann in gleiche Hälften geteilt werden.

Naltrexone Accord 50 mg Filmtabletten sind in weiß-opaken PVC/PE/Aclar-Alu-Blisterpackungen und Alu-

Alu-Blisterpackungen mit 7, 14, 28, 30, 50 und 56 Tabletten verpackt.

Es werden möglicherweise nicht alle Packungsgrößen in den Verkehr gebracht.

Pharmazeutischer Unternehmer und Hersteller:

Accord Healthcare Limited

Sage House, 319, Pinner Road, North Harrow, Middlesex, HA1 4HF, Vereinigtes Königreich

Zulassungsnummer:

BE374665 ( PVC/PE/ACLAR – ALU Blisterpackungen )

BE374674 (ALU – ALU Blisterpackungen)

Art der Abgabe :

Verschreibungspflichtig

Dieses Arzneimittel ist in den Mitgliedsstaaten des Europäischen Wirtschaftsraumes (EWR) unter den

folgenden Bezeichnungen zugelassen:

Mitgliedsstaat

Arzneimittelname

Belgien

Naltrexone Accord 50 mg Filmtabletten

Dänemark

Naltrexone Accord 50 mg filmovertrukne tabletter

Estland

Naltrexone Accord 50 mg õhukese polümeerikattega tabletid

Finnland

Naltrexone

Accord

kalvopäällysteinen

tabletti/

filmdragerade tabletter

Deutschland

Naltrexonhydrochlorid Accord 50 mg Filmtabletten

Irland

Naltrexone Hydrochloride 50 mg Film-coated Tablets

Italien

Naltrexone Accord Healthcare 50 mg compresse rivestite con

film

Lettland

Naltrexone Accord 50 mg apvalkotās tabletes

Litauen

Naltrexone Accord 50 mg plėvele dengtos tabletės

Norwegen

Naltrexone Accord 50 mg Filmdrasjert tablett

Polen

Naltrexone Hydrochloride Accord 50 mg tabletki powlekane

Portugal

Naltrexone

Hydrochloride

Accord

comprimidos

revestidos por película

Spanien

Naltrexone

Hydrochloride

Accord

comprimidos

recubiertos con pelicula EFG

Niederlande

Naltrexonhydrochloride Accord 50 mg filmomhulde tabletten

Vereinigtes

Königreich

Naltrexone Hydrochloride 50 mg Film-coated Tablets

Diese Gebrauchsinformation wurde zuletzt überarbeitet im 03/2014.

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

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

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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...

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

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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...

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

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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...

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

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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...

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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...

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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

7-8-2018

Rote-Hand-Brief zu Argatroban Accord 1 mg/ml lnfusionslösung vom 06.08.2018

Rote-Hand-Brief zu Argatroban Accord 1 mg/ml lnfusionslösung vom 06.08.2018

Rote-Hand-Brief zu Argatroban Accord 1 mg/ml lnfusionslösung

Deutschland - BfArM - Bundesinstitut für Arzneimittel und Medizinprodukte

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

30-5-2018

Bortezomib Accord (Accord Healthcare Limited)

Bortezomib Accord (Accord Healthcare Limited)

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

Europe -DG Health and Food Safety

23-5-2018

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

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

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

Europe - EMA - European Medicines Agency

15-5-2018

Pramipexole Accord (Accord Healthcare Limited)

Pramipexole Accord (Accord Healthcare Limited)

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

Europe -DG Health and Food Safety