Cisatracurium Accord Healthcare

Hauptinformation

  • Handelsname:
  • Cisatracurium Accord Healthcare Injektionslösung 5 mg-ml
  • Dosierung:
  • 5 mg-ml
  • Darreichungsform:
  • Injektionslösung
  • 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:
  • Cisatracurium Accord Healthcare Injektionslösung 5 mg-ml
    Belgien
  • Sprache:
  • Deutsch

Weitere Informationen

Status

  • Quelle:
  • AFMPS - Agence Fédérale des Médicaments et des Produits de Santé - Belgium
  • Zulassungsnummer:
  • BE467457
  • Letzte Änderung:
  • 11-04-2018

Packungsbeilage: zusammensetzung, kinische angaben, nebenwirkungen, wechselwirkungen, dosierung, schwangerschaft, stillzeit

Gebrauchsinformation: Information für Patienten

Cisatracurium Accord Healthcare 2 mg/ml Injektions-/Infusionslösung

Cisatracurium Accord Healthcare 5 mg/ml Injektions-/Infusionslösung

Cisatracurium

Dieses Arzneimittel trägt den Namen „Cisatracurium Accord 2 mg/ml Injektions-/Infusionslösung“

und „Cisatracurium Accord 5 mg/ml Injektions-/Infusionslösung“. In der restlichen Packungsbeilage

wird das Arzneimittel aber „Cisatracurium Accord Healthcare ” genannt.

Lesen Sie die gesamte Packungsbeilage sorgfältig durch, bevor Sie mit der Anwendung

dieses Arzneimittels beginnen, da sie wichtige Informationen für Sie enthält.

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.

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 ist Cisatracurium Accord Healthcare und wofür wird es angewendet?

2.

Was sollten Sie vor der Anwendung von Cisatracurium Accord Healthcare beachten?

3.

Wie ist Cisatracurium Accord Healthcare anzuwenden?

4.

Welche Nebenwirkungen sind möglich?

5.

Wie ist Cisatracurium Accord Healthcare aufzubewahren?

6.

Inhalt der Packung und weitere Informationen

1.

Was ist Cisatracurium Accord Healthcare und wofür wird es angewendet?

Cisatracurium Accord Healthcare enthält den Wirkstoff Cisatracurium, der zu einer Gruppe von

Wirkstoffen gehört, die Muskelrelaxantien genannt werden.

Cisatracurium ist ein mittellang wirkender, nicht depolarisierender neuromuskulärer Blocker, der

intravenös verabreicht wird.

Cisatracurium Accord Healthcare wird angewendet zur:

Entspannung von Muskeln im Rahmen von Operationen bei Erwachsenen und Kindern im

Alter von über einem Monat, einschließlich Herzoperationen

Zur Erleichterung des Einführens eines Schlauches in die Luftröhre (endotracheale

Intubation), um einem Patienten das Atmen zu erleichtern

Zur Entspannung der Muskulatur von Patienten auf der Intensivstation.

Fragen Sie Ihren Arzt oder Apotheker, wenn Sie weitere Fragen zu diesem Medikament haben.

2.

Was sollten Sie vor der Anwendung von Cisatracurium Accord Healthcare beachten?

Cisatracurium Accord Healthcare darf nicht angewendet werden

Wenn Sie allergisch (überempfindlich) sind gegen Cisatracurium, einen anderen Muskelrelaxans

oder einen der anderen Bestandteile von Cisatracurium Accord Healthcare (in Abschnitt 6

aufgelistet)

Wenn Sie in der Vergangenheit bereits schlecht auf eine Narkose reagiert haben.

Wenn eines davon auf Sie zutrifft, dürfen Sie Cisatracurium Accord Healthcare nicht anwenden.

Fragen Sie im Zweifelsfall bitte Ihren Arzt oder Apotheker, bevor Sie mit Cisatracurium Accord

Healthcare behandelt werden.

Warnhinweise und Vorsichtsmaßnahmen

Sprechen Sie mit Ihrem Arzt, Pflegepersonal oder Apotheker, bevor Ihnen dieses Arzneimittel

verabreicht wird, wenn:

Sie an Muskelschwäche oder Müdigkeit leiden oder wenn Sie Probleme haben, Ihre

Bewegungen zu koordinieren (Mysthenia gravis)

Sie eine neuromuskuläre Erkrankung haben, wie zum Beispiel Muskelschwund, Lähmungen

oder eine Motoneuronerkrankung oder Zerebralparese

Sie eine Verbrennung haben, die medizinischer Behandlung bedarf

Sie schon einmal eine allergische Reaktion gegen ein Muskelrelaxans hatten, das im Rahmen

einer Operation gegeben wurde

Wenn Sie sich nicht sicher sind, ob einer der oben genannten Punkte auf Sie zutrifft, sprechen Sie mit

Ihrem Arzt, Pflegepersonal oder Apotheker, bevor Ihnen Cisatracurium Accord Healthcare

verabreicht wird.

Anwendung von Cisatracurium Accord Healthcare zusammen mit anderen Arzneimitteln

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

anwenden bzw. vor Kurzem eingenommen/angewendet haben. Dazu gehören auch pflanzliche

Medikamente sowie nicht verschreibungspflichtige Arzneimittel.

Dies ist besonders wichtig bei folgenden Arzneimitteln:

Anästhetika(zur Verringerung von Empfindungen und Schmerzen bei Operationen)

Antibiotika (zur Behandlung von Infektionen)

Antiarrhythmika (zur Behandlung eines unregelmäßigen Herzschlags)

Arzneimittel zur Behandlung von hohem Blutdruck

Diuretika (Entwässerungstabletten), z.B. Furosemid

Arzneimittel zur Behandlung von Gelenkentzündungen, z.B. Chloroquin oder D-Penicillamin

Steroide

Arzneimittel zur Behandlung von Krampfanfällen (Epilepsie), z. B. Phenytoin oder Carbamazepin

Arzneimittel zur Behandlung psychischer Erkrankungen, wie Lithium oder Chlorpromazin (wird

auch zur Behandlung von Übelkeit angewendet)

Arzneimittel, die Magnesium enthalten

Cholinesterase-Hemmer zur Behandlung der Alzheimer-Krankheit, wie z. B. Donepezil.

Schwangerschaft undStillzeit

Wenn Sie schwanger sind, den Verdacht haben, schwanger zu sein, schwanger werden

möchten oder stillen, fragen Sie vor der Einnahme von allen Arzneimitteln Ihren Arzt um Rat.

Als Vorsichtsmaßnahme sollten Frauen während der Behandlung mit diesem Arzneimittel sowie für

einen Zeitraum von 24 Stunden nach der Behandlung nicht stillen.

Verkehrstüchtigkeit und Fähigkeit zum Bedienen von Maschinen

Wenn Sie nur einen Tag lang im Krankenhaus bleiben, wird Ihr Arzt Ihnen mitteilen, wann genau Sie

das Krankenhaus verlassen oder Autofahren dürfen. Es kann gefährlich sein, zu schnell nach einer

Operation wieder Auto zu fahren.

3.Wie ist Cisatracurium Accord Healthcare anzuwenden?

Wie wird Ihnen die Injektion verabreicht?

Sie müssen sich dieses Arzneimittel niemals selbst verabreichen. Die Verabreichung erfolgt immer

durch eine qualifizierte Person.

Cisatracurium Accord Healthcare kann folgendermaßen verabreicht werden:

als Einzelinjektion in eine Vene (intravenöse Bolusinjektion)

als Dauerinfusion in eine Vene. Hierbei wird das Arzneimittel langsam über eine längere

Zeitspanne gegeben

Ihr Arzt wird entscheiden, wie und in welcher Dosis Ihnen Cisatracurium Accord Healthcare

verabreicht wird. Dies hängt von folgenden Faktoren ab:

Ihrem Körpergewicht

dem Ausmaß und der Dauer der erforderlichen Muskelerschlaffung

Ihrem erwarteten Ansprechen auf das Arzneimittel

Kinder, die jünger sind als 1 Monat, sollten nicht mit Cisatracurium Accord Healthcare behandelt

werden.

Wenn Sie eine größere Menge von Cisatracurium Accord Healthcare erhalten haben, als Sie

sollten

Cisatracurium Accord Healthcare wird immer unter sorgfältig kontrollierten Bedingungen verabreicht.

Wenn Sie aber das Gefühl haben, dass Sie eine zu große Menge erhalten haben, müssen Sie umgehend

Ihren Arzt oder das Pflegepersonal verständigen.

Wenn Sie weitere Fragen zur Anwendung des Arzneimittels haben, fragen Sie Ihren Arzt.

Wenn Sie eine größere Menge von

Cisatracurium Accord Healthcare

haben angewendet,

kontaktieren Sie sofort Ihren Arzt, Ihren Apotheker oder das Antigiftzentrum (070/245.245).

4.

Welche Nebenwirkungen sind möglich?

Wie alle Arzneimittel kann Cisatracurium Accord Healthcare Nebenwirkungen haben, die aber nicht

bei jedem auftreten müssen.

Wenn bei Ihnen Nebenwirkungen auftreten, informieren Sie Ihren Arzt, das Pflegepersonal oder Ihren

Apotheker. Dazu gehören auch Nebenwirkungen, die nicht in dieser Packungsbeilage aufgeführt sind.

Allergische Reaktionen (betreffen weniger als 1 von 10.000 Behandelten)

Falls bei Ihnen eine allergische Reaktion auftritt, informieren Sie umgehend Ihren Arzt oder das

Pflegepersonal. Zu den Anzeichen einer allergischen Reaktion gehören:

Plötzliche Atemnot, Schmerzen oder ein Engegefühl in der Brust

Anschwellen der Augenlider, des Gesichts, der Lippen, des Mundes oder der Zunge

Ausschlag bzw. Nesselausschlag irgendwo am Körper

Kollaps.

Informieren Sie Ihren Arzt, das Pflegepersonal oder Ihren Apothekern, wenn bei Ihnen eine oder

mehrere der folgenden Nebenwirkungen auftreten:

Häufig (betreffen weniger als 1 von 10 Behandelten)

Verringerung der Herzfrequenz

Abnahme des Blutdrucks.

Gelegentlich (betreffen weniger als 1 von 100 Behandelten)

Ausschlag oder Rötung der Haut

Atemnot oder Husten.

Sehr selten (betreffen weniger als 1 von 10.000 Behandelten)

Schwache oder schmerzende Muskeln.

Meldung von Nebenwirkungen

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

medizinische Fachpersonal. Dies gilt auch für Nebenwirkungen, die nicht in dieser Packungsbeilage

angegeben sind. Sie können Nebenwirkungen auch direkt über bei unten genannten Adresse.

Föderalagentur für Arzneimittel und Gesundheitsprodukte

Abteilung Vigilanz

EUROSTATION II

Victor Hortaplein, 40/40

B-1060 BRUSSEL

Website: www.fagg-afmps.be

E-Mail: patientinfo@fagg-afmps.be

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

Sicherheit dieses Arzneimittels zur Verfügung gestellt werden.

5.

Wie ist Cisatracurium Accord Healthcare aufzubewahren?

Bewahren Sie dieses Arzneimittel für Kinder unzugänglich auf.

Cisatracurium Accord Healthcare darf nach dem auf der Packung nach „Verwendbar bis“

angegebenen Verfalldatum nicht mehr verwendet werden. Das Verfalldatum bezieht sich auf den

letzten Tag des Monats.

Im Kühlschrank lagern (2°C- 8°C). Nicht einfrieren.

Das Arzneimittel im Umkarton aufbewahren, um den Inhalt vor Licht zu schützen.

Die verdünnte Infusionslösung zwischen 2°C und 8°C aufbewahren und innerhalb von 24

Stunden verbrauchen. Nicht verbrauchte Lösung muss innerhalb von 24 Stunden nach der

Zubereitung entsorgt werden.

Arzneimittel dürfen niemals im Abwasser oder Haushaltsmüll entsorgt werden. Ihr Arzt oder das

Pflegepersonal wird nicht mehr benötigte Arzneimittel entsorgen. Diese Maßnahme hilft, die

Umwelt zu schützen.

6. Inhalt der Packung und weitere Informationen

Was Cisatracurium Accord Healthcare enthält

Der Wirkstoff ist 2 mg/ml oder 5 mg/ml Cisatracurium (als Besilat).

Die sonstigen Bestandteile sind Benzolsulfonsäure und Wasser für Injektionszwecke.

Wie Cisatracurium Accord Healthcare aussieht und Inhalt der Packung

Cisatracurium Accord Healthcare 2 mg/ml ist in den folgenden Packungsgrößen erhältlich:

Eine 2,5 ml-

Durchstechflascheaus klarem Glas enthält 5 mg Cisatracurium (als Cisatracurium-

Besilat) und ist in 1- und 5-Stück-Packungen erhältlich.

Eine 5 ml-Durchstechflasche aus klarem Glas enthält 10 mg Cisatracurium (als Cisatracurium-

Besilat) und ist in 1- und 5-Stück-Packungen erhältlich.

Eine 10 ml-Durchstechflasche aus klarem Glas enthält 20 mg Cisatracurium (als Cisatracurium-

Besilat) und ist in 1- und 5-Stück-Packungen erhältlich.

Eine 25 ml-Durchstechflascheaus klarem Glas enthält 50 mg Cisatracurium (als Cisatracurium-

Besilat) und ist in 1- und 2-Stück-Packungen erhältlich.

Cisatracurium Accord Healthcare 5 mg/ml ist in der folgenden Packungsgröße erhältlich:

Eine 30 ml-Durchstechflasche aus klarem Glas enthält 150 mg Cisatracurium (als Cisatracurium-

Besilat) und ist 1- und 5-Stück-Packungen erhältlich.

Es werden möglicherweise nicht alle Packungsgrößen in den Verkehr gebracht.

Inhaber der Zulassung

Accord Healthcare Limited,

Sage House,

319 Pinner Road,

North Harrow,

Middlesex, HA1 4HF,

Vereinigtes Königreich

Hersteller

Accord Healthcare Limited,

Sage House,

319 Pinner Road,

North Harrow,

Middlesex, HA1 4HF,

Vereinigtes Königreich

Cemelog-BRS Ltd.

Vasùt Utca 13 (Pharma Park), Budaörs,

Ungarn

Zulassungsnummer:

Cisatracurium Accord Healthcare 2 mg/ml Injektions-/Infusionslösung

2.5 ml: BE467413

5 ml: BE467422

10 ml: BE467431

25 ml: BE467440

Cisatracurium Accord Healthcare 5 mg/ml Injektions-/Infusionslösung

30 ml: BE467457

Art der Abgabe:

Verschreibungspflichtig.

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

unter den folgenden Bezeichnungen zugelassen:

Land

Bezeichnung des Arzneimittels

Österreich

Cisatracurium Accord 2 mg/ml & 5 mg/ml Injektions-/Infusionslösung

Belgien

Cisatracurium Accord Healthcare 2 mg/ml & 5 mg/ml, Injektions-/Infusionslösung

Zypern

Cisatracurium Accord 2 mg/ml & 5 mg/ml Solution for injection or infusion

Tschechisch

e Republik

Cisatracurium Accord 2 mg/ml & 5 mg/ml injekční/infuzní roztok

Deutschland

Cisatracurium Accord 2 mg/ml & 5 mg/ml Injektionslösung/ Infusionslösung

Spanien

Cisatracurium Accord 2 mg/ml & 5 mg/ml solución inyectable y para perfusión

Finnland

Cisatracurium Accord 2 mg/ml & 5 mg/ml injektio/infuusioneste, liuos

Land

Bezeichnung des Arzneimittels

Frankreich

CISATRACURIUM ACCORD 2 mg/ml & 5 mg/ml, solution injectable/pour

perfusion

Italien

Cisatracurio Accord

Litauen

Cisatracurium Accord 2 mg/ml & 5 mg/ml injekcinis/infuzinis tirpalas

Polen

Cisatracurium Accord

Niederlande

Cisatracurium Accord 2 mg/ml & 5 mg/ml oplossing voor injectie of infusie

Portugal

Cisatracúrio Accord

Vereinigtes

Königreich

Cisatracurium 2 mg/ml & 5 mg/ml Solution for injection/infusion

Diese Packungsbeilage wurde zuletzt genehmigt im 12/2014

Die folgenden Informationen sind nur für medizinisches Fachpersonal bestimmt:

Das Arzneimittel darf außer mit den unter Abschnitt „Hinweise zur Verwendung und Handhabung“

aufgeführten nicht mit anderen Arzneimitteln gemischt werden.

Da Cisatracurium nur in sauren Lösungen stabil ist, darf es nicht mit alkalischen Lösungen z. B.

Thiopental-Natrium in derselben Spritze gemischt oder gleichzeitig durch dieselbe Nadel verabreicht

werden.Cisatracurium

nicht

kompatibel

Ketorolac,

Trometamol

oder

Propofol-

Injektionsemulsion.

Hinweise zur Verwendung und Handhabung

Dieses Produkt ist nur für die Verwendung am einzelnen Patienten gedacht.

Nur klare, nahezu farblose bzw. leicht gelbliche/grünlich-gelbliche Lösung verwenden. Das Produkt

muss vor Verwendung einer Sichtprüfung unterzogen werden. Falls sich das Erscheinungsbild des

Produktes verändert hat oder der Behälter beschädigt ist, muss das Produkt entsorgt werden.

Die chemische und physikalische Stabilität einer verdünnten Cisatracurium Accord Healthcare wurde

für 24 Stunden bei 5°C und 25 °C bei Konzentrationen von 0,1 und 2mg/ml in den folgenden

Infusionsflüssigkeiten nachgewiesen, im PVC- und Nicht-PVC-Infusionsbeutel:

Natriumchlorid-Lösung (0,9% w/v) für die intravenöse Infusion.

Glukose-Lösung (5% w/v) für die intravenöse Infusion.

Natriumchlorid-Lösung (0,18% w/v) und Glukose-Lösung (4% w/v) für die intravenöse

Infusion

Natriumchlorid-Lösung (0,45% w/v) und Glukose-Lösung (2,5% w/v) für die intravenöse

Infusion.

Da das Produkt keine antimikrobiellen Konservierungsstoffe enthält, soll die Verdünnung unmittelbar

vor dem Gebrauch erfolgen bzw. die verdünnte Lösung wie nachstehend angeführt aufbewahrt

werden.

Aus mikrobiologischer Sicht sollte das Produkt sofort verwendet werden. Wird es nicht sofort

verwendet, ist der Anwender für die Dauer und die Bedingungen der Aufbewahrung vor der

Anwendung verantwortlich. Die gebrauchsfertige Zubereitung sollte normalerweise nicht länger als

24 Stunden bei 2 °C bis 8 °C aufbewahrt werden, außer, die Verdünnung erfolge in kontrollierten und

validierten aseptischen Bedingungen.

Cisatracurium war mit folgenden häufig perioperativ eingesetzten Arzneimitteln kompatibel, wenn es

unter Bedingungen gemischt wurde, die eine Gabe in eine laufende intravenöse Infusion über ein Y-

förmiges

Verbindungsstück

simulierten:

Alfentanilhydrochlorid,

Droperidol,

Fentanylcitrat,

Midazolamhydrochlorid und Sulfentanilcitrat. Falls andere Arzneimittel durch dieselbe Dauerkanüle

verabreicht werden wie dieses Arzneimittel, wird empfohlen, dass jedes Arzneimittel mit einer

ausreichenden Menge einer entsprechenden intravenösen Flüssigkeit durchgespült wird, z.B.

Natriumchlorid-Lösung für die intravenöse Infusion (0,9% w/v).

Wie bei anderen intravenös verabreichten Arzneimitteln sollte bei Auswahl einer kleinen Vene als

Injektionsstelle Cisatracurium mit einer entsprechenden intravenösen Flüssigkeit durch die Vene

gespült werden, z.B. Natriumchlorid-Lösung für die intravenöse Infusion (0,9% w/v).

Nicht verwendetes Arzneimittel oder Abfallmaterial ist entsprechend den örtlichen Vorschriften zu

entsorgen.

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

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

Published on: Fri, 16 Nov 2018 According to Article 12 of Regulation (EC) No 396/2005, EFSA has reviewed the maximum residue levels (MRLs) currently established at European level for the pesticide active substance tau‐fluvalinate. To assess the occurrence of tau‐fluvalinate residues in plants, processed commodities, rotational crops and livestock, EFSA considered the conclusions derived in the framework of Commission Regulation (EC) No 33/2008 as well as the European authorisations reported by Member St...

Europe - EFSA - European Food Safety Authority Publications

16-11-2018

Setting of an import tolerance for pyraclostrobin in rice

Setting of an import tolerance for pyraclostrobin in rice

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

Europe - EFSA - European Food Safety Authority Publications

15-11-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

13-11-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

13-11-2018

The importance of vector abundance and seasonality

The importance of vector abundance and seasonality

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

Europe - EFSA - European Food Safety Authority Publications

10-11-2018

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

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

Published on: Fri, 09 Nov 2018 00:00:00 +0100 The European Food Safety Authority (EFSA) was asked by the European Commission to provide scientific assistance with respect to the evaluation of applications received by the European Commission concerning basic substances. In this context, EFSA's scientific views on the specific points raised during the commenting phase conducted with Member States and EFSA on the basic substance application for propolis extract are presented. The context of the evaluation ...

Europe - EFSA - European Food Safety Authority Publications

6-11-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

31-10-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

23-10-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

20-10-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

20-10-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

17-10-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

16-10-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

6-10-2018

Modification of the existing maximum residue level for epoxiconazole in beetroots

Modification of the existing maximum residue level for epoxiconazole in beetroots

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

Europe - EFSA - European Food Safety Authority Publications

2-10-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

28-9-2018

Avian influenza overview May – August 2018

Avian influenza overview May – August 2018

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

Europe - EFSA - European Food Safety Authority Publications

27-9-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

27-9-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

26-9-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

25-9-2018

Daiso Holdings Ltd. recalls Daiso Brand Consumer Chemical Products

Daiso Holdings Ltd. recalls Daiso Brand Consumer Chemical Products

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

Health Canada

21-9-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

21-9-2018

Modification of the existing maximum residue level for clothianidin in potatoes

Modification of the existing maximum residue level for clothianidin in potatoes

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

Europe - EFSA - European Food Safety Authority Publications

19-9-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

19-9-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

13-9-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

11-9-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

11-9-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

11-9-2018

Assessment of occupational and dietary exposure to pesticide residues

Assessment of occupational and dietary exposure to pesticide residues

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

Europe - EFSA - European Food Safety Authority Publications

4-9-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

1-9-2018

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

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

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

Health Canada

1-9-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

1-9-2018

Review of the existing MRLs for fenbuconazole

Review of the existing MRLs for fenbuconazole

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

Europe - EFSA - European Food Safety Authority Publications

30-8-2018

National summary reports on pesticide residue analysis performed in 2016

National summary reports on pesticide residue analysis performed in 2016

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

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

11-12-2018

Ziagen (ViiV Healthcare BV)

Ziagen (ViiV Healthcare BV)

Ziagen (Active substance: abacavir sulfate) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)8685 of Tue, 11 Dec 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/252/T/104

Europe -DG Health and Food Safety

26-11-2018

A hemodialysis system, which has modernized through miniaturization; and a patient monitoring system that can monitor more patients and/or more parameters and which are increasingly becoming networked in healthcare facilities increasing the risk for cyber

A hemodialysis system, which has modernized through miniaturization; and a patient monitoring system that can monitor more patients and/or more parameters and which are increasingly becoming networked in healthcare facilities increasing the risk for cyber

A hemodialysis system, which has modernized through miniaturization; and a patient monitoring system that can monitor more patients and/or more parameters and which are increasingly becoming networked in healthcare facilities increasing the risk for cybersecurity threats.

FDA - U.S. Food and Drug Administration

22-11-2018

Rapiscan (GE Healthcare AS)

Rapiscan (GE Healthcare AS)

Rapiscan (Active substance: regadenoson) - Centralised - Yearly update - Commission Decision (2018)7875 of Thu, 22 Nov 2018

Europe -DG Health and Food Safety

18-10-2018

Kivexa (ViiV Healthcare BV)

Kivexa (ViiV Healthcare BV)

Kivexa (Active substance: abacavir / Lamivudine) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)6924 of Thu, 18 Oct 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/000581/T/0076

Europe -DG Health and Food Safety

2-10-2018

Nexium Control (Pfizer Healthcare Ireland)

Nexium Control (Pfizer Healthcare Ireland)

Nexium Control (Active substance: esomeprazole) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)6474 of Tue, 02 Oct 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/002618/T/0023

Europe -DG Health and Food Safety

2-10-2018

Ritemvia (Celltrion Healthcare Hungary Kft.)

Ritemvia (Celltrion Healthcare Hungary Kft.)

Ritemvia (Active substance: rituximab) - Centralised - Yearly update - Commission Decision (2018)6480 of Tue, 02 Oct 2018

Europe -DG Health and Food Safety

2-10-2018

Trizivir (ViiV Healthcare BV)

Trizivir (ViiV Healthcare BV)

Trizivir (Active substance: abacavir, lamivudine, zidovudine) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)6483 of Tue, 02 Oct 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/338/T/108

Europe -DG Health and Food Safety

2-10-2018

Telzir (ViiV Healthcare BV)

Telzir (ViiV Healthcare BV)

Telzir (Active substance: Fosamprenavir) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)6468 of Tue, 02 Oct 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/534/T/93

Europe -DG Health and Food Safety

2-10-2018

Celsentri (ViiV Healthcare BV)

Celsentri (ViiV Healthcare BV)

Celsentri (Active substance: maraviroc) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)6467 of Tue, 02 Oct 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/811/T/56

Europe -DG Health and Food Safety

25-9-2018

Pelgraz (Accord Healthcare Limited)

Pelgraz (Accord Healthcare Limited)

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

Europe -DG Health and Food Safety

24-9-2018

#FDA announces the release of the Collaborative Communities Toolkit for interested stakeholder organizations to work together on healthcare challenges. Learn about the program, download the Toolkit, and submit comments:  https://go.usa.gov/xPjKX pic.twitt

#FDA announces the release of the Collaborative Communities Toolkit for interested stakeholder organizations to work together on healthcare challenges. Learn about the program, download the Toolkit, and submit comments: https://go.usa.gov/xPjKX pic.twitt

#FDA announces the release of the Collaborative Communities Toolkit for interested stakeholder organizations to work together on healthcare challenges. Learn about the program, download the Toolkit, and submit comments: https://go.usa.gov/xPjKX  pic.twitter.com/iQsKIAAQTn

FDA - U.S. Food and Drug Administration

24-9-2018

Blitzima (Celltrion Healthcare Hungary Kft.)

Blitzima (Celltrion Healthcare Hungary Kft.)

Blitzima (Active substance: rituximab) - Centralised - Yearly update - Commission Decision (2018)6228 of Mon, 24 Sep 2018

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

19-9-2018

 12th Pharmacovigilance stakeholder forum, European Medicines Agency, London, UK, From: 24-Sep-2018, To: 24-Sep-2018

12th Pharmacovigilance stakeholder forum, European Medicines Agency, London, UK, From: 24-Sep-2018, To: 24-Sep-2018

This forum brings together regulators with patients, healthcare professionals and industry, to take stock of what we have achieved and what needs to be the focus over the coming years.

Europe - EMA - European Medicines Agency

17-9-2018

 European Medicines Agency (EMA) Human Scientific Committees' Working Party with Healthcare Professionals’ Organisations (HCPWP), European Medicines Agency, London, UK, From: 26-Sep-2018, To: 26-Sep-2018

European Medicines Agency (EMA) Human Scientific Committees' Working Party with Healthcare Professionals’ Organisations (HCPWP), European Medicines Agency, London, UK, From: 26-Sep-2018, To: 26-Sep-2018

This Healthcare Professionals' Working Party (HCPWP) plenary meeting will include discussions on advances in clinical practice and the scientific and regulatory challenges. Members will also be invited to present how they are including regulatory sciences in fellowships and young researchers’ training. Feedback will be given from the representatives of the Scientific Committees.

Europe - EMA - European Medicines Agency

17-9-2018

 European Medicines Agency (EMA) Human Scientific Committees' Working Parties with Patients’ and Consumers’ Organisations (PCWP) and with Healthcare Professionals’ Organisations (HCPWP), European Medicines Agency, London, UK, From: 25-Sep-2018, To: 25-Sep

European Medicines Agency (EMA) Human Scientific Committees' Working Parties with Patients’ and Consumers’ Organisations (PCWP) and with Healthcare Professionals’ Organisations (HCPWP), European Medicines Agency, London, UK, From: 25-Sep-2018, To: 25-Sep

This joint Patients' and Consumers' Working Party (PCWP) and Healthcare Professionals' Working Party (HCPWP) meeting will include results of the 2017 EMA perception survey. EMA regulatory science to 2025 will be discussed together with updates on Good Pharmacovigilance Practices (GVP). The Topic Group on Digital media and health will feedback to the working parties’ members. Participants will also receive an update on ongoing work on electronic product information and on availability of authorised med...

Europe - EMA - European Medicines Agency

7-9-2018

Newsletter:  Human medicines highlights - September 2018

Newsletter: Human medicines highlights - September 2018

This newsletter is addressed primarily to organisations representing patients, consumers and healthcare professionals. It provides a summary of key information relating to medicines for human use published during the previous month by the European Medicines Agency.

Europe - EMA - European Medicines Agency