Oxycodonhydrochlorid

Hauptinformation

  • Handelsname:
  • Oxycodonhydrochlorid G.L. 20 mg Filmtabletten
  • Darreichungsform:
  • Filmtablette
  • Zusammensetzung:
  • Oxycodonhydrochlorid (Ph.Eur.) 20.mg
  • Verwenden für:
  • Menschen
  • Art der Medizin:
  • allopathic Droge

Dokumenten

Lokalisierung

  • Erhältlich in:
  • Oxycodonhydrochlorid G.L. 20 mg Filmtabletten
    Deutschland
  • Sprache:
  • Deutsch

Weitere Informationen

Status

  • Quelle:
  • BfArM - Bundesinstitut für Arzneimittel und Medizinprodukte
  • Zulassungsnummer:
  • 96062.00.00
  • Letzte Änderung:
  • 11-04-2018

Packungsbeilage

Gebrauchsinformation: Information für Patienten

Oxycodonhydrochlorid G.L. 20 mg Filmtabletten

Oxycodonhydrochlorid

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 ist Oxycodonhydrochlorid G.L. und wofür wird es angewendet?

2. Was sollten Sie vor der Einnahme von Oxycodonhydrochlorid G.L. beachten?

3. Wie ist Oxycodonhydrochlorid G.L. einzunehmen?

4. Welche Nebenwirkungen sind möglich?

5. Wie ist Oxycodonhydrochlorid G.L. aufzubewahren?

6. Inhalt der Packung und weitere Informationen

1. Was ist Oxycodonhydrochlorid G.L. und wofür wird es angewendet?

Oxycodonhydrochlorid G.L. ist ein starkes Schmerzmittel aus der Gruppe der Opioide.

Oxycodonhydrochlorid G.L. wird angewendet zur Behandlung von starken Schmerzen, die

eine Behandlung mit einem Opioid-Schmerzmittel erforderlich machen, weil andere

Schmerzmittel nicht gewirkt haben

2. Was sollten Sie vor der Einnahme von Oxycodonhydrochlorid G.L. beachten?

Oxycodonhydrochlorid G.L. darf nicht eingenommen werden,

wenn Sie allergisch gegen Oxycodonhydrochlorid, Erdnüsse, Soja oder einen der in

Abschnitt 6. genannten sonstigen Bestandteile dieses Arzneimittels sind.

wenn Sie Atembeschwerden haben, wie z.B. langsamere oder schwächere Atmung als

erwartet (Atemdepression).

wenn Sie zu viel Kohlendioxid im Blut haben.

wenn Sie an einer schweren chronischen Lungenerkrankung leiden, die mit einer

Verengung der Atemwege verbunden ist (COPD = chronisch obstruktive

Lungenerkrankung).

wenn Sie eine bestimmte Herzerkrankung, bekannt als Cor pulmonale, haben.

wenn Sie Asthma haben.

wenn Sie eine bestimmte Form von Darmlähmung namens paralytischer Ileus haben.

bei plötzlichen starken Bauchschmerzen oder verzögerter Magenentleerung.

Warnhinweise und Vorsichtsmaßnahmen

Bitte sprechen Sie mit Ihrem Arzt oder Apotheker, bevor Sie Oxycodonhydrochlorid G.L.

einnehmen,

wenn Sie schon älter oder geschwächt sind.

wenn die Tätigkeit Ihrer Lungen, Leber oder Nieren stark eingeschränkt ist.

wenn Sie eine bestimmte Erkrankung der Schilddrüse (Myxödem) haben oder Ihre

Schilddrüse nicht genug Hormone produziert (Unterfunktion).

wenn Ihre Nebennieren nicht genug Hormone produzieren (Addison-Krankheit oder

Nebennierenschwäche).

wenn Ihre Vorsteherdrüse (Prostata) krankhaft vergrößert ist.

wenn Sie alkoholabhängig sind oder eine Alkohol-Entziehungskur machen.

wenn Sie von starken Schmerzmitteln (Opioiden) abhängig sind oder waren.

wenn Ihre Bauchspeicheldrüse entzündet ist (Pankreatitis) oder wenn Sie Probleme mit

Ihrer Gallenblase haben.

wenn Sie Schwierigkeiten oder Schmerzen beim Wasserlassen haben.

wenn Ihr Hirndruck erhöht ist.

wenn Sie niedrigen Blutdruck haben oder sich beim Aufstehen schwindlig fühlen.

wenn Sie Epilepsie haben oder zu Krampfanfällen neigen.

wenn Sie zusätzlich so genannte MAO-Hemmer (üblicherweise zur Behandlung von

Depressionen oder der Parkinson-Krankheit) einnehmen oder in den letzten zwei

Wochen eingegenommen haben.

Abhängigkeit und Gewöhnung

Bei längerfristiger Anwendung von Oxycodonhydrochlorid G.L. kann es zur Gewöhnung an

das Arzneimittel (Toleranz) kommen. Das bedeutet, dass Sie eine höhere Dosis benötigen,

um die gewünschte Schmerzlinderung zu erreichen.

Oxycodonhydrochlorid G.L. kann abhängig machen. Wenn die Behandlung zu plötzlich

abgebrochen wird, können Entzugssymptome auftreten. Wenn Sie keine weitere Behandlung

benötigen, wird Ihr Arzt die Tagesdosis allmählich reduzieren.

Bei bestimmungsgemäßer Anwendung dieses Arzneimittels ist das Risiko körperlicher oder

psychischer Abhängigkeit gering. Ihr Arzt wird die möglichen Risiken gegenüber dem

erwarteten Nutzen abwägen. Wenn Sie weitere Fragen haben, wenden Sie sich an Ihren

Arzt.

Auswirkungen bei Fehlgebrauch zu Dopingzwecken

Die Anwendung von Oxycodonhydrochlorid G.L. kann bei Dopingkontrollen zu positiven

Ergebnissen führen. Die Anwendung von Oxycodonhydrochlorid G.L. als Dopingmittel kann

zu einer Gefährdung der Gesundheit führen.

Kinder

Die Anwendung von Oxycodonhydrochlorid G.L. bei Kindern unter 12 Jahren wird nicht

empfohlen, da die Sicherheit und Wirksamkeit in dieser Altersgruppe nicht untersucht

wurden.

Einnahme von Oxycodonhydrochlorid G.L. zusammen mit anderen Arzneimitteln

Informieren Sie Ihren Arzt oder Apotheker, wenn Sie andere Arzneimittel

einnehmen/anwenden, kürzlich andere Arzneimittel eingenommen/angewendet haben oder

beabsichtigen, andere Arzneimittel einzunehmen/anzuwenden.

Das Risiko für Nebenwirkungen ist erhöht, wenn Oxycodonhydrochlorid G.L. gleichzeitig mit

Arzneimitteln, die die Gehirnfunktionen beeinflussen, eingenommen wird. Sie können sich

z.B. sehr schläfrig fühlen, oder Ihre Atemprobleme können sich verschlechtern.

Zu Arzneimitteln, die die Gehirnfunktionen beeinflussen, gehören:

andere starke Schmerzmittel (Opioide),

Schlaftabletten und Beruhigungsmittel,

Arzneimittel gegen Depressionen,

Arzneimittel zur Behandlung von Allergien, Reisekrankheit oder Übelkeit

(Antihistaminika oder Antiemetika),

andere Arzneimittel mit Wirkung auf das Nervensystem (Phenothiazine, Neuroleptika),

Arzneimittel zur Behandlung der Parkinson-Krankheit (so genannte MAO-Hemmer,

siehe auch Abschnitt „Warnhinweise und Vorsichtsmaßnahmen“).

Weitere Wechselwirkungen können auftreten mit

Cimetidin (gegen zu viel Magensäure). Es kann die Wirkungsdauer von

Oxycodonhydrochlorid G.L. im Körper verlängern.

Arzneimitteln, die die Blutgerinnung hemmen (z.B. Warfarin). Oxycodonhydrochlorid

G.L. kann deren Wirkung beeinflussen.

bestimmten Antibiotika, Arzneimitteln gegen Pilzkrankheiten und Arzneimitteln, die

Johanniskraut enthalten.

Einnahme von Oxycodonhydrochlorid G.L. zusammen mit Getränken und Alkohol

Oxycodonhydrochlorid G.L. soll nicht gleichzeitig mit Alkohol eingenommen werden.

Alkoholkonsum kann schwerwiegende Nebenwirkungen von Oxycodon verstärken, wie z.B.

Schläfrigkeit und Benommenheit und langsames und flaches Atmen.

Bei Patienten, die alkohol- oder drogenabhängig sind oder waren, sollte die Anwendung des

Arzneimittels vermieden werden.

Grapefruitsaft kann den Spiegel von Oxycodonhydrochlorid in Ihrem Blut erhöhen. Wenden

Sie sich an Ihren Arzt, wenn Sie regelmäßig Grapefruitsaft trinken.

Schwangerschaft und Stillzeit

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 um Rat.

Schwangerschaft

Oxycodonhydrochlorid G.L. sollte während der Schwangerschaft nur angewendet werden,

wenn es zwingend erforderlich ist.

Eine längerfristige Anwendung von Oxycodonhydrochlorid G.L. während der

Schwangerschaft kann zu Entzugserscheinungen beim Neugeborenen führen. Die

Anwendung von Oxycodon während der Geburt kann zu einer Abflachung und

Verlangsamung der Atmung (Atemdepression) beim Neugeborenen führen.

Stillzeit

Das Stillen sollte während der Behandlung mit Oxycodonhydrochlorid G.L. unterbrochen

werden. Oxycodon geht in die Muttermilch über. Daher kann ein Risiko für das gestillte Kind

nicht ausgeschlossen werden, vor allem nach wiederholter Einnahme von

Oxycodonhydrochlorid G.L.

Verkehrstüchtigkeit und Fähigkeit zum Bedienen von Maschinen

Oxycodonhydrochlorid G.L. kann die Aufmerksamkeit und das Reaktionsvermögen so weit

beeinträchtigen, dass Sie nicht länger in der Lage sind, ein Fahrzeug zu führen oder

Werkzeuge und Maschinen zu bedienen.

Bitte besprechen Sie mit Ihrem Arzt, ob Sie ein Fahrzeug führen oder Maschinen bedienen

dürfen.

Oxycodonhydrochlorid G.L. enthält Lactose und Phospholipide aus Sojabohnen

(E322)

Oxycodonhydrochlorid G.L. enthält Lactose. Bitte nehmen Sie Oxycodonhydrochlorid G.L.

daher erst nach Rücksprache mit Ihrem Arzt ein, wenn Ihnen bekannt ist, dass Sie unter

einer Unverträglichkeit gegenüber bestimmten Zuckern leiden.

Oxycodonhydrochlorid G.L. enthält Phospholipide aus Sojabohnen (E322). Wenn Sie

allergisch gegen Soja oder Erdnuss sind, dürfen Sie Oxycodonhydrochlorid G.L. nicht

einnehmen.

3. Wie ist Oxycodonhydrochlorid G.L. einzunehmen?

Nehmen Sie dieses Arzneimittel immer genau nach Absprache mit Ihrem Arzt oder

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

sind.

Dosierung

Für Dosierungen, die mit dieser Stärke nicht durchführbar/praktikabel sind, stehen andere

Stärken dieses Arzneimittels zur Verfügung.

Ihr Arzt wird die Dosierung an die Stärke der Schmerzen und Ihre persönliche

Empfindlichkeit anpassen.

Bitte sprechen Sie mit Ihrem Arzt, wenn Sie den Eindruck haben, dass die Wirkung von

Oxycodonhydrochlorid G.L. zu stark oder zu schwach ist.

Falls von Ihrem Arzt nicht anders verordnet, beträgt die empfohlene Dosis

Erwachsene und Jugendliche (ab 12 Jahren):

Die übliche Anfangsdosis beträgt 5 mg Oxycodonhydrochlorid alle 6 Stunden. Bei

Bedarf kann das Dosierungsintervall von Ihrem Arzt auf 4 Stunden verkürzt werden.

Oxycodonhydrochlorid G.L. darf nicht öfter als 6-mal täglich eingenommen werden.

ältere Patienten (ab 65 Jahren):

Ältere Patienten mit normaler Leber- und/oder Nierenfunktion können die die gleiche

Dosis wie Erwachsene (siehe oben) einnehmen.

Patienten mit Nieren- oder Lebererkrankungen oder niedrigem Körpergewicht:

Ihr Arzt wird Ihnen möglicherweise eine niedrigere Anfangsdosis verordnen.

Kinder (unter 12 Jahren):

Die Anwendung von Oxycodonhydrochlorid G.L. bei Kindern unter 12 Jahren wird

nicht empfohlen, da die Sicherheit und Wirksamkeit in dieser Altersgruppe nicht

untersucht wurden.

Bei Patienten, die vor der Behandlung mit Oxycodonhydrochlorid G.L. mit anderen starken

Schmerzmitteln (Opioide) behandelt wurden, kann der Arzt eine höhere Anfangsdosierung

verordnen.

Ihr Arzt wird über Ihre weitere Dosierung entscheiden und Ihnen mitteilen, wie Sie Ihre

tägliche Gesamttagesdosis aufteilen sollen. Ihr Arzt wird auch über Dosisanpassungen

entscheiden, die während der Behandlung eventuell erforderlich werden.

Wenn Sie zwischen den Einnahmen von Oxycodonhydrochlorid G.L. Schmerzen bekommen,

benötigen Sie möglicherweise eine höhere Dosis von Oxycodonhydrochlorid G.L.. Bitte

sprechen Sie mit Ihrem Arzt, wenn dieses Problem auftritt.

Wenn Sie eine Langzeitbehandlung von schweren Schmerzen benötigen, werden Sie auf

Oxycodonhydrochlorid mit veränderterWirkstofffreisetzung umgestellt.

Art der Anwendung

Zum Einnehmen.

Nehmen Sie die Tabletten mit ausreichend Flüssigkeit (z.B. einem halben Glas Wasser) alle

4 oder 6 Stunden je nach ärztlicher Verordnung ein. Sie können die Tabletten mit oder

unabhängig von Mahlzeiten einnehmen.

Anleitung zum Öffnen der Blisterpackung:

Dieses Arzneimittel ist in einer kindergesicherten Verpackung. Die Filmtabletten müssen

kräftig aus der Blisterpackung gepresst werden.

Wenn Sie eine größere Menge von Oxycodonhydrochlorid G.L. eingenommen haben, als Sie

sollten

Verständigen Sie sofort einen Arzt, wenn Sie mehr Tabletten als verordnet eingenommen

haben.

Anzeichen einer Überdosierung können sein: Verengung der Pupillen, Atembeschwerden

(Abflachung und Verlangsamung der Atmung), Schwächegefühl in den Muskeln (verminderte

Muskelspannung) und Abfall des Blutdrucks. In schweren Fällen können Benommenheit

oder Ohnmacht infolge einer Störung des Kreislaufs (Kreislaufversagen), Beeinträchtigungen

des Denkens und der Bewegungen, Bewusstlosigkeit (Koma), langsamer Puls und

Ansammlung von Flüssigkeit in der Lunge auftreten.

Die Anwendung großer Mengen von Oxycodonhydrochlorid G.L. kann zum Tod führen.

Wenn Sie die Einnahme von Oxycodonhydrochlorid G.L. vergessen haben

Wenn Sie eine geringere Dosis von Oxycodonhydrochlorid G.L. als verordnet eingenommen

oder eine Dosis vergessen haben, wird die erwünschte Schmerzlinderung wahrscheinlich

nicht erreicht.

Sollten Sie eine Einnahme vergessen haben, so können Sie die vergessene Dosis

nachholen, sobald Sie es bemerken.

Bitte beachten Sie aber, dass Sie dieses Arzneimittel nur alle 4 bis 6 Stunden einnehmen

dürfen.

Nehmen Sie nicht die doppelte Menge ein, wenn Sie die vorherige Einnahme vergessen

haben.

Wenn Sie die Einnahme von Oxycodonhydrochlorid G.L. abbrechen

Brechen Sie die Behandlung nicht ohne vorherige Rücksprache mit Ihrem Arzt ab, weil sonst

Entzugserscheinungen auftreten können.

Falls Sie die Behandlung mit Oxycodonhydrochlorid G.L. nicht länger benötigen, wird Ihr Arzt

Ihnen mitteilen, wie Sie die Tagesdosis schrittweise verringern sollen, um das Auftreten von

Entzugserscheinungen zu vermeiden.

Wenn Sie weitere Fragen zur Einnahme dieses Arzneimittels haben, wenden Sie sich an

Ihren Arzt oder Apotheker.

4. Welche Nebenwirkungen sind möglich?

Wie alle Arzneimittel kann auch dieses Arzneimittel Nebenwirkungen haben, die aber nicht

bei jedem auftreten müssen.

Wenn Sie eines der folgenden Anzeichen bemerken, wenden Sie sich umgehend an

einen Arzt:

Sehr langsame oder schwache Atmung (Atemdepression). Das ist die gefährlichste

Nebenwirkung, die bei der Einnahme von Arzneimitteln wie Oxycodonhydrochlorid G.L.

(Opioiden) auftreten und nach hohen Dosen dieses Arzneimittel sogar zum Tod führen

kann.

Weitere Nebenwirkungen

Sehr häufig (kann mehr als 1 von 10 Behandelten betreffen)

Schläfrigkeit bis Benommenheit, Schwindel, Kopfschmerzen

Verstopfung, Übelkeit, Erbrechen. Gegen diese Nebenwirkungen wird Ihnen Ihr Arzt ein

geeignetes Arzneimittel verordnen.

Juckreiz

Häufig (kann bis zu 1 von 10 Behandelten betreffen)

Stimmungsveränderungen (Angstzustände, Verwirrtheit, Depression, Nervosität,

Schlafstörungen; abnorme Gedanken)

Unkontrolliertes Zittern oder schüttelnde Bewegungen in einem oder mehreren Teilen

Ihres Körpers, Schwächezustände

Blutdrucksenkung, selten mit Herzklopfen oder Ohnmacht

Schwierigkeiten beim Atmen oder pfeifende Atemgeräusche

Mundtrockenheit, selten mit Durstgefühl und Schluckbeschwerden, allgemeine

Verdauungsstörungen wie Bauchschmerzen, Durchfall, Sodbrennen

Hautausschlag, starkes Schwitzen

Schwitzen, Schwäche

Gelegentlich (kann bis zu 1 von 100 Behandelten betreffen)

Allergische Reaktionen

Anstieg der Menge eines bestimmten Hormons (ADH = antidiuretisches Hormon) im Blut

Wassermangel im Körper (Dehydratation)

Ruhelosigkeit, Stimmungsschwankungen, Wahnvorstellungen, Euphorie, vermindertes

sexuelles Verlangen, Arzneimittelabhängigkeit

Erinnerungslücken, Kribbeln oder Taubheitsgefühl (z.B. in den Händen oder Füßen),

erhöhte oder verminderte Muskelspannung, unwillkürliche Muskelzuckungen,

verminderte Schmerz- oder Berührungsempfindlichkeit, Geschmacksveränderungen

Sehstörungen, Verringerung der Pupillengröße

Drehschwindel

Unangenehmes Empfinden eines unregelmäßigen und/oder starken Herzschlags,

beschleunigter Puls

Weitung der Blutgefäße, dadurch niedriger Blutdruck

Kurzatmigkeit, vermehrtes Husten, Halsentzündung, Schnupfen, Veränderung der

Stimme

Schluckbeschwerden, Geschwüre im Mund, Entzündung von Zahnfleisch oder

Mundschleimhaut, Blähungen (übermäßige Ansammlung von Luft in Magen oder Darm),

Aufstoßen, Darmverschluss (Ileus)

Erhöhte Blutspiegel bestimmter Leberenzyme

Trockene Haut

Probleme beim Wasserlassen, häufiges Wasserlassen

Vermindertes sexuelles Verlangen und Unfähigkeit, während des Geschlechtsverkehrs

eine Erektion zu haben oder aufrecht zu erhalten

Schüttelfrost, Übelkeit, Verletzungen durch Unfälle wegen verminderter Aufmerksamkeit,

Schmerzen (z.B. Schmerzen im Brustkorb), Flüssigkeitsansammlungen (Ödeme),

Migräne, Durst, physische Abhängigkeit mit Entzugsbeschwerden, Gewöhnung

Selten (kann bis zu 1 von 1.000 Behandelten betreffen)

Erkrankung der Lymphknoten

Muskelkrämpfe, epileptische Anfälle, besonders bei Patienten mit Epilepsie oder Neigung

zu Krampfanfällen

Niedriger Blutdruck

Zahnfleischbluten, gesteigerter Appetit, dunkel gefärbte Stühle

Juckender Hautausschlag, Bläschen auf Haut und Schleimhäuten (Fieberblasen oder

Herpes), erhöhte Lichtempfindlichkeit

Blut im Harn

Gewichtsveränderungen (Abnahme oder Zunahme), Entzündungen der Haut

Sehr selten (kann bis zu 1 von 10.000 Behandelten betreffen)

Sprachstörungen

Schuppender Hautausschlag

Ausbleiben der Regelblutung

Nicht bekannt (Häufigkeit auf Grundlage der verfügbaren Daten nicht abschätzbar)

Schwere allergische Reaktionen

Aggression

Erhöhte Schmerzempfindlichkeit

Zahnschäden oder -karies

Behinderung der Gallensekretion, Gallenkolik (die Bauchschmerzen verursacht)

Meldung von Nebenwirkungen

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

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

Sie können Nebenwirkungen auch direkt dem Bundesinstitut für Arzneimittel und

Medizinprodukte, Abt. Pharmakovigilanz, Kurt-Georg-Kiesinger-Allee 3, D-53175 Bonn,

Website: www.bfarm.de

anzeigen.

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

über die Sicherheit dieses Arzneimittels zur Verfügung gestellt werden.

5. Wie ist Oxycodonhydrochlorid G.L. aufzubewahren?

Bewahren Sie dieses Arzneimittel für Kinder unzugänglich auf.

Sie dürfen dieses Arzneimittel nach dem auf der Blisterpackung und dem Umkarton nach

„verwendbar bis“ angegebenen Verfalldatum nicht mehr verwenden. Das Verfalldatum

bezieht sich auf den letzten Tag des angegebenen Monats.

Für dieses Arzneimittel sind keine besonderen Lagerungsbedingungen erforderlich.

Entsorgen Sie Arzneimittel nicht im Abwasser. 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 Oxycodonhydrochlorid G.L. enthält

Der Wirkstoff ist Oxycodonhydrochlorid.

Jede Filmtablette enthält 20 mg Oxycodonhydrochlorid entsprechend 17,93 mg Oxycodon.

Die sonstigen Bestandteile sind:

Tablettenkern: Carboxymethylstärke-Natrium (Typ A) (Ph.Eur.), Lactose-Monohydrat,

mikrokristalline Cellulose, hochdisperses Siliciumdioxid, Magnesiumstearat (Ph.Eur.)

[pflanzlich]

Filmüberzug: Poly(vinylalkohol), Talkum, Macrogol 3350, Titandioxid (E 171), Phospholipide

aus Sojabohnen (E322), Indigocarmin-Aluminiumsalz (E132), Eisen(III)-hydroxid-oxid x H

(E172).

Wie Oxycodonhydrochlorid G.L. aussieht und Inhalt der Packung

Oxycodonhydrochlorid G.L. 20 mg Filmtabletten sind hellblaue, gewölbte, oblonge

Filmtalbetten mit einer Bruchkerbe auf beiden Seiten. Länge: 10,1 mm, Dicke: 4,2 mm,

Breite: 4,6 mm.

Die Tablette kann in gleiche Hälften geteilt werden.

Oxycodonhydrochlorid G.L. 20 mg Filmtabletten sind in kindergesicherten Blisterpackungen

zu 7, 10, 14, 20, 28, 30, 50, 56, 60, 72, 98 und 100 Filmtabletten oder in kindergesicherten

Blisterpackungen zur Abgabe von Einzeldosen zu 30x1, 50x1, 56x1, 60x1, 72x1, 98x1 und

100x1 Filmtabletten erhältlich.

Es werden möglicherweise nicht alle Packungsgrößen in den Verkehr gebracht.

Pharmazeutischer Unternehmer und Hersteller

G.L. Pharma GmbH

Schlossplatz 1

8502 Lannach

Österreich

Dieses Arzneimittel ist in den Mitgliedstaaten des Europäischen Wirtschaftsraumes

(EWR) unter den folgenden Bezeichnungen zugelassen

Österreich: Oxygerolan 20 mg

Dänemark: Oxycodonhydrochlorid G.L. 20 mg filmovertrukket tabletter

Deutschland: Oxycodonhydrochlorid G.L. 20 mg Filmtabletten

Niederlande: Oxycodon HCl G.L. 20 mg filmomhulde tabletten

Schweden: Oxygerolan 20 mg filmdragerad tablett

Diese Packungsbeilage wurde zuletzt überarbeitet im Jänner 2017.

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European Antibiotic Awareness Day 2018

Europe - EFSA - European Food Safety Authority Press Releases & News Stories

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

1-11-2018

Information required for dossiers to support demands for import of high risk plants, plant products and other objects as foreseen in Article 42 of Regulation (EU) 2016/2031

Information required for dossiers to support demands for import of high risk plants, plant products and other objects as foreseen in Article 42 of Regulation (EU) 2016/2031

Published on: Wed, 31 Oct 2018 00:00:00 +0100 Article 42 of the new Plant Health Law (Regulation (EU) 2016/2031 on protective measures against pests of plants), introduce a concept of “high risk plants, plant products and other objects” in relation to the presence of a pest risk of an unacceptable level for the Union territory, identified on the basis of a preliminary assessment to be followed by a risk assessment. Upon request of the European Commission (EC), the European Food Safety Authority (EFSA) d...

Europe - EFSA - European Food Safety Authority Publications

1-11-2018

Safety evaluation of the food enzyme endo‐1,4‐β‐xylanase from a genetically modified Bacillus subtilis (strain LMG S‐24584)

Safety evaluation of the food enzyme endo‐1,4‐β‐xylanase from a genetically modified Bacillus subtilis (strain LMG S‐24584)

Published on: Wed, 31 Oct 2018 00:00:00 +0100 The food enzyme endo‐1,4‐β‐xylanase (EC 3.2.1.8) is produced with the genetically modified Bacillus subtilis strain LMG S‐24584 by Puratos N. V. The genetic modifications do not give rise to safety concerns. The Panel noted that, although the production strain was not detected in the food enzyme, recombinant DNA was present in all batches of the food enzyme tested. The food enzyme is intended to be used in baking processes. Based on the maximum use levels re...

Europe - EFSA - European Food Safety Authority Publications

1-11-2018

Safety of the food enzyme glucoamylase from a genetically modified Aspergillus niger (strain NZYM‐BF)

Safety of the food enzyme glucoamylase from a genetically modified Aspergillus niger (strain NZYM‐BF)

Published on: Wed, 31 Oct 2018 00:00:00 +0100 The food enzyme glucoamylase (glucan 1,4‐α‐glucosidase; EC 3.2.1.3) is produced with the genetically modified strain of Aspergillus niger by Novozymes A/S. The genetic modifications do not give rise to safety concerns. The food enzyme is free from viable cells of the production organism and recombinant DNA. This glucoamylase is intended to be used in brewing processes and in starch processing for glucose syrups production. Residual amounts of total organic s...

Europe - EFSA - European Food Safety Authority Publications

1-11-2018

Pest categorisation of Acrobasis pirivorella

Pest categorisation of Acrobasis pirivorella

Published on: Wed, 31 Oct 2018 00:00:00 +0100 The European Commission requested EFSA to conduct a pest categorisation of Acrobasis pirivorella (Lepidoptera: Pyralidae), a monophagous moth whose larvae exclusively feed on developing buds, flowers, and fruits of cultivated and wild Pyrus spp. A. pirivorella is a species with reliable methods available for identification. A. pirivorellaoccurs in north‐east Asia only, causing significant damage in cultivated pears. It is regulated in the EU by Council Direc...

Europe - EFSA - European Food Safety Authority Publications

1-11-2018

Safety evaluation of the food enzyme α‐amylase from a genetically modified Aspergillus niger (strain NZYM‐MC)

Safety evaluation of the food enzyme α‐amylase from a genetically modified Aspergillus niger (strain NZYM‐MC)

Published on: Wed, 31 Oct 2018 00:00:00 +0100 The food enzyme alpha‐amylase (4‐α‐d‐glucan glucanohydrolase; EC 3.2.1.1) is produced with the genetically modified strain of Aspergillus niger by Novozymes A/S. The genetic modifications do not give rise to safety concerns. The food enzyme is free from viable cells of the production organism and recombinant DNA. This α‐amylase is intended to be used in starch processing for glucose syrups production, beverage alcohol (distilling) processes and baking proces...

Europe - EFSA - European Food Safety Authority Publications

31-10-2018

Outcome of a public consultation on the draft guidance on the scientific requirements for health claims related to muscle function and physical performance

Outcome of a public consultation on the draft guidance on the scientific requirements for health claims related to muscle function and physical performance

Published on: Tue, 30 Oct 2018 00:00:00 +0100 The European Food Safety Authority (EFSA) carried out a public consultation to receive input from the scientific community and all interested parties on a draft guidance on the scientific requirements for health claims related to muscle function and physical performance, prepared by the EFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA), supported by the Working Group on Claims. The draft guidance was endorsed by the Panel for public consultation ...

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

31-10-2018

Safety and efficacy of a super critical carbon dioxide extract of Humulus lupulus L. flos when used as a feed flavouring for all animal species

Safety and efficacy of a super critical carbon dioxide extract of Humulus lupulus L. flos when used as a feed flavouring for all animal species

Published on: Tue, 30 Oct 2018 00:00:00 +0100 Following a request from the European Commission, the EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on the safety and efficacy of a super critical carbon dioxide extract of Humulus lupulus L. flos (hop strobiles) when used as a sensory feed additive for all animal species. The additive is specified to containing 40% beta acids and less than 0.2% alpha acids. Known substances of conce...

Europe - EFSA - European Food Safety Authority Publications

31-10-2018

Safety and efficacy of Lactobacillus hilgardii CNCM I‐4785 and Lactobacillus buchneri CNCM I‐4323/NCIMB 40788 as a silage additive for all animal species

Safety and efficacy of Lactobacillus hilgardii CNCM I‐4785 and Lactobacillus buchneri CNCM I‐4323/NCIMB 40788 as a silage additive for all animal species

Published on: Tue, 30 Oct 2018 00:00:00 +0100 Following a request from the European Commission, the Panel on Additives and Products or Substances used in Animal Feed was asked to deliver a scientific opinion on the safety and efficacy of a strain of Lactobacillus hilgardii and of Lactobacillus buchneri when used as a technological additive intended to improve ensiling at a proposed application rate of 3.0 x 108 colony forming units (CFU)/kg fresh material. The two bacterial species are considered by EFS...

Europe - EFSA - European Food Safety Authority Publications

30-10-2018

Pest categorisation of Sternochetus mangiferae

Pest categorisation of Sternochetus mangiferae

Published on: Mon, 29 Oct 2018 00:00:00 +0100 The European Commission requested EFSA to conduct a pest categorisation of Sternochetus mangiferae (Coleoptera: Curculionidae), a monophagous pest weevil whose larvae exclusively feed on mango seeds, whereas adults feed on mango foliage. S. mangiferae is a species with reliable methods available for identification. It is regulated in the EU by Council Directive 2000/29/EC where it is listed in Annex IIB as a harmful organism whose introduction into EU Protec...

Europe - EFSA - European Food Safety Authority Publications

24-10-2018

Safety and efficacy of Hostazym® X (endo‐1,4‐beta‐xylanase) as a feed additive for sows in order to have benefit in piglets

Safety and efficacy of Hostazym® X (endo‐1,4‐beta‐xylanase) as a feed additive for sows in order to have benefit in piglets

Published on: Tue, 23 Oct 2018 00:00:00 +0200 Following a request from the European Commission, the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on the safety and efficacy of HOSTAZYM® X as a feed additive for sows in order to have benefit in piglets. The additive HOSTAZYM® X contains endo‐1,4‐beta‐xylanase and is available in liquid and solid formulations. This product is authorised as a feed additive for chickens for fattening, tu...

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

20-10-2018

Scientific Opinion on Flavouring Group Evaluation 200, Revision 1 (FGE.200 Rev.1): 74 α,β‐unsaturated aliphatic aldehydes and precursors from chemical subgroup 1.1.1 of FGE.19

Scientific Opinion on Flavouring Group Evaluation 200, Revision 1 (FGE.200 Rev.1): 74 α,β‐unsaturated aliphatic aldehydes and precursors from chemical subgroup 1.1.1 of FGE.19

Published on: Fri, 19 Oct 2018 00:00:00 +0200 The Panel on Food Additives and Flavourings of the European Food Safety Authority was requested to evaluate the genotoxic potential of 74 flavouring substances from subgroup 1.1.1 of FGE.19 in the Flavouring Group Evaluation 200 Revision 1 (FGE.200 Rev1). In FGE.200, genotoxicity studies were provided for one representative substance, namely hex‐2(trans)‐enal [FL‐no: 05.073], and for other two substances in the same subgroup, namely 2‐dodecenal [FL‐no: 05.03...

Europe - EFSA - European Food Safety Authority Publications

18-10-2018

Scientific Opinion on Flavouring Group Evaluation 201 Revision 2 (FGE.201Rev2): 2‐alkylated, aliphatic, acyclic alpha,beta‐unsaturated aldehydes and precursors, with or without additional double‐bonds, from chemical subgroup 1.1.2 of FGE.19

Scientific Opinion on Flavouring Group Evaluation 201 Revision 2 (FGE.201Rev2): 2‐alkylated, aliphatic, acyclic alpha,beta‐unsaturated aldehydes and precursors, with or without additional double‐bonds, from chemical subgroup 1.1.2 of FGE.19

Published on: Wed, 17 Oct 2018 00:00:00 +0200 The Panel on Food Additives and Flavourings of the European Food Safety Authority was requested to consider in this revision 2 of Flavouring Group Evaluation 201, the additional data on genotoxicity submitted by the Industry on two substances, 2‐methylpent‐2‐enal [FL‐no: 05.090] and 2 methylcrotonaldehyde [FL‐no: 05.095], from subgroup 1.1.2 of FGE.19. In FGE.201Rev1, the Panel concluded that further data were required in order to clarify the genotoxic poten...

Europe - EFSA - European Food Safety Authority Publications

18-10-2018

Training courses in systematic reviews or in specific steps of systematic review for EFSA Risk Assessment

Training courses in systematic reviews or in specific steps of systematic review for EFSA Risk Assessment

Published on: Wed, 17 Oct 2018 00:00:00 +0200 The present document has been produced and adopted by the bodies identified above as author(s). This task has been carried out exclusively by the author(s) in the context of a contract between the European Food Safety Authority and the author(s), awarded following a tender procedure. The present document is published complying with the transparency principle to which the Authority is subject. It may not be considered as an output adopted by the Authority. Th...

Europe - EFSA - European Food Safety Authority Publications

16-10-2018

Pest categorisation of Cronartium harknessii, Cronartium kurilense and Cronartium sahoanum

Pest categorisation of Cronartium harknessii, Cronartium kurilense and Cronartium sahoanum

Published on: Mon, 15 Oct 2018 00:00:00 +0200 Following a request from the European Commission, the EFSA Panel on Plant Health performed a pest categorisation of Cronartium harknessii, Cronartium kurilense and Cronartium sahoanum, which are well‐defined and distinguishable tree fungal pathogens of the family Cronartiaceae. In 2018, these species were moved from the genus Endocronartium to the genus Cronartium. These pathogens are not known to be present in the EU and are regulated in Council Directive 2...

Europe - EFSA - European Food Safety Authority Publications

16-10-2018

Pest categorisation of Melampsora farlowii

Pest categorisation of Melampsora farlowii

Published on: Mon, 15 Oct 2018 00:00:00 +0200 Following a request from the European Commission, the EFSA Panel on Plant Health performed a pest categorisation of Melampsora farlowii, a well‐defined and distinguishable fungus of the family Melampsoraceae. M. farlowii is the causal agent of a leaf and twig rust of hemlocks (Tsuga spp.) in eastern North America. The pathogen is regulated in Council Directive 2000/29/EC (Annex IAI) as a harmful organism whose introduction into the EU is banned. M. farlowii ...

Europe - EFSA - European Food Safety Authority Publications

15-10-2018

EFSA Focal Points: a decade of networking for European food safety

EFSA Focal Points: a decade of networking for European food safety

EFSA Focal Points: a decade of networking for European food safety

Europe - EFSA - European Food Safety Authority Press Releases & News Stories

11-10-2018

Wild boar in focus: Review of existing models on spatial distribution and density of wild boar and proposal for next steps

Wild boar in focus: Review of existing models on spatial distribution and density of wild boar and proposal for next steps

Published on: Wed, 10 Oct 2018 00:00:00 +0200 This report provides a review of existing models for predicting the spatial distribution and abundance of wild boar at various scales (global, continental, national and regional) in order to inform the development of a new model to produce estimates of wild boar abundance at European level. The review identifies and discusses a range of models based on a wide variety of data types, corresponding to those targeted by the data collection model set by ENETwild,...

Europe - EFSA - European Food Safety Authority Publications

9-10-2018

Peer review of the pesticide risk assessment for the active substance flumioxazin in light of negligible exposure data submitted

Peer review of the pesticide risk assessment for the active substance flumioxazin in light of negligible exposure data submitted

Published on: Mon, 08 Oct 2018 00:00:00 +0200 The conclusions of EFSA following the peer review of the initial risk assessment carried out by the competent authority of the rapporteur Member State, Czech Republic, for the pesticide active substance flumioxazin are reported. The European Commission requested EFSA to conduct a peer review and provide its conclusions on whether exposure of humans to flumioxazin can be considered negligible, taking into account the European Commission's draft guidance on th...

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

Peer review of the pesticide risk assessment of the active substance ABE‐IT 56 (components of lysate of Saccharomyces cerevisiae strain DDSF623)

Peer review of the pesticide risk assessment of the active substance ABE‐IT 56 (components of lysate of Saccharomyces cerevisiae strain DDSF623)

Published on: Thu, 27 Sep 2018 00:00:00 +0200 The conclusions of EFSA following the peer review of the initial risk assessments carried out by the competent authority of the rapporteur Member State, France, for the pesticide active substance ABE‐IT 56 (components of lysate of Saccharomyces cerevisiae strain DDSF623) are reported. The context of the peer review was that required by Regulation (EC) No 1107/2009 of the European Parliament and of the Council. The conclusions were reached on the basis of the...

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

Technical Report on the notification of syrup from Sorghum bicolor (L.) Moench as a traditional food from a third country pursuant to Article 14 of Regulation (EU) 2015/2283

Technical Report on the notification of syrup from Sorghum bicolor (L.) Moench as a traditional food from a third country pursuant to Article 14 of Regulation (EU) 2015/2283

Published on: Tue, 25 Sep 2018 00:00:00 +0200 Abstract Following a notification from Sorghum Zrt., submitted to the European Commission under Article 14 of Regulation (EU) 2015/2283 to place on the market syrup from Sorghum bicolor (L.) Moench as a traditional food from a third country (TF), and in line with Article 15(2) of that Regulation, EFSA was asked by the European Commission whether there are duly reasoned safety objections to the placing on the market of the TF within the European Union. The ap...

Europe - EFSA - European Food Safety Authority Publications

22-9-2018

Risk assessment of new sequencing information on genetically modified carnation FLO‐40689‐6

Risk assessment of new sequencing information on genetically modified carnation FLO‐40689‐6

Published on: Fri, 21 Sep 2018 00:00:00 +0200 The GMO Panel has previously assessed genetically modified (GM) carnation FLO‐40689‐6 and concluded that there is no scientific reason to consider that the import, distribution and retailing in the EU of carnation FLO‐40689‐6 cut flowers for ornamental use will cause any adverse effects on human health or the environment. On 27 October 2017, the European Commission requested EFSA to analyse new nucleic acid sequencing data and updated bioinformatics data for...

Europe - EFSA - European Food Safety Authority Publications

22-9-2018

Risk assessment of new sequencing information for genetically modified soybean BPS‐CV127‐9

Risk assessment of new sequencing information for genetically modified soybean BPS‐CV127‐9

Published on: Fri, 21 Sep 2018 00:00:00 +0200 The GMO Panel has previously assessed genetically modified (GM) soybean BPS‐CV127‐9. This soybean was found to be as safe and nutritious as its conventional counterpart and commercial soybean varieties with respect to potential effects on human and animal health and the environment in the context of its intended uses. On 16 February 2018, European Commission requested EFSA to analyse new nucleic acid sequencing data and updated bioinformatics data for GM soy...

Europe - EFSA - European Food Safety Authority Publications

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

20-9-2018

Report of the third Joint Meeting of the ECDC's Food‐ and Waterborne Diseases and Zoonoses Network and of the EFSA's Zoonoses Monitoring Data Network

Report of the third Joint Meeting of the ECDC's Food‐ and Waterborne Diseases and Zoonoses Network and of the EFSA's Zoonoses Monitoring Data Network

Published on: Wed, 19 Sep 2018 00:00:00 +0200 The third Joint Meeting of the ECDC's Food‐ and Waterborne Disease and Zoonoses Network and of the EFSA's Zoonoses Monitoring Data Network was held on 16 and 17 October 2017 in Parma. The meeting was constructed around the principle of ‘One health approach to collaborative response to foodborne disease outbreaks in EU/EEA’ and served as an opportunity for public health authorities and food safety/veterinary authorities to meet and exchange information on the...

Europe - EFSA - European Food Safety Authority Publications

19-9-2018

Danish Medicines Agency aces European benchmark survey

Danish Medicines Agency aces European benchmark survey

The Danish Medicines Agency has just scored 4.5 of a possible 5 in the common-European survey known as the Benchmarking of European Medicines Agencies (BEMA). ”It's a really good result that will benefit all of us and may help raise the standard throughout Europe,” said the Danish health minister.

Danish Medicines Agency

19-9-2018

National dietary survey in 2012‐2016 on the general population aged 1‐79 years in the Netherlands

National dietary survey in 2012‐2016 on the general population aged 1‐79 years in the Netherlands

Published on: Tue, 18 Sep 2018 00:00:00 +0200 During the years 2012‐2016, the Dutch National Food Consumption survey was conducted in the Netherlands. For the survey, a random sample was drawn from consumer panels stratified by age and gender and maintained representative to the population with regard to region, address density and educational level. Complete results were obtained for 4,313 persons (response rate 65%); including toddlers, children, adolescents, adults and elderly. Pregnant or lactating ...

Europe - EFSA - European Food Safety Authority Publications

18-9-2018

Peer review of the pesticide risk assessment of the active substance sodium hydrogen carbonate

Peer review of the pesticide risk assessment of the active substance sodium hydrogen carbonate

Published on: Fri, 14 Sep 2018 00:00:00 +0200 The conclusions of EFSA following the peer review of the initial risk assessments carried out by the competent authority of the rapporteur Member State Austria for the pesticide active substance sodium hydrogen carbonate are reported. The context of the peer review was that required by Regulation (EC) No 1107/2009 of the European Parliament and of the Council. The conclusions were reached on the basis of the evaluation of the representative use of sodium hyd...

Europe - EFSA - European Food Safety Authority Publications

14-9-2018

Peer review of the pesticide risk assessment of the active substance azadirachtin (Margosa extract)

Peer review of the pesticide risk assessment of the active substance azadirachtin (Margosa extract)

Published on: Thu, 13 Sep 2018 00:00:00 +0200 The conclusions of the EFSA following the peer review of the initial risk assessments carried out by the competent authority of the rapporteur Member State, Germany, for the pesticide active substance azadirachtin are reported. The context of the peer review was that required by Regulation (EC) No 1107/2009 of the European Parliament and of the Council. The conclusions were reached on the basis of the evaluation of the additional representative use of azadir...

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

Update of the Xylella spp. host plant database

Update of the Xylella spp. host plant database

Published on: Mon, 10 Sep 2018 00:00:00 +0200 Following a request from the European Commission, EFSA periodically updates the database on the host plants of Xylella spp. While previous editions of the database (2015 and 2016) dealt with the species Xylella fastidiosa only, this database version addresses the whole genus Xylella, including therefore both species X. fastidiosa and Xylella taiwanensis. The database now includes information on host plants of Xylella spp. retrieved from scientific literature...

Europe - EFSA - European Food Safety Authority Publications

11-9-2018

Novel foods: a risk profile for the house cricket (Acheta domesticus)

Novel foods: a risk profile for the house cricket (Acheta domesticus)

Published on: Tue, 28 Aug 2018 00:00:00 +0200 Novel foods could represent a sustainable alternative to traditional farming and conventional foodstuffs. Starting in 2018, Regulation (EU) 2283/2015 entered into force, laying down provisions for the approval of novel foods in Europe, including insects. This Approved Regulation establishes the requirements that enable Food Business Operators to bring new foods into the EU market, while ensuring high levels of food safety for European consumers. The present ...

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

11-9-2018

Preparation of Dutch food consumption data for risk assessment

Preparation of Dutch food consumption data for risk assessment

Published on: Mon, 27 Aug 2018 00:00:00 +0200 The availability of detailed and high‐quality food consumption data collected at an individual level is essential for assessing the exposure to potential risks in the food chain. During the years 2012–2016, the Dutch National Food Consumption Survey was conducted in the Netherlands as part of the EU Menu survey, following the EFSA 2009 guidance on ‘General principles for the collection of national food consumption data in the view of a pan‐European dietary s...

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

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

Scientific Opinion about the Guidance of the Chemical Regulation Directorate (UK) on how aged sorption studies for pesticides should be conducted, analysed and used in regulatory assessments

Scientific Opinion about the Guidance of the Chemical Regulation Directorate (UK) on how aged sorption studies for pesticides should be conducted, analysed and used in regulatory assessments

Published on: Mon, 27 Aug 2018 00:00:00 +0200 The EFSA Panel on Plant Protection Products and their Residues reviewed the guidance on how aged sorption studies for pesticides should be conducted, analysed and used in regulatory assessment. The inclusion of aged sorption is a higher tier in the groundwater leaching assessment. The Panel based its review on a test with three substances taken from a data set provided by the European Crop Protection Association. Particular points of attention were the quali...

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

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

Joint EFSA and ECDC 2018 workshop on preparedness for a multi‐national food safety/public health incident

Joint EFSA and ECDC 2018 workshop on preparedness for a multi‐national food safety/public health incident

Published on: Tue, 21 Aug 2018 00:00:00 +0200 Abstract In May 2018, EFSA and ECDC co‐facilitated a workshop on preparedness for a multi‐national food safety/public health incident. The workshop, hosted at AGES in Vienna, was conceived to closely align with EFSA's Strategy 2020 commitment to prepare for future risk assessment challenges. EFSA, ECDC, AGES and BfR worked together closely to develop a workshop and associated training materials to be delivered over a 2.5‐day agenda. The workshop was attended...

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

Risk to human and animal health related to the presence of 4,15‐diacetoxyscirpenol in food and feed

Risk to human and animal health related to the presence of 4,15‐diacetoxyscirpenol in food and feed

Published on: Thu, 16 Aug 2018 00:00:00 +0200 4,15‐Diacetoxyscirpenol (DAS) is a mycotoxin primarily produced by Fusarium fungi and occurring predominantly in cereal grains. As requested by the European Commission, the EFSA Panel on Contaminants in the Food Chain (CONTAM) assessed the risk of DAS to human and animal health related to its presence in food and feed. Very limited information was available on toxicity and on toxicokinetics in experimental and farm animals. Due to the limitations in the avai...

Europe - EFSA - European Food Safety Authority Publications

13-11-2018

EU/3/17/1836 (Zogenix GmbH)

EU/3/17/1836 (Zogenix GmbH)

EU/3/17/1836 (Active substance: Fenfluramine hydrochloride) - Transfer of orphan designation - Commission Decision (2018)7576 of Tue, 13 Nov 2018 European Medicines Agency (EMA) procedure number: EMA/OD/233/16/T/01

Europe -DG Health and Food Safety

13-11-2018

EU/3/13/1219 (Zogenix GmbH)

EU/3/13/1219 (Zogenix GmbH)

EU/3/13/1219 (Active substance: Fenfluramine hydrochloride) - Transfer of orphan designation - Commission Decision (2018)7575 of Tue, 13 Nov 2018 European Medicines Agency (EMA) procedure number: EMA/OD/140/13/T/01

Europe -DG Health and Food Safety

2-10-2018

EU/3/14/1242 (Neurolixis SAS)

EU/3/14/1242 (Neurolixis SAS)

EU/3/14/1242 (Active substance: 3-Chloro-4-fluorophenyl-[4-fluoro-4-{[(5-methylpyrimidin-2-ylmethyl) amino]methyl}piperidin-1-yl]methanone) - Transfer of orphan designation - Commission Decision (2018)6436 of Tue, 02 Oct 2018 European Medicines Agency (EMA) procedure number: EMA/OD/163/13/T/01

Europe -DG Health and Food Safety

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

17-9-2018

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

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

This Patients' and Consumers' Working Party (PCWP) plenary meeting will include discussions on patient engagement along the regulatory lifecycle and visibility of patient input throughout scientific procedures. Feedback will also be given from the representatives of the Scientific Committees.

Europe - EMA - European Medicines Agency

13-9-2018

 European Medicines Agency stakeholder interaction on the development of medicinal products for chronic non-infectious liver diseases (PBC, PSC, NASH), European Medicines Agency, London, UK, From: 03-Dec-2018, To: 03-Dec-2018

European Medicines Agency stakeholder interaction on the development of medicinal products for chronic non-infectious liver diseases (PBC, PSC, NASH), European Medicines Agency, London, UK, From: 03-Dec-2018, To: 03-Dec-2018

This workshop on the development of medicines for chronic non-infectious liver diseases, including primary biliary cholangitis, primary sclerosing cholangitis and nonalcoholic steatohepatitis, provides a platform for discussion on appropriate endpoints including validation of surrogate endpoints/biomarkers, suitable study populations, potentially adequate trial designs and the specific challenges with paediatric medicine development. The workshop will support the drafting of a reflection paper on regul...

Europe - EMA - European Medicines Agency

11-9-2018

 Risk assessment guideline focus group meeting, European Medicines Agency, London, UK, From: 19-Sep-2018, To: 19-Sep-2018

Risk assessment guideline focus group meeting, European Medicines Agency, London, UK, From: 19-Sep-2018, To: 19-Sep-2018

The Antimicrobials Working Party of the European Medicines Agency’s Committee for Medicinal Products for Veterinary Use (CVMP) is holding a focus group meeting with stakeholders to discuss the revision of the antimicrobial veterinary medicinal product risk assessment guideline, following a public consultation on the draft revised guideline ending on 31 October 2018. The meeting will focus on topics identified during this public consultation. This guideline aims to provide guidance to marketing authorisat...

Europe - EMA - European Medicines Agency

11-9-2018

 Focus group meeting  on dose optimisation of established veterinary antibiotics in the context of summary of product characteristics harmonisation, European Medicines Agency, London, UK, From: 12-Oct-2018, To: 12-Oct-2018

Focus group meeting on dose optimisation of established veterinary antibiotics in the context of summary of product characteristics harmonisation, European Medicines Agency, London, UK, From: 12-Oct-2018, To: 12-Oct-2018

This meeting will allow a direct exchange of views between the Agency’s working party and stakeholders on its draft reflection paper on dose optimisation of established veterinary antibiotics in the context of summary of product characteristics (SPC) harmonisation (EMA/CVMP/849775/2017). It complements the public consultation on this reflection paper ending on 31 January 2019. The reflection paper follows considerations in the report on a pilot project that aimed to develop and test non-experimental appr...

Europe - EMA - European Medicines Agency

7-9-2018

 European network of paediatric research at the European Medicines Agency (Enpr-EMA) Coordinating Group and networks meeting, European Medicines Agency, London, UK, From: 08-Jun-2018, To: 08-Jun-2018

European network of paediatric research at the European Medicines Agency (Enpr-EMA) Coordinating Group and networks meeting, European Medicines Agency, London, UK, From: 08-Jun-2018, To: 08-Jun-2018

The 2018 face-to-face meeting of Enpr-EMA networks and coordinating members takes place after the annual open workshop on 8 June. The networks meeting will focus on the outcome of the 2018 annual workshop of the 7 June and the action plan for 2018/2019.

Europe - EMA - European Medicines Agency

7-9-2018

 2018 Annual workshop of the European Network of Paediatric Research at the European Medicines Agency (Enpr-EMA), European Medicines Agency, London, UK, From: 07-Jun-2018, To: 07-Jun-2018

2018 Annual workshop of the European Network of Paediatric Research at the European Medicines Agency (Enpr-EMA), European Medicines Agency, London, UK, From: 07-Jun-2018, To: 07-Jun-2018

Enpr-EMA will hold its tenth annual workshop on 7-8 June 2018 at EMA. The workshop brings relevant stakeholders together to discuss requirements, barriers and opportunities for the conduct of high-quality clinical studies in children. The overall theme of this year’s workshop will be a ‘holistic approach to paediatric research’. Highlights of this year’s workshop include: i) short perspectives of the various stakeholders involved in paediatric research (patient/young people advisory groups, research netw...

Europe - EMA - European Medicines Agency