Lidocaine Accord

Hauptinformation

  • Handelsname:
  • Lidocaine Accord Injektionslösung 20 mg-ml
  • Dosierung:
  • 20 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:
  • Lidocaine Accord Injektionslösung 20 mg-ml
    Belgien
  • Sprache:
  • Deutsch

Therapeutische Informationen

  • Therapiegruppe:
  • Lokalanästhetika, Amide.

Weitere Informationen

Status

  • Quelle:
  • AFMPS - Agence Fédérale des Médicaments et des Produits de Santé - Belgium
  • Zulassungsnummer:
  • BE479351
  • Letzte Änderung:
  • 12-04-2018

Packungsbeilage

Gebrauchsinformation: Information für Anwender

Lidocaine Accord 10 mg/ml Injektionslösung

Lidocaine Accord 20 mg/ml Injektionslösung

Lidocainhydrochlorid

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

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 Lidocaine Accord und wofür wird es angewendet?

2.Was sollten Sie vor der Anwendung von Lidocaine Accord beachten?

Wie ist Lidocaine Accord anzuwenden?

4.Welche Nebenwirkungen sind möglich?

Wie ist Lidocaine Accord aufzubewahren?

6.Inhalt der Packung und weitere Informationen

1.

Was ist Lidocaine Accord und wofür wird es angewendet?

Lidocain ist ein örtliches Betäubungsmittel. Es wird dazu verwendet, Teile des Körpers bei kleineren

chirurgischen Eingriffen gefühllos zu machen. Es verhindert, dass die Nerven Schmerzsignale an das

Gehirn weiterleiten, und unterbindet so das Schmerzempfinden. Seine Wirkung setzt wenige Minuten

nach der Injektion ein und lässt allmählich nach, nachdem der chirurgischen Eingriff beendet ist.

2. Was sollten Sie vor der Anwendung von Lidocaine Accord beachten?

Dieses Arzneimittel darf nicht bei Ihnen angewendet werden,

wenn Sie allergisch gegen Lidocainhydrochlorid, gegen lokale Betäubungsmittel vom

Amidtyp oder gegen einen der in Abschnitt 6 genannten sonstigen Bestandteile dieses

Arzneimittels sind

wenn Sie sehr niedrigen Blutdruck haben, wenn Sie zu viel Blut oder andere

Körperflüssigkeiten verloren haben oder wenn Ihr Herz aus anderem Grund nicht in der Lage

ist, ausreichend Blut zu pumpen, sollte Ihnen Lidocaine Accord nicht in die Wirbelsäule

injiziert werden.

Wenn einer dieser Punkte auf Sie zutrifft, sprechen Sie mit Ihrem Arzt, bevor dieses Arzneimittel bei

Ihnen angewendet wird.

Warnhinweise und Vorsichtsmaßnahmen

Bitte sprechen Sie mit Ihrem Arzt oder Apotheker oder dem medizinischen Fachpersonal, bevor

Lidocain bei Ihnen angewendet wird,

wenn Sie älter oder allgemein geschwächt sind

wenn Sie Herzproblemewie einen langsamen oder unregelmäßigen Herzschlag haben oder an

Herzinsuffizienz leiden

wenn Sie Probleme mit der Lunge oder mit dem Atmen haben

wenn Sie eine Lebererkrankung oder Nierenprobleme haben

wenn Sie an Anfällen (Epilepsie) leiden

wenn der Bereich, in den die Injektion erfolgen soll, entzündet oder infiziert ist

wenn Sie an Porphyrie leiden (einer seltenen erblichen Krankheit, die die Haut und das

Nervensystem betrifft)

wenn Sie Probleme mit der Blutgerinnung haben

wenn Sie in den letzten drei Monaten einer Schwangerschaft sind.

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

Ihrem Arzt, bevor Lidocaine Accord bei Ihnen angewendet wird.

Anwendung von Lidocaine Accord zusammen mit anderen Arzneimitteln

Informieren Sie Ihren Arzt, wenn Sie andere Arzneimittel einnehmen, kürzlich andere Arzneimittel

eingenommen haben oder beabsichtigen, andere Arzneimittel einzunehmen.

Informieren Sie Ihren Arzt insbesondere, wenn Sie irgendwelche der folgenden Arzneimittel

anwenden:

andere örtliche Betäubungsmittel

Arzneimittel, die zur Behandlung von Magen- oder Zwölffingerdarmgeschwüren eingesetzt

werden (z.B. Cimetidin)

Arzneimittel gegen unregelmäßigen Herzschlag (z.B. Amiodaron).

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 Anwendung dieses Arzneimittels Ihren Arzt

oder Apotheker um Rat.

Verkehrstüchtigkeit und Fähigkeit zum Bedienen von Maschinen

Abhängig von der Dosis und der Art der Verabreichung kann Lidocaine Accord vorübergehend Ihre

Verkehrstüchtigkeit und Fähigkeit zum Bedienen von Maschinen beeinträchtigen.

Fragen Sie Ihren Arzt, wann Sie diese Aktivitäten gefahrlos wieder aufnehmen können.

Lidocaine Accord enthält Natrium

Ein Milliliter Injektionslösung enthält ca. 0,118 mmol Natrium (Wirkstärke 10 mg/ml) bzw. 0,082

mmol Natrium (Wirkstärke 20 mg/ml). Dies ist bei Patienten unter natriumkontrollierter Diät zu

berücksichtigen.

3. Wie ist Lidocaine Accord anzuwenden?

Lidocaine Accord wird Ihnen von einem Arzt verabreicht. Es wird Ihnen als Injektion in eine Vene,

einen Muskel, unter die Haut oder in den Epiduralraum um das Rückenmark gegeben.

Die Dosis, die Ihr Arzt Ihnen gibt, hängt von der Art der Schmerzlinderung ab, die Sie benötigen.

Außerdem ist die Dosis von Ihrer Körpergröße, Ihrem Alter, Ihrer körperlichen Verfassung sowie dem

Körperteil abhängig, in den das Arzneimittel injiziert wird. Sie erhalten die geringstmögliche Dosis,

die zur Erzielung der gewünschten Wirkung erforderlich ist.

Kinder und Jugendliche

Bei Kindern und Patienten mit reduziertem Allgemeinzustand ist die Dosis zu verringert.

Lidocaine Accord wird meist in der Nähe der Körperstelle verabreicht, an der der Eingriff erfolgen

soll.

Wenn bei Ihnen eine größere Menge Lidocaine Accord angewendet wurde als vorgesehen

Wenn Sie eine größere Menge von Lidocaine Accord haben angewendet, kontaktieren Sie sofort Ihren

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

Der Arzt, der Sie behandelt, ist im Umgang mit schweren Nebenwirkungen einer zu hohen Dosis

Lidocaine Accord geschult.

Die ersten Anzeichen einer Überdosierung von Lidocaine Accord sind wie folgt:

Krämpfe

Unruhe

Schwindel oder Benommenheit

Übelkeit

Taubheits- oder Kribbelgefühl in den Lippen und um den Mund

Sehstörungen.

Informieren Sie sofort Ihren Arzt oder das Pflegepersonal, wenn eine dieser Beschwerden bei Ihnen

auftritt oder wenn Sie glauben, dass Sie zu viel Lidocaine Accord erhalten haben.

Schwerere Nebenwirkungen einer Überdosierung von Lidocaine Accord können folgen, z.B.

Gleichgewichts- und Koordinationsstörungen, Hörveränderungen, Euphorie, Verwirrtheit,

Sprechstörungen, Blässe, Schwitzen, Zittern, Krämpfe, Auswirkungen auf Herz und Blutgefäße,

Bewusstlosigkeit, Koma und kurzzeitiges Aussetzen der Atmung (Apnoe).

Wenn Sie weitere Fragen zur Anwendung dieses Arzneimittels haben, wenden Sie sich an Ihren Arzt.

4. Welche Nebenwirkungen sind möglich?

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

jedem auftreten müssen.

Informieren Sie sofort Ihren Arzt oder das Pflegepersonal, wenn eine schwere allergische Reaktion

(Angioödem oder anaphylaktischer Schock) bei Ihnen auftritt. Zu den Anzeichen einer solchen

Reaktion gehört das plötzliche Auftreten von Folgendem:

Schwellungen von Gesicht, Lippen, Zunge oder Rachen, möglicherweise mit einhergehenden

Schluckbeschwerden

starkes oder plötzliches Anschwellen der Hände, Füße und Fußknöchel

Atembeschwerden

starker Hautjuckreiz (mit Quaddelbildung)

Fieber

Blutdruckabfall.

Diese Nebenwirkungen sind selten (sie können bis zu 1 von 1000 Behandelten betreffen).

Weitere mögliche Nebenwirkungen:

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

Niedriger Blutdruck

Übelkeit

Häufig (kann bis zu 1 von 10 Behandelten betreffen)

Kribbeln

Schwindelgefühl

Langsamer Herzschlag

Hoher Blutdruck

Erbrechen

Gelegentlich (kann bis zu 1 von 100 Behandelten betreffen)

Krämpfe

Taubheitsgefühl der Zunge oder Kribbeln um den Mund

Klingeln in den Ohren oder Geräuschempfindlichkeit

Sehstörungen

Bewusstlosigkeit

Zittern

Schläfrigkeit

Benommenheit

Tinnitus

Intoxikationsgefühl

Sprechstörungen

Selten (kann bis zu 1 von 1000 Behandelten betreffen)

Überempfindlichkeitsreaktionen wie Quaddeln (Urtikaria), Hautausschlag, Angioödem und in

schweren Fällen anaphylaktischer Schock

Gefühlsstörungen oder Muskelschwäche (Neuropathie)

Entzündung der Membran um das Rückenmark (Arachnoiditis), die zu Schmerzen im unteren

Rücken oder zu Schmerzen, Taubheitsgefühl oder Schwäche in den Beinen führen kann

Doppeltsehen

Unregelmäßiger oder aussetzender Herzschlag

Langsame oder aussetzende Atmung

Meldung von Nebenwirkungen

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

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

angegeben sind. Sie können Nebenwirkungen auch direkt der

Föderalagentur für Arzneimittel und Gesundheitsprodukte,

Abteilung Vigilanz,

EUROSTATION II,

Victor Hortaplein, 40/40, B-1060 BRÜSSEL

Website: www.fagg-afmps.be

E-Mail: patientinfo@fagg-afmps.be, anzeigen. Indem Sie Nebenwirkungen melden, können Sie dazu

beitragen, dass mehr Informationen über die Sicherheit dieses Arzneimittels zur Verfügung gestellt

werden.

5. Wie ist Lidocaine Accord aufzubewahren?

Bewahren Sie dieses Arzneimittel für Kinder unzugänglich auf.

Für dieses Arzneimittel sind keine besonderen Lagerungsbedingungen erforderlich.

Sie dürfen dieses Arzneimittel nach dem auf der Ampulle/Durchstechflasche und dem Umkarton nach

„Verwendbar bis“/„Verw. bis“ angegebenen Verfalldatum nicht mehr verwenden. Das Verfalldatum

bezieht sich auf den letzten Tag des angegebenen Monats.

Nur zum einmaligen Gebrauch. Nach dem ersten Öffnen sofort verwenden. Nicht verbrauchter Inhalt

ist zu entsorgen.

Arzneimittel nicht verwenden, wenn der Inhalt verfärbt ist. Bei Vorliegen von Partikeln darf die

Injektionslösung nicht verwendet werden.

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

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

umwelt bei.

6. Inhalt der Packung und weitere Informationen

Was Lidocaine Accord enthält

Der Wirkstoff ist Lidocainhydrochlorid.

Lidocaine Accord 10 mg/ml Injektionslösung: 1 ml Injektionslösung enthält 10 mg

Lidocainhydrochlorid.

Lidocaine Accord 20 mg/ml Injektionslösung: 1 ml Injektionslösung enthält 20 mg

Lidocainhydrochlorid.

Die sonstigen Bestandteile sind Natriumchlorid, Salzsäure (zur pH-Einstellung), Natriumhydroxid

(zur pH-Einstellung) und Wasser für Injektionszwecke.

Wie Lidocaine Accord aussieht und Inhalt der Packung

Lidocaine Accord ist eine klare, farblose, sterile Injektionslösung. Sie ist in zwei verschiedenen

Stärken, 10 mg/ml und 20 mg/ml, erhältlich.

Lidocaine Accord 10 mg/ml Injektionslösung ist erhältlich in

Glasampullen:

5 x 2 ml, 10 x 2 ml, 20 x 2 ml

5 x 5 ml, 10 x 5 ml, 20 x 5 ml

10 x 10 ml, 20 x 10 ml

Glas-Durchstechflaschen:

1 x 20 ml

Lidocaine Accord 20 mg/ml Injektionslösung ist erhältlich in

Glasampullen:

5 x 2 ml,10 x 2 ml, 20 x 2 ml

5 x 5 ml,10 x 5 ml, 20 x 5 ml

5 x 10 ml,10 x 10 ml, 20 x 10 ml

Glas-Durchstechflaschen:

1 x 20 ml

Es werden möglicherweise nicht alle Packungsgrößen in den Verkehr gebracht.

Pharmazeutischer Unternehmer und Hersteller:

Pharmazeutischer Unternehmer:

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

Wessling Hungary Kft

Budapest, Fòti ùt 56.,

1047, Ungarn

Zulassungsnummer

Lidocaine Accord 10 mg/ml

Injektionslösung

2 ml: BE479280

5 ml: BE479297

10 ml: BE479306

20 ml: BE479315

Lidocaine Accord 20 mg/ml

Injektionslösung

2 ml: BE479324

5 ml: BE479333

10 ml: BE479342

20 ml: BE479351

Art der Abgabe

Verschreibungspflichtig

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

folgenden Bezeichnungen zugelassen:

Name des

Mitgliedstaate

s

Bezeichnung des Arzneimittels

Lidocaine Accord

Lidocain Accord 10 mg/ml, 20 mg/ml Injektionslösung

Lidocaine Accord 10 mg/ml, 20 mg/ml oplossing voor injectie /solution

injectable/ injektionslösung

Lidocaine Accord 10 mg/ml, 20 mg/ml инжекционен разтвор

Lidocaine Accord 10 mg/ml, 20 mg/ml ενέσιμο διάλυμα

Lidocain Accord 10 mg/ml Injektionslösung

Lidocain Accord 20 mg/ml Injektionslösung

Lidocain Accord 10 mg/ml, 20 mg/ml injektionsvæske, opløsning

Lidocaine Accord

Lidocaína Accord10 mg/ml, 20 mg/ml solucióninyectable

Lidocaine Accord 10 mg/ml, 20 mg/ml injektioneste, liuos

Lidocaine Accord 10 mg/ml, 20 mg/ml solution injectable

Lidocaina Accord

Lidocaine Accord 10 mg/ml, 20 mg/ml injekcinis tirpalas

Lidocaine Accord 20 mg/ml šķīdums injekcijām

Lidocaine Accord 10 mg/ml, 20 mg/ml oplossingvoorinjectie

Lidocaine Accord 10 mg/ml, 20 mg/ml injeksjonsvæske, oppløsning

Lidocaine Accord 10 mg/ml, 20 mg/ml

Lidocaína Accord 10 mg/ml, 20 mg/ml

Diese Packungsbeilage wurde zuletzt genehmigt im 10/2017.

-----------------------------------------------------------------------------------------------

Die folgenden Informationen sind für medizinisches Fachpersonal bestimmt:

Da keine Kompatibilitätsstudien durchgeführt wurden, darf das Arzneimittel nicht mit anderen

Arzneimitteln gemischt werden.

Nur zum einmaligen Gebrauch. Nach dem ersten Öffnen sofort verwenden. Nicht verbrauchter Inhalt

ist zu entsorgen.

Arzneimittel nicht verwenden, wenn der Inhalt verfärbt ist. Bei Vorliegen von Partikeln darf die

Injektionslösung nicht verwendet werden.

Art der Anwendung

Lidocain Accord soll nur durch oder unter Aufsicht von in der Regionalanästhesie erfahrenen und mit

der Durchführung von Wiederbelebungsmaßnahmen vertrauten Ärzten angewendet werden. Bei der

Anwendung von Lokalanästhetika müssen Ausrüstungen zur Wiederbelebung verfügbar sein.

Informationen zur Dosierung entnehmen Sie bitte der Zusammenfassung der Merkmale des

Arzneimittels.

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Avian influenza overview May – August 2018

Avian influenza overview May – August 2018

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

Europe - EFSA - European Food Safety Authority Publications

27-9-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

27-9-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

26-9-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

25-9-2018

Daiso Holdings Ltd. recalls Daiso Brand Consumer Chemical Products

Daiso Holdings Ltd. recalls Daiso Brand Consumer Chemical Products

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

Health Canada

21-9-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

21-9-2018

Modification of the existing maximum residue level for clothianidin in potatoes

Modification of the existing maximum residue level for clothianidin in potatoes

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

Europe - EFSA - European Food Safety Authority Publications

19-9-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

19-9-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

13-9-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

11-9-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

11-9-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

11-9-2018

Assessment of occupational and dietary exposure to pesticide residues

Assessment of occupational and dietary exposure to pesticide residues

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

Europe - EFSA - European Food Safety Authority Publications

4-9-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

1-9-2018

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

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

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

Health Canada

1-9-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

1-9-2018

Review of the existing MRLs for fenbuconazole

Review of the existing MRLs for fenbuconazole

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

Europe - EFSA - European Food Safety Authority Publications

30-8-2018

National summary reports on pesticide residue analysis performed in 2016

National summary reports on pesticide residue analysis performed in 2016

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

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

Modification of the existing maximum residue levels for fluoxastrobin in oilseeds

Modification of the existing maximum residue levels for fluoxastrobin in oilseeds

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

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

28-8-2018

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

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

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

FDA - U.S. Food and Drug Administration

7-8-2018

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

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

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

Deutschland - BfArM - Bundesinstitut für Arzneimittel und Medizinprodukte

2-7-2018

Blissful Remedies Issues Voluntary Nationwide Recall of Certain Kratom Powder Capsule

Blissful Remedies Issues Voluntary Nationwide Recall of Certain Kratom Powder Capsule

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

FDA - U.S. Food and Drug Administration

22-6-2018

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

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

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

FDA - U.S. Food and Drug Administration

21-6-2018

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

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

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

FDA - U.S. Food and Drug Administration

25-9-2018

Pelgraz (Accord Healthcare Limited)

Pelgraz (Accord Healthcare Limited)

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

Europe -DG Health and Food Safety

24-9-2018

Lenalidomide Accord (Accord Healthcare Limited)

Lenalidomide Accord (Accord Healthcare Limited)

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

Europe -DG Health and Food Safety

19-9-2018

Fortacin (Recordati Ireland Ltd)

Fortacin (Recordati Ireland Ltd)

Fortacin (Active substance: lidocaine / prilocaine) - Centralised - Renewal - Commission Decision (2018)6103 of Wed, 19 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2693/R/23

Europe -DG Health and Food Safety

7-8-2018

Accofil (Accord Healthcare Limited)

Accofil (Accord Healthcare Limited)

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

Europe -DG Health and Food Safety

7-8-2018

Memantine Accord (Accord Healthcare Limited)

Memantine Accord (Accord Healthcare Limited)

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

Europe -DG Health and Food Safety

6-8-2018

Zoledronic acid Accord (Accord Healthcare Limited)

Zoledronic acid Accord (Accord Healthcare Limited)

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

Europe -DG Health and Food Safety

18-7-2018

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

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

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

FDA - U.S. Food and Drug Administration

4-7-2018

Docetaxel Accord (Accord Healthcare Limited)

Docetaxel Accord (Accord Healthcare Limited)

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

Europe -DG Health and Food Safety

3-7-2018

Temozolomide Accord (Accord Healthcare Limited)

Temozolomide Accord (Accord Healthcare Limited)

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

Europe -DG Health and Food Safety

11-6-2018

Pemetrexed Accord (Accord Healthcare Limited)

Pemetrexed Accord (Accord Healthcare Limited)

Pemetrexed Accord (Active substance: pemetrexed) - Centralised - Yearly update - Commission Decision (2018)3761 of Mon, 11 Jun 2018

Europe -DG Health and Food Safety

30-5-2018

Bortezomib Accord (Accord Healthcare Limited)

Bortezomib Accord (Accord Healthcare Limited)

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

Europe -DG Health and Food Safety