Prostap 11,25 mg/ml Gyn

Hauptinformation

  • Handelsname:
  • Prostap 11,25 mg/ml Gyn Retardmikrokapseln und Suspensionsmittel
  • Darreichungsform:
  • Retardmikrokapseln und Suspensionsmittel
  • Zusammensetzung:
  • Leuprorelin (Ph.Eur.) 11.25mg
  • Verwenden für:
  • Menschen
  • Art der Medizin:
  • allopathic Droge

Dokumenten

Lokalisierung

  • Erhältlich in:
  • Prostap 11,25 mg/ml Gyn Retardmikrokapseln und Suspensionsmittel
    Deutschland
  • Sprache:
  • Deutsch

Weitere Informationen

Status

  • Quelle:
  • BfArM - Bundesinstitut für Arzneimittel und Medizinprodukte
  • Zulassungsnummer:
  • 94078.00.00
  • Letzte Änderung:
  • 14-12-2018

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

Gebrauchsinformation: Information für Anwender

L-Thyroxin AL 25 Mikrogramm Tabletten

Levothyroxin-Natrium

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 L-Thyroxin AL und wofür wird es angewendet?

2. Was sollten Sie vor der Einnahme von L-Thyroxin AL beachten?

3. Wie ist L-Thyroxin AL einzunehmen?

4. Welche Nebenwirkungen sind möglich?

5. Wie ist L-Thyroxin AL aufzubewahren?

6. Inhalt der Packung und weitere Informationen

1. Was ist L-Thyroxin AL und wofür wird es angewendet?

Levothyroxin, der Wirkstoff in L-Thyroxin AL, ist ein synthetisch hergestelltes

Schilddrüsenhormon, das zur Behandlung von Erkrankungen und Funktionsstörungen der

Schilddrüse eingesetzt wird. Es hat die gleiche Wirkung wie die natürlichen

Schilddrüsenhormone.

L-Thyroxin AL 25 Mikrogramm wird angewendet

zur Therapie eines gutartigen Kropfes bei Patienten mit normaler

Schilddrüsenfunktion,

zur Verhütung einer erneuten Kropfbildung nach Operation,

als Ersatz für das natürliche Schilddrüsenhormon, wenn Ihre Schilddrüse nicht

genügend Hormone produziert,

zur Unterdrückung erneuten Tumorwachstums bei Patienten mit

Schilddrüsenkrebs.

Mit L-Thyroxin AL 25 Mikrogramm Tabletten kann auch der Schilddrüsenhormonspiegel

stabilisiert werden, wenn eine Schilddrüsenüberfunktion mit Schilddrüsenblockern

behandelt wird.

2. Was sollten Sie vor der Einnahme von L-Thyroxin AL beachten?

L-Thyroxin AL darf NICHT eingenommen werden,

wenn Sie allergisch gegen Levothyroxin-Natrium oder einen der in Abschnitt 6.

genannten sonstigen Bestandteile dieses Arzneimittels sind,

wenn Sie unbehandelte Funktionsstörung der Nebenniere, der Hirnanhangdrüse oder

eine unbehandelte Schilddrüsenüberfunktion (Hyperthyreose) haben,

wenn Sie eine akute Herzkrankheit (Myokardinfarkt oder Entzündung des Herzens)

haben.

Wenn Sie schwanger sind, dürfen Sie L-Thyroxin AL nicht in Kombination mit

Schilddrüsenblockern einnehmen (siehe unten Abschnitt 2.: Schwangerschaft und

Stillzeit).

Warnhinweise und Vorsichtsmaßnahmen

Bitte sprechen Sie mit Ihrem Arzt oder Apotheker, bevor Sie L-Thyroxin AL einnehmen,

wenn bei Ihnen eine der folgenden Herzerkrankungen vorliegt:

Mangeldurchblutung der Herzkranzgefäße (Angina pectoris),

Herzinsuffizienz,

schneller und unregelmäßiger Herzschlag,

hoher Blutdruck,

Fettablagerungen an den Arterienwänden (Arteriosklerose).

Diese Erkrankungen müssen vor Einnahme von L-Thyroxin AL oder der Durchführung

eines Schilddrüsensuppressionstests medikamentös behandelt sein. Während der

Einnahme von L-Thyroxin AL müssen Ihre Schilddrüsenhormonwerte häufig kontrolliert

werden. Wenn Sie sich nicht sicher sind, ob eine dieser Erkrankungen auf Sie zutrifft,

oder wenn Sie an diesen Erkrankungen leiden, aber noch nicht behandelt werden, wenden

Sie sich an Ihren Arzt.

Ihr Arzt wird untersuchen, ob eine Funktionsstörung der Nebenniere, der

Hirnanhangdrüse oder der Schilddrüse mit unkontrollierter Überproduktion von

Schilddrüsenhormonen (Schilddrüsenautonomie) bei Ihnen vorliegt, weil

Funktionsstörungen der Nebenniere und/oder der Hirnanhangdrüse vor Einnahme von L-

Thyroxin AL oder der Durchführung eines Schilddrüsensuppressionstests medikamentös

behandelt werden müssen.

Sprechen Sie mit Ihrem Arzt,

wenn Sie in den Wechseljahren sind oder diese bereits hinter sich haben. Aufgrund

des Osteoporoserisikos können regelmäßige Kontrollen Ihrer Schilddrüsenfunktion

notwendig sein.

wenn Sie von Ihrem bisherigen Levothyroxin-Präparat auf ein anderes wechseln. Die

Wirkung kann sich geringfügig unterscheiden, d. h. Sie müssen gegebenenfalls

häufiger kontrolliert werden und eventuell muss Ihre Dosis angepasst werden.

wenn Sie an Epilepsie (Krampfanfällen) leiden. Zu Beginn der Behandlung mit

Levothyroxin wurde selten über Krampfanfälle berichtet.

bevor Sie mit der Einnahme von Orlistat (Arzneimittel zur Behandlung von

Übergewicht) beginnen oder die Therapie damit beenden oder die Therapie mit

Orlistat verändern. In diesen Fällen kann eine engmaschigere Überwachung und

gegebenenfalls eine Anpassung der Dosis erforderlich werden.

wenn Sie Anzeichen von psychotischen Störungen bei sich beobachten, in diesem

Falle kann eine engmaschigere Überwachung und gegebenenfalls eine Anpassung der

Dosis erforderlich werden.

Einnahme von L-Thyroxin AL zusammen mit anderen Arzneimitteln

Informieren Sie Ihren Arzt oder Apotheker wenn Sie andere Arzneimittel anwenden,

kürzlich andere Arzneimittel angewendet haben oder beabsichtigen andere Arzneimittel

anzuwenden.

Sprechen Sie mit Ihrem Arzt, wenn Sie eines der folgenden Arzneimittel einnehmen, da

L-Thyroxin AL ihre Wirkung beeinträchtigen kann:

Antidiabetika (blutzuckersenkende Arzneimittel): L-Thyroxin AL kann die

Wirkung Ihres blutzuckersenkenden Mittels herabsetzen, dadurch können

insbesondere zu Beginn der L-Thyroxin AL-Therapie zusätzliche Untersuchungen

Ihres Blutzuckerspiegels erforderlich werden. Während der L-Thyroxin AL-

Behandlung muss gegebenenfalls eine Dosisanpassung Ihres Antidiabetikums

erfolgen.

Cumarinderivate, z.B. Warfarin oder Phenprocoumon (blutgerinnungshemmende

Arzneimittel): L-Thyroxin AL kann die Wirkung dieser Arzneimittel verstärken,

dies kann, besonders bei älteren Patienten, das Blutungsrisiko erhöhen. Aus diesem

Grunde können zu Beginn und während der L-Thyroxin AL-Behandlung

regelmäßige Kontrollen der Blutgerinnung erforderlich sein. Während der L-

Thyroxin AL-Behandlung ist gegebenenfalls die Dosierung Ihres Cumarin-

Präparates anzupassen.

Arzneimittel zur Behandlung von Depressionen und anderen Zuständen,

einschließlich Amitryptilin, Imipramin und Dosulepin,

abschwellende Arzneimittel, wie Phenylephedrin, oder Adrenalin (zur Behandlung

von schweren Allergien),

Digoxin; Arzneimittel zur Behandlung von Herzbeschwerden, einschließlich

unregelmäßiger Herzschlag,

Orlistat (Arzneimittel zur Behandlung von Übergewicht).

Achten Sie darauf, dass Sie die empfohlenen Zeitabstände einhalten, wenn Sie eines der

folgenden Arzneimittel einnehmen müssen:

Arzneimittel zur Bindung von Gallensäuren und zur Senkung hoher

Cholesterinwerte (wie z.B. Colestyramin oder Colestipol): Achten Sie darauf, dass

Sie L-Thyroxin AL 4 - 5 Stunden vor diesen Arzneimitteln einnehmen, da sie die

L-Thyroxin AL-Aufnahme aus dem Darm hemmen können.

Antazida (Arzneimittel zur Linderung von Magenbeschwerden und Sodbrennen),

Sucralfat (zur Behandlung von Magen- oder Zwölffingerdarmgeschwüren), andere

aluminiumhaltige Arzneimittel, eisenhaltige Arzneimittel, Calciumcarbonat:

Achten Sie darauf, dass Sie L-Thyroxin AL mindestens 2 Stunden vor diesen

Arzneimitteln einnehmen, da es sonst zu einer Wirkungsabschwächung von L-

Thyroxin AL kommen kann.

Sprechen Sie mit Ihrem Arzt, wenn Sie eines der folgenden Arzneimittel einnehmen, weil

sie die Wirkung von L-Thyroxin AL herabsetzen können:

Propylthiouracil (Arzneimittel gegen Schilddrüsenüberfunktion),

Glucocorticoide (antiallergische und entzündungshemmende Arzneimittel),

Beta-Blocker (blutdrucksenkende Arzneimittel, mit denen auch Herzerkrankungen

behandelt werden),

Sertralin (Arzneimittel gegen Depressionen),

Chloroquin oder Proguanil (Arzneimittel zur Verhütung oder Behandlung von

Malaria),

Arzneimittel, die bestimmte Leberenzyme aktivieren, wie z.B. Barbiturate

(Beruhigungsmittel, Schlaftabletten) oder Carbamazepin (Arzneimittel gegen

Epilepsie, wird auch angewandt, um bestimmte Schmerzformen zu beeinflussen

und zur Kontrolle von bestimmten depressiven Erkrankungen),

östrogenhaltige Arzneimittel zur Hormonersatztherapie während und nach den

Wechseljahren oder zur Empfängnisverhütung,

Sevelamer (phosphatbindendes Arzneimittel, das zur Behandlung von Patienten

mit chronischem Nierenversagen eingesetzt wird),

Tyrosinkinase-Inhibitoren (Arzneimittel gegen Krebs und entzündungshemmende

Arzneimittel).

Sprechen Sie mit Ihrem Arzt, wenn Sie eines der folgenden Arzneimittel einnehmen oder

kürzlich eingenommen haben, weil sie die Wirkung von L-Thyroxin AL verstärken

können:

Salicylate (schmerzlindernde und fiebersenkende Arzneimittel),

Dicumarol (Arzneimittel zur Hemmung der Blutgerinnung),

Furosemid in hoher Dosierung ab 250 mg (harntreibendes Arzneimittel),

Clofibrat (Arzneimittel zur Senkung der Blutfette).

Sprechen Sie mit Ihrem Arzt, wenn Sie eines der folgenden Arzneimittel einnehmen, weil

diese die Wirksamkeit von L-Thyroxin AL beeinflussen können.

Ritonavir, Indinavir, Lopinavir (Protease-Inhibitoren, Arzneimittel zur Behandlung

einer HIV-Infektion),

Phenytoin (Arzneimittel gegen Epilepsie).

Sie benötigen möglicherweise regelmäßige Kontrollen Ihrer Schilddrüsenwerte. Eine

Anpassung Ihrer L-Thyroxin AL-Dosis kann erforderlich sein.

Sprechen Sie mit Ihrem Arzt, wenn Sie Amiodaron einnehmen (Arzneimittel gegen

Herzrhythmusstörungen), weil dieses Arzneimittel die Funktion und Aktivität Ihrer

Schilddrüse beeinflussen kann.

Wenn Sie sich einer Röntgenuntersuchung oder einer anderen diagnostischen

Untersuchung mit einem iodhaltigen Kontrastmittel unterziehen müssen, informieren Sie

Ihren Arzt darüber, dass Sie L-Thyroxin AL einnehmen, weil Ihnen möglicherweise ein

Mittel gespritzt wird, das Ihre Schilddrüsenfunktion beeinflussen kann.

Schilddrüsenhormone eignen sich nicht zur Gewichtsabnahme. Die Einnahme von

Schilddrüsenhormonen führt nicht zu einer Reduktion Ihres Gewichtes, wenn bei Ihnen

eine normale Schilddrüsenfunktion vorliegt. Schwere und sogar lebensbedrohliche

Nebenwirkungen können auftreten, wenn Sie die Dosierung ohne Anweisung Ihres Arztes

steigern.

Einnahme von L-Thyroxin AL zusammen mit Nahrungsmitteln und Getränken

Informieren Sie Ihren Arzt, wenn Sie Sojaprodukte essen, vor allem dann, wenn Sie den

Anteil der Sojaprodukte in Ihrer Nahrung ändern. Sojaprodukte können die Aufnahme

von L-Thyroxin AL aus dem Darm herabsetzen, deshalb muss Ihre L-Thyroxin AL-Dosis

möglicherweise angepasst werden.

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.

Wenn Sie schwanger sind, nehmen Sie L-Thyroxin AL weiter ein. Sprechen Sie mit

Ihrem Arzt, da Ihre Dosis eventuell angepasst werden muss.

Wenn Sie L-Thyroxin AL zusammen mit einem Schilddrüsenmittel zur Behandlung einer

Schilddrüsenüberfunktion einnehmen, wird Ihr Arzt Sie anweisen, die L-Thyroxin AL-

Behandlung mit Beginn der Schwangerschaft abzusetzen.

Wenn Sie stillen, nehmen Sie L-Thyroxin AL nach Anleitung Ihres Arztes weiter ein. Die

Arzneimittelmenge, die in die Muttermilch übergeht, ist so gering, dass sie das Baby

nicht beeinträchtigt.

Verkehrstüchtigkeit und Fähigkeit zum Bedienen von Maschinen

Es wurden keine Studien zur Auswirkung auf die Verkehrstüchtigkeit und die Fähigkeit,

Maschinen zu bedienen, durchgeführt. Da Levothyroxin identisch mit dem natürlich

vorkommenden Schilddrüsenhormon ist, ist nicht zu erwarten, dass L-Thyroxin AL einen

Einfluss auf die Verkehrstüchtigkeit und die Fähigkeit, Maschinen zu bedienen, hat.

3. Wie ist L-Thyroxin AL einzunehmen

Nehmen Sie dieses Arzneimittel immer genau nach Absprache mit Ihrem Arzt ein. Fragen

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

Ihr Arzt legt Ihre individuelle Dosis aufgrund von Untersuchungen und Labortests fest. In

der Regel erhalten Sie zu Beginn eine niedrige Dosis, die alle 2 - 4 Wochen gesteigert

wird, bis Ihre individuelle Enddosis erreicht ist. In den ersten Behandlungswochen

werden Sie zu Laboruntersuchungen einbestellt, anhand deren Ergebnisse wird Ihre Dosis

angepasst.

Wenn Ihr Baby an einer angeborenen Schilddrüsenunterfunktion leidet, wird Ihr Arzt

möglicherweise mit einer höheren Dosis beginnen, da ein rascher Hormonersatz wichtig

ist. Die empfohlene Anfangsdosis beträgt in den ersten 3 Monaten 10 bis 15 Mikrogramm

pro kg Körpergewicht. Danach wird Ihr Arzt die Dosis individuell anpassen.

Der übliche Dosisbereich ist in der unten stehenden Tabelle aufgeführt. Möglicherweise

ist eine niedrigere Dosis ausreichend,

wenn Sie ein älterer Patient sind,

wenn Sie herzkrank sind,

wenn Sie eine schwere oder lange bestehende Schilddrüsenunterfunktion haben,

wenn Sie ein niedriges Körpergewicht oder einen großen Kropf aufweisen.

Anwendung von L-Thyroxin AL

25 μg

Empfohlene L-Thyroxin AL-Tagesdosis

- zur Therapie eines gutartigen

Kropfes bei Patienten mit

normaler Schilddrüsenfunktion

75 - 200 Mikrogramm

- zur Verhütung einer erneuten

Kropfbildung nach Operation

75 - 200 Mikrogramm

- als Ersatz für das natürliche

Schilddrüsenhormon, wenn Ihre

Schilddrüse nicht genügend

Hormone produziert

Anfangsdosis

Erhaltungsdosis

Erwachsene

25 - 50 Mikrogramm

100 - 200 Mikrogramm

Kinder

12,5 - 50 Mikrogramm 100 - 150

Mikrogramm/m

Körperoberfläche

- zur Unterdrückung des erneuten

Tumorwachstums bei Patienten

mit Schilddrüsenkrebs

150 - 300 Mikrogramm

- zur Stabilisierung der

Schilddrüsenhormonspiegel,

wenn eine Überproduktion der

Hormone mit

Schilddrüsenblockern behandelt

wird

50 - 100 Mikrogramm

Anwendung

L-Thyroxin AL ist zum Einnehmen bestimmt. Nehmen Sie die gesamte Tagesdosis

morgens nüchtern ein (mindestens eine halbe Stunde vor dem Frühstück), am besten mit

etwas Flüssigkeit, zum Beispiel mit einem halben Glas Wasser. Die Tablette kann in

gleiche Dosen geteilt werden.

Säuglinge erhalten die gesamte L-Thyroxin AL-Tagesdosis mindestens eine halbe Stunde

vor der ersten Tagesmahlzeit. Zerdrücken Sie dazu die Tablette unmittelbar vor der

Einnahme und vermischen Sie sie mit etwas Wasser, dann geben Sie diese Mischung dem

Kind mit etwas weiterer Flüssigkeit. Bereiten Sie die Mischung stets frisch zu.

Dauer der Behandlung

Die Dauer der Behandlung hängt von der Erkrankung ab, wegen der Sie L-Thyroxin AL

einnehmen. Ihr Arzt wird deshalb mit Ihnen besprechen, wie lange die Einnahme

notwendig ist. Bei den meisten Patienten ist eine lebenslange L-Thyroxin AL-Einnahme

erforderlich.

Wenn Sie eine größere Menge von L-Thyroxin AL eingenommen haben, als Sie

sollten

Wenn Sie eine höhere Dosis als verordnet eingenommen haben, können bei Ihnen

Symptome, wie schneller Herzschlag, Angstzustände, innere Unruhe oder unwillkürliche

Bewegungen, auftreten. Bei Patienten mit neurologischen Störungen, wie z.B. Epilepsie,

können in Einzelfällen Krampfanfälle auftreten. Bei Patienten mit einem Risiko für

psychotische Störungen können Symptome einer akuten Psychose auftreten. Bitte wenden

Sie sich in solchen Fällen an Ihren Arzt.

Wenn Sie die Einnahme von L-Thyroxin AL vergessen haben

Nehmen Sie nicht die doppelte Menge ein, wenn Sie die vorhergehende Einnahme

vergessen haben, sondern nehmen Sie am darauffolgenden Tag wieder die normale Dosis

ein.

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.

Alle Arzneimittel können allergische Reaktionen hervorrufen, obwohl

schwerwiegende allergische Reaktionen selten vorkommen. Jedes plötzlich

auftretende Keuchen, Atemschwierigkeiten, Anschwellen von Augenlidern, Gesicht

oder Lippen, Ausschlag oder Juckreiz (insbesondere dann, wenn Ihr gesamter

Körper davon betroffen ist) oder Gelenkschmerz sollten Sie sofort einem Arzt

berichten.

Die folgenden Nebenwirkungen können auftreten, insbesondere dann, wenn die

Anfangsdosis zu hoch ist:

Fieber,

Hitzeunverträglichkeit,

weicher Stuhl (Durchfall),

Tremor (Zittern), Unruhe, Erregbarkeit,

Schlafschwierigkeiten,

rasender Herzschlag (Tachykardie) oder Angina (Brustschmerzen mit Engegefühl

der Brust, wenn sie sich bewegen),

Herzversagen,

Gelbfärbung der Haut und der Augen (Gelbsucht),

Verwirrtheit, Krampfanfälle und Koma.

Kinder

Selten wurde über eine Anstauung von Flüssigkeit im Gehirn (benigne

intrakranielle Hypertonie) berichtet. Anzeichen dafür können sein: Kopfschmerzen,

Übelkeit, Erbrechen, und/oder Beschwerden beim Sehen oder Hören,

Entwicklungsstörung des Schädelknochens (Kraniostenose),

Deformationen der Knochen (vorzeitiger Verschluß der Epiphyse -

Wachstumsfuge),

leichter Haarausfall.

Sie sollten Ihren Arzt informieren, wenn eine der zuvor genannten Wirkungen auftritt.

Die Wirkungen verschwinden in der Regel, wenn die Dosis verändert wird.

Andere Nebenwirkungen, die bei Ihnen auftreten können:

unregelmäßige Herzschläge, Palpitationen (Herzklopfen),

Muskelkrämpfe oder –schwäche,

niedriger Blutdruck,

Erbrechen,

Kopfschmerzen, Hitzegefühl, übermäßiges Schwitzen,

Gewichtsabnahme,

bei Frauen - Störungen der Regelblutung.

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 L-Thyroxin AL aufzubewahren?

Bewahren Sie dieses Arzneimittel für Kinder unzugänglich auf.

Sie dürfen dieses Arzneimittel nach dem auf den Blistern und dem Umkarton

angegebenen Verfallsdatum nicht mehr verwenden. Das Verfallsdatum bezieht sich auf

den letzten Tag des angegebenen Monats.

Nicht über 25ºC lagern. Die Blister im Umkarton aufbewahren, um den Inhalt vor Licht

zu schützen.

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 L-Thyroxin AL enthält

- Der Wirkstoff ist: Levothyroxin-Natrium. Jede 25-Mikrogramm-Tablette enthält

25 Mikrogramm Levothyroxin-Natrium.

Die sonstigen Bestandteile sind Mannitol (Ph.Eur.), mikrokristalline Cellulose,

Hypromellose, Magnesiumstearat (Ph.Eur.).

Wie L-Thyroxin AL aussieht und Inhalt der Packung

Weiße bis fast weiße, runde, bikonvexe Tablette mit einer Bruchkerbe auf der einen Seite,

der Prägung “25” auf der anderen Seite und einem Durchmesser von 7 mm.

Die Tablette kann in gleiche Dosen geteilt werden.

L-Thyroxin AL ist in PVC/PVDC/Aluminium-Blisterpackungen erhältlich.

Packungsgröße(n):

50 und 100 Tabletten

Pharmazeutischer Unternehmer

ALIUD PHARMA GmbH

Gottlieb-Daimler-Straße 19

89150 Laichingen

info@aliud.de

Hersteller

CENEXI

17 rue de Pontoise

95520 OSNY

Frankreich

STADA Arzneimittel AG

Stadastrasse 2 – 18

61118 Bad Vilbel

STADA Arzneimittel GmbH

Muthgasse 36

1190 Wien

Österreich

Centrafarm Services B.V.

Nieuwe Donk 9

4879 AC Etten-Leur

Niederlande

Clonmel Healthcare Ltd.

Waterford Road

Clonmel, Co. Tipperary

Irland

Dieses Arzneimittel ist in den Mitgliedstaaten des Europäischen Wirtschaftsraumes

(EWR) unter den folgenden Bezeichnungen zugelassen

Deutschland

L-Thyroxin AL 25 Mikrogramm Tabletten

Irland

Levothyroxine Clonmel 25 μg tablets

Italien

LEVOTIROXINA EG 25 μg compresse

Niederlande

Levothyroxine CF 0,025 mg, tabletten

Österreich Thyrostad 25 Mikrogramm Tabletten

Schweden Levothyroxin STADA 25 mikrogram tabletter

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Annual Report of the Scientific Network on BSE‐TSE 2018

Annual Report of the Scientific Network on BSE‐TSE 2018

Published on: Fri, 14 Dec 2018 The EFSA Scientific Network on bovine spongiform encephalopathies and other transmissible spongiform encephalopathies (BSE‐TSE) held its 13th meeting on 15‐16 October 2018 in Parma. The meeting served as an opportunity to exchange scientific information on BSE‐TSE related issues among EU Member States, countries from the European Free Trade Association (EFTA), EFSA, the European Commission and ad hocparticipants. In this occasion, ad hoc representation included the World A...

Europe - EFSA - European Food Safety Authority Publications

14-12-2018

Risk to human health related to the presence of perfluorooctane sulfonic acid and perfluorooctanoic acid in food

Risk to human health related to the presence of perfluorooctane sulfonic acid and perfluorooctanoic acid in food

Published on: Thu, 13 Dec 2018 The European Commission asked EFSA for a scientific evaluation on the risks to human health related to the presence of perfluorooctane sulfonic acid (PFOS) and perfluorooctanoic acid (PFOA) in food. Regarding PFOS and PFOA occurrence, the final data set available for dietary exposure assessment contained a total of 20,019 analytical results (PFOS n = 10,191 and PFOA n = 9,828). There were large differences between upper and lower bound exposure due to analytical methods with i...

Europe - EFSA - European Food Safety Authority Publications

14-12-2018

Response to comments on the Scientific Opinion on the scientific substantiation of a health claim related to Symbiosal® and lowering of blood pressure and reduced risk of hypertension pursuant to Article 14 of Regulation (EC) No 1924/2006

Response to comments on the Scientific Opinion on the scientific substantiation of a health claim related to Symbiosal® and lowering of blood pressure and reduced risk of hypertension pursuant to Article 14 of Regulation (EC) No 1924/2006

Published on: Thu, 13 Dec 2018 Following a request from the European Commission, EFSA was asked to review the comments received on the Scientific Opinion of the EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA) on the scientific substantiation of a health claim related to Symbiosal® and lowering of blood pressure and reduced risk of hypertension pursuant to Article 14 of Regulation (EC) No 1924/2006. Comments originating from the applicant (Han‐Biotech GmbH) were submitted to EFSA via the E...

Europe - EFSA - European Food Safety Authority Publications

14-12-2018

Analysis of hunting statistics collection frameworks for wild boar across Europe and proposals for improving the harmonisation of data collection

Analysis of hunting statistics collection frameworks for wild boar across Europe and proposals for improving the harmonisation of data collection

Published on: Thu, 13 Dec 2018 Heterogeneities in the wild boar data collection frameworks across Europe were analysed using questionnaires to explore comparability of hunting data in the short term and propose a common framework for future collection. Fifty‐seven respondents representing 32 countries covering more than 95% of European territory participated to the questionnaire. The most frequently recorded information in the official statistics included the quantity of animals shot per hunting ground ...

Europe - EFSA - European Food Safety Authority Publications

14-12-2018

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

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

Published on: Thu, 13 Dec 2018 The conclusions of EFSA following the peer review of the initial risk assessment carried out by the competent authority of the rapporteur Member State France for the pesticide active substance bromoxynil are reported. The European Commission requested EFSA to conduct a peer review and provide its conclusions on whether exposure of humans to bromoxynil can be considered negligible, taking into account the European Commission's draft guidance on this topic. The conclusions w...

Europe - EFSA - European Food Safety Authority Publications

14-12-2018

Statement on the safety of d‐ribose

Statement on the safety of d‐ribose

Published on: Thu, 13 Dec 2018 In 2018, the EFSA NDA Panel adopted the Scientific Opinion on the safety of d‐ribose as a novel food pursuant to Regulation (EU) 2015/2283 when used in a variety of food, concluding that d‐ribose is safe for the general population at intake levels up to 36 mg/kg body weight (bw) per day, but that its safety at the intended uses and use levels as proposed by the applicant could not be established. Following a request from the European Commission, the EFSA NDA Panel was aske...

Europe - EFSA - European Food Safety Authority Publications

13-12-2018

Evaluation of the safety and efficacy of the organic acids lactic and acetic acids to reduce microbiological surface contamination on pork carcasses and pork cuts

Evaluation of the safety and efficacy of the organic acids lactic and acetic acids to reduce microbiological surface contamination on pork carcasses and pork cuts

Published on: Wed, 12 Dec 2018 Studies evaluating the safety and efficacy of lactic and acetic acids to reduce microbiological surface contamination on pork carcasses pre‐chill and pork meat cuts post‐chill were assessed. Lactic acid treatments consisted of 2–5% solutions at temperatures of up to 80°C applied to carcasses by spraying or up to 55°C applied on cuts by spraying or dipping. Acetic acid treatments consisted of 2–4% solutions at temperatures of up to 40°C applied on carcasses by spraying or o...

Europe - EFSA - European Food Safety Authority Publications

13-12-2018

The European Union summary report on trends and sources of zoonoses, zoonotic agents and food-borne outbreaks in 2017

The European Union summary report on trends and sources of zoonoses, zoonotic agents and food-borne outbreaks in 2017

Published on: Wed, 12 Dec 2018 This report of the European Food Safety Authority and the European Centre for Disease Prevention and Control presents the results of zoonoses monitoring activities carried out in 2017 in 37 European countries (28 Member States (MS) and nine non-MS). Campylobacteriosis was the commonest reported zoonosis and its EU trend for confirmed human cases increasing since 2008 stabilised during 2013–2017. The decreasing EU trend for confirmed human salmonellosis cases since 2008 end...

Europe - EFSA - European Food Safety Authority Publications

12-12-2018

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

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

Published on: Tue, 11 Dec 2018 The main goal of the Framework Partnership Agreement project is to put in place a relevant organisation in order to improve gathering, checking, storage and providing of data from national monitoring programs to EFSA. By accepting to participate in the pilot project, France has committed to implement several enhancement actions on the overall system of data collection and submission. This report describes the results of the implementations of these measures and presents th...

Europe - EFSA - European Food Safety Authority Publications

8-12-2018

Annual assessment of Echinococcus multilocularis surveillance reports submitted in 2018 in the context of Commission Regulation (EU) No 1152/2011

Annual assessment of Echinococcus multilocularis surveillance reports submitted in 2018 in the context of Commission Regulation (EU) No 1152/2011

Published on: Fri, 07 Dec 2018 This report is part of the `Echinococcus multilocularis surveillance’ scientific reports which are presented annually by EFSA to the European Commission and are intended to assess the sampling strategy, data collection and detection methods used by Finland, Ireland, Malta, the United Kingdom (UK) and Norway in their respective surveillance programmes. The surveillance programmes of these five countries were evaluated by checking the information submitted by each of them an...

Europe - EFSA - European Food Safety Authority Publications

1-12-2018

Safety evaluation of the food enzyme endo‐1,4‐β‐xylanase from a genetically modified Trichoderma reesei (strain DP‐Nzd22)

Safety evaluation of the food enzyme endo‐1,4‐β‐xylanase from a genetically modified Trichoderma reesei (strain DP‐Nzd22)

Published on: Fri, 30 Nov 2018 The food enzyme endo‐1,4‐β‐xylanase (EC 3.2.1.8) is produced with a genetically modified Trichoderma reesei (strain DP‐Nzd22) by DuPont. 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. The endo‐1,4‐β‐xylanase is intended to be used in distilled alcohol production, bakery and brewery. Residual amounts of total organic solids (TOS) are removed during the production of dis...

Europe - EFSA - European Food Safety Authority Publications

30-11-2018

The European Union summary report on surveillance for the presence of transmissible spongiform encephalopathies (TSEs) in 2017

The European Union summary report on surveillance for the presence of transmissible spongiform encephalopathies (TSEs) in 2017

Published on: Thu, 29 Nov 2018 This report presents the results of surveillance on transmissible spongiform encephalopathies (TSEs) in bovine animals, sheep, goats, cervids and other animal species, as well as genotyping in sheep, carried out in 2017 in the European Union (EU) according to Regulation (EC) 999/2001, and in Iceland, Norway and Switzerland. In total, 1,312,714 cattle were tested by the 28 EU Member States (MSs) which is a decrease of 3% compared with 2016; 18,526 were tested by the three n...

Europe - EFSA - European Food Safety Authority Publications

30-11-2018

Epidemiological analyses of African swine fever in the European Union (November 2017 until November 2018)

Epidemiological analyses of African swine fever in the European Union (November 2017 until November 2018)

Published on: Thu, 29 Nov 2018 This update on the African swine fever (ASF) outbreaks in the EU demonstrated that out of all tested wild boar found dead, the proportion of positive samples peaked in winter and summer. For domestic pigs only, a summer peak was evident. Despite the existence of several plausible factors that could result in the observed seasonality, there is no evidence to prove causality. Wild boar density was the most influential risk factor for the occurrence of ASF in wild boar. In th...

Europe - EFSA - European Food Safety Authority Publications

30-11-2018

Reporting Avian Influenza surveillance

Reporting Avian Influenza surveillance

Published on: Thu, 29 Nov 2018 Avian influenza viruses infect domestic poultry and wild birds as well as humans. In poultry, depending on whether these viruses are of high pathogenicity (HPAI) or low pathogenicity (LPAI), the infection can cause different clinical signs, with HPAI causing high mortality in poultry flocks. In order to ensure early detection of avian influenza viruses, surveillance in poultry and wild birds is considered essential. In 2010, the European Commission provided some guidelines...

Europe - EFSA - European Food Safety Authority Publications

28-11-2018

EFSA Scientific Colloquium 24 – 'omics in risk assessment: state of the art and next steps

EFSA Scientific Colloquium 24 – 'omics in risk assessment: state of the art and next steps

Published on: Tue, 27 Nov 2018 In recent years, the development of innovative tools in genomics, transcriptomics, proteomics and metabolomics (designated collectively as 'omics technologies) has opened up new possibilities for applications in scientific research and led to the availability of vast amounts of analytical data. The interpretation and integration of 'omics data can provide valuable information on the functional status of an organism and on the effect of external factors such as stressors. T...

Europe - EFSA - European Food Safety Authority Publications

27-11-2018

Database of processing techniques and processing factors compatible with the EFSA food classification and description system FoodEx 2 Objective 1: Compendium of Representative Processing Techniques investigated in regulatory studies for pesticides

Database of processing techniques and processing factors compatible with the EFSA food classification and description system FoodEx 2 Objective 1: Compendium of Representative Processing Techniques investigated in regulatory studies for pesticides

Published on: Mon, 26 Nov 2018 EFSA is conducting pan‐European dietary exposure and risk assessments related to actual levels of pesticide residues in food commodities. These assessments use the pesticide occurrence data generated under the official monitoring programs of Member States, the consumption data from EFSA's comprehensive food consumption database and pesticide‐specific information such as processing factors. Currently no harmonised list of processing factors is available within Europe and wo...

Europe - EFSA - European Food Safety Authority Publications

27-11-2018

Database of processing techniques and processing factors compatible with the EFSA food classification and description system FoodEx 2 Objective 3: European database of processing factors for pesticides in food

Database of processing techniques and processing factors compatible with the EFSA food classification and description system FoodEx 2 Objective 3: European database of processing factors for pesticides in food

Published on: Mon, 26 Nov 2018 EFSA is conducting pan‐European dietary exposure and risk assessments related to actual levels of pesticide residues in food commodities. These assessments use the pesticide occurrence data generated under the official monitoring programs of Member States, the consumption data from EFSA's comprehensive food consumption database and pesticide‐specific information such as processing factors. Currently no harmonised list of processing factors is available within Europe and wo...

Europe - EFSA - European Food Safety Authority Publications

27-11-2018

Risk assessment of new sequencing information for genetically modified soybean A2704‐12

Risk assessment of new sequencing information for genetically modified soybean A2704‐12

Published on: Mon, 26 Nov 2018 The GMO Panel has previously assessed genetically modified (GM) soybean A2704‐12. This soybean was found to be as safe and nutritious as its conventional counterpart with respect to potential effects on human and animal health and the environment in the context of its intended uses. On 5 June 2018, the European Commission requested EFSA to analyse new nucleic acid sequencing data and updated bioinformatics data for GM soybean A2704‐12 and to indicate whether the previous c...

Europe - EFSA - European Food Safety Authority Publications

24-11-2018

The EFSA‐funded collection of dietary and related data in the general population aged 10‐74 years in Greece

The EFSA‐funded collection of dietary and related data in the general population aged 10‐74 years in Greece

Published on: Fri, 23 Nov 2018 The Hellenic Health Foundation received support from the European Food Safety Authority in order to organise a national nutrition survey according to the methodology described in the EFSA Guidance document and to collect food consumption and related information among 780 adolescents, adults and elderly residing permanently in Greece. The EFSA‐funded data collection was largely based on the protocol of a large scale Greek national nutrition and health survey, called HYDRIA....

Europe - EFSA - European Food Safety Authority Publications

24-11-2018

Hazard identification and ranking for poultry at slaughter

Hazard identification and ranking for poultry at slaughter

Published on: Fri, 23 Nov 2018 The Hellenic Health Foundation received support from the European Food Safety Authority in order to organise a national nutrition survey according to the methodology described in the EFSA Guidance document and to collect food consumption and related information among 780 adolescents, adults and elderly residing permanently in Greece. The EFSA‐funded data collection was largely based on the protocol of a large scale Greek national nutrition and health survey, called HYDRIA....

Europe - EFSA - European Food Safety Authority Publications

22-11-2018

Safety and efficacy of Monteban® G100 (narasin) for ducks for fattening

Safety and efficacy of Monteban® G100 (narasin) for ducks for fattening

Published on: Wed, 21 Nov 2018 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 Monteban® G100 for ducks. Monteban® G100, containing narasin, is intended for the prevention of coccidiosis in ducks for fattening at a dose range of 60–70 mg/kg of complete feed. Narasin from Monteban® G100 is safe for ducks for fattening at a level of 70 mg/kg complete feed...

Europe - EFSA - European Food Safety Authority Publications

21-11-2018

Extensive Literature Search, Selection for Relevance and Data Extraction of Studies Related to the Toxicity of PCDD/Fs and DL‐PCBs in Experimental Animals

Extensive Literature Search, Selection for Relevance and Data Extraction of Studies Related to the Toxicity of PCDD/Fs and DL‐PCBs in Experimental Animals

Published on: Tue, 20 Nov 2018 Polychlorinated dibenzodioxins (PCDD), polychlorinated dibenzofurans (PCDFs) and dioxin‐like polychlorinated biphenyls (DL‐PCBs) are detected ubiquitously in the environment, diet and human tissues. The European Food Safety Authority (EFSA) CONTAM Panel received a mandate from the European Commission for a scientific opinion on the risks for human and animal health related to the presence of dioxins and DL‐PCBs in food and feed. To support preparatory work for the hazard i...

Europe - EFSA - European Food Safety Authority Publications

21-11-2018

Risk for animal and human health related to the presence of dioxins and dioxin-like PCBs in feed and food

Risk for animal and human health related to the presence of dioxins and dioxin-like PCBs in feed and food

Published on: Tue, 20 Nov 2018 The European Commission asked EFSA for a scientific opinion on the risks for animal and human health related to the presence of dioxins (PCDD/Fs) and DL‐PCBs in feed and food. The data from experimental animal and epidemiological studies were reviewed and it was decided to base the human risk assessment on effects observed in humans and to use animal data as supportive evidence. The critical effect was on semen quality, following pre‐ and postnatal exposure. The critical s...

Europe - EFSA - European Food Safety Authority Publications

20-11-2018

Relevance of new scientific information (Santos‐Vigil et al., 2018*) in relation to the risk assessment of genetically modified crops with Cry1Ac

Relevance of new scientific information (Santos‐Vigil et al., 2018*) in relation to the risk assessment of genetically modified crops with Cry1Ac

Published on: Wed, 14 Nov 2018 Following a request from the European Commission, EFSA assessed the scientific publication by Santos‐Vigil et al. (2018). The outstanding question was whether or not the new scientific information contains elements that could lead the EFSA GMO Panel to reconsider the outcome of its previous risk assessments on genetically modified crops expressing Cry1Ac protein. Santos‐Vigil et al. (2018) investigated the allergenic potential and immunological effects of the Cry1Ac protei...

Europe - EFSA - European Food Safety Authority Publications

20-11-2018

Peer review of the pesticide risk assessment of the active substance (EZ)‐1,3‐dichloropropene

Peer review of the pesticide risk assessment of the active substance (EZ)‐1,3‐dichloropropene

Published on: Mon, 19 Nov 2018 The conclusions of EFSA following the peer review of the initial risk assessments carried out by the competent authority of the rapporteur Member State, Spain, for the pesticide active substance (EZ)‐1,3‐dichloropropene 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 uses of (EZ)‐1,3‐dichloropropene ...

Europe - EFSA - European Food Safety Authority Publications

17-11-2018

Assessment of genetically modified soybean MON 89788 for renewal of authorisation under Regulation (EC) No 1829/2003 (application EFSA‐GMO‐RX‐011)

Assessment of genetically modified soybean MON 89788 for renewal of authorisation under Regulation (EC) No 1829/2003 (application EFSA‐GMO‐RX‐011)

Published on: Fri, 16 Nov 2018 Following the submission of application EFSA‐GMO‐RX‐011 under Regulation (EC) No 1829/2003 from Monsanto Europe, the Panel on Genetically Modified Organisms of the European Food Safety Authority (GMO Panel) was asked to deliver a scientific risk assessment on the data submitted in the context of the renewal of authorisation application for the herbicide‐tolerant genetically modified soybean MON 89788, for food and feed uses, excluding cultivation within the European Union....

Europe - EFSA - European Food Safety Authority Publications

17-11-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

17-11-2018

Safety evaluation of the food enzyme endo‐1,4‐β‐xylanase from a genetically modified Aspergillus oryzae (strain NZYM‐FA)

Safety evaluation of the food enzyme endo‐1,4‐β‐xylanase from a genetically modified Aspergillus oryzae (strain NZYM‐FA)

Published on: Fri, 16 Nov 2018 The food enzyme is an endo‐1,4‐β‐xylanase (EC 3.2.1.8) produced with a genetically modified strain of Aspergillus oryzae 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 xylanase is intended to be used in baking and cereal‐based processes. Based on the proposed maximum use levels, dietary exposure to the food enzyme–total organic solids (TOS) was e...

Europe - EFSA - European Food Safety Authority Publications

15-11-2018

Safety evaluation of the food enzyme maltogenic amylase from a genetically modified Bacillus subtilis (strain NZYM‐OC)

Safety evaluation of the food enzyme maltogenic amylase from a genetically modified Bacillus subtilis (strain NZYM‐OC)

Published on: Wed, 14 Nov 2018 The food enzyme maltogenic amylase (glucan 1,4‐a‐maltohydrolase; EC 3.2.1.133) is produced with a genetically modified Bacillus subtilis strain NZYM‐OC 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 microorganism and recombinant DNA. This maltogenic amylase is intended to be used in baking processes. Based on the maximum use levels recommended, dietary exposure to the food enzyme–...

Europe - EFSA - European Food Safety Authority Publications

15-11-2018

Recommendations on the use of the proportionality approach in the framework of risk assessment for pesticide residues

Recommendations on the use of the proportionality approach in the framework of risk assessment for pesticide residues

Published on: Wed, 14 Nov 2018 The technical report reflects the outcome of the discussions and agreements that were reached in the pesticides peer review meeting on residues and maximum residue levels regarding the principles and guidance for application of the proportionality concept in the risk assessment methodologies used at European level for the estimation of the maximum residue levels for pesticides. In addition, practical experiences on the use of the proportionality approach gained by EFSA hav...

Europe - EFSA - European Food Safety Authority Publications

15-11-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

15-11-2018

Assessment of genetically modified maize MZHG0JG for food and feed uses, import and processing under Regulation (EC) No 1829/2003 (application EFSA‐GMO‐DE‐2016‐133)

Assessment of genetically modified maize MZHG0JG for food and feed uses, import and processing under Regulation (EC) No 1829/2003 (application EFSA‐GMO‐DE‐2016‐133)

Published on: Wed, 14 Nov 2018 The scope of application EFSA‐GMO‐DE‐2016‐133 is for food and feed uses, import and processing of genetically modified (GM) maize MZHG0JG in the European Union. Maize MZHG0JG was developed to confer tolerance to the herbicidal active substances glyphosate and glufosinate‐ammonium. The molecular characterisation data and bioinformatic analyses do not identify issues requiring food/feed safety assessment. None of the identified differences in the agronomic/phenotypic and com...

Europe - EFSA - European Food Safety Authority Publications

15-11-2018

Safety evaluation of the food enzyme maltogenic amylase from a genetically modified Bacillus subtilis (strain NZYM‐SO)

Safety evaluation of the food enzyme maltogenic amylase from a genetically modified Bacillus subtilis (strain NZYM‐SO)

Published on: Wed, 14 Nov 2018 The food enzyme maltogenic amylase (glucan 1,4‐α‐maltohydrolase; EC 3.2.1.133) is produced with a genetically modified Bacillus subtilis strain NZYM‐SO 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 microorganism and recombinant DNA. This maltogenic amylase is intended to be used in baking processes. Based on the maximum use levels, dietary exposure to the food enzyme–total organi...

Europe - EFSA - European Food Safety Authority Publications

15-11-2018

Safety evaluation of the food enzyme acetolactate decarboxylase from a genetically modified Bacillus licheniformis (strain NZYM‐JB)

Safety evaluation of the food enzyme acetolactate decarboxylase from a genetically modified Bacillus licheniformis (strain NZYM‐JB)

Published on: Wed, 14 Nov 2018 The food enzyme acetolactate decarboxylase (α‐acetolactate decarboxylase; EC 4.1.1.5) is produced with a genetically modified Bacillus licheniformis strain NZYM‐JB 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 acetolactate decarboxylase is intended to be used in distilled alcohol production and brewing processes. Residual amounts of total organi...

Europe - EFSA - European Food Safety Authority Publications

13-11-2018

Peer review of the pesticide risk assessment of the active substance napropamide‐M

Peer review of the pesticide risk assessment of the active substance napropamide‐M

Published on: Mon, 12 Nov 2018 00:00:00 +0100 The conclusions of EFSA following the peer review of the initial risk assessments carried out by the competent authority of the rapporteur Member State the United Kingdom for the pesticide active substance napropamide‐M 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 uses of napropamid...

Europe - EFSA - European Food Safety Authority Publications

13-11-2018

The importance of vector abundance and seasonality

The importance of vector abundance and seasonality

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

Europe - EFSA - European Food Safety Authority Publications

12-11-2018

European Antibiotic Awareness Day 2018

European Antibiotic Awareness Day 2018

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

9-10-2018

Umsetzung des einstimmigen Beschlusses der Koordinierungsgruppe EMA/CMDh/h/229253/2018 vom 25.04.2018 betreffend die Zulassungen für Humanarzneimittel mit dem Wirkstoff Leuprorelin

Umsetzung des einstimmigen Beschlusses der Koordinierungsgruppe EMA/CMDh/h/229253/2018 vom 25.04.2018 betreffend die Zulassungen für Humanarzneimittel mit dem Wirkstoff Leuprorelin

Das BfArM veröffentlicht den Umsetzungsbescheid für den Wirkstoff Leuprorelin infolge des Europäischen PSUR Single Assessment Verfahrens nach Artikel 107d) bis g) der Richtlinie 2001/83/EG.

Deutschland - BfArM - Bundesinstitut für Arzneimittel und Medizinprodukte

11-12-2018

Ziagen (ViiV Healthcare BV)

Ziagen (ViiV Healthcare BV)

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

Europe -DG Health and Food Safety

11-12-2018

Rubraca (Clovis Oncology Ireland Limited)

Rubraca (Clovis Oncology Ireland Limited)

Rubraca (Active substance: rucaparib) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)8686 of Tue, 11 Dec 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4272/T/5

Europe -DG Health and Food Safety

22-10-2018

EU/3/11/901 (Merck Sharp and Dohme B.V.)

EU/3/11/901 (Merck Sharp and Dohme B.V.)

EU/3/11/901 (Active substance: Dinaciclib) - Transfer of orphan designation - Commission Decision (2018)6990 of Mon, 22 Oct 2018 European Medicines Agency (EMA) procedure number: EMA/OD/052/11/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