Ophenic

Hauptinformation

  • Handelsname:
  • Ophenic 1 mg/ml + 20 mg/ml Spray zur Anwendung auf der Haut, Lösung
  • Darreichungsform:
  • Spray zur Anwendung auf der Haut, Lösung
  • Zusammensetzung:
  • Octenidindihydrochlorid 1.mg; Phenoxyethanol (Ph.Eur.) 20.09mg
  • Verwenden für:
  • Menschen
  • Art der Medizin:
  • allopathic Droge

Dokumenten

Lokalisierung

  • Erhältlich in:
  • Ophenic 1 mg/ml + 20 mg/ml Spray zur Anwendung auf der Haut, Lösung
    Deutschland
  • Sprache:
  • Deutsch

Weitere Informationen

Status

  • Quelle:
  • BfArM - Bundesinstitut für Arzneimittel und Medizinprodukte
  • Zulassungsnummer:
  • 89796.00.00
  • Letzte Änderung:
  • 11-04-2018

Packungsbeilage

GEBRAUCHSINFORMATION: INFORMATION FÜR DEN ANWENDER

Octenidindihydrochlorid + Phenoxyethanol FGK 1 mg/ml + 20 mg/ml Spray zur Anwendung

auf der Haut, Lösung

Octenidindihydrochlorid

Phenoxyethanol

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

Arzneimittels beginnen, denn sie enthält wichtige Informationen.

Wenden Sie dieses Arzneimittel immer genau wie in dieser Packungsbeilage beschrieben bzw.

genau nach Anweisung Ihres Arztes, Apothekers oder des medizinischen Fachpersonals an.

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

Fragen Sie Ihren Apotheker, wenn Sie weitere Informationen oder einen Rat benötigen.

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

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

Packungsbeilage angegeben sind. Siehe Abschnitt 4.

Wenn Sie sich nach 14 Tagen nicht besser oder gar schlechter fühlen, müssen Sie sich an Ihren

Arzt wenden.

Was in dieser Packungsbeilage steht

Was ist Octenidindihydrochlorid + Phenoxyethanol FGK und wofür wird es angewendet?

Was sollten Sie vor der Anwendung von Octenidindihydrochlorid + Phenoxyethanol FGK

beachten?

3. Wie ist Octenidindihydrochlorid + Phenoxyethanol FGK anzuwenden?

4. Welche Nebenwirkungen sind möglich?

5. Wie ist Octenidindihydrochlorid + Phenoxyethanol FGK aufzubewahren?

6. Inhalt der Packung und weitere Informationen

1.

Was ist Octenidindihydrochlorid + Phenoxyethanol FGK und wofür wird es angewendet?

Octenidindihydrochlorid + Phenoxyethanol FGK ist eine Lösung zur Anwendung auf der Haut mit

den Wirkstoffen Octenidindihydrochlorid und Phenoxyethanol, die antiseptische Eigenschaften

besitzen.

Octenidindihydrochlorid + Phenoxyethanol FGK wird angewendet zur wiederholten, zeitlich

begrenzten vorbereitenden antiseptischen Behandlung von Schleimhäuten und angrenzender Haut

vor diagnostischen Maßnahmen an oder in der Nähe der Geschlechts- und Ausscheidungsorgane

sowie vor dem Legen eines Harnkatheters.

Es wird ferner angewendet zur antiseptischen Behandlung kleiner oberflächlicher Wunden sowie

zur Hautdesinfektion vor nicht-chirurgischen Maßnahmen.

Octenidindihydrochlorid + Phenoxyethanol FGK kann bei Patienten aller Altersgruppen

angewendet werden.

2. Was sollten Sie vor der Anwendung von Octenidindihydrochlorid + Phenoxyethanol FGK

beachten??

Octenidindihydrochlorid + Phenoxyethanol FGK darf nicht angewendet werden,

wenn Sie allergisch gegen Octenidindihydrochlorid, Phenoxyethanol oder einen der in

Abschnitt 6 genannten sonstigen Bestandteile dieses Arzneimittels sind.

in der Bauchhöhle (z. B. während einer Operation) oder der Harnblase. Nicht auf das

Trommelfell applizieren.

Warnhinweise und Vorsichtsmaßnahmen

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

Octenidindihydrochlorid + Phenoxyethanol FGK anwenden.

Um möglichen Gewebeschädigungen vorzubeugen, ist darauf zu achten, dass das Präparat

nicht injiziert oder unter Druck ins Gewebe eingebracht wird.

Es ist darauf zu achten, dass Octenidindihydrochlorid + Phenoxyethanol FGK nicht in die

Blutbahn, z. B. durch versehentliche Injektion, gelangt.

Wenn

Octenidindihydrochlorid

Phenoxyethanol

anionischen

Tensiden

(Seife,

Waschpräparaten)

Kontakt

gebracht

wird,

kann

Wirkung

Wirkstoffs

Octenidindihydrochlorid aufgehoben werden.

Anwendung von Octenidindihydrochlorid + Phenoxyethanol FGK zusammen mit anderen

Arzneimitteln

Informieren Sie Ihren Arzt oder Apotheker, wenn Sie andere Arzneimittel einnehmen bzw. vor

kurzem eingenommen haben, auch wenn es sich um nicht verschreibungspflichtige Arzneimittel

handelt.

Octenidindihydrochlorid + Phenoxyethanol FGK nicht in der Nähe von Hautarealen aufbringen,

die mit Antiseptika (Desinfektionsmitteln) auf Povidon-Iod-Basis behandelt werden, da es in den

Grenzbereichen zu starken braunen bis violetten Verfärbungen kommen kann.

Octenidindihydrochlorid + Phenoxyethanol FGK nicht zusammen mit anionischen Tensiden (Seife,

Waschpräparaten) anwenden, da diese seine Wirksamkeit abschwächen oder ganz aufheben

können.

Schwangerschaft, Stillzeit und Fortpflanzungsfähigkeit

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.

Bisherige Erfahrungen beim Menschen mit der Anwendung von

Octenidindihydrochlorid + Phenoxyethanol FGK während der Schwangerschaft weisen auf keine

schädlichen Wirkungen hin.

Zur Anwendung von Octenidindihydrochlorid + Phenoxyethanol FGK während der Stillzeit liegen

keine Daten vor. Aus Vorsichtsgründen soll Octenidindihydrochlorid + Phenoxyethanol FGK bei

Stillenden nicht im Bereich der Brust angewendet werden.

Verkehrstüchtigkeit und Fähigkeit zum Bedienen von Maschinen

Octenidindihydrochlorid + Phenoxyethanol FGK hat keinen Einfluss auf die Verkehrstüchtigkeit

und die Fähigkeit zum Bedienen von Maschinen.

3. Wie ist Octenidindihydrochlorid + Phenoxyethanol FGK anzuwenden?

Wenden Sie dieses Arzneimittel immer genau wie in dieser Packungsbeilage beschrieben bzw.

genau nach der mit Ihrem Arzt, Apotheker oder dem medizinischen Fachpersonal getroffenen

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

Art der Anwendung

Die Lösung ist zur Anwendung auf der Haut vorgesehen.

Bringen Sie das Arzneimittel sorgfältig auf das zu behandelnde Areal bis zur vollständigen

Benetzung auf. In jedem Fall müssen Sie nach erfolgter Anwendung und vor weiteren Maßnahmen

auf dem behandelten Areal (z. B. Anlegen eines Wundverbandes) eine Einwirkzeit von mindestens

zwei Minuten abwarten. Dies ist wichtig, weil sich die gewünschte Wirkung dieses Arzneimittels

nur dann voll entfalten kann, wenn eine Mindesteinwirkzeit von zwei Minuten abgewartet wird.

Anwendung bei Kindern und Jugendlichen

Die empfohlene Dosis ist bei Erwachsenen und Kindern identisch.

Dauer der Anwendung

Dieses Arzneimittel darf ohne ärztlichen Rat nicht länger als 2 Wochen angewendet werden.

Wenn Sie eine größere Menge von Octenidindihydrochlorid + Phenoxyethanol FGK

angewendet haben, als Sie sollten

Erkenntnisse zu Überdosierungen liegen nicht vor. Wenn das Arzneimittel nach Anweisung

angewendet wird, ist eine Überdosierung höchst unwahrscheinlich.

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

Arzt, Apotheker oder das medizinische Fachpersonal.

4. Welche Nebenwirkungen sind möglich?

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

jedem auftreten müssen.

Mögliche Nebenwirkungen:

Selten (kann bis zu 1 von 1.000 Behandelten betreffen):

Brennen, Rötung, Juckreiz und Wärmegefühl auf den behandelten Arealen.

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

Kontaktallergische Reaktionen, z. B. eine vorübergehende Rötung an der Applikationsstelle

Kinder und Jugendliche

Nebenwirkungen bei Kindern entsprechen nach Häufigkeit, Art und Schweregrad denjenigen bei

Erwachsenen.

Meldung von Nebenwirkungen

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

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

Packungsbeilage angegeben sind.

Sie können Nebenwirkungen auch direkt 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 Octenidindihydrochlorid + Phenoxyethanol FGK aufzubewahren?

Bewahren Sie dieses Arzneimittel für Kinder unzugänglich auf.

Sie dürfen dieses Arzneimittel nach dem auf der Packung angegebenen Verfalldatum nicht mehr

verwenden. Das Verfalldatum bezieht sich auf den letzten Tag des angegebenen Monats.

Für dieses Arzneimittel sind keine besonderen Lagerungsbedingungen erforderlich.

Nach erstmaligem Anbruch ist dieses Arzneimittel innerhalb von einem Jahr aufzubrauchen.

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 Octenidindihydrochlorid + Phenoxyethanol FGK enthält

Die Wirkstoffe sind Octenidindihydrochlorid und Phenoxyethanol. Ein ml der Lösung enthält 1 mg

Octenidindihydrochlorid und 20 mg Phenoxyethanol.

Die sonstigen Bestandteile sind: 2-[(3-Kokosfettsäureamidopropyl)dimethylazaniumyl]acetat,

Natrium-D-gluconat, Glycerol 85%, Natriumchlorid, Natriumhydroxidlösung (10%), gereinigtes

Wasser.

Wie Octenidindihydrochlorid + Phenoxyethanol FGK aussieht und Inhalt der Packung

Octenidindihydrochlorid + Phenoxyethanol FGK ist ein klares, farbloses, fast geruchloses Spray

zur Anwendung auf der Haut, Lösung, und steht in weißen Kunststoffflaschen, die mit einer

Sprühpumpe bestückt sind, zur Verfügung.

Die Packungsgrößen sind 50 und 250 ml.

Es werden möglicherweise nicht alle Packungsgrößen in den Verkehr gebracht.

Pharmazeutischer Unternehmer

FGK Representative Service GmbH

Heimeranstr. 35

D-80339 München

Deutschland

Tel: +49 89 893 119 22

Fax: +49 89 893 119 20

Hersteller

Schülke & Mayr GmbH

Robert-Koch-Str. 2

D- 22851 Norderstedt

Deutschland

Tel.: +49(0)40 521 00-0

Fax: +49(0)40 521 00-318

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

unter den folgenden Bezeichnungen zugelassen

Bulgarien

- Октенидин дихидрохлорид + феноксиетанол FGK 1 mg/ml + 20

mg/ml Спрей за кожа, разтвор

Deutschland

- Octenidindihydrochlorid + Phenoxyethanol FGK 1 mg/ml + 20 mg/ml

Spray zur Anwendung auf der Haut, Lösung

Estland

- Oktenidiin/fenoksüetanool FGK 1 mg/20 mg/ml nahasprei, lahus

Finnland

- Oktenidiinidihydrokloridi + fenoksietanoli FGK 1 mg/ml + 20 mg/ml

Sumute iholle, liuos

Hungary

- Oktenidin-dihidroklorid + Fenoxietanol FGK 1 mg/ml + 20 mg/ml

Külsőleges oldatos spray

Italien

- Octenidina e fenossietanolo FGK

Lettland

- Oktenidīna dihidrohlorīdu + Fenoksietanolu FGK 1 mg/ml + 20 mg/ml

Uz ādas izsmidzināms aeroso šķīdums

Litauen

- Oktenidino dihidrochloridas + Fenoksietanolis FGK 1 mg / 20 mg / ml

odos purškalas (tirpalas)

Niederlande

– Octenidine dihydrochloride + fenoxyethanol FGK 1 mg/ml + 20 mg/ml

huidspray, oplossing

Slowakische Republik

- Oktenidín dihydrochlorid + fenoxyetanol FGK 1 mg/ml + 20

mg/ml

Dermálna roztoková aerodisperzia

Slowenien

- Oktenidinijev diklorid + Fenoksietanol FGK 1 mg/20 mg v 1 ml

Dermalno pršilo

Spanien

- Octenidina dihidrocloruro + fenoxietanol FGK 1 mg/ml + 20 mg/ml

Solución para pulverización cutánea

Schweden

– Oktenidindihydroklorid/Fenoxietanol FGK 1 mg/ml + 20 mg/ml kutan

spray, lösning

Großbritannien

- Octenidine dihydrochloride / Phenoxyethanol FGK 1 mg/ml + 20 mg/ml

cutaneous spray, solution

Zypern

- Διυδροχλωρική οκτενιδίνη + Φαινοξυαιθανόλη FGK 1 mg/ml + 20

mg/ml Δερματικό εκνέφωμα, διάλυμα

Diese Packungsbeilage wurde zuletzt überarbeitet im November 2015.

20-9-2018

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

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Danish Medicines Agency aces European benchmark survey

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Danish Medicines Agency

19-9-2018

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

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

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

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14-9-2018

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

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

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13-9-2018

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

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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 ...

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11-9-2018

Update of the Xylella spp. host plant database

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

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

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11-9-2018

Assessment of occupational and dietary exposure to pesticide residues

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Preparation of Dutch food consumption data for risk assessment

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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

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1-9-2018

Review of the existing MRLs for fenbuconazole

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30-8-2018

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29-8-2018

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

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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 ...

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29-8-2018

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

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

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

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

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

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

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

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

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

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

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

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

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

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

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

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

Outcome of the public consultation on a draft protocol for the Scientific Opinion on dietary sugars

Outcome of the public consultation on a draft protocol for the Scientific Opinion on dietary sugars

Published on: Fri, 10 Aug 2018 00:00:00 +0200 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 protocol for the Scientific Opinion on free sugars from all dietary sources, prepared by the EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA Panel), supported by the ad‐hoc Working Group on Sugars. The draft protocol was endorsed by the Panel for public consultation at its plenary meeti...

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

Protocol for the scientific opinion on the Tolerable Upper Intake Level of dietary sugars

Protocol for the scientific opinion on the Tolerable Upper Intake Level of dietary sugars

Published on: Fri, 10 Aug 2018 00:00:00 +0200 In June 2016, EFSA received a mandate from the national food competent authorities of five European countries (Denmark, Finland, Iceland, Norway and Sweden) to provide a dietary reference value (DRV) for sugars, with particular attention to added sugars. A draft protocol was developed with the aim of defining as much as possible beforehand the strategy that will be applied for collecting data, appraising the relevant evidence, and analysing and integrating t...

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

Update of the tolerable upper intake level for vitamin D for infants

Update of the tolerable upper intake level for vitamin D for infants

Published on: Tue, 07 Aug 2018 00:00:00 +0200 The European Food Safety Authority (EFSA) carried out a public consultation to receive input from the scientific community and all interested parties on the draft Scientific Opinion on the update of the tolerable upper intake level for vitamin D for infants. This draft Scientific Opinion was prepared by the EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA Panel) and endorsed by the Panel for public consultation by written procedure on 9 April 20...

Europe - EFSA - European Food Safety Authority Publications

20-8-2018

Danish Medicines Agency lands new European chairmanship

Danish Medicines Agency lands new European chairmanship

Nikolai Brun, Director of Medical Evaluation & Biostatistics, has been elected chair of the Task Force on Big Data in the pharmaceutical area. The task force is a collaboration between the European Medicines Agency (EMA) and the Heads of Medicines Agencies (HMA) which is to identify advantages and challenges of using big data for the development of medicine.

Danish Medicines Agency

14-8-2018

Scientific guideline:  Procedure for the review and revision of European Union herbal monographs and European Union list entries - Revision 2, adopted

Scientific guideline: Procedure for the review and revision of European Union herbal monographs and European Union list entries - Revision 2, adopted

The purpose of this procedure is to enable a consistent and proportionate process in reviewing and revising all European Union herbal monographs and European Union list entries adopted by the HMPC. The aim of this document is to describe how to identify the criteria/reasons that trigger the revision of European Union herbal monographs and list entries and the associated procedure and timelines for both the review and the revision.

Europe - EFSA - European Food Safety Authority EFSA Journal

31-5-2018

Neurologie/Psychiatrie

Neurologie/Psychiatrie

Das Ergebnisprotokoll der konstituierenden Sitzung (26. Sitzung) der Expertengruppe Off-Label - Fachbereich Neurologie / Psychiatrie – wurde veröffentlicht

Deutschland - BfArM - Bundesinstitut für Arzneimittel und Medizinprodukte

29-5-2018

Stand der Umsetzung des European Medicines Verification System in der EU

Stand der Umsetzung des European Medicines Verification System in der EU

Vortragsfolien von Andreas M. Walter, European Medicines Verification Organisation, im Rahmen der Veranstaltung "BfArM im Dialog - Arzneimittelfälschungen und Umsetzung der Fälschungsschutzrichtlinie" vom 8. Mai 2018

Deutschland - BfArM - Bundesinstitut für Arzneimittel und Medizinprodukte

14-11-2017

The European Commission has published three recommendations for the clinical trials regulation

The European Commission has published three recommendations for the clinical trials regulation

In cooperation with the clinical trials expert group, the European Commission is updating and issuing new recommendations as a result of the regulation on clinical trials on medicinal products for human use.

Danish Medicines Agency

6-7-2017

The European Commission's decision concerning veterinary medicinal products containing zinc oxide

The European Commission's decision concerning veterinary medicinal products containing zinc oxide

On 26 June 2017, the European Commission adopted a decision to withdraw all marketing authorisations for veterinary medicinal products containing zinc oxide administered orally to food producing species. The medicinal products affected by the decision appear from Annex I to the decision.

Danish Medicines Agency

14-6-2017

To marketing authorisation holders and their representatives in Iceland: The European Medicines Agency improves and updates the database for adverse reactions, EudraVigilance

To marketing authorisation holders and their representatives in Iceland: The European Medicines Agency improves and updates the database for adverse reactions, EudraVigilance

The European Medicines Agency (EMA) will improve and update EudraVigilance, the database for collection and administration of adverse reaction reports for pharmaceutical companies and authorities. It is important that marketing authorisation holders and representatives become familiar with technical functionalities in time. New EudraVigilance will be launched on 22 November 2017. 

IMA - Icelandic Medicines Agency

21-3-2017

New recommendation for phasing out zinc oxide for young pigs

New recommendation for phasing out zinc oxide for young pigs

The European Medicines Agency's Committee for Medicinal Products for Veterinary Use (CVMP) has confirmed a previous decision to phase out zinc oxide. Consequently, the CVMP has once more recommended to the European Commission that medicinal products containing zinc oxide for the prevention of diarrhoea in young pigs should be withdrawn from the market.

Danish Medicines Agency

19-12-2016

Zinc oxide for young pigs to be phased out

Zinc oxide for young pigs to be phased out

The European Medicines Agency's Committee for Medicinal Products for Veterinary Use (CVMP) has recommended to the European Commission that medicinal products containing zinc oxide for the prevention of diarrhoea in young pigs should be withdrawn from the market.

Danish Medicines Agency

7-10-2016

Experts for the European Pharmacopoeia's groups of experts and working parties

Experts for the European Pharmacopoeia's groups of experts and working parties

A very large part of the work related to the drafting of new monographs for the European Pharmacopoeia (EDQM) is carried out by external experts in 75 groups of experts and working parties. Experts for the groups are appointed for a period of three years, and the EDQM is now seeking experts for the period from 2017 to 2019.

Danish Medicines Agency

3-10-2014

Consultation procedure about medicinal products and safety measure requirements not completed yet

Consultation procedure about medicinal products and safety measure requirements not completed yet

On 5 September 2014, the Danish Health and Medicines Authority submitted a draft list of the medicinal products comprised by the new safety measures rules (Directive 2001/83) for consultation. The consultation period expired on 17 September 2014, and on 3 October we were to inform the European Commission of the medicinal products we recommend including in the common EU lists. We have received 22 consultation responses. But on 24 September 2014 the European Commission amended the original guideline for...

Danish Medicines Agency

3-6-2014

Regulation on clinical trials on medicinal products adopted

Regulation on clinical trials on medicinal products adopted

The European Commission's proposal for new European legislation on clinical trials of medicinal products was adopted in early 2014. The objective is to promote the number of clinical trials in the EU.

Danish Medicines Agency

28-8-2018

Webinar: New warning statements on labels of neuromuscular blocking agents

Webinar: New warning statements on labels of neuromuscular blocking agents

Webinar providing an update on new warning statements on labels of neuromuscular blocking agents (NMBAs)

Therapeutic Goods Administration - Australia

30-7-2018

Ceplene (Noventia Pharma Srl)

Ceplene (Noventia Pharma Srl)

Ceplene (Active substance: Histamine dihydrochloride) - Centralised - Renewal - Commission Decision (2018)5116 of Mon, 30 Jul 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/796/R/36

Europe -DG Health and Food Safety

29-6-2018

EU/3/18/2028 (BioCryst UK Ltd)

EU/3/18/2028 (BioCryst UK Ltd)

EU/3/18/2028 (Active substance: (R)-1-(3-(aminomethyl) phenyl)-N-(5-((3-cyanophenyl)(cyclopropylmethylamino)methyl)-2-fluorophenyl)-3-(trifluoromethyl)-1H-pyrazole-5-carboxamide dihydrochloride) - Orphan designation - Commission Decision (2018)4173 of Fri, 29 Jun 2018 European Medicines Agency (EMA) procedure number: EMA/OD/003/18

Europe -DG Health and Food Safety

29-6-2018

New warnings on labels of medicines containing neuromuscular blocking agents

New warnings on labels of medicines containing neuromuscular blocking agents

New requirements for neuromuscular blocking agent containing medicines come into effect on 2 July

Therapeutic Goods Administration - Australia

12-6-2018

EU/3/10/811 (Celgene Europe B.V.)

EU/3/10/811 (Celgene Europe B.V.)

EU/3/10/811 (Active substance: N-tert-butyl-3-[(5-methyl-2-{[4-(2-pyrrolidin-1-ylethoxy)phenyl]amino}pyrimidin-4-yl)amino] benzenesulfonamide dihydrochloride monohydrate) - Transfer of orphan designation - Commission Decision (2018)3809 of Tue, 12 Jun 2018 European Medicines Agency (EMA) procedure number: EMA/OD/092/10/T/03

Europe -DG Health and Food Safety

12-6-2018

EU/3/10/810 (Celgene Europe B.V.)

EU/3/10/810 (Celgene Europe B.V.)

EU/3/10/810 (Active substance: N-tert-butyl-3-[(5-methyl-2-{[4-(2-pyrrolidin-1-ylethoxy)phenyl]amino}pyrimidin-4-yl)amino] benzenesulfonamide dihydrochloride monohydrate) - Transfer of orphan designation - Commission Decision (2018)3808 of Tue, 12 Jun 2018 European Medicines Agency (EMA) procedure number: EMA/OD/084/10/T/03

Europe -DG Health and Food Safety

12-6-2018

EU/3/10/794 (Celgene Europe B.V.)

EU/3/10/794 (Celgene Europe B.V.)

EU/3/10/794 (Active substance: N-tert-butyl-3-[(5-methyl-2-{[4-(2-pyrrolidin-1-ylethoxy)phenyl]amino}pyrimidin-4-yl)amino] benzenesulfonamide dihydrochloride monohydrate) - Transfer of orphan designation - Commission Decision (2018)3803 of Tue, 12 Jun 2018 European Medicines Agency (EMA) procedure number: EMA/OD/069/10/T/03

Europe -DG Health and Food Safety

12-6-2018

EU/3/11/888 (Gilead Sciences Ireland UC)

EU/3/11/888 (Gilead Sciences Ireland UC)

EU/3/11/888 (Active substance: N-(cyanomethyl)-4-(2-{[4-(morpholin-4-yl)phenyl]amino}pyrimidin-4-yl)benzamide, dihydrochloride salt) - Transfer of orphan designation - Commission Decision (2018)3802 of Tue, 12 Jun 2018 European Medicines Agency (EMA) procedure number: EMA/OD/152/10/T/03

Europe -DG Health and Food Safety

12-6-2018

EU/3/11/887 (Gilead Sciences Ireland UC)

EU/3/11/887 (Gilead Sciences Ireland UC)

EU/3/11/887 (Active substance: N-(cyanomethyl)-4-(2-{[4-(morpholin-4-yl)phenyl]amino}pyrimidin-4-yl)benzamide, dihydrochloride salt) - Transfer of orphan designation - Commission Decision (2018)3801 of Tue, 12 Jun 2018 European Medicines Agency (EMA) procedure number: EMA/OD/020/11/T/03

Europe -DG Health and Food Safety

12-6-2018

EU/3/11/886 (Gilead Sciences Ireland UC)

EU/3/11/886 (Gilead Sciences Ireland UC)

EU/3/11/886 (Active substance: N-(cyanomethyl)-4-(2-{[4-(morpholin-4-yl)phenyl]amino}pyrimidin-4-yl)benzamide, dihydrochloride salt) - Transfer of orphan designation - Commission Decision (2018)3799 of Tue, 12 Jun 2018 European Medicines Agency (EMA) procedure number: EMA/OD/019/11/T/03

Europe -DG Health and Food Safety

3-5-2018

Regulatory and procedural guideline:  How to use the defective product report to notify a quality defect to European Medicines Agency

Regulatory and procedural guideline: How to use the defective product report to notify a quality defect to European Medicines Agency

How to use the defective product report to notify a quality defect to European Medicines Agency

Europe - EMA - European Medicines Agency

18-4-2018

EU/3/18/2012 (IDEA Innovative Drug European Associates Limited)

EU/3/18/2012 (IDEA Innovative Drug European Associates Limited)

EU/3/18/2012 (Active substance: Genetically modified replication-incompetent herpes simplex virus-1 expressing collagen VII) - Orphan designation - Commission Decision (2018)2408 of Wed, 18 Apr 2018 European Medicines Agency (EMA) procedure number: EMA/OD/244/17

Europe -DG Health and Food Safety