Betnovate Scalp Application

Hauptinformation

  • Handelsname:
  • Betnovate Scalp Application Lösung
  • Darreichungsform:
  • Lösung
  • Zusammensetzung:
  • betamethasonum 1 mg bis betamethasoni valeras, excipiens ad-Lösung für 1 g.
  • Verwenden für:
  • Menschen
  • Art der Medizin:
  • Biologische Medizin

Dokumenten

Lokalisierung

  • Erhältlich in:
  • Betnovate Scalp Application Lösung
    Schweiz
  • Sprache:
  • Deutsch

Therapeutische Informationen

  • Therapiegruppe:
  • Synthetika
  • Therapiebereich:
  • Entzündliche, nicht infizierte Dermatosen der Kopfhaut

Weitere Informationen

Status

  • Quelle:
  • Swissmedic - Swiss Agency for Therapeutic Products
  • Zulassungsnummer:
  • 33311
  • Berechtigungsdatum:
  • 12-09-1967
  • Letzte Änderung:
  • 24-10-2018

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

Patienteninformation

Betnovate®

GlaxoSmithKline AG

Was ist Betnovate und wann wird es angewendet?

Betnovate enthält als Wirkstoff ein stark wirksames Kortikosteroid zur äusserlichen Anwendung. Es

wird zur Behandlung von Ekzemen verschiedenen Ursprungs, Schuppenflechte,

Insektenstichreaktionen und anderen entzündlichen und allergischen Hauterkrankungen verwendet.

Die Anwendung von Betnovate führt zu einer raschen Linderung der Begleiterscheinungen der

Hauterkrankung wie Juckreiz, Brennen oder Rötung.

Betnovate darf nur auf Verschreibung des Arztes oder der Ärztin verwendet werden.

Wann darf Betnovate nicht angewendet werden?

Bei Rosacea (Kupferfinne), Akne, juckender Haut ohne Entzündung, Juckreiz um Anus oder

Genitalien, entzündlichen Hautreaktionen um den Mund und bei Hauterkrankungen, welche in erster

Linie durch Viren (z.B. Herpesinfektionen wie Fieberbläschen, Windpocken (Spitze Blattern) usw.),

Bakterien oder Pilze verursacht sind.

Bei Kindern unter 1 Jahr sollte Betnovate nicht angewendet werden.

Betnovate Scalp Application darf nicht in Augennähe aufgetragen werden.

Wann ist bei der Anwendung von Betnovate Vorsicht geboten?

Betnovate ist ein stark wirksames Arzneimittel. Überschreiten Sie nicht die vom Arzt oder von der

Ärztin vorgeschriebene Behandlungsdauer, die normalerweise 2 bis 4 Wochen beträgt, da sich sonst

Hautschäden einstellen können.

Wenn eine Hautkrankheit nicht innert einiger Tage auf die Behandlung anspricht oder sich gar

verschlimmert, konsultieren Sie Ihren Arzt oder Ihre Ärztin. Eine Allergie oder eine Infektion könnte

die Ursache sein. Teilen Sie ihm oder ihr ebenfalls mit, wenn Juckreiz und Rötung, Bläschen, eine

starke Verdünnung der Haut oder Verletzungen auftreten.

Sprechen Sie mit ihrem Arzt bzw. Ihrer Ärztin, wenn Sie allergisch gegen Betamethason oder einen

sonstigen Bestandteil des Arzneimittels sind.

Dieses Arzneimittel sollte nicht länger als vier Wochen ununterbrochen täglich angewendet werden.

Eine ununterbrochene Langzeitanwendung ist nur auf ausdrückliche ärztliche Verordnung

vorzunehmen.

Eine grossflächige Anwendung (mehr als 10% der Körperoberfläche) sowie eine Anwendung auf

Hautbereichen, an denen der Wirkstoff leichter ins Blut übertreten kann (offene Wunden,

geschädigte Haut, in Hautfalten, in Gelenkbeugen sowie zwischen den Fingern bzw. Zehen, an

Haut/Schleimhautgrenzen und um die Augen herum) ist zu vermeiden.

Wenden Sie luftdichte Verbände über diesem Arzneimittel nur an, wenn es Ihnen Ihr Arzt bzw. Ihre

Ärztin gesagt hat. Wenn Sie Betnovate unter einem luftdichten Verband anwenden, achten Sie

darauf, dass die Haut vor dem Anlegen eines frischen Verbands gereinigt ist, um Infektionen zu

vermeiden.

Wenn Sie ein Ekzem im Bereich eines Beingeschwürs haben, kann die Anwendung eines topischen

Kortikosteroids das Risiko einer allergischen Reaktion oder einer Infektion im Bereich des

Geschwürs erhöhen.

Wenden Sie sich an Ihren Arzt bzw. Ihre Ärztin, wenn sich bei Ihnen eine Infektion entwickelt.

Wie bei allen Kortikosteroiden sollte eine langfristige Anwendung (länger als 1 Woche) auf der

besonders empfindlichen Gesichtshaut und im Genitalbereich vermieden werden. Wird

ausnahmsweise die Anwendung auf den Augenlidern vom Arzt oder von der Ärztin angeordnet,

sollte sorgfältig darauf geachtet werden, dass das Präparat nicht in die Augen gelangt.

Bei Kleinkindern ab 1 Jahr und Kindern soll Betnovate mit Vorsicht, nicht über längere Zeit und

nicht grossflächig aufgetragen werden.

Bei der Behandlung von Windelekzem begünstigen fest sitzende Windeln oder

Plastikhöschenwindeln die Aufnahme des Wirkstoffs in die Blutbahn. Deshalb sollten nach

Möglichkeit Stoffwindeln ohne Plastikhose verwendet werden.

Während der Anwendung von Betnovate Scalp Application und Lotion darf nicht geraucht werden

und die Nähe von offenen Flammen und Hitze, einschliesslich die Verwendung eines Haarföhns, ist

zu meiden (feuergefährlich).

Verwenden Sie Betnovate nur für Ihr jetziges Hautleiden, für das der Arzt oder die Ärztin es Ihnen

verschrieben hat, nicht aber für andere spätere Hautleiden. Geben Sie Betnovate nicht an andere

Personen weiter.

Informieren Sie Ihren Arzt oder Apotheker bzw. Ihre Ärztin oder Apothekerin, wenn Sie

·an anderen Krankheiten leiden,

·Allergien haben oder

·andere Arzneimittel (auch selbstgekaufte!) einnehmen oder äusserlich anwenden.

Darf Betnovate während der Schwangerschaft oder in der Stillzeit angewendet werden?

Wenn Sie schwanger sind oder es werden möchten, sollen Sie Betnovate ausschliesslich nach

Rücksprache mit dem Arzt oder der Ärztin verwenden. Das gleiche gilt, wenn Sie Ihr Kind stillen.

Sollten Sie Betnovate dennoch anwenden, wenn Sie stillen, dürfen Sie es nicht im Bereich der Brüste

auftragen, um eine versehentliche Einnahme durch das Kind zu vermeiden.

Wie verwenden Sie Betnovate?

Falls vom Arzt oder von der Ärztin nicht anders verordnet, wird Betnovate sparsam 1–2-mal täglich

auf die erkrankten Hautpartien aufgetragen, bis eine Besserung eintritt. Anschliessend wird der

Heilungsvorgang gemäss Verordnung des Arztes oder der Ärztin durch eine 1-mal tägliche

Anwendung oder mit einer noch geringeren Anwendungshäufigkeit aufrechterhalten. Waschen Sie

sich nach der Anwendung die Hände, es sei denn, Sie behandeln Ihre Hände.

Wenn Sie zusätzlich ein Pflegeprodukt (Feuchtigkeitscreme) anwenden, lassen Sie Betnovate nach

jeder Anwendung richtig einziehen, bevor Sie das Pflegeprodukt auftragen.

Das Fläschchen von Betnovate Scalp Application hat einen verlängerten Ausguss, mit dem das

Präparat leicht direkt auf die befallenen behaarten Hautstellen aufgetragen werden kann. Gewaschene

oder schamponierte Haare sollten trocken sein, bevor Sie die Flüssigkeit aufbringen. Betnovate Scalp

Application breitet sich nach dem Auftragen sofort aus und bildet einen dünnen Film über den

erkrankten Stellen; es verklebt die Haare nicht und hinterlässt beim Trocknen keine sichtbaren

Rückstände. Die Kopfhaut fühlt sich kühl an, bis die Flüssigkeit getrocknet ist.

Wenn Sie die Anwendung von Betnovate vergessen haben, holen Sie sie nach, sobald Sie sich daran

erinnern, und setzen Sie dann die Behandlung wie gewohnt fort. Tragen Sie keine zusätzliche Menge

auf, wenn Sie die vorherige Anwendung vergessen haben. Ändern Sie nicht von sich aus die

verschriebene Dosierung. Wenn Sie glauben, das Arzneimittel wirke zu schwach oder zu stark, so

sprechen Sie mit Ihrem Arzt oder Apotheker bzw. Ihrer Ärztin oder Apothekerin.

Welche Nebenwirkungen kann Betnovate haben?

Folgende Nebenwirkungen können bei der Anwendung von Betnovate auftreten: lokale

unerwünschte Wirkungen wie Reizungen der Haut, Brennen, Jucken und Trockenheit sowie

Überempfindlichkeitsreaktionen.

Sollten Anzeichen einer Überempfindlichkeit auftreten, ist die Anwendung sofort abzubrechen und

der Arzt oder die Ärztin darüber zu informieren.

Auch eine Verschlechterung/Wiederausbrechen der Anzeichen der behandelten Hauterkrankung ist

beobachtet worden.

Langandauernde und intensive Behandlungen mit stark wirksamen Kortikosteroiden, besonders bei

Anwendung unter Deckverbänden oder in Körperfalten, können ein Dünnerwerden der Haut,

Streifenbildung, Hautfalten, Erweiterung kleiner oberflächlicher Hautgefässe,

Pigmentveränderungen, Gewichtszunahme/Übergewicht, Mondgesicht, Hauttrockenheit, Haarausfall

und vermehrte Körperbehaarung zur Folge haben.

Wenn Sie an Psoriasis leiden, können sich in sehr seltenen Fällen während oder nach der Behandlung

erhabene Knötchen mit Eiter unter der Haut bilden.

Bei Kindern, besonders Säuglingen und Kleinkindern, ist zu beachten, dass der Wirkstoff vermehrt

in die Blutbahn aufgenommen wird, so dass bei längerer Anwendung u.a. Wachstumsstörungen

auftreten können. Windeln können zudem die Wirkung eines Deckverbands haben.

Wenn Sie Nebenwirkungen bemerken, die hier nicht beschrieben sind, sollten Sie Ihren Arzt oder

Apotheker bzw. Ihre Ärztin oder Apothekerin informieren.

Was ist ferner zu beachten?

Betnovate ist bei Raumtemperatur (15-25 °C) und ausser Reichweite von Kindern aufzubewahren. Es

darf nur bis zu dem auf der Packung mit «EXP» bezeichneten Verfalldatum verwendet werden.

Betnovate Scalp Application/Lotion soll nicht in der Nähe einer offenen Flamme oder Hitze

verwendet werden (feuergefährlich). Vor direktem Sonnenlicht schützen.

Weitere Auskünfte erteilt Ihnen Ihr Arzt oder Apotheker bzw. Ihre Ärztin oder Apothekerin. Diese

Personen verfügen über die ausführliche Fachinformation.

Was ist in Betnovate enthalten?

1 g Betnovate Creme enthält als Wirkstoff 1 mg Betamethason als Betamethasonvalerat, das

Konservierungsmittel Chlorocresol sowie weitere Hilfsstoffe (nicht fettende, abwaschbare

Grundlage).

1 g Betnovate Salbe enthält als Wirkstoff 1 mg Betamethason als Betamethasonvalerat sowie

Hilfsstoffe (fettende, nicht abwaschbare Grundlage).

1 g Betnovate Lotion enthält als Wirkstoff 1 mg Betamethason als Betamethasonvalerat und das

Konservierungsmittel Methyl-p-Hydroxybenzoat (E 218) sowie weitere Hilfsstoffe (nicht fettende,

leicht aufzutragende Grundlage).

1 g Betnovate Scalp Application enthält als Wirkstoff 1 mg Betamethason als Betamethasonvalerat

sowie Hilfsstoffe (alkoholische Lösung zur Anwendung auf der behaarten Haut).

Zulassungsnummer

Betnovate Creme: 30968 (Swissmedic).

Betnovate Salbe: 30970 (Swissmedic).

Betnovate Lotion: 30969 (Swissmedic).

Betnovate Scalp Application: 33311 (Swissmedic).

Wo erhalten Sie Betnovate? Welche Packungen sind erhältlich?

Betnovate ist in Apotheken nur gegen ärztliche Verschreibung erhältlich.

Creme und Salbe zu 15 g und 30 g; Lotion zu 20 ml; Scalp Application zu 30 ml und 100 ml.

Zulassungsinhaberin

GlaxoSmithKline AG, 3053 Münchenbuchsee.

Diese Packungsbeilage wurde im Februar 2014 letztmals durch die Arzneimittelbehörde

(Swissmedic) geprüft.

21-2-2019

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Assessment of the application for renewal of authorisation of Lantharenol® (lanthanum carbonate octahydrate) for cats

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22-12-2018

Modification of the existing maximum residue level for captan in cranberries

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21-12-2018

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17-12-2018

New format requirements for Marketing Authorization submissions from 1 January 2019

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The NeeS submission format will be discontinued for all applications submitted under the national procedure (NP), i.e. applications for variations, renewals etc. This change is related to medicinal products for human use. Parallel import and parallel distribution are not affected by this change.

Danish Medicines Agency

13-12-2018

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10-12-2018

FDA clears mobile medical app to help those with opioid use disorder stay in recovery programs

FDA clears mobile medical app to help those with opioid use disorder stay in recovery programs

FDA clears a mobile medical application (app) to help increase retention (the amount of time a patient participates) in an outpatient treatment program for individuals with opioid use disorder

FDA - U.S. Food and Drug Administration

6-12-2018

Application deadlines in 2018

Application deadlines in 2018

The Danish Medicines Agency will be closed between Christmas and New Year from 22 December 2018 to 1 January 2019, both days inclusive. This means that enquiries made to the Danish Medicines Agency, with a few exceptions, will not be read and replied during this period. On this page, you can find the deadlines that apply to applications in the Danish Medicines Agency's area in 2018.

Danish Medicines Agency

4-12-2018

Joint project on Benchmark Dose modelling with RIVM

Joint project on Benchmark Dose modelling with RIVM

Published on: Mon, 03 Dec 2018 A web application for PROAST, a software package for BMD modelling, was developed to make the use of the BMD approach significantly easier for toxicologists and risk assessors. In addition, model averaging was included in the software, for the most frequently occurring types of data in toxicological studies. The PROAST web application now allows for applying model averaging for the case of both quantal and continuous data, as well as for combined datasets (dose‐response da...

Europe - EFSA - European Food Safety Authority Publications

1-12-2018

Safety assessment of the process ‘RecyPET Hungária’, based on RecyPET Hungária technology, used to recycle post‐consumer PET into food contact materials

Safety assessment of the process ‘RecyPET Hungária’, based on RecyPET Hungária technology, used to recycle post‐consumer PET into food contact materials

Published on: Fri, 30 Nov 2018 The EFSA Panel on Food Contact Materials, Enzymes and Processing Aids (CEP) assessed the safety of the recycling process RecyPET Hungária (EU register number RECYC0146). The input is hot caustic washed and dried poly(ethylene terephthalate) (PET) flakes originating from collected post‐consumer PET containers, containing no more than 5% of PET from non‐food applications. The flakes are dried and extruded. The output of the extrusion step is cut into pellets in an underwater...

Europe - EFSA - European Food Safety Authority Publications

29-11-2018

Glyphosate: ANSES launches a comparative assessment with the available alternatives

Glyphosate: ANSES launches a comparative assessment with the available alternatives

Following the five-year re-approval of this active substance at European level in December 2017, ANSES is reassessing marketing authorisations for products containing glyphosate. For products for which an application for authorisation or re-authorisation has been submitted, the Agency will carry out a comparative assessment with the available alternatives. For each glyphosate-based product, all uses for which there is an alternative that meets the substitution criteria will therefore be prohibited.

France - Agence Nationale du Médicament Vétérinaire

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

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

26-11-2018

FDA Welcomes Grant Applications for Animal Drugs for Minor Uses and Minor Species

FDA Welcomes Grant Applications for Animal Drugs for Minor Uses and Minor Species

The U.S. Food and Drug Administration today announced an open period for applications for grants to support the development of new animal drugs intended to treat uncommon diseases (minor uses) in major species (horses, dogs, cats, cattle, pigs, turkeys and chickens) or to treat minor species.

FDA - U.S. Food and Drug Administration

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

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

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

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

8-11-2018

Hazard analysis approaches for certain small retail establishments and food donations: second scientific opinion

Hazard analysis approaches for certain small retail establishments and food donations: second scientific opinion

Published on: Wed, 07 Nov 2018 00:00:00 +0100 In 2017, EFSA published a ‘simplified’ food safety management system (FSMS) for certain small retail establishments (butcher, grocer, baker, fish and ice cream shop) based on the application of prerequisite programme (PRP) criteria. The aim of this opinion was to develop similar FSMSs for other small retail enterprises including retail distribution centres, supermarkets, restaurants (including pubs and other catering activities) and food donation. The latter...

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

Guidance on the scientific requirements for health claims related to muscle function and physical performance

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 EFSA has asked the Panel on Nutrition, Novel Foods and Food Allergens (NDA) to update the guidance on the scientific requirements for health claims related to physical performance published in 2012. The update takes into account the experience gained by the NDA Panel with the evaluation of additional health claim applications, changes introduced to the general scientific guidance for stakeholders for health claims applications and information collected from ...

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

22-10-2018

Statement from FDA Commissioner Scott Gottlieb, M.D., on agency’s ongoing commitment to improving efficiency, transparency of tobacco product application review process as part of FDA’s comprehensive framework to reduce tobacco-related disease and death

Statement from FDA Commissioner Scott Gottlieb, M.D., on agency’s ongoing commitment to improving efficiency, transparency of tobacco product application review process as part of FDA’s comprehensive framework to reduce tobacco-related disease and death

Statement from FDA Commissioner Scott Gottlieb, M.D., on agency’s ongoing commitment to improving efficiency, transparency of tobacco product application review process as part of FDA’s comprehensive framework to reduce tobacco-related disease and death.

FDA - U.S. Food and Drug Administration

20-10-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

17-10-2018

Pest categorisation of Stagonosporopsis andigena

Pest categorisation of Stagonosporopsis andigena

Published on: Tue, 16 Oct 2018 00:00:00 +0200 The Panel on Plant Health performed a pest categorisation of Stagonosporopsis andigena, the causal agent of black blight of potato, for the EU. The pest is a well‐defined fungal species and reliable methods exist for its detection and identification. S. andigena is present in Bolivia and Peru. The pest is not known to occur in the EU and is listed in Annex IAI of Directive 2000/29/EC as Phoma andina, meaning its introduction into the EU is prohibited. The ma...

Europe - EFSA - European Food Safety Authority Publications

17-10-2018

Pest categorisation of Thecaphora solani

Pest categorisation of Thecaphora solani

Published on: Tue, 16 Oct 2018 00:00:00 +0200 The Panel on Plant Health performed a pest categorisation of the fungus Thecaphora solani, the causal agent of smut of potato, for the EU. The identity of the pest is well established and reliable methods exist for its detection and identification. T. solaniis present in Bolivia, Chile, Colombia, Ecuador, Mexico, Panama, Peru and Venezuela. The pathogen is not known to occur in the EU and is listed in Annex IAI of Directive 2000/29/EC, meaning its introducti...

Europe - EFSA - European Food Safety Authority Publications

8-2-2019


EMA launches checklist to facilitate validation for initial marketing authorisation applications

EMA launches checklist to facilitate validation for initial marketing authorisation applications

EMA launches checklist to facilitate validation for initial marketing authorisation applications

Europe - EMA - European Medicines Agency

1-2-2019


Withdrawn application: Cavoley, pegfilgrastim, Date of withdrawal: 20/12/2018, Initial authorisation

Withdrawn application: Cavoley, pegfilgrastim, Date of withdrawal: 20/12/2018, Initial authorisation

Withdrawn application: Cavoley, pegfilgrastim, Date of withdrawal: 20/12/2018, Initial authorisation

Europe - EMA - European Medicines Agency

1-2-2019


Withdrawn application: Efgratin, pegfilgrastim, Date of withdrawal: 20/12/2019, Initial authorisation

Withdrawn application: Efgratin, pegfilgrastim, Date of withdrawal: 20/12/2019, Initial authorisation

Withdrawn application: Efgratin, pegfilgrastim, Date of withdrawal: 20/12/2019, Initial authorisation

Europe - EMA - European Medicines Agency

1-2-2019


Withdrawn application: Vynpenta (previously AvacopanChemoCentryx), avacopan, Date of withdrawal: 31/01/2019, Initial authorisation

Withdrawn application: Vynpenta (previously AvacopanChemoCentryx), avacopan, Date of withdrawal: 31/01/2019, Initial authorisation

Withdrawn application: Vynpenta (previously AvacopanChemoCentryx), avacopan, Date of withdrawal: 31/01/2019, Initial authorisation

Europe - EMA - European Medicines Agency

23-1-2019


Withdrawn application: Graspa, asparaginase, Date of withdrawal: 22/06/2018, Initial authorisation

Withdrawn application: Graspa, asparaginase, Date of withdrawal: 22/06/2018, Initial authorisation

Withdrawn application: Graspa, asparaginase, Date of withdrawal: 22/06/2018, Initial authorisation

Europe - EMA - European Medicines Agency

18-1-2019


European Medicines Agency practical guidance on the application form for centralised type IA and IB variations for veterinary medicinal products

European Medicines Agency practical guidance on the application form for centralised type IA and IB variations for veterinary medicinal products

European Medicines Agency practical guidance on the application form for centralised type IA and IB variations for veterinary medicinal products

Europe - EMA - European Medicines Agency

16-1-2019

TGA vs Industry time for GMP clearance applications

TGA vs Industry time for GMP clearance applications

We have started to accurately capture the processing times of CV applications by consistently applying our stop clock process throughout the entire application

Therapeutic Goods Administration - Australia

14-1-2019


Applications for new human medicines under evaluation by the CHMP: January 2019

Applications for new human medicines under evaluation by the CHMP: January 2019

Applications for new human medicines under evaluation by the CHMP: January 2019

Europe - EMA - European Medicines Agency

14-12-2018


Withdrawn application: Fyzoclad, adalimumab, Date of withdrawal: 05/12/2018, Initial authorisation

Withdrawn application: Fyzoclad, adalimumab, Date of withdrawal: 05/12/2018, Initial authorisation

Withdrawn application: Fyzoclad, adalimumab, Date of withdrawal: 05/12/2018, Initial authorisation

Europe - EMA - European Medicines Agency

14-12-2018


Withdrawn application: Canakinumab Novartis, canakinumab, Date of withdrawal: 04/12/2018, Initial authorisation

Withdrawn application: Canakinumab Novartis, canakinumab, Date of withdrawal: 04/12/2018, Initial authorisation

Withdrawn application: Canakinumab Novartis, canakinumab, Date of withdrawal: 04/12/2018, Initial authorisation

Europe - EMA - European Medicines Agency

11-12-2018


Withdrawn application: Opdivo, nivolumab, Date of withdrawal: 27/06/2018, Post-authorisation

Withdrawn application: Opdivo, nivolumab, Date of withdrawal: 27/06/2018, Post-authorisation

Withdrawn application: Opdivo, nivolumab, Date of withdrawal: 27/06/2018, Post-authorisation

Europe - EMA - European Medicines Agency

4-12-2018

TGA presentation: Advertising therapeutic goods in 2019: The Code basics, 13 and 15 November 2018

TGA presentation: Advertising therapeutic goods in 2019: The Code basics, 13 and 15 November 2018

A detailed walkthrough of the Code with examples to illustrate the application of the key sections.

Therapeutic Goods Administration - Australia

3-12-2018


Withdrawn application: Zydax, glucuronoxylan sulfate sodium, Date of withdrawal: 03/12/2018, Initial authorisation

Withdrawn application: Zydax, glucuronoxylan sulfate sodium, Date of withdrawal: 03/12/2018, Initial authorisation

Withdrawn application: Zydax, glucuronoxylan sulfate sodium, Date of withdrawal: 03/12/2018, Initial authorisation

Europe - EMA - European Medicines Agency

30-11-2018

Selected participants will work directly with the FDA to accelerate the development of and eventual review of marketing applications for these innovative products. Read more:  https://go.usa.gov/xPMPk pic.twitter.com/6rRnfSyLy4

Selected participants will work directly with the FDA to accelerate the development of and eventual review of marketing applications for these innovative products. Read more: https://go.usa.gov/xPMPk pic.twitter.com/6rRnfSyLy4

Selected participants will work directly with the FDA to accelerate the development of and eventual review of marketing applications for these innovative products. Read more: https://go.usa.gov/xPMPk  pic.twitter.com/6rRnfSyLy4

FDA - U.S. Food and Drug Administration

26-11-2018


Withdrawn application: HopGuard Gold, purified semi-solid extract from Humulus lupulus L. containing approximately 48% of beta acids as potassium salts, Date of withdrawal: 12/04/2018, Initial authorisation

Withdrawn application: HopGuard Gold, purified semi-solid extract from Humulus lupulus L. containing approximately 48% of beta acids as potassium salts, Date of withdrawal: 12/04/2018, Initial authorisation

Withdrawn application: HopGuard Gold, purified semi-solid extract from Humulus lupulus L. containing approximately 48% of beta acids as potassium salts, Date of withdrawal: 12/04/2018, Initial authorisation

Europe - EMA - European Medicines Agency

26-11-2018

Today’s statement highlights increased expectations for information required in 510(k) submissions; each averages 1,185 pages, compared to 475 pages in 2009. Reviewers spend more time reviewing applications, but time to decision has become more efficient

Today’s statement highlights increased expectations for information required in 510(k) submissions; each averages 1,185 pages, compared to 475 pages in 2009. Reviewers spend more time reviewing applications, but time to decision has become more efficient

Today’s statement highlights increased expectations for information required in 510(k) submissions; each averages 1,185 pages, compared to 475 pages in 2009. Reviewers spend more time reviewing applications, but time to decision has become more efficient https://go.usa.gov/xPHdE 

FDA - U.S. Food and Drug Administration

31-10-2018

Advertising to the public

Advertising to the public

This guidance is designed to provide further information about the understanding, interpretation and application of the Code provisions

Therapeutic Goods Administration - Australia