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

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.

10-11-2018

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

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Updated review of the existing maximum residue levels for imazalil according to Article 12 of Regulation (EC) No 396/2005 following new toxicological information

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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...

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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...

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

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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 ...

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31-10-2018

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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...

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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

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FDA - U.S. Food and Drug Administration

20-10-2018

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

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17-10-2018

Pest categorisation of Stagonosporopsis andigena

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17-10-2018

Pest categorisation of Thecaphora solani

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16-10-2018

Modification of the existing maximum residue levels for mepiquat in cotton seeds and animal commodities

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Published on: Mon, 15 Oct 2018 00:00:00 +0200 In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant, BASF SE, submitted an application to the competent national authority in Greece to modify the existing maximum residue level (MRL) for the active substance mepiquat in cotton seeds. The data submitted in support of the application were found to be sufficient to derive a MRL proposal for cotton seeds and the previously derived MRL proposals for animal commodities were found to be stil...

Europe - EFSA - European Food Safety Authority Publications

26-9-2018

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

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24-9-2018

FDA Announces Availability of Resources for Animal Drug Sponsors

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FDA - U.S. Food and Drug Administration

21-9-2018

Scientific guideline:  Guideline on determination of withdrawal periods for edible tissues - Revision 1, adopted

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13-9-2018

Use of next‐generation sequencing in microbial risk assessment

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12-9-2018

Application of data science in risk assessment and early warning

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11-9-2018

Identification and evaluation of potentially mutagenic and carcinogenic food contaminants

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Published on: Mon, 27 Aug 2018 00:00:00 +0200 Heat processing of food gives rise to a plethora of chemical compounds whose toxicological effects are largely unknown. Due to a general lack of experimental toxicological data, assessing the risks associated with the consumption of these substances remains a challenge. Computer models that allow for an in silico prediction of physicochemical and toxicological characteristics, may be able to fill current data gaps and facilitate the risk assessment of toxico...

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11-9-2018

Preparation of Dutch food consumption data for risk assessment

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

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4-9-2018

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

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

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

Scientific Opinion on the state of the art of Toxicokinetic/Toxicodynamic (TKTD) effect models for regulatory risk assessment of pesticides for aquatic organisms

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Published on: Thu, 23 Aug 2018 00:00:00 +0200 Following a request from EFSA, the Panel on Plant Protection Products and their Residues (PPR) developed an opinion on the state of the art of Toxicokinetic/Toxicodynamic (TKTD) models and their use in prospective environmental risk assessment (ERA) for pesticides and aquatic organisms. TKTD models are species‐ and compound‐specific and can be used to predict (sub)lethal effects of pesticides under untested (time‐variable) exposure conditions. Three differen...

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

Safety assessment of the process ‘General Plastic’, based on Starlinger Decon technology, used to recycle post‐consumer PET into food contact materials

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Published on: Fri, 10 Aug 2018 00:00:00 +0200 This scientific opinion of the EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF Panel) deals with the safety evaluation of the recycling process General Plastic (EU register No RECYC153), which is based on the Starlinger Decon technology. The decontamination efficiency of the process was demonstrated by a challenge test. The input of this process is hot caustic washed and dried poly(ethylene terephthalate) (PET) flakes orig...

Europe - EFSA - European Food Safety Authority Publications

17-8-2018

Animal Drug Under Fee Amendments Reauthorized Through September 2023 to Allow for FDA’s Continued Timely Review of Animal Drug Applications

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On 8/14/18, the Animal Drug and Animal Generic Drug User Fee Amendments of 2018 was signed into law to reauthorize ADUFA and AGDUFA. These programs help FDA maintain a predictable and timely animal drug review process, foster innovation, and expedite access to new therapies for animals.

FDA - U.S. Food and Drug Administration

7-8-2018

FDA’s Center for Veterinary Medicine Announces Second eSubmitter Webinar in Ongoing Series

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On August 22, 2018, FDA-CVM will host the second of a three-part webinar series on using eSubmitter, CVM’s electronic submission tool for the animal drug approval process. Sponsors must use eSubmitter to submit applications as of October 1, 2018.

FDA - U.S. Food and Drug Administration

10-7-2018

Dringende Sicherheitsinformation zu Guardian Connect Application von Medtronic Minimed

Dringende Sicherheitsinformation zu Guardian Connect Application von Medtronic Minimed

Weitere Informationen sowie Details zum Produkt entnehmen Sie bitte der anliegenden Kundeninformation des Herstellers.

Deutschland - BfArM - Bundesinstitut für Arzneimittel und Medizinprodukte

6-7-2018

Dringende Sicherheitsinformation zu ProteusPLUS von IBA (Ion Beam Applications)

Dringende Sicherheitsinformation zu ProteusPLUS von IBA (Ion Beam Applications)

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Deutschland - BfArM - Bundesinstitut für Arzneimittel und Medizinprodukte

27-6-2018

ITW Canada recalls Red Head Trubolt wedge anchors

ITW Canada recalls Red Head Trubolt wedge anchors

The affected product does not meet the requirements for use in cracked concrete andseismic applications, which may lead to incidents or injuries to consumers.

Health Canada

30-5-2018

12 applications for allocation of special funds related to medicinal cannabis

12 applications for allocation of special funds related to medicinal cannabis

The application deadline for the second allocation of special funds for accumulation of scientific knowledge in regard to the medicinal cannabis pilot programme has now expired. The Danish Medicines Agency received 12 applications.

Danish Medicines Agency

30-9-2018

Today is the last day to submit applications to the #FDAInnovationChallenge. Thanks to all who have applied.  Selected applications will be announced in November. For more information about the challenge, click the link:   https://go.usa.gov/xP4Nk pic.twi

Today is the last day to submit applications to the #FDAInnovationChallenge. Thanks to all who have applied. Selected applications will be announced in November. For more information about the challenge, click the link: https://go.usa.gov/xP4Nk pic.twi

Today is the last day to submit applications to the #FDAInnovationChallenge. Thanks to all who have applied. Selected applications will be announced in November. For more information about the challenge, click the link: https://go.usa.gov/xP4Nk  pic.twitter.com/pFJZ39oGJC

FDA - U.S. Food and Drug Administration

29-9-2018

Reminder: the last day to submit applications to the #FDAInnovationChallenge is tomorrow, September 30th. Click the link to find out more about the challenge and how to submit your application:  https://go.usa.gov/xP4Nk pic.twitter.com/lLYiMa0cLe

Reminder: the last day to submit applications to the #FDAInnovationChallenge is tomorrow, September 30th. Click the link to find out more about the challenge and how to submit your application: https://go.usa.gov/xP4Nk pic.twitter.com/lLYiMa0cLe

Reminder: the last day to submit applications to the #FDAInnovationChallenge is tomorrow, September 30th. Click the link to find out more about the challenge and how to submit your application: https://go.usa.gov/xP4Nk  pic.twitter.com/lLYiMa0cLe

FDA - U.S. Food and Drug Administration

26-9-2018

Today, Wednesday, September 26th 2018 at 12 pm EST is the last day that the #FDA will be soliciting site visit proposals for the 2018 Experiential Learning Program. Click the link to find more about the program & submit your application:   http://go.usa.g

Today, Wednesday, September 26th 2018 at 12 pm EST is the last day that the #FDA will be soliciting site visit proposals for the 2018 Experiential Learning Program. Click the link to find more about the program & submit your application: http://go.usa.g

Today, Wednesday, September 26th 2018 at 12 pm EST is the last day that the #FDA will be soliciting site visit proposals for the 2018 Experiential Learning Program. Click the link to find more about the program & submit your application: http://go.usa.gov/xPrum  #MedicalDevice pic.twitter.com/Zsmq00NCdd

FDA - U.S. Food and Drug Administration

25-9-2018

Withdrawn application:  Entolimod TMC, entolimod, Initial authorisation

Withdrawn application: Entolimod TMC, entolimod, Initial authorisation

Europe - EMA - European Medicines Agency

24-9-2018

For more information about the #FDA’s effort to address the epidemic of  #opioid addiction, click the link to find out more about the  #FDAInnovationChallenge:  https://go.usa.gov/xPja7  The last day to submit  applications is September 30th, 2018.https:/

For more information about the #FDA’s effort to address the epidemic of #opioid addiction, click the link to find out more about the #FDAInnovationChallenge: https://go.usa.gov/xPja7  The last day to submit applications is September 30th, 2018.https:/

For more information about the #FDA’s effort to address the epidemic of #opioid addiction, click the link to find out more about the #FDAInnovationChallenge: https://go.usa.gov/xPja7  The last day to submit applications is September 30th, 2018. https://twitter.com/NIDAnews/status/1032719474934382593 …

FDA - U.S. Food and Drug Administration

21-9-2018

Regulatory and procedural guideline:  Draft qualification opinion on stride velocity 95th centile as a secondary endpoint in Duchenne Muscular Dystrophy measured by a valid and suitable wearable device, draft: consultation open

Regulatory and procedural guideline: Draft qualification opinion on stride velocity 95th centile as a secondary endpoint in Duchenne Muscular Dystrophy measured by a valid and suitable wearable device, draft: consultation open

This report provides a final agreed draft Context of Use for public consultation describing where Stride Velocity measured at the ankle 95th Centile is deemed by CHMP as an appropriate endpoint in studies to support regulatory decision making on medicines for the treatment of Duchenne Muscular Dystrophy (DMD), together with CHMP’s scientific consideration of the submission leading to the draft opinion. The document also includes the questions posed by the applicant and also raised by CHMP to the Applic...

Europe - EMA - European Medicines Agency

19-9-2018

Reminder: #FDA site visit proposal solicitation period for the 2018  Experiential Learning Program is currently OPEN through Wednesday,  9/26/18 @ 12 pm EST. Click the link to find more about the  program & to submit your application  https://go.usa.gov/x

Reminder: #FDA site visit proposal solicitation period for the 2018 Experiential Learning Program is currently OPEN through Wednesday, 9/26/18 @ 12 pm EST. Click the link to find more about the program & to submit your application https://go.usa.gov/x

Reminder: #FDA site visit proposal solicitation period for the 2018 Experiential Learning Program is currently OPEN through Wednesday, 9/26/18 @ 12 pm EST. Click the link to find more about the program & to submit your application https://go.usa.gov/xPrum  #MedicalDevice pic.twitter.com/FN1mNN65dD

FDA - U.S. Food and Drug Administration

18-9-2018

 Third industry stakeholder platform on research and development support, European Medicines Agency, London, UK, From: 18-May-2018, To: 18-May-2018

Third industry stakeholder platform on research and development support, European Medicines Agency, London, UK, From: 18-May-2018, To: 18-May-2018

This third meeting between regulators and representatives of industry stakeholder organisations addresses all areas of product-development support, including scientific advice, specifics for paediatric and orphan medicines and support for innovation. The meeting focuses on the implementation of the orphan notice, ‘histology-independent indications’ in the context of orphan designations, the upcoming rollout of a new tool for orphan designation applications, digital technology proposals in medicine develo...

Europe - EMA - European Medicines Agency

17-9-2018

Reminder: the FDA is accepting applications through Sept. 30, 2018, for the #FDAInnovationChallenge for devices to help combat #opioid addiction.   Submissions will be evaluated based on the feasibility, potential public health impact and novelty of the c

Reminder: the FDA is accepting applications through Sept. 30, 2018, for the #FDAInnovationChallenge for devices to help combat #opioid addiction. Submissions will be evaluated based on the feasibility, potential public health impact and novelty of the c

Reminder: the FDA is accepting applications through Sept. 30, 2018, for the #FDAInnovationChallenge for devices to help combat #opioid addiction. Submissions will be evaluated based on the feasibility, potential public health impact and novelty of the concept.

FDA - U.S. Food and Drug Administration

17-9-2018

Scientific guideline:  Concept paper on the need for revision of the guideline on the investigation of medicinal products in the term and preterm neonate - Revision 1, draft: consultation open

Scientific guideline: Concept paper on the need for revision of the guideline on the investigation of medicinal products in the term and preterm neonate - Revision 1, draft: consultation open

The Guideline on the investigation of medicinal products in the term and preterm neonates was prepared during the period from 2007 to 2009 and came into effect in 2010 (EMEA/536810/2008). Considerable experience of assessing PIP applications covering neonatal age subset has been gained since then and it has become apparent that some essential questions arise repeatedly during the assessment of Paediatric Investigation Plans (PIP) applications for products intended to be investigated and used in neonates....

Europe - EMA - European Medicines Agency

12-9-2018

The FDA site visit proposal solicitation period for the 2018 Experiential Learning Program is currently OPEN through Wednesday, September 26th 2018 12 pm EST. Click the link to find more about the program & to submit your application  https://go.usa.gov/x

The FDA site visit proposal solicitation period for the 2018 Experiential Learning Program is currently OPEN through Wednesday, September 26th 2018 12 pm EST. Click the link to find more about the program & to submit your application https://go.usa.gov/x

The FDA site visit proposal solicitation period for the 2018 Experiential Learning Program is currently OPEN through Wednesday, September 26th 2018 12 pm EST. Click the link to find more about the program & to submit your application https://go.usa.gov/xPrum  #FDA #MedicalDevice pic.twitter.com/Kyo5z44Os4

FDA - U.S. Food and Drug Administration

5-9-2018

The FDA's site visit proposal solicitation period for the 2018 Experiential Learning Program is currently OPEN through Wednesday, September 26th 2018 at 12 pm EST. Click the link to find more about the program and to submit your application:  https://go.u

The FDA's site visit proposal solicitation period for the 2018 Experiential Learning Program is currently OPEN through Wednesday, September 26th 2018 at 12 pm EST. Click the link to find more about the program and to submit your application: https://go.u

The FDA's site visit proposal solicitation period for the 2018 Experiential Learning Program is currently OPEN through Wednesday, September 26th 2018 at 12 pm EST. Click the link to find more about the program and to submit your application: https://go.usa.gov/xPcpn  #MedicalDevice

FDA - U.S. Food and Drug Administration

23-8-2018

GMP clearance - Extension application processing timeframes

GMP clearance - Extension application processing timeframes

Updates on current processing timeframes of applications to extend GMP clearance

Therapeutic Goods Administration - Australia

20-8-2018

Comparable overseas regulators for medical device applications

Comparable overseas regulators for medical device applications

Use of market authorisation evidence from comparable overseas regulators for medical devices

Therapeutic Goods Administration - Australia

20-8-2018

Application requirements for medical devices - preliminary assessment

Application requirements for medical devices - preliminary assessment

Applications for the inclusion of medical devices (including IVDs) in the ARTG must meet certain requirements in order to pass preliminary assessment

Therapeutic Goods Administration - Australia

8-8-2018

Updates on GMP clearance application forms

Updates on GMP clearance application forms

Updates on GMP Clearance application forms

Therapeutic Goods Administration - Australia

27-7-2018

Scientific guideline:  Draft VICH GL58 Stability testing of new veterinary drug substances and medicinal products in climatic zones III and IV - First version, draft: consultation open

Scientific guideline: Draft VICH GL58 Stability testing of new veterinary drug substances and medicinal products in climatic zones III and IV - First version, draft: consultation open

The guideline is an annex to the VICH parent stability guideline, stability testing of new veterinary drug substances and medicinal products (VICH GL3 (R)), and provides guidance regarding the stability data package for a new veterinary drug substance and medicinal product to be included in a registration application submitted within the regions in the climatic zones III and IV.

Europe - EMA - European Medicines Agency

27-7-2018

Withdrawn application:  Sutent, sunitinib, Post-authorisation

Withdrawn application: Sutent, sunitinib, Post-authorisation

Europe - EMA - European Medicines Agency

27-7-2018

Withdrawn application:  Raligize, axalimogene filolisbac, Initial authorisation

Withdrawn application: Raligize, axalimogene filolisbac, Initial authorisation

Europe - EMA - European Medicines Agency

27-7-2018

Withdrawn application:  Opdivo, nivolumab, Post-authorisation

Withdrawn application: Opdivo, nivolumab, Post-authorisation

Europe - EMA - European Medicines Agency

19-7-2018

Regulatory and procedural guideline:  Post-orphan medicinal product designation procedures: guidance for sponsors to submit an application via the current existing submission process until 19 Sept 2018

Regulatory and procedural guideline: Post-orphan medicinal product designation procedures: guidance for sponsors to submit an application via the current existing submission process until 19 Sept 2018

The opinions on orphan designation are adopted by the Committee for Orphan Medicinal Products (COMP) at their monthly meetings at the European Medicines Agency (EMA).

Europe - EMA - European Medicines Agency

11-7-2018

Withdrawn application:  Rotigotine Mylan, rotigotine, Initial authorisation

Withdrawn application: Rotigotine Mylan, rotigotine, Initial authorisation

Europe - EMA - European Medicines Agency

5-7-2018

Scientific guideline:  Draft guideline on the use of adjuvanted veterinary vaccines, draft: consultation open

Scientific guideline: Draft guideline on the use of adjuvanted veterinary vaccines, draft: consultation open

The main aim of the guideline is to outline the information which should be included for the adjuvant in the marketing authorisation application (MAA) of an immunological veterinary medicinal product (IVMP). This guideline replaces the ‘Note for Guidance on the use of adjuvanted veterinary vaccines’. The guideline discusses the important aspects to consider for the adjuvant in an IVMP and provides guidance on the information on the adjuvant which should be included in Parts 2, 3 and 4 of the MAA. The d...

Europe - EMA - European Medicines Agency

5-7-2018

Withdrawn application:  Prohippur, sodium benzoate, Initial authorisation

Withdrawn application: Prohippur, sodium benzoate, Initial authorisation

Europe - EMA - European Medicines Agency

4-7-2018

Proposal for a new Australian Cell & Tissue Name (ACN) application form

Proposal for a new Australian Cell & Tissue Name (ACN) application form

Proposal form for a new Australian Cell and Tissue Name (ACN)

Therapeutic Goods Administration - Australia

29-6-2018

Withdrawn application:  Graspa, asparaginase, Initial authorisation

Withdrawn application: Graspa, asparaginase, Initial authorisation

Europe - EMA - European Medicines Agency

11-6-2018

SomaKit TOC (Advanced Accelerator Applications)

SomaKit TOC (Advanced Accelerator Applications)

SomaKit TOC (Active substance: edotreotide) - Centralised - Yearly update - Commission Decision (2018)3762 of Mon, 11 Jun 2018

Europe -DG Health and Food Safety

6-6-2018

Update: Increased application audit requirements for some medical devices applications

Update: Increased application audit requirements for some medical devices applications

TGA no longer considers it necessary to apply increased audit requirements to particular European notified bodies for medical devices.

Therapeutic Goods Administration - Australia

1-6-2018

Withdrawn application:  Restaysis, ciclosporin, Initial authorisation

Withdrawn application: Restaysis, ciclosporin, Initial authorisation

Europe - EMA - European Medicines Agency

29-5-2018

Withdrawn application:  Fulphila, pegfilgrastim, Initial authorisation

Withdrawn application: Fulphila, pegfilgrastim, Initial authorisation

Europe - EMA - European Medicines Agency