Dermovate Scalp Application

Hauptinformation

  • Handelsname:
  • Dermovate Scalp Application Lösung
  • Darreichungsform:
  • Lösung
  • Zusammensetzung:
  • clobetasoli-17 propionas 0.5 mg, alcohol isopropylicus, excipiens zur Lösung pro 1 g.
  • Verwenden für:
  • Menschen
  • Art der Medizin:
  • Biologische Medizin

Dokumenten

Lokalisierung

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

Therapeutische Informationen

  • Therapiegruppe:
  • Synthetika
  • Therapiebereich:
  • Nicht infizierte, entzündliche Dermatosen der Kopfhaut

Weitere Informationen

Status

  • Quelle:
  • Swissmedic - Swiss Agency for Therapeutic Products
  • Zulassungsnummer:
  • 41823
  • Berechtigungsdatum:
  • 23-02-1979
  • Letzte Änderung:
  • 24-10-2018

Packungsbeilage

Patienteninformation

Dermovate®

GlaxoSmithKline AG

Was ist Dermovate und wann wird es angewendet?

Dermovate enthält als Wirkstoff ein sehr stark wirksames Kortikosteroid zur äusserlichen

Anwendung. Es wird zur Behandlung von hartnäckigen, nicht infizierten Hauterkrankungen wie

Schuppenflechte und Ekzemen verschiedenen Ursprungs verwendet, vor allem wenn diese nicht auf

schwächer wirksame Kortikosteroide ansprechen.

Die Anwendung von Dermovate führt zu einer raschen Linderung der Begleitsymptome der

Hauterkrankung wie Juckreiz, Brennen und Rötung.

Es darf nur auf Verschreibung des Arztes oder der Ärztin hin angewendet werden.

Wann darf Dermovate 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 durch

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

oder Pilze verursacht sind.

Ebenso sollte Dermovate nicht auf offene Wunden oder eitrige Entzündungen, wie z.B. Furunkel

oder Abszesse, aufgetragen werden.

Bei Kindern unter 1 Jahr soll Dermovate nicht angewendet werden.

Dermovate Scalp Application darf nicht in Augennähe aufgetragen werden.

Wann ist bei der Anwendung von Dermovate Vorsicht geboten?

Dermovate ist ein stark wirksames Arzneimittel. Überschreiten Sie nicht die vom Arzt bzw. von der

Ärztin vorgeschriebene Behandlungsdauer, die normalerweise 2 bis 3 Wochen beträgt, da sich sonst

Hautschäden einstellen können. Ist eine längere Behandlungsdauer notwendig, soll eine

ununterbrochene Anwendung ohne ärztliche Kontrolle nicht länger als 4 Wochen andauern. Eine

ununterbrochene Langzeitanwendung sowie eine ausgedehnte und wiederholte Anwendung sind nur

auf ausdrückliche ärztliche Verordnung vorzunehmen.

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

verschlimmert, suchen Sie Ihren Arzt bzw. Ihre Ärztin auf. Teilen Sie ihm bzw. 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 Clobetasol oder einen

sonstigen Bestandteil des Arzneimittels sind.

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 Dermovate 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 mit allen Kortikosteroiden sollte eine langfristige Anwendung auf der besonders empfindlichen

Gesichtshaut und im Genitalbereich vermieden werden.

Dermovate darf nicht in die Augen gelangen oder in Augennähe aufgetragen werden; Während der

Anwendung von Dermovate Scalp Application darf nicht geraucht werden und die Nähe von offenen

Flammen und Hitze, einschliesslich die Verwendung eines Haarföhns, ist zu meiden

(feuergefährlich).

Bei Kindern sollte Dermovate mit Vorsicht, nicht über längere Zeit und nicht grossflächig

aufgetragen werden.

Verwenden Sie Dermovate nur für Ihr jetziges Hautleiden, für das der Arzt bzw. die Ärztin es Ihnen

verschrieben hat, nicht aber für andere spätere Hautleiden. Geben Sie Dermovate 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 Dermovate während einer Schwangerschaft oder in der Stillzeit angewendet werden?

Wenn Sie schwanger sind oder es werden möchten, sollten Sie Dermovate ausschliesslich nach

Rücksprache mit Ihrem Arzt bzw. Ihrer Ärztin verwenden. Das gleiche gilt, wenn Sie Ihr Kind

stillen.

Sollten Sie Dermovate 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 Dermovate?

Falls vom Arzt bzw. von der Ärztin nicht anders verordnet, wird Dermovate Creme oder Salbe 1-2×

täglich sparsam auf die erkrankten Hautstellen, Dermovate Scalp Application morgens und abends

sparsam auf die Kopfhaut aufgetragen, bis eine Besserung eintritt. Anschliessend wird die

Behandlung im Allgemeinen mit einem schwächer wirksamen Kortikosteroid weitergeführt.

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

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

jeder Anwendung richtig einziehen, bevor Sie das Pflegeprodukt auftragen. Das Fläschchen von

Dermovate 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. Dermovate 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 Dermovate 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. mit Ihrer

Ärztin oder Apothekerin.

Welche Nebenwirkungen kann Dermovate haben?

Folgende Nebenwirkungen können bei der Anwendung von Dermovate auftreten:

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

Überempfindlichkeitsreaktionen können auftreten.

Sollten Zeichen einer Überempfindlichkeit auftreten, ist die Anwendung sofort abzubrechen und der

Arzt bzw. die Ärztin darüber zu informieren.

Auch eine Verschlechterung bzw. ein Wiederausbrechen der behandelten Hautkrankheit ist

beobachtet worden. In sehr seltenen Fällen ist das Auftreten von Akne 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.

Falls Sie während der Behandlung eine Verschlimmerung der Hauterkrankung feststellen,

informieren Sie Ihren Arzt bzw. Ihre Ärztin.

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

Apotheker bzw. Ihre Ärztin oder Apothekerin informieren.

Was ist ferner zu beachten?

Das Arzneimittel darf nur bis zu dem auf der Packung mit «EXP» bezeichneten Datum verwendet

werden.

Dermovate ist in der Originalverpackung, bei Raumtemperatur (15-25 °C) und ausser Reichweite

von Kindern aufzubewahren. Dermovate Scalp Application soll nicht in der Nähe einer offenen

Flamme oder Hitze verwendet werden (feuergefährlich). Dermovate Scalp Application 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 Dermovate enthalten?

Salbe: 1 g Dermovate Salbe enthält 0,5 mg Clobetasol-17-propionat als Wirkstoff und

Propylenglycol sowie weitere Hilfsstoffe (nicht abwaschbare, fettende Grundlage).

Creme: 1 g Dermovate Creme enthält 0,5 mg Clobetasol-17-propionat als Wirkstoff und das

Konservierungsmittel Chlorocresol sowie Propylenglycol und weitere Hilfsstoffe (abwaschbare

Grundlage).

Scalp Application: 1 g Dermovate Scalp Application enthält 0,5 mg Clobetasol-17-propionat als

Wirkstoff und Isopropylalkohol sowie weitere Hilfsstoffe (alkoholische Lösung zur Anwendung auf

der behaarten Haut).

Zulassungsnummer

39905, 39906, 41823 (Swissmedic).

Wo erhalten Sie Dermovate? Welche Packungen sind erhältlich?

Dermovate ist in Apotheken nur gegen ärztliche Verschreibung erhältlich.

Dermovate Creme: 25 g, 30 g und 100 g.

Dermovate Salbe: 25 g, 30 g und 100 g.

Dermovate Scalp Application: 25 ml und 100 ml.

Zulassungsinhaberin

GlaxoSmithKline AG, 3053 Münchenbuchsee.

Diese Packungsbeilage wurde im September 2016 letztmals durch die Arzneimittelbehörde

(Swissmedic) geprüft.

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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

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

Published on: Wed, 19 Sep 2018 00:00:00 +0200 The third Joint Meeting of the ECDC's Food‐ and Waterborne Disease and Zoonoses Network and of the EFSA's Zoonoses Monitoring Data Network was held on 16 and 17 October 2017 in Parma. The meeting was constructed around the principle of ‘One health approach to collaborative response to foodborne disease outbreaks in EU/EEA’ and served as an opportunity for public health authorities and food safety/veterinary authorities to meet and exchange information on the...

Europe - EFSA - European Food Safety Authority Publications

13-9-2018

Use of next‐generation sequencing in microbial risk assessment

Use of next‐generation sequencing in microbial risk assessment

Published on: Mon, 27 Aug 2018 00:00:00 +0200 Despite the ever increase in rigorous control and monitoring measures to assure safe food along the entire farm‐to‐fork chain, the past decade has also witnessed an increase in microbial food alerts. Hence, research on food safety and quality remain of utmost importance. Complementary, and at least as important, is the necessity to be able to assess the potential microbial risks along the food chain. Risk assessment relies on sound scientific data. Unfortuna...

Europe - EFSA - European Food Safety Authority Publications

12-9-2018

Application of data science in risk assessment and early warning

Application of data science in risk assessment and early warning

Published on: Mon, 27 Aug 2018 00:00:00 +0200 The currently applied approaches, procedures and tools used for the identification of emerging risks vary greatly among Member States of the EU. EFSA established a structured approach for emerging risk identification that mainly consists of systematically searching, collecting, collating and analysing information and data. In addition, EFSA concluded that new methodologies and tools are needed to facilitate efficient and transparent sharing of data, knowledg...

Europe - EFSA - European Food Safety Authority Publications

11-9-2018

Identification and evaluation of potentially mutagenic and carcinogenic food contaminants

Identification and evaluation of potentially mutagenic and carcinogenic food contaminants

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...

Europe - EFSA - European Food Safety Authority Publications

11-9-2018

Preparation of Dutch food consumption data for risk assessment

Preparation of Dutch food consumption data for risk assessment

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...

Europe - EFSA - European Food Safety Authority Publications

4-9-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

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

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

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

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

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

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

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

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

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

23-8-2018

Companies cease sales of e-liquids with labeling or advertising that resembled kid-friendly foods following FDA, FTC warnings

Companies cease sales of e-liquids with labeling or advertising that resembled kid-friendly foods following FDA, FTC warnings

FDA announced that all 17 manufacturers, distributors, and retailers that were warned in May have stopped selling the e-liquids used in e-cigarettes with labeling or advertising resembling kid-friendly food products.

FDA - U.S. Food and Drug Administration

23-8-2018

Liste der betroffenen Arzneimittel, Stand 17. August 2018

Liste der betroffenen Arzneimittel, Stand 17. August 2018

Das Bundesinstitut für Arzneimittel und Medizinprodukte (BfArM) veröffentlicht hier die Liste der Arzneimittel, bei denen wegen invalider Studiendaten der indischen Firma GVK Biosciences ein Ruhen der Zulassung angeordnet wurde. Diese Liste wird vom BfArM nur noch bei Änderungen aktualisiert. Das BfArM weist ausdrücklich darauf hin, dass eine aktuelle Version der Liste ausschließlich von der BfArM-Internetseite bezogen werden kann und nicht aus anderen Quellen. RSS-Feed

Deutschland - BfArM - Bundesinstitut für Arzneimittel und Medizinprodukte

20-8-2018

August 17, 2018: Unlicensed Pharmacy Technician Pleads Guilty to Working at New England Compounding Center

August 17, 2018: Unlicensed Pharmacy Technician Pleads Guilty to Working at New England Compounding Center

August 17, 2018: Unlicensed Pharmacy Technician Pleads Guilty to Working at New England Compounding Center

FDA - U.S. Food and Drug Administration

17-8-2018

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

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

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

13-11-2018

EU/3/17/1863 (Celgene Europe B.V.)

EU/3/17/1863 (Celgene Europe B.V.)

EU/3/17/1863 (Active substance: Autologous T lymphocyte-enriched population of cells transduced with a lentiviral vector encoding a chimeric antigen receptor targeting human B cell maturation antigen with 4-1BB and CD3-zeta intracellular signalling domains) - Transfer of orphan designation - Commission Decision (2018)7574 of Tue, 13 Nov 2018 European Medicines Agency (EMA) procedure number: EMA/OD/270/16/02

Europe -DG Health and Food Safety

13-11-2018

EU/3/17/1836 (Zogenix GmbH)

EU/3/17/1836 (Zogenix GmbH)

EU/3/17/1836 (Active substance: Fenfluramine hydrochloride) - Transfer of orphan designation - Commission Decision (2018)7576 of Tue, 13 Nov 2018 European Medicines Agency (EMA) procedure number: EMA/OD/233/16/T/01

Europe -DG Health and Food Safety

13-11-2018

EU/3/17/1964 (Incyte Biosciences Distribution B.V.)

EU/3/17/1964 (Incyte Biosciences Distribution B.V.)

EU/3/17/1964 (Active substance: Itacitinib) - Transfer of orphan designation - Commission Decision (2018)7573 of Tue, 13 Nov 2018 European Medicines Agency (EMA) procedure number: EMA/OD/169/17/T/01

Europe -DG Health and Food Safety

22-10-2018

EU/3/17/1966 (Sirius Regulatory Consulting EU Limited)

EU/3/17/1966 (Sirius Regulatory Consulting EU Limited)

EU/3/17/1966 (Active substance: N-(bromoacetyl)-3,3-dinitroazetidine) - Transfer of orphan designation - Commission Decision (2018)6986 of Mon, 22 Oct 2018

Europe -DG Health and Food Safety

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

Agenda:  Agenda - CHMP agenda of the 17-20 September 2018 meeting

Agenda: Agenda - CHMP agenda of the 17-20 September 2018 meeting

Europe - EMA - European Medicines Agency

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

28-8-2018

LIFMIOR (Pfizer Europe MA EEIG)

LIFMIOR (Pfizer Europe MA EEIG)

LIFMIOR (Active substance: etanercept) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)5700 of Tue, 28 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4167T/17

Europe -DG Health and Food Safety

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

17-8-2018

EU/3/17/1870 (Pharma Gateway AB)

EU/3/17/1870 (Pharma Gateway AB)

EU/3/17/1870 (Active substance: Thymidine and deoxycytidine) - Transfer of orphan designation - Commission Decision (2018)5403 of Fri, 17 Aug 2018 European Medicines Agency (EMA) procedure number: EMA/OD/317/16/T/01

Europe -DG Health and Food Safety