Oxis 12 Turbuhaler

Hauptinformation

  • Handelsname:
  • Oxis 12 Turbuhaler Pulverinhalator
  • Darreichungsform:
  • Pulverinhalator
  • Zusammensetzung:
  • formoteroli fumaras dihydricus 12 µg, excipiens Pulver für dosi.
  • Verwenden für:
  • Menschen
  • Art der Medizin:
  • Biologische Medizin

Dokumenten

Lokalisierung

  • Erhältlich in:
  • Oxis 12 Turbuhaler Pulverinhalator
    Schweiz
  • Sprache:
  • Deutsch

Therapeutische Informationen

  • Therapiegruppe:
  • Synthetika
  • Therapiebereich:
  • Bronchospasmolytikum

Weitere Informationen

Status

  • Quelle:
  • Swissmedic - Swiss Agency for Therapeutic Products
  • Zulassungsnummer:
  • 53997
  • Berechtigungsdatum:
  • 18-02-1997
  • Letzte Änderung:
  • 24-10-2018

Packungsbeilage

Patienteninformation

Oxis® 6/12 Turbuhaler®

AstraZeneca AG

Was ist Oxis Turbuhaler und wann wird er angewendet?

Oxis ist ein Trockenpulverinhalator mit dem Wirkstoff Formoterol.

Formoterol gehört zur einer Gruppe von Arzneimitteln, die lang-wirksame «Beta-Agonisten» oder

«Bronchodilatatoren» genannt wird. Es bewirkt, dass sich die Bronchialmuskeln entspannen. Dies

verhilft Ihnen zu einer Erleichterung der Atmung. Ihr Arzt bzw. Ihre Ärztin hat Ihnen dieses

Arzneimittel verschrieben, um Ihren Atemproblemen, hervorgerufen durch Asthma oder chronisch-

obstruktive Lungenkrankheit (COPD), vorzubeugen.

Asthma: Oxis Turbuhaler sollte als regelmässige Erhaltungstherapie bei Asthma immer in

Kombination mit einem Arzneimittel gegen Entzündungen der Atemwege, einem Kortikosteroid

verwendet werden. Die Wirkung tritt rasch ein (innerhalb von 1-3 Minuten nach Inhalation). Oxis

besitzt eine bis zu 12 Stunden anhaltende Wirkung zur Lösung von Bronchialmuskelkrämpfen. Oxis

wird ebenfalls verwendet, um anstrengungsbedingtem Asthma vorzubeugen.

COPD: Oxis Turbuhaler kann auch zur Behandlung von COPD bei Erwachsenen verwendet werden.

COPD ist eine chronische Erkrankung der Atemwege, welche gewöhnlich durch das langjährige

Einatmen von Schadstoffen (z.B. Zigarettenrauchen) entsteht.

Oxis darf nur auf Verschreibung und unter ständiger Kontrolle der Ärztin oder des Arztes

angewendet werden.

Wann darf Oxis Turbuhaler nicht angewendet werden?

Oxis darf bei bekannter Überempfindlichkeit gegenüber dem Wirkstoff Formoterol oder dem

Hilfsstoff Laktose nicht angewendet werden.

Wann ist bei der Anwendung von Oxis Turbuhaler Vorsicht geboten?

Dieses Arzneimittel kann die Reaktionsfähigkeit, die Fahrtüchtigkeit und die Fähigkeit, Werkzeuge

oder Maschinen zu bedienen, beeinträchtigen.

Bei speziellen Erkrankungen des Herzens bzw. des Herzmuskels, bei Zuckerkrankheit oder bei einer

Überfunktion der Schilddrüse sollte Oxis nur auf ausdrückliche Anweisung der Ärztin oder des

Arztes angewendet werden.

Bei akuter oder sich rasch verschlimmernder Atemnot sollten Sie sofort den Arzt bzw. die Ärztin

oder das nächste Spital aufsuchen.

Oxis ist nicht zur Therapie des akuten Asthmaanfalles geeignet.

Oxis enthält sehr kleine Mengen von Laktose (ca. 0.9 mg pro Dosis). Es wird nicht erwartet, dass

diese kleinen Mengen zu Problemen bei Patienten mit Laktose-Intoleranz führen. Die Laktose kann

Restmengen von Milchprotein enthalten.

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

·an anderen Krankheiten leiden,

·Allergien haben oder

·andere Arzneimittel (auch selbstgekaufte!) einnehmen!

Darf Oxis Turbuhaler während einer Schwangerschaft oder in der Stillzeit angewendet werden?

Wenn Sie schwanger sind oder es werden möchten sowie in der Stillzeit, darf Oxis nur nach

Rücksprache mit der Ärztin oder dem Arzt angewendet werden.

Wie verwenden Sie Oxis Turbuhaler?

Die Ärztin bzw. der Arzt wird aufgrund regelmässiger Untersuchungen die für Sie zutreffende

Dosierung festlegen, v.a. wenn Sie die Behandlung neu beginnen. Falls Sie Oxis häufiger als

verschrieben anwenden müssen, falls Sie keuchen müssen oder atemlos werden, müssen Sie Oxis

weiter verwenden, aber so bald als möglich Ihre Ärztin bzw. Ihren Arzt kontaktieren. Erhöhen Sie

die Dosierung nicht ohne ärztliche Konsultation.

Üblicherweise gelten folgende Dosierungsrichtlinien:

Erwachsene

Behandlung nach Bedarf: Zur Linderung von Symptomen werden 1-2 Inhalationen von Oxis 6 oder 1

Inhalation von Oxis 12 je nach Bedarf inhaliert.

Regelmässige Behandlung von Asthma

1-2× täglich 1-2 Inhalationen von Oxis 6 oder 1 Inhalation von Oxis 12 inhalieren. Falls erforderlich

kann die Dosierung auf 2× täglich 4 Inhalationen von Oxis 6 oder 2 Inhalationen von Oxis 12 erhöht

werden.

Diese Dosis von 48 µg (= 8 Inhalationen von Oxis 6 oder 4 Inhalationen von Oxis 12) sollte

allerdings nicht überschritten werden.

Regelmässige Behandlung der chronisch-obstruktiven Lungenkrankheit (COPD)

2× täglich 1 Inhalation von Oxis 6 oder von Oxis 12 (entspricht total 12-24 µg täglich).

Falls erforderlich kann die Dosierung auf 2× täglich 2 Inhalationen Oxis 6 (entspricht total 24 µg)

erhöht werden.

Kinder ab 6 Jahren

Behandlung nach Bedarf: Zur Linderung von Symptomen werden 1-2 Inhalationen von Oxis 6 oder

1 Inhalation von Oxis 12 je nach Bedarf inhaliert.

Regelmässige Anwendung: 1-2 Inhalationen von Oxis 6 oder 1 Inhalation von Oxis 12 1-2mal

täglich. Mehr als 4 Inhalationen von Oxis 6 oder als 2 Inhalationen von Oxis 12 dürfen nicht inhaliert

werden.

Erwachsene und Kinder über 6 Jahre

Prophylaxe von Asthmaanfällen, welche durch körperliche Anstrengung hervorgerufen werden: vor

der körperlichen Anstrengung 1-2 Inhalationen von Oxis 6 oder 1 Inhalation von Oxis 12 inhalieren.

1 Anwendung reicht für 4–12 Stunden.

Ändern Sie nicht von sich aus die verschriebene Dosierung. Wenn Sie glauben, das Arzneimittel

wirke zu schwach oder zu stark, so sprechen Sie mit Ihrer Ärztin oder Ihrem Arzt bzw. Ihrer

Apothekerin oder Ihrem Apotheker.

Anwendungsanweisung

Der Turbuhaler ist ein Mehrdosenpulverinhalator, mit welchem pro Inhalation nur sehr wenig

Wirkstoffpulver freigesetzt wird (Abbildung 1). Mit der Einatmung durch den Turbuhaler gelangt

das Pulver in die Lunge. Es ist wichtig, dass Sie kräftig und tief durch das Mundstück einatmen.

Vorbereitung des neuen Turbuhalers vor der ersten Inhalation

1.Weisse Schutzkappe abschrauben.

2.Das Inhalationsgerät aufrecht halten, mit dem Dosierrad nach unten. Das Mundstück nicht

festhalten.

3.Das türkisfarbene Dosierrad zweimal bis zum Anschlag und wieder zurück in die

Ausgangsposition drehen (Abbildung 2). Dabei ist ein «Klick» zu hören. Es ist egal, in welche

Richtung Sie zuerst drehen. Das Gerät ist nun zur Inhalation bereit.

Anwendung des Turbuhalers

1.Schutzkappe abschrauben

2.Das Inhalationsgerät aufrecht halten, mit dem Dosierrad nach unten. Das Mundstück nicht

festhalten.

3.Zum Laden einer Dosis das türkisfarbene Dosierrad bis zum Anschlag und wieder zurück in die

Ausgangsposition drehen (Abbildung 2). Dabei ist ein «Klick» zu hören. Es ist egal, in welche

Richtung Sie zuerst drehen.

4.In die Luft ausatmen, nicht in den Turbuhaler.

5.Dann das Mundstück sanft mit den Zähnen und den Lippen umschliessen und tief und kräftig

einatmen (Abbildung 3). Das Mundstück darf weder gekaut noch darf darauf gebissen werden.

6.Das Gerät vom Mund absetzen und den Atem einige Sekunden anhalten. Langsam ausatmen. Nicht

durch das Mundstück ausatmen.

7.Schutzkappe wieder fest aufschrauben.

Wird mehr als eine Inhalation pro Anwendung benötigt, müssen die Schritte 2/3/4/5/6 entsprechend

wiederholt werden.

Wichtige Hinweise

Nie durch das Mundstück ausatmen, und die Schutzkappe nach jeder Anwendung wieder gut

schliessen. Es ist möglich, dass Sie bei der Inhalation den Wirkstoff weder spüren noch einen

Geschmack wahrnehmen, da nur sehr wenig Wirkstoff freigesetzt wird.

Kinder dürfen nur unter Aufsicht von Erwachsenen mit Oxis behandelt werden.

Verwenden Sie den Oxis Turbuhaler nicht mehr, falls er beschädigt ist oder sich das Mundstück

gelöst hat.

Reinigung des Mundstücks

Das Mundstück sollte wöchentlich mit einem trockenen Tuch aussen abgerieben werden. Zur

Reinigung des Mundstückes darf kein Wasser verwendet werden.

Wann ist der Oxis Turbuhaler aufgebraucht?

Die Dosisanzeige zeigt Ihnen, wieviele Dosen noch im Turbuhaler sind, bei 60 beginnend

(Abbildung 4). Die Dosisanzeige wird in Intervallen von 10 Dosen angezeigt. Wenn Sie eine rote

Markierung im Fenster bemerken, sind noch rund 20 Dosen übrig. Bei den letzten 10 Dosen wird der

Hintergrund des Fensters ganz rot. Wenn die «0» auf dem roten Hintergrund die Mitte des Fensters

erreicht hat (Abbildung 5), müssen Sie einen neuen Turbuhaler verwenden.

Das Geräusch, das beim Schütteln des Inhaliergerätes auftritt, wird durch das Trocknungsmittel

verursacht. Es ist auch dann noch zu hören, wenn das Gerät nicht mehr genügend oder keinen

Wirkstoff mehr enthält.

Welche Nebenwirkungen kann Oxis Turbuhaler haben?

Folgende Nebenwirkungen können bei der Anwendung von Oxis auftreten:

Häufig: Kopfschmerzen, Zittern, Schwindel, Übelkeit, Muskelkrämpfe. Gelegentlich:

Überempfindlichkeitsreaktionen wie eine Verengung der Bronchien oder Hautausschlag und

Juckreiz, Kaliummangel (kann sich in Form einer Kraftlosigkeit, Muskelschwäche, Darmträgheit,

Wassereinlagerungen im Gewebe und/oder einer beschleunigten Herzschlagfolge äussern), erhöhte

Blutzuckerwerte, Schlafstörungen, Geschmacksstörungen, unregelmässiger Herzschlag, Schmerzen

in der Brust, Blutdruckschwankungen.

Selten: Stimmungsschwankungen, Unruhe.

Diese Begleiterscheinungen klingen jedoch im Verlauf der Behandlung nach 1-2 Wochen ab.

Wenn Sie Nebenwirkungen bemerken, die hier nicht beschrieben sind, sollten Sie Ihre Ärztin oder

Arzt bzw. Ihre Apothekerin oder Apotheker informieren.

Was ist ferner zu beachten?

Oxis ist nicht über 30 °C und ausser Reichweite von Kindern aufzubewahren. Oxis darf nur bis zu

dem auf der Packung unter «EXP» aufgedruckten Datum verwendet werden. Falls Sie im Besitze

eines aufgebrauchten oder verfallenen Oxis Turbuhalers sind, bringen Sie diesen zur Entsorgung in

die Apotheke zurück. Weitere Auskünfte erteilt Ihnen Ihre Ärztin oder Ihr Arzt bzw. Ihre

Apothekerin oder Ihr Apotheker, die über die ausführliche Fachinformation verfügen.

Was ist in Oxis Turbuhaler enthalten?

1 Inhalationshub Oxis Turbuhaler enthält als Wirkstoff 6 µg resp. 12 µg Formoterol und als

Hilfsstoff Laktose.

Zulassungsnummer

53997 (Swissmedic).

Wo erhalten Sie Oxis Turbuhaler? Welche Packungen sind erhältlich?

Oxis Turbuhaler erhalten Sie in Apotheken nur gegen ärztliches Rezept.

Packungen zu 60 Einzeldosen à 6 µg resp. 12 µg.

Zulassungsinhaberin

AstraZeneca AG, 6340 Baar.

Diese Packungsbeilage wurde im November 2016 letztmals durch die Arzneimittelbehörde

(Swissmedic) geprüft.

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1-9-2018

Acknowledgement:EFSA  wishes  to  thank  the  rapporteur  Member  State  Denmark  for  thepreparatory work on this scientific output.Suggested citation:EFSA (European Food Safety Authority), Brancato A, Brocca D, Carrasco Cabrera L,De Lentdecker C, Erdos

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Europe - EFSA - European Food Safety Authority Publications

1-9-2018

Review of the existing MRLs for fenbuconazole

Review of the existing MRLs for fenbuconazole

Published on: Fri, 31 Aug 2018 00:00:00 +0200 According to Article 12 of Regulation (EC) No 396/2005, EFSA has reviewed the maximum residue levels (MRLs) currently established at European level for the pesticide active substance fenbuconazole. To assess the occurrence of fenbuconazole residues in plants, processed commodities, rotational crops and livestock, EFSA considered the conclusions derived in the framework of Directive 91/414/EEC, the MRLs established by the Codex Alimentarius Commission as well...

Europe - EFSA - European Food Safety Authority Publications

30-8-2018

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

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

Published on: Tue, 07 Aug 2018 00:00:00 +0200 During the project seven standard operating procedures (SOP) were developed for the four data domains (zoonoses, chemical contaminant, pesticide residues and veterinary medical products residues). The SOPs describe 1) How the national governance of risk assessment data is organised, 2) how data are collected and validated before delivering to EFSA covering all four domains, 3) How data is transferred to EFSA, 4) how to respond to EFSA request for clarificati...

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

Product Quest Manufacturing LLC Recalls All Nasal Products and Baby Oral Gels Manufactured at Florida Facility Due to Possible Microbial Contamination

Product Quest Manufacturing LLC Recalls All Nasal Products and Baby Oral Gels Manufactured at Florida Facility Due to Possible Microbial Contamination

Product Quest Manufacturing (“Product Quest”) announced its voluntary recall of Lot# 173089J of CVS Health 12 Hour Sinus Relief Nasal Mist due to a finding of microbial contamination identified as Pseudomonas aeruginosa.

FDA - U.S. Food and Drug Administration

29-8-2018

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

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

Published on: Tue, 28 Aug 2018 00:00:00 +0200 According to Article 12 of Regulation (EC) No 396/2005, EFSA has reviewed the maximum residue levels (MRLs) currently established at European level for the pesticide active substance sintofen. To assess the occurrence of sintofen residues in plants, processed commodities, rotational crops and livestock, EFSA considered the conclusions derived in the framework of Commission Regulation (EC) No 33/2008, as well as the European authorisations reported by Member ...

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

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

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

Published on: Mon, 13 Aug 2018 00:00:00 +0200 According to Article 12 of Regulation (EC) No 396/2005, EFSA has reviewed the maximum residue levels (MRLs) currently established at European level for the pesticide active substance myclobutanil. To assess the occurrence of myclobutanil residues in plants, processed commodities, rotational crops and livestock, EFSA considered the conclusions derived in the framework of Commission Regulation (EC) No 33/2008, the MRLs established by the Codex Alimentarius Com...

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

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

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

Published on: Fri, 10 Aug 2018 00:00:00 +0200 The European Food Safety Authority (EFSA) carried out a public consultation to receive input from the scientific community and all interested parties on a draft protocol for the Scientific Opinion on free sugars from all dietary sources, prepared by the EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA Panel), supported by the ad‐hoc Working Group on Sugars. The draft protocol was endorsed by the Panel for public consultation at its plenary meeti...

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

12-11-2018

Efavirenz/Emtricitabine/Tenofovir disoproxil Zentiva (Zentiva, k.s.)

Efavirenz/Emtricitabine/Tenofovir disoproxil Zentiva (Zentiva, k.s.)

Efavirenz/Emtricitabine/Tenofovir disoproxil Zentiva (Active substance: efavirenz / emtricitabine / tenofovir disoproxil) - Centralised - Yearly update - Commission Decision (2018)7547 of Mon, 12 Nov 2018

Europe -DG Health and Food Safety

30-10-2018

SUTENT® 12,5/25/37,5/50 mg Hartkapseln

Rote - Liste

25-10-2018

Moventig® 12,5 mg/25 mg Filmtabletten

Rote - Liste

12-10-2018

Irbesartan Zentiva (Zentiva k.s.)

Irbesartan Zentiva (Zentiva k.s.)

Irbesartan Zentiva (Active substance: Irbesartan) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)6772 of Fri, 12 Oct 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/785T/79

Europe -DG Health and Food Safety

1-10-2018

EU/3/05/328 (Celgene Europe B.V.)

EU/3/05/328 (Celgene Europe B.V.)

EU/3/05/328 (Active substance: (E)-(1S,4S,10S,21R)-7-[(Z)-ethylidene]-4,21-diisopropyl-2-oxa-12,13-dithia-5,8,20,23- tetraazabicyclo[8.7.6]tricos-16-ene-3,6,9,19,22-pentone) - Transfer of orphan designation - Commission Decision (2018)6434 of Mon, 01 Oct 2018 European Medicines Agency (EMA) procedure number: EMA/OD/056/05/T/03

Europe -DG Health and Food Safety

1-10-2018

EU/3/05/279 (Celgene Europe B.V.)

EU/3/05/279 (Celgene Europe B.V.)

EU/3/05/279 (Active substance: (E)-(1S,4S,10S,21R)-7-[(Z)-ethylidene]-4,21-diisopropyl-2-oxa-12,13-dithia-5,8,20,23- tetraazabicyclo[8.7.6]tricos-16-ene-3,6,9,19,22-pentone) - Transfer of orphan designation - Commission Decision (2018)6433 of Mon, 01 Oct 2018 European Medicines Agency (EMA) procedure number: EMA/OD/001/05/T/03

Europe -DG Health and Food Safety

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

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

19-9-2018

Memantine Mylan (Mylan S.A.S.)

Memantine Mylan (Mylan S.A.S.)

Memantine Mylan (Active substance: Memantine) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)5972 of Wed, 19 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2660/T/12

Europe -DG Health and Food Safety

14-9-2018

Agenda:  Agenda - CAT agenda of the 12-14 September 2018 meeting

Agenda: Agenda - CAT agenda of the 12-14 September 2018 meeting

Europe - EMA - European Medicines Agency

14-9-2018

Fentanyl AWD® Matrix 12 Mikrogramm/h

Rote - Liste

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

12-9-2018

ADCETRIS (Takeda Pharma A/S)

ADCETRIS (Takeda Pharma A/S)

ADCETRIS (Active substance: Brentuximab vedotin) - Centralised - Annual renewal - Commission Decision (2018)5973 of Wed, 12 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2455/R/58

Europe -DG Health and Food Safety

11-9-2018

 Focus group meeting  on dose optimisation of established veterinary antibiotics in the context of summary of product characteristics harmonisation, European Medicines Agency, London, UK, From: 12-Oct-2018, To: 12-Oct-2018

Focus group meeting on dose optimisation of established veterinary antibiotics in the context of summary of product characteristics harmonisation, European Medicines Agency, London, UK, From: 12-Oct-2018, To: 12-Oct-2018

This meeting will allow a direct exchange of views between the Agency’s working party and stakeholders on its draft reflection paper on dose optimisation of established veterinary antibiotics in the context of summary of product characteristics (SPC) harmonisation (EMA/CVMP/849775/2017). It complements the public consultation on this reflection paper ending on 31 January 2019. The reflection paper follows considerations in the report on a pilot project that aimed to develop and test non-experimental appr...

Europe - EMA - European Medicines Agency

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