Gaois

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6 results

  1. SOCIAL QUESTIONS|health|pharmaceutical industry · EUROPEAN UNION|EU institutions and European civil service|EU office or agency|European Medicines Agency

    #688267

    IATE #3640006
    iarratas tar éis údarú margaíochta Reference Faomhadh an téarma seo mar chuid de Thionscadal Lex
    ga
    Antrag nach der Zulassung
    de
    post-marketing authorisation application
    en
    Definition application for the amendment of the conditions of an initial marketing authorisation, via a variation application procedure Reference European Commission. DG SANTE. Correspondence dated 18.8.2023
    Comment e.g. concerning a change in the initial composition, name of a medicinal product, the addition of a new theareputic indication or new safety measures. Any amendment that is made after authorisation is applied via a variation application.
    demande de modification des termes d’une autorisation de mise sur le marché postérieure à l’octroi de celle-ci
    fr
    Definition demande de modification des termes d’une autorisation de mise sur le marché postérieure à l’octroi de celle-ci, au moyen d'un dossier de variation Reference "COM-FR d'après- Proposition de directive du Parlement européen et du Conseil instituant un code de l’Union relatif aux médicaments à usage humain et abrogeant la directive 2001/83/CE et la directive 2009/35/CE, COM(2023) 192- Agence fédérale des médicaments et des produits de santé > Usage humain > Médicaments > Médicaments > Procédures d'autorisation de mise sur le marché > Procédures après la délivrance de l'autorisation initiale > Variations (30.11.2023)"
  2. SOCIAL QUESTIONS|health|pharmaceutical industry

    #683141

    IATE #3544244
    staidéar éifeachtúlachta iar-údarúcháin Reference Faomhadh an téarma seo mar chuid de Thionscadal Lex
    ga
    Context 'Déanfar an oibleagáid go ndéanfaí an staidéar éifeachtúlachta iar-údarúcháin a bhunú ar na gníomhartha tarmligthe a ghlactar de bhun Airteagal 10b, agus an treoraíocht eolaíoch dá dtagraítear in Airteagal 108a de Threoir 2001/83/CE á cur san áireamh.' Reference "Rialachán (AE) Uimh. 1235/2010 lena leasaítear, maidir le cógas-aireachas ar tháirgí íocshláinte lena n-úsáid ag an duine, Rialachán (CE) Uimh. 726/2004 lena leagtar síos nósanna imeachta Comhphobail maidir le húdarú agus maoirseacht táirgí íocshláinte lena n-úsáid ag an duine agus le haghaidh úsáide tréidliachta agus lena mbunaítear Gníomhaireacht Leigheasra Eorpach, agus Rialachán (CE) Uimh. 1394/2007 maidir le táirgí íocshláinte ardteiripe, CELEX:32010R1235/GA"
    post-authorisation efficacy study | post-marketing efficacy study | post-authorisation efficacy studies
    en
    Definition study conducted after a product has been placed on the market when the understanding of the disease or the clinical methodology indicate that previous efficacy evaluations might have to be revised significantly Reference "COM-Terminology Coordination, based on: Directive 2001/83/EC on the Community code relating to medicinal products for human use"
    étude d'efficacité postautorisation | étude d'efficacité post-commercialisation | PAES | étude d'efficacité post-autorisation
    fr
    Definition étude effectuée après qu'un produit a été mis sur le marché lorsque la compréhension de la maladie ou la méthodologie clinique indique que les évaluations d'efficacité antérieures pourraient devoir être revues de manière significative Reference "Conseil-FR, d'après la directive 2001/83/CE instituant un code communautaire relatif aux médicaments à usage humain"
  3. SOCIAL QUESTIONS|health|pharmaceutical industry

    #681973

    IATE #2251252
    staidéar sábháilteachta iarúdaraithe Reference Faomhadh an téarma seo mar chuid de Thionscadal Lex
    ga
    Context 'I gcás ina bhforchuireann an Coimisiún an oibleagáid chun staidéar sábháilteachta iarúdaraithe a dhéanamh ar níos mó ná sealbhóir údaraithe margaíochta amháin, i gcás ina mbaineann na hábhair imní chéanna le níos mó ná táirge íocshláinte amháin agus ina ndéanann na sealbhóirí údaraithe margaíochta lena mbaineann staidéar sábháilteachta iarúdaraithe comhpháirteach ...' Reference "Rialachán (AE) 2024/568 maidir le táillí agus muirir is iníoctha leis an nGníomhaireacht Leigheasra Eorpach, lena leasaítear Rialacháin (AE) 2017/745 agus (AE) 2022/123 ó Pharlaimint na hEorpa agus ón gComhairle agus lena n-aisghairtear Rialachán (AE) Uimh. 658/2014 ó Pharlaimint na hEorpa agus ón gComhairle agus Rialachán (CE) Uimh. 297/95 ón gComhairle, CELEX:32024R0568/GA"
    Unbedenklichkeitsstudie nach der Zulassung
    de
    Definition Studie zur Unbedenklichkeit zugelassener Arzneimittel, bei der es sich nicht um klinische Prüfungen handelt (insbesondere um sicherzustellen, dass sie nicht Werbezwecken dient), sowie zur Überwachung der Folgemaßnahmen hinsichtlich der aus solchen Studien hervorgehenden Sicherheitsdaten Reference "Vorschlag für eine Richtlinie zur Änderung der Richtlinie 2001/83/EG zur Schaffung eines Gemeinschaftskodexes für Humanarzneimittel hinsichtlich der Pharmakovigilanz, CELEX:52008PC0665"
    Comment Verfahren zur Änderung der genannten Richtlinie läuft (Stand: 31.8. 2010).
    post-authorisation safety study | PASS | post-marketing safety study
    en
    Definition pharmacoepidemiological study or a clinical trial carried out in accordance with the terms of the marketing authorisation, conducted with the aim of identifying or quantifying a safety hazard relating to an authorised medicinal product Reference "Directive 2001/83/EC on the Community code relating to medicinal products for human use"
    Comment "A PASS may be a clinical trial or a non-interventional study.For more information, see: European Medicines Agency, Guideline on good pharmacovigilance practices (GVP). Module VIII – Post-authorisation safety studies. 2012 (15.3.2023)"
    étude de sécurité post-autorisation
    fr
    Definition étude portant sur un médicament autorisé et visant à identifier, décrire ou quantifier un risque de sécurité, à confirmer le profil de sécurité du médicament ou à mesurer l’efficacité des mesures de gestion des risques Reference COM-Document interne: ENTR/2008/80076/02/02
  4. SOCIAL QUESTIONS|health|pharmaceutical industry

    #687799

    IATE #3638719
    staidéar iarmhargaíochta Reference Faomhadh an téarma seo mar chuid de Thionscadal Lex
    ga
    Context '... an oibleagáid staidéir iarmhargaíochta a dhéanamh lena n‑áirítear staidéir sábháilteachta iarúdaraithe agus staidéir éifeachtúlachta iarúdaraithe, agus iad a chur isteach lena n‑athbhreithniú, dá bhforáiltear in Airteagal 20 ...' Reference "Togra le haghaidh Rialachán lena leagtar síos nósanna imeachta Aontais maidir le húdarú agus maoirseacht táirgí íocshláinte lena n-úsáid ag an duine agus lena mbunaítear rialacha lena rialaítear an Ghníomhaireacht Leigheasra Eorpach, lena leasaítear Rialachán (CE) Uimh. 1394/2007 agus Rialachán (AE) Uimh. 536/2014 agus lena n-aisghairtear Rialachán (CE) Uimh. 726/2004, Rialachán (CE) Uimh. 141/2000 agus Rialachán (CE) Uimh. 1901/2006, CELEX:52023PC0193/GA"
    staidéar iarúdaraithe Reference Faomhadh an téarma seo mar chuid de Thionscadal Lex
    ga
    Context 'Féadfar cur chun feidhme beart nó staidéar iarúdaraithe a bhreithniú ar bhonn cás ar chás chun aghaidh a thabhairt ar bhearnaí sna sonraí nó éiginnteachtaí tráth údaraithe an táirge.' Reference "Rialachán Tarmligthe (AE) 2021/805 lena leasaítear Iarscríbhinn II a ghabhann le Rialachán (AE) 2019/6 ó Pharlaimint na hEorpa agus ón gComhairle, CELEX:32021R0805/GA"
    post-authorisation study | post-marketing study
    en
    Definition "a post-authorisation efficacy study or a post-authorisation safety study or a post-marketing surveillance study or any other study requested after a medicinal product has been granted marketing authorisation" Reference "COM-Terminology Coordination, based on: - Regulation (EC) No 726/2004 laying down Union procedures for the authorisation and supervision of medicinal products for human use and establishing a European Medicines Agency- Regulation (EC) No 1901/2006 on medicinal products for paediatric use and amending Regulation (EEC) No 1768/92, Directive 2001/20/EC, Directive 2001/83/EC and Regulation (EC) No 726/2004- Implementing Regulation (EU) 2021/1281 laying down rules for the application of Regulation (EU) 2019/6 as regards good pharmacovigilance practice and on the format, content and summary of the pharmacovigilance system master file for veterinary medicinal products"
  5. SOCIAL QUESTIONS|health|pharmaceutical industry|veterinary medicinal product|veterinary drug

    #644049

    IATE #3518703
    staidéar ar fhaireachas iarmhargaíochta Reference Faomhadh an téarma seo mar chuid de Thionscadal Lex
    ga
    Context 'Féadfaidh an Ghníomhaireacht iarraidh ar shealbhóir údaraithe margaíochta do tháirgí íocshláinte tréidliachta arna n-údarú go lárnach, nó do tháirgí íocshláinte tréidliachta arna n-údarú go náisiúnta i gcás ina dtagann siad faoi raon feidhme tarchuir ar leas an Aontais dá dtagraítear in Airteagal 82, sonraí faireachais cógas sonracha breise a bhailiú maidir leis na sonraí a liostaítear in Airteagal 73(2) agus staidéir ar fhaireachas iarmhargaíochta a dhéanamh. Luafaidh an Ghníomhaireacht na cúiseanna mionsonraithe atá leis an iarraidh, socróidh sí teorainn ama iomchuí léi agus cuirfidh sí na húdaráis inniúla ar an eolas faoi.' Reference "Rialachán (AE) 2019/6 maidir le táirgí íocshláinte tréidliachta agus lena n-aisghairtear Treoir 2001/82/CE, CELEX:32019R0006/GA"
    Überwachungsstudie nach dem Inverkehrbringen
    de
    Definition pharmako-epidemiologische Studie oder klinische Prüfung entsprechend den Bedingungen der Genehmigung für das Inverkehrbringen mit dem Ziel, eine Gesundheitsgefahr im Zusammenhang mit einem zugelassenen Tierarzneimittel festzustellen und zu beschreiben Reference "Richtlinie 2001/82/EG des Europäischen Parlaments und des Rates vom 6. November 2001 zur Schaffung eines Gemeinschaftskodexes für Tierarzneimittel"
    post-marketing surveillance study | post-marketing surveillance studies
    en
    Definition pharmacoepidemiological study or a clinical trial carried out in accordance with the terms of the marketing authorisation, conducted with the aim of identifying and investigating a safety hazard relating to an authorised veterinary medicinal product Reference "Directive 2001/82/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to veterinary medicinal products"
    étude de surveillance après mise sur le marché
    fr
    Definition étude pouvant être volontaire ou imposée par les autorités réglementaires et réalisée après l’autorisation de mise sur le marché d’un médicament et de son utilisation généralisée, dans le but de recueillir des informations complémentaires sur les effets secondaires et la sécurité d’emploi, les risques et bénéfices à long-terme et/ou l’efficacité du médicament lorsqu’il est utilisé plus largement Reference "COM-FR d'après:EUPATI: Patient Engagement Through Education > Toolbox > Glossaire > Études de surveillance post-AMM (15.11.2021)"
  6. SOCIAL QUESTIONS|health|pharmaceutical industry|pharmaceutical product|vaccine

    #630221

    IATE #1528795
    éifeachtacht vacsaíne Reference Faomhadh an téarma seo mar chuid de Thionscadal Lex
    ga
    éifeachtacht vacsaíne tar éis margaíochta Reference Faomhadh an téarma seo mar chuid de Thionscadal Lex
    ga
    éifeachtacht vacsaíne tar éis a údaraithe Reference Faomhadh an téarma seo mar chuid de Thionscadal Lex
    ga
    Impfeffektivität | Impfstoffeffektivität
    de
    Definition die Gesamtauswirkungen des Einsatzes eines Impfstoffs Reference "Robert-Koch-Institut > Service > Publikationen > Fachwörterbuch Infektionsschutz und Infektions­epidemiologie. Fachwörter – Definitionen – Interpretationen (25.3.2021)"
    Comment neben der direkten Impfstoffwirksamkeit können die indirekten Wirkungen der Impfung (wie die Reduktion der Inzidenz, Krankenhausbehandlungen, tödliche Ausgänge der Zielkrankheit) nach breiter Anwendung des Impfstoffs in einer Population unter Alltagsbedingungen in Studien ermittelt werden
    vaccine effectiveness | post-marketing vaccine effectiveness | post-authorisation effectiveness | post-authorisation efficacy
    en
    Definition ability of a vaccine to protect against the disease for which it is administered Reference "COM-Terminology Coordination, based on:CDC. 'Vaccine Effectiveness: How Well Do the Flu Vaccines Work?' (18.5.2021)"
    Comment "1) No vaccine is 100% effective. To make vaccines safer than the disease, the bacteria or virus is killed or weakened (attenuated). For reasons related to the individual, not all vaccinated persons develop immunity. Most routine childhood vaccines are effective for 85% to 95% of recipients.2) Before a vaccine is granted a market authorisation, vaccine efficacy is measured."
    efficacité réelle du vaccin
    fr
    Definition efficacité d'un vaccin mesurée par l’observation de la protection que le vaccin apporte à des communautés dans leur ensemble Reference "Organisation mondiale de la santé > Centre des médias > Reportages > Détail > Efficacité potentielle, efficacité réelle et protection des vaccins (11.11.2021)"