Gaois

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3 results

  1. SOCIAL QUESTIONS|health|pharmaceutical industry
    tuarascáil thréimhsiúil chun dáta maidir le sábháilteacht Reference Faomhadh an téarma seo mar chuid de Thionscadal Lex
    ga
    regelmäßiger aktualisierter Unbedenklichkeitsbericht | PSUR | regelmäßig aktualisierter Sicherheitsbericht
    de
    PSUR | Periodic Safety Update Report
    en
    Definition update report on the worldwide safety experience of a medicinal product that must be submitted by the marketing authorisation holder to the competent authorities at defined time points after authorisation Reference COM-EN based on: European Medicines Agency. ICH Topic E 2 C (R1). Clinical Safety Data Management: Periodic Safety Update Reports for Marketed Drugs. Step 5. Note For Guidance On Clinical Safety Data Management: Periodic Safety Update Reports For Marketed Drugs. http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500002780.pdf [28.3.2012]
    Comment A single report may cover all products containing the same active substance(s) licensed by one MA holder. The report will usually include all dosage forms and formulations, as well as all indications, associated with such an active.For combinations of substances which are also registered individually, safety information for the fixed combination may be reported either in a separate PSUR or be included as a separate presentation in the report for one of the separate components, depending on the circumstances. Cross-referencing all relevant PSURs is essential.References:MHRA (Medicines and Healthcare products Regulatory Agency) > How we regulate > Medicines > Licensing of medicines > Information for licence holders > Periodic Safety Update Reports, http://www.mhra.gov.uk/Howweregulate/Medicines/Licensingofmedicines/Informationforlicenceapplicants/PeriodicSafetyUpdateReports/index.htm [23.4.2012]& European Medicines Agency. Guideline on good pharmacovigilance practices (GVP). Module VII – Periodic safety update report. http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2012/02/WC500123207.pdf [23.4.2012]
    PSUR | rapport périodique actualisé de sécurité | rapport périodique actualisé relatif à la sécurité | rapport périodique actualisé de pharmacovigilance
    fr
    Definition document qui propose une évaluation des effets indésirables recensés par un laboratoire et qui doit être régulièrement soumis aux autorités sanitaires compétentes Reference Sénat français > Travaux parlementaires > Missions d'information > Mission commune d'information Mediator > Comptes rendus, comptes rendus de la mission commune d'information sur le Mediator, http://www.senat.fr/compte-rendu-commissions/20110523/mediator.html [8.10.2012]
    Comment L'enjeu n'est pas de savoir comment assurer le suivi en matière de pharmacovigilance, mais de faire connaître les événements indésirables qui se sont produits depuis le dernier rapport dans le cadre de l'utilisation d'un médicament.
  2. SOCIAL QUESTIONS|health|pharmaceutical industry
    tuarascáil aonair thréimhsiúil chun dáta maidir le sábháilteacht Reference Faomhadh an téarma seo mar chuid de Thionscadal Lex
    ga
    tuarascáil thréimhsiúil chun dáta maidir le sábháilteacht i gcás substaint aonair Reference Faomhadh an téarma seo mar chuid de Thionscadal Lex
    ga
    Sicherheitsbericht über einen einzigen Wirkstoff | regelmäßig aktualisierter Sicherheitsbericht über einen einzigen Wirkstoff
    de
    single PSUR | single periodic safety update report | single-substance periodic safety update report | single-substance PSUR | single agent PSUR | single substance PSUR
    en
    Definition periodic safety update report [ IATE:3535677 ] covering all products containing the same active substance [ IATE:35093 ] authorised to one marketing authorisation holder; periodic safety update report [ IATE:3535677 ] covering all products containing the same active substance [ IATE:35093 ] authorised to one marketing authorisation holder Reference COM-EN, based on: European Medicines Agency. Guideline on good pharmacovigilance practices (GVP). Module VII – Periodic safety update report. http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2012/02/WC500123207.pdf [23.4.2012] & European Medicines Agency. ICH Topic E 2 C (R1). Clinical Safety Data Management: Periodic Safety Update Reports for Marketed Drugs. Step 5. Note For Guidance On Clinical Safety Data Management: Periodic Safety Update Reports For Marketed Drugs. http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500002780.pdf [28.3.2012]& MHRA (Medicines and Healthcare products Regulatory Agency) > How we regulate > Medicines > Licensing of medicines > Information for licence holders > Periodic Safety Update Reports, http://www.mhra.gov.uk/Howweregulate/Medicines/Licensingofmedicines/Informationforlicenceapplicants/PeriodicSafetyUpdateReports/index.htm [23.4.2012]
    rapport périodique de sécurité unique
    fr
    Definition rapport périodique de sécurité [ IATE:3535677 ] établi pour des médicaments contenant la même substance active Reference TERM-FR, d'après: Conseil de l'Union européenne, Effets indésirables des médicaments: le Conseil prend des mesures, 29 novembre 2010, http://register.consilium.europa.eu/pdf/fr/10/st17/st17054.fr10.pdf [8.10.2012]
  3. SOCIAL QUESTIONS|health|pharmaceutical industry
    tuarascáil neamhspléach thréimhsiúil chun dáta maidir le sábháilteacht Reference Faomhadh an téarma seo mar chuid de Thionscadal Lex
    ga
    eigenständiger regelmäßig aktualisierter Sicherheitsbericht
    de
    stand-alone periodic safety update report | stand-alone PSUR | PSURs | reports
    en
    Definition independent periodic safety update report (PSUR) [ IATE:3535677 ] prepared for a combination of active substances authorised to one marketing authorisation holder for which separate single-substance PSURs [ IATE:3542065 ] have been provided Reference COM-EN, based on:European Medicines Agency. Guideline on good pharmacovigilance practices (GVP). Module VII – Periodic safety update report http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2012/02/WC500123207.pdf [11.4.2012] and on information provided by DG SANCO [30.3.2012]
    Comment Stand-alone PSURs should be cross-referenced to the related single-substance PSURs.