Gaois

Cóip statach de shonraí a easpórtáiltear ó IATE ó am go chéile atá sa chnuasach seo. Níor cheart glacadh leis gurb ionann i gcónaí an t-eolas a thugtar faoi iontráil anseo agus a bhfuil sa leagan reatha den iontráil ar IATE. Is féidir an leagan reatha sin a cheadú ach cliceáil ar an nasc atá ar thaobh na láimhe deise ag barr gach iontrála. Breis eolais »

2 thoradh

  1. SOCIAL QUESTIONS|health|pharmaceutical industry
    tuarascáil sábháilteachta maidir le cás aonair Tagairt Téarmeolaithe COM-GA
    ga
    tuairisc shábháilteachta do chás ar leith Tagairt Faomhadh an téarma seo mar chuid de Thionscadal Lex
    ga
    Sicherheitsberichte für Einzelfälle
    de
    ICSR | ICSRs | individual case safety report
    en
    Sainmhíniú report of information describing adverse events or reactions experienced by an individual patient, in which the events or reactions can be related to the administration of one or more medicinal products at a particular point in time Tagairt "COM-EN, based on: European Medicines Agency. ICH guideline E2B (R3) Electronic transmission of individual case safety reports (ICSRs) - implementation guide - data elements and message specification. 2011. http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500002767.pdf [28.3.2012]"
    Nóta "The ICSR can also be used for exchange of other information, such as medication errors that do not involve adverse events or reactions. See also:adverse event [ IATE:1863780 ] adverse reaction [ IATE:1146946 ]"
    rapport individuel d'effets indésirables | observation individuelle d'effets indésirables | ICSR
    fr
    Sainmhíniú rapport d'information décrivant les effets indésirables subis par un patient Tagairt COM-FR
  2. SOCIAL QUESTIONS|health|pharmaceutical industry
    tuarascáil sábháilteachta uasdátaithe thréimhsiúil maidir le substaint aonair Tagairt Téarmeolaithe COM-GA
    ga
    TSUT substainte aonair Tagairt Téarmeolaithe COM-GA
    ga
    tuarascáil thréimhsiúil chun dáta maidir le sábháilteacht i gcás substaint aonair Tagairt Faomhadh an téarma seo mar chuid de Thionscadal Lex
    ga
    tuarascáil aonair thréimhsiúil chun dáta maidir le sábháilteacht Tagairt Faomhadh an téarma seo mar chuid de Thionscadal Lex
    ga
    regelmäßig aktualisierter Sicherheitsbericht über einen einzigen Wirkstoff | Sicherheitsbericht über einen einzigen Wirkstoff
    de
    single-substance PSUR | single substance PSUR | single-substance periodic safety update report | single periodic safety update report | single PSUR | single agent PSUR
    en
    Sainmhíniú "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" Tagairt "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
    Sainmhíniú "rapport périodique de sécurité [ IATE:3535677 ] établi pour des médicaments contenant la même substance active" Tagairt "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]"