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 »

1 toradh

  1. SOCIAL QUESTIONS|health|pharmaceutical industry
    tuarascáil aonair thréimhsiúil chun dáta maidir le sábháilteacht Tagairt Faomhadh an téarma seo mar chuid de Thionscadal Lex
    ga
    tuarascáil thréimhsiúil chun dáta maidir le sábháilteacht i gcás substaint aonair Tagairt 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
    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]