18099 results
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Periodic safety update reports (PSURs)
Last updated: 27/07/2022Periodic safety update reports (PSURs … includes information on A report prepared by the marketing-authorisation … under 'Periodic safety update reports - questions and answers' …
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Variations requiring assessment (veterinary medicines)
Last updated: 20/01/2022Variations requiring assessment (veterinary medicines … application. Rapporteur circulates assessment report to Committee for Veterinary … of variations requiring assessment according to Article 62 of …
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News: Guidance on submission of single assessment PSURs published
Last updated: 24/06/2013ance on submission of single assessment PSURs published … submit periodic safety update reports (PSURs) for medicines subject … to European Union single assessment via its eSubmission Gateway … -
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EudraVigilance: electronic reporting
Last updated: 15/02/2022EudraVigilance: electronic reporting … organisations that electronically report ICSRs to A centralised European … relating to the detection, assessment, understanding and prevention …
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PDCO: Agendas, minutes and reports (updated)
Last updated: 17/01/2023PDCO: Agendas, minutes and reports … the agendas, minutes and reports of the plenary meetings of … committee that is responsible for assessing the content of paediatric …
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Environmental risk assessment of veterinary medicines
Last updated: 02/06/2020Environmental risk assessment of veterinary medicines … is summarised in the assessment report of the Committee for Veterinary … medicine's European Public Assessment Report (EPAR). The ERA is tier-based …
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CAT: Agendas, minutes and reports (updated)
Last updated: 16/01/2023CAT: Agendas, minutes and reports … agendas, minutes and meeting reports of the plenary meetings of … committee that is responsible for assessing the quality, safety and efficacy …
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Reporting a quality defect to EMA
Last updated: 03/05/2018Reporting a quality defect to EMA … on product quality defects assessment and reporting obligations, see Quality …
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Workshop on paediatric formulations for assessors in national regulatory agencies
London, UK, 31/05/2010, Last updated: 05/10/2010paediatric formulations for assessors in national regulatory agenci … 05/2010 London, UK Documents Report: Workshop on paediatric formulations … paediatric formulations for assessors in national regulatory agencies … -
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Renewal and annual re-assessment of marketing authorisation
Last updated: 20/06/2022Renewal and annual re-assessment of marketing authorisation … under 'Renewal and annual re-assessment of marketing authorisation' … Renewal , on the basis of the A report prepared by the marketing-authorisation …
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Periodic safety update report information day
European Medicines Agency, London, UK, 28/10/2016, Last updated: 14/06/2016Periodic safety update report information day … of periodic safety update report (PSUR) single assessment procedures, with a particular … understanding of the single assessment. The roadmap is key to optimising … -
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Paediatric development and juvenile animal studies assessors meeting
London, 03/07/2009, Last updated: 02/12/2009and juvenile animal studies assessors meeting … non-clinical and clinical assessors involved in paediatric-investigation-plan … animal testing. Documents Report on paediatric development … -
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Reporting safety information on clinical trials
Last updated: 29/03/2022Reporting safety information on clinical … sponsors must report the information below for assessment by the relevant EU and EEA … INFORMATION DESCRIPTION WHERE TO REPORT Suspected unexpected An adverse …
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Workshop on paediatric formulations for assessors in national regulatory agencies
European Medicines Agency, London, UK, 08/11/2011, Last updated: 31/01/2012paediatric formulations for assessors in national regulatory agenci … Registration closed. Documents Report - Workshop on paediatric … paediatric formulations for assessors in national regulatory agencies … -
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News: Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 30 August – 2 September 2021
PRAC, Last updated: 17/09/2021the Pharmacovigilance Risk Assessment Committee (PRAC) 30 August … Pharmacovigilance Risk Assessment Committee - the committee … committee that is responsible for assessing all aspects of the risk management … -
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Reporting requirements for marketing-authorisation holders
Last updated: 22/01/2016Reporting requirements for marketing-authorisation … relating to the detection, assessment, understanding and prevention … eXtended EudraVigilance Product Report Message (XEVPRM) format …
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News: EMA publishes annual report 2021
Last updated: 10/06/2022EMA publishes annual report 2021 … News 10/06/2022 EMA annual report 2021 EMA’s annual report 2021 published today provides … related to the scientific assessment and supervision of medicines … -
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News: Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 3-6 May 2021
PRAC, Last updated: 07/05/2021the Pharmacovigilance Risk Assessment Committee (PRAC) 3-6 May 2021 … evidence, including cases reported to the European database … between the vaccine and the reported cases of facial swelling … -
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News: Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 11-14 January 2021
PRAC, Last updated: 15/01/2021the Pharmacovigilance Risk Assessment Committee (PRAC) 11-14 January … First monthly summary safety report for COVID-19 vaccine Comirnaty … will evaluate summary safety reports submitted monthly by marketing … -
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News: Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 5 August 2021
PRAC, Last updated: 06/08/2021the Pharmacovigilance Risk Assessment Committee (PRAC) 5 August … the Pharmacovigilance Risk Assessment Committee - the committee … committee that is responsible for assessing all aspects of the risk management … -
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News: Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 10 - 13 January 2022
PRAC, Last updated: 14/01/2022the Pharmacovigilance Risk Assessment Committee (PRAC) 10 - 13 … The Pharmacovigilance Risk Assessment Committee - the committee … committee that is responsible for assessing all aspects of the risk management … -
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News: Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 6-9 April 2021
PRAC, Last updated: 09/04/2021the Pharmacovigilance Risk Assessment Committee (PRAC) 6-9 April … review of a safety signal to assess reports of capillary leak syndrome … drop in blood pressure, were reported in the EudraVigilance database … -
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News: Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 28 September - 1 October 2020
PRAC, Last updated: 02/10/2020the Pharmacovigilance Risk Assessment Committee (PRAC) 28 September … review of a safety signal to assess reports of acute kidney injury … monitoring is in place to pick up reports of unwanted effects and acute … -
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News: Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 8-11 February 2021
PRAC, Last updated: 12/02/2021the Pharmacovigilance Risk Assessment Committee (PRAC) 8-11 February … review of a safety signal to assess reports of acute kidney injury (AKI … Veklury (remdesivir) . The PRAC assessed all available information … -
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News: Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 8-11 March 2021
PRAC, Last updated: 12/03/2021the Pharmacovigilance Risk Assessment Committee (PRAC) 8-11 March … cases of leukaemia have been reported with Zynteglo itself. The … which is responsible for assessing this type of medicine, and …