16953 results
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Opinion/decision on a Paediatric investigation plan (PIP): Glybera, alipogene tiparvovec
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Cardiovascular diseases
PIP number: EMEA-000292-PIP01-08-M03, Route(s) of administration: Intramuscular use, Pharmaceutical form(s): Solution for injection
Decision date: 04/11/2016, Last updated: 23/01/2017, Compliance check: XKey facts Glybera alipogene tiparvovec Cardiovascular … for alipogene tiparvovec (Glybera), (EMEA-000292-PIP01-08-M03 … 23/01/2017 EMA/639652/2016 Generic Glybera: EPAR … -
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Human medicine European public assessment report (EPAR): Glybera
alipogene tiparvovec, Hyperlipoproteinemia Type I
Date of authorisation: 25/10/2012,
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, Revision: 8, Withdrawn, Last updated: 30/10/2017
Glybera Hyperlipoproteinemia Type I … marketing authorisation for Glybera has expired following the … medicine on 8 March 2004. Glybera was withdrawn from the Community … -
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Press release: European Medicines Agency maintains recommendation not to grant a marketing authorisation for Glybera
CHMP, Last updated: 20/04/2012marketing authorisation for Glybera … authorisation for the orphan medicine Glybera (alipogene tiparvovec), from … review the benefit risk of Glybera in a restricted group of … -
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European public assessment reports: background and context
Last updated: 27/09/2018European public assessment reports: background and context … information on the medicines assessed by the Committee for Medicinal … known as a European public assessment report. …
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Press release: Outcome report on first European collaboration between regulators and HTA organisations: improving the contribution of regulatory assessment reports to health technology assessment
Last updated: 25/06/2014Outcome report on first European collaboration … contribution of regulatory assessment reports to health technology assessment … Press release 25/06/2014 The report of an initiative undertaken … -
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Maximum residue limit assessment reports
Last updated: 12/03/2010Maximum residue limit assessment reports … Medicines Agency (EMA) publishes assessment reports on maximum residue limits … medicines, which have been assessed by the EMA's Committee for …
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Press release: European Medicines Agency and EUnetHTA Joint Action start collaboration on European Public Assessment Report (EPAR) contribution to relative effectiveness assessments
Last updated: 16/02/2010collaboration on European Public Assessment Report (EPAR) contribution to relative … to relative effectiveness assessments … collaboration on European Public Assessment Report (EPAR) contribution to relative … -
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News: Central repository to facilitate assessment of medicines safety reports
Last updated: 26/01/2015repository to facilitate assessment of medicines safety reports … for periodic safety update reports (PSURs) and their assessment reports is launched by the European … -
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Recommendation on management and assessment of periodic safety update reports (PSURs) of veterinary medicinal products
Last updated: 20/12/2016mmendation on management and assessment of periodic safety update reports (PSURs) of veterinary medicinal … efficacy, periodic safety update report (PSUR assessment, competent authority …
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News: New search page for periodic safety update report single assessments (PSUSAs)
Last updated: 26/10/2016for periodic safety update report single assessments (PSUSAs … outcome. PSUSAs are single assessments of related periodic safety … related periodic safety update reports (PSURs) for active substances … -
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Template for assessment report for the development of European Union herbal monographs and list entries
Last updated: 24/06/2016Template for assessment report for the development of European … traditional use; benefit-risk assessment; assessment report Current effective version … effective version Template for assessment …
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News: European Medicines Agency publishes public assessment reports for ancillary medicinal substances included in medical devices
CHMP, Last updated: 08/08/2012Medicines Agency publishes public assessment reports for ancillary medicinal substances … started publishing public assessment reports for ancillary substances … accredited by a Member State to assess whether a medical device … -
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Template for assessment report for the development of European Union herbal monographs and list entries
Last updated: 12/03/2016Template for assessment report for the development of European …
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News: Regulatory information - European Medicines Agency updates guidance on European Union periodic-safety-update-report single assessment for nationally authorised medicines
Last updated: 01/09/2014periodic-safety-update-report single assessment for nationally authorised … of periodic safety update reports (PSURs) for nationally authorised … European Union (EU) single assessment. The single assessment of nationally authorised … -
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Press release: European Medicines Agency annual report for 2006 shows record numbers of applications; assessment times in core processes significantly reduced
Last updated: 15/03/2007pean Medicines Agency annual report for 2006 shows record numbers … numbers of applications; assessment times in core processes significantly … pean Medicines Agency annual report for 2006 shows record numbers … -
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Template for information exchange for the preparation of the assessment report supporting the establishment of European Union monographs and European Union list entries
Last updated: 25/02/2019for the preparation of the assessment report supporting the establishment … for the preparation of the assessment report supporting the establishment … for the preparation of the assessment report supporting the establishment …
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Assessment templates and guidance
Last updated: 25/06/2021Assessment templates and guidance … Therapies (CAT) should use the assessment report templates and documents listed … documents listed below for the assessment of any new application in …
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Periodic safety update reports: questions and answers
Last updated: 04/12/2018Periodic safety update reports: questions and answers … What is the scope of PSUR assessment under the EU single assessment? The Pharmacovigilance Risk Assessment Committee (PRAC) is in charge …
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Health technology assessment bodies
Last updated: 12/07/2021Health technology assessment bodies … Network for Health Technology Assessment (EUnetHTA), an EU-financed … plans and implementation reports and in the EMA / EUnetHTA meeting …
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Templates for assessors
Last updated: 04/08/2017Templates for assessors … authorisation measure (PAM) assessment report templates … Assessment Report for non-imposed non-interventional …
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Pharmacovigilance assessments: challenges and solutions for pharmacovigilance assessors
European Medicines Agency, Amsterdam, The Netherlands, from 11/11/2019 to 12/11/2019, Last updated: 03/10/2019Pharmacovigilance assessments: challenges and solutions … solutions for pharmacovigilance assessors … pharmacovigilance assessors … -
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Accelerated assessment
Last updated: 17/02/2021Accelerated assessment … regarding an accelerated assessment. If necessary, the CHMP may … be summarised in the CHMP assessment report. If a request for an accelerated …
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News: 2013 annual report on EudraVigilance: over 1 million adverse reaction reports received and processed
Last updated: 28/04/20142013 annual report on EudraVigilance: over 1 … million adverse reaction reports received and processed … application/pdf second annual report on EudraVigilance for the … -
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Annual re-assessment: questions and answers
Last updated: 08/02/2019Annual re-assessment: questions and answers … 1. What is the annual re-assessment? In exceptional circumstances … be linked to the annual re-assessment of the conditions mentioned …
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Analysis of antimicrobial consumption and resistance ('JIACRA' reports)
Last updated: 30/06/2021and resistance ('JIACRA' reports) … and resistance ('JIACRA' reports) … INTER-AGENCY REPORT JIACRA III 2016–2018 Antimicrobial …