20265 results
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Reporting safety information on clinical trials
Last updated: 29/03/2022 -
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Extended EudraVigilance medicinal product dictionary (XEVMPD) training course for clinical trial sponsors - February 2023 (new)
Online, 09:00 - 13:00 Amsterdam time (CET), from 16/02/2023 to 17/02/2023, Last updated: 12/12/2023 -
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Extended EudraVigilance medicinal product dictionary (XEVMPD) training course for clinical trial sponsors - May 2023 (new)
Online, 14:00 - 18:00 Amsterdam time (CET), from 04/05/2023 to 05/05/2023, Last updated: 12/12/2023 -
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EMA virtual technical media briefing on the RNA technology (new)
Online, 10:00 - 10:45 Amsterdam time (CET), 03/02/2023, Last updated: 03/02/2023 -
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News: Public consultation on a multi-stakeholder platform to improve clinical trials in the EU (new)
Last updated: 03/02/2023 -
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News: EMA Committee on Herbal Medicinal Products re-elects Emiel van Galen as Chair (new)
HMPC, Last updated: 03/02/2023 -
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News: A new role for EMA in monitoring and mitigating critical medical device shortages during public health emergencies (new)
Last updated: 02/02/2023 -
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European Union (EU) International Organisation for Standardization (ISO) for identification of medical products (IDMP)/Substance, Product, Organisation and Referential (SPOR) data Task Force meeting - January 2023 (new)
European Medicines Agency, Amsterdam, the Netherlands, 26/01/2023, Last updated: 02/02/2023 -
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Oncology European Specialised Expert Community (new)
Last updated: 01/02/2023 -
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EMA virtual workshop on myocarditis post COVID-19 vaccination (new)
Online, 16/01/2023, Last updated: 31/01/2023 -
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News: Use of Clinical Trials Information System becomes mandatory for new clinical trial applications in the EU (new)
Last updated: 31/01/2023 -
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Direct healthcare professional communication (DHPC): Lymphoseek (tilmanocept) 50 micrograms kit for radiopharmaceutical preparation: temporary extension of shelf life (new)
Active substance: tilmanocept, DHPC type: Medicine shortage, Last updated: 31/01/2023 -
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SPOR and XEVMPD Week (new)
from 17/04/2023 to 20/04/2023, Last updated: 30/01/2023 -
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News: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 23-26 January 2023 (new)
CHMP, Last updated: 27/01/2023 -
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Summary of opinion: Trulicity (new)
dulaglutide, opinion date: 26/01/2023, Positive, Last updated: 27/01/2023 -
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Summary of opinion: Trecondi (new)
treosulfan, opinion date: 26/01/2023, Positive, Last updated: 27/01/2023 -
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Summary of opinion: Wakix (new)
pitolisant, opinion date: 26/01/2023, Positive, Last updated: 27/01/2023 -
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Summary of opinion: Dapagliflozin Viatris (new)
dapagliflozin, opinion date: 26/01/2023, Positive, Last updated: 27/01/2023 -
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Summary of opinion: Reblozyl (new)
luspatercept, opinion date: 26/01/2023, Positive, Last updated: 27/01/2023 -
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Summary of opinion: Tolvaptan Accord (new)
tolvaptan, opinion date: 26/01/2023, Positive, Last updated: 27/01/2023 -
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Summary of opinion: Byfavo (new)
remimazolam, opinion date: 26/01/2023, Positive, Last updated: 27/01/2023 -
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Summary of opinion: Dupixent (new)
dupilumab, opinion date: 26/01/2023, Positive, Last updated: 27/01/2023 -
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Summary of opinion: Sitagliptin / Metformin hydrochloride Sun (new)
sitagliptin, metformin hydrochloride, opinion date: 26/01/2023, Positive, Last updated: 27/01/2023 -
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Withdrawn application: Imbruvica (new)
ibrutinib, date of withdrawal: 13/12/2022, Post-authorisation, Last updated: 27/01/2023 -
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Summary of opinion: Sotyktu (new)
deucravacitinib, opinion date: 26/01/2023, Positive, Last updated: 27/01/2023