20641 results
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Reporting safety information on clinical trials
Last updated: 29/03/2022 -
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News: Progress with EU-US mutual recognition agreement for inspections for veterinary medicines (new)
Last updated: 31/05/2023 -
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Human medicine European public assessment report (EPAR): Vafseo (new)
Vadadustat, Renal Insufficiency, Chronic; Anemia
Date of authorisation: 24/04/2023,
, Authorised, Last updated: 31/05/2023
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EMA regular press briefing on public health emergencies (new)
Online, 15:30 – 16:00 Amsterdam time (CEST), 06/06/2023, Last updated: 31/05/2023 -
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Human variations electronic Application Form (eAF) & Product Management Service (PMS) Q&A clinics - Session 2 (new)
Online, 15:00 - 15:30 Amsterdam time (CET), 22/06/2023, Last updated: 30/05/2023 -
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Human variations electronic Application Form (eAF) & Product Management Service (PMS) Q&A clinics - Session 1 (new)
Online, 15:00 - 15:30 Amsterdam time (CET), 15/06/2023, Last updated: 30/05/2023 -
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Tenth meeting the industry stakeholder platform on the operation of the centralised procedure for human medicines (new)
Online, 09:30 - 13:30 Amsterdam time (CET), 27/06/2023, Last updated: 30/05/2023 -
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Clinical Trials Information System (CTIS) sponsor end user training programme - December 2023 (new)
Online, 09:00 - 13:30 Amsterdam time (CET), from 11/12/2023 to 14/12/2023, Last updated: 30/05/2023 -
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Clinical Trials Information System (CTIS) sponsor end user training programme - November 2023 (new)
Online, 14:00 - 18:30 Amsterdam time (CET), from 06/11/2023 to 09/11/2023, Last updated: 30/05/2023 -
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Clinical Trials Information System (CTIS) sponsor end user training programme - September 2023 (new)
Online, 09:00 - 13:30 Amsterdam time (CET), from 19/09/2023 to 22/09/2023, Last updated: 30/05/2023 -
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News: Global regulators agree on way forward to adapt COVID-19 vaccines to emerging variants (new)
Last updated: 30/05/2023 -
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Mandatory use of ISO/ICH E2B(R3) individual case safety reporting in the EU: hands-on training course on using the EudraVigilance system (new)
Online, from 04/12/2023 to 08/12/2023, Last updated: 30/05/2023 -
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Mandatory use of ISO/ICH E2B(R3) individual case safety reporting in the EU: hands-on training course on using the EudraVigilance system (new)
Online, from 23/10/2023 to 27/10/2023, Last updated: 30/05/2023 -
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Mandatory use of ISO/ICH E2B(R3) individual case safety reporting in the EU: hands-on training course on using the EudraVigilance system (new)
Online, from 13/11/2023 to 17/11/2023, Last updated: 30/05/2023 -
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Mandatory use of ISO/ICH E2B(R3) individual case safety reporting in the EU: hands-on training course on using the EudraVigilance system (new)
Online, from 25/09/2023 to 29/09/2023, Last updated: 30/05/2023 -
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Withdrawn application: Tidhesco (new)
ivosidenib, date of withdrawal: 23/02/2023, Initial authorisation, Last updated: 30/05/2023 -
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Electronic product information (ePI) (updated)
Last updated: 30/05/2023 -
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Quarterly system demo - Q2 2023 (new)
Online, 09:00 - 13:00 Amsterdam time (CEST), 22/06/2023, Last updated: 26/05/2023 -
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News: EMA business hours over Whit Monday, 29 May (new)
Last updated: 26/05/2023 -
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Withdrawn application: Asimtufii (new)
aripiprazole, date of withdrawal: 02/05/2023, Initial authorisation, Last updated: 26/05/2023 -
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Summary of opinion: Pylclari (new)
piflufolastat (18F), opinion date: 25/05/2023, Positive, Last updated: 26/05/2023 -
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Summary of opinion: Opdivo (new)
nivolumab, opinion date: 25/05/2023, Positive, Last updated: 26/05/2023 -
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Summary of opinion: Sogroya (new)
somapacitan, opinion date: 26/05/2023, Positive, Last updated: 26/05/2023 -
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Withdrawn application: Susvimo (new)
ranibizumab, date of withdrawal: 02/05/2023, Initial authorisation, Last updated: 26/05/2023 -
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Summary of opinion: Ztalmy (new)
ganaxolone, opinion date: 26/05/2023, Positive, Last updated: 26/05/2023