25 results
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Opinion/decision on a Paediatric investigation plan (PIP): Concizumab
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Therapeutic area: Haematology-Hemostaseology
PIP number: EMEA-002326-PIP04-20, Route(s) of administration: Subcutaneous use, Pharmaceutical form(s): Solution for injection
Decision date: 08/09/2021, Last updated: 10/01/2023, Compliance check: X -
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Second European Medicines Agency (EMA) and EUCOPE bilateral meeting (updated)
European Medicines Agency, 29/11/2023, Last updated: 01/12/2023 -
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Methodology Working Party stakeholder interaction meeting
Online, 07/12/2023, Last updated: 31/10/2023 -
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Policies and procedures
Last updated: 04/01/2022 -
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Legal notice
Last updated: 04/01/2021 -
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History of EMA
Last updated: 27/01/2020 -
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European medicines regulatory network
Last updated: 19/12/2017 -
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Publications
Last updated: 02/12/2016 -
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How we work
Last updated: 07/03/2016 -
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Regulatory science research
Last updated: 15/03/2013 -
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General procedures
Last updated: 31/12/2009 -
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Inspection activities procedures
Last updated: 31/12/2009 -
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Meeting management procedures
Last updated: 31/12/2009 -
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Centralised procedure procedures
Last updated: 31/12/2009 -
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Initial evaluation procedures
Last updated: 31/12/2009 -
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Post-authorisation procedures
Last updated: 31/12/2009 -
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Product authorisation lifecycle procedures
Last updated: 31/12/2009 -
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Maximum residue limits procedures
Last updated: 31/12/2009 -
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Scientific advice procedures
Last updated: 31/12/2009 -
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Referrals procedures
Last updated: 31/12/2009 -
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Pharmacovigilance procedures
Last updated: 31/12/2009 -
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News: End-of-year message from EMA’s Executive Director
Last updated: 21/12/2022 -
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News: EMA Committee on Herbal Medicinal Products re-elects Emiel van Galen as Chair
HMPC, Last updated: 03/02/2023 -
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Guidelines Consistency Group
Last updated: 30/03/2023 -
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News: Getting ready for EMA’s website relaunch on 5 December 2023 (new)
Last updated: 09/11/2023