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Human medicines committee meeting: May 2025 highlights

CHMP recommends ten new medicines for approval in the EU

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Finasteride referral
New safety recommendations on finasteride and dutasteride

Measures minimise risk of suicidal thoughts

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NDSG workplan
Leveraging large volumes of data and new tools for public and animal health

EU regulators agree workplan to optimise use of data and AI

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Ixchiq chikungunya vaccine
Safety review of chikungunya vaccine Ixchiq started

Vaccine must not be used in people 65 years and above

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Magnified biosimilar medicine
Streamlining development and assessment of biosimilar medicines

Public consultation open until end September 2025

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Network strategy to 2028
EU medicines agencies’ network strategy to 2028

Seizing opportunities in a changing medicines landscape

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Events

Mandatory use of ISO/ICH E2B(R3) individual case safety reporting in the EU: hands-on training course using the EudraVigilance system

EudraVigilance is the EU's system for managing and analysing information on adverse reactions to medicines which have been authorised or are being studied in clinical trials in the European Economic Area (EEA) and supports the reporting and analysis of suspected adverse reactions originating from clinical trials and the post-authorisation phase of...

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Start date: 2 June 2025
End date: 6 June 2025
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