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EMA withdrawal · 2024-05-17

Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 13-16 May 2024

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Summary

PRAC recommended suspending hydroxyprogesterone caproate medicines from the EU market due to safety concerns.

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Diseases / indications

Drugs mentioned

  • Hydroxyprogesterone caproate (hydroxyprogesterone caproate)

Snippet

Hydroxyprogesterone caproate medicines to be suspended from the EU market