Primary source: European Medicines Agency (EMA)
EMA issued PSUSA outcome for calcifediol: regulatory outcome is maintenance of marketing authorisation.
The PSUSA outcome confirms that no significant new safety concerns were identified, and no changes to the benefit-risk balance are needed. However, MAHs should review the PSUSA assessment report for any specific recommendations.
Review the PSUSA documents for calcifediol and ensure alignment with any PRAC recommendations if applicable.
Regulatory Intelligence Lead
quarterly
None specified beyond maintenance of current marketing authorisation.
Review the PSUSA documents for calcifediol and ensure alignment with any PRAC recommendations if applicable.
The EMA's PSUSA procedure for calcifediol (PSUSA/00000491/202506) concluded with maintenance of the marketing authorisation. No additional risk minimisation measures or labelling changes were specified.
What changed: EMA issued PSUSA outcome for calcifediol: regulatory outcome is maintenance of marketing authorisation.
Why it matters: The PSUSA outcome confirms that no significant new safety concerns were identified, and no changes to the benefit-risk balance are needed. However, MAHs should review the PSUSA assessment report for any specific recommendations.
Practical implication: Review the PSUSA documents for calcifediol and ensure alignment with any PRAC recommendations if applicable.
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