PV Bulletin

Calcifediol PSUSA: Maintenance of Marketing Authorisation (PSUSA/00000491/202506)

EMA completed PSUSA for calcifediol; outcome is maintenance of marketing authorisation.

Primary source: European Medicines Agency (EMA)

PV Impact Brief

MonitoringConfidence: high

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.

Action needed

Review the PSUSA documents for calcifediol and ensure alignment with any PRAC recommendations if applicable.

Relevant for
Regulatory Intelligence LeadSignal Management Lead
Processes impacted
Signal ManagementLabeling
Owner

Regulatory Intelligence Lead

Review cadence

quarterly

Regulatory action details

Action type
PSUSA
Publication date
2026-06-05
Safety issue
Maintenance of the marketing authorisation after periodic safety review (PSUSA/00000491/202506).

Affected products

  • Calcifediol

PV internal implications

None specified beyond maintenance of current marketing authorisation.

View regulator source

Evidence and confidence

Confidence: highSource updated: Jun 5, 2026

Full briefing

Practical implication

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.

View original source

Published from the Firecrawl agent regulatory extraction pipeline.

#Safety Signals#PSUSA#European Medicines Agency (EMA)#other#firecrawl-agent#regulatory-extraction

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