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PSUSA

publicEMA · European Union · Updated Jun 5, 2026

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

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

Signal ManagementLabelingRegulatory Intelligence Lead

SOP Impact2 SOPs

Relevant for: Regulatory Intelligence Lead, Signal Management Lead

verifiedRegulatory action: PSUSA

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Tag: PSUSA | PV Bulletin