PV Bulletin

PSUSA/00001345/202512 - periodic safety update report single assessment

The European Medicines Agency (EMA) has published PSUSA/00001345/202512, a periodic safety update report single assessment for exemestane.

Primary source: Website data protection notice

Translated From French

PV Bulletin does not take any responsibility for translation errors or omissions, though it has used the best available translation engine.

PV Impact Brief

Urgency: HighConfidence: high

What changed

The PSUSA for exemestane has been published, necessitating updates to the periodic safety reporting.

Why it matters

The periodic safety update report is crucial for ongoing safety evaluations of medicines, ensuring that risks are continuously assessed and managed.

Action needed

Regulatory intelligence processes must update reporting timelines and workflows to incorporate the new PSUSA findings for exemestane.

Relevant for
Regulatory Intelligence Lead
Processes impacted
Signal Management
Owner

Regulatory Intelligence Lead

Review cadence

Review in the next regulatory intelligence cycle.

Evidence and confidence

Confidence: highSource updated: Sep 4, 2026

Full briefing

Practical implication

Regulatory intelligence processes must update reporting timelines and workflows to incorporate the new PSUSA findings for exemestane.

The periodic safety update report (PSUR) systems are being refined, with the latest single assessment for exemestane published by the EMA. This assessment is critical for ongoing safety evaluations and impacts reporting requirements.

What changed: The PSUSA for exemestane has been published, necessitating updates to the periodic safety reporting.

Why it matters: The periodic safety update report is crucial for ongoing safety evaluations of medicines, ensuring that risks are continuously assessed and managed.

Practical implication: Regulatory intelligence processes must update reporting timelines and workflows to incorporate the new PSUSA findings for exemestane.

View original source

  • Source: EMA - What's new RSS
  • Published at source: 2026-09-04T00:00:00.000Z
  • Discovered by monitor: 2026-09-04T21:35:10.355Z

Published from the regulator source ingestion pipeline after PV impact triage.

#Safety Signals#Reporting Requirement#Source-ingestion#Regulator-monitor#European Union#Ema.europa.eu#Translated From French

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