PV Bulletin

PSUSA/00011041/202510 - Periodic Safety Update Report Single Assessment

This update pertains to the assessment of ramipril and bisoprolol, focusing on safety revisions due to potential risks.

Primary source: View

PV Impact Brief

Urgency: HighConfidence: high

What changed

The CMDh has approved a variation to the marketing authorization terms for ramipril and bisoprolol, mandating revised warnings and interactions in the product information.

Why it matters

These changes are critical for ensuring patient safety, particularly for diabetic patients using medications that impact blood sugar levels.

Action needed

The marketing authorization holder must submit amended product information reflecting the new safety guidelines by October 9, 2026, with translations due by August 10, 2026.

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: Aug 28, 2026

Full briefing

Practical implication

The marketing authorization holder must submit amended product information reflecting the new safety guidelines by October 9, 2026, with translations due by August 10, 2026.

The PSUSA procedure for ramipril and bisoprolol has resulted in a regulatory outcome recommending changes to the product information due to concerns about severe hypoglycemia risks associated with their co-administration with sulfonylureas.

What changed: The CMDh has approved a variation to the marketing authorization terms for ramipril and bisoprolol, mandating revised warnings and interactions in the product information.

Why it matters: These changes are critical for ensuring patient safety, particularly for diabetic patients using medications that impact blood sugar levels.

Practical implication: The marketing authorization holder must submit amended product information reflecting the new safety guidelines by October 9, 2026, with translations due by August 10, 2026.

View original source

  • Source: EMA - What's new
  • Published at source: 2026-08-28T08:49:33.000Z
  • Discovered by monitor: 2026-08-29T05:25:08.265Z

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

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

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