Primary source: View
The CMDh has approved a variation to the marketing authorization terms for ramipril and bisoprolol, mandating revised warnings and interactions in the product information.
These changes are critical for ensuring patient safety, particularly for diabetic patients using medications that impact blood sugar levels.
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.
Regulatory Intelligence Lead
Review in the next regulatory intelligence cycle.
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.
Published from the regulator source ingestion pipeline after PV impact triage.
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