PV Bulletin

Prasugrel Viatris (previously Prasugrel Mylan)

This medicine is authorised for use in the European Union.

Primary source: View

PV Impact Brief

Urgency: HighConfidence: high

What changed

The product's name has changed from Prasugrel Mylan to Prasugrel Viatris as part of regulatory updates.

Why it matters

Updating the product name is essential to maintain clear communication with healthcare professionals and patients about the medication being used for safety and efficacy.

Action needed

Ensure that all labeling and safety information reflects the updated product name 'Prasugrel Viatris' instead of 'Prasugrel Mylan'.

Relevant for
Labeling LeadRegulatory Intelligence Lead
Processes impacted
Labeling
Owner

Regulatory Intelligence Lead

Review cadence

Review in the next regulatory intelligence cycle.

Evidence and confidence

Confidence: highSource updated: Sep 2, 2026

Full briefing

Practical implication

Ensure that all labeling and safety information reflects the updated product name 'Prasugrel Viatris' instead of 'Prasugrel Mylan'.

Prasugrel Viatris, a generic of Efient, is indicated for the prevention of atherothrombotic events in acute coronary syndrome patients undergoing percutaneous coronary intervention. The product has been rebranded from Prasugrel Mylan to Prasugrel Viatris as authorized by the EMA.

What changed: The product's name has changed from Prasugrel Mylan to Prasugrel Viatris as part of regulatory updates.

Why it matters: Updating the product name is essential to maintain clear communication with healthcare professionals and patients about the medication being used for safety and efficacy.

Practical implication: Ensure that all labeling and safety information reflects the updated product name 'Prasugrel Viatris' instead of 'Prasugrel Mylan'.

View original source

  • Source: EMA - What's new RSS
  • Published at source: 2026-09-02T00:00:00.000Z
  • Discovered by monitor: 2026-09-02T21:39:15.998Z

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

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

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