MHRAsafety guidance84% confidence
Class 4 Medicines Defect Notification: Cadila Pharmaceuticals Limited, Mirtazapine 30mg Tablets, EL(26)A/28
Source: MHRA
Why This Matters
Why this matters: illustrates how regulators handled a comparable safety guidance decision relevant to pharmaceutical companies; the same agency is already in play for this signal, so precedent weight is higher.
Regulatory Analysis
Cadila Pharmaceuticals Limited has informed the MHRA of an error with the European Article Number (EAN) barcode on the cartons of a batch of Mirtazapine 30mg Film-Coated Tablets distributed in Crescent Pharma Limited livery.
Supporting Context
- Therapeutic area
- General · AI in Drug Development
- Sub-indication
- General
Related signal: MHRA Launches AI Sandbox to Enhance Medicines Development and Safety