MHRAsafety guidance54% confidence
Class 4 Medicines Defect Notification: Cadila Pharmaceuticals Limited, Mirtazapine 30mg Tablets, EL(26)A/28
Source: MHRA
Why This Matters
Why this matters: sets a safety guidance precedent in the same sub-indication (pain) as Rhodes Pharmaceuticals.
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
- Pain Management · Opioid
- Sub-indication
- Pain
Related signal: FDA Accepts Supplemental NDA for Dilaudid by Rhodes Pharmaceuticals