MHRAsafety guidance54% confidence
Class 4 Medicines Defect Notification: Sandoz Limited, Apixaban 2.5mg and 5mg Tablets, EL(26)A/17
Source: MHRA
Why This Matters
Why this matters: provides agency context on safety guidance that may shape timing or evidence expectations for Sandoz.
Regulatory Analysis
Sandoz Ltd. have informed the MHRA that the Patient Information Leaflet included in specified batches of Apixaban does not contain up‑to‑date information.
Supporting Context
- Therapeutic area
- Immunology · Corticosteroid
- Sub-indication
- General
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