MHRAsafety guidance54% confidence
Class 4 Medicines Defect Notification: Brancaster Pharma Limited, Benzylpenicillin benzathine 1.2 Million I.U. and 2.4 Million I.U. powder for suspension for injection, EL(26)A/30
Source: MHRA
Why This Matters
Why this matters: sets a safety guidance precedent in the same sub-indication (pain) as Novitium Pharma.
Regulatory Analysis
Brancaster Pharma Limited has informed the MHRA that the Patient Information Leaflet (PIL) in the cartons for the batches listed in this notification were released with an outdated PIL.
Supporting Context
- Therapeutic area
- Pain Management · NSAID
- Sub-indication
- Pain
Related signal: FDA Accepts Supplement for Naproxen by Novitium Pharma