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Employment Tribunal decision.
Urgent and clinically significant safety updates arising from pharmacovigilance data, including reported adverse events, for veterinary medicines authorised in the UK.
Remedy Employment Tribunal decision.
Bristol-Myers Squibb Pharmaceuticals Limited has informed the MHRA that a potential product quality issue has been detected, relating to incomplete crimping of the metal crimp cap of OPDIVO 10mg/mL concentrate for solution for infusion (nivolumab) (1VLX10ML).
Information for manufacturers of Software as a Medical Device, detailing events that may cause indirect harm and are therefore reportable.
How marketing authorisation holders should inform MHRA of a signal or an ADR to a medicine.
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