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Official EDA safety communications for professional review. These briefs do not provide individual patient treatment recommendations.
SAFETY ALERT
EDA communicates labelling information concerning insulin autoimmune syndrome and angioedema.
Who should review: Marketing Authorization Holders · Pharmacovigilance teams · Regulatory Affairs · Healthcare professionals
SAFETY ALERT
The EDA alert addresses haemolytic anaemia, hepatobiliary information and Kounis syndrome in labelling updates.
Who should review: Marketing Authorization Holders · Pharmacovigilance teams · Regulatory Affairs · Healthcare professionals
SAFETY ALERT
The EDA alert concerns pulmonary-nodule risk and associated respiratory labelling information.
Who should review: Marketing Authorization Holders · Pharmacovigilance teams · Regulatory Affairs · Healthcare professionals
SAFETY ALERT
EDA highlights severe-hypoglycaemia risk with concurrent sulfonylureas and related interaction and warning information.
Who should review: Marketing Authorization Holders · Pharmacovigilance teams · Regulatory Affairs · Healthcare professionals
SAFETY ALERT
The EDA alert communicates a labelling update concerning uveitis.
Who should review: Marketing Authorization Holders · Pharmacovigilance teams · Regulatory Affairs · Healthcare professionals
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