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. 2021 Jul 28;8(4):589–601. doi: 10.1007/s40801-021-00262-7
This retrolective safety analysis of pharmacovigilance data covered 99.4% (1596/1606) of all AMPs marketed in Germany during the study period 2010–2017.
A total of 5506 ADRs were identified that had occurred in 2765 different patients, comprising 370 different AMPs.
The relative frequency of ADRs for AMPs was 1.5 per million maximum daily administration doses sold.
The large majority of patients (91.9%) had recovered or were recovering from the ADRs and there were no reports with a fatal outcome.