Table 3 Characteristics of INNs authorized by the EMA.
Authorized drugs for human use | Total number of INN N (%) | Additional monitoring N (%) | Conditional approval N (%) | Exceptional circumstances N (%) | Accelerated assessment N (%) | Orphan medicine N (%) | EML 2023 N (%) |
|---|---|---|---|---|---|---|---|
Frequency and type of HADR | 883 (100.00) | 296 (33.52) | 41 (4.64) | 36 (4.08) | 32 (3.62) | 142 (16.08) | 197 (22.31) |
Any frequency of any HADR | 462 (52.32) | 130 (43.92) | 22 (53.66) | 12 (33.33) | 14 (43.75) | 66 (46.48) | 117 (59.39) |
Very common frequency of any HADR | 191 (21.63) | 80 (27.03) | 20 (48.78) | 6 (16.67) | 10 (31.25) | 45 (31.69) | 39 (19.80) |
Any frequency of ANEMIA | 327 (37.03) | 95 (32.09) | 19 (46.34) | 8 (22.22) | 11 (34.38) | 48 (33.80) | 89 (45.18) |
Very common frequency of ANEMIA | 140 (15.86) | 65 (21.96) | 18 (43.90) | 5 (13.89) | 8 (25.00) | 36 (25.35) | 25 (12.69) |
Any frequency of LEUCOPENIA | 298 (33.75) | 90 (30.41) | 17 (41.46) | 7 (19.44) | 10 (31.25) | 49 (34.51) | 80 (40.61) |
Very common frequency of LEUCOPENIA | 137 (15.52) | 59 (19.93) | 15 (36.59) | 3 (8.33) | 6 (18.75) | 34 (23.94) | 29 (14.72) |
Any frequency of THROMBOCYTOPENIA | 320 (36.24) | 86 (29.05) | 16 (39.02) | 6 (16.67) | 12 (37.50) | 48 (33.80) | 87 (44.16) |
Very common frequency of THROMBOCYTOPENIA | 114 (12.91) | 65 (21.96) | 14 (34.15) | 4 (11.11) | 9 (28.13) | 32 (22.54) | 22 (11.17) |
