Table 1 Characteristics of drugs for which marketing authorization was granted by the EMA.
Authorized drugs for human use | Number of MA | Route of administration* N (%) | Additional monitoring N (%) | Generic N (%) | Biosimilar N (%) | Conditional approval N (%) | Exceptional circumstances N (%) | Accelerated assessment N (%) | Orphan medicine N (%) | EML 2023 N (%) | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Enteral | Parenteral | Local | Enteral and parenteral | ||||||||||
Frequency and type of HADR | 1349 (100.00) | 641 (47.52) | 642 (47.59) | 43 (3.19) | 23 (1.70) | 338 (25.06) | 232 (17.20) | 76 (5.63) | 42 (3.11) | 37 (2.74) | 36 (2.67) | 146 (10.82) | 387 (28.69) |
any frequency of any HADR | 739 (54.78) | 368 (57.41) | 349 (54.36) | 5 (11.63) | 17 (73.91) | 161 (47.63) | 166 (71.55) | 66 (86.84) | 22 (52.38) | 12 (32.43) | 16 (44.44) | 68 (46.58) | 278 (71.83) |
very common frequency of any HADR | 278 (20.61) | 98 (15.29) | 178 (27.73) | 0 (0.00) | 2 (8.70) | 93 (27.51) | 43 (18.53) | 37 (48.68) | 20 (47.62) | 6 (16.22) | 11 (30.56) | 45 (30.82) | 97 (25.06) |
any frequency of ANEMIA | 546 (40.47) | 272 (42.43) | 261 (40.65) | 2 (4.65) | 11 (47.83) | 125 (36.98) | 124 (53.45) | 67 (88.16) | 19 (45.24) | 8 (21.62) | 13 (36.11) | 50 (34.25) | 231 (59.69) |
very common frequency of ANEMIA | 199 (14.75) | 77 (12.01) | 120 (18.69) | 0 (0.00) | 2 (8.70) | 71 (21.01) | 32 (13.79) | 23 (30.26) | 18 (42.86) | 5 (13.51) | 9 (25.00) | 36 (24.66) | 69 (17.83) |
any frequency of LEUCOPENIA | 488 (36.17) | 250 (39.00) | 227 (35.36) | 2 (4.65) | 9 (39.13) | 106 (31.36) | 124 (53.45) | 38 (50.00) | 17 (40.48) | 7 (18.92) | 12 (33.33) | 51 (34.93) | 200 (51.68) |
very common frequency of LEUCOPENIA | 214 (15.86) | 73 (11.39) | 139 (21.65) | 0 (0.00) | 2 (8.70) | 72 (21.30) | 40 (17.24) | 29 (38.16) | 15 (35.71) | 3 (8.11) | 7 (19.44) | 34 (23.29) | 81 (20.93) |
any frequency of THROMBOCYTOPENIA | 555 (41.14) | 283 (44.15) | 261 (40.65) | 1 (2.33) | 10 (43.48) | 110 (32.54) | 140 (60.34) | 54 (71.05) | 16 (38.10) | 6 (16.22) | 14 (38.89) | 50 (34.25) | 237 (61.24) |
very common frequency of THROMBOCYTOPENIA | 173 (12.82) | 62 (9.67) | 109 (16.98) | 0 (0.00) | 2 (8.70) | 59 (17.46) | 31 (13.36) | 26 (34.21) | 14 (33.33) | 4 (10.81) | 10 (27.78) | 32 (21.92) | 67 (17.31) |
