Table 4 Main characteristics of the Pediatric Investigation Plans (PIPs) and related active ingredients (NCEs)
Characteristics | Num. of PIPs (%) | Num. of NCEs (%) |
|---|---|---|
Total | 103 (100) | 95 (100) |
Type of intervention | ||
Prevention | 11 (10.7) | 8 (8.4) |
Diagnosis | - | - |
Treatment | 85 (82.5) | 80 (84.2) |
Palliative care/rehabilitation | 7 (6.8) | 7 (7.4) |
Disease seriousness | ||
Serious disease | 73 (70.1) | 66 (69.5) |
Nonserious disease | 20 (19.4) | 19 (20.0) |
Risk factor for serious disease | 10 (9.7) | 10 (10.5) |
New mechanism of action | 21 (20.4) | 20 (21.0) |
Fixed-dose combinations | 11 (10.7) | 11 (11.6) |
Biotechnological/biological product | 31 (30.1) | 25 (26.3) |
Orphan medicinal product | 16 (15.5) | 16 (16.8) |