Table 2.
Characteristics of products authorised with and without aRMMs
| Total | Products without aRMMs at approval | Products with introduced aRMMs | Products with aRMMs at approval | Products with discontinued aRMMs | |
|---|---|---|---|---|---|
| Number of products | 476 | 346 | 14 | 130 | 4 |
| Median follow-up time in months (range) | 60 (8–150) | 58 (8–150) | 43 (17–137) | 65 (8–150) | 90 (25–96) |
| Type of MA (N, %) | |||||
| Regular MA | 431 (91) | 320 (92) | 13 (93) | 111 (85) | 4 (100) |
| Conditional MA | 20 (4) | 12 (3) | 0 | 8 (6) | 0 |
| MA under exceptional circumstances | 25 (5) | 14 (4) | 1 (7) | 11 (8) | 0 |
| Orphan designation** (yes) (N, %) | 86 (18) | 54 (16) | 1 (7) | 32 (25) | 0 |
| ATC group (N, %) | |||||
| Alimentary tract and metabolism (A) | 57 (12) | 47 (14) | 1 (7) | 10 (8) | 0 |
| Blood and blood forming organs (B) | 38 (8) | 25 (7) | 5 (36) | 13 (10) | 1 (25) |
| Cardiovascular system (C) | 25 (5) | 15 (4) | 0 | 10 (8) | 0 |
| Dermatologicals (D) | 7 (1) | 5 (1) | 0 | 2 (2) | 0 |
| Genitourinary tract (G) | 15 (3) | 12 (3) | 0 | 3 (2) | 0 |
| Hormones for systemic use (H) | 6 (1) | 5 (1) | 0 | 1 (1) | 0 |
| Antiinfectives for systemic use (J) | 91 (19) | 77 (22) | 3 (21) | 14 (11) | 1 (25) |
| Antineoplastic and immunomodulatory agents (L) | 129 (27) | 82 (24) | 1 (7) | 47 (36) | 0 |
| Musculoskeletal system (M) | 13 (3) | 9 (3) | 2 (14) | 4 (3) | 0 |
| Nervous system (N) | 37 (8) | 29 (8) | 1 (7) | 8 (6) | 0 |
| Antiparasitic drugs (P) | 1 (0.2) | 0 | 0 | 1 (1) | 0 |
| Respiratory system (R) | 16 (3) | 13 (4) | 0 | 3 (2) | 1 (25) |
| Sensory organs (S) | 16 (3) | 10 (3) | 0 | 6 (5) | 0 |
| Various (V) | 25 (5) | 17 (5) | 1 (7) | 8 (6) | 1 (25) |
| Type of aRMMs (N, %) | |||||
| Educational materials for HCP | 12 (86) | 122 (94) | 4 (100) | ||
| Educational materials for patients/caregivers | 7 (50) | 72 (55) | 2 (50) | ||
| Controlled access | 0 | 7 (5) | 0 | ||
| Controlled distribution | 2 (14) | 6 (5) | 0 | ||
| Pregnancy prevention programme | 0 | 8 (6) | 0 | ||
| Authorisation status* (N, %) | |||||
| Authorised | 433 (91) | 316 (91) | 11 (79) | 117 (90) | 4 (100) |
| Suspended | 1 (0.2) | 1 (0.3) | 0 | 0 | 0 |
| Withdrawn | 42 (9) | 29 (8) | 3 (21) | 13 (10) | 0 |
aRMMs additional risk minimisation measures, ATC Anatomical Therapeutic Chemical, HCP healthcare professionals, MA marketing authorisation
*At time of data collection (1 July 2018)
**Statistically significant difference between products without aRMMs at approval and products with aRMMs at approval