Table 1.
Classification of excipients to which studied neonates were exposed according to available safety data †
| Category | Safety status | Description | No of excipients identified |
|---|---|---|---|
|
1 |
Potentially safe |
No adverse reactions reported |
42 |
|
2 |
Potentially harmful and known to be harmful |
Adverse reactions reported |
47 |
|
3 |
No safety data found |
No data found in the literature on human exposure and toxicity |
19 |
|
4 |
Description of the excipient in SPC or PIL unspecific |
Description does not allow a specific literature search |
15 |
| Total | 123 |