Table 1 Off-label and unlicensed categories
| Â | Category | Definition | |
|---|---|---|---|
Off-label medicines | Medicines licensed for use in children | 1 | Authorized - medicine used within the terms of its marketing authorization |
2 | Contraindication exists | ||
3 | Dose greater than recommended | ||
4 | Dose greater than recommended and contraindication exists | ||
5 | Not licensed in child of this age (or child below minimum weight stated) | ||
6 | Not licensed in child of this age and contraindication exists | ||
7 | Not licensed by this route | ||
8 | Not licensed by this route and contraindication exists | ||
9 | Not licensed by this route or in a child of this age | ||
10 | Not licensed by this route or in a child of this age and contraindication exists | ||
11 | Not licensed for this indication | ||
12 | Not licensed for this indication and contraindication exists | ||
13 | Not licensed for this indication or at this dose | ||
14 | Not licensed for this indication or at this dose and contraindication exists | ||
15 | Not licensed for this indication or at this age | ||
16 | Not licensed for this indication or at this age and a contraindication exists | ||
17 | Not licensed for this indication or by this route | ||
18 | Not licensed for this indication or by this route and a contraindication exists | ||
19 | Not licensed for this indication or by this route or at this age | ||
20 | Not licensed for this indication or by this route or at this age and a contraindication exists | ||
Medicines not licensed for use in children | 21 | Not licensed for use in children | |
22 | Not licensed for use in children and a contraindication exists | ||
23 | Not licensed for use in children or in adults by this route | ||
24 | Not licensed for use in children or in adults by this route and a contraindication exists | ||
25 | Not licensed for use in children or in adults for this indication | ||
26 | Not licensed for use in children or in adults for this indication and a contraindication exists | ||
27 | Not licensed for use in children or in adults for this indication or in adults by this route | ||
28 | Not licensed for use in children or in adults for this indication or in adults by this route and a contraindication exists. | ||
Medicines excluded from analysis | 29 | Category cannot be assigned | |
30 | Theater medicine | ||
Unlicensed medicines | 31 | Prepared extemporaneously | |
32 | Manufactured under a specials manufacturing license | ||
33 | Chemical | ||
34 | Import | ||
35 | Awaiting a MA (for example, previous trial medicine) | ||