| 0 |
Pharmacodynamic animal studies; in vitro studies with a limited predictive value for the human in vivo situation; data on file |
| 1 |
Incomplete, published case reports (no re- or dechallenge, presence of other explanatory factors for the adverse reaction) |
| 2 |
Well-documented, published case reports; retrospective analyses of case series |
| 3 |
Controlled, published interaction studies in patients or healthy volunteers with surrogate end-points |
| 4 |
Controlled, published interaction studies in patients or healthy volunteers with clinically relevant end-points |
| – |
Posters and abstracts from scientific meetings: 0 or 1, depending on the information provided. When the information of the poster or abstract is not published in a peer-reviewed journal within 3 years after the scientific meeting, this information is recategorized as 0 |
| – |
Information from the Summary of Product Characteristics/European Public Assessment Report (EPAR): 0, 1 or 2, depending on the information provided |
| – |
Retrospective case series: 2 or 3, depending on the information provided |
