Clinical trial data. Evidence generated from clinical trials with the medicinal product during development and post-authorisation (Phase I–IV) Non-clinical trial data. Data from non-clinical studies that constitutes an important safety finding, e.g., toxicity, safety pharmacology or other toxicity-related information Post-marketing data. Evidence generated from post-authorisation experience, e.g., Individual Case Safety Report (ICSR) and literature (excluding data from clinical trials and additional pharmacovigilance activities) Regulation. Introduction of new or revised European Pharmacovigilance Legislations, Regulations and/or Regulatory Guidelines Class effect. A risk which is common to the pharmacological class. Target population. Risk factors associated with disease population characteristics such as comorbidities and concomitant medications. PASS. Post-authorisation safety study irrespective of the design (interventional/non-interventional) included in the EU-RMP as an additional pharmacovigilance activity linked to a safety concern in the RMP *Based on the information provided in the EU-RMP Section: Safety Specification