Table 1.

Basic scientific requirements for a fixed-dose combination [8]

1. Justification of the pharmacological and medical rationale for the combination

2. Establishment of the evidence base for the:

a. relevant contribution of all active substances to the desired therapeutic effect (efficacy and/or safety)

b. positive benefit-risk for the combination in the targeted indication

3.  Demonstration that the evidence presented is relevant to the fixed combination medicinal product for which the application is made

Adapted from: EMA. Guideline on clinical development of fixed combination medicinal products 2017 (8)