CRED SMPC 2024

23/09/2024

SmPC Guideline

4.9

Overdose

Symptoms, signs and potential sequelae. Describe management taking into account all relevant evidence. Additional information on special populations.

The Organisation for Professionals in Regulatory Affairs

21

SmPC Guideline

5.1: Pharmacodynamic properties:

Mechanism of action; Main results of the clinical trials supporting the marketing authorization; Statistically compelling and clinically relevant results; Information on clinically relevant populations studied e.g. paediatric

5.2: Pharmacokinetic properties:

Absorption, distribution, biotransformation (including results from in vitro interaction studies), elimination, linearity/non linearity, special populations

The Organisation for Professionals in Regulatory Affairs

22

11