Evaluator’s commentary on the clinical dossier The dossier was comprehensive. Pharmacokinetics Studies providing pharmacokinetic information The following PK studies were submitted (Table 2): Table 2: Submitted pharmacokinetic studies PK Subtopic * Synopsis topic ID PK in General * To assess healthy PK - the safety adults Single and dose of single ascending doses of Rekovelle: 37.5, 75, 150, 225 and 450IU - * Safety and of multiple doses of 225IU Absolute * To 020 determine and compare the absolute of Rekovelle and Gonal-F after a single dose of 45IU
Evaluator’s commentary on the clinical dossier The dossier was comprehensive. Pharmacokinetics Studies providing pharmacokinetic information The following PK studies were submitted (Table 2): Table 2: Submitted pharmacokinetic studies PK topic Subtopic ID * Synopsis PK in healthy adults General PK - Single dose * To assess the safety and of single ascending doses of Rekovelle: 37.5, 75, 150, 225 and 450IU - * Safety and of multiple doses of 225IU Absolute * To determine and compare the absolute of Rekovelle and Gonal-F after a single dose of 45IU 020