2 results
Approved WMOCompleted
The purpose of the study is to investigate how quickly and to what extent MYL-1401H is absorbed and eliminated from the body (this is called pharmacokinetics) as compared to Neulasta® EU and US. It will also be investigated what the effect is of MYL…
Approved WMOCompleted
The primary efficacy variable is the change in PV from baseline as assessed by 3 D ultrasonography after 78 weeks of double-blind treatment with OM 20-40 mg daily compared to ATE 50-100 mg daily.Secondary efficacy variables:Change from baseline PV…