Similar biological medicinal products containing recombinant erythropoietins

Keywords Erythropoietin, epoetin, recombinant biological medicinal products, indication, efficacy, safety, comparability, extrapolation
Description This document lays down lays down the non-clinical and clinical requirements for recombinant human erythropoietin (epoetin)-containing medicinal products claiming to be similar to another one already marketed.

How useful was this page?

Add your rating
Average
1 rating