本剤は、国内臨床試験および海外第Ⅱ相、第Ⅲ相、第Ⅳ相臨床試験の成績をもとに承認されました。このため、海外第Ⅱ相臨床試験M49P2試験、海外第Ⅲ相臨床試験V49_23試験、V49_24試験、および7T-304RA試験、海外第Ⅳ相臨床試験V49_25試験では、一部承認外の用法・用量を含む成績を掲載しています。
臨床成績・安全性情報
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