PROBLEM TO BE SOLVED: To provide a highly concentrated and stable pharmaceutical formulation of a pharmaceutically active anti-CD20 antibody, such as rituximab or ocrelizumab, or a mixture of the antibody molecules for subcutaneous injection.SOLUTION: According to the present invention, there is provided a pharmaceutical formulation comprising an anti-CD20 antibody in an amount of approximately 50-350 mg/ml, preferably 100-150 mg/ml, more preferably 120 ± 20 mg/ml in combination with at least one hyaluronidase enzyme in an amount of approximately 1000 to approximately 16000 U/ml, preferably approximately 2000-12000 U/ml, at least one buffer such as a histidine buffer giving a pH of 5.5 ± 2.0, a stabilizer of 1-500 mM or a mixture of two or more stabilizers (e.g., sugar, such as α,α-trehalose dihydrate or sucrose, optionally methionine as a second stabilizer), and a nonionic surfactant in amount of 0.01-0.1%.SELECTED DRAWING: None【課題】皮下注射のための薬学的に活性なリツキシマブ、オクレリズマブ等の抗ＣＤ２０抗体、又はかかる抗体分子の混合物の高度に濃縮された安定な薬学的製剤の提供。【解決手段】約５０～３５０ｍｇ／ｌ好ましくは１００～１５０ｍｇ／ｍｌより好ましくは、１２０±２０ｍｇ／ｍｌの量の抗ＣＤ２０抗体に加えて、約１０００～約１６０００Ｕ／ｍｌ、好ましくは約２０００～１２０００Ｕ／ｍｌ量の少なくとも一のヒアルロニダーゼ酵素を組み合わせ、更にｐＨが５．５±２．０を与えるヒスチジンバッファー等の少なくとも一の緩衝剤、１～５００ｍＭの安定剤又は二以上の安定剤の混合物（例えば糖、例えばα，α－トレハロース二水和物又はスクロースと、場合によっては第二安定剤としてメチオニン）と０．０１～０．１％の非イオン性界面活性剤を含有する薬学的製剤。【選択図】なし
