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Highly concentrated pharmaceutical formulations comprising anti-cd20 antibody
专利权人:
F. HOFFMANN-LA ROCHE AG
发明人:
STAUCH OLIVER BORIS,MAHLER HANNS-CHRISTIAN,ADLER MICHAEL
申请号:
NZ59865310
公开号:
NZ598653A
申请日:
2010.09.10
申请国别(地区):
NZ
年份:
2014
代理人:
摘要:
NZ 598653 Disclosed is a highly concentrated, stable pharmaceutical formulation for subcutaneous administration of a pharmaceutically active anti-CD20 antibody comprising: about 50 to 350 mg/ml anti-CD20 antibody; about 1 to 100 mM of a buffering agent providing a pH of 5.5 ± 2.0; about 1 to 500 mM of a stabiliser or a mixture of two or more stabilisers; about 0.01 to 0.1 % of a nonionic surfactant; and about 1’000 to about 16’000 U/ml of a hyaluronidase enzyme.
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