国药现代：国药一心氟尿嘧啶注射液新增规格获批

Core Viewpoint - The announcement indicates that Guoyao Modern's subsidiary, Guoyao Yixin Pharmaceutical Co., Ltd., has received approval from the National Medical Products Administration for the addition of two new specifications for Fluorouracil Injection, expanding its product offerings [1] Group 1: Product Information - The drug name is Fluorouracil Injection, with the new specifications being 10ml:0.25g and 20ml:0.5g [1] - The existing specification of 10ml:0.5g remains unchanged, and the drug is classified as a chemical drug [1] - The approval notification numbers for the new specifications are 2025B02363 and 2025B02347, with the corresponding drug approval numbers being Guoyao Zhunzi H20258091 and H20258090 [1] Group 2: Regulatory Approval - The approval was granted based on compliance with the relevant requirements of the Drug Administration Law of the People's Republic of China [1] - The drug is produced by Harbin Sanlian Pharmaceutical Co., Ltd., and the marketing authorization holder is Guoyao Yixin Pharmaceutical Co., Ltd. [1]