SinoReg

TAKHZYRO / 达泽优

国药准字SJ20200025 · 注射剂

Statutory filing line: 2030-10-26

The certificate expires 2031-04-26. Under the Provisions for Drug Registration (药品注册管理办法) Art. 82, an application to renew is filed no later than 6 months before expiry.

Approval number (批准文号)国药准字SJ20200025
Generic name (通用名)Lanadelumab Injection
拉那利尤单抗注射液
Marketing Authorisation Holder (上市许可持有人)Takeda Pharmaceuticals U.S.A., Inc.
United States
Certificate valid until (有效期至)2031-04-26
Filing line, Art. 82 (法定申报时限)2030-10-26
Data as of (数据快照日)2026-06-28
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Every figure above is taken from the public NMPA overseas-drug database (境外生产药品库) as of 2026-06-28, or computed from it under Art. 82. Registration data changes; the NMPA portal governs. This page states no view on whether this product’s Domestic Responsible Person (境内责任人) arrangement meets NMPA Announcement No. 137 — that cannot be determined from a single public entry.