SinoReg

IRESSA / 易瑞沙

国药准字HJ20171297 · 片剂

Statutory filing line: 2026-11-05

The certificate expires 2027-05-05. 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HJ20171297
Generic name (通用名)Gefitinib Tablets
吉非替尼片
Marketing Authorisation Holder (上市许可持有人)AstraZeneca AB
Sweden
Certificate valid until (有效期至)2027-05-05
Filing line, Art. 82 (法定申报时限)2026-11-05
Data as of (数据快照日)2026-06-28
Check another product →

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.