SinoReg

Larotrectinib Sulfate Oral Solution / 硫酸拉罗替尼口服溶液

国药准字HJ20220056 · 口服溶液剂

Re-registration deadline: 2026-12-22

The certificate expires 2027-06-22. 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HJ20220056
Generic name (通用名)Larotrectinib Sulfate Oral Solution
硫酸拉罗替尼口服溶液
Marketing Authorisation Holder (上市许可持有人)Bayer AG
Germany
Certificate valid until (有效期至)2027-06-22
Re-registration deadline, Art. 82 (法定申报时限)2026-12-22
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.