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Ganaxolone Oral Suspension / 泽元安

国药准字HJ20240071 · 口服混悬剂

Statutory filing line: 2029-01-08

The certificate expires 2029-07-08. 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HJ20240071
Generic name (通用名)Ganaxolone Oral Suspension
加那索龙口服混悬剂
Marketing Authorisation Holder (上市许可持有人)Immedica Pharma AB
Sweden
Certificate valid until (有效期至)2029-07-08
Filing line, Art. 82 (法定申报时限)2029-01-08
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.