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Olanzapine Orally Disintegrating Tablets / 奥氮平口崩片

国药准字HJ20160529 · 片剂

Statutory filing line: 2028-08-22

The certificate expires 2029-02-22. 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HJ20160529
Generic name (通用名)Olanzapine Orally Disintegrating Tablets
奥氮平口崩片
Marketing Authorisation Holder (上市许可持有人)CHEPLAPHARM Registration GmbH
Germany
Certificate valid until (有效期至)2029-02-22
Filing line, Art. 82 (法定申报时限)2028-08-22
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.