Opsumit / 傲朴舒
国药准字HJ20170376 · 片剂
Statutory filing line: 2030-01-21
The certificate expires 2030-07-21. 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HJ20170376 |
|---|---|
| Generic name (通用名) | Macitentan Tablets 马昔腾坦片 |
| Marketing Authorisation Holder (上市许可持有人) | Janssen-Cilag International NV Belgium |
| Certificate valid until (有效期至) | 2030-07-21 |
| Filing line, Art. 82 (法定申报时限) | 2030-01-21 |
| Data as of (数据快照日) | 2026-06-28 |
All China registrations held by Janssen-Cilag International NV →
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.