Novartis Pharma Schweiz AG — China drug registrations and re-registration deadlines
47 certificates in the NMPA overseas-manufactured drug database (境外生产药品库), snapshot 2026-06-28. Earliest re-registration deadline: 2026-09-14.
| Approval number | Product | Certificate expires | Re-registration deadline (Art. 82) |
|---|---|---|---|
| 国药准字HJ20171030 | Trileptal 奥卡西平片 | 2027-03-14 | 2026-09-14 |
| 国药准字HJ20171031 | Trileptal 奥卡西平片 | 2027-03-14 | 2026-09-14 |
| 国药准字HJ20171032 | Trileptal 奥卡西平片 | 2027-03-14 | 2026-09-14 |
| 国药准字HJ20171033 | Trileptal 奥卡西平片 | 2027-03-14 | 2026-09-14 |
| 国药准字HJ20171034 | Eucreas 二甲双胍维格列汀片(Ⅱ) | 2027-03-20 | 2026-09-20 |
| 国药准字HJ20171145 | Afinitor 依维莫司片 | 2027-03-29 | 2026-09-29 |
| 国药准字SJ20171040 | Simulect 注射用巴利昔单抗 | 2027-04-26 | 2026-10-26 |
| 国药准字HJ20181069 | Co-Diovan 缬沙坦氢氯噻嗪片 | 2027-05-05 | 2026-11-05 |
| 国药准字HJ20181070 | Co-Diovan 缬沙坦氢氯噻嗪片 | 2027-05-05 | 2026-11-05 |
| 国药准字HJ20171151 | Tasigna 尼洛替尼胶囊 | 2027-06-08 | 2026-12-08 |
| 国药准字HJ20171152 | Tasigna 尼洛替尼胶囊 | 2027-06-08 | 2026-12-08 |
| 国药准字HJ20171261 | SANDOSTATIN LAR 注射用醋酸奥曲肽微球 | 2027-08-17 | 2027-02-17 |
| 国药准字HJ20171262 | SANDOSTATIN LAR 注射用醋酸奥曲肽微球 | 2027-08-17 | 2027-02-17 |
| 国药准字HJ20170387 | Revolade 艾曲泊帕乙醇胺片 | 2027-11-03 | 2027-05-03 |
| 国药准字SJ20181010 | Lucentis 雷珠单抗注射液 | 2027-11-16 | 2027-05-16 |
| 国药准字HJ20230003 | Kisqali 琥珀酸瑞波西利片 | 2028-01-18 | 2027-07-18 |
| 国药准字HJ20140647 | Oxcarbazepine Oral Suspension 奥卡西平口服混悬液 | 2028-06-08 | 2027-12-08 |
| 国药准字HJ20140149 | Femara 来曲唑片 | 2028-06-18 | 2027-12-18 |
| 国药准字HJ20140287 | Sandimmun Neoral 环孢素软胶囊 | 2028-06-27 | 2027-12-27 |
| 国药准字HJ20140288 | Sandimmun Neoral 环孢素软胶囊 | 2028-06-27 | 2027-12-27 |
| 国药准字HJ20140291 | Sandimmun Neoral 环孢素软胶囊 | 2028-06-27 | 2027-12-27 |
| 国药准字HJ20150093 | Afinitor 依维莫司片 | 2028-07-31 | 2028-01-31 |
| 国药准字HJ20140333 | Tasigna 尼洛替尼胶囊 | 2028-08-28 | 2028-02-28 |
| 国药准字HJ20140334 | Tasigna 尼洛替尼胶囊 | 2028-08-28 | 2028-02-28 |
| 国药准字HJ20191028 | Tasigna 尼洛替尼胶囊 | 2028-08-28 | 2028-02-28 |
| 国药准字HJ20150112 | Glivec 甲磺酸伊马替尼片 | 2028-09-26 | 2028-03-26 |
| 国药准字HJ20150364 | Sandostatin 醋酸奥曲肽注射液 | 2028-09-26 | 2028-03-26 |
| 国药准字SJ20190023 | Cosentyx 司库奇尤单抗注射液 | 2028-11-02 | 2028-05-02 |
| 国药准字SJ20225001 | Cosentyx 司库奇尤单抗注射液 | 2028-11-02 | 2028-05-02 |
| 国药准字SJ20225003 | Cosentyx 司库奇尤单抗注射液 | 2028-11-02 | 2028-05-02 |
| 国药准字HJ20190044 | Gilenya 盐酸芬戈莫德胶囊 | 2029-02-27 | 2028-08-27 |
| 国药准字HJ20150310 | Valsartan and Amlodipine Tablets(I) 缬沙坦氨氯地平片(Ⅰ) | 2029-04-02 | 2028-10-02 |
| 国药准字HJ20240016 | FABHALTA 盐酸伊普可泮胶囊 | 2029-04-23 | 2028-10-23 |
| 国药准字HJ20240041 | Tabrecta 盐酸卡马替尼片 | 2029-06-10 | 2028-12-10 |
| 国药准字HJ20240042 | Tabrecta 盐酸卡马替尼片 | 2029-06-10 | 2028-12-10 |
| 国药准字HJ20150095 | Sandimmun 环孢素注射液 | 2029-06-26 | 2028-12-26 |
| 国药准字HJ20150208 | Exjade 地拉罗司分散片 | 2029-08-21 | 2029-02-21 |
| 国药准字HJ20200010 | Mayzent 西尼莫德片 | 2029-11-19 | 2029-05-19 |
| 国药准字HJ20200011 | Mayzent 西尼莫德片 | 2029-11-19 | 2029-05-19 |
| 国药准字HJ20170390 | Ultibro 茚达特罗格隆溴铵吸入粉雾剂 | 2030-03-24 | 2029-09-24 |
| 国药准字HJ20170391 | Ultibro 茚达特罗格隆溴铵吸入粉雾剂 | 2030-03-24 | 2029-09-24 |
| 国药准字HJ20250056 | SCEMBLIX 盐酸阿思尼布片 | 2030-05-12 | 2029-11-12 |
| 国药准字SJ20250019 | Beovu 布西珠单抗注射液 | 2030-05-26 | 2029-11-26 |
| 国药准字SJ20250020 | Beovu 布西珠单抗注射液 | 2030-05-26 | 2029-11-26 |
| 国药准字HJ20250133 | PLUVICTO 镥[¹⁷⁷Lu]特昔维匹肽注射液 | 2030-11-03 | 2030-05-03 |
| 国药准字HJ20250136 | RHAPSIDO 瑞米布替尼片 | 2030-11-24 | 2030-05-24 |
| 国药准字HJ20250137 | Kit for the Preparation of Gallium (68Ga) Gozetotide Injection 注射用镓[68Ga]戈泽肽药盒 | 2030-11-24 | 2030-05-24 |
Under the Provisions for Drug Registration (药品注册管理办法) Art. 82, an application to renew an overseas-manufactured drug registration is filed with the Center for Drug Evaluation no later than 6 months before the certificate expires; the filing line column is that arithmetic applied to the expiry cell. Art. 84(1): a certificate with no application by expiry is not re-registered and is cancelled at expiry. Every figure is taken from the public NMPA database as of 2026-06-28, or computed from it. Registration data changes; the NMPA portal governs. This page states no view on whether any of these products' Domestic Responsible Person (境内责任人) arrangements meet NMPA Announcement No. 137 — that cannot be determined from a public entry.