Overview
Rebamipide has been investigated for the treatment of Stomach Ulcer, Keratoconjunctivitis Sicca, and Gastric Adenoma and Early Gastric Cancer.
Indication
主要用于胃溃疡，但不宜单独用于Hp感染。也用于改善胃炎及慢性胃炎急性加重期的胃黏膜病变（如糜烂、出血、充血、水肿等）。
Associated Conditions
- Gastric Ulcer
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2023/10/16 | Phase 1 | Not yet recruiting | |||
2021/12/21 | Phase 1 | Recruiting | |||
2021/05/13 | Phase 4 | UNKNOWN | Seoul National University Boramae Hospital | ||
2020/12/02 | Phase 3 | Recruiting | |||
2020/09/16 | N/A | UNKNOWN | |||
2019/12/06 | Phase 3 | Completed | |||
2019/11/04 | Phase 1 | Completed | |||
2019/11/04 | Phase 1 | Completed | |||
2019/08/26 | Phase 3 | Completed | |||
2018/09/05 | Phase 3 | Completed | Galeno Desenvolvimento de Pesquisas Clínicas |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| No FDA approvals found for this drug. | |||||
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
| No EMA approvals found for this drug. | |||
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No HSA approvals found for this drug. | |||||
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| Rebamipide Capsules | 国药准字H20110123 | 化学药品 | 胶囊剂 | 6/8/2021 | |
| Rebamipide Tablets | 国药准字H20249201 | 化学药品 | 片剂 | 10/29/2024 | |
| Rebamipide Tablets | 国药准字H20234327 | 化学药品 | 片剂 | 10/18/2023 | |
| Rebamipide Tablets | 国药准字H20244627 | 化学药品 | 片剂 | 8/5/2024 | |
| Rebamipide Tablets | 国药准字H20249490 | 化学药品 | 片剂 | 12/1/2024 | |
| Rebamipide Tablets | 国药准字H20243595 | 化学药品 | 片剂 | 4/24/2024 | |
| Rebamipide Tablets | 国药准字H20244267 | 化学药品 | 片剂 | 6/28/2024 | |
| Rebamipide Tablets | 国药准字H20244429 | 化学药品 | 片剂 | 7/9/2024 | |
| Rebamipide Tablets | 国药准字H20249489 | 化学药品 | 片剂 | 12/1/2024 | |
| Rebamipide Tablets | 国药准字H20020541 | 化学药品 | 片剂 | 2/28/2024 |
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| No TGA approvals found for this drug. | |||||
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