Overview
Racecadotril has been investigated for the basic science and treatment of Diarrhea, Acute Diarrhea, and Acute Gastroenteritis.
Indication
主要用于腹泻，包括急性腹泻、与人免疫缺陷病毒(HIV)感染或获得性免疫缺陷综合征(艾滋病，AIDS)有关的慢性腹泻，也可与洛哌丁胺合用治疗依立替康所致腹泻。本品静注可用于阿片类物质的戒断症状。
Associated Conditions
- Acute Diarrhea
- Diarrhea
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2024/07/31 | Phase 1 | Not yet recruiting | |||
2024/03/07 | Phase 1 | Not yet recruiting | Pharma Nueva | ||
2022/10/31 | Not Applicable | Recruiting | |||
2022/02/01 | Phase 1 | Completed | |||
2021/05/13 | Not Applicable | UNKNOWN | |||
2018/03/22 | Phase 3 | Completed | |||
2018/03/13 | Phase 3 | Completed | |||
2013/09/23 | Phase 1 | Completed | |||
2012/04/13 | Phase 4 | Completed | Centro Pediatrico Albina de Patino | ||
2011/11/22 | Phase 1 | Completed |
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 |
|---|---|---|---|---|---|
| Hidrasec Children Granules for Oral Suspension 30mg | SIN14413P | GRANULE, FOR SUSPENSION | 30.00mg | 9/30/2013 | |
| Hidrasec Infants Granules for Oral Suspension 10mg | SIN14412P | GRANULE, FOR SUSPENSION | 10.00mg | 9/30/2013 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| Racecadotril Capsules | H20130353 | 化学药品 | 胶囊剂 | 12/27/2019 | |
| Racecadotril Capsules | 国药准字H20054342 | 化学药品 | 胶囊剂 | 9/9/2020 | |
| Racecadotril Capsules | 国药准字H20054194 | 化学药品 | 胶囊剂 | 8/11/2020 | |
| Racecadotril Capsules | 国药准字H20083800 | 化学药品 | 胶囊剂 | 5/15/2023 | |
| Racecadotril Tablets | 国药准字H20052604 | 化学药品 | 片剂 | 12/11/2020 | |
| Racecadotril Tablets | 国药准字H20052603 | 化学药品 | 片剂 | 12/7/2020 | |
| Racecadotril Orally Disintegrating Tablets | 国药准字H20051487 | 化学药品 | 片剂(口崩片) | 3/2/2020 | |
| Racecadotril Granules | 国药准字H20050412 | 化学药品 | 颗粒剂 | 3/27/2020 | |
| Racecadotril Granules | 国药准字H20051055 | 化学药品 | 颗粒剂 | 8/11/2020 | |
| Racecadotril Granules | 国药准字H20050411 | 化学药品 | 颗粒剂 | 3/27/2020 |
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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