Overview
Antibiotic substance produced by Streptomyces garyphalus.
Indication
本品与其他抗结核药联合，用于经一线药物（如吡嗪酰胺、链霉素、异烟肼、利福平和乙胺丁醇）治疗失败的患者。本品还可用于治疗非结核分枝杆菌感染如鸟复合分枝杆菌病的治疗。
Associated Conditions
- Pulmonary Tuberculosis (TB)
- Tuberculosis, Extrapulmonary
- Grade 1, grade 2, grade 3, grade 4 Urinary Tract Infection
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2023/11/13 | Phase 2 | Not yet recruiting | |||
2023/11/07 | Phase 2 | Recruiting | |||
2023/10/13 | Phase 3 | Active, not recruiting | Beijing Chest Hospital | ||
2023/08/16 | Phase 2 | Recruiting | |||
2023/02/16 | Phase 1 | Completed | |||
2022/10/24 | Phase 2 | Recruiting | The Alfred | ||
2022/05/27 | Phase 2 | Recruiting | |||
2022/04/01 | Phase 4 | Recruiting | Beijing Chest Hospital | ||
2022/01/04 | Phase 2 | Active, not recruiting | |||
2021/10/18 | Phase 2 | Completed |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Parsolex Gmp Center, Inc. | 13845-1203 | ORAL | 250 mg in 1 1 | 1/19/2023 | |
| Parsolex Gmp Center, Inc. | 13845-1202 | ORAL | 250 mg in 1 1 | 1/19/2023 | |
| Dr. Reddy’s Laboratories, Inc. | 43598-235 | ORAL | 250 mg in 1 1 | 2/13/2023 | |
| Parsolex Gmp Center, Inc. | 13845-1201 | ORAL | 250 mg in 250 mg | 1/19/2023 | |
| Parsolex Gmp Center, Inc. | 13845-1200 | ORAL | 250 mg in 250 mg | 1/19/2023 |
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 |
|---|---|---|---|---|---|
| No NMPA approvals found for this drug. | |||||
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 |
|---|---|---|---|---|---|
| Closina 250mg Capsule | 28637 | Medicine | A | 11/4/1991 |
Health Canada Drug Approvals
Approved Product | Company | DIN | Dosage Form | Strength | Market Date |
|---|---|---|---|---|---|
| SEROMYCIN CAP 250MG | eli lilly canada inc | 02032414 | Capsule - Oral | 250 MG / CAP | 12/31/1994 |
CIMA AEMPS Drug Approvals
Approved Product | Company | Registration Number | Pharmaceutical Form | Prescription Type | Status |
|---|---|---|---|---|---|
| No CIMA AEMPS (Spain) approvals found for this drug. | |||||
Philippines FDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Philippines FDA approvals found for this drug. | |||||
Saudi SFDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Saudi SFDA approvals found for this drug. | |||||
Malaysia NPRA Drug Approvals
Approved Product | Company | Registration Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Malaysia NPRA approvals found for this drug. | |||||
UK EMC Drug Information
Medicine Name | MA Holder | MA Number | Pharmaceutical Form | Active Ingredient | Authorization Date |
|---|---|---|---|---|---|
| No UK EMC drug information found for this drug. | |||||
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