Overview
An RNA synthesis inhibitor that is used as an antiviral agent in the prophylaxis and treatment of influenza.
Background
An RNA synthesis inhibitor that is used as an antiviral agent in the prophylaxis and treatment of influenza.
Indication
For the prophylaxis and treatment of illness caused by various strains of influenza A virus in adults.
Associated Conditions
- Influenza A Virus Infection
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2023/04/24 | Phase 1 | Active, not recruiting | |||
2011/08/10 | N/A | Completed | The Leeds Teaching Hospitals NHS Trust | ||
2010/07/30 | Phase 1 | Completed |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Carilion Materials Management | 68151-2103 | ORAL | 100 mg in 1 1 | 5/17/2010 | |
| STAT Rx USA LLC | 16590-202 | ORAL | 100 mg in 1 1 | 8/14/2012 | |
| Amneal Pharmaceuticals of New York LLC | 0115-1911 | ORAL | 100 mg in 1 1 | 12/31/2023 | |
| H.J. Harkins Company, Inc. | 52959-305 | ORAL | 100 mg in 1 1 | 9/12/2011 |
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 |
|---|---|---|---|---|---|
| Rimantadine Hydrochloride Oral Solution | 国药准字H20010786 | 化学药品 | 口服溶液剂 | 4/17/2020 | |
| Rimantadine Hydrochloride Tablets | 国药准字H20030599 | 化学药品 | 片剂 | 7/13/2020 | |
| Rimantadine Hydrochloride Tablets | 国药准字H20010785 | 化学药品 | 片剂 | 4/17/2020 | |
| Rimantadine Hydrochloride Granules | 国药准字H20051475 | 化学药品 | 颗粒剂 | 8/10/2020 | |
| Rimantadine Hydrochloride Granules | 国药准字H20100029 | 化学药品 | 颗粒剂 | 2/26/2020 | |
| Rimantadine Hydrochloride Granules | 国药准字H20090150 | 化学药品 | 颗粒剂 | 11/28/2023 | |
| Rimantadine Hydrochloride Syrup | 国药准字H20041181 | 化学药品 | 糖浆剂 | 6/15/2020 |
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. | |||||