Overview
An antiarrhythmia agent that is particularly effective in ventricular arrhythmias. It also has weak beta-blocking activity. The drug is generally well tolerated.
Background
An antiarrhythmia agent that is particularly effective in ventricular arrhythmias. It also has weak beta-blocking activity. The drug is generally well tolerated.
Indication
Used to prolong the time to recurrence of paroxysmal atrial fibrillation/flutter (PAF) associated with disabling symptoms in patients without structural heart disease. Also used for the treatment of life-threatening documented ventricular arrhythmias, such as sustained ventricular tachycardia.
Associated Conditions
- Atrial Fibrillation
- Paroxysmal Atrial Fibrillation (PAF)
- Paroxysmal Supraventricular Tachycardia (PSVT)
- Ventricular Arrhythmia
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2023/02/09 | Phase 4 | Recruiting | Centre of Postgraduate Medical Education | ||
2022/07/19 | N/A | Recruiting | Shandong University | ||
2019/04/16 | Phase 1 | Completed | |||
2019/03/29 | Phase 4 | UNKNOWN | |||
2018/09/17 | Not Applicable | Completed | |||
2018/06/19 | Not Applicable | Withdrawn | Yong Seog Oh | ||
2017/01/24 | Phase 4 | Completed | Charles University, Czech Republic | ||
2015/12/17 | Not Applicable | UNKNOWN | |||
2014/11/19 | Not Applicable | UNKNOWN | |||
2014/05/23 | Phase 4 | UNKNOWN |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Rebel Distributors Corp | 21695-814 | ORAL | 325 mg in 1 1 | 1/27/2011 |
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 |
|---|---|---|---|---|---|
| RYTMONORM TABLET 150 mg | SIN00395P | TABLET, FILM COATED | 150 mg | 4/26/1988 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| Propafenone Hydrochloride Injection | 国药准字H44020249 | 化学药品 | 注射剂 | 3/15/2024 | |
| Propafenone Hydrochloride Injection | 国药准字H11020468 | 化学药品 | 注射剂（小容量注射剂） | 9/24/2021 | |
| Propafenone Hydrochloride Injection | 国药准字H50021208 | 化学药品 | 注射剂 | 9/25/2020 | |
| Propafenone Hydrochloride Injection | 国药准字H32021718 | 化学药品 | 注射剂 | 8/13/2020 | |
| Propafenone Hydrochloride Injection | 国药准字H44020248 | 化学药品 | 注射剂 | 4/9/2024 | |
| Propafenone Hydrochloride Injection | 国药准字H23022200 | 化学药品 | 注射剂 | 5/26/2021 | |
| Propafenone Hydrochloride Injection | 国药准字H32021719 | 化学药品 | 注射剂 | 8/13/2020 | |
| Propafenone Hydrochloride Injection | 国药准字H50021767 | 化学药品 | 注射剂 | 9/25/2020 | |
| Propafenone Hydrochloride Injection | 国药准字H31022214 | 化学药品 | 注射剂 | 8/13/2020 | |
| Propafenone Hydrochloride Tablets | 国药准字H32020486 | 化学药品 | 片剂 | 5/22/2020 |
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. | |||||