Overview
Rufinamide is a triazole derivative and an anticonvulsant medication to treat seizure disorders like Lennox-Gastuat syndrome, a form of childhood epilepsy. Clinical trials suggest its efficacy in the treatment of partial seizures.
Indication
治疗4岁以上及成人Lennox-Gastaut症候群的癫痫症。
Associated Conditions
- Lennox-Gastaut Syndrome
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2024/12/18 | Phase 1 | Completed | |||
2020/09/22 | Phase 3 | Withdrawn | |||
2018/12/19 | N/A | AVAILABLE | |||
2017/06/22 | N/A | Recruiting | |||
2015/01/06 | Phase 1 | Completed | Wuhan Union Hospital, China | ||
2014/06/26 | N/A | Completed | |||
2014/03/26 | Phase 2 | Withdrawn | |||
2011/07/29 | Phase 3 | Completed | |||
2010/06/28 | Phase 3 | Completed | |||
2010/06/22 | Phase 3 | Completed |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Camber Pharmaceuticals, Inc. | 31722-688 | ORAL | 40 mg in 1 mL | 12/28/2023 | |
| Hikma Pharmaceuticals USA Inc. | 0054-0528 | ORAL | 40 mg in 1 mL | 9/3/2020 | |
| Glenmark Pharmaceuticals Inc., USA | 68462-714 | ORAL | 400 mg in 1 1 | 1/31/2021 | |
| Mylan Pharmaceuticals Inc. | 0378-2331 | ORAL | 400 mg in 1 1 | 6/15/2021 | |
| Micro Labs Limited | 42571-392 | ORAL | 400 mg in 1 1 | 5/17/2023 | |
| Lupin Pharmaceuticals, Inc. | 68180-802 | ORAL | 100 mg in 1 1 | 12/8/2023 | |
| Camber Pharmaceuticals, Inc. | 31722-599 | ORAL | 400 mg in 1 1 | 6/2/2021 | |
| Mylan Pharmaceuticals Inc. | 0378-2330 | ORAL | 200 mg in 1 1 | 6/15/2021 | |
| Camber Pharmaceuticals, Inc. | 31722-598 | ORAL | 200 mg in 1 1 | 6/2/2021 | |
| Eisai Inc. | 62856-583 | ORAL | 400 mg in 1 1 | 11/17/2023 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
Authorised | 1/16/2007 |
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| INOVELON FILM-COATED TABLET 200 MG | SIN15146P | TABLET, FILM COATED | 200 mg | 1/5/2017 |
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 |
|---|---|---|---|---|---|
| INOVELON TABLETS 200MG | N/A | N/A | N/A | 10/28/2015 | |
| INOVELON TABLETS 400MG | N/A | N/A | N/A | 10/28/2015 | |
| INOVELON TABLETS 100MG | N/A | N/A | N/A | 10/28/2015 |
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| INOVELON rufinamide 200 mg film-coated tablet blister pack | 287524 | Medicine | A | 6/27/2018 | |
| INOVELON rufinamide 400 mg film-coated tablet blister pack | 287537 | Medicine | A | 6/27/2018 | |
| INOVELON rufinamide 100 mg film-coated tablet blister pack | 287523 | Medicine | A | 6/27/2018 |
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