Overview
Safinamide is for the treatment of parkinson's disease. It was approved in Europe in February 2015, and in the United States on March 21, 2017.
Indication
用于治疗帕金森病
Associated Conditions
- Parkinson's Disease (PD)
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2022/04/05 | Phase 4 | Completed | |||
2019/06/17 | Phase 3 | Withdrawn | |||
2019/05/30 | Phase 4 | Recruiting | |||
2019/05/10 | N/A | Completed | |||
2019/03/22 | Phase 1 | Completed | |||
2019/03/19 | Phase 3 | Completed | |||
2019/02/18 | Phase 4 | Completed | IRCCS San Raffaele Roma | ||
2019/02/15 | Phase 4 | Completed | |||
2018/11/27 | Phase 2 | Completed | |||
2018/08/27 | N/A | UNKNOWN | Universita di Verona |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| MDD US Operations LLC, a subsidiary of Supernus Pharmaceuticals, Inc. | 27505-110 | ORAL | 50 mg in 1 1 | 12/20/2023 | |
| MDD US Operations LLC, a subsidiary of Supernus Pharmaceuticals, Inc. | 27505-111 | ORAL | 100 mg in 1 1 | 12/20/2023 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
Authorised | 2/23/2015 |
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| EQUFINA FILM-COATED TABLET 50MG | SIN16615P | TABLET, FILM COATED | 50mg | 9/28/2022 |
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 |
|---|---|---|---|---|---|
| EQUFINA TABLETS 50MG | N/A | N/A | N/A | 5/2/2023 |
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| XADAGO safinamide (as mesilate) 100 mg film-coated tablet blister pack | 292144 | Medicine | A | 11/2/2018 | |
| MSN-SAFINAMIDE safinamide (as mesilate) 50 mg tablet blister pack | 449610 | Medicine | A | 7/8/2025 | |
| MSN-SAFINAMIDE safinamide (as mesilate) 100 mg tablet blister pack | 449609 | Medicine | A | 7/8/2025 | |
| XADAGO safinamide (as mesilate) 50 mg film-coated tablet blister pack | 292145 | Medicine | A | 11/2/2018 |
Health Canada Drug Approvals
Approved Product | Company | DIN | Dosage Form | Strength | Market Date |
|---|---|---|---|---|---|
| No Health Canada approvals found for this drug. | |||||
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. | |||||
Help Us Improve
Your feedback helps us provide better drug information and insights.