Overview
Nimesulide is a relatively COX-2 selective, non-steroidal anti-inflammatory drug (NSAID) with analgesic and antipyretic properties. Its approved indications are the treatment of acute pain, the symptomatic treatment of osteoarthritis and primary dysmenorrhoea in adolescents and adults above 12 years old. Due to concerns about the risk of hepatotoxicity, nimesulide has been withdrawn from market in many countries.
Indication
For the treatment of acute pain, the symptomatic treatment of osteoarthritis and primary dysmenorrhoea in adolescents and adults above 12 years old.
Associated Conditions
- Acute Pain
- Menstrual Distress (Dysmenorrhea)
- Pain
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2023/09/15 | Phase 2 | Not yet recruiting | |||
2022/03/10 | N/A | TEMPORARILY_NOT_AVAILABLE | |||
2020/10/30 | Phase 2 | UNKNOWN | Pomeranian Medical University Szczecin | ||
2018/08/06 | Phase 1 | Completed | |||
2017/04/18 | Not Applicable | Completed | University of Roma La Sapienza | ||
2014/09/01 | Phase 4 | Completed | |||
2012/12/10 | Phase 1 | Completed | |||
2012/08/22 | Phase 3 | Completed | EMS | ||
2011/12/28 | Phase 2 | Completed | European Institute of Oncology | ||
2010/12/09 | Phase 4 | Withdrawn |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| No FDA approvals found for this drug. | |||||
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 |
|---|---|---|---|---|---|
| Nimesulide Gel | 国药准字H20050131 | 化学药品 | 凝胶剂 | 12/2/2019 | |
| Nimesulide Sustained-release Tablets | 国药准字H20090235 | 化学药品 | 片剂 | 4/2/2024 | |
| Nimesulide Sustained-release Capsules | 国药准字H20050832 | 化学药品 | 胶囊剂 | 9/1/2020 | |
| Nimesulide Orally Disintegrating Tablets | 国药准字H20080826 | 化学药品 | 口腔崩解片 | 4/19/2023 | |
| Nimesulide for Suspension | 国药准字H20000381 | 化学药品 | 口服混悬剂 | 1/22/2020 | |
| Nimesulide for Suspension | 国药准字H20000380 | 化学药品 | 口服混悬剂 | 1/22/2020 | |
| Nimesulide for Suspension | 国药准字H20051989 | 化学药品 | 干混悬剂 | 5/22/2020 | |
| Nimesulide for Suspension | 国药准字H20073377 | 化学药品 | 干混悬剂 | 5/8/2020 | |
| Nimesulide Capsules | 国药准字H20010751 | 化学药品 | 胶囊剂 | 6/29/2020 | |
| Nimesulide Capsules | 国药准字H20010428 | 化学药品 | 胶囊剂 | 7/30/2020 |
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| EMDON TAB 100MG | N/A | N/A | N/A | 4/18/2008 | |
| NIMILL TABLETS 100MG | N/A | N/A | N/A | 3/15/2012 | |
| NIBERAN TABLETS 100MG | N/A | N/A | N/A | 8/28/2014 |
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| No TGA approvals found for this drug. | |||||
Help Us Improve
Your feedback helps us provide better drug information and insights.