Overview
Ketoprofen, a propionic acid derivative, is a nonsteroidal anti-inflammatory agent (NSAIA) with analgesic and antipyretic properties.
Background
Ketoprofen, a propionic acid derivative, is a nonsteroidal anti-inflammatory agent (NSAIA) with analgesic and antipyretic properties.
Indication
For symptomatic treatment of acute and chronic rheumatoid arthritis, osteoarthritis, ankylosing spondylitis, primary dysmenorrhea and mild to moderate pain associated with musculotendinous trauma (sprains and strains), postoperative (including dental surgery) or postpartum pain.
Associated Conditions
- Ankylosing Spondylitis (AS)
- Migraine
- Mild pain
- Osteoarthritis (OA)
- Post Partum Pain
- Postoperative pain
- Primary Dysmenorrhoea
- Rheumatoid Arthritis
- Moderate Pain
Clinical Trials
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Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2018/12/21 | N/A | Terminated | |||
2018/07/13 | Phase 3 | Completed | |||
2018/01/19 | Phase 4 | Completed | |||
2017/08/09 | Phase 4 | Completed | |||
2017/01/19 | Phase 3 | Completed | EMS | ||
2016/09/19 | Phase 3 | Completed | |||
2016/09/19 | Phase 3 | Completed | |||
2016/08/11 | Phase 3 | Completed | EMS | ||
2016/06/17 | Phase 4 | Completed | Michał Borys | ||
2016/04/06 | Phase 4 | Completed | Luis Fernando Simoneti |
FDA Drug Approvals
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Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| No FDA approvals found for this drug. | |||||
EMA Drug Approvals
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Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
| No EMA approvals found for this drug. | |||
HSA Drug Approvals
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Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| FASTUM GEL MAX 2.5% | SIN15511P | GEL | 2.5g/100g | 7/11/2018 |
NMPA Drug Approvals
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Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| Ketoprofen Capsules | 国药准字H41024847 | 化学药品 | 胶囊剂 | 12/9/2019 | |
| Ketoprofen Capsules | 国药准字H41024615 | 化学药品 | 胶囊剂 | 8/31/2020 | |
| Ketoprofen Capsules | 国药准字H23023013 | 化学药品 | 胶囊剂 | 3/24/2020 | |
| Ketoprofen Capsules | 国药准字H52020954 | 化学药品 | 胶囊剂 | 7/16/2020 | |
| Ketoprofen Capsules | 国药准字H14020833 | 化学药品 | 胶囊剂 | 8/31/2020 | |
| Ketoprofen Capsules | 国药准字H22025760 | 化学药品 | 胶囊剂 | 3/11/2020 | |
| Ketoprofen Liniment | 国药准字H10950341 | 化学药品 | 搽剂 | 9/18/2020 | |
| Ketoprofen Liniment | 国药准字H10940113 | 化学药品 | 搽剂 | 4/25/2020 | |
| Ketoprofen Liniment | 国药准字H20184138 | 化学药品 | 搽剂 | 5/8/2023 | |
| Ketoprofen Liniment | 国药准字H20057870 | 化学药品 | 搽剂 | 7/14/2020 |
PPB Drug Approvals
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Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
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Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| No TGA approvals found for this drug. | |||||