Overview
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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|---|---|---|---|---|---|
| No NMPA approvals found for this drug. | |||||
PPB Drug Approvals
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|---|---|---|---|---|---|
| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
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Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
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| No TGA approvals found for this drug. | |||||
Health Canada Drug Approvals
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Approved Product | Company | DIN | Dosage Form | Strength | Market Date |
|---|---|---|---|---|---|
| NU-KETOPROFEN CAP 50MG | nu-pharm inc | 02044633 | Capsule - Oral | 50 MG | 12/31/1993 |
| PMS-KETOPROFEN | 02015951 | Suppository - Rectal | 100 MG | 12/31/1993 | |
| ORAFEN - SUP RT 100MG | technilab pharma inc. | 02165481 | Suppository - Rectal | 100 MG / SUP | 12/31/1996 |
| ORUDIS E-100 | aventis pharma inc | 01926365 | Tablet (Enteric-Coated) - Oral | 100 MG | 12/31/1987 |
| ORUVAIL 200 | aventis pharma inc | 01913069 | Capsule (Sustained-Release) - Oral | 200 MG / CAP | 12/31/1991 |
| KETOPROFEN-E | aa pharma inc | 00842664 | Tablet (Enteric-Coated) - Oral | 100 MG | 12/31/1989 |
| KETOPROFEN-E ECT 50MG | PRO DOC LIMITEE | 02084171 | Tablet (Enteric-Coated) - Oral | 50 MG / ECT | 12/31/1995 |
| RHOVAIL 200 | rhodiapharm inc | 02183102 | Capsule (Sustained-Release) - Oral | 200 MG | 12/31/1995 |
| NU-KETOPROFEN-E ECT 100MG | nu-pharm inc | 02044641 | Tablet (Enteric-Coated) - Oral | 100 MG / ECT | 12/31/1994 |
| RHOVAIL 150 | rhodiapharm inc | 02183099 | Capsule (Sustained-Release) - Oral | 150 MG | 12/31/1995 |
CIMA AEMPS Drug Approvals
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Approved Product | Company | Registration Number | Pharmaceutical Form | Prescription Type | Status |
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| No CIMA AEMPS (Spain) approvals found for this drug. | |||||
Philippines FDA Drug Approvals
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|---|---|---|---|---|---|
| No Philippines FDA approvals found for this drug. | |||||
Saudi SFDA Drug Approvals
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| No Saudi SFDA approvals found for this drug. | |||||
Malaysia NPRA Drug Approvals
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UK EMC Drug Information
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Medicine Name | MA Holder | MA Number | Pharmaceutical Form | Active Ingredient | Authorization Date |
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| No UK EMC drug information found for this drug. | |||||
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