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 |
|---|---|---|---|---|---|
2014/07/02 | Phase 2 | UNKNOWN | University Hospital, Clermont-Ferrand | ||
2014/06/30 | Phase 4 | Completed | |||
2014/03/28 | Phase 2 | Completed | |||
2014/02/07 | Phase 1 | Completed | Achelios Therapeutics | ||
2013/07/02 | Phase 3 | Withdrawn | |||
2013/06/20 | Phase 4 | Terminated | Rennes University Hospital | ||
2013/03/22 | Phase 4 | Completed | University Hospital, Grenoble | ||
2012/09/14 | Phase 4 | Withdrawn | Centre Hospitalier Universitaire de Nīmes | ||
2011/06/15 | Phase 3 | UNKNOWN | Laboratório Teuto Brasileiro S/A | ||
2010/10/18 | Phase 3 | Withdrawn |
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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|---|---|---|---|
| No EMA approvals found for this drug. | |||
HSA Drug Approvals
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|---|---|---|---|---|---|
| No HSA approvals found for this drug. | |||||
NMPA Drug Approvals
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PPB Drug Approvals
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|---|---|---|---|---|---|
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TGA Drug Approvals
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Health Canada Drug Approvals
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Approved Product | Company | DIN | Dosage Form | Strength | Market Date |
|---|---|---|---|---|---|
| KETOPROFEN SR | aa pharma inc | 02172577 | Tablet (Extended-Release) - Oral | 200 MG | 12/31/1995 |
| PMS-KETOPROFEN CAPSULES | 02150808 | Capsule - Oral | 50 MG | 12/31/1995 | |
| KETOPROFEN-E | aa pharma inc | 00790435 | Tablet (Enteric-Coated) - Oral | 50 MG | 12/31/1989 |
| KETOPROFEN SUPPOSITORIES | pharmel inc | 02237011 | Suppository - Rectal | 100 MG | 6/4/1998 |
| RHODIS EC | sanofi-aventis canada inc | 00761672 | Tablet (Enteric-Coated) - Oral | 50 MG | 12/31/1988 |
| RHODIS | sanofi-aventis canada inc | 00761699 | Suppository - Rectal | 100 MG / SUP | 12/31/1988 |
CIMA AEMPS Drug Approvals
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|---|---|---|---|---|---|
| No CIMA AEMPS (Spain) approvals found for this drug. | |||||
Philippines FDA Drug Approvals
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Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| 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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| No Malaysia NPRA approvals found for this drug. | |||||
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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