Overview
A diphenylbutylpiperidine that is effective as an antipsychotic agent and as an alternative to haloperidol for the suppression of vocal and motor tics in patients with Tourette syndrome. Although the precise mechanism of action is unknown, blockade of postsynaptic dopamine receptors has been postulated. (From AMA Drug Evaluations Annual, 1994, p403)
Indication
适用于急、慢性精神分裂症，对精神分裂症的阴性症状疗效较好，亦可用于治疗偏执状态、亨廷顿病、抽动秽语综合征、躁狂症、神经性厌食、青少年行为障碍等。
Associated Conditions
- Delusional Parasitosis
- Tics
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2023/02/08 | Phase 1 | Completed | Food and Drug Administration (FDA) | ||
2022/08/19 | Not Applicable | UNKNOWN | |||
2017/09/05 | Phase 2 | UNKNOWN | |||
2015/11/09 | N/A | Completed | |||
2015/06/04 | Phase 2 | UNKNOWN | |||
2015/03/02 | Phase 3 | Terminated | |||
2014/12/04 | Phase 4 | Completed | Technical University of Munich | ||
2006/09/11 | Phase 2 | Completed | |||
2005/09/12 | Phase 4 | Completed | |||
2000/02/25 | Phase 2 | Completed | National Center for Research Resources (NCRR) |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Par Pharmaceutical, Inc. | 49884-347 | ORAL | 1 mg in 1 1 | 11/25/2017 | |
| Par Pharmaceutical, Inc. | 49884-348 | ORAL | 2 mg in 1 1 | 11/25/2017 |
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 |
|---|---|---|---|---|---|
| No NMPA approvals found for this drug. | |||||
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| No TGA approvals found for this drug. | |||||
Health Canada Drug Approvals
Approved Product | Company | DIN | Dosage Form | Strength | Market Date |
|---|---|---|---|---|---|
| ORAP TAB 10MG | mcneil pharmaceutical, division of ortho-mcneil inc. | 00573817 | Tablet - Oral | 10 MG / TAB | 12/31/1983 |
| PMS-PIMOZIDE | 02239829 | Tablet - Oral | 2 MG | 10/18/2002 | |
| ORAP | aa pharma inc | 00313823 | Tablet - Oral | 4 MG | 12/31/1975 |
| PIMOZIDE | aa pharma inc | 02245432 | Tablet - Oral | 2 MG | 4/1/2003 |
| ORAP | aa pharma inc | 00313815 | Tablet - Oral | 2 MG | 12/31/1975 |
| PIMOZIDE | aa pharma inc | 02245433 | Tablet - Oral | 4 MG | 4/1/2003 |
| PMS-PIMOZIDE | 02239830 | Tablet - Oral | 4 MG | 10/18/2002 | |
| PMS-PIMOZIDE | 02239831 | Tablet - Oral | 10 MG | N/A |
CIMA AEMPS Drug Approvals
Approved Product | Company | Registration Number | Pharmaceutical Form | Prescription Type | Status |
|---|---|---|---|---|---|
| ORAP FUERTE 4 mg COMPRIMIDOS | Eumedica. | 49504 | COMPRIMIDO | Medicamento Sujeto A Prescripción Médica | Commercialized |
| ORAP 1 mg COMPRIMIDOS | Eumedica. | 49503 | COMPRIMIDO | Medicamento Sujeto A Prescripción Médica | Commercialized |
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. | |||||
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