Overview
Cidofovir is an injectable antiviral medication employed in the treatment of cytomegalovirus (CMV) retinitis in patients diagnosed with AIDS. It suppresses CMV replication through selective inhibition of viral DNA synthesis. It was manufactured by Gilead and initially approved by the FDA in 1996, but has since been discontinued.
Indication
用于治疗免疫功能缺陷患者不能耐受更昔洛韦和膦甲酸钠治疗或治疗无效的巨细胞病毒感染。
Associated Conditions
- Cytomegalovirus Retinitis
- Herpes Simplex Virus
- Monkeypox
- Variola Major (Smallpox)
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2019/08/13 | Phase 3 | Completed | |||
2016/11/30 | Phase 2 | Completed | |||
2016/10/13 | Phase 3 | Completed | |||
2015/10/02 | Phase 2 | Withdrawn | |||
2015/09/22 | Phase 2 | UNKNOWN | Centro de Investigación en. Enfermedades Infecciosas, Mexico | ||
2015/08/05 | Phase 1 | Completed | |||
2013/09/19 | Not Applicable | Completed | |||
2013/03/22 | Phase 1 | Completed | |||
2011/02/14 | Phase 2 | Active, not recruiting | |||
2009/10/05 | Phase 1 | Completed | Mithra Pharmaceuticals |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Mylan Institutional LLC | 67457-210 | INTRAVENOUS | 75 mg in 1 mL | 2/25/2020 | |
| Gilead Sciences, Inc. | 61958-0101 | INTRAVENOUS | 75 mg in 1 mL | 9/24/2013 | |
| Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | 23155-216 | INTRAVENOUS | 375 mg in 5 mL | 4/21/2021 |
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 |
|---|---|---|---|---|---|
| EMPOVIR cidofovir 375 mg/5 mL concentrated injection for infusion vial | 287040 | Medicine | A | 4/4/2018 |
Health Canada Drug Approvals
Approved Product | Company | DIN | Dosage Form | Strength | Market Date |
|---|---|---|---|---|---|
| No Health Canada approvals found for this drug. | |||||
CIMA AEMPS Drug Approvals
Approved Product | Company | Registration Number | Pharmaceutical Form | Prescription Type | Status |
|---|---|---|---|---|---|
| No CIMA AEMPS (Spain) approvals found for this drug. | |||||
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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