Overview
An acyclovir analog that is a potent inhibitor of the Herpesvirus family including cytomegalovirus. Ganciclovir is used to treat complications from AIDS-associated cytomegalovirus infections.
Indication
For induction and maintenance in the treatment of cytomegalovirus (CMV) retinitis in immunocompromised patients, including patients with acquired immunodeficiency syndrome (AIDS). Also used in the treatment of severe cytomegalovirus (CMV) disease, including CMV pneumonia, CMV gastrointestinal disease, and disseminated CMV infections, in immunocompromised patients.
Associated Conditions
- CMV colitis
- Cytomegalovirus (CMV) Infections
- Cytomegalovirus Retinitis
- Cytomegalovirus gastroesophagitis
- Varicella-zoster Progressive outer retinal necrosis
- Acute Herpetic keratitis
- Cytomegalovirus neurological disease
- Varicella-zoster virus acute retinal necrosis
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2025/05/14 | Phase 2 | Not yet recruiting | |||
2025/02/28 | Phase 2 | Not yet recruiting | |||
2025/01/03 | Not Applicable | Completed | |||
2024/05/31 | Not Applicable | Recruiting | Wuhan Union Hospital, China | ||
2024/04/02 | Phase 3 | Not yet recruiting | Hospital do Rim e Hipertensão | ||
2022/10/13 | Phase 1 | Completed | |||
2021/01/12 | Phase 3 | Active, not recruiting | |||
2020/07/20 | N/A | Completed | |||
2020/01/13 | Phase 1 | UNKNOWN | |||
2019/10/18 | N/A | UNKNOWN |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Fresenius Kabi USA, LLC | 63323-315 | INTRAVENOUS | 500 mg in 10 mL | 9/30/2022 | |
| Hainan Poly Pharm. Co., Ltd. | 14335-030 | INTRAVENTRICULAR | 50 mg in 1 mL | 1/30/2019 | |
| Par Pharmaceutical, Inc. | 42023-173 | INTRAVENOUS | 500 mg in 10 mL | 9/17/2018 | |
| Ranbaxy Pharmaceuticals Inc. | 63304-636 | ORAL | 250 mg in 1 1 | 10/20/2011 | |
| Hikma Pharmaceuticals USA Inc. | 0143-9299 | INTRAVENOUS | 50 mg in 1 mL | 7/1/2021 | |
| Ranbaxy Pharmaceuticals Inc. | 63304-637 | ORAL | 500 mg in 1 1 | 10/20/2011 | |
| Fresenius Kabi USA, LLC | 63323-315 | INTRAVENOUS | 500 mg in 10 mL | 8/31/2019 | |
| Slate Run Pharmaceuticals, LLC | 70436-089 | INTRAVENTRICULAR | 500 mg in 10 mL | 8/31/2021 | |
| Bausch & Lomb Incorporated | 24208-535 | OPHTHALMIC | 1.5 mg in 1 g | 2/27/2024 | |
| EXELA PHARMA SCIENCES, LLC | 51754-2500 | INTRAVENOUS | 2 mg in 1 mL | 9/19/2017 |
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 |
|---|---|---|---|---|---|
| VIRGAN EYE GEL 1.5 mg/g | SIN11778P | OINTMENT | 0.15g/ 100g | 1/18/2002 | |
| CYMEVENE FOR INJECTION 500 mg | SIN05051P | INJECTION, POWDER, FOR SOLUTION | 500 mg | 9/6/1990 |
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 |
|---|---|---|---|---|---|
| CYMEVENE 500mg (as sodium) powder for injection vial | 10047 | Pharmaco Australia Ltd | Medicine | A | 6/11/1991 |
| GANCICLOVIR MYLAN ganciclovir 500mg powder for injection vial | 233584 | Medicine | A | 1/14/2022 | |
| GANCICLOVIR HHH ganciclovir (as sodium) 500 mg powder for injection vial | 280239 | Medicine | A | 8/31/2017 | |
| GANCICLOVIR ALPHAPHARM ganciclovir 500mg powder for injection vial | 233585 | Medicine | A | 1/14/2022 | |
| GANCICLOVIR AGILA ganciclovir 500mg powder for injection vial | 233583 | Medicine | A | 1/14/2022 | |
| GANCICLOVIR LUPIN ganciclovir (as sodium) 500 mg powder for injection vial | 280238 | Medicine | A | 8/31/2017 |
Health Canada Drug Approvals
Approved Product | Company | DIN | Dosage Form | Strength | Market Date |
|---|---|---|---|---|---|
| CYTOVENE - CAP 250MG | Hoffmann-La Roche Limited | 02186802 | Capsule - Oral | 250 MG / CAP | 12/31/1995 |
| CYTOVENE INJ 500MG/VIAL | syntex inc. | 00865516 | Powder For Solution - Intravenous | 500 MG / VIAL | 12/31/1990 |
| VITRASERT, INTRAVITREAL IMPLANT | bausch & lomb inc | 02233015 | Implant - Intravitreal | 4.5 MG / IMP | 3/25/1998 |
| EYEZIRGAN | 02530546 | Gel - Ophthalmic | 0.15 % / W/W | 9/26/2023 | |
| CYTOVENE, 500 MG | Hoffmann-La Roche Limited | 02240362 | Capsule - Oral | 500 MG / CAP | 1/14/2000 |
CIMA AEMPS Drug Approvals
Approved Product | Company | Registration Number | Pharmaceutical Form | Prescription Type | Status |
|---|---|---|---|---|---|
| VIRGAN 1,5 mg/g GEL OFTALMICO | 67075 | GEL OFTÁLMICO | Diagnóstico Hospitalario | Commercialized | |
| VIRGAN 1,5 MG/G GEL OFTALMICO | 1213503022014 | GEL OFTÁLMICO | Diagnóstico Hospitalario | Not Commercialized | |
| VIRGAN 1,5 MG/G GEL OFTÁLMICO | 037145012 | GEL OFTÁLMICO | Diagnóstico Hospitalario | Not 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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