GANCICLOVIR FOR INJECTION, USP DIN 02404761
Status: Marketed
Holder: FRESENIUS KABI CANADA LTD
Molecule: GANCICLOVIR (GANCICLOVIR SODIUM)
Available to quote
Health Canada record
| Active ingredient(s) | GANCICLOVIR (GANCICLOVIR SODIUM) 500 MG |
|---|---|
| Dosage form | Powder For Solution |
| Route | Intravenous |
| Schedule | PRESCRIPTION |
| Class | Human |
| ATC | J05AB06 GANCICLOVIR |
| Original market date | 08-Apr-2014 |
| Current status date | 14-Nov-2025 |
| Source | Health Canada DPD |
Establishment licence of the holder
Fresenius Kabi Canada Ltd. — licence 102232, currently licensed, last inspection rating C (2025-10-01).
No Canadian shortage report is currently matched to this DIN.
Other Canadian products containing GANCICLOVIR (GANCICLOVIR SODIUM)
| DIN | Product | Company | Form | Strength | Status |
|---|---|---|---|---|---|
| 02162695 | CYTOVENE | CHEPLAPHARM ARZNEIMITTEL GMBH | Powder For Solution | GANCICLOVIR (GANCICLOVIR SODIUM) 500 MG | Marketed |
| 02537168 | GANCICLOVIR FOR INJECTION | FORMATIVE PHARMA INC. | Powder For Solution | GANCICLOVIR (GANCICLOVIR SODIUM) 500 MG | Marketed |
| 02471930 | GANCICLOVIR FOR INJECTION USP | AURO PHARMA INC | Powder For Solution | GANCICLOVIR (GANCICLOVIR SODIUM) 500 MG | Approved |
| 02475391 | GANCICLOVIR FOR INJECTION USP | STERIMAX INC | Powder For Solution | GANCICLOVIR (GANCICLOVIR SODIUM) 500 MG | Marketed |
| 02538911 | GANCICLOVIR FOR INJECTION USP | EUGIA PHARMA INC. | Powder For Solution | GANCICLOVIR (GANCICLOVIR SODIUM) 500 MG | Approved |
Notices of Compliance
| NOC | Date | Submission | Reason |
|---|---|---|---|
| 36380 | 2025-11-14 | Supplement to an Abbreviated New Drug Submission (SANDS) | Addition of a drug product manufacturing site and/or manufacturer involving production New package labels Administrative: Change in product name |
| 16846 | 2015-04-27 | Abbreviated New Drug Submission (ANDS) | MANUFACTURER AND PRODUCT NAME CHANGE |
| 14273 | 2013-04-10 | Abbreviated New Drug Submission (ANDS) |