GLIADEL WAFER DIN 02238985
Health Canada record
| Active ingredient(s) | CARMUSTINE 7.7 MG |
|---|---|
| Dosage form | Wafer |
| Route | Intralesional |
| Schedule | PRESCRIPTION |
| Class | Human |
| ATC | L01AD01 CARMUSTINE |
| Original market date | 02-Jul-2002 |
| Current status date | 02-Mar-2015 |
| Source | Health Canada DPD |
Establishment licence of the holder
Eisai Limited — licence 101843, currently licensed, last inspection rating C (2023-03-29).
No Canadian shortage report is currently matched to this DIN.
Other Canadian products containing CARMUSTINE
| DIN | Product | Company | Form | Strength | Status |
|---|---|---|---|---|---|
| 00297763 | BICNU | MARCAN PHARMACEUTICALS INC | Powder For Solution | CARMUSTINE 100 MG | Marketed |
| 02531879 | CARMUSTINE FOR INJECTION USP | STERIMAX INC | Powder For Solution | CARMUSTINE 100 MG | Marketed |
| 02555093 | BICNU | MARCAN PHARMACEUTICALS INC | Solution | CARMUSTINE 100 MG | Cancelled Post Market |
Notices of Compliance
| NOC | Date | Submission | Reason |
|---|---|---|---|
| 12247 | 2011-04-11 | Supplement to a New Drug Submission (SNDS) | Reactivation of Drug Identification Number (DIN). Updates to the Product Monograph |
| 11555 | 2010-06-24 | New Drug Submission (NDS) | Manufacturer name change |
| 7817 | 2006-03-09 | New Drug Submission (NDS) | MANUFACTURER NAME CHANGE |
| 378 | 2002-04-10 | New Drug Submission (NDS) | MANUFACTURER NAME CHANGE |
| 2745 | 1998-11-01 | New Drug Submission (NDS) |
International API supply for CARMUSTINE
7 valid EDQM Certificates of Suitability from 7 holders. 12 active FDA Drug Master Files.
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