DARZALEX SC DIN 02502712
Health Canada record
| Active ingredient(s) | DARATUMUMAB 1800 MG |
|---|---|
| Dosage form | Solution |
| Route | Subcutaneous |
| Schedule | SCHEDULE D; PRESCRIPTION |
| Class | Human |
| ATC | L01FC01 DARATUMUMAB |
| Original market date | 12-Aug-2020 |
| Current status date | 12-Aug-2020 |
| Source | Health Canada DPD |
Establishment licence of the holder
Janssen Inc — licence 100239, currently licensed, last inspection rating C (2026-03-09).
No Canadian shortage report is currently matched to this DIN.
Other Canadian products containing DARATUMUMAB
| DIN | Product | Company | Form | Strength | Status |
|---|---|---|---|---|---|
| 02455951 | DARZALEX | JANSSEN INC | Solution | DARATUMUMAB 100 MG | Marketed |
| 02455978 | DARZALEX | JANSSEN INC | Solution | DARATUMUMAB 400 MG | Marketed |
Notices of Compliance
| NOC | Date | Submission | Reason |
|---|---|---|---|
| 23981 | 2020-07-29 | Supplement to a New Drug Submission (SNDS) | New formulation for subcutaneous administration and additional manufacturing facility |
International API supply for DARATUMUMAB
1 active FDA Drug Master Files.
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