Drug · DIN 02455951
DARZALEX
SINGLE-USE VIAL
Yes: authorized and sold in Canada
Authorized, and the company reports that it sells it in Canada.
Status Marketed since July 12, 2016; first marketed July 12, 2016.
- Drug Identification Number (DIN)
- 02455951
- Company (DIN owner)
- Janssen Inc.Toronto, Ontario, Canada
- Schedule
- Schedule D; Prescription
- Dosage form
- Solution
- Route
- Intravenous
- Therapeutic class (ATC)
- Daratumumab L01FC01
- Class
- Human
- Record last updated
- August 12, 2026
Active ingredients
As listed in the Drug Product Database.
| Ingredient | Strength | Per |
|---|---|---|
| DARATUMUMAB | 100 MG | 5 ML |
Notices of Compliance
Health Canada approvals that name this DIN.
- June 29, 2016: NOC 18215New Drug Submission (NDS)
Recalls and safety alerts that mention it
Health Canada’s recall notices do not carry licence numbers, so these are matched by name: notices whose title or product names “darzalex”. A notice may cover another product or only some lots: read it to see what it covers.
- DARZALEX (daratumumab) and Hepatitis B Virus ReactivationMarch 25, 2019 · Biologic or vaccine · Product safety
Other DINs named DARZALEX
- DIN 02455978 · Marketed