HEMLIBRA DIN 02556049
Status: Marketed
Holder: HOFFMANN-LA ROCHE LIMITED
Health Canada record
| Active ingredient(s) | EMICIZUMAB 12 MG |
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| Dosage form | Solution |
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| Route | Subcutaneous |
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| Schedule | SCHEDULE D; PRESCRIPTION |
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| Class | Human |
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| ATC | B02BX06 EMICIZUMAB |
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| Original market date | 10-Dec-2025 |
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| Current status date | 10-Dec-2025 |
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| Source | Health Canada DPD |
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Establishment licence of the holder
Hoffmann-La Roche Limited — licence 100006, currently licensed, last inspection rating C (2024-06-25).
No Canadian shortage report is currently matched to this DIN.
Other Canadian products containing EMICIZUMAB
| DIN | Product | Company | Form | Strength | Status |
|---|
| 02479621 | HEMLIBRA | HOFFMANN-LA ROCHE LIMITED | Solution | EMICIZUMAB 30 MG | Marketed |
| 02479648 | HEMLIBRA | HOFFMANN-LA ROCHE LIMITED | Solution | EMICIZUMAB 60 MG | Marketed |
| 02479656 | HEMLIBRA | HOFFMANN-LA ROCHE LIMITED | Solution | EMICIZUMAB 105 MG | Marketed |
| 02479664 | HEMLIBRA | HOFFMANN-LA ROCHE LIMITED | Solution | EMICIZUMAB 150 MG | Marketed |
| 02556057 | HEMLIBRA | HOFFMANN-LA ROCHE LIMITED | Solution | EMICIZUMAB 300 MG | Marketed |
Notices of Compliance
| NOC | Date | Submission | Reason |
|---|
| 34981 | 2025-03-06 | Supplement to a New Drug Submission (SNDS) | New fill volume. Change in manufacturing process |
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