XOLAIR DIN 02545160
Status: Marketed
Holder: NOVARTIS PHARMACEUTICALS CANADA INC
Health Canada record
| Active ingredient(s) | OMALIZUMAB 300 MG |
|---|
| Dosage form | Solution |
|---|
| Route | Subcutaneous |
|---|
| Schedule | SCHEDULE D; PRESCRIPTION |
|---|
| Class | Human |
|---|
| ATC | R03DX05 OMALIZUMAB |
|---|
| Original market date | 15-Oct-2025 |
|---|
| Current status date | 15-Oct-2025 |
|---|
| Source | Health Canada DPD |
|---|
Establishment licence of the holder
Novartis Pharmaceuticals Canada Inc — licence 100273, currently licensed, last inspection rating C (2025-01-14).
No Canadian shortage report is currently matched to this DIN.
Other Canadian products containing OMALIZUMAB
| DIN | Product | Company | Form | Strength | Status |
|---|
| 02565013 | OMLYCLO | CELLTRION INC. | Solution | OMALIZUMAB 300 MG | Approved |
| 02553805 | OMLYCLO | CELLTRION INC. | Solution | OMALIZUMAB 75 MG | Marketed |
| 02553813 | OMLYCLO | CELLTRION INC. | Solution | OMALIZUMAB 150 MG | Marketed |
| 02561018 | OMLYCLO | CELLTRION INC. | Solution | OMALIZUMAB 75 MG | Marketed |
| 02561026 | OMLYCLO | CELLTRION INC. | Solution | OMALIZUMAB 150 MG | Marketed |
| 02565021 | OMLYCLO | CELLTRION INC. | Solution | OMALIZUMAB 300 MG | Approved |
| 02260565 | XOLAIR | NOVARTIS PHARMACEUTICALS CANADA INC | Powder For Solution | OMALIZUMAB 150 MG | Marketed |
| 02459787 | XOLAIR | NOVARTIS PHARMACEUTICALS CANADA INC | Solution | OMALIZUMAB 75 MG | Marketed |
| 02459795 | XOLAIR | NOVARTIS PHARMACEUTICALS CANADA INC | Solution | OMALIZUMAB 150 MG | Marketed |
| 02545136 | XOLAIR | NOVARTIS PHARMACEUTICALS CANADA INC | Solution | OMALIZUMAB 75 MG | Marketed |
| 02545144 | XOLAIR | NOVARTIS PHARMACEUTICALS CANADA INC | Solution | OMALIZUMAB 150 MG | Marketed |
| 02545152 | XOLAIR | NOVARTIS PHARMACEUTICALS CANADA INC | Solution | OMALIZUMAB 300 MG | Approved |
Notices of Compliance
| NOC | Date | Submission | Reason |
|---|
| 32695 | 2024-02-08 | Supplement to a New Drug Submission (SNDS) | New drug product manufacturing site and addition of new
presentations |
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