SPEVIGO DIN 02561697
Status: Approved
Holder: LEO PHARMA INC
Health Canada record
| Active ingredient(s) | SPESOLIMAB 300 MG |
|---|
| 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 | L04AC22 SPESOLIMAB |
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| Original market date | |
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| Current status date | 26-Mar-2026 |
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| Source | Health Canada DPD |
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Establishment licence of the holder
LEO Pharma Inc — licence 100195, currently licensed, last inspection rating C (2026-05-27).
No Canadian shortage report is currently matched to this DIN.
Other Canadian products containing SPESOLIMAB
| DIN | Product | Company | Form | Strength | Status |
|---|
| 02536455 | SPEVIGO | LEO PHARMA INC | Solution | SPESOLIMAB 60 MG | Marketed |
| 02550296 | SPEVIGO | LEO PHARMA INC | Solution | SPESOLIMAB 150 MG | Marketed |
Notices of Compliance
| NOC | Date | Submission | Reason |
|---|
| 37202 | 2026-03-26 | New Drug Submission (NDS) | Change in product ownership |
| 36128 | 2025-10-07 | Supplement to a New Drug Submission (SNDS) | Addition of a new presentation |
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