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OMLYCLO DIN 02553805

Status: Marketed
Holder: CELLTRION INC.
Molecule: OMALIZUMAB

Health Canada record

Active ingredient(s)OMALIZUMAB 75 MG
Dosage formSolution
RouteSubcutaneous
SchedulePRESCRIPTION; SCHEDULE D
ClassHuman
ATCR03DX05 OMALIZUMAB
Original market date04-Mar-2025
Current status date04-Mar-2025
SourceHealth Canada DPD

Establishment licence of the holder

Celltrion Healthcare Canada Limited — licence 3-002622, currently licensed, last inspection rating C (2025-11-12).

No Canadian shortage report is currently matched to this DIN.

Other Canadian products containing OMALIZUMAB

DINProductCompanyFormStrengthStatus
02553813OMLYCLOCELLTRION INC.SolutionOMALIZUMAB 150 MGMarketed
02561018OMLYCLOCELLTRION INC.SolutionOMALIZUMAB 75 MGMarketed
02561026OMLYCLOCELLTRION INC.SolutionOMALIZUMAB 150 MGMarketed
02565021OMLYCLOCELLTRION INC.SolutionOMALIZUMAB 300 MGApproved
02565013OMLYCLOCELLTRION INC.SolutionOMALIZUMAB 300 MGApproved
02545152XOLAIRNOVARTIS PHARMACEUTICALS CANADA INCSolutionOMALIZUMAB 300 MGApproved
02260565XOLAIRNOVARTIS PHARMACEUTICALS CANADA INCPowder For SolutionOMALIZUMAB 150 MGMarketed
02545160XOLAIRNOVARTIS PHARMACEUTICALS CANADA INCSolutionOMALIZUMAB 300 MGMarketed
02459787XOLAIRNOVARTIS PHARMACEUTICALS CANADA INCSolutionOMALIZUMAB 75 MGMarketed
02459795XOLAIRNOVARTIS PHARMACEUTICALS CANADA INCSolutionOMALIZUMAB 150 MGMarketed
02545136XOLAIRNOVARTIS PHARMACEUTICALS CANADA INCSolutionOMALIZUMAB 75 MGMarketed
02545144XOLAIRNOVARTIS PHARMACEUTICALS CANADA INCSolutionOMALIZUMAB 150 MGMarketed

Notices of Compliance

NOCDateSubmissionReason
345192024-12-06New Drug Submission (NDS)
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