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XOLAIR DIN 02545136

Status: Marketed
Holder: NOVARTIS PHARMACEUTICALS CANADA INC
Molecule: OMALIZUMAB

Health Canada record

Active ingredient(s)OMALIZUMAB 75 MG
Dosage formSolution
RouteSubcutaneous
ScheduleSCHEDULE D; PRESCRIPTION
ClassHuman
ATCR03DX05 OMALIZUMAB
Original market date25-Sep-2024
Current status date25-Sep-2024
SourceHealth 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

DINProductCompanyFormStrengthStatus
02565013OMLYCLOCELLTRION INC.SolutionOMALIZUMAB 300 MGApproved
02553805OMLYCLOCELLTRION INC.SolutionOMALIZUMAB 75 MGMarketed
02553813OMLYCLOCELLTRION INC.SolutionOMALIZUMAB 150 MGMarketed
02561018OMLYCLOCELLTRION INC.SolutionOMALIZUMAB 75 MGMarketed
02561026OMLYCLOCELLTRION INC.SolutionOMALIZUMAB 150 MGMarketed
02565021OMLYCLOCELLTRION INC.SolutionOMALIZUMAB 300 MGApproved
02260565XOLAIRNOVARTIS PHARMACEUTICALS CANADA INCPowder For SolutionOMALIZUMAB 150 MGMarketed
02459787XOLAIRNOVARTIS PHARMACEUTICALS CANADA INCSolutionOMALIZUMAB 75 MGMarketed
02459795XOLAIRNOVARTIS PHARMACEUTICALS CANADA INCSolutionOMALIZUMAB 150 MGMarketed
02545144XOLAIRNOVARTIS PHARMACEUTICALS CANADA INCSolutionOMALIZUMAB 150 MGMarketed
02545152XOLAIRNOVARTIS PHARMACEUTICALS CANADA INCSolutionOMALIZUMAB 300 MGApproved
02545160XOLAIRNOVARTIS PHARMACEUTICALS CANADA INCSolutionOMALIZUMAB 300 MGMarketed

Notices of Compliance

NOCDateSubmissionReason
326952024-02-08Supplement to a New Drug Submission (SNDS)New drug product manufacturing site and addition of new presentations
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