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RITUXAN SC DIN 02473976

Status: Marketed
Holder: HOFFMANN-LA ROCHE LIMITED
Molecule: RITUXIMAB

Health Canada record

Active ingredient(s)RITUXIMAB 1600 MG
Dosage formSolution
RouteSubcutaneous
SchedulePRESCRIPTION; SCHEDULE D
ClassHuman
ATCL01FA01 RITUXIMAB
Original market date24-Apr-2018
Current status date24-Apr-2018
SourceHealth Canada DPD

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 RITUXIMAB

DINProductCompanyFormStrengthStatus
02565781ADRUXEDR. REDDY'S LABORATORIES SASolutionRITUXIMAB 10 MGApproved
02241927RITUXANHOFFMANN-LA ROCHE LIMITEDSolutionRITUXIMAB 10 MGMarketed
02457350RITUXAN SCHOFFMANN-LA ROCHE LIMITEDSolutionRITUXIMAB 1400 MGMarketed
02498316RIXIMYOSANDOZ CANADA INCORPORATEDSolutionRITUXIMAB 10 MGMarketed
02495724RUXIENCEPFIZER CANADA ULCSolutionRITUXIMAB 10 MGMarketed
02478382TRUXIMACELLTRION INC.SolutionRITUXIMAB 100 MGMarketed
02478390TRUXIMACELLTRION INC.SolutionRITUXIMAB 500 MGMarketed
02513447RIABNIAMGEN CANADA INCSolutionRITUXIMAB 10 MGCancelled Post Market

Notices of Compliance

NOCDateSubmissionReason
206472018-03-21Supplement to a New Drug Submission (SNDS)A NEW SUBCUTANEWOUS PRESENTATION (16009 MG/13.4 ML) FOR USE IN PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA (CLL). NEW MANUFACTURING FACILTY

International API supply for RITUXIMAB

0 active FDA Drug Master Files.

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