Canadian DIN & Molecule SearchMolecules A–ZDrug ShortagesResourcesHealth Canada WeeklyRequest a Quote

TREMFYA DIN 02559137

Status: Approved
Holder: JANSSEN INC
Molecule: GUSELKUMAB

Health Canada record

Active ingredient(s)GUSELKUMAB 200 MG
Dosage formSolution
RouteSubcutaneous
SchedulePRESCRIPTION; SCHEDULE D
ClassHuman
ATCL04AC16 GUSELKUMAB
Original market date
Current status date07-Jul-2025
SourceHealth Canada DPD

Establishment licence of the holder

Janssen Inc — licence 100239, currently licensed, last inspection rating C (2026-03-09).

No Canadian shortage report is currently matched to this DIN.

Other Canadian products containing GUSELKUMAB

DINProductCompanyFormStrengthStatus
02469758TREMFYAJANSSEN INCSolutionGUSELKUMAB 100 MGMarketed
02559145TREMFYAJANSSEN INCSolutionGUSELKUMAB 200 MGMarketed
02566877TREMFYAJANSSEN INCSolutionGUSELKUMAB 100 MGMarketed
02570890TREMFYAJANSSEN INCSolutionGUSELKUMAB 45 MGApproved
02559153TREMFYA I.V.JANSSEN INCSolutionGUSELKUMAB 200 MGMarketed
02487314TREMFYA ONE-PRESSJANSSEN INCSolutionGUSELKUMAB 100 MGMarketed

Notices of Compliance

NOCDateSubmissionReason
356472025-07-07Supplement to a New Drug Submission (SNDS)New indication: TREMFYA /TREMFYA I.V. (guselkumab injection / guselkumab for injection) is indicated for: -the treatment of adult patients with moderately to severely active Crohn’s disease. New presentations
Request a quote for TREMFYA

How to read a Canadian DIN record