ApprovalTrail

Drug · DIN 02559137

TREMFYA

SINGLE-USE PREFILLED SYRINGE

Authorized, not yet reported as sold

Authorized for sale in Canada; the company has not yet told Health Canada that it is on the market.

Status Approved since July 7, 2025.
Drug Identification Number (DIN)
02559137
Company (DIN owner)
Janssen Inc.Toronto, Ontario, Canada
Schedule
Prescription; Schedule D
Dosage form
Solution
Route
Subcutaneous
Therapeutic class (ATC)
Guselkumab L04AC16
Class
Human
Record last updated
September 17, 2026

Active ingredients

As listed in the Drug Product Database.

IngredientStrengthPer
GUSELKUMAB200 MG2 ML

Notices of Compliance

Health Canada approvals that name this DIN.

  • July 7, 2025: NOC 35647Supplement 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

Other DINs named TREMFYA