ApprovalTrail

Drug · DIN 02570890

TREMFYA

SINGLE-USE PREFILLED PEN

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 August 14, 2026.
Drug Identification Number (DIN)
02570890
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
GUSELKUMAB45 MG0.45 ML

Notices of Compliance

Health Canada approvals that name this DIN.

  • August 14, 2026: NOC 38113Supplement to a New Drug Submission (SNDS) · New Indications: Plaque Psoriasis • (6 years to 17 years): TREMFYA (guselkumab injection) is indicated for the treatment of pediatric patients 6 years of age and older with moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy. • (< 6 years of age): No data are available to Health Canada; therefore, Health Canada has not authorized an indication for pediatric patients less than 6 years of age. Psoriatic Arthritis • (6 years to 17 years): TREMFYA (guselkumab injection) is indicated in pediatric patients 6 years of age and older with active psoriatic arthritis supported by model-based extrapolation. • (< 6 years of age): No data are available to Health Canada; therefore, Health Canada has not authorized an indication for pediatric patients less than 6 years of age.

Other DINs named TREMFYA