ApprovalTrail

Drug · DIN 02324776

SIMPONI

SINGLE-USE PREFILLED SYRINGE

Yes: authorized and sold in Canada

Authorized, and the company reports that it sells it in Canada.

Status Marketed since September 20, 2013; first marketed June 22, 2009.
Drug Identification Number (DIN)
02324776
Company (DIN owner)
Janssen Inc.Toronto, Ontario, Canada
Schedule
Prescription; Schedule D
Dosage form
Solution
Route
Subcutaneous
Therapeutic class (ATC)
Golimumab L04AB06
Class
Human
Record last updated
August 11, 2026

Active ingredients

As listed in the Drug Product Database.

IngredientStrengthPer
GOLIMUMAB50 MG0.5 ML

Notices of Compliance

Health Canada approvals that name this DIN.

  • June 23, 2016: NOC 18202Supplement to a New Drug Submission (SNDS) · New indication: simponi is indicated for the treatment of adults with severe active non-radiographic axial sponyloarthritis with objective signs of inflammation as indicated by elevated C-reactive protein (crp) and/or magnetic resonance imaging (mri) evidence who have had an inadequate response to or are intolerant to nonsteroidal anti-inflammatory drugs (nsaids)
  • September 19, 2013: NOC 14745Supplement to a New Drug Submission (SNDS) · Expanded indication: sympponi is indicated in adult patients with moderate to severely active ulcerative colitis who have had an inadequate response to, or have medical contraindiations for conventional therapy including corticosteroids, amino salucylates, azathioprine (aza) or 6-mercatopurine for: inducing and maintaining clinical response (reduction in signs and symptoms), inducing clinical remission, achieving sustaines clinical remission in indution responders, improving endoscopic appearance of the mucosa during indution
  • August 5, 2011: NOC 12521New Drug Submission (NDS) · Manufacturer Name Change
  • April 7, 2009: NOC 10135New Drug Submission (NDS)

Other DINs named SIMPONI