Regulatory Decision Summary for Tremfya / Tremfya One-Press / Tremfya I.V.
Review decision
The Regulatory Decision Summary explains Health Canada’s decision for the product seeking market authorization. The Regulatory Decision Summary includes the purpose of the submission and the reason for the decision.
Product type:
Contact:
Medicinal Ingredient(s):
Guselkumab
Control Number:
285952
Brand/Product Name:
Tremfya / Tremfya One-Press / Tremfya I.V.
Therapeutic Area:
Immunosuppressants
Type of Submission:
Supplement to a New Drug Submission
Decision Issued:
Authorized; issued a Notice of Compliance in accordance with the Food and Drug Regulations
What was the purpose of this submission?
The purpose of the submission is to seek marketing authorisation for a new indication for the treatment of adult patients with moderately to severely active ulcerative colitis (UC), new intravenous (IV) route of administration under new Tremfya I.V. brand name; new pre-filled syringe (PFS), pre-filled pen (PFP), and vial presentations.
Why was the decision issued?
Tremfya / Tremfya One-Press / Tremfya I.V. presents a favourable benefit–risk profile for patients with moderate to severe ulcerative colitis (UC) who have not responded adequately or are intolerant to conventional or advanced therapies. The consistent efficacy outcomes, alongside a well-understood and manageable safety profile, support its use as a valuable therapeutic option in the UC treatment landscape.
The comprehensive analysis of the Tremfya / Tremfya One-Press / Tremfya I.V. safety data identified no safety signals. There are no safety concerns that are expected to change the favourable risk/benefit assessment or lead to increased risk with administration of Tremfya in the postmarket setting. Therefore, a Notice of Compliance (NOC) was recommended.
An updated Risk Management Plan (RMP) for Tremfya / Tremfya One-Press / Tremfya I.V. was reviewed by Health Canada and considered acceptable.
The chemistry and manufacturing information submitted for Tremfya / Tremfya One-Press / Tremfya I.V. has demonstrated that the drug substance and drug product can be consistently manufactured to meet the approved specifications. Adequate process validation and stability information is provided to support approval of the proposed 200 mg/ 2 mL pre-filled syringe/pen and 200 mg/20 mL vial presentations.
Following review and requested revisions, the final labelling and Product Monograph were considered to be acceptable.
For further details about Tremfya / Tremfya One-Press / Tremfya I.V., please refer to the Product Monograph, approved by Health Canada and available through the Drug Product Database.
Date of Decision:
2025-09-03
Manufacturer/Sponsor:
Drug Identification Number(s) Issued:
N/A
Prescription Status:
Available by prescription only
Date Filed:
2024-04-15
Related Drug Products
| Product name | DIN | Company name | Active ingredient(s) & strength |
|---|---|---|---|
| TREMFYA ONE-PRESS | 02487314 | JANSSEN INC | GUSELKUMAB 100 MG / 1 ML |
| TREMFYA | 02469758 | JANSSEN INC | GUSELKUMAB 100 MG / 1 ML |