Home Canadian DIN search USTEKINUMAB DIN 02565420 OTULFI DIN 02565420
Status: Approved
Holder: FRESENIUS KABI CANADA LTD
Health Canada record
Active ingredient(s) USTEKINUMAB 45 MG Dosage form Solution Route Subcutaneous Schedule SCHEDULE D; PRESCRIPTION Class Human ATC L04AC05 USTEKINUMAB Original market date Current status date 02-Feb-2026 Source Health Canada DPD
Establishment licence of the holder Fresenius Kabi Canada Ltd. — licence 102232, currently licensed, last inspection rating C (2025-10-01).
No Canadian shortage report is currently matched to this DIN.
Other Canadian products containing USTEKINUMAB DIN Product Company Form Strength Status 02537257 FINLIUS JANSSEN INC Solution USTEKINUMAB 90 MG Marketed 02537303 FINLIUS JANSSEN INC Solution USTEKINUMAB 45 MG Marketed 02537311 FINLIUS I.V. JANSSEN INC Solution USTEKINUMAB 5 MG Marketed 02564904 IMULDOSA ACCORD HEALTHCARE INC Solution USTEKINUMAB 90 MG Approved 02564890 IMULDOSA ACCORD HEALTHCARE INC Solution USTEKINUMAB 45 MG Approved 02564882 IMULDOSA IV ACCORD HEALTHCARE INC Solution USTEKINUMAB 5 MG Approved 02543036 JAMTEKI JAMP PHARMA CORPORATION Solution USTEKINUMAB 45 MG Marketed 02543044 JAMTEKI JAMP PHARMA CORPORATION Solution USTEKINUMAB 90 MG Marketed 02553120 JAMTEKI I.V. JAMP PHARMA CORPORATION Solution USTEKINUMAB 5 MG Marketed 02554291 OTULFI FRESENIUS KABI CANADA LTD Solution USTEKINUMAB 90 MG Marketed 02554283 OTULFI FRESENIUS KABI CANADA LTD Solution USTEKINUMAB 45 MG Marketed 02554305 OTULFI I.V. FRESENIUS KABI CANADA LTD Solution USTEKINUMAB 5 MG Marketed 02562995 PYZCHIVA SAMSUNG BIOEPIS CO., LTD Solution USTEKINUMAB 45 MG Approved 02563002 PYZCHIVA SAMSUNG BIOEPIS CO., LTD Solution USTEKINUMAB 90 MG Approved 02550539 PYZCHIVA SAMSUNG BIOEPIS CO., LTD Solution USTEKINUMAB 45 MG Marketed 02550547 PYZCHIVA SAMSUNG BIOEPIS CO., LTD Solution USTEKINUMAB 90 MG Marketed 02562987 PYZCHIVA SAMSUNG BIOEPIS CO., LTD Solution USTEKINUMAB 45 MG Approved 02550520 PYZCHIVA I.V. SAMSUNG BIOEPIS CO., LTD Solution USTEKINUMAB 5 MG Marketed 02320681 STELARA JANSSEN INC Solution USTEKINUMAB 90 MG Marketed 02320673 STELARA JANSSEN INC Solution USTEKINUMAB 45 MG Marketed 02459671 STELARA I.V. JANSSEN INC Solution USTEKINUMAB 5 MG Marketed 02566540 STEQEYMA CELLTRION INC. Solution USTEKINUMAB 90 MG Approved 02558270 STEQEYMA CELLTRION INC. Solution USTEKINUMAB 45 MG Approved 02550245 STEQEYMA CELLTRION INC. Solution USTEKINUMAB 45 MG Marketed 02566532 STEQEYMA CELLTRION INC. Solution USTEKINUMAB 45 MG Approved 02550253 STEQEYMA CELLTRION INC. Solution USTEKINUMAB 90 MG Marketed 02550261 STEQEYMA IV CELLTRION INC. Solution USTEKINUMAB 5 MG Marketed 02553317 WEZLANA AMGEN CANADA INC Solution USTEKINUMAB 45 MG Marketed 02544180 WEZLANA AMGEN CANADA INC Solution USTEKINUMAB 45 MG Marketed 02544199 WEZLANA AMGEN CANADA INC Solution USTEKINUMAB 90 MG Marketed 02553309 WEZLANA AMGEN CANADA INC Solution USTEKINUMAB 90 MG Marketed 02544202 WEZLANA AMGEN CANADA INC Solution USTEKINUMAB 45 MG Marketed 02544210 WEZLANA I.V. AMGEN CANADA INC Solution USTEKINUMAB 5 MG Marketed 02562103 YESINTEK BIOCON BIOLOGICS CANADA INC Solution USTEKINUMAB 90 MG Marketed 02566478 YESINTEK BIOCON BIOLOGICS CANADA INC Solution USTEKINUMAB 45 MG Approved 02569841 YESINTEK BIOCON BIOLOGICS CANADA INC Solution USTEKINUMAB 90 MG Approved 02562081 YESINTEK BIOCON BIOLOGICS CANADA INC Solution USTEKINUMAB 45 MG Marketed 02569833 YESINTEK BIOCON BIOLOGICS CANADA INC Solution USTEKINUMAB 45 MG Approved 02562111 YESINTEK I.V. BIOCON BIOLOGICS CANADA INC Solution USTEKINUMAB 5 MG Marketed
Notices of Compliance NOC Date Submission Reason 36822 2026-02-02 Supplement to a New Drug Submission (SNDS) New presentation. Indication expansion: OTULFI (ustekinumab) is indicated for the treatment of chronic moderate to severe plaque psoriasis in pediatric patients (6-17 years of age) who are inadequately controlled by, or are intolerant to, other systemic therapies or phototherapies.
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