JAMTEKI I.V. DIN 02553120
Health Canada record
| Active ingredient(s) | USTEKINUMAB 5 MG |
|---|---|
| Dosage form | Solution |
| Route | Intravenous |
| Schedule | PRESCRIPTION; SCHEDULE D |
| Class | Human |
| ATC | L04AC05 USTEKINUMAB |
| Original market date | 19-May-2026 |
| Current status date | 19-May-2026 |
| Source | Health Canada DPD |
Establishment licence of the holder
Jamp Pharma Corporation — licence 100590, currently licensed, last inspection rating C (2025-01-13).
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 |
| 02554291 | OTULFI | FRESENIUS KABI CANADA LTD | Solution | USTEKINUMAB 90 MG | Marketed |
| 02554283 | OTULFI | FRESENIUS KABI CANADA LTD | Solution | USTEKINUMAB 45 MG | Marketed |
| 02565420 | OTULFI | FRESENIUS KABI CANADA LTD | Solution | USTEKINUMAB 45 MG | Approved |
| 02554305 | OTULFI I.V. | FRESENIUS KABI CANADA LTD | Solution | USTEKINUMAB 5 MG | Marketed |
| 02562995 | PYZCHIVA | SAMSUNG BIOEPIS CO., LTD | Solution | USTEKINUMAB 45 MG | Approved |
| 02562987 | 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 |
| 02550520 | PYZCHIVA I.V. | SAMSUNG BIOEPIS CO., LTD | Solution | USTEKINUMAB 5 MG | Marketed |
| 02320673 | STELARA | JANSSEN INC | Solution | USTEKINUMAB 45 MG | Marketed |
| 02320681 | STELARA | JANSSEN INC | Solution | USTEKINUMAB 90 MG | Marketed |
| 02459671 | STELARA I.V. | JANSSEN INC | Solution | USTEKINUMAB 5 MG | Marketed |
| 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 |
| 02566540 | STEQEYMA | CELLTRION INC. | Solution | USTEKINUMAB 90 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 |
| 02553309 | WEZLANA | AMGEN CANADA INC | Solution | USTEKINUMAB 90 MG | Marketed |
| 02544199 | WEZLANA | AMGEN CANADA INC | Solution | USTEKINUMAB 90 MG | Marketed |
| 02544180 | WEZLANA | AMGEN CANADA INC | Solution | USTEKINUMAB 45 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 |
|---|---|---|---|
| 34401 | 2024-11-13 | Supplement to a New Drug Submission (SNDS) | New indication :Jamteki (ustekinumab) is indicated for: - the treatment of chronic moderate to severe plaque psoriasis in adult patients who are candidates for phototherapy or systemic therapy. - 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. Jamteki/Jamteki I.V. (ustekinumab) is indicated for the treatment of adult patients with moderately to severely active Crohn's disease, who have had an inadequate response, loss of response to, or were intolerant to either immunomodulators or one or more tumour necrosis factor-alpha (TNFa) antagonists, or have had an inadequate response, intolerance or demonstrated dependence on corticosteroids. Jamteki/Jamteki I.V. (ustekinumab) is indicated for the treatment of adult patients with moderately to severely active ulcerative colitis who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a biologic or have medical contraindications to such therapies. 2. New strength. 3. New presentation. 4. New route of administration. 5. Alternate drug product manufacturing site. |