Approval · Notice of Compliance 34401 · 2024
JAMTEKI: Notice of Compliance 34401
Issued November 13, 2024
A Notice of Compliance is Health Canada’s approval of a drug submission: a new drug, a new use or form, or a change to an approved one. The product itself is in the Drug Product Database, with its current status.
- Notice number
- 34401
- Date
- November 13, 2024
- Company
- JAMP Pharma CorporationBoucherville, Quebec, Canada
- Product type
- Biologic
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- 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.
- Canadian reference product
- STELARA , STELARA I.V
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| JAMTEKI | Not yet assigned | — |
| JAMTEKI IV | 02553120 | Marketed |
Medicinal ingredients
- USTEKINUMAB 45 MG per 0.5ML
- USTEKINUMAB 90 MG per ML
- USTEKINUMAB 5 MG per ML