Return to Special Authority drug list
Generic name |
ustekinumab |
|
Brand name |
Strength |
Form |
Staqeyma® |
90 mg/1 mL | pre-filled, single-use syringe for subcutaneous injection |
130 mg/26 mL (5 mg/mL) | single-use vial for intravenous infusion | |
Wezlana™ | 90 mg/1 mL | pre-filled, single-use syringe for subcutaneous injection |
130 mg/26 mL (5 mg/mL) | single-use vial for intravenous infusion |
Special Authority criteria |
Approval period |
---|---|
InitialModerately to severely active Crohn's disease For the treatment of adult patients with moderately to severely active Crohn's disease when ALL of the following criteria are met:
AND
AND
Fistulizing Crohn's disease For the treatment of adult patients with active fistulizing Crohn's disease when ALL of the following criteria are met:
AND
|
12 weeks |
RenewalModerately to severely active Crohn's disease For the continued treatment of adult patients with moderately to severely active Crohn's disease when ALL of the following criteria are met:
AND
Fistulizing Crohn's disease For the continued treatment of adult patients with active fistulizing Crohn's disease when ALL of the following criteria are met:
AND
|
1 year |