Approval · Notice of Compliance 35335 · 2025
ITULATEK: Notice of Compliance 35335
Issued May 2, 2025
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
- 35335
- Date
- May 2, 2025
- Company
- Alk-Abello IncPort Washington, New York, United States
- Product type
- Biologic
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- Indication expansion: Itulatek (Standardized Allergen Extract, White Birch (Betula Verrucosa) Sublingual Tablet) is indicated as an allergy immunotherapy for the treatment of moderate to severe seasonal allergic rhinitis, with or without conjunctivitis, induced by pollen from birch, alder, hazel, and/or oak, in children and adults 5 to 65 years of age who have a clinical history of symptoms of allergic rhinitis, despite use of symptom-relieving medication, and a positive test of sensitization to one or more of the pollen of birch, alder, hazel or oak (skin prick test and/or specific IgE)
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| ITULATEK | Not yet assigned | — |
Medicinal ingredients
- STANDARDIZED ALLERGEN EXTRACT, WHITE BIRCH (BETULA VERRUCOSA) 12 UNIT per TAB