Notice of Compliance Information
From Health Canada
- Notice of Compliance date :
- 2023-01-06
- Manufacturer :
- ASTRAZENECA CANADA INC
- Product type:
- Biologic
- NOC with conditions:
- No
- Submission type:
- Supplement to a New Drug Submission (SNDS)
- Reason for supplement:
- New indication: HER2-Low Breast Cancer: ENHERTU as monotherapy is indicated for the treatment of adult patients with unresectable or metastatic HER2-low (IHC 1+ or IHC 2+/ISH-) breast cancer who have received at least one prior line of chemotherapy in the metastatic setting or developed disease recurrence during or within 6 months of completing adjuvant chemotherapy. Patients with hormone receptor positive (HR+) breast cancer should have received at least one and be no longer considered eligible for endocrine therapy.
- Submission class:
- Priority
Brand 1 of 1 :
ENHERTU
Product 1 of 1 :
Drug identification number:
00000N/A
Dosage form(s):
Powder For Solution
Route(s) of administration:
Intravenous
Ingredient | Strength |
---|---|
TRASTUZUMAB DERUXTECAN | 100 MG/VIAL |