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
Medicinal ingredient(s):
This table displays medicinal ingredients information.
Ingredient Strength
TRASTUZUMAB DERUXTECAN 100 MG/VIAL

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