Review decisions
Showing 50 results of 342 total
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD1698862620995
… sickle cell disease, neurodevelopmental disorders, active cancer, and medically related technological dependence. …
Product Type: Drug
Control Number: 275936
DIN(s): 02541270
Manufacturer: Moderna Biopharma Canada Corporation
Submission Type: New Drug Submission (New Active Substance) (COVID-19)
Date Filed / Submission Date: 2023-06-29
Issued / Original Publication Date: 2023-10-31
Decision / Authorization Date: 2023-09-12
Updated Date: 2025-08-22
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD1700495075939
… sickle cell disease, neurodevelopmental disorders, active cancer, and medically related technological dependence. …
Product Type: Drug
Control Number: 276302
DIN(s): 02541823, 02541831, 02541858, 02541866, 02552035, 02552078
Manufacturer: BioNTech Manufacturing GmbH
Submission Type: New Drug Submission (New Active Substance) (COVID-19)
Date Filed / Submission Date: 2023-06-29
Issued / Original Publication Date: 2023-11-22
Decision / Authorization Date: 2023-09-28
Updated Date: 2025-08-21
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD1728318721334
… lead to the development of malignancies, particularly liver cancer due to integration of the liver‑targeting AAV vector. … that patients with pre-existing risk factors for liver cancer should receive regular abdominal ultrasound …
Product Type: Drug
Control Number: 275853
DIN(s): 02544156
Manufacturer: Pfizer Canada ULC
Submission Type: New Drug Submission (New Active Substance) - Priority Review
Date Filed / Submission Date: 2023-06-01
Issued / Original Publication Date: 2024-10-06
Decision / Authorization Date: 2023-12-27
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD1736954230750
… growth factor receptor (HER2)-positive metastatic breast cancer. Based on Health Canada’s review , the benefit-risk … (which include relevant caveat statements): Early Breast Cancer Adheroza (trastuzumab) is indicated for the treatment of patients with early-stage breast cancer with Eastern Cooperative Oncology Group (ECOG) 0-1 …
Product Type: Drug
Control Number: 275910
DIN(s): 02550970, 02550989
Manufacturer: Accord Healthcare Inc.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2023-06-01
Issued / Original Publication Date: 2025-01-15
Decision / Authorization Date: 2024-08-20
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD1728656969053
… 2 (HER2)-negative locally advanced or metastatic breast cancer with one or more … 2 (HER2)-negative locally advanced or metastatic breast cancer with one or more … 2 (HER2)-negative locally advanced or metastatic breast cancer with one or more … or within 12 months of completing adjuvant therapy. Breast cancer is the second most common cancer in Canada and the …
Product Type: Drug
Control Number: 274859
DIN(s): 02544733, 02544741
Manufacturer: AstraZeneca Canada Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2023-04-28
Issued / Original Publication Date: 2024-10-11
Decision / Authorization Date: 2024-01-26
Updated Date: 2025-06-20
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD1749475835167
… clinical use. Tapinarof is not expected to inhibit breast cancer resistance protein (BCRP), bile salt export pump …
Product Type: Drug
Control Number: 272063
DIN(s): 02448254
Manufacturer: Dermavant Sciences, GmbH
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2023-03-31
Issued / Original Publication Date: 2025-06-07
Decision / Authorization Date: 2025-04-04
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD1738678252634
… which were non-ocular in nature. One death due to gastric cancer was reported and the event was not considered to be … and cardiometabolic dysfunction, poor perinatal health, and cancer. Therefore, uncertainties remain regarding the …
Product Type: Drug
Control Number: 272066
DIN(s): 02551403
Manufacturer: Bausch & Lomb Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2023-03-29
Issued / Original Publication Date: 2025-02-03
Decision / Authorization Date: 2024-09-04
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD1715173505610
… One patient with pre‑existing risk factors for liver cancer developed a hepatocellular carcinoma following … One patient with pre‑existing risk factors for liver cancer developed a hepatocellular carcinoma following …
Product Type: Drug
Control Number: 273721
DIN(s): 02542560
Manufacturer: CSL Behring Canada Inc.
Submission Type: New Drug Submission (New Active Substance) - Priority Review
Date Filed / Submission Date: 2023-03-27
Issued / Original Publication Date: 2024-05-05
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD1722283649339
… to confirm the clinical benefit. Multiple myeloma is a cancer of plasma cells. Malignant plasma cells produce … BCMA on malignant myeloma cells and CD3 on mature T cells, cancerous cells are brought into proximity with T cells, … project is an international partnership designed to give cancer patients faster access to promising cancer …
Product Type: Drug
Control Number: 273519
DIN(s): 02543559, 02543567
Manufacturer: Pfizer Canada ULC
Submission Type: New Drug Submission (New Active Substance) - Notice of Compliance with Conditions
Date Filed / Submission Date: 2023-03-21
Issued / Original Publication Date: 2024-07-29
Decision / Authorization Date: 2023-12-06
Updated Date: 2025-05-27
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD1725979957573
… bleeding, pregnancy, postpartum blood loss, as well as cancer and chemotherapy. In children, there are also …
Product Type: Drug
Control Number: 272960
DIN(s): 02546078
Manufacturer: Vifor (International) Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2023-03-01
Issued / Original Publication Date: 2024-09-10
Decision / Authorization Date: 2024-03-11
Updated Date: 2025-06-30