Review decisions
Showing 140 results of 688 total
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/RDS1685721892425
… with locally advanced or metastatic non-small cell lung cancer (NSCLC) with no Epithelial Growth Factor Receptor … or metastatic, squamous or non-squamous non-small cell lung cancer (NSCLC). The focus of this submission was part 2 of …
Product Type: Drug
Control Number: 263700
DIN(s): 02487144, 02487152
Manufacturer: Sanofi-Aventis Canada Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2022-04-26
Decision / Authorization Date: 2023-04-27
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1683570485222
… transmembrane glycoprotein and is overexpressed in prostate cancer, particularly in advanced-stage prostate carcinomas. … antigen (PSMA)-positive lesions in men with prostate cancer: with suspected metastasis who are candidates for … with progressive metastatic castration-resistant prostate cancer (mCRPC), for whom PSMA-targeted therapy is indicated. …
Product Type: Drug
Control Number: 263638
DIN(s): 02537117
Manufacturer: Advanced Accelerator Application USA, Inc.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2022-04-22
Decision / Authorization Date: 2023-04-05
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
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD1729522137894
… myeloma and in patients with bone metastases from breast cancer, prostate cancer, non-small cell lung cancer, and other solid tumours. Treatment of adults and …
Product Type: Drug
Control Number: 267788
DIN(s): 02545764
Manufacturer: Sandoz Canada Inc.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2023-01-27
Issued / Original Publication Date: 2024-10-17
Decision / Authorization Date: 2024-03-01
Updated Date: 2024-10-17
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD1729523262756
… to increase bone mass in men with nonmetastatic prostate cancer receiving androgen-deprivation therapy, who are at … to increase bone mass in women with nonmetastatic breast cancer receiving adjuvant aromatase-inhibitor therapy, who … to increase bone mass in men with nonmetastatic prostate cancer receiving androgen-deprivation therapy, who are at …
Product Type: Drug
Control Number: 271806
DIN(s): 02545411
Manufacturer: Sandoz Canada Inc.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2023-01-27
Issued / Original Publication Date: 2024-10-17
Decision / Authorization Date: 2024-02-16
Updated Date: 2024-10-17