Review decisions
Showing 40 results of 342 total
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD1740491309253
… serious health risks, notably the potential for endometrial cancer with unopposed estrogen therapy and breast cancer with combined estrogen and progestin therapy. … two cases of endometrial adenocarcinoma, two cases of colon cancer, one case of malignant melanoma in situ , one case of …
Product Type: Drug
Control Number: 280470
DIN(s): 02553600
Manufacturer: Astellas Pharma Canada, Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2023-11-01
Issued / Original Publication Date: 2025-02-24
Decision / Authorization Date: 2024-12-02
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD1742837642143
… use has not been authorized. Of the 930 patients with cancer who received pegfilgrastim in clinical studies, …
Product Type: Drug
Control Number: 273871
DIN(s): 02553945
Manufacturer: JAMP Pharma Corporation
Submission Type: New Drug Submission
Date Filed / Submission Date: 2023-10-18
Issued / Original Publication Date: 2025-03-23
Decision / Authorization Date: 2024-12-13
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD1750434053010
… to myocardial infarction, and one due to small cell lung cancer. All six deaths were assessed as not related to … to myocardial infarction, and one due to small cell lung cancer. All six deaths were assessed as not related to …
Product Type: Drug
Control Number: 274979
Manufacturer: UCB Canada Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2023-10-06
Issued / Original Publication Date: 2025-06-19
Decision / Authorization Date: 2025-03-28
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD1741184642625
… headaches current diagnosis of, or history of, breast cancer, which may be hormone-sensitive liver tumors, acute …
Product Type: Drug
Control Number: 279315
DIN(s): 02554070
Manufacturer: Duchesnay Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2023-09-20
Issued / Original Publication Date: 2025-03-05
Decision / Authorization Date: 2024-12-18
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD1734969149034
… the treatment of adult patients with metastatic colorectal cancer (mCRC) who have been previously treated with or are … the treatment of adult patients with metastatic colorectal cancer (mCRC) who have been previously treated with or are … the treatment of adult patients with metastatic colorectal cancer (mCRC) who have been previously treated with or are …
Product Type: Drug
Control Number: 275803
DIN(s): 02551454, 02551462
Manufacturer: Takeda Canada Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2023-09-14
Issued / Original Publication Date: 2024-12-19
Decision / Authorization Date: 2025-01-02
Updated Date: 2025-01-02
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD1707315192044
… sickle cell disease, neurodevelopmental disorders, active cancer, and medically related technological dependence. …
Product Type: Drug
Control Number: 278519
DIN(s): 02543656
Manufacturer: Novavax Inc.
Submission Type: New Drug Submission (New Active Substance) (COVID-19)
Date Filed / Submission Date: 2023-09-01
Issued / Original Publication Date: 2024-02-09
Decision / Authorization Date: 2023-12-05
Updated Date: 2025-03-21
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD1732553847408
… to confirm the clinical benefit. Multiple myeloma is a cancer of plasma cells. The malignant plasma cells produce … project is an international partnership designed to give cancer patients faster access to promising cancer treatments. The submission for Talvey was classified …
Product Type: Drug
Control Number: 278277
DIN(s): 02547392, 02547406
Manufacturer: Janssen Inc.
Submission Type: New Drug Submission (New Active Substance) - Notice of Compliance with Conditions
Date Filed / Submission Date: 2023-08-15
Issued / Original Publication Date: 2024-11-23
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD1737486518137
… In Canada, all leukemia cases account for 3% of new cancers, making it a rare disease. Acute myeloid leukemia … makes up 24% of all leukemia cases or approximately 1% of cancers, but is a leading cause of adult leukemia deaths. … in Canada. Cholangiocarcinomas are a heterogeneous group of cancers arising from the epithelium of the bile duct. These …
Product Type: Drug
Control Number: 277139
Manufacturer: Servier Canada Inc
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2023-07-11
Issued / Original Publication Date: 2025-01-21
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD1739202346124
… [33.1%]) groups. There was one report of malignancy [breast cancer] in the Steqeyma group. There were no reports of …
Product Type: Drug
Control Number: 274939
DIN(s): 02550245, 02550253, 02550261
Manufacturer: Celltrion, Inc.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2023-06-30
Issued / Original Publication Date: 2025-02-10
Decision / Authorization Date: 2024-07-30
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD1737492567696
… monoclonal antibody that is used to treat certain types of cancer and rheumatoid arthritis. It has also been used in … not substrates of drug transporters (P‑glycoprotein/breast cancer resistance protein/organic anion transporting …
Product Type: Drug
Control Number: 276757
DIN(s): 02549220, 02549239, 02549247
Manufacturer: UCB Canada Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2023-06-30
Issued / Original Publication Date: 2025-01-21
Decision / Authorization Date: 2024-07-11