Review decisions
Showing 80 results of 342 total
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD1704300260963
… drug. As of 2022, approximately 3,500 new cases of liver cancer are diagnosed each year in Canada and 1,650 Canadians … from hepatocytes, which accounts for 75 to 85% of all liver cancers. Some of the most common risk factors for HCC … treatment. Patients with a Barcelona Clinic Liver Cancer (BCLC) Stage D who are unfit for systemic therapy are …
Product Type: Drug
Control Number: 262740
DIN(s): 02541009
Manufacturer: AstraZeneca Canada Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2022-03-24
Issued / Original Publication Date: 2024-01-03
Decision / Authorization Date: 2023-08-31
Updated Date: 2024-08-02
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD1730903762975
… are available for this population. Of the 930 patients with cancer who received pegfilgrastim in clinical studies, 139 … chemotherapy therapy after surgical resection of breast cancer, in accordance with the Guidance Document: … active-controlled, parallel-group study in breast cancer patients undergoing adjuvant myelosuppressive …
Product Type: Drug
Control Number: 262438
DIN(s): 02546973
Manufacturer: Nora Pharma Inc.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2022-03-23
Issued / Original Publication Date: 2024-11-07
Decision / Authorization Date: 2024-04-17
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD1684955300002
… Yescarta, and Carvykti related to T-cell malignancy (cancer that forms in white blood cells called T cells). … 10% of hematological malignancies. The Canadian Cancer Society estimated that in 2022 approximately …
Product Type: Drug
Control Number: 262122
DIN(s): 02535270
Manufacturer: Janssen Inc.
Submission Type: New Drug Submission (New Active Substance) - Notice of Compliance with Conditions
Date Filed / Submission Date: 2022-03-04
Issued / Original Publication Date: 2023-05-09
Decision / Authorization Date: 2023-02-09
Updated Date: 2025-05-09
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00621
… (PSMA)‑positive metastatic castration‑resistant prostate cancer (mCRPC) who have received at least one androgen … (PSMA)‑positive metastatic castration-resistant prostate cancer (mCRPC) who have received at least one androgen … (PSMA)‑positive metastatic castration-resistant prostate cancer (mCRPC) who have received at least one androgen …
Product Type: Drug
Control Number: 260951
DIN(s): 02530198
Manufacturer: Advanced Accelerator Applications USA, Inc.
Submission Type: New Drug Submission (New Active Substance) - Priority Review
Date Filed / Submission Date: 2022-01-28
Issued / Original Publication Date: 2023-01-20
Decision / Authorization Date: 2022-08-25
Updated Date: 2025-11-13
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD1684869579695
… for the following indications: Metastatic Colorectal Cancer (mCRC) Vegzelma in combination with … given to current standard of care guidelines for colorectal cancer. See the Drug-Drug Interactions section of the … Advanced, Metastatic or Recurrent Non-Small Cell Lung Cancer (NSCLC) Vegzelma, in combination with a …
Product Type: Drug
Control Number: 258973
DIN(s): 02534177, 02534185
Manufacturer: Celltrion Healthcare Co., Ltd.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2021-12-29
Issued / Original Publication Date: 2023-05-02
Decision / Authorization Date: 2023-01-03
Updated Date: 2025-08-19
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00625
… is an inhibitor of p-glycoprotein (P-gp) and breast cancer resistance protein (BCRP) and it is expected that …
Product Type: Drug
Control Number: 259676
DIN(s): 02530740
Manufacturer: Takeda Canada Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2021-12-16
Issued / Original Publication Date: 2023-02-17
Decision / Authorization Date: 2022-09-15
Updated Date: 2024-11-21
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00628
… is a substrate of P‑glycoprotein (P‑gp) and breast cancer resistance protein (BCRP), which are important …
Product Type: Drug
Control Number: 259397
DIN(s): 02533030
Manufacturer: Bristol-Myers Squibb Canada Co.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2021-12-08
Issued / Original Publication Date: 2023-03-10
Decision / Authorization Date: 2022-11-24
Updated Date: 2024-06-10
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00577
… propafenone, quinidine antibiotic: fusidic acid anticancer agents: apalutamide, neratinib, venetoclax … offset of the recently discontinued CYP3A inducer: anticancer agent: apalutamide anticonvulsants: carbamazepine, … sickle cell disease, neurodevelopmental disorders, active cancer, and medically related technological dependence. …
Product Type: Drug
Control Number: 259186
DIN(s): 02524031, 02527804
Manufacturer: Pfizer Canada ULC
Submission Type: New Drug Submission (New Active Substance) (COVID-19)
Date Filed / Submission Date: 2021-12-01
Issued / Original Publication Date: 2022-02-28
Decision / Authorization Date: 2022-01-17
Updated Date: 2025-05-16
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00605
… partnership of drug regulatory agencies designed to give cancer patients faster access to promising treatments. It …
Product Type: Drug
Control Number: 258717
DIN(s): 02527588
Manufacturer: Immunocore Ireland Ltd.
Submission Type: New Drug Submission (New Active Substance) - Priority Review
Date Filed / Submission Date: 2021-11-19
Issued / Original Publication Date: 2022-10-03
Decision / Authorization Date: 2022-06-07
Updated Date: 2023-06-30
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00589
… obesity, heart disease, chronic kidney disease, diabetes, cancer, and pulmonary obstructive disease. Health Canada has … obesity (42%), diabetes (14%), cardiovascular disease (8%), cancer, including a history of cancer (7%), chronic obstructive pulmonary disease (5%), …
Product Type: Drug
Control Number: 258295
DIN(s): 02526271
Manufacturer: AstraZeneca Canada Inc.
Submission Type: New Drug Submission (New Active Substance) (COVID-19)
Date Filed / Submission Date: 2021-11-03
Issued / Original Publication Date: 2022-06-15
Decision / Authorization Date: 2022-04-14
Updated Date: 2024-05-17