Review decisions
Showing 30 results of 688 total
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1764947218405
… approved indication is for the treatment of prostate cancer, which had been previously authorized. The submission …
Product Type: Drug
Control Number: 254192
DIN(s): 02429977, 02462699
Manufacturer: Verity Pharmaceuticals Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2021-06-25
Decision / Authorization Date: 2024-01-12
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SSR1760464254070
… in Canada for the treatment of: Melanoma (a type of skin cancer), when used in combination with binimetinib. This type of skin cancer must have: a mutation (change) in the BRAF gene, and … (has spread to other parts of the body) colorectal cancer (a type of large intestine cancer), when used in …
DIN(s): 02513099
Issued / Original Publication Date: 2025-10-20
Updated Date: 2025-10-20
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1760644087054
… instability-high or mismatch repair deficient colorectal cancer. After review, Health Canada authorized the following … (MSI-H) or mismatch repair deficient (dMMR) colorectal cancer. The submission was classified as a Project Orbis … with MSI-H/dMMR unresectable or metastatic colorectal cancer (CRC). The dosing regimen evaluated in the study was …
Product Type: Drug
Control Number: 289379
DIN(s): 02446626, 02446634
Manufacturer: Bristol-Myers Squibb Canada
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2024-08-07
Decision / Authorization Date: 2025-07-16
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1760638567382
… for the treatment of patients with muscle invasive bladder cancer (MIBC) in combination with cisplatin-based … of patients with resectable muscle invasive bladder cancer (MIBC) in combination with gemcitabine and cisplatin … (≥ 18 years of age) with resectable muscle-invasive bladder cancer (MIBC). Randomized patients had no prior systemic …
Product Type: Drug
Control Number: 292883
DIN(s): 02468816
Manufacturer: AstraZeneca Canada Inc.
Submission Type: Supplement to a New Drug Submission - Priority Review
Date Filed / Submission Date: 2024-12-02
Decision / Authorization Date: 2025-07-17
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1761918610510
… with locally advanced or metastatic non-small cell lung cancer (NSCLC) with activating epidermal-growth factor … to curative therapy) or metastatic non-small cell lung cancer (NSCLC) with activating epidermal-growth factor … with locally advanced or metastatic non-small cell lung cancer (NSCLC) whose tumours harboured activating …
Product Type: Drug
Control Number: 282121
DIN(s): 02526182
Manufacturer: Janssen Inc.
Submission Type: Supplement to a New Drug Submission - Priority Review
Date Filed / Submission Date: 2023-12-15
Decision / Authorization Date: 2024-06-28
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1759428430511
… epithelial ovarian, fallopian tube, or primary peritoneal cancer, who have received one to three prior systemic … epithelial ovarian, fallopian tube, or primary peritoneal cancer, who have received one to three prior systemic … epithelial ovarian, primary peritoneal, or fallopian tube cancers whose tumours were positive for folate …
Product Type: Drug
Control Number: 294637
Manufacturer: AbbVie Corporation
Submission Type: New Drug Submission - Priority Review
Date Filed / Submission Date: 2025-01-28
Decision / Authorization Date: 2025-08-29
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1759426743003
… arm (16.0% vs. 8.8% in the VRd arm). Most SPMs were skin cancers, followed by solid tumours and hematological …
Product Type: Drug
Control Number: 286449
DIN(s): 02498235, 02498243
Manufacturer: Sanofi-Aventis Canada Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2024-04-30
Decision / Authorization Date: 2025-04-17
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SSR1746542979258
… congenital conditions (those present at birth), infection, cancer and drugs, can cause TMA. Use in Canada Stivarga is a … drug authorized in Canada for the treatment of: metastatic cancer (cancer that has spread) of the colon and rectum (colorectal) …
DIN(s): 02403390
Issued / Original Publication Date: 2025-05-22
Updated Date: 2025-05-22
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1758909378800
… anaplastic lymphoma kinase ALK-positive non-small cell lung cancer (NSCLC). The recommended indication was for adjuvant … lymphoma kinase (ALK)-positive non-small cell lung cancer (NSCLC) who had complete tumor resection. In the …
Product Type: Drug
Control Number: 282375
DIN(s): 02458136
Manufacturer: Hoffman-La Roche Limited
Submission Type: Supplement to a New Drug Submission - Priority Review
Date Filed / Submission Date: 2023-12-22
Decision / Authorization Date: 2024-06-27
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1758566878414
… of adult patients with metastatic Non-small Cell Lung Cancer (NSCLC) with no sensitizing epidermal growth factor …
Product Type: Drug
Control Number: 285745
DIN(s): 02468816
Manufacturer: AstraZeneca Canada Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2024-04-08
Decision / Authorization Date: 2025-04-10