Review decisions
Showing 370 results of 688 total
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00514
… high (MSI-H), including mismatch repair deficient (dMMR), cancer who have received prior therapy. After evaluation of … high (MSI-H) or mismatch repair deficient (dMMR) colorectal cancer that has progressed following treatment with a … oxaliplatin, and irinotecan. or endometrial cancer that has progressed following prior therapy and who …
Product Type: Drug
Control Number: 218779
Manufacturer: Merck Canada Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2018-07-31
Decision / Authorization Date: 2019-04-18
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00493
… PIK3CA ‑mutated advanced or metastatic breast cancer after disease progression following an … PIK3CA ‑mutated advanced or metastatic breast cancer after disease progression following an … PIK3CA ‑mutated advanced or metastatic breast cancer after disease progression following an …
Product Type: Drug
Control Number: 226941
DIN(s): 02497042, 02497069, 02497077, 02497085
Manufacturer: Novartis Pharmaceuticals Canada Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2019-04-17
Issued / Original Publication Date: 2020-08-27
Decision / Authorization Date: 2020-03-11
Updated Date: 2025-08-26
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00488
… the reference biologic drug in female patients with breast cancer receiving established myelosuppressive chemotherapy. … Both studies were conducted in female patients with breast cancer receiving established myelosuppressive chemotherapy. … between Ziextenzo and EU‑Neulasta in patients with breast cancer. Treatment with any therapeutic protein is naturally …
Product Type: Drug
Control Number: 220445
DIN(s): 02497395
Manufacturer: Sandoz Canada Inc.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2019-04-09
Issued / Original Publication Date: 2020-07-31
Decision / Authorization Date: 0020-04-21
Updated Date: 2024-03-07
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00671
… receptor 2 (HER2)-negative advanced or metastatic breast cancer in the following proposed settings: In combination … receptor 2 (HER2)-negative advanced or metastatic breast cancer in combination with an aromatase inhibitor in … the treatment of postmenopausal women with advanced breast cancer. Why was the decision issued? Two randomized …
Product Type: Drug
Control Number: 215268
DIN(s): 02487098, 02487101, 02487128, 02487136
Manufacturer: Eli Lilly Canada Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2018-04-16
Decision / Authorization Date: 2019-04-08
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00482
… of patients with metastatic castration-sensitive prostate cancer (mCSPC) in combination with docetaxel. The submission … patients with non-metastatic castration-resistant prostate cancer (nmCRPC). Nubeqa has not been studied in patients … patients with non-metastatic castration-resistant prostate cancer (nmCRPC). Nubeqa has not been studied in patients …
Product Type: Drug
Control Number: 226146
DIN(s): 02496348
Manufacturer: Bayer Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2019-03-27
Issued / Original Publication Date: 2020-06-29
Decision / Authorization Date: 2020-02-20
Updated Date: 2025-08-01
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00483
… leukemia is a heterogeneous group of aggressive blood cancers, characterized by increased blast counts, … biological processes and is disrupted in various types of cancer. A pivotal Phase Ib/II study, BRIGHT AML 1003 … of biological processes and disrupted in various types of cancer. Glasdegib binds to Smoothened (SMO), a transmembrane …
Product Type: Drug
Control Number: 225793
DIN(s): 02498472, 02498480
Manufacturer: Pfizer Canada ULC
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2019-03-15
Issued / Original Publication Date: 2020-07-10
Decision / Authorization Date: 2020-04-28
Updated Date: 2025-06-12
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00552
… with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor … locally advanced or metastatic non-small cell lung cancer (NSCLC) with confirmed epidermal growth factor …
Product Type: Drug
Control Number: 214572
Manufacturer: Pfizer Canada Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2018-03-16
Decision / Authorization Date: 2019-02-26
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00554
… kinase (ALK)-positive metastatic non-small cell lung cancer (NSCLC) who have progressed on: crizotinib and at … treatment of patients with ALK-positive non-small cell lung cancer (NSCLC). However, therapy is not currently available …
Product Type: Drug
Control Number: 215733
DIN(s): 02485966, 02485974
Manufacturer: Pfizer Canada Inc.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2018-04-26
Decision / Authorization Date: 2019-02-22
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00459
… renal pelvis to the urethra. It accounts for 90% of bladder cancer. Bladder cancer is the fifth most common malignancy in Canada, with … 15% to 20% of locally advanced or metastatic urothelial cancers. The medicinal ingredient in Balversa, erdafitinib, …
Product Type: Drug
Control Number: 224529
DIN(s): 02493217, 02493225, 02493233, 02493241
Manufacturer: Janssen Inc.
Submission Type: New Drug Submission (New Active Substance) - Notice of Compliance with Conditions
Date Filed / Submission Date: 2019-02-08
Issued / Original Publication Date: 2020-01-28
Decision / Authorization Date: 2019-10-25
Updated Date: 2025-05-05
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SSR00215
… Potential Safety Issue Non-melanoma skin cancer; specifically, squamous cell carcinoma (SCC) and … body. Health Canada reviewed the risk of non-melanoma skin cancer (NMSC) related to the use of hydrochlorothiazide … has a potential risk of non-melanoma skin cancer that is at least four times the risk of not using …
Issued / Original Publication Date: 2019-01-30