Review decisions
Showing 310 results of 688 total
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SSR00236
… Safety Issue Potential risk of new or returning liver cancer (Hepatocellular Carcinoma) Key Messages Direct-acting … scarring of the liver (cirrhosis) or a type of liver cancer called Hepatocellular Carcinoma (HCC). Health Canada … Antivirals - Assessing the Potential Risk of Liver Cancer Recurrence Footnotes Canadian reports can be accessed …
Issued / Original Publication Date: 2020-04-02
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00533
… V600K mutations. Melanoma is the most lethal form of skin cancer due to its propensity to metastasize to vital organs, … melanoma than other populations. According to the Canadian Cancer Society, approximately 8,200 Canadians will be … pathway), promoting the proliferation and survival of cancer cells. In a prospective study of 197 patients with …
Product Type: Drug
Control Number: 237410
DIN(s): 02513080
Manufacturer: Pfizer Canada ULC
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2020-03-20
Issued / Original Publication Date: 2021-06-08
Decision / Authorization Date: 2021-03-02
Updated Date: 2023-07-12
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00534
… for the treatment of patients with metastatic colorectal cancer (mCRC) with a BRAF V600E mutation, as detected by a … V600K mutations. Melanoma is the most lethal form of skin cancer due to its propensity to metastasize to vital organs, … melanoma than other populations. According to the Canadian Cancer Society, approximately 8,200 Canadians will be …
Product Type: Drug
Control Number: 237413
DIN(s): 02513099
Manufacturer: Pfizer Canada ULC
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2020-03-20
Issued / Original Publication Date: 2021-06-08
Decision / Authorization Date: 2021-03-02
Updated Date: 2025-01-28
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00815
… hormone receptor-positive, HER2-negative advanced breast cancer with a Phosphatidylinositol-4,5-Bisphosphate 3-Kinase … HER2-negative, PIK3CA-mutated advanced or metastatic breast cancer after disease progression following an … regimen. Why was the decision issued? Advanced breast cancer is serious, life-threatening, and incurable. Although …
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
Decision / Authorization Date: 2020-03-11
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00507
… toxicity study in rats. A relationship between these cancers to luspatercept treatment cannot be ruled out and …
Product Type: Drug
Control Number: 236441
DIN(s): 02505541, 02505568
Manufacturer: Celgene Inc.
Submission Type: New Drug Submission (New Active Substance) - Priority Review
Date Filed / Submission Date: 2020-03-05
Issued / Original Publication Date: 2020-11-30
Decision / Authorization Date: 2020-09-25
Updated Date: 2025-11-20
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00628
… the indications held by Herceptin in Canada: early breast cancer, metastatic breast cancer and metastatic gastric cancer. Why was the decision issued? Kanjinti …
Product Type: Drug
Control Number: 208836
DIN(s): 02496690
Manufacturer: Amgen Canada Inc.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2017-08-21
Decision / Authorization Date: 2020-02-27
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00591
… favourable for the following indications: Early Breast Cancer (EBC) Ontruzant (trastuzumab) is indicated for the treatment of patients with early stage breast cancer with Eastern Cooperative Oncology Group (ECOG) 0-1 … was not studied. Metastatic Breast Cancer (MBC) Ontruzant is indicated for the treatment of …
Product Type: Drug
Control Number: 235995
DIN(s): 02524317, 02524325
Manufacturer: Samsung Bioepis Co., Ltd.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2020-02-27
Issued / Original Publication Date: 2022-06-23
Decision / Authorization Date: 2022-01-28
Updated Date: 2024-06-13
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00619
… authorization of Mvasi for the platinum-resistant ovarian cancer indication held by the reference biologic drug … of Mvasi in the proposed platinum-resistant ovarian cancer was provided. Health Canada has thoroughly assessed … epithelial ovarian, fallopian tube and primary peritoneal cancer. A Notice of Compliance (NOC) was recommended for …
Product Type: Drug
Control Number: 230254
Manufacturer: Amgen Canada Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2019-08-21
Decision / Authorization Date: 2020-02-21
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00648
… Reduced immune surveillance may increase the risk of cancer but an increased risk cannot be well characterized … rate with siponimod and placebo but other types of skin cancers (e.g., malignant melanoma, squamous cell carcinoma) and non-cutaneous cancers (seminoma) were also reported, in one or two …
Product Type: Drug
Control Number: 223225
DIN(s): 02496429, 02496437
Manufacturer: Novartis Pharmaceuticals Canada Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2018-12-21
Decision / Authorization Date: 2020-02-20
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00798
… patients with non-metastatic castration resistant prostate cancer (nmCRPC)." Why was the decision issued? Clinical … to initiation of first cytotoxic chemotherapy for prostate cancer, and time to first symptomatic skeletal event were …
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
Decision / Authorization Date: 2020-02-20