Review decisions
Showing 130 results of 342 total
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00587
… epithelial ovarian, fallopian tube, or primary peritoneal cancer. These patients should not have received prior … epithelial ovarian, fallopian tube, or primary peritoneal cancer was not proposed for Abevmy. The market authorization … for the following indications: Metastatic Colorectal Cancer Abevmy in combination with fluoropyrimidine-based …
Product Type: Drug
Control Number: 237499
DIN(s): 02522160, 02522179
Manufacturer: BGP Pharma ULC
Submission Type: New Drug Submission
Date Filed / Submission Date: 2020-06-07
Issued / Original Publication Date: 2022-04-21
Decision / Authorization Date: 2021-11-05
Updated Date: 2024-04-02
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/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/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/SBD00536
… implied that estetrol acts as a P-glycoprotein and Breast Cancer Resistance Protein (BCRP) substrate. Since estetrol …
Product Type: Drug
Control Number: 236197
DIN(s): 02513218
Manufacturer: Searchlight Pharma Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2020-02-18
Issued / Original Publication Date: 2021-06-16
Decision / Authorization Date: 2021-03-05
Updated Date: 2023-07-21
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00458
Product Type: Drug
Control Number: 220584
DIN(s): 02492032, 02492040
Manufacturer: Pfizer Canada ULC., on behalf of BioNTech Manufacturing GmbH
Submission Type: New Drug Submission
Issued / Original Publication Date: 2020-01-21
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00524
… in 2 patients (2%, unrelated). A case of papillary thyroid cancer was detected in the EU registry study. In the …
Product Type: Drug
Control Number: 235023
DIN(s): 02509733
Manufacturer: Ipsen Biopharmaceuticals Canada Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2020-01-09
Issued / Original Publication Date: 2021-03-25
Decision / Authorization Date: 2020-12-17
Updated Date: 2023-10-31
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00497
… care professional who is experienced in the use of anticancer medicinal products. 1 What was approved? Qinlock, … care professional who is experienced in the use of anticancer medicinal products. No data are available to Health … care professional who is experienced in the use of anticancer medicinal products. Gastrointestinal stromal tumours …
Product Type: Drug
Control Number: 234688
DIN(s): 02500833
Manufacturer: Deciphera Pharmaceuticals, LLC
Submission Type: New Drug Submission (New Active Substance) - Priority Review
Date Filed / Submission Date: 2019-12-23
Issued / Original Publication Date: 2020-09-22
Decision / Authorization Date: 2020-06-19
Updated Date: 2025-10-16
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00501
… as an autoimmune disorder or develop due to an underlying cancer (paraneoplastic type). In the autoimmune type, …
Product Type: Drug
Control Number: 234655
DIN(s): 02503034
Manufacturer: Medunik Canada
Submission Type: New Drug Submission (New Active Substance) - Priority Review
Date Filed / Submission Date: 2019-12-20
Issued / Original Publication Date: 2020-10-22
Decision / Authorization Date: 2023-01-10
Updated Date: 2024-11-18