Review decisions
Showing 220 results of 688 total
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00877
… or metastatic gastric (GC), gastroesophogeal junction cancer (GEJC), or esophageal adenocarcinoma (EC). Patients …
Product Type: Drug
Control Number: 247339
Manufacturer: Bristol-Myers Squibb Canada Co.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2020-12-11
Decision / Authorization Date: 2021-10-28
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00884
… first-line treatment of patients with non-small cell lung cancer (NSCLC) expressing programmed cell death ligand 1 … Why was the decision issued? Non-Small Cell Lung Cancer Indication Market authorization of Libtayo was based … first-line treatment of patients with non-small cell lung cancer expressing PD-L1 in ≥ 50% of tumour cells (by tumour …
Product Type: Drug
Control Number: 246918
Manufacturer: Sanofi-Aventis Canada Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2020-12-01
Decision / Authorization Date: 2021-10-26
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS01085
… irradiation for patients with locally advanced prostate cancer (Stage T3-T4). What did the company submit to …
Product Type: Drug
Control Number: 232286
Manufacturer: JAMP Pharma Corporation
Submission Type: New Drug Submission
Date Filed / Submission Date: 2020-04-14
Decision / Authorization Date: 2021-10-20
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00866
… locally advanced or metastatic triple-negative breast cancer (mTNBC) who have received two or more prior … locally advanced or metastatic triple-negative breast cancer (mTNBC) who had relapsed after at least two prior chemotherapies for breast cancer (one of which could be in the neoadjuvant or adjuvant …
Product Type: Drug
Control Number: 248753
DIN(s): 02520788
Manufacturer: Gilead Sciences Canada Inc.
Submission Type: New Drug Submission - Priority Review
Date Filed / Submission Date: 2021-01-25
Decision / Authorization Date: 2021-09-24
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00864
… for use in the treatment of metastatic colorectal cancer, locally advanced or recurrent non-small cell lung cancer, platinum-resistant ovarian, fallopian tube and primary peritoneal cancer, and malignant glioma. The authorization relied on …
Product Type: Drug
Control Number: 244450
DIN(s): 02520729, 02520737
Manufacturer: Apotex Inc.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2020-09-25
Decision / Authorization Date: 2021-09-23
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00892
… (IV) use for: First-line therapy for metastatic colorectal cancer (mCRC) in combination with fluoropyrimidine-based … advanced, metastatic or recurrent non-small cell lung cancer (NSCLC); Combination therapy with paclitaxel, … epithelial ovarian, fallopian tube and primary peritoneal cancer; Combination therapy with lomustine for malignant …
Product Type: Drug
Control Number: 242395
Manufacturer: Centus Biotherapeutics Ltd.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2020-08-20
Decision / Authorization Date: 2021-09-23
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00881
… mutated locally advanced or metastatic non-small cell lung cancer (NSCLC). Upon review, Health Canada recommended … mutated locally advanced or metastatic non-small cell lung cancer (NSCLC). Advanced NSCLC (stage IIIB and IV) is a … ORR estimates for docetaxel ranged between 6-15%. A full cancer drug approval (NOC) is based on more direct evidence …
Product Type: Drug
Control Number: 248435
DIN(s): 02520095
Manufacturer: Amgen Canada Inc.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2021-01-14
Decision / Authorization Date: 2021-09-10
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00581
… sickle cell disease, neurodevelopmental disorders, active cancer, and medically related technological dependence. … 0.20 e/100 PY were COVID-19 (0.37 e/100 PY) and prostate cancer (0.28 e/100 PY) in participants who received …
Product Type: Drug
Control Number: 255370
DIN(s): 02525364
Manufacturer: Novavax Inc.
Submission Type: New Drug Submission (New Active Substance) (COVID-19)
Date Filed / Submission Date: 2021-08-27
Issued / Original Publication Date: 2022-04-08
Decision / Authorization Date: 2022-02-17
Updated Date: 2024-07-19
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00631
… (by 80%). Although ubrogepant is a substrate for breast cancer resistant protein (BCRP) and P-glycoprotein (P-gp), … to be a substrate for P-glycoprotein (P-gp), breast cancer resistant protein (BCRP), OATP1B1, OATP1B3, and …
Product Type: Drug
Control Number: 256191
DIN(s): 02532530, 02532581
Manufacturer: AbbVie Corporation
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2021-08-27
Issued / Original Publication Date: 2023-03-30
Decision / Authorization Date: 2022-11-10
Updated Date: 2026-01-06
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD1691500592141
… in patients with insomnia, or with rosuvastatin, a breast cancer resistance protein substrate. Similarly, no …
Product Type: Drug
Control Number: 255507
DIN(s): 02537435, 02537443
Manufacturer: Idorsia Pharmaceuticals Ltd
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2021-08-25
Issued / Original Publication Date: 2023-08-04
Decision / Authorization Date: 2023-04-28
Updated Date: 2025-10-09