Review decisions
Showing 240 results of 688 total
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS01028
… infarction, deep vein thrombosis, and invasive breast cancer when used in conjunction with estrogens for hormone …
Product Type: Drug
Control Number: 239820
DIN(s): 02515504
Manufacturer: Ibsa Institut Biochimique SA
Submission Type: New Drug Submission
Date Filed / Submission Date: 2020-05-22
Decision / Authorization Date: 2021-04-30
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00610
… of P‑glycoprotein (P‑gp), and is not an inhibitor of breast cancer resistance protein (BCRP). No dose reductions for …
Product Type: Drug
Control Number: 252301
DIN(s): 02527693
Manufacturer: BioCryst Pharmaceuticals, Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2021-04-30
Issued / Original Publication Date: 2022-10-19
Decision / Authorization Date: 2022-06-02
Updated Date: 2025-06-25
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00795
… treatment of patients with HER2-positive metastatic breast cancer who have not received prior anti-HER2 therapy or …
Product Type: Drug
Control Number: 237674
Manufacturer: Celltrion Healthcare Co., Ltd.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2020-04-08
Decision / Authorization Date: 2021-04-16
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00797
… with unresectable or metastatic HER2-positive breast cancer who have received two or more prior anti-HER2-based … with unresectable or metastatic HER2-positive breast cancer who have received prior treatment with trastuzumab … with unresectable or metastatic HER2-positive breast cancer who had received prior treatment with trastuzumab …
Product Type: Drug
Control Number: 242104
DIN(s): 02514400
Manufacturer: AstraZeneca Canada Inc.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2020-07-27
Decision / Authorization Date: 2021-04-15
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00852
… treatment of patients with HER2-positive metastatic breast cancer who have not received prior anti-HER2 therapy or … treatment of patients with HER2-positive metastatic breast cancer who have not received prior anti-HER2 therapy or …
Product Type: Drug
Control Number: 239083
Manufacturer: Amgen Canada Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2020-04-30
Decision / Authorization Date: 2021-04-14
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00573
… with unresectable locally advanced or metastatic urothelial cancer (mUC) with no prior systemic therapy for mUC. The … with unresectable locally advanced or metastatic urothelial cancer who have previously received a platinum-containing … with unresectable locally advanced or metastatic urothelial cancer who have previously received a platinum-containing …
Product Type: Drug
Control Number: 251438
DIN(s): 02521903, 02521911
Manufacturer: Seagen Inc.
Submission Type: New Drug Submission (New Active Substance) - Priority Review
Date Filed / Submission Date: 2021-04-06
Issued / Original Publication Date: 2022-02-04
Decision / Authorization Date: 2021-10-29
Updated Date: 2025-06-18
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00548
… obesity, heart disease, chronic kidney disease, diabetes, cancer, and pulmonary obstructive disease. In addition, the …
Product Type: Drug
Control Number: 251285
DIN(s): 02518341
Manufacturer: GlaxoSmithKline Canada Inc.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2021-04-01
Issued / Original Publication Date: 2021-09-10
Decision / Authorization Date: 2021-07-30
Updated Date: 2024-07-19
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS01025
… for the treatment of patients with metastatic colorectal cancer with a BRAF V600E mutation, after prior therapy. Upon … for the treatment of patients with metastatic colorectal cancer (mCRC) with a BRAF V600E mutation, as detected by a … to have BRAF V600E mutation-positive metastatic colorectal cancer. Patients were randomized 1:1:1 to receive the …
Product Type: Drug
Control Number: 238571
DIN(s): 02513099
Manufacturer: Pfizer Canada ULC., on behalf of BioNTech Manufacturing GmbH
Submission Type: New Drug Submission
Date Filed / Submission Date: 2020-04-17
Decision / Authorization Date: 2021-03-30
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00611
… Guidelines) and international (National Comprehensive Cancer Network Clinical Practice Guidelines) treatment … or expressed at high frequency on the surface of cancer cells. Poteligeo targets and binds to CCR4, enhancing …
Product Type: Drug
Control Number: 251277
DIN(s): 02527715
Manufacturer: Kyowa Kirin, Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2021-03-31
Issued / Original Publication Date: 2022-10-25
Decision / Authorization Date: 2022-06-02
Updated Date: 2025-06-27
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00580
… (dMMR)/microsatellite instability-high (MSI-H) endometrial cancer who are candidates for systemic therapy. The … instability-high (MSI-H) recurrent or advanced endometrial cancer that has progressed on or following prior treatment … instability-high (MSI-H) recurrent or advanced endometrial cancer that has progressed on or following prior treatment …
Product Type: Drug
Control Number: 251105
DIN(s): 02523434
Manufacturer: GlaxoSmithKline Canada Inc.
Submission Type: New Drug Submission (New Active Substance) - Notice of Compliance with Conditions
Date Filed / Submission Date: 2021-03-26
Issued / Original Publication Date: 2022-03-09
Decision / Authorization Date: 2021-12-23
Updated Date: 2024-07-26