Review decisions
Showing 60 results of 688 total
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1761924898908
… prevention of its recurrence in adult patients with active cancer”. What did the company submit to supports its … PE and prevention of their recurrence in adults with active cancer over a 6-month period. What was the status of the …
Product Type: Drug
Control Number: 292028
Manufacturer: Sanofi-Aventis Canada Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2024-11-06
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD1765291966794
… of the nasopharynx. The development of nasopharyngeal cancer is thought to involve Epstein-Barr virus infection, … in vivo with syngeneic and xenograft mouse models of cancer in which toripalimab slowed the tumour growth. …
Product Type: Drug
Control Number: 290985
DIN(s): 02562219
Manufacturer: Apotex Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2024-11-01
Issued / Original Publication Date: 2025-12-08
Decision / Authorization Date: 2025-10-17
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1726763640809
… for the treatment of adult patients with small cell lung cancer (SCLC) with disease progression on or after at least … of adult patients with extensive-stage small cell lung cancer (ES-SCLC) with disease progression on or after at … trial in 99 patients with extensive-stage small cell lung cancer (SCLC) who had disease progression following 2 prior …
Product Type: Drug
Control Number: 281963
DIN(s): 02551551, 02551578
Manufacturer: Amgen Canada Inc.
Submission Type: New Drug Submission (New Active Substance) - Notice of Compliance with Conditions
Date Filed / Submission Date: 2023-12-11
Decision / Authorization Date: 2024-09-11
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1725633192834
… held by Herceptin in Canada: HER2-positive early breast cancer (EBC), metastatic breast cancer (MBC) and metastatic gastric cancer (MGC). Why was the decision issued? To support the …
Product Type: Drug
Control Number: 275910
DIN(s): 02550970, 02550989
Manufacturer: Accord Healthcare Inc.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2023-06-01
Decision / Authorization Date: 2024-08-20
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1724779172737
… patients, with locally advanced or metastatic urothelial cancer. After evaluation of the submitted data package, … with unresectable locally advanced or metastatic urothelial cancer (mUC) with no prior systemic therapy for mUC. See … Monograph for other authorised indications for urothelial cancer. Why was the decision issued? The authorization of …
Product Type: Drug
Control Number: 282981
DIN(s): 02456869
Manufacturer: Merck Canada Inc.
Submission Type: Supplement to a New Drug Submission - Priority Review
Date Filed / Submission Date: 2024-01-19
Decision / Authorization Date: 2024-08-20
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1724850954021
… of patients, with locally advanced or metastatic urothelial cancer. After evaluation of the submitted data package, … with unresectable locally advanced or metastatic urothelial cancer (mUC) with no prior systemic therapy for mUC. See … Monograph for other authorised indications for urothelial cancer. Why was the decision issued? The authorization of …
Product Type: Drug
Control Number: 283003
Manufacturer: Seagen Inc.
Submission Type: Supplement to a New Drug Submission - Priority Review
Date Filed / Submission Date: 2024-01-22
Decision / Authorization Date: 2024-08-20
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1724332454521
… volunteers and in a randomized, open-label study in breast cancer patients receiving myelosuppressive chemotherapy. No …
Product Type: Drug
Control Number: 262990
Manufacturer: Lupin Pharma Canada Limited
Submission Type: New Drug Submission
Date Filed / Submission Date: 2022-03-31
Decision / Authorization Date: 2024-08-16
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD1748527113506
… accordingly. Omaveloxolone is a weak inducer of breast cancer resistance protein (BCRP) and organic anion …
Product Type: Drug
Control Number: 289541
DIN(s): 02556219
Manufacturer: Biogen Canada Inc.
Submission Type: New Drug Submission (New Active Substance) - Priority Review
Date Filed / Submission Date: 2024-08-13
Issued / Original Publication Date: 2025-05-29
Decision / Authorization Date: 2025-03-13
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD1760450740287
… in women with conditions such as hormone-sensitive cancers, thromboembolic disease, or active liver disease. … with proton pump inhibitors or substrates of breast cancer resistance protein (BCRP), organic anion transporting … management. No clinical safety data are available in breast cancer patients, a population with high unmet need for …
Product Type: Drug
Control Number: 289506
DIN(s): 02559714
Manufacturer: Bayer Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2024-08-13
Issued / Original Publication Date: 2025-10-12
Decision / Authorization Date: 2025-07-23
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD1762969841968
… hypercalcemia, and/or weight loss. In 2024, the Canadian Cancer Society projected that 4,100 Canadians would be … with hepatic impairment. Hepatic function, as per National Cancer Institute Organ Dysfunction Working Group …
Product Type: Drug
Control Number: 288908
DIN(s): 02559617, 02559625
Manufacturer: GlaxoSmithKline Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2024-07-25
Issued / Original Publication Date: 2025-11-10
Decision / Authorization Date: 2025-07-18