Review decisions
Showing 90 results of 688 total
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1710769045419
… myeloma and in patients with bone metastases from breast cancer, prostate cancer, non-small cell lung cancer, and other solid tumours. Treatment of adults and …
Product Type: Drug
Control Number: 267788
DIN(s): 02545764
Manufacturer: Sandoz Canada Inc.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2023-01-27
Decision / Authorization Date: 2024-03-01
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD1743686266671
… of the multidrug resistance protein 1 (MDR1), breast cancer resistance protein (BCRP), organic anion transporter … resistance mutation 1 (MDR1)/P-glycoprotein (P-gp), breast cancer resistance protein (BCRP), organic anion transporter …
Product Type: Drug
Control Number: 284667
DIN(s): 02554429, 02554437
Manufacturer: Xediton Pharmaceuticals Inc.
Submission Type: New Drug Submission (New Active Substance) - Priority Review
Date Filed / Submission Date: 2024-03-05
Issued / Original Publication Date: 2025-04-02
Decision / Authorization Date: 2025-01-17
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD1745520433225
… cells, and natural killer cells. According to the Canadian Cancer Society, it was estimated that in 2024, 11,700 … antibody-drug conjugate designed to target CD19-expressing cancers. It consists of a humanized immunoglobulin G1 kappa … tesirine, which is in line with relevant guidelines for anticancer agents. The SG3199 component of loncastuximab …
Product Type: Drug
Control Number: 284436
DIN(s): 02556138
Manufacturer: Swedish Orphan Biovitrum Ab (publ)
Submission Type: New Drug Submission (New Active Substance) - Notice of Compliance with Conditions
Date Filed / Submission Date: 2024-02-29
Issued / Original Publication Date: 2025-04-28
Decision / Authorization Date: 2025-03-07
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD1751029009341
… ROS proto-oncogene 1 ( ROS1 )-positive non-small cell lung cancer (NSCLC). 1 What was approved? Augtyro, an … ROS proto-oncogene 1 ( ROS1 )-positive non-small cell lung cancer (NSCLC). Augtyro is not authorized for use in … ROS proto-oncogene 1 ( ROS1 )-positive non-small cell lung cancer (NSCLC). In Canada, lung cancer is the leading cause …
Product Type: Drug
Control Number: 284373
DIN(s): 02557444, 02557452
Manufacturer: Bristol-Myers Squibb Canada
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2024-02-28
Issued / Original Publication Date: 2025-06-27
Decision / Authorization Date: 2025-05-07
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD1749131274419
… considered favourable for the following indications: Cancer Patients Receiving Myelosuppressive Chemotherapy … Filra is indicated in adult and pediatric patients with cancer receiving myelosuppressive chemotherapy. A complete … and consolidation treatment for acute myeloid leukemia. Cancer Patients Receiving Myeloablative Chemotherapy …
Product Type: Drug
Control Number: 273870
DIN(s): 02556537, 02556545
Manufacturer: JAMP Pharma Corporation
Submission Type: New Drug Submission
Date Filed / Submission Date: 2024-02-25
Issued / Original Publication Date: 2025-06-03
Decision / Authorization Date: 2025-03-24
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1712086340348
… for the treatment of adult patients with advanced prostate cancer. Why was the decision issued? The safety and efficacy … for the treatment of adult patients with advanced prostate cancer were supported by the pivotal study HERO. This phase …
Product Type: Drug
Control Number: 269372
DIN(s): 02542137
Manufacturer: Sumitomo Pharma Switzerland GmbH
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2022-11-03
Decision / Authorization Date: 2023-10-10
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1712843981486
… osteoporosis/other metabolic bone disease, breast cancer, stroke, myocardial infarction (MI), deep vein …
Product Type: Drug
Control Number: 268111
DIN(s): 02541742
Manufacturer: Sumitomo Pharma Switzerland GmbH
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2022-09-23
Decision / Authorization Date: 2023-10-17
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD1744031364691
… Merkel cell carcinoma is a rare neuroendocrine skin cancer. It has a high recurrence rate and a propensity for …
Product Type: Drug
Control Number: 284125
DIN(s): 02555239
Manufacturer: Incyte Corporation
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2024-02-20
Issued / Original Publication Date: 2025-04-03
Decision / Authorization Date: 2025-02-06
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1707836185816
… mutagenesis leading to tumorgenicity, particularly liver cancer due to integration of the liver-targeting AAV vector, … viral/transgene DNA to offspring. Patients at risk of liver cancer should be followed closely for five years following …
Product Type: Drug
Control Number: 275853
DIN(s): 02544156
Manufacturer: Pfizer Canada ULC
Submission Type: New Drug Submission (New Active Substance) - Priority Review
Date Filed / Submission Date: 2023-06-01
Decision / Authorization Date: 2023-12-27
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SSR1707157428464
… It is authorized for the treatment of metastatic breast cancer in combination with certain prescription drugs. Th e … for sale in Canada for the treatment of metastatic breast cancer in combination with certain prescription drugs. … in Canada, Ibrance is the most commonly used for breast cancer treatment. It is estimated that over 60,000 breast …
DIN(s): 02453150, 02453169, 02453177, 02493535, 02493543, 02493551
Issued / Original Publication Date: 2024-02-09
Updated Date: 2024-02-09