Review decisions
Showing 110 results of 342 total
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00560
… with non-Hodgkin lymphoma. Diffuse-large B-cell lymphoma, a cancer that starts in a type of white blood cells called B … Orbis , an international partnership designed to give cancer patients faster access to promising treatments. The …
Product Type: Drug
Control Number: 247025
DIN(s): 02518627
Manufacturer: Incyte Corporation
Submission Type: New Drug Submission (New Active Substance) - Notice of Compliance with Conditions
Date Filed / Submission Date: 2020-12-04
Issued / Original Publication Date: 2021-11-25
Decision / Authorization Date: 2021-08-19
Updated Date: 2025-05-28
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00522
… heart disease, chronic kidney disease, type 2 diabetes, cancer, and, pulmonary obstructive disease. Care for …
Product Type: Drug
Control Number: 246758
DIN(s): 02513153
Manufacturer: Janssen Inc.
Submission Type: Application for authorization under the Interim Order Respecting the Importation, Sale and Advertising of Drugs for Use in Relation to COVID-19
Date Filed / Submission Date: 2020-11-30
Issued / Original Publication Date: 2021-03-19
Decision / Authorization Date: 2021-03-05
Updated Date: 2024-01-19
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00561
… They account for approximately 15% of all primary liver cancers and approximately 3% of gastrointestinal … is increasing and approximately 2% of all annual cancer-related deaths are due to these malignancies. Fusions … project is an international partnership designed to give cancer patients faster access to promising cancer …
Product Type: Drug
Control Number: 246904
Manufacturer: QED Therapeutics, Inc.
Submission Type: New Drug Submission (New Active Substance) - Notice of Compliance with Conditions
Date Filed / Submission Date: 2020-11-30
Issued / Original Publication Date: 2021-11-30
Decision / Authorization Date: 2021-09-27
Updated Date: 2025-06-19
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00563
… Kymriah, Yescarta, Carvykti related to T-cell malignancy (cancer that forms in white blood cells called T cells). Drug … T-cell immunotherapy that binds to CD19-expressing cancer cells and normal B cells. Studies demonstrated that …
Product Type: Drug
Control Number: 246355
DIN(s): 02516667, 02532719
Manufacturer: Gilead Sciences Canada Inc.
Submission Type: New Drug Submission (New Active Substance) - Priority Review
Date Filed / Submission Date: 2020-11-13
Issued / Original Publication Date: 2021-12-06
Decision / Authorization Date: 2021-06-08
Updated Date: 2025-03-20
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00575
… reported rates of malignancies excluding non-melanoma skin cancers (0.7% vs. 0.6%) and malignant neoplasms including non-melanoma skin cancers (1.2% vs. 0.6%) did not differ between the treatment …
Product Type: Drug
Control Number: 246187
DIN(s): 02522845
Manufacturer: AstraZeneca Canada Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2020-11-09
Issued / Original Publication Date: 2022-02-08
Decision / Authorization Date: 2021-11-30
Updated Date: 2025-10-09
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00595
… project is an international partnership designed to give cancer patients faster access to promising cancer treatments. The NDS for Rholistiq was classified as a …
Product Type: Drug
Control Number: 245791
DIN(s): 02526115
Manufacturer: Kadmon Pharmaceuticals LLC
Submission Type: New Drug Submission (New Active Substance) - Priority Review
Date Filed / Submission Date: 2020-11-03
Issued / Original Publication Date: 2022-07-07
Decision / Authorization Date: 2022-03-23
Updated Date: 2025-06-19
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00620
… of serious heart-related problems, fatal blood clots and cancer ), containing labelling updates for healthcare … in Cibinqo-treated patients (7 cases of non-melanoma skin cancer and 3 cases of other cancers), with the exception of one case in a control group …
Product Type: Drug
Control Number: 245854
DIN(s): 02528363, 02528371, 02528398
Manufacturer: Pfizer Canada ULC
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2020-10-29
Issued / Original Publication Date: 2022-12-02
Decision / Authorization Date: 2022-06-29
Updated Date: 2025-06-12
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00498
Product Type: Drug
Control Number: 235295
DIN(s): 02499827, 02499835
Manufacturer: Seattle Genetics Inc.
Submission Type: New Drug Submission
Issued / Original Publication Date: 2020-10-01
Updated Date: 2022-12-14
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00568
… epithelial ovarian, fallopian tube, or primary peritoneal cancer. These patients should not have received prior … include relevant caveat statements): Metastatic Colorectal Cancer Bambevi in combination with fluoropyrimidine-based … given to current standard of care guidelines for colorectal cancer. See Drug-Drug Interactions section of the Bambevi …
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
Issued / Original Publication Date: 2022-01-11
Decision / Authorization Date: 2021-09-23
Updated Date: 2023-08-30
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00557
… benefit. Multiple myeloma is a largely incurable blood cancer characterized by the proliferation of malignant … sites (plasmacytomas). It accounts for 1% of all cancers, and 10% of hematologic malignancies. Although it is …
Product Type: Drug
Control Number: 244266
DIN(s): 02516233
Manufacturer: Celgene Inc.
Submission Type: New Drug Submission (New Active Substance) - Priority Review
Date Filed / Submission Date: 2020-09-22
Issued / Original Publication Date: 2021-11-22
Decision / Authorization Date: 2021-05-26
Updated Date: 2024-01-05