Review decisions
Showing 280 results of 688 total
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/RDS00718
… agents on ozanimod and the major active metabolites: Breast Cancer Resistance Protein (BCRP; increased exposure of …
Product Type: Drug
Control Number: 232761
DIN(s): 02505991, 02506009
Manufacturer: Celgene Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2019-10-25
Decision / Authorization Date: 2020-10-02
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
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00696
… treatment of patients with extensive-stage small cell lung cancer. After evaluation of the submitted data package, … of adult patients with extensive-stage small cell lung cancer (ES-SCLC). he purpose of the submission is to seek … treatment of patients with extensive-stage small cell lung cancer (ES-SCLC). Why was the decision issued? …
Product Type: Drug
Control Number: 233107
Manufacturer: AstraZeneca Canada Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2019-11-01
Decision / Authorization Date: 2020-09-21
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS01013
… pulmonary embolism, deep vein thrombosis, invasive breast cancer, and probable dementia. However, the overall risk of …
Product Type: Drug
Control Number: 224010
DIN(s): 02505215, 02505223
Manufacturer: Knight Therapeutics Inc.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2019-09-17
Decision / Authorization Date: 2020-09-17
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SSR00245
… to treat certain types of bone marrow and white blood cell cancers, alone or in combination with other therapies. It is … in Canada to treat: Certain types of blood and bone marrow cancers, such as chronic lymphocytic leukemia, mantle cell … medical conditions (present in all 25 cases), such as cancer or infections that could have been possible causes of …
Issued / Original Publication Date: 2020-09-15
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00559
… advanced unresectable or metastatic non‑small cell lung cancer (NSCLC). A validated test is required prior to … advanced unresectable or metastatic non‑small cell lung cancer (NSCLC). A validated test is required prior to … advanced unresectable or metastatic non‑small cell lung cancer (NSCLC). Gavreto was authorized under the Notice of …
Product Type: Drug
Control Number: 243731
DIN(s): 02517590
Manufacturer: Hoffmann-La Roche Ltd.
Submission Type: New Drug Submission (New Active Substance) - Notice of Compliance with Conditions
Date Filed / Submission Date: 2020-09-10
Issued / Original Publication Date: 2021-11-26
Decision / Authorization Date: 2021-06-30
Updated Date: 2025-06-04
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD1749640931774
… is favourable for the treatment of the following cancers that harbour genetic alterations in the rearranged … ) gene: metastatic RET fusion-positive non-small cell lung cancer in adult patients, RET -mutant medullary thyroid cancer in adult and pediatric patients 12 years of age and …
Product Type: Drug
Control Number: 243748
DIN(s): 02516918, 02516926
Manufacturer: Loxo Oncology, Inc.
Submission Type: New Drug Submission (New Active Substance) - Notice of Compliance with Conditions
Date Filed / Submission Date: 2020-09-10
Issued / Original Publication Date: 2021-11-09
Decision / Authorization Date: 2021-06-15
Updated Date: 2025-06-04