Review decisions
Showing 390 results of 688 total
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00457
… locally advanced or metastatic non-small cell lung cancer, advanced or metastatic renal cell carcinoma and recurrent or metastatic squamous cell cancer of the head and neck (Opdivo Product Monograph dated …
Product Type: Drug
Control Number: 211838
Manufacturer: Bristol-Myers Squibb Canada Co.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2017-12-01
Decision / Authorization Date: 2018-11-15
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SSR00212
… Canada to treat adult patients with certain types of blood cancers. Health Canada carried out a safety review after … the symptoms caused by myelofibrosis, a rare form of blood cancer. It is also used to control the excess amount of red … in certain patients with polycythemia vera, a type of blood cancer. Ruxolitinib has been marketed in Canada since 2012 …
Issued / Original Publication Date: 2018-10-09
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00449
… zoster, opportunistic infections, and non-melanoma skin cancer (NMSC). Other important potential risks of …
Product Type: Drug
Control Number: 209643
Manufacturer: Pfizer Canada Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2017-09-26
Decision / Authorization Date: 2018-10-04
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00455
… clinical benefit. Tropomyosin receptor kinase (TRK) fusion cancer is defined by the presence of a specific type of … in cell proliferation and survival, leading to TRK fusion cancer. Current estimates indicate that an NTRK gene fusion … fusions are present at low frequencies in some common adult cancers, such as non-small cell lung cancer (NSCLC), …
Product Type: Drug
Control Number: 219998
DIN(s): 02490315, 02490323, 02490331
Manufacturer: Bayer Inc.
Submission Type: New Drug Submission (New Active Substance) - Notice of Compliance with Conditions
Date Filed / Submission Date: 2018-09-18
Issued / Original Publication Date: 2019-12-18
Decision / Authorization Date: 2019-07-10
Updated Date: 2025-06-04
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SSR00210
… in Canada to treat the signs and symptoms of a type of non-cancerous tumour in the womb (uterine fibroids) in women of … in patients with liver disease. Uterine fibroids are non-cancerous (benign) tumours of the womb. While not …
Issued / Original Publication Date: 2018-09-07
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00461
… treatment for patients with HER2-positive early breast cancer. After reviewing the submitted data package, Health … treatment of patients with HER2-positive early breast cancer with lymph node positive and/or hormone receptor … the previously authorized indication for metastatic breast cancer (see Product Monograph). Why was the decision …
Product Type: Drug
Control Number: 209467
Manufacturer: Hoffmann-La Roche Ltd.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2017-09-15
Decision / Authorization Date: 2018-08-30
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00517
… in the risk of a variety of serious AEs, such as breast cancer, thromboembolic events, and myocardial infarction. …
Product Type: Drug
Control Number: 211548
DIN(s): 02480247
Manufacturer: Pharmascience Inc.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2017-11-23
Decision / Authorization Date: 2018-08-22
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00443
… Libtayo for the treatment of adult patients with cervical cancer who have progressed on or after prior platinum-based … treatment of adult patients with non-small cell lung cancer (NSCLC) expressing programmed cell death ligand 1 … In Canada, CSCC is the second most common non-melanoma skin cancer, after basal cell carcinoma. The vast majority of …
Product Type: Drug
Control Number: 218718
DIN(s): 02487144, 02487152
Manufacturer: Sanofi-Aventis Canada Inc.
Submission Type: New Drug Submission (New Active Substance) - Notice of Compliance with Conditions
Date Filed / Submission Date: 2018-07-27
Issued / Original Publication Date: 2019-08-27
Decision / Authorization Date: 2019-04-10
Updated Date: 2024-12-06
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00434
… to curative therapy) or metastatic non-small cell lung cancer (NSCLC), who have progressed on, or who were … kinase (ALK)-positive metastatic non-small cell lung cancer (NSCLC) who have progressed on or who were intolerant …
Product Type: Drug
Control Number: 210369
DIN(s): 02479206, 02479214, 02479222, 02479230
Manufacturer: Takeda Canada Inc.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2017-10-24
Decision / Authorization Date: 2018-07-26
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SSR00206
… sale in Canada to treat bone marrow and white blood cell cancers. It is also used for the treatment of patients who … tachyarrhythmia. Overview Ibrutinib belongs to a class of cancer drugs called protein kinase inhibitors. It is used for the treatment of adult patients who have a cancer of the bone marrow called chronic lymphocytic …
Issued / Original Publication Date: 2018-07-26