Review decisions
Showing 520 results of 688 total
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00297
Product Type: Drug
Control Number: 172617
Manufacturer: Bristol-Myers Squibb Canada Co.
Submission Type: New Drug Submission
Issued / Original Publication Date: 2016-04-25
Updated Date: 2020-10-09
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SSR00071
… that is used to treat malignant melanoma (a type of skin cancer) that has spread or that cannot be removed by …
Issued / Original Publication Date: 2016-04-22
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00360
… review for Erelzi related to mycosis fungoides (a type of cancer that begins in white blood cells called T cells, …
Product Type: Drug
Control Number: 193864
DIN(s): 02462850, 02462869, 02462877
Manufacturer: Sandoz Canada Inc.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2016-04-18
Issued / Original Publication Date: 2017-08-03
Decision / Authorization Date: 2017-04-06
Updated Date: 2024-04-24
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00129
… treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumours express programmed death ligand … was the decision issued? Metastatic Non-Small Cell Lung Cancer (NSCLC) is a serious and life-threatening disease. …
Product Type: Drug
Control Number: 186275
Manufacturer: Merck Canada Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2015-07-16
Decision / Authorization Date: 2016-04-15
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00345
… 28 (71%) underwent liver transplantation, for cirrhosis or cancer (13 patients), acute hepatic failure (2) or …
Product Type: Drug
Control Number: 193770
DIN(s): 02458616, 02458624, 02458632
Manufacturer: Cycle Pharmaceuticals Ltd.
Submission Type: New Drug Submission (New Active Substance) - Priority Review
Date Filed / Submission Date: 2016-04-05
Issued / Original Publication Date: 2017-02-17
Decision / Authorization Date: 2016-11-04
Updated Date: 2025-07-30
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SSR00075
… combination with two other drugs, is used to treat breast cancer that has spread to other parts of the body. This … other treatments, is used to treat patients with breast cancer that has spread to other parts of the body. Perjeta …
Issued / Original Publication Date: 2016-04-04
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00085
… Mantle Cell Lymphoma patients. However, non-melanoma skin cancer was identified as a new risk associated with …
Product Type: Drug
Control Number: 183766
Manufacturer: Janssen Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2015-04-16
Decision / Authorization Date: 2016-03-31
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00354
… locally advanced or metastatic squamous non-small cell lung cancer who have not received prior chemotherapy for this … locally advanced or metastatic squamous non-small cell lung cancer who have not received prior chemotherapy for this … locally advanced or metastatic squamous non-small cell lung cancer (NSCLC) who have not received prior chemotherapy for …
Product Type: Drug
Control Number: 193689
Manufacturer: Eli Lilly Canada Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2016-03-29
Issued / Original Publication Date: 2017-05-16
Decision / Authorization Date: 2017-03-16
Updated Date: 2024-06-10
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00410
… of serious heart-related problems, fatal blood clots and cancer ) for the general public and health professionals. … risks of serious heart-related problems, blood clots, cancer and death ). SNDS # 260967 2022-02-02 Issued NOC … events (MACE, serious heart-related problems), malignancy (cancer), and thrombosis (blood clots). Application # 252683 …
Product Type: Drug
Control Number: 193687
DIN(s): 02480018, 02544768
Manufacturer: Eli Lilly Canada Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2016-03-29
Issued / Original Publication Date: 2018-12-17
Decision / Authorization Date: 2018-08-17
Updated Date: 2025-01-31
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00082
… growth factor receptor 2 (HER2)-negative advanced breast cancer as initial endocrine-based therapy for their … growth factor receptor 2 (HER2)-negative advanced breast cancer in the first line setting is currently ongoing. … patients with hormone-receptor-positive metastatic breast cancer who had progression of disease during prior endocrine …
Product Type: Drug
Control Number: 182048
DIN(s): 02453150, 02453169, 02453177
Manufacturer: Pfizer Canada Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2015-02-12
Decision / Authorization Date: 2016-03-16