Review decisions
Showing 440 results of 688 total
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00371
… (Assessing the potential risk of new or returning liver cancer named hepatocellular carcinoma). SNDS # 227240 …
Product Type: Drug
Control Number: 202233
DIN(s): 02467550, 02522470
Manufacturer: AbbVie Corporation
Submission Type: New Drug Submission
Issued / Original Publication Date: 2017-12-07
Updated Date: 2022-11-15
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00400
… of patients with metastatic castration sensitive prostate cancer. The submission was reviewed and considered … patients with non-metastatic castration-resistant prostate cancer at high risk of developing metastases. 1 What was … patients with non-metastatic castration-resistant prostate cancer. Erleada has not been studied in patients with …
Product Type: Drug
Control Number: 211942
DIN(s): 02478374, 02540185
Manufacturer: Janssen Inc.
Submission Type: New Drug Submission (New Active Substance) - Priority Review
Date Filed / Submission Date: 2017-12-07
Issued / Original Publication Date: 2018-08-27
Decision / Authorization Date: 2018-07-03
Updated Date: 2025-06-13
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SSR00179
… type of non-Hodgkin lymphoma. Non-Hodgkin lymphoma is a cancer that originates from lymphatic cells, which are part … system (the system that fights infections). It is not a cancer of the breast tissue. It is usually in the form of a …
Issued / Original Publication Date: 2017-11-24
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00330
… (everolimus) is an antineoplastic product with a number of cancer-related indications such as advanced breast cancer, neuroendocrine tumours of GI, lung, or pancreas in … agent. Currently in Canada, everolimus has multiple cancer-related indications. To support the proposed seizure …
Product Type: Drug
Control Number: 200814
Manufacturer: Novartis Pharmaceuticals Canada Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2016-12-01
Decision / Authorization Date: 2017-11-17
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00402
… and efflux transporters P-glycoprotein (P-gp) and breast cancer resistance protein (BCRP). The pharmacologically …
Product Type: Drug
Control Number: 211292
DIN(s): 02478080
Manufacturer: Vertex Pharmaceuticals Inc.orporated
Submission Type: New Drug Submission (New Active Substance) - Priority Review
Date Filed / Submission Date: 2017-11-17
Issued / Original Publication Date: 2018-09-06
Decision / Authorization Date: 2018-06-27
Updated Date: 2025-03-26
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00452
… hormonal treatment of locally advanced or metastatic breast cancer in postmenopausal women, regardless of age, who have … the current approved indication in the treatment of breast cancer in postmenopausal women following prior anti-estrogen … 2 (HER2)- negative locally advanced or metastatic breast cancer in postmenopausal women not previously treated with …
Product Type: Drug
Control Number: 201150
Manufacturer: AstraZeneca Canada Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2016-12-13
Decision / Authorization Date: 2017-11-08
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00437
… that safinamide transiently inhibits intestinal breast cancer resistance protein (BCRP) and based on clinical drug … for the transporters P-glycoprotein (P-gp), breast cancer resistance protein (BCRP), OATP1B1, OATP1B3, OATP1A2 …
Product Type: Drug
Control Number: 207115
DIN(s): 02484641, 02484668
Manufacturer: Valeo Pharma Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2017-11-08
Issued / Original Publication Date: 2019-07-03
Decision / Authorization Date: 2019-01-10
Updated Date: 2025-07-23
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00473
… treatment of patients with HER2-positive metastatic breast cancer who have not received prior anti-HER2 therapy or … growth factor receptor 2 (HER2)-positive metastatic breast cancer. The market authorization was based on the quality … relating to the following conditions: Early Breast Cancer Herzuma (trastuzumab) is indicated for the treatment …
Product Type: Drug
Control Number: 210238
DIN(s): 02480794, 02506211
Manufacturer: Celltrion Healthcare Co., Ltd.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2017-10-24
Issued / Original Publication Date: 2020-04-29
Decision / Authorization Date: 2019-09-03
Updated Date: 2024-02-08
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00367
… (Assessing the potential risk of new or returning liver cancer named hepatocellular carcinoma). Summary Safety …
Product Type: Drug
Control Number: 202324
DIN(s): 02467542
Manufacturer: Gilead Sciences Canada Inc.
Submission Type: New Drug Submission
Issued / Original Publication Date: 2017-10-17
Updated Date: 2022-11-07
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00415
… kinase (ALK)-positive metastatic non-small cell lung cancer (NSCLC) who have progressed on or who were intolerant … to curative therapy) or metastatic non-small cell lung cancer (NSCLC). The submission was reviewed and considered … 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 (New Active Substance)
Date Filed / Submission Date: 2017-10-17
Issued / Original Publication Date: 2019-01-28
Decision / Authorization Date: 2018-07-26
Updated Date: 2025-02-05