Review decisions
Showing 450 results of 688 total
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00324
… and repeat courses of highly and moderately emetogenic cancer chemotherapy. Why was the decision issued? The … nausea and vomiting associated with highly emetogenic cancer chemotherapy. Briefly, statistical superiority of the … with no emetic episodes and no use of rescue medication. Cancer patients were chemotherapy naïve patients and …
Product Type: Drug
Control Number: 196495
DIN(s): 02468735
Manufacturer: Purdue Pharma
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2016-10-13
Decision / Authorization Date: 2017-09-28
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00290
… perforations and necrotizing colitis, risk of skin cancer due to photosensitivity, and uncertainty regarding …
Product Type: Drug
Control Number: 199259
Manufacturer: Aspen Pharmacare Canada Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2016-10-13
Decision / Authorization Date: 2017-09-21
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00403
… bilirubin events were more common than in the colorectal cancer (CRC) and gastrointestinal stromal tumors (GIST) …
Product Type: Drug
Control Number: 203322
Manufacturer: Bayer Inc.
Submission Type: Supplement to a New Drug Submission - Priority Review
Date Filed / Submission Date: 2017-02-28
Decision / Authorization Date: 2017-09-18
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00299
… with HCV and HBV, and an increase in cases of early liver cancer recurrence. The latter is postulated to be based on a …
Product Type: Drug
Control Number: 199753
Manufacturer: Gilead Sciences Canada Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2016-10-27
Decision / Authorization Date: 2017-09-14
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00289
… of the indication for Stivarga for metastatic colorectal cancer (mCRC) to change the "KRAS wild type" specification … approved for use in patients with metastatic colorectal cancer (mCRC) and metastatic gastrointestinal stromal tumors …
Product Type: Drug
Control Number: 199667
Manufacturer: Bayer Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2016-10-25
Decision / Authorization Date: 2017-08-29
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00480
… 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 … biologic drug for the following indications: Early breast cancer Kanjinti (trastuzumab) is indicated for the treatment …
Product Type: Drug
Control Number: 208836
DIN(s): 02496690, 02518244
Manufacturer: Amgen Canada Inc.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2017-08-29
Issued / Original Publication Date: 2020-06-15
Decision / Authorization Date: 2020-02-27
Updated Date: 2024-02-15
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00285
… patients with ROS-1 positive advanced non-small cell lung cancer (NSCLC), to provide the final overall-survival and …
Product Type: Drug
Control Number: 198322
DIN(s): 02384256
Manufacturer: Pfizer Canada Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2016-09-14
Decision / Authorization Date: 2017-08-28
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00281
… the risk of infections/opportunistic infections and breast cancer. Other safety concerns include depression, …
Product Type: Drug
Control Number: 198094
DIN(s): 02467224
Manufacturer: Hoffmann-La Roche Ltd.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2016-09-16
Decision / Authorization Date: 2017-08-14
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00273
… both men (41%) and women (59%) with various forms of cancer who were being treated with MEC. The results of the … in the sponsors clinical trial database. Finally, the cancer care treatment guidelines do not distinguish between … and anthrocycline-based treatments in women with breast cancer. Taken together, there appears to be no reason to …
Product Type: Drug
Control Number: 197185
Manufacturer: Merck Canada Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2016-08-05
Decision / Authorization Date: 2017-07-26
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00427
… type 1 (RFC-1), a protein that is overexpressed on certain cancer cells compared to normal cells. In addition, … type 1 (RFC-1), a protein that is overexpressed on certain cancer cells compared to normal cells. Pralatrexate … deoxyribonucleic acid replication in dividing cells and to cancer growth inhibition and apoptosis. The recommended dose …
Product Type: Drug
Control Number: 207545
DIN(s): 02481820, 02481855
Manufacturer: Servier Canada Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2017-07-18
Issued / Original Publication Date: 2019-04-29
Decision / Authorization Date: 2018-10-26
Updated Date: 2025-05-13