Review decisions
Showing 180 results of 342 total
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00416
… Yescarta, and Carvykti related to T-cell malignancy (cancer that forms in white blood cells called T cells). SNDS … Kymriah (tisagenlecleucel) is an autologous, immunocellular cancer therapy which involves reprogramming a patient's own … SCT while in remission, and 6 patients received new anti-cancer therapy (including additional CD19 chimeric antigen …
Product Type: Drug
Control Number: 213547
DIN(s): 02480514
Manufacturer: Novartis Pharmaceuticals Canada Inc.
Submission Type: New Drug Submission (New Active Substance) - Priority Review
Date Filed / Submission Date: 2018-02-09
Issued / Original Publication Date: 2019-02-08
Decision / Authorization Date: 2018-09-05
Updated Date: 2025-02-28
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00462
… treatment of patients with HER2-positive metastatic breast cancer who have not received prior anti-HER2 therapy or … (which include relevant caveat statements): Early Breast Cancer For detailed information on the inclusion criteria … for the clinical trials of trastuzumab in early breast cancer according to the TNM (Tumour, Node, Metastasis) …
Product Type: Drug
Control Number: 212140
DIN(s): 02483467, 02483475
Manufacturer: Pfizer Canada ULC
Submission Type: New Drug Submission
Date Filed / Submission Date: 2017-12-15
Issued / Original Publication Date: 2020-02-04
Decision / Authorization Date: 2019-08-15
Updated Date: 2024-08-12
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00428
… diagnosed by five years of age. According to the Canadian Cancer Society (CCS), approximately 380 children in the age … of dinutuximab manufactured by the United States National Cancer Institute (NCI) and dinutuximab manufactured by … dinutuximab, manufactured by the United States National Cancer Institute (NCI) and dinutuximab, manufactured by …
Product Type: Drug
Control Number: 212066
DIN(s): 02483076
Manufacturer: United Therapeutics Corporation
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2017-12-14
Issued / Original Publication Date: 2019-05-06
Decision / Authorization Date: 2018-11-28
Updated Date: 2024-03-01
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/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/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