Review decisions
Showing 400 results of 688 total
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00442
… Yescarta, and Carvykti related to T-cell malignancy (cancer that forms in white blood cells called T cells). SNDS …
Product Type: Drug
Control Number: 218389
DIN(s): 02485648
Manufacturer: Gilead Sciences Canada Inc.
Submission Type: New Drug Submission (New Active Substance) - Priority Review
Date Filed / Submission Date: 2018-07-23
Issued / Original Publication Date: 2019-08-15
Decision / Authorization Date: 2019-02-13
Updated Date: 2026-03-16
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00461
… with metastatic HER2-overexpressed/amplified breast cancer, who have received two or more prior anti-HER2-based … factor receptor 2 (HER2)-overexpressed/amplified breast cancer within one year after completion of trastuzumab-based … factor receptor (HER2)-overexpressed/amplified breast cancer within one year after completion of trastuzumab-based …
Product Type: Drug
Control Number: 218224
DIN(s): 02490536
Manufacturer: Puma Biotechnology Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2018-07-19
Issued / Original Publication Date: 2020-01-29
Decision / Authorization Date: 2019-07-16
Updated Date: 2023-12-07
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00439
… a recommendation for using caution and monitoring for cancer progression during and after use of Oxervate in … a recommendation for using caution and monitoring for cancer progression during and after use of Oxervate in …
Product Type: Drug
Control Number: 218145
DIN(s): 02485613
Manufacturer: Dompé farmaceutici S.p.A.
Submission Type: New Drug Submission (New Active Substance) - Priority Review
Date Filed / Submission Date: 2018-07-16
Issued / Original Publication Date: 2019-07-24
Decision / Authorization Date: 2019-02-08
Updated Date: 2024-12-16
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00449
… include relevant caveat statements): Metastatic Colorectal Cancer Zirabev in combination with fluoropyrimidine-based … given to current standard of care guidelines for colorectal cancer. See Drug-Drug Interactions section of the Zirabev … Advanced, Metastatic or Recurrent Non-Small Cell Lung Cancer Zirabev, in combination with carboplatin/paclitaxel …
Product Type: Drug
Control Number: 218183
DIN(s): 02489430, 02489449
Manufacturer: Pfizer Canada ULC., on behalf of BioNTech Manufacturing GmbH
Submission Type: New Drug Submission
Date Filed / Submission Date: 2018-07-13
Issued / Original Publication Date: 2019-11-15
Decision / Authorization Date: 2019-06-14
Updated Date: 2024-03-08
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00392
… treatment of patients with castration-resistant prostate cancer who have no detectable distant metastases by either … patients with non-metastatic castration-resistant prostate cancer (NM-CRPC). This NDS was granted priority review …
Product Type: Drug
Control Number: 211942
DIN(s): 02478374
Manufacturer: Janssen Inc.
Submission Type: New Drug Submission (New Active Substance) - Priority Review
Date Filed / Submission Date: 2017-12-07
Decision / Authorization Date: 2018-07-03
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00543
… include relevant caveat statements): Metastatic Colorectal Cancer Zirabev in combination with fluoropyrimidine-based … given to current standard of care guidelines for colorectal cancer. See Drug-Drug Interactions section of the Zirabev … Advanced, Metastatic or Recurrent Non-Small Cell Lung Cancer Zirabev, in combination with carboplatin/paclitaxel …
Product Type: Drug
Control Number: 217524
DIN(s): 02489430, 02489449
Manufacturer: Pfizer Canada ULC., on behalf of BioNTech Manufacturing GmbH
Submission Type: New Drug Submission
Date Filed / Submission Date: 2018-06-22
Issued / Original Publication Date: 2021-07-21
Decision / Authorization Date: 2021-01-05
Updated Date: 2024-03-08
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00433
… designed to deliver cytotoxic levels of radiation to cancer cells that overexpress specific receptors. The …
Product Type: Drug
Control Number: 217184
DIN(s): 02484552
Manufacturer: Advanced Accelerator Applications USA, Inc.
Submission Type: New Drug Submission (New Active Substance) - Priority Review
Date Filed / Submission Date: 2018-06-18
Issued / Original Publication Date: 2019-05-29
Decision / Authorization Date: 2019-01-09
Updated Date: 2024-03-11
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00441
… is also an inhibitor of P-glycoprotein (P-gp), Breast Cancer Resistance Protein (BCRP), organic anion transporter … favorable-risk status according to National Comprehensive Cancer Network (NCCN) Guidelines (NCCN, 2015). … for therapeutics indicated for the treatment of advanced cancer. Non-clinical pharmacology Enasidenib targets the …
Product Type: Drug
Control Number: 217033
DIN(s): 02485427, 02485435
Manufacturer: Celgene Inc.
Submission Type: New Drug Submission (New Active Substance) - Priority Review
Date Filed / Submission Date: 2018-06-15
Issued / Original Publication Date: 2019-08-19
Decision / Authorization Date: 2019-02-06
Updated Date: 2024-06-13
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SSR00202
… Imatinib is a drug authorized for sale in Canada to treat cancer (chemotherapy). It is used to treat several solid tumours or blood cancers. Health Canada reviewed the potential risk of tendon … to a bone. Use in Canada Imatinib belongs to a class of cancer drugs called tyrosine kinase inhibitors. It is used …
Issued / Original Publication Date: 2018-06-08
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00387
… locally advanced or metastatic non-small cell lung cancer. Why was the decision issued? In this submission, … to curative therapy) or metastatic non-small cell lung cancer (NSCLC) based on results of study A2301 (ASCEND-4), a …
Product Type: Drug
Control Number: 205116
Manufacturer: Novartis Pharmaceuticals Canada Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2017-05-04
Decision / Authorization Date: 2018-06-06