Review decisions
Showing 190 results of 342 total
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/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
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00419
… remodeling, drug resistance, and metastatic progression of cancer. Cabozantinib was evaluated for its inhibitory … was originally developed as a treatment for thyroid cancer; several studies included in this submission were … also observed in mouse xenograft models of human thyroid cancer, lung cancer and breast cancer, as well as in a rat …
Product Type: Drug
Control Number: 206230
DIN(s): 02480824, 02480832, 02480840
Manufacturer: Ipsen Biopharmaceuticals Canada Inc.
Submission Type: New Drug Submission (New Active Substance) - Priority Review
Date Filed / Submission Date: 2017-06-06
Issued / Original Publication Date: 2019-02-12
Decision / Authorization Date: 2018-09-14
Updated Date: 2025-07-10
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00456
… progestin-dependent malignant neoplasia (e.g. endometrial cancer); endometrial hyperplasia; known, suspected, or past history of breast cancer (Tibella increased the risk of breast cancer recurrence in placebo-controlled trials); undiagnosed …
Product Type: Drug
Control Number: 206099
DIN(s): 02488361
Manufacturer: Biosyent Pharma Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2017-06-01
Issued / Original Publication Date: 2020-01-07
Decision / Authorization Date: 2019-05-10
Updated Date: 2025-03-25
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00389
… for the treatment of adult patients with metastatic gastric cancer or adenocarcinoma of the gastroesophageal junction, … the treatment of adult patients with metastatic colorectal cancer who have been previously treated with, or are not … the treatment of adult patients with metastatic colorectal cancer who have been previously treated with, or are not …
Product Type: Drug
Control Number: 205852
DIN(s): 02472104, 02472112
Manufacturer: Taiho Pharma Canada Inc.
Submission Type: New Drug Submission (New Active Substance) - Priority Review
Date Filed / Submission Date: 2017-05-30
Issued / Original Publication Date: 2018-04-06
Decision / Authorization Date: 2018-01-25
Updated Date: 2023-08-14
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00396
… favourable benefit-risk profile for the treatment of cancer patients with non-myeloid malignancies undergoing … active-controlled study in patients with early breast cancer receiving docetaxel, doxorubicin, and cyclophosphamide (the TAC regimen) anticancer chemotherapy in the adjuvant setting. No clinically …
Product Type: Drug
Control Number: 204841
DIN(s): 02474565, 02529343
Manufacturer: Apotex Inc.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2017-04-21
Issued / Original Publication Date: 2018-07-06
Decision / Authorization Date: 2018-04-05
Updated Date: 2025-02-25
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00448
… 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 Ogivri (trastuzumab) is indicated for the treatment …
Product Type: Drug
Control Number: 204579
DIN(s): 02474425, 02474433
Manufacturer: BGP Pharma ULC
Submission Type: New Drug Submission
Date Filed / Submission Date: 2017-04-18
Issued / Original Publication Date: 2019-10-23
Decision / Authorization Date: 2019-05-03
Updated Date: 2024-02-13
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00373
… efflux transporters P-glycoprotein (P-gp) and breast cancer resistance protein (BCRP), hepatic uptake …
Product Type: Drug
Control Number: 204165
DIN(s): 02469367, 02469375, 02469383, 02469405
Manufacturer: Merck Canada Inc.
Submission Type: New Drug Submission (New Active Substance) - Priority Review
Date Filed / Submission Date: 2017-04-10
Issued / Original Publication Date: 2018-06-04
Decision / Authorization Date: 2017-11-01
Updated Date: 2025-07-09
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00385
… has been demonstrated in a syngeneic mouse model of colon cancer. The toxicity of avelumab was evaluated in cynomolgus …
Product Type: Drug
Control Number: 204052
DIN(s): 02469723
Manufacturer: EMD Serono, A division of EMD Inc. Canada
Submission Type: New Drug Submission (New Active Substance) - Notice of Compliance with Conditions
Date Filed / Submission Date: 2017-03-23
Issued / Original Publication Date: 2018-03-09
Decision / Authorization Date: 2017-12-08
Updated Date: 2025-06-04
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00395
… receptor 2 (HER2)-negative advanced or metastatic breast cancer, as initial endocrine-based therapy. In … HR-positive, HER2-negative advanced or metastatic breast cancer, as initial endocrine-based therapy or following … receptor 2 (HER2)-negative advanced or metastatic breast cancer, as initial endocrine-based therapy; In …
Product Type: Drug
Control Number: 203884
DIN(s): 02473569
Manufacturer: Novartis Pharmaceuticals Canada Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2017-03-17
Issued / Original Publication Date: 2018-06-18
Decision / Authorization Date: 2018-03-02
Updated Date: 2024-12-20