Review decisions
Showing 60 results of 342 total
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD1729522137894
… myeloma and in patients with bone metastases from breast cancer, prostate cancer, non-small cell lung cancer, and other solid tumours. Treatment of adults and …
Product Type: Drug
Control Number: 267788
DIN(s): 02545764
Manufacturer: Sandoz Canada Inc.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2023-01-27
Issued / Original Publication Date: 2024-10-17
Decision / Authorization Date: 2024-03-01
Updated Date: 2024-10-17
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD1729523262756
… to increase bone mass in men with nonmetastatic prostate cancer receiving androgen-deprivation therapy, who are at … to increase bone mass in women with nonmetastatic breast cancer receiving adjuvant aromatase-inhibitor therapy, who … to increase bone mass in men with nonmetastatic prostate cancer receiving androgen-deprivation therapy, who are at …
Product Type: Drug
Control Number: 271806
DIN(s): 02545411
Manufacturer: Sandoz Canada Inc.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2023-01-27
Issued / Original Publication Date: 2024-10-17
Decision / Authorization Date: 2024-02-16
Updated Date: 2024-10-17
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD1708102173051
… for the treatment of adult patients with advanced prostate cancer. 1 What was approved? Orgovyx, a … for the treatment of adult patients with advanced prostate cancer. Orgovyx is not authorized for use in pediatric … for the treatment of adult patients with advanced prostate cancer. Excluding non-melanoma skin cancers, prostate cancer …
Product Type: Drug
Control Number: 269372
DIN(s): 02542137
Manufacturer: Sumitomo Pharma Switzerland GmbH
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2022-11-03
Issued / Original Publication Date: 2024-02-16
Decision / Authorization Date: 2023-10-10
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD1695302358644
… incurable disease representing approximately 1.6% of new cancers with about 3,800 new cases and 1,600 deaths from MM annually. Multiple myeloma is a cancer of plasma cells. The malignant plasma cells produce … project is an international partnership designed to give cancer patients faster access to promising cancer …
Product Type: Drug
Control Number: 269369
DIN(s): 02539756, 02539764
Manufacturer: Janssen Inc.
Submission Type: New Drug Submission (New Active Substance) - Notice of Compliance with Conditions
Date Filed / Submission Date: 2022-11-02
Issued / Original Publication Date: 2023-09-20
Decision / Authorization Date: 2023-07-26
Updated Date: 2025-05-21
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD1721405092068
… events, 7 malignancies excluding non‑melanoma skin cancer, 4 cases of peripheral neuropathies, and 15 cases of … events, 7 malignancies excluding non‑melanoma skin cancer, 4 cases of peripheral neuropathies, and 15 cases of …
Product Type: Drug
Control Number: 268723
DIN(s): 02543532
Manufacturer: Pfizer Canada ULC
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2022-10-14
Issued / Original Publication Date: 2024-07-18
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD1688741986480
… is unlikely to be a p-glycoprotein (P-gp) or breast cancer resistance protein (BCRP) substrate. Setmelanotide …
Product Type: Drug
Control Number: 268412
DIN(s): 02537745
Manufacturer: Rhythm Pharmaceuticals, Inc.
Submission Type: New Drug Submission (New Active Substance) - Priority Review
Date Filed / Submission Date: 2022-10-04
Issued / Original Publication Date: 2023-07-07
Decision / Authorization Date: 2023-05-05
Updated Date: 2024-11-20
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD1718207489396
… Acute lymphoblastic leukemia is the most commonly diagnosed cancer in children. With contemporary treatments, the … two weeks (Q2W; n = 116) as a component of the Dana Farber Cancer Institute ALL consortium regimen. In Study AALL07P4, … in both studies. Study DFCI 11-001 was a Dana Farber Cancer Institute (DFCI) cooperative group study. Patients …
Product Type: Drug
Control Number: 268282
DIN(s): 02542943
Manufacturer: Servier Canada Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2022-09-29
Issued / Original Publication Date: 2024-06-11
Decision / Authorization Date: 2023-11-08
Updated Date: 2025-04-03
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00617
… sickle cell disease, neurodevelopmental disorders, active cancer, and medically related technological dependence. … adverse reactions. Two serious adverse events (prostate cancer and traumatic fracture) were reported in Spikevax …
Product Type: Drug
Control Number: 267589
DIN(s): 02532352
Manufacturer: Moderna Biopharma Canada Corporation
Submission Type: New Drug Submission (New Active Substance) (COVID-19)
Date Filed / Submission Date: 2022-09-12
Issued / Original Publication Date: 2023-01-05
Decision / Authorization Date: 2022-11-03
Updated Date: 2024-05-17
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00612
… sickle cell disease, neurodevelopmental disorders, active cancer, and medically related technological dependence. … BA.1 group, as well as dehydration, prostate cancer, and nephrolithiasis in a group receiving a different …
Product Type: Drug
Control Number: 267502
DIN(s): 02531461, 02533197, 02541025
Manufacturer: BioNTech Manufacturing GmbH
Submission Type: New Drug Submission (New Active Substance) (COVID-19)
Date Filed / Submission Date: 2022-09-02
Issued / Original Publication Date: 2022-12-05
Decision / Authorization Date: 2022-10-07
Updated Date: 2024-09-20
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD1712172719912
… osteoporosis; have known, suspected, or history of breast cancer or other hormone-sensitive malignancies (e.g. endometrial cancer), or with increased risk for hormone-sensitive … (a sensitive CYP3A substrate), rosuvastatin (breast cancer resistance protein [BCRP] substrate) or dabigatran …
Product Type: Drug
Control Number: 267148
DIN(s): 02541742
Manufacturer: Sumitomo Pharma Switzerland GmbH
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2022-08-18
Issued / Original Publication Date: 2024-03-28
Decision / Authorization Date: 2023-09-22
Updated Date: 2025-01-29