Review decisions
Showing 160 results of 688 total
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/RDS01021
… of patients with metastatic castration-sensitive prostate cancer (mCSPC) in combination with docetaxel. This SNDS was … endpoints of time to castration-resistant prostate cancer, time to pain progression, symptomatic skeletal … event profile in metastatic castration-sensitive prostate cancer differed from the previously established profile of …
Product Type: Drug
Control Number: 262749
Manufacturer: Bayer Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2022-03-24
Decision / Authorization Date: 2022-09-29
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/RDS01007
… remarkable, but manageable through treatment in specialised cancer centres, close monitoring, and the use of …
Product Type: Drug
Control Number: 256106
Manufacturer: Gilead Sciences Canada Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2021-08-26
Decision / Authorization Date: 2022-09-28
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS01064
… patients with locally advanced or metastatic biliary tract cancer (BTC). This submission was granted priority review …
Product Type: Drug
Control Number: 262782
Manufacturer: AstraZeneca Canada Inc.
Submission Type: Supplement to a New Drug Submission - Priority Review
Date Filed / Submission Date: 2022-02-25
Decision / Authorization Date: 2022-09-28
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SSR00287
… stroke or cardiovascular death), blood clots (thrombosis), cancer (malignancies) and death (all-cause mortality) Key … risks of serious heart-related problems, blood clots, cancer and death with the use of Olumiant and Rinvoq. The … the risks of serious heart-related problems, blood clots, cancer and death cannot be excluded for Olumiant and Rinvoq, …
Issued / Original Publication Date: 2022-09-16
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/RDS01005
… was 66.0% (95% CI: 51, 79), assessed by the National Cancers Institute (NCI) central analysis using REiNS …
Product Type: Drug
Control Number: 243733
DIN(s): 02530139, 02530147
Manufacturer: AstraZeneca Canada Inc.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2020-09-09
Decision / Authorization Date: 2022-08-31
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00991
… (PSMA)-positive metastatic castration-resistant prostate cancer (mCRPC) who have been treated with androgen receptor … (PSMA)-positive metastatic castration-resistant prostate cancer (mCRPC) who have received at least one androgen … (PSMA)-positive metastatic castration-resistant prostate cancer who have received at least one androgen receptor …
Product Type: Drug
Control Number: 260951
DIN(s): 02530198
Manufacturer: Advanced Accelerator Applications USA, Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2022-01-28
Decision / Authorization Date: 2022-08-25