Review decisions
Showing 90 results of 342 total
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00581
… sickle cell disease, neurodevelopmental disorders, active cancer, and medically related technological dependence. … 0.20 e/100 PY were COVID-19 (0.37 e/100 PY) and prostate cancer (0.28 e/100 PY) in participants who received …
Product Type: Drug
Control Number: 255370
DIN(s): 02525364
Manufacturer: Novavax Inc.
Submission Type: New Drug Submission (New Active Substance) (COVID-19)
Date Filed / Submission Date: 2021-08-27
Issued / Original Publication Date: 2022-04-08
Decision / Authorization Date: 2022-02-17
Updated Date: 2024-07-19
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00631
… (by 80%). Although ubrogepant is a substrate for breast cancer resistant protein (BCRP) and P-glycoprotein (P-gp), … to be a substrate for P-glycoprotein (P-gp), breast cancer resistant protein (BCRP), OATP1B1, OATP1B3, and …
Product Type: Drug
Control Number: 256191
DIN(s): 02532530, 02532581
Manufacturer: AbbVie Corporation
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2021-08-27
Issued / Original Publication Date: 2023-03-30
Decision / Authorization Date: 2022-11-10
Updated Date: 2026-01-06
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD1691500592141
… in patients with insomnia, or with rosuvastatin, a breast cancer resistance protein substrate. Similarly, no …
Product Type: Drug
Control Number: 255507
DIN(s): 02537435, 02537443
Manufacturer: Idorsia Pharmaceuticals Ltd
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2021-08-25
Issued / Original Publication Date: 2023-08-04
Decision / Authorization Date: 2023-04-28
Updated Date: 2025-10-09
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00602
… advanced unresectable or metastatic non‑small cell lung cancer (NSCLC) harbouring mesenchymal‑epithelial transition … advanced unresectable or metastatic non‑small cell lung cancer (NSCLC) harbouring mesenchymal‑epithelial transition … advanced unresectable or metastatic non‑small cell lung cancer (NSCLC) harbouring mesenchymal‑epithelial transition …
Product Type: Drug
Control Number: 255972
DIN(s): 02527391, 02527405
Manufacturer: Novartis Pharmaceuticals Canada Inc.
Submission Type: New Drug Submission (New Active Substance) - Notice of Compliance with Conditions
Date Filed / Submission Date: 2021-08-20
Issued / Original Publication Date: 2022-08-30
Decision / Authorization Date: 2022-05-26
Updated Date: 2026-02-02
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00582
… sickle cell disease, neurodevelopmental disorders, active cancer, and medically related technological dependence. …
Product Type: Drug
Control Number: 254598
Manufacturer: Medicago Inc.
Submission Type: New Drug Submission (New Active Substance) (COVID-19)
Date Filed / Submission Date: 2021-08-09
Issued / Original Publication Date: 2022-04-11
Decision / Authorization Date: 2022-02-24
Updated Date: 2023-05-26
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00616
… disease is a rare autosomal dominant hereditary cancer syndrome with an estimated incidence of one in 36,000 … project is an international partnership designed to give cancer patients faster access to promising cancer treatments. The NDS for Welireg was classified as a …
Product Type: Drug
Control Number: 254495
DIN(s): 02528908
Manufacturer: Merck Canada Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2021-07-09
Issued / Original Publication Date: 2022-12-20
Decision / Authorization Date: 2022-07-11
Updated Date: 2026-02-16
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00608
… least one prior therapy. Multiple myeloma is a hematologic cancer characterized by proliferation of clonal plasma cells … oncoproteins such as c-Myc and cyclin D1, and apoptosis of cancer cells. The combination of selinexor and dexamethasone … has a linear pharmacokinetics that is not affected by cancer type. Selinexor exhibited dose-proportional exposures …
Product Type: Drug
Control Number: 253182
DIN(s): 02527677
Manufacturer: FORUS Therapeutics Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2021-05-28
Issued / Original Publication Date: 2022-10-12
Decision / Authorization Date: 2022-05-31
Updated Date: 2023-07-17
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00610
… of P‑glycoprotein (P‑gp), and is not an inhibitor of breast cancer resistance protein (BCRP). No dose reductions for …
Product Type: Drug
Control Number: 252301
DIN(s): 02527693
Manufacturer: BioCryst Pharmaceuticals, Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2021-04-30
Issued / Original Publication Date: 2022-10-19
Decision / Authorization Date: 2022-06-02
Updated Date: 2025-06-25
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00573
… with unresectable locally advanced or metastatic urothelial cancer (mUC) with no prior systemic therapy for mUC. The … with unresectable locally advanced or metastatic urothelial cancer who have previously received a platinum-containing … with unresectable locally advanced or metastatic urothelial cancer who have previously received a platinum-containing …
Product Type: Drug
Control Number: 251438
DIN(s): 02521903, 02521911
Manufacturer: Seagen Inc.
Submission Type: New Drug Submission (New Active Substance) - Priority Review
Date Filed / Submission Date: 2021-04-06
Issued / Original Publication Date: 2022-02-04
Decision / Authorization Date: 2021-10-29
Updated Date: 2025-06-18
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00548
… obesity, heart disease, chronic kidney disease, diabetes, cancer, and pulmonary obstructive disease. In addition, the …
Product Type: Drug
Control Number: 251285
DIN(s): 02518341
Manufacturer: GlaxoSmithKline Canada Inc.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2021-04-01
Issued / Original Publication Date: 2021-09-10
Decision / Authorization Date: 2021-07-30
Updated Date: 2024-07-19