Review decisions
Showing 100 results of 688 total
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD1746714399832
… (OCT)1, or OCT2. However, a 37% inhibition effect on breast cancer resistance protein (BCRP) was detected, which is …
Product Type: Drug
Control Number: 283158
DIN(s): 02555735
Manufacturer: Biogen Canada Inc.
Submission Type: New Drug Submission (New Active Substance) - Notice of Compliance with Conditions
Date Filed / Submission Date: 2024-01-26
Issued / Original Publication Date: 2025-05-08
Decision / Authorization Date: 2025-02-28
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD1749130248379
… sickle cell disease, neurodevelopmental disorders, active cancer, and medically related technological dependence. …
Product Type: Drug
Control Number: 283047
DIN(s): 02556332
Manufacturer: AstraZeneca Canada Inc.
Submission Type: New Drug Submission (New Active Substance) (COVID-19)
Date Filed / Submission Date: 2024-01-23
Issued / Original Publication Date: 2025-06-05
Decision / Authorization Date: 2025-03-21
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD1733494552846
… and acute myeloid leukemia cells, and numerous other cancer types, while also acting in the cross talk of tumours … disease progression. Patients who received prior anti-cancer treatment, including chemotherapy or radiation … randomization to the initiation of first subsequent anticancer therapy or death due to any cause. Voranigo …
Product Type: Drug
Control Number: 282910
DIN(s): 02551225, 02551233
Manufacturer: Servier Canada Inc.
Submission Type: New Drug Submission (New Active Substance) - Priority Review
Date Filed / Submission Date: 2024-01-17
Issued / Original Publication Date: 2024-12-05
Decision / Authorization Date: 2024-08-27
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1706819201300
… Yervoy for patients with metastatic non-small cell lung cancer (NSCLC) within the Yervoy product monograph. Both the …
Product Type: Drug
Control Number: 270801
DIN(s): 02379384
Manufacturer: Bristol-Myers Squibb Canada
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2022-12-19
Decision / Authorization Date: 2023-12-07
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD1763476617645
… 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: 282455
DIN(s): 02560917
Manufacturer: Celltrion Inc.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2023-12-29
Issued / Original Publication Date: 2025-11-16
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD1763475745099
… 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: 278930
DIN(s): 02560895
Manufacturer: Celltrion Inc.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2023-12-29
Issued / Original Publication Date: 2025-11-16
Decision / Authorization Date: 2025-09-17
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1706106900025
… of patients with metastatic castration-sensitive prostate cancer (mCSPC) and the treatment of patients with non-metastatic castration-resistant prostate cancer (nmCRPC). Erleada is currently marketed in Canada as …
Product Type: Drug
Control Number: 270698
DIN(s): 02478374, 02540185
Manufacturer: Janssen Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2022-12-15
Decision / Authorization Date: 2023-08-02
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1706285264505
… in adult patients with melanoma and non-small-cell lung cancer. The majority of all-grade AEs reported in at least …
Product Type: Drug
Control Number: 270386
DIN(s): 02409623, 02409658, 02539993
Manufacturer: Novartis Pharmaceuticals Canada Inc.
Submission Type: Supplement to a New Drug Submission - Priority Review
Date Filed / Submission Date: 2022-12-05
Decision / Authorization Date: 2023-07-24
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD1740407272003
… 18.2 positive as determined by a validated test. Gastric cancer is the fifth most common cancer and the fourth leading cause of death due to cancer worldwide. In 2023, there were approximately 4,100 …
Product Type: Drug
Control Number: 282144
DIN(s): 02553996
Manufacturer: Astellas Pharma Canada, Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2023-12-15
Issued / Original Publication Date: 2024-02-19
Decision / Authorization Date: 2024-12-13
Updated Date: 2025-08-18
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD1739374529873
… of adult patients with extensive-stage small cell lung cancer (ES-SCLC) with disease progression on or after at … of adult patients with extensive-stage small cell lung cancer (ES-SCLC) with disease progression on or after at … for pediatric use. Of the 187 patients with small cell lung cancer (SCLC) who received Imdelltra at the recommended 10 …
Product Type: Drug
Control Number: 281963
DIN(s): 02551551, 02551578
Manufacturer: Amgen Canada Inc.
Submission Type: New Drug Submission (New Active Substance) - Notice of Compliance with Conditions
Date Filed / Submission Date: 2023-12-11
Issued / Original Publication Date: 2025-02-11
Decision / Authorization Date: 2024-09-11
Updated Date: 2026-02-02