Review decisions
Showing 110 results of 688 total
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD1744723057257
… Momelotinib may increase the exposure of sensitive breast cancer resistance protein (BCRP) substrates, which may …
Product Type: Drug
Control Number: 281695
DIN(s): 02552965, 02552973, 02552981
Manufacturer: GlaxoSmithKline Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2023-11-30
Issued / Original Publication Date: 2025-04-14
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1700599569568
… (dMMR)/microsatellite instability-high (MSI-H) endometrial cancer. After evaluation of the submitted data package, … (dMMR)/microsatellite instability-high (MSI-H) endometrial cancer who are candidates for systemic therapy. This was a … primary advanced (Stage III-IV) or recurrent endometrial cancer (EC). The efficacy and safety results supporting the …
Product Type: Drug
Control Number: 274515
DIN(s): 02523434
Manufacturer: GlaxoSmithKline Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2023-04-19
Decision / Authorization Date: 2023-11-15
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD1744035408183
… of modern healthcare, including surgeries, transplants, and cancer treatments. In 2018, approximately one million …
Product Type: Drug
Control Number: 280730
DIN(s): 02554151
Manufacturer: Xediton Pharmaceuticals Inc.
Submission Type: New Drug Submission (New Active Substance) - Priority Review
Date Filed / Submission Date: 2023-11-03
Issued / Original Publication Date: 2025-04-04
Decision / Authorization Date: 2024-12-20
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1699385708073
… viral/transgene DNA to offspring. Patients at risk of liver cancer should be followed closely for five years following …
Product Type: Drug
Control Number: 273721
DIN(s): 02542560
Manufacturer: CSL Behring Canada Inc.
Submission Type: New Drug Submission (New Active Substance) - Priority Review
Date Filed / Submission Date: 2023-03-27
Decision / Authorization Date: 2023-10-23
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD1740491309253
… serious health risks, notably the potential for endometrial cancer with unopposed estrogen therapy and breast cancer with combined estrogen and progestin therapy. … two cases of endometrial adenocarcinoma, two cases of colon cancer, one case of malignant melanoma in situ , one case of …
Product Type: Drug
Control Number: 280470
DIN(s): 02553600
Manufacturer: Astellas Pharma Canada, Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2023-11-01
Issued / Original Publication Date: 2025-02-24
Decision / Authorization Date: 2024-12-02
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD1742837642143
… use has not been authorized. Of the 930 patients with cancer who received pegfilgrastim in clinical studies, …
Product Type: Drug
Control Number: 273871
DIN(s): 02553945
Manufacturer: JAMP Pharma Corporation
Submission Type: New Drug Submission
Date Filed / Submission Date: 2023-10-18
Issued / Original Publication Date: 2025-03-23
Decision / Authorization Date: 2024-12-13
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD1750434053010
… to myocardial infarction, and one due to small cell lung cancer. All six deaths were assessed as not related to … to myocardial infarction, and one due to small cell lung cancer. All six deaths were assessed as not related to …
Product Type: Drug
Control Number: 274979
Manufacturer: UCB Canada Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2023-10-06
Issued / Original Publication Date: 2025-06-19
Decision / Authorization Date: 2025-03-28
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD1741184642625
… headaches current diagnosis of, or history of, breast cancer, which may be hormone-sensitive liver tumors, acute …
Product Type: Drug
Control Number: 279315
DIN(s): 02554070
Manufacturer: Duchesnay Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2023-09-20
Issued / Original Publication Date: 2025-03-05
Decision / Authorization Date: 2024-12-18
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD1734969149034
… the treatment of adult patients with metastatic colorectal cancer (mCRC) who have been previously treated with or are … the treatment of adult patients with metastatic colorectal cancer (mCRC) who have been previously treated with or are … the treatment of adult patients with metastatic colorectal cancer (mCRC) who have been previously treated with or are …
Product Type: Drug
Control Number: 275803
DIN(s): 02551454, 02551462
Manufacturer: Takeda Canada Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2023-09-14
Issued / Original Publication Date: 2024-12-19
Decision / Authorization Date: 2025-01-02
Updated Date: 2025-01-02
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1696430838362
… with locally advanced or metastatic non-small cell lung cancer (NSCLC) whose tumors have epidermal growth factor … from randomisation to second progression on subsequent anti-cancer treatment or death (PFS2), time from randomisation to …
Product Type: Drug
Control Number: 211762
DIN(s): 02456214, 02456222
Manufacturer: AstraZeneca Canada Inc.
Submission Type: Supplement to a New Drug Submission - Priority Review
Date Filed / Submission Date: 2017-02-13
Decision / Authorization Date: 2018-07-10