Review decisions
Showing 210 results of 688 total
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00625
… is an inhibitor of p-glycoprotein (P-gp) and breast cancer resistance protein (BCRP) and it is expected that …
Product Type: Drug
Control Number: 259676
DIN(s): 02530740
Manufacturer: Takeda Canada Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2021-12-16
Issued / Original Publication Date: 2023-02-17
Decision / Authorization Date: 2022-09-15
Updated Date: 2024-11-21
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00628
… is a substrate of P‑glycoprotein (P‑gp) and breast cancer resistance protein (BCRP), which are important …
Product Type: Drug
Control Number: 259397
DIN(s): 02533030
Manufacturer: Bristol-Myers Squibb Canada Co.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2021-12-08
Issued / Original Publication Date: 2023-03-10
Decision / Authorization Date: 2022-11-24
Updated Date: 2024-06-10
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00910
… treatment of patients with HER2-positive metastatic breast cancer who have not received prior anti-HER2 therapy or … treatment of patients with HER2-positive metastatic breast cancer who have not received prior anti-HER2 therapy or …
Product Type: Drug
Control Number: 247842
Manufacturer: BGP Pharma ULC
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2020-12-23
Decision / Authorization Date: 2021-12-06
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00577
… propafenone, quinidine antibiotic: fusidic acid anticancer agents: apalutamide, neratinib, venetoclax … offset of the recently discontinued CYP3A inducer: anticancer agent: apalutamide anticonvulsants: carbamazepine, … sickle cell disease, neurodevelopmental disorders, active cancer, and medically related technological dependence. …
Product Type: Drug
Control Number: 259186
DIN(s): 02524031, 02527804
Manufacturer: Pfizer Canada ULC
Submission Type: New Drug Submission (New Active Substance) (COVID-19)
Date Filed / Submission Date: 2021-12-01
Issued / Original Publication Date: 2022-02-28
Decision / Authorization Date: 2022-01-17
Updated Date: 2025-05-16
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00900
… other chemotherapy to treat certain types of the following cancers: metastatic colorectal cancer (mCRC), locally advanced, metastatic or recurrent Non-small Cell Lung Cancer (NSCLC), platinum-sensitive recurrent epithelial …
Product Type: Drug
Control Number: 247369
DIN(s): 02522829, 02522837
Manufacturer: Samsung Bioepis Co., Ltd.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2020-11-12
Decision / Authorization Date: 2021-11-30
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00605
… partnership of drug regulatory agencies designed to give cancer patients faster access to promising treatments. It …
Product Type: Drug
Control Number: 258717
DIN(s): 02527588
Manufacturer: Immunocore Ireland Ltd.
Submission Type: New Drug Submission (New Active Substance) - Priority Review
Date Filed / Submission Date: 2021-11-19
Issued / Original Publication Date: 2022-10-03
Decision / Authorization Date: 2022-06-07
Updated Date: 2023-06-30
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS01036
… injection for the palliative treatment of advanced prostate cancer and the treatment of hormone dependant advanced prostate cancer and for the treatment of high-risk localized and locally advanced hormone dependant prostate cancer in combination with radiotherapy. Upon review, the …
Product Type: Drug
Control Number: 246800
DIN(s): 02522446
Manufacturer: Accord Healthcare Inc.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2020-12-07
Decision / Authorization Date: 2021-11-16
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00888
… biologic were proposed for Abevmy: 1) metastatic colorectal cancer, 2) locally advanced, recurrent non-small cell lung cancer (NSCLC), 3) platinum-resistant recurrent epithelial ovarian, fallopian tube and primary peritoneal cancer, and 4) malignant glioma. Why was the decision …
Product Type: Drug
Control Number: 237499
DIN(s): 02522160, 02522179
Manufacturer: BGP Pharma ULC
Submission Type: New Drug Submission
Date Filed / Submission Date: 2020-06-07
Decision / Authorization Date: 2021-11-05
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00589
… obesity, heart disease, chronic kidney disease, diabetes, cancer, and pulmonary obstructive disease. Health Canada has … obesity (42%), diabetes (14%), cardiovascular disease (8%), cancer, including a history of cancer (7%), chronic obstructive pulmonary disease (5%), …
Product Type: Drug
Control Number: 258295
DIN(s): 02526271
Manufacturer: AstraZeneca Canada Inc.
Submission Type: New Drug Submission (New Active Substance) (COVID-19)
Date Filed / Submission Date: 2021-11-03
Issued / Original Publication Date: 2022-06-15
Decision / Authorization Date: 2022-04-14
Updated Date: 2024-05-17
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00885
… with inoperable locally advanced or metastatic urothelial cancer who had previously been treated with platinum-based … with unresectable locally advanced or metastatic urothelial cancer who have previously received a platinum-containing … with inoperable locally advanced or metastatic urothelial cancer received either Padcev (1.25 mg/kg on days 1, 8 and …
Product Type: Drug
Control Number: 251438
DIN(s): 02521903, 02521911
Manufacturer: Seagen Inc.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2021-04-06
Decision / Authorization Date: 2021-10-29