Review decisions
Showing 120 results of 688 total
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1698937127708
… after tumour resection in patients with non-small cell lung cancer (NSCLC) whose tumours have epidermal growth factor … in patients with stage IB-IIIA non-small cell lung cancer (NSCLC) whose tumours have epidermal growth factor … after tumour resection in patients with non-small cell lung cancer (NSCLC) whose tumours have epidermal growth factor …
Product Type: Drug
Control Number: 243288
DIN(s): 02456214, 02456222
Manufacturer: AstraZeneca Canada Inc.
Submission Type: Supplement to a New Drug Submission - Priority Review
Date Filed / Submission Date: 2020-08-27
Decision / Authorization Date: 2021-01-18
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD1707315192044
… sickle cell disease, neurodevelopmental disorders, active cancer, and medically related technological dependence. …
Product Type: Drug
Control Number: 278519
DIN(s): 02543656
Manufacturer: Novavax Inc.
Submission Type: New Drug Submission (New Active Substance) (COVID-19)
Date Filed / Submission Date: 2023-09-01
Issued / Original Publication Date: 2024-02-09
Decision / Authorization Date: 2023-12-05
Updated Date: 2025-03-21
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SSR1691503886633
… (pembrolizumab) and Tecentriq (atezolizumab) are anti-cancer agents belonging to a class of drugs called immune … authorized for sale in Canada to treat different types of cancers. Health Canada reviewed the potential risk of … work with the immune system to help control the growth of cancer cells. Other members of this drug class authorized …
DIN(s): 02456869, 02462990, 02468816, 02469723, 02487144, 02487152, 02492393, 02523434
Issued / Original Publication Date: 2023-08-17
Updated Date: 2023-08-17
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD1732553847408
… to confirm the clinical benefit. Multiple myeloma is a cancer of plasma cells. The malignant plasma cells produce … project is an international partnership designed to give cancer patients faster access to promising cancer treatments. The submission for Talvey was classified …
Product Type: Drug
Control Number: 278277
DIN(s): 02547392, 02547406
Manufacturer: Janssen Inc.
Submission Type: New Drug Submission (New Active Substance) - Notice of Compliance with Conditions
Date Filed / Submission Date: 2023-08-15
Issued / Original Publication Date: 2024-11-23
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1690902285653
… 2 (HER2)-negative (IHC 0, IHC 1+ or IHC 2+/ISH-) breast cancer who have received endocrine-based therapy and at … locally advanced or metastatic triple-negative breast cancer (mTNBC) who have received two or more prior … advanced or metastatic HR-positive, HER2-negative breast cancer received either Trodelvy (10 mg/kg intravenously on …
Product Type: Drug
Control Number: 270849
DIN(s): 02520788
Manufacturer: Gilead Sciences Canada Inc.
Submission Type: Supplement to a New Drug Submission - Priority Review
Date Filed / Submission Date: 2022-12-20
Decision / Authorization Date: 2023-07-19
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1694526985734
… for the treatment of adult patients with prostate cancer who have progressed to metastatic castration resistant prostate cancer (mCRPC) and are positive for homologous recombination … and/or somatic) metastatic castration resistant prostate cancer (mCRPC), who are asymptomatic/mildly symptomatic, and …
Product Type: Drug
Control Number: 265223
DIN(s): 02538555, 02538563
Manufacturer: Janssen Inc.
Submission Type: New Drug Submission - Notice of Compliance with Conditions
Date Filed / Submission Date: 2022-06-15
Decision / Authorization Date: 2023-06-12
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1697728420996
… patients with metastatic castration-resistant prostate cancer (mCRPC). After review, a notice with compliance with … BRCA mutated metastatic castration resistant prostate cancer (mCRPC) in whom chemotherapy is not clinically … in men with metastatic castration-resistant prostate cancer (mCRPC) was conducted in support of the proposed …
Product Type: Drug
Control Number: 265427
DIN(s): 02475200, 02475219
Manufacturer: AstraZeneca Canada Inc
Submission Type: Supplement to a New Drug Submission - Notice of Compliance with Conditions
Date Filed / Submission Date: 2022-06-22
Decision / Authorization Date: 2023-07-11
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SSR1690380271165
… sale in Canada to treat adults with a specific type of lung cancer . Health Canada reviewed the potential risks of … for sale in Canada to treat a specific type of lung cancer at various stages in adults. Osimertinib has been … of osimertinib: Case series and review of the literature. Cancer Treatment and Research Communications 2020 25. …
DIN(s): 02456214, 02456222
Issued / Original Publication Date: 2023-07-26
Updated Date: 2023-07-26
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1694621051185
… screening or surveillance colonoscopy for colorectal cancer (Study CB-17-01/06). This study was conducted in … that could not be overcome include: The risk of interval cancer potentially associated with the mutagenic properties …
Product Type: Drug
Control Number: 219788
Manufacturer: Pendopharm Division of Pharmascience Inc.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2018-09-17
Decision / Authorization Date: 2021-12-22
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD1737486518137
… In Canada, all leukemia cases account for 3% of new cancers, making it a rare disease. Acute myeloid leukemia … makes up 24% of all leukemia cases or approximately 1% of cancers, but is a leading cause of adult leukemia deaths. … in Canada. Cholangiocarcinomas are a heterogeneous group of cancers arising from the epithelium of the bile duct. These …
Product Type: Drug
Control Number: 277139
Manufacturer: Servier Canada Inc
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2023-07-11
Issued / Original Publication Date: 2025-01-21