Review decisions
Showing 170 results of 688 total
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00990
… of adult patients with resectable non-small cell lung cancer (NSCLC)”. Upon review and evaluation of the data, the … with unresectable or metastatic non-small cell lung cancer (NSCLC), known epidermal growth factor receptor …
Product Type: Drug
Control Number: 261300
Manufacturer: Bristol-Myers Squibb Canada Co.
Submission Type: Supplement to a New Drug Submission - Priority Review
Date Filed / Submission Date: 2022-02-08
Decision / Authorization Date: 2022-08-18
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD1712172719912
… osteoporosis; have known, suspected, or history of breast cancer or other hormone-sensitive malignancies (e.g. endometrial cancer), or with increased risk for hormone-sensitive … (a sensitive CYP3A substrate), rosuvastatin (breast cancer resistance protein [BCRP] substrate) or dabigatran …
Product Type: Drug
Control Number: 267148
DIN(s): 02541742
Manufacturer: Sumitomo Pharma Switzerland GmbH
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2022-08-18
Issued / Original Publication Date: 2024-03-28
Decision / Authorization Date: 2023-09-22
Updated Date: 2025-01-29
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SSR00286
… Canada to treat advanced forms of liver, kidney and thyroid cancers. Health Canada reviewed the potential risk of TMA … congenital conditions (those present at birth), infection, cancer and drugs, can cause TMA. Use in Canada Nexavar is a … drug authorized in Canada for the treatment of liver cancer (hepatocellular carcinoma) that cannot be treated by …
Issued / Original Publication Date: 2022-08-11
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00989
… factor receptor 2 (HER2)-negative high risk early breast cancer who have previously been treated with neoadjuvant or … factor receptor 2 (HER2)-negative high risk early breast cancer who have been treated with neoadjuvant or adjuvant … with gBRCAm HER2-negative high risk early breast cancer (EBC) previously treated with adjuvant or neoadjuvant …
Product Type: Drug
Control Number: 259417
Manufacturer: AstraZeneca Canada Inc.
Submission Type: Supplement to a New Drug Submission - Notice of Compliance with Conditions
Date Filed / Submission Date: 2021-12-09
Decision / Authorization Date: 2022-07-27
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD1695821197450
… with an increased risk of dysplasia and colorectal cancer. Canada has among the highest incidence and … were adenocarcinoma of colon (3 patients) and rectal cancer (3 patients). None of these events were considered …
Product Type: Drug
Control Number: 266471
DIN(s): 02539845, 02539853, 02539861
Manufacturer: Eli Lilly Canada Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2022-07-27
Issued / Original Publication Date: 2023-09-25
Decision / Authorization Date: 2023-07-20
Updated Date: 2024-06-06
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS01077
… who test positive for PD-L1 and have a type of esophageal cancer called squamous cell carcinoma, which cannot be …
Product Type: Drug
Control Number: 257103
Manufacturer: Bristol-Myers Squibb Canada Co.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2021-09-29
Decision / Authorization Date: 2022-07-25
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD1715956069651
… sickle cell disease, neurodevelopmental disorders, active cancer, and medically related technological dependence. … BA.1 group, as well as dehydration, prostate cancer, and nephrolithiasis in a group receiving a different …
Product Type: Drug
Control Number: 266189
DIN(s): 02532018
Manufacturer: BioNTech Manufacturing GmbH
Submission Type: New Drug Submission (New Active Substance) (COVID-19)
Date Filed / Submission Date: 2022-07-25
Issued / Original Publication Date: 2022-12-19
Decision / Authorization Date: 2022-10-21
Updated Date: 2024-05-17
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00594
Product Type: Drug
Control Number: 254440
DIN(s): 02526182
Manufacturer: Janssen Inc.
Submission Type: New Drug Submission
Issued / Original Publication Date: 2022-07-11
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00609
… sickle cell disease, neurodevelopmental disorders, active cancer, and medically related technological dependence. … Spikevax group. Two serious adverse events (prostate cancer and traumatic fracture) were reported in the Spikevax …
Product Type: Drug
Control Number: 265656
DIN(s): 02530252
Manufacturer: Moderna Biopharma Canada Corporation
Submission Type: New Drug Submission (New Active Substance) (COVID-19)
Date Filed / Submission Date: 2022-06-30
Issued / Original Publication Date: 2022-10-27
Decision / Authorization Date: 2022-09-01
Updated Date: 2024-05-17
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00963
… epidermal growth factor receptor 2 (HER2)-positive breast cancer who have received a prior anti-HER2-based regimen. … with unresectable or metastatic HER2-positive breast cancer who have received at least one prior anti-HER2-based … epidermal growth factor receptor 2 (HER2)-positive breast cancer who had received at least one prior anti-HER2-based …
Product Type: Drug
Control Number: 259440
Manufacturer: AstraZeneca Canada Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2021-12-10
Decision / Authorization Date: 2022-06-15