Review decisions
Showing 330 results of 688 total
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00598
… of adult patients with advanced or recurrent gastric or GEJ cancer after two or more prior systemic therapies". What did …
Product Type: Drug
Control Number: 215535
Manufacturer: Bristol-Myers Squibb Canada Co.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2018-04-17
Decision / Authorization Date: 2019-11-29
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00590
… for the adjuvant treatment of HER2-positive early breast cancer patients who have residual disease. The indication … is for the adjuvant treatment of HER2-positive early breast cancer patients who have residual invasive disease following … study of 1486 patients with HER2-positive, early breast cancer (EBC) with residual invasive tumour in the breast …
Product Type: Drug
Control Number: 227372
Manufacturer: Hoffmann-La Roche Ltd.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2019-05-01
Decision / Authorization Date: 2019-11-25
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00660
… for the treatment of adult patients with metastatic gastric cancer or adenocarcinoma of the gastroesophageal junction. … for the treatment of adult patients with metastatic gastric cancer or adenocarcinoma of the gastroesophageal junction, … in support of Lonsurf in patients with metastatic gastric cancer (mGC) or adenocarcinoma of the gastroesophageal …
Product Type: Drug
Control Number: 227070
DIN(s): 02472104, 02472112
Manufacturer: Taiho Pharma Canada Inc.
Submission Type: Supplement to a New Drug Submission - Priority Review
Date Filed / Submission Date: 2019-04-23
Decision / Authorization Date: 2019-11-19
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00523
… clinical studies, 15% of the total number of patients with cancer who received pegfilgrastim were 65 years or older. No … and one supportive clinical study conducted in breast cancer patients further support the immunogenicity and/or … was conducted in patients with non‑metastatic breast cancer. The initial objective of this study was to evaluate …
Product Type: Drug
Control Number: 233373
DIN(s): 02506238
Manufacturer: Pfizer Canada ULC
Submission Type: New Drug Submission
Date Filed / Submission Date: 2019-11-12
Issued / Original Publication Date: 2021-03-22
Decision / Authorization Date: 2020-10-28
Updated Date: 2024-07-31
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00504
… CYP3A5, CYP2C8, bile salt efflux pump (BSEP), breast cancer-resistance protein (BCRP), OCT1, and multidrug and …
Product Type: Drug
Control Number: 233292
DIN(s): 02501821, 02501848
Manufacturer: Sunovion Pharmaceuticals Canada Inc.
Submission Type: New Drug Submission (New Active Substance) - Priority Review
Date Filed / Submission Date: 2019-11-07
Issued / Original Publication Date: 2020-11-02
Decision / Authorization Date: 2020-07-10
Updated Date: 2025-01-28
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00503
… carcinoma, the majority of which are small cell lung cancer. The primary symptom of LEMS is muscle weakness. The …
Product Type: Drug
Control Number: 232685
DIN(s): 02502984
Manufacturer: Catalyst Pharmaceuticals Inc.
Submission Type: New Drug Submission (New Active Substance) - Priority Review
Date Filed / Submission Date: 2019-11-06
Issued / Original Publication Date: 2020-10-30
Decision / Authorization Date: 2020-07-31
Updated Date: 2023-02-21
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00530
… monitoring patients for the onset or exacerbation of cancer. Reproductive and developmental toxicity studies were …
Product Type: Drug
Control Number: 233097
DIN(s): 02505851
Manufacturer: Novartis Pharmaceuticals Canada Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2019-10-31
Issued / Original Publication Date: 2021-05-17
Decision / Authorization Date: 2020-10-13
Updated Date: 2023-10-12
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00800
… disease (SD), and partial responses in other doses and/or cancer types, it is reasonable and acceptable to conclude …
Product Type: Drug
Control Number: 224529
DIN(s): 02493217, 02493225, 02493233, 02493241
Manufacturer: Janssen Inc.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2019-02-08
Decision / Authorization Date: 2019-10-25
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00508
… seen with coadministration of an inhibitor of the breast cancer resistance protein (BCRP). This may potentially lead … such as melanoma, basal cell carcinoma, breast cancer, and seminoma, were reported with Zeposia in clinical …
Product Type: Drug
Control Number: 232761
DIN(s): 02505991, 02506009
Manufacturer: Celgene Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2019-10-25
Issued / Original Publication Date: 2020-12-02
Decision / Authorization Date: 2020-10-02
Updated Date: 2025-06-23
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00526
… the concentrations of certain substrates of CYP3A4, breast cancer resistance protein (BCRP), and P‑glycoprotein (P‑gp). …
Product Type: Drug
Control Number: 232078
DIN(s): 02508052, 02508060
Manufacturer: Rigel Pharmaceuticals Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2019-09-30
Issued / Original Publication Date: 2021-03-31
Decision / Authorization Date: 2020-11-19
Updated Date: 2023-07-10