Review decisions
Showing 140 results of 342 total
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/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
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00502
… of serious heart-related problems, fatal blood clots and cancer ), containing important information about labelling … to the European Organization for Research and Treatment of Cancer quality of life questionnaire (EORTC QLQ-C30) also …
Product Type: Drug
Control Number: 229866
DIN(s): 02502445
Manufacturer: Celgene Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2019-07-19
Issued / Original Publication Date: 2020-10-22
Decision / Authorization Date: 2020-07-27
Updated Date: 2024-07-17
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00509
… and second primary malignancies (mainly non-melanoma skin cancers) occurred more commonly in the Isa-Pd group and a … S6(R1) and S9 guidelines for non-clinical evaluation of anticancer pharmaceuticals and biotechnology-derived …
Product Type: Drug
Control Number: 229245
DIN(s): 02498235, 02498243
Manufacturer: Sanofi-Aventis Canada Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2019-06-28
Issued / Original Publication Date: 2020-12-08
Decision / Authorization Date: 2020-04-29
Updated Date: 2024-09-06
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00476
… Based on in vitro studies, tafamidis inhibits breast cancer resistant protein (BCRP), both systemically and in …
Product Type: Drug
Control Number: 228368
DIN(s): 02495732
Manufacturer: Pfizer Canada ULC., on behalf of BioNTech Manufacturing GmbH
Submission Type: New Drug Submission (New Active Substance) - Priority Review
Date Filed / Submission Date: 2019-06-03
Issued / Original Publication Date: 2020-05-21
Decision / Authorization Date: 2020-01-20
Updated Date: 2025-03-25
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00469
… the intended use of Xospata in patients with advanced cancer, there are no pharmacological or toxicological issues …
Product Type: Drug
Control Number: 227918
DIN(s): 02495058
Manufacturer: Astellas Pharma Canada Inc.
Submission Type: New Drug Submission (New Active Substance) - Priority Review
Date Filed / Submission Date: 2019-05-22
Issued / Original Publication Date: 2020-03-23
Decision / Authorization Date: 2019-12-23
Updated Date: 2025-03-12