Review decisions
Showing 20 results of 342 total
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD1758215873791
… of Alyftrek with P-glycoprotein (P-gp) substrates, breast cancer resistance protein (BCRP) substrates, or CYP2C9 …
Product Type: Drug
Control Number: 281029
DIN(s): 02559676, 02559684
Manufacturer: Vertex Pharmaceuticals (Canada) Incorporated
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2024-06-27
Issued / Original Publication Date: 2025-10-10
Decision / Authorization Date: 2025-07-21
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD1746715804692
… 2 (HER2)-negative, locally advanced or metastatic breast cancer, following recurrence on or after completing adjuvant … 2 (HER2)-negative, locally advanced or metastatic breast cancer, following recurrence on or after completing adjuvant … 2 (HER2)-negative, locally advanced or metastatic breast cancer, following recurrence on or after completing adjuvant …
Product Type: Drug
Control Number: 288071
DIN(s): 02555476, 02555484
Manufacturer: Hoffmann-La Roche Limited
Submission Type: New Drug Submission (New Active Substance) - Priority Review
Date Filed / Submission Date: 2024-06-26
Issued / Original Publication Date: 2025-05-08
Decision / Authorization Date: 2025-02-14
Updated Date: 2026-03-16
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD1751981071024
… retention leading to congestive heart failure, bladder cancer). No safety issues were identified when assessing the …
Product Type: Drug
Control Number: 287772
DIN(s): 02557010
Manufacturer: Ipsen Biopharmaceuticals Canada Inc.
Submission Type: New Drug Submission (New Active Substance) - Notice of Compliance with Conditions
Date Filed / Submission Date: 2024-06-19
Issued / Original Publication Date: 2025-07-07
Decision / Authorization Date: 2025-04-25
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD1760535633085
… multidrug resistance protein 1 (P‑glycoprotein) and breast cancer resistance protein, and inhibited bile salt export …
Product Type: Drug
Control Number: 285622
DIN(s): 02559056
Manufacturer: Amivas Ireland Ltd.
Submission Type: New Drug Submission (New Active Substance) - Priority Review
Date Filed / Submission Date: 2024-04-03
Issued / Original Publication Date: 2025-10-10
Decision / Authorization Date: 2025-07-04
Updated Date: 2025-07-04
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD1751980281334
… tract hemorrhage, myocardial infarction, colorectal cancer, COVID-19, COVID-19 pneumonia, and pneumonia … tract hemorrhage, myocardial infarction, colorectal cancer, COVID-19, COVID-19 pneumonia, and pneumonia …
Product Type: Drug
Control Number: 285444
DIN(s): 02558262
Manufacturer: Hoffmann-La Roche Limited
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2024-03-28
Issued / Original Publication Date: 2025-07-07
Decision / Authorization Date: 2025-06-04
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD1748529563500
… to curative therapy) or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) … to curative therapy) or metastatic non-small cell lung cancer (NSCLC) with EGFR exon 19 deletions or exon 21 L858R … to curative therapy) or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) …
Product Type: Drug
Control Number: 285014
DIN(s): 02555964, 02555972
Manufacturer: Janssen Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2024-03-15
Issued / Original Publication Date: 2025-05-28
Decision / Authorization Date: 2025-03-06
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD1743686266671
… of the multidrug resistance protein 1 (MDR1), breast cancer resistance protein (BCRP), organic anion transporter … resistance mutation 1 (MDR1)/P-glycoprotein (P-gp), breast cancer resistance protein (BCRP), organic anion transporter …
Product Type: Drug
Control Number: 284667
DIN(s): 02554429, 02554437
Manufacturer: Xediton Pharmaceuticals Inc.
Submission Type: New Drug Submission (New Active Substance) - Priority Review
Date Filed / Submission Date: 2024-03-05
Issued / Original Publication Date: 2025-04-02
Decision / Authorization Date: 2025-01-17
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD1745520433225
… cells, and natural killer cells. According to the Canadian Cancer Society, it was estimated that in 2024, 11,700 … antibody-drug conjugate designed to target CD19-expressing cancers. It consists of a humanized immunoglobulin G1 kappa … tesirine, which is in line with relevant guidelines for anticancer agents. The SG3199 component of loncastuximab …
Product Type: Drug
Control Number: 284436
DIN(s): 02556138
Manufacturer: Swedish Orphan Biovitrum Ab (publ)
Submission Type: New Drug Submission (New Active Substance) - Notice of Compliance with Conditions
Date Filed / Submission Date: 2024-02-29
Issued / Original Publication Date: 2025-04-28
Decision / Authorization Date: 2025-03-07
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD1751029009341
… ROS proto-oncogene 1 ( ROS1 )-positive non-small cell lung cancer (NSCLC). 1 What was approved? Augtyro, an … ROS proto-oncogene 1 ( ROS1 )-positive non-small cell lung cancer (NSCLC). Augtyro is not authorized for use in … ROS proto-oncogene 1 ( ROS1 )-positive non-small cell lung cancer (NSCLC). In Canada, lung cancer is the leading cause …
Product Type: Drug
Control Number: 284373
DIN(s): 02557444, 02557452
Manufacturer: Bristol-Myers Squibb Canada
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2024-02-28
Issued / Original Publication Date: 2025-06-27
Decision / Authorization Date: 2025-05-07
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD1749131274419
… considered favourable for the following indications: Cancer Patients Receiving Myelosuppressive Chemotherapy … Filra is indicated in adult and pediatric patients with cancer receiving myelosuppressive chemotherapy. A complete … and consolidation treatment for acute myeloid leukemia. Cancer Patients Receiving Myeloablative Chemotherapy …
Product Type: Drug
Control Number: 273870
DIN(s): 02556537, 02556545
Manufacturer: JAMP Pharma Corporation
Submission Type: New Drug Submission
Date Filed / Submission Date: 2024-02-25
Issued / Original Publication Date: 2025-06-03
Decision / Authorization Date: 2025-03-24