Review decisions
Showing 230 results of 688 total
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00602
… advanced unresectable or metastatic non‑small cell lung cancer (NSCLC) harbouring mesenchymal‑epithelial transition … advanced unresectable or metastatic non‑small cell lung cancer (NSCLC) harbouring mesenchymal‑epithelial transition … advanced unresectable or metastatic non‑small cell lung cancer (NSCLC) harbouring mesenchymal‑epithelial transition …
Product Type: Drug
Control Number: 255972
DIN(s): 02527391, 02527405
Manufacturer: Novartis Pharmaceuticals Canada Inc.
Submission Type: New Drug Submission (New Active Substance) - Notice of Compliance with Conditions
Date Filed / Submission Date: 2021-08-20
Issued / Original Publication Date: 2022-08-30
Decision / Authorization Date: 2022-05-26
Updated Date: 2026-02-02
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00582
… sickle cell disease, neurodevelopmental disorders, active cancer, and medically related technological dependence. …
Product Type: Drug
Control Number: 254598
Manufacturer: Medicago Inc.
Submission Type: New Drug Submission (New Active Substance) (COVID-19)
Date Filed / Submission Date: 2021-08-09
Issued / Original Publication Date: 2022-04-11
Decision / Authorization Date: 2022-02-24
Updated Date: 2023-05-26
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS01033
… patient population treated with Brukinsa. These are skin cancer, atrial fibrillation, diarrhea, cytopenias and …
Product Type: Drug
Control Number: 242885
DIN(s): 02512963
Manufacturer: Beigene Switzerland GmbH
Submission Type: New Drug Submission
Date Filed / Submission Date: 2020-08-14
Decision / Authorization Date: 2021-07-22
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00616
… disease is a rare autosomal dominant hereditary cancer syndrome with an estimated incidence of one in 36,000 … project is an international partnership designed to give cancer patients faster access to promising cancer treatments. The NDS for Welireg was classified as a …
Product Type: Drug
Control Number: 254495
DIN(s): 02528908
Manufacturer: Merck Canada Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2021-07-09
Issued / Original Publication Date: 2022-12-20
Decision / Authorization Date: 2022-07-11
Updated Date: 2026-02-16
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1691759711587
… in Canada: for the treatment of patients with early breast cancer, metastatic breast cancer or metastatic gastric cancer. What did the company submit to supports its …
Product Type: Drug
Control Number: 253850
Manufacturer: Prestige Biopharma Ltd.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2021-07-05
Decision / Authorization Date: 2023-06-30
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00831
… of resected esophageal or gastroesophageal junction cancer in adults who had previous chemo-radiotherapy (CRT) and complete resection of the cancer. After evaluation of the submitted data package, … of Resected Esophageal or Gastroesophageal Junction (GEJ) Cancer Opdivo is indicated for the adjuvant treatment of …
Product Type: Drug
Control Number: 247045
Manufacturer: Bristol-Myers Squibb Canada Co.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2020-12-04
Decision / Authorization Date: 2021-07-02
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SSR00270
… Issue Tumor Lysis Syndrome, a condition that occurs when cancer cells are killed rapidly, releasing their contents … in Canada for the treatment of early or late stage breast cancer. Health Canada reviewed the risk of tumor lysis … life-threatening condition that can occur during cancer treatment. When cancer cells are killed by the cancer …
Issued / Original Publication Date: 2021-06-24
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS01032
… Eleven of 255 (4%) patients developed non-melanoma skin cancer (nMSC) during the course of the clinical trial or …
Product Type: Drug
Control Number: 238994
DIN(s): 02516764
Manufacturer: Recordati Rare Diseases Canada Inc.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2020-05-05
Decision / Authorization Date: 2021-06-08
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00608
… least one prior therapy. Multiple myeloma is a hematologic cancer characterized by proliferation of clonal plasma cells … oncoproteins such as c-Myc and cyclin D1, and apoptosis of cancer cells. The combination of selinexor and dexamethasone … has a linear pharmacokinetics that is not affected by cancer type. Selinexor exhibited dose-proportional exposures …
Product Type: Drug
Control Number: 253182
DIN(s): 02527677
Manufacturer: FORUS Therapeutics Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2021-05-28
Issued / Original Publication Date: 2022-10-12
Decision / Authorization Date: 2022-05-31
Updated Date: 2023-07-17
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SSR00267
… damage; and tumor lysis syndrome, a rapid breakdown of cancer cells with the release of substances into the blood … with Yervoy (ipilimumab), to treat certain types of cancers of the skin, head and neck, blood cells, lungs, … life-threatening condition that can occur during cancer treatment. When cancer cells break down (die) from …
Issued / Original Publication Date: 2021-05-19
Updated Date: 2021-06-09