Review decisions
Showing 290 results of 688 total
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00576
… The 5-year survival rate by the American Joint Committee on Cancer stage is 50% for Stage I, 30% for Stage II, 10% for … and signaling and selectively decreases cell viability in cancer cell lines with activating FGFR genetic alterations, … and signaling, and selectively decreases cell viability in cancer cell lines with activating FGFR genetic alterations, …
Product Type: Drug
Control Number: 242569
DIN(s): 02519933, 02519941, 02519968
Manufacturer: Incyte Corporation
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2020-09-10
Issued / Original Publication Date: 2022-02-16
Decision / Authorization Date: 2021-09-17
Updated Date: 2024-06-07
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00618
… with neurofibromatosis type 1include gliomas, breast cancer, leukemia, pheochromocytomas, and gastrointestinal … in neurofibromatosis type 1 syndrome and different types of cancers. The market authorization of Koselugo was based on … within 3 to 6 months), based on the United States National Cancer Institute (NCI) central review. The target plexiform …
Product Type: Drug
Control Number: 243733
DIN(s): 02530139, 02530147
Manufacturer: AstraZeneca Canada Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2020-09-09
Issued / Original Publication Date: 2022-12-20
Decision / Authorization Date: 2022-08-31
Updated Date: 2024-11-22
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00685
… to add an indication for prevention of anal dysplasia and cancer caused by HPV types contained in the vaccine for … included in the vaccine: Cervical, vulvar, and vaginal cancer caused by HPV types 16, 18, 31, 33, 45, 52, and 58 … caused by HPV types 6 and 11 And the following precancerous or dysplastic lesions caused by HPV types 6, 11, …
Product Type: Drug
Control Number: 223244
Manufacturer: Merck Canada Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2018-12-20
Decision / Authorization Date: 2020-08-20
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00542
… Waldenström’s macroglobulinemia (WM) is a rare form of cancer that begins in the white blood cells. An estimated … by a qualified physician experienced in the use of anticancer therapies, and highlights the risk of serious … by a qualified physician experienced in the use of anticancer therapies, and highlights the risk of serious …
Product Type: Drug
Control Number: 242748
DIN(s): 02512963, 02554267
Manufacturer: Beigene Switzerland GmbH
Submission Type: New Drug Submission (New Active Substance) - Priority Review
Date Filed / Submission Date: 2020-08-12
Issued / Original Publication Date: 2021-07-15
Decision / Authorization Date: 2021-03-01
Updated Date: 2026-02-23
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00490
Product Type: Drug
Control Number: 229407
DIN(s): 02500337
Manufacturer: Sun Pharma Global FZE
Submission Type: New Drug Submission
Issued / Original Publication Date: 2020-08-11
Updated Date: 2022-11-09
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00679
… treatment of patients with metastatic non-small cell lung cancer (NSCLC) with no EGFR or ALK genomic tumor … the risks in the indicated population with metastatic cancer and an otherwise low survival probability. The …
Product Type: Drug
Control Number: 236255
Manufacturer: Bristol-Myers Squibb Canada Co.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2020-02-19
Decision / Authorization Date: 2020-08-06
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00554
… for the treatment of patients with non-small cell lung cancer harbouring MET exon 14 skipping alterations who are … advanced unresectable or metastatic non-small cell lung cancer harbouring mesenchymal-epithelial transition tyrosine … advanced unresectable or metastatic non-small cell lung cancer (NSCLC) harbouring mesenchymal-epithelial transition …
Product Type: Drug
Control Number: 242300
DIN(s): 02516322
Manufacturer: EMD Serono, A division of EMD Inc. Canada
Submission Type: New Drug Submission - Notice of Compliance with Conditions
Date Filed / Submission Date: 2020-07-31
Issued / Original Publication Date: 2021-10-21
Decision / Authorization Date: 2021-05-27
Updated Date: 2024-09-05
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00544
… risdiplam. Additionally, risdiplam is a substrate of breast cancer resistance protein (BCRP) and may be a substrate of …
Product Type: Drug
Control Number: 242373
DIN(s): 02514931
Manufacturer: Hoffmann-La Roche Ltd.
Submission Type: New Drug Submission (New Active Substance) - Priority Review
Date Filed / Submission Date: 2020-07-31
Issued / Original Publication Date: 2021-07-27
Decision / Authorization Date: 2021-04-14
Updated Date: 2025-07-11
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00539
… or metastatic HER2-low (IHC 1+ or IHC 2+/ISH-) breast cancer who have received at least one prior line of … Patients with hormone receptor positive (HR+) breast cancer should have received at least one and be no longer … with unresectable or metastatic HER2-positive breast cancer who have received at least one prior anti-HER2-based …
Product Type: Drug
Control Number: 242104
DIN(s): 02514400
Manufacturer: AstraZeneca Canada Inc.
Submission Type: New Drug Submission (New Active Substance) - Notice of Compliance with Conditions
Date Filed / Submission Date: 2020-07-24
Issued / Original Publication Date: 2021-07-09
Decision / Authorization Date: 2021-04-15
Updated Date: 2025-05-30
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SSR00242
… Picato (ingenol mebutate) Potential Safety Issue Skin cancer Key Messages Picato (ingenol mebutate) is a … sun (UV exposure). Health Canada reviewed the risk of skin cancer with Picato based on new safety information from … clinical trials that found an increased risk of skin cancer in patients treated with this drug. Health Canada's …
Issued / Original Publication Date: 2020-07-02