Review decisions
Showing 70 results of 342 total
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD1695821197450
… with an increased risk of dysplasia and colorectal cancer. Canada has among the highest incidence and … were adenocarcinoma of colon (3 patients) and rectal cancer (3 patients). None of these events were considered …
Product Type: Drug
Control Number: 266471
DIN(s): 02539845, 02539853, 02539861
Manufacturer: Eli Lilly Canada Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2022-07-27
Issued / Original Publication Date: 2023-09-25
Decision / Authorization Date: 2023-07-20
Updated Date: 2024-06-06
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD1715956069651
… sickle cell disease, neurodevelopmental disorders, active cancer, and medically related technological dependence. … BA.1 group, as well as dehydration, prostate cancer, and nephrolithiasis in a group receiving a different …
Product Type: Drug
Control Number: 266189
DIN(s): 02532018
Manufacturer: BioNTech Manufacturing GmbH
Submission Type: New Drug Submission (New Active Substance) (COVID-19)
Date Filed / Submission Date: 2022-07-25
Issued / Original Publication Date: 2022-12-19
Decision / Authorization Date: 2022-10-21
Updated Date: 2024-05-17
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00594
Product Type: Drug
Control Number: 254440
DIN(s): 02526182
Manufacturer: Janssen Inc.
Submission Type: New Drug Submission
Issued / Original Publication Date: 2022-07-11
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00609
… sickle cell disease, neurodevelopmental disorders, active cancer, and medically related technological dependence. … Spikevax group. Two serious adverse events (prostate cancer and traumatic fracture) were reported in the Spikevax …
Product Type: Drug
Control Number: 265656
DIN(s): 02530252
Manufacturer: Moderna Biopharma Canada Corporation
Submission Type: New Drug Submission (New Active Substance) (COVID-19)
Date Filed / Submission Date: 2022-06-30
Issued / Original Publication Date: 2022-10-27
Decision / Authorization Date: 2022-09-01
Updated Date: 2024-05-17
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD1703192825535
… for unresectable or metastatic melanoma. Melanoma, a cancer which originates from melanocytes, is the most lethal form of skin cancer due to its propensity to metastasize to various organs. According to the Canadian Cancer Society, in 2022, 9,000 Canadians were estimated to …
Product Type: Drug
Control Number: 256629
DIN(s): 02541416
Manufacturer: Bristol-Myers Squibb Canada
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2022-06-01
Issued / Original Publication Date: 2023-12-21
Decision / Authorization Date: 2023-09-13
Updated Date: 2025-02-24
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD1687370834165
… antigen (PSMA)-positive lesions in men with prostate cancer: with suspected metastasis who are candidates for … with progressive metastatic castration-resistant prostate cancer (mCRPC), for whom PSMA-targeted therapy is indicated. … antigen (PSMA)-positive lesions in men with prostate cancer: with suspected metastasis who are candidates for …
Product Type: Drug
Control Number: 263638
DIN(s): 02537117
Manufacturer: Advanced Accelerator Applications USA, Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2022-04-22
Issued / Original Publication Date: 2023-06-21
Decision / Authorization Date: 2023-04-05
Updated Date: 2025-10-23
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD1682951781384
… organic cation transporter 2, p-glycoprotein, or breast cancer resistance protein). Toxicology The toxicology …
Product Type: Drug
Control Number: 263432
DIN(s): 02533294
Manufacturer: Swedish Orphan Biovitrum Ab (publ)
Submission Type: New Drug Submission (New Active Substance) - Priority Review
Date Filed / Submission Date: 2022-04-19
Issued / Original Publication Date: 2023-04-13
Decision / Authorization Date: 2022-12-08
Updated Date: 2024-11-20
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD1689944674439
… Actinic keratosis is an ultraviolet light-induced precancerous lesion of the skin that represents the initial … squamous cell carcinoma represents 20% to 50% of skin cancers and poses a significant threat due to its ability to … or multiple lesions or as an entire field (known as “field cancerization”). The prevalence of actinic keratoses is high …
Product Type: Drug
Control Number: 262080
DIN(s): 02537818
Manufacturer: Avir Pharma Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2022-04-08
Issued / Original Publication Date: 2023-07-20
Decision / Authorization Date: 2023-05-12
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00627
… on organic anion transporting polypeptide (OATP), breast cancer resistance protein (BCRP), and P-gp transporters; as …
Product Type: Drug
Control Number: 262999
DIN(s): 02532468, 02532476
Manufacturer: Gilead Sciences Canada Inc.
Submission Type: New Drug Submission - Priority Review
Date Filed / Submission Date: 2022-04-06
Issued / Original Publication Date: 2023-03-10
Decision / Authorization Date: 2022-11-02
Updated Date: 2025-06-27
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD1734963810994
… a comparative immunogenicity study in patients with breast cancer. Based on Health Canada’s review , the benefit-risk … use has not been authorized. Of the 930 subjects with cancer who received pegfilgrastim in clinical studies, … immunogenicity study conducted in patients with breast cancer receiving myelosuppressive chemotherapy (Study …
Product Type: Drug
Control Number: 262990
DIN(s): 02550857
Manufacturer: Lupin Pharma Canada Limited
Submission Type: New Drug Submission
Date Filed / Submission Date: 2022-03-31
Issued / Original Publication Date: 2024-12-22
Decision / Authorization Date: 2024-08-16