Review decisions
Showing 130 results of 688 total
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD1739202346124
… [33.1%]) groups. There was one report of malignancy [breast cancer] in the Steqeyma group. There were no reports of …
Product Type: Drug
Control Number: 274939
DIN(s): 02550245, 02550253, 02550261
Manufacturer: Celltrion, Inc.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2023-06-30
Issued / Original Publication Date: 2025-02-10
Decision / Authorization Date: 2024-07-30
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD1737492567696
… monoclonal antibody that is used to treat certain types of cancer and rheumatoid arthritis. It has also been used in … not substrates of drug transporters (P‑glycoprotein/breast cancer resistance protein/organic anion transporting …
Product Type: Drug
Control Number: 276757
DIN(s): 02549220, 02549239, 02549247
Manufacturer: UCB Canada Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2023-06-30
Issued / Original Publication Date: 2025-01-21
Decision / Authorization Date: 2024-07-11
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD1698862620995
… sickle cell disease, neurodevelopmental disorders, active cancer, and medically related technological dependence. …
Product Type: Drug
Control Number: 275936
DIN(s): 02541270
Manufacturer: Moderna Biopharma Canada Corporation
Submission Type: New Drug Submission (New Active Substance) (COVID-19)
Date Filed / Submission Date: 2023-06-29
Issued / Original Publication Date: 2023-10-31
Decision / Authorization Date: 2023-09-12
Updated Date: 2025-08-22
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD1700495075939
… sickle cell disease, neurodevelopmental disorders, active cancer, and medically related technological dependence. …
Product Type: Drug
Control Number: 276302
DIN(s): 02541823, 02541831, 02541858, 02541866, 02552035, 02552078
Manufacturer: BioNTech Manufacturing GmbH
Submission Type: New Drug Submission (New Active Substance) (COVID-19)
Date Filed / Submission Date: 2023-06-29
Issued / Original Publication Date: 2023-11-22
Decision / Authorization Date: 2023-09-28
Updated Date: 2025-08-21
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1688667089344
… not using contraception. The risk of progression to skin cancer was also labelled. The potential of development of risk of skin cancer in long-term use of Onakta is not known. Onakta has …
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
Decision / Authorization Date: 2023-05-12
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD1728318721334
… lead to the development of malignancies, particularly liver cancer due to integration of the liver‑targeting AAV vector. … that patients with pre-existing risk factors for liver cancer should receive regular abdominal ultrasound …
Product Type: Drug
Control Number: 275853
DIN(s): 02544156
Manufacturer: Pfizer Canada ULC
Submission Type: New Drug Submission (New Active Substance) - Priority Review
Date Filed / Submission Date: 2023-06-01
Issued / Original Publication Date: 2024-10-06
Decision / Authorization Date: 2023-12-27
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD1736954230750
… growth factor receptor (HER2)-positive metastatic breast cancer. Based on Health Canada’s review , the benefit-risk … (which include relevant caveat statements): Early Breast Cancer Adheroza (trastuzumab) is indicated for the treatment of patients with early-stage breast cancer with Eastern Cooperative Oncology Group (ECOG) 0-1 …
Product Type: Drug
Control Number: 275910
DIN(s): 02550970, 02550989
Manufacturer: Accord Healthcare Inc.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2023-06-01
Issued / Original Publication Date: 2025-01-15
Decision / Authorization Date: 2024-08-20
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1684156979784
… for Keytruda (Pembrolizumab), a humanized antibody used in cancer immunotherapy, as monotherapy for the adjuvant … with Stage IB (T2a ≥ 4 cm), II, or IIIA non-small cell lung cancer (NSCLC) who have undergone complete resection. … Canada for multiple indications including melanoma, bladder cancer, head and neck squamous cell carcinoma, classic …
Product Type: Drug
Control Number: 264318
DIN(s): 02456869
Manufacturer: Merck Canada Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2022-05-16
Decision / Authorization Date: 2023-04-19
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SSR1683309818342
… in Canada as maintenance t herapy for a specific type of cancer of the blood and bone marrow (acute lymphoblastic …
DIN(s): 00004723, 02415275
Issued / Original Publication Date: 2023-05-10
Updated Date: 2023-05-10
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1683828447298
… chronic obstructive pulmonary disease, or active cancer. In the interim analysis patient population, (n = 387 …
Product Type: Drug
Control Number: 255584
Manufacturer: Merck Canada Inc.
Submission Type: New Drug Submission (New Active Substance) (COVID-19)
Date Filed / Submission Date: 2021-08-20
Decision / Authorization Date: 2023-04-26