Review decisions
Showing 150 results of 688 total
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SSR00289
… are authorized in Canada for the treatment of breast cancer in women who have reached menopause. Health Canada … authorized for sale in Canada for the treatment of breast cancer in women who have reached menopause. There are …
Issued / Original Publication Date: 2023-01-17
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00737
… majority of patients, it can develop due to an underlying cancer. The most common type of cancer associated with the development of LEMS is small cell … malignancy, both chemotherapy (to treat the underlying cancer) and a variety of immunosuppressive therapies (to …
Product Type: Drug
Control Number: 234655
DIN(s): 02503034
Manufacturer: Medunik Canada
Submission Type: New Drug Submission (New Active Substance) - Priority Review
Date Filed / Submission Date: 2019-12-20
Decision / Authorization Date: 2023-01-10
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS01054
… human epidermal growth factor receptor 2 (HER2)-low breast cancer (BC). After evaluation of the submitted data package, … or metastatic HER2-low (IHC1+ or IHC2+/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 …
Product Type: Drug
Control Number: 265333
Manufacturer: AstraZeneca Canada Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2022-06-17
Decision / Authorization Date: 2023-01-06
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS01055
… for use in the treatment of metastatic colorectal cancer, locally advanced or recurrent non-small cell lung cancer, platinum-resistant ovarian, platinum-sensitive … ovarian, fallopian tube and primary peritoneal cancer, and malignant glioma. Why was the decision issued? …
Product Type: Drug
Control Number: 258973
DIN(s): 02534177, 02534185
Manufacturer: Celltrion Healthcare Co., Ltd.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2021-11-24
Decision / Authorization Date: 2023-01-03
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS01051
… of Kymriah are manageable through treatment in specialised cancer centres, close monitoring, and the use of …
Product Type: Drug
Control Number: 263500
Manufacturer: Novartis Pharmaceuticals Canada Inc.
Submission Type: Supplement to a New Drug Submission - Priority Review
Date Filed / Submission Date: 2022-04-19
Decision / Authorization Date: 2022-12-19
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD1708102173051
… for the treatment of adult patients with advanced prostate cancer. 1 What was approved? Orgovyx, a … for the treatment of adult patients with advanced prostate cancer. Orgovyx is not authorized for use in pediatric … for the treatment of adult patients with advanced prostate cancer. Excluding non-melanoma skin cancers, prostate cancer …
Product Type: Drug
Control Number: 269372
DIN(s): 02542137
Manufacturer: Sumitomo Pharma Switzerland GmbH
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2022-11-03
Issued / Original Publication Date: 2024-02-16
Decision / Authorization Date: 2023-10-10
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD1695302358644
… incurable disease representing approximately 1.6% of new cancers with about 3,800 new cases and 1,600 deaths from MM annually. Multiple myeloma is a cancer of plasma cells. The malignant plasma cells produce … project is an international partnership designed to give cancer patients faster access to promising cancer …
Product Type: Drug
Control Number: 269369
DIN(s): 02539756, 02539764
Manufacturer: Janssen Inc.
Submission Type: New Drug Submission (New Active Substance) - Notice of Compliance with Conditions
Date Filed / Submission Date: 2022-11-02
Issued / Original Publication Date: 2023-09-20
Decision / Authorization Date: 2023-07-26
Updated Date: 2025-05-21
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD1721405092068
… events, 7 malignancies excluding non‑melanoma skin cancer, 4 cases of peripheral neuropathies, and 15 cases of … events, 7 malignancies excluding non‑melanoma skin cancer, 4 cases of peripheral neuropathies, and 15 cases of …
Product Type: Drug
Control Number: 268723
DIN(s): 02543532
Manufacturer: Pfizer Canada ULC
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2022-10-14
Issued / Original Publication Date: 2024-07-18
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS01017
… antigen (PSMA) positive lesions in men with prostate cancer: 1) with suspected metastasis who are suitable for … prostate specific membrane antigen (PSMA) positive prostate cancer: In the first trial, a total of 277 subjects received …
Product Type: Drug
Control Number: 242332
DIN(s): 02531836
Manufacturer: Telix Pharmaceuticals (US) Inc.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2020-12-06
Decision / Authorization Date: 2022-10-13
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS01063
… epithelial ovarian, fallopian tube, or primary peritoneal cancer. This is an authorized indication held by Avastin, … epithelial ovarian, fallopian tube, or primary peritoneal cancer, a scientific rationale was provided. Based on the … epithelial ovarian, fallopian tube, or primary peritoneal cancer, in combination with carboplatin and gemcitabine. An …
Product Type: Drug
Control Number: 257734
Manufacturer: Apotex Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2021-09-10
Decision / Authorization Date: 2022-10-06