Review decisions
Showing 430 results of 688 total
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SSR00190
… Canada to treat adult patients with certain types of blood cancers. Health Canada carried out a safety review after … the symptoms caused by myelofibrosis, a rare form of blood cancer. It is also used to control the excess amount of red … in certain patients with polycythemia vera, a type of blood cancer. Ruxolitinib has been marketed in Canada since 2012 …
Issued / Original Publication Date: 2018-02-26
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00333
… risk of infections/ opportunistic infections and breast cancer. Other safety concerns include depression, …
Product Type: Drug
Control Number: 197969
Manufacturer: Hoffmann-La Roche Ltd.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2016-08-29
Decision / Authorization Date: 2018-02-14
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00335
… patients with newly diagnosed high-risk metastatic prostate cancer, who may have received up to 3 months of prior ADT. … patients with newly diagnosed high-risk metastatic prostate cancer, who may have received up to 3 months of prior ADT. … diagnosed (within 3 months prior to randomization) prostate cancer with high-risk prognostic factors. The addition of …
Product Type: Drug
Control Number: 207915
Manufacturer: Janssen Inc.
Submission Type: Supplement to a New Drug Submission - Priority Review
Date Filed / Submission Date: 2017-07-26
Decision / Authorization Date: 2018-02-13
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00380
… stromal cells and its signalling pathway is important in cancer cell proliferation, metastasis, and the tumour … sarcomas account for only approximately 0.7% to 1.0% of all cancers and approximately 2% of all cancer-related deaths. In Canada (based on the most recent …
Product Type: Drug
Control Number: 203478
DIN(s): 02469227
Manufacturer: Eli Lilly Canada Inc.
Submission Type: New Drug Submission
Issued / Original Publication Date: 2018-02-09
Updated Date: 2021-11-12
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00416
… Yescarta, and Carvykti related to T-cell malignancy (cancer that forms in white blood cells called T cells). SNDS … Kymriah (tisagenlecleucel) is an autologous, immunocellular cancer therapy which involves reprogramming a patient's own … SCT while in remission, and 6 patients received new anti-cancer therapy (including additional CD19 chimeric antigen …
Product Type: Drug
Control Number: 213547
DIN(s): 02480514
Manufacturer: Novartis Pharmaceuticals Canada Inc.
Submission Type: New Drug Submission (New Active Substance) - Priority Review
Date Filed / Submission Date: 2018-02-09
Issued / Original Publication Date: 2019-02-08
Decision / Authorization Date: 2018-09-05
Updated Date: 2025-02-28
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00325
… hydrochloride) for the treatment of metastatic colorectal cancer in patients who have received prior treatment with …
Product Type: Drug
Control Number: 205852
DIN(s): 02472104, 02472112
Manufacturer: Taiho Pharma Canada Inc.
Submission Type: New Drug Submission (New Active Substance) - Priority Review
Date Filed / Submission Date: 2017-05-30
Decision / Authorization Date: 2018-01-25
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00336
… from trials conducted in patients with a wide variety of cancer types. Phase 3 trial data was not part of the …
Product Type: Drug
Control Number: 203593
Manufacturer: Bristol-Myers Squibb Canada Co.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2017-03-09
Decision / Authorization Date: 2018-01-19
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00462
… treatment of patients with HER2-positive metastatic breast cancer who have not received prior anti-HER2 therapy or … (which include relevant caveat statements): Early Breast Cancer For detailed information on the inclusion criteria … for the clinical trials of trastuzumab in early breast cancer according to the TNM (Tumour, Node, Metastasis) …
Product Type: Drug
Control Number: 212140
DIN(s): 02483467, 02483475
Manufacturer: Pfizer Canada ULC
Submission Type: New Drug Submission
Date Filed / Submission Date: 2017-12-15
Issued / Original Publication Date: 2020-02-04
Decision / Authorization Date: 2019-08-15
Updated Date: 2024-08-12
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SSR00183
… for sale in Canada to treat certain types of blood cancer. Health Canada reviewed the potential risk of … drug authorized for sale in Canada to treat 2 types of cancers: chronic lymphocytic leukemia (cancer of the blood and bone marrow), when used together …
Issued / Original Publication Date: 2017-12-15
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00428
… diagnosed by five years of age. According to the Canadian Cancer Society (CCS), approximately 380 children in the age … of dinutuximab manufactured by the United States National Cancer Institute (NCI) and dinutuximab manufactured by … dinutuximab, manufactured by the United States National Cancer Institute (NCI) and dinutuximab, manufactured by …
Product Type: Drug
Control Number: 212066
DIN(s): 02483076
Manufacturer: United Therapeutics Corporation
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2017-12-14
Issued / Original Publication Date: 2019-05-06
Decision / Authorization Date: 2018-11-28
Updated Date: 2024-03-01