Review decisions
Showing 160 results of 342 total
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00569
… considered favourable for the following indications: Cancer patients receiving myelosuppressive chemotherapy … Nypozi is indicated in adult and pediatric patients with cancer receiving myelosuppressive chemotherapy. A complete … and consolidation treatment for acute myeloid leukemia. Cancer patients receiving myeloablative chemotherapy …
Product Type: Drug
Control Number: 220512
DIN(s): 02520990, 02521008
Manufacturer: Tanvex BioPharma USA, Inc.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2019-01-17
Issued / Original Publication Date: 2022-01-18
Decision / Authorization Date: 2021-10-08
Updated Date: 2024-06-19
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00474
… of serious heart-related problems, fatal blood clots and cancer ), containing labelling information for healthcare … Risks of Serious Heart-related Problems, Blood Clots, Cancer and Death ). SNDS # 262176 2022-03-08 Issued NOC … Events (MACE, serious heart-related problems), malignancy (cancer), and thrombosis (blood clots). Drug product (DIN …
Product Type: Drug
Control Number: 223734
DIN(s): 02495155, 02520893, 02539721
Manufacturer: AbbVie Corporation
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2019-01-16
Issued / Original Publication Date: 2020-05-05
Decision / Authorization Date: 2019-12-23
Updated Date: 2025-06-09
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00471
… associated with Mayzent may increase the risk of cancer but such an increased risk cannot be well … similar rate with Mayzent and placebo. Other types of skin cancer (e.g., malignant melanoma, squamous cell carcinoma) and non-cutaneous cancers (seminoma) were reported only in patients treated …
Product Type: Drug
Control Number: 223225
DIN(s): 02496429, 02496437, 02543370
Manufacturer: Novartis Pharmaceuticals Canada Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2018-12-21
Issued / Original Publication Date: 2020-04-29
Decision / Authorization Date: 2020-02-20
Updated Date: 2025-03-07
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00564
… mg may be associated with an increased risk of endometrial cancer. While current Osphena trials have not shown any cases of endometrial cancer with treatment exposure up to 52 weeks, one patient … there is a potential increased risk of endometrial cancer in a woman with a uterus who uses unopposed …
Product Type: Drug
Control Number: 222001
DIN(s): 02518112
Manufacturer: Duchesnay Inc.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2018-11-19
Issued / Original Publication Date: 2021-12-08
Decision / Authorization Date: 2021-07-16
Updated Date: 2024-06-13
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00455
… clinical benefit. Tropomyosin receptor kinase (TRK) fusion cancer is defined by the presence of a specific type of … in cell proliferation and survival, leading to TRK fusion cancer. Current estimates indicate that an NTRK gene fusion … fusions are present at low frequencies in some common adult cancers, such as non-small cell lung cancer (NSCLC), …
Product Type: Drug
Control Number: 219998
DIN(s): 02490315, 02490323, 02490331
Manufacturer: Bayer Inc.
Submission Type: New Drug Submission (New Active Substance) - Notice of Compliance with Conditions
Date Filed / Submission Date: 2018-09-18
Issued / Original Publication Date: 2019-12-18
Decision / Authorization Date: 2019-07-10
Updated Date: 2025-06-04
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00443
… Libtayo for the treatment of adult patients with cervical cancer who have progressed on or after prior platinum-based … treatment of adult patients with non-small cell lung cancer (NSCLC) expressing programmed cell death ligand 1 … In Canada, CSCC is the second most common non-melanoma skin cancer, after basal cell carcinoma. The vast majority of …
Product Type: Drug
Control Number: 218718
DIN(s): 02487144, 02487152
Manufacturer: Sanofi-Aventis Canada Inc.
Submission Type: New Drug Submission (New Active Substance) - Notice of Compliance with Conditions
Date Filed / Submission Date: 2018-07-27
Issued / Original Publication Date: 2019-08-27
Decision / Authorization Date: 2019-04-10
Updated Date: 2024-12-06
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00442
… Yescarta, and Carvykti related to T-cell malignancy (cancer that forms in white blood cells called T cells). SNDS …
Product Type: Drug
Control Number: 218389
DIN(s): 02485648
Manufacturer: Gilead Sciences Canada Inc.
Submission Type: New Drug Submission (New Active Substance) - Priority Review
Date Filed / Submission Date: 2018-07-23
Issued / Original Publication Date: 2019-08-15
Decision / Authorization Date: 2019-02-13
Updated Date: 2026-03-16
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00461
… with metastatic HER2-overexpressed/amplified breast cancer, who have received two or more prior anti-HER2-based … factor receptor 2 (HER2)-overexpressed/amplified breast cancer within one year after completion of trastuzumab-based … factor receptor (HER2)-overexpressed/amplified breast cancer within one year after completion of trastuzumab-based …
Product Type: Drug
Control Number: 218224
DIN(s): 02490536
Manufacturer: Puma Biotechnology Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2018-07-19
Issued / Original Publication Date: 2020-01-29
Decision / Authorization Date: 2019-07-16
Updated Date: 2023-12-07
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00439
… a recommendation for using caution and monitoring for cancer progression during and after use of Oxervate in … a recommendation for using caution and monitoring for cancer progression during and after use of Oxervate in …
Product Type: Drug
Control Number: 218145
DIN(s): 02485613
Manufacturer: Dompé farmaceutici S.p.A.
Submission Type: New Drug Submission (New Active Substance) - Priority Review
Date Filed / Submission Date: 2018-07-16
Issued / Original Publication Date: 2019-07-24
Decision / Authorization Date: 2019-02-08
Updated Date: 2024-12-16
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00449
… include relevant caveat statements): Metastatic Colorectal Cancer Zirabev in combination with fluoropyrimidine-based … given to current standard of care guidelines for colorectal cancer. See Drug-Drug Interactions section of the Zirabev … Advanced, Metastatic or Recurrent Non-Small Cell Lung Cancer Zirabev, in combination with carboplatin/paclitaxel …
Product Type: Drug
Control Number: 218183
DIN(s): 02489430, 02489449
Manufacturer: Pfizer Canada ULC., on behalf of BioNTech Manufacturing GmbH
Submission Type: New Drug Submission
Date Filed / Submission Date: 2018-07-13
Issued / Original Publication Date: 2019-11-15
Decision / Authorization Date: 2019-06-14
Updated Date: 2024-03-08