Review decisions
Showing 380 results of 688 total
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00551
… intravenous antibiotics), malignancies (non-melanoma skin cancers and melanoma skin cancers), and major adverse cardiovascular events. Based on … intravenous antibiotics), malignancies (non-melanoma skin cancers and melanoma skin cancers), and major adverse …
Product Type: Drug
Control Number: 224036
DIN(s): 02516098
Manufacturer: Sun Pharma Global FZE
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2019-01-25
Issued / Original Publication Date: 2021-09-15
Decision / Authorization Date: 2021-05-19
Updated Date: 2023-10-11
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/RDS00559
… of neutropenia in patients with Stage II/III breast cancer receiving 6 cycles of TAC (docetaxel, doxorubicin, …
Product Type: Drug
Control Number: 200807
DIN(s): 02484153
Manufacturer: BGP Pharma ULC
Submission Type: New Drug Submission
Date Filed / Submission Date: 2018-01-19
Decision / Authorization Date: 2018-12-24
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00473
… and/or visceral site lesions as well as decreases in blood cancer cell counts were also reported in patients treated …
Product Type: Drug
Control Number: 213996
Manufacturer: Seattle Genetics Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2018-02-28
Decision / Authorization Date: 2018-12-21
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/SSR00213
… for sale in Canada for the treatment of various types of cancer, including kidney, liver and soft tissue cancers. Health Canada reviewed the potential risk of 2 … for the treatment of various types of advanced/metastatic cancers, including kidney (renal cell carcinoma), liver …
Issued / Original Publication Date: 2018-12-03
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SSR00211
… to prevent sunburns and reduce the risk of developing skin cancer. The use of sunscreen is an important part of overall … of sunscreen to prevent sunburn and reduce the risk of skin cancer continue to greatly outweigh any risk of local skin … to prevent sunburn and reduce the risk of developing skin cancer. Overview In 2017, Health Canada received a greater …
Issued / Original Publication Date: 2018-11-26
Updated Date: 2020-06-26
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00478
… an additional product claim for treating patients with Cancer Associated Thrombosis and to revise the associated … and prevention of recurrence in patients with cancer. Revised Duration of Use Statement: A dose of 175 …
Product Type: Drug
Control Number: 199839
Manufacturer: Leo Pharma Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2016-10-30
Decision / Authorization Date: 2018-11-22
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