Review decisions
Showing 500 results of 688 total
Summary Safety Review - Incretin-Based Therapies - Assessing the Potential Risk of Pancreatic Cancer
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SSR00126
… metformin) and exenatide. Potential Safety Issue Pancreatic cancer Key Messages Incretin-based therapies are … therapies and an increased risk of pancreatic cancer. Health Canada's safety review concluded that there … therapies and an increased risk of pancreatic cancer. Worldwide, the number of case reports of pancreatic …
Issued / Original Publication Date: 2016-10-21
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SSR00141
… (fingolimod) Potential Safety Issue Abnormal tissue growth (cancer) Key Messages Gilenya (fingolimod) is used to treat … to conduct annual assessments of abnormal tissue growth (cancer), particularly those related to skin as associated … between Gilenya (fingolimod) and abnormal tissue growth (cancer). When a cancer forms a mass, it can commonly be …
Issued / Original Publication Date: 2016-10-19
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00236
… for Kuvan to inhibit P-glycoprotein (P-gp) and Breast Cancer Resistance Protein (BCRP) in the gut at therapeutic …
Product Type: Drug
Control Number: 186959
Manufacturer: Biomarin Pharmaceutical Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2015-08-14
Decision / Authorization Date: 2016-10-18
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00466
… is contraindicated in women with a known history of breast cancer. Therefore, the Warnings and Precautions section of … has not been studied in women with a history of breast cancer and recommends regular breast exams. A Risk … is contraindicated in women with a known history of breast cancer. Therefore, the Warnings and Precautions section of …
Product Type: Drug
Control Number: 198822
DIN(s): 02493500
Manufacturer: Endoceutics, Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2016-10-05
Issued / Original Publication Date: 2020-03-10
Decision / Authorization Date: 2019-11-01
Updated Date: 2025-08-19
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00375
… nausea and vomiting associated with highly emetogenic cancer chemotherapy Prevention of acute nausea and vomiting associated with moderately emetogenic cancer therapy that is uncontrolled by a 5-hydroxytryptamine … nausea and vomiting associated with highly emetogenic cancer chemotherapy Prevention of acute nausea and vomiting …
Product Type: Drug
Control Number: 196495
DIN(s): 02468735
Manufacturer: Purdue Pharma
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2016-10-03
Issued / Original Publication Date: 2018-01-10
Decision / Authorization Date: 2017-09-28
Updated Date: 2024-06-24
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00163
… locally advanced or metastatic non-small cell lung cancer (NSCLC) who have progressed on or are intolerant to … to curative therapy) or metastatic non-small cell lung cancer (NSCLC) is a life-threatening, incurable disease. …
Product Type: Drug
Control Number: 189442
DIN(s): 02458136
Manufacturer: Hoffmann-La Roche Ltd.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2015-11-12
Decision / Authorization Date: 2016-09-29
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00328
… in patients with stage IB-IIIA non-small cell lung cancer whose tumours have epidermal growth factor receptor … with locally advanced or metastatic non-small cell lung cancer whose tumours have epidermal growth factor receptor …
Product Type: Drug
Control Number: 188171
DIN(s): 02456214, 02456222
Manufacturer: AstraZeneca Canada Inc.
Submission Type: New Drug Submission
Issued / Original Publication Date: 2016-09-22
Updated Date: 2022-10-20
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00366
… female patients who received Ocrevus developed breast cancer, whereas no breast cancer was reported in the Rebif group. This information has … include but are not limited to: malignancies (e.g., breast cancer), serious/opportunistic infections, hepatitis B virus …
Product Type: Drug
Control Number: 198094
DIN(s): 02467224
Manufacturer: Hoffmann-La Roche Ltd.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2016-09-16
Issued / Original Publication Date: 2017-10-19
Decision / Authorization Date: 2017-08-14
Updated Date: 2024-02-23
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SSR00106
… Messages Bortezomib (Velcade and generics) is used to treat cancers of the bone marrow (multiple myeloma) and of the … Use in Canada VELCADE (bortezomib) is used to treat cancers of the bone marrow (multiple myeloma) and the … is used for the treatment of adult patients who have cancers of the bone marrow called Multiple Myeloma (MM) or …
Issued / Original Publication Date: 2016-08-26
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00161
… with locally advanced or metastatic non-small cell lung cancer (NSCLC) of squamous histology, and to update the … Why was the decision issued? Squamous non-small cell lung cancer (NSCLC) is a serious life threatening condition that … open label study in the metastatic squamous cell lung cancer second line setting of Giotrif versus erlotinib …
Product Type: Drug
Control Number: 187656
Manufacturer: Boehringer Ingelheim Canada Ltd./Ltée.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2015-09-14
Decision / Authorization Date: 2016-08-25