Review decisions
Showing 510 results of 688 total
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SSR00108
… (fingolimod): Safety information on the risk of skin cancer and a rare brain infection . September 30, 2015. …
Issued / Original Publication Date: 2016-08-19
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SSR00114
… receptor modulators (SERMs) Potential Safety Issue Ovarian cancer in menopausal women Key Messages Hormone replacement … a study showing a potential for increased risk of ovarian cancer in women undergoing HRT for less than 5 years. As of … includes warning statements about the risk of ovarian cancer during treatment, especially after 5 years of …
Issued / Original Publication Date: 2016-08-09
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SSR00102
… Yondelis is used alone to treat some advanced soft tissue cancers, or together with another drug to treat ovarian cancer, when other treatments did not work. This safety … Use in Canada Yondelis is used alone to treat some advanced cancers, such as those from fat cells (liposarcoma) or from …
Issued / Original Publication Date: 2016-08-04
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00151
… (including intracranial hemorrhages), non-melanoma skin cancers (including basal and squamous cell carcinoma), and …
Product Type: Drug
Control Number: 190730
Manufacturer: Janssen Inc.
Submission Type: Supplement to a New Drug Submission - Priority Review
Date Filed / Submission Date: 2015-12-21
Decision / Authorization Date: 2016-07-19
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00356
… First-line treatment of extensive-stage small cell lung cancer (ES-SCLC) First-line treatment of non-small cell lung cancer (NSCLC) First-line treatment of hepatocellular … of locally advanced or metastatic triple-negative breast cancer (TNBC) In addition, the submission was filed for …
Product Type: Drug
Control Number: 196843
DIN(s): 02462990
Manufacturer: Hoffmann-La Roche Ltd.
Submission Type: New Drug Submission (New Active Substance) - Notice of Compliance with Conditions
Date Filed / Submission Date: 2016-07-18
Issued / Original Publication Date: 2017-05-30
Decision / Authorization Date: 2017-04-12
Updated Date: 2025-06-03
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00181
… with HCV and HBV, and an increase in cases of early liver cancer recurrence - postulated to be based on a disruption …
Product Type: Drug
Control Number: 190521
DIN(s): 02456370
Manufacturer: Gilead Sciences Canada Inc.
Submission Type: New Drug Submission (New Active Substance) - Priority Review
Date Filed / Submission Date: 2015-12-14
Decision / Authorization Date: 2016-07-11
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00329
… (Assessing the potential risk of new or returning liver cancer named hepatocellular carcinoma). Summary Safety … for Epclusa related to hepatocellular carcinoma (liver cancer). NC # 212690 2018-01-10 Issued NOL 2018-04-16 … antivirals posted (Assessing the potential risk of liver cancer recurrence). Information Update Not applicable Posted …
Product Type: Drug
Control Number: 190521
DIN(s): 02456370
Manufacturer: Gilead Sciences Canada Inc.
Submission Type: New Drug Submission
Issued / Original Publication Date: 2016-07-11
Updated Date: 2022-10-28
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00135
… receptor (EGFR) T790M mutation-positive non-small cell lung cancer (NSCLC) who have progressed on or after EGFR tyrosine …
Product Type: Drug
Control Number: 188171
DIN(s): 02456214, 02456222
Manufacturer: AstraZeneca Canada Inc.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2015-10-01
Decision / Authorization Date: 2016-07-05
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SSR00093
… as a less common side effect for people with advanced bone cancer, but not for Prolia. Overview A safety review was … (less common side effect for people with advanced bone cancer), but not for Prolia. Use in Canada Prolia is used to … of bone fracture due to treatments for certain types of cancer (breast cancer or prostate cancer). Xgeva is used to …
Issued / Original Publication Date: 2016-06-06
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00130
… of adult patients with platinum-sensitive relapsed breast cancer susceptibility gene ( BRCA )-mutated (germline and/or somatic) high grade serous ovarian cancer (including fallopian tube or primary peritoneal) who … deleterious germline BRCA -mutated advanced ovarian cancer who have been treated with three or more prior lines …
Product Type: Drug
Control Number: 182823
Manufacturer: AstraZeneca Canada Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2015-03-16
Decision / Authorization Date: 2016-04-29