Review decisions
Showing 560 results of 688 total
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00013
… treatment of patients with advanced or metastatic gastric cancer or gastro-esophageal junction adenocarcinoma with …
Product Type: Drug
Control Number: 176810
DIN(s): 02443805
Manufacturer: Eli Lilly Canada Inc.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2014-07-28
Decision / Authorization Date: 2015-07-16
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00033
… constipation (OIC) in adult patients with non-cancer pain who have had an inadequate response to … indication was then restricted to adult patients with non-cancer pain who have had an inadequate response to … with OIC treated with opioids for at least 4 weeks for non-cancer pain [number of patients (n) = 1,337]. The mean age …
Product Type: Drug
Control Number: 167790
DIN(s): 02442167, 02442175
Manufacturer: AstraZeneca Canada Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2013-08-30
Decision / Authorization Date: 2015-06-02
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SSR00026
… It is used to increase bone mass in men with prostate cancer that has not spread (nonmetastatic) and who are … It is used to increase bone mass in women with breast cancer that has not spread (nonmetastatic), who are taking …
Issued / Original Publication Date: 2015-05-29
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SSR00027
… dysfunction Key Messages NEXAVAR (sorafenib) is an anti-cancer drug from the multikinase inhibitor family of drugs … used to treat specific types of liver, kidney, and thyroid cancers in adults. A safety review was done after a case of … form of hyperthyroidism. Use in Canada NEXAVAR is an anti-cancer drug from the multikinase inhibitor family of drugs …
Issued / Original Publication Date: 2015-05-28
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00008
… first recurrence of platinum-sensitive epithelial ovarian cancer (EOC), fallopian tube cancer (FTC) and primary peritoneal cancer (PPC). These patients should not have received prior …
Product Type: Drug
Control Number: 170054
Manufacturer: Hoffmann-La Roche Ltd.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2013-11-15
Decision / Authorization Date: 2015-05-15
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00060
… of patients with metastatic castration resistant prostate cancer (CRPC) who have received prior chemotherapy treatment …
Product Type: Drug
Control Number: 177983
Manufacturer: Astellas Pharma Canada Inc.
Submission Type: Supplement to a New Drug Submission - Priority Review
Date Filed / Submission Date: 2014-09-15
Decision / Authorization Date: 2015-04-15
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00083
… acts by targeting several proteins on the surface of cancer cells, as well as targets within the cell. By …
Product Type: Drug
Control Number: 165121
DIN(s): 02437333, 02437341
Manufacturer: ARIAD Pharmaceuticals, Inc.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2013-05-23
Decision / Authorization Date: 2015-04-02
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00250
Product Type: Drug
Control Number: 174739
DIN(s): 02436027
Manufacturer: AbbVie Corporation
Submission Type: New Drug Submission
Issued / Original Publication Date: 2015-03-19
Updated Date: 2020-10-08
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SSR00035
… regarding the possibility of an increased risk of the cancerous (malignant) brain tumour called … did not find an increased risk of glioblastoma or other cancers associated with TNF blockers. Observational studies … did not find an increased risk of glioblastoma or other cancers with TNF blockers. Conclusions and actions Given the …
Issued / Original Publication Date: 2015-03-18
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00292
… epithelial ovarian, fallopian tube or primary peritoneal cancer: Who are in response (complete or partial) to prior … chemotherapy in combination with bevacizumab and Whose cancer is associated with homologous recombination … 2023 (SNDS #265427) for the indication to treat prostate cancer, and to update the PM with the data from this study. …
Product Type: Drug
Control Number: 182823
DIN(s): 02475200, 02475219
Manufacturer: AstraZeneca Canada Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2015-03-16
Issued / Original Publication Date: 2016-07-12
Decision / Authorization Date: 2016-04-29
Updated Date: 2025-07-31