Review decisions
Showing 550 results of 688 total
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00285
Product Type: Drug
Control Number: 165145
Manufacturer: GlaxoSmithKline Canada Inc.
Submission Type: New Drug Submission
Issued / Original Publication Date: 2015-10-08
Updated Date: 2018-05-22
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SSR00015
… Product Remicade (infliximab) Potential Safety Issue Blood cancers (lymphoma, hepatosplenic T-cell lymphoma, and … review to evaluate the risk of developing three types of cancers (lymphoma, hepatosplenic T-cell lymphoma, and … analysis of the reports found no association between these cancers with Remicade use for psoriasis. A review of …
Issued / Original Publication Date: 2015-09-29
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00007
… ovarian (EOC), fallopian tube (FTC), or primary peritoneal cancer (PPC) who received no more than two prior … for the treatment of recurrent platinum-resistant ovarian cancer in combination with paclitaxel, topotecan or …
Product Type: Drug
Control Number: 171255
Manufacturer: Hoffmann-La Roche Ltd.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2014-01-08
Decision / Authorization Date: 2015-09-28
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SSR00016
… and an increased risk of lymphomas and other malignant cancers, particularly of the skin. The Canadian product … tumour. Tumours can be further divided into those that are cancerous (malignant) and those that are non-cancerous (benign). Use in Canada Gilenya is a medicine used …
Issued / Original Publication Date: 2015-09-14
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SSR00018
… Key Messages VELCADE (bortezomib) is used to treat cancers of the bone marrow (multiple myeloma) and the … 1 , 2 Use in Canada VELCADE (bortezomib) is used to treat cancers of the bone marrow (multiple myeloma) and the …
Issued / Original Publication Date: 2015-09-03
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00338
… including elderly patients, patients with history of cancer, and patients using concomitant P-gp inhibitors, were …
Product Type: Drug
Control Number: 187363
DIN(s): 02458640, 02458659, 02458667
Manufacturer: Daiichi Sankyo, Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2015-09-03
Issued / Original Publication Date: 2016-12-21
Decision / Authorization Date: 2016-11-04
Updated Date: 2026-03-09
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00056
… oncogene) patients with untreated metastatic colorectal cancer (mCRC). Why was the decision issued? The pivotal …
Product Type: Drug
Control Number: 166626
Manufacturer: Amgen Canada Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2013-07-17
Decision / Authorization Date: 2015-08-31
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00179
… for the treatment of patients with metastatic colorectal cancer with disease progression on or after prior therapy … with locally advanced or metastatic non-small cell lung cancer (NSCLC) with disease progression on or after platinum …
Product Type: Drug
Control Number: 176810
DIN(s): 02443805
Manufacturer: Eli Lilly Canada Inc.
Submission Type: New Drug Submission
Issued / Original Publication Date: 2015-08-20
Updated Date: 2022-12-22
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00086
… including malignant melanoma, lung, bladder, and breast cancer, will be monitored as a post-market commitment …
Product Type: Drug
Control Number: 162552
DIN(s): 02443937, 02443945
Manufacturer: Boehringer Ingelheim Canada Ltd./Ltée.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2013-04-17
Decision / Authorization Date: 2015-07-23
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00205
Product Type: Drug
Control Number: 172652
DIN(s): 02438798, 02438801
Manufacturer: Gilead Sciences Canada Inc.
Submission Type: New Drug Submission
Issued / Original Publication Date: 2015-07-20
Updated Date: 2021-11-22