Review decisions
Showing 220 results of 342 total
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00290
Product Type: Drug
Control Number: 184479
DIN(s): 02451034
Manufacturer: Amgen Canada Inc.
Submission Type: New Drug Submission
Issued / Original Publication Date: 2016-03-15
Updated Date: 2011-11-02
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00286
Product Type: Drug
Control Number: 181399
DIN(s): 02449498
Manufacturer: Gilead Sciences Canada Inc.
Submission Type: New Drug Submission
Issued / Original Publication Date: 2016-01-26
Updated Date: 2021-11-12
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00339
… of BCL-2 in various hematologic malignancies contributes to cancer cell survival by binding and sequestering high levels … resulting in programmed cell death (apoptosis) of the cancer cells. In non-clinical studies, venetoclax has … resulting in programmed cell death (apoptosis) of the cancer cells. The pharmacokinetics of venetoclax was …
Product Type: Drug
Control Number: 190761
DIN(s): 02458039, 02458047, 02458055, 02458063
Manufacturer: AbbVie Corporation
Submission Type: New Drug Submission (New Active Substance) - Notice of Compliance with Conditions
Date Filed / Submission Date: 2015-12-18
Issued / Original Publication Date: 2016-12-22
Decision / Authorization Date: 2016-09-30
Updated Date: 2023-02-28
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00334
… the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire and Multiple Myeloma … (ICH) S9 guideline on Nonclinical Evaluation for Anticancer Pharmaceuticals (2009), stand-alone safety pharmacology studies in patients with advanced cancer are not necessary. The non-clinical toxicology …
Product Type: Drug
Control Number: 190498
DIN(s): 02456796, 02456818, 02456826
Manufacturer: Takeda Canada Inc.
Submission Type: New Drug Submission (New Active Substance) - Priority Review
Date Filed / Submission Date: 2015-12-14
Issued / Original Publication Date: 2016-10-21
Decision / Authorization Date: 2016-08-04
Updated Date: 2025-03-05
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00340
… to Adynovate. There was one death due to an unrelated cancer. The most common adverse events related to Adynovate …
Product Type: Drug
Control Number: 189709
DIN(s): 02459035, 02459043, 02459051, 02459078, 02498537, 02498545, 02498553, 02498561, 02498588, 02498596, 02498618, 02498626
Manufacturer: Baxalta Canada Corporation
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2015-12-02
Issued / Original Publication Date: 2016-12-30
Decision / Authorization Date: 2016-11-17
Updated Date: 2023-11-01
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00332
… anaplastic lymphoma kinase ALK-positive non-small cell lung cancer (NSCLC). The submission was reviewed and considered … to curative therapy) 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. The submission was reviewed and considered …
Product Type: Drug
Control Number: 189442
DIN(s): 02458136
Manufacturer: Hoffmann-La Roche Ltd.
Submission Type: New Drug Submission (New Active Substance) - Notice of Compliance with Conditions
Date Filed / Submission Date: 2015-11-12
Issued / Original Publication Date: 2016-10-31
Decision / Authorization Date: 2016-09-29
Updated Date: 2026-02-09
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00180
Product Type: Drug
Control Number: 172616
Manufacturer: Bristol-Myers Squibb Canada Co.
Submission Type: New Drug Submission
Issued / Original Publication Date: 2015-10-27
Updated Date: 2020-10-13
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/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/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