Review decisions
Showing 280 results of 342 total
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00256
… the clinical safety of Istodax in patients with advanced cancer and moderate or severe hepatic impairment, is … Study of single-dose romidepsin in patients with advance cancer and moderate or severe hepatic impairment. It is … Istodax (romidepsin) is an agent in a class of anticancer agents known as a histone deacetylase (HDAC) …
Product Type: Drug
Control Number: 152293
DIN(s): 02414295
Manufacturer: Celgene Inc.
Submission Type: New Drug Submission (New Active Substance) - Notice of Compliance with Conditions
Date Filed / Submission Date: 2011-12-22
Issued / Original Publication Date: 2013-11-26
Decision / Authorization Date: 2013-10-16
Updated Date: 2026-01-26
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00173
… with CML have the Philadelphia chromosome; therefore this cancer is typically referred to as Philadelphia chromosome … enzymes, and neutropenia. Fewer patients in the advanced cancer groups discontinued due to AEs since in most of these … for drug efflux transporters P-glycoprotein (P-gp), breast cancer resistance protein (BCRP) and multidrug resistance …
Product Type: Drug
Control Number: 152211
DIN(s): 02419149, 02419157, 02483793
Manufacturer: Pfizer Canada Inc.
Submission Type: New Drug Submission (New Active Substance) - Notice of Compliance with Conditions
Date Filed / Submission Date: 2011-12-16
Issued / Original Publication Date: 2014-05-14
Decision / Authorization Date: 2014-03-07
Updated Date: 2023-06-01
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00079
Product Type: Drug
Control Number: 151723
DIN(s): 02388006, 02388014, 02388022
Manufacturer: Novartis Pharmaceuticals Canada Inc.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2011-11-29
Issued / Original Publication Date: 2012-11-06
Updated Date: 2012-06-19
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00274
… interaction with organic anion transporter 3 (OAT3); breast cancer resistant protein (BCRP) transporter and organic …
Product Type: Drug
Control Number: 160646
DIN(s): 02416328
Manufacturer: Genzyme Canada a division of Sanofi-Aventis Canada Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2011-11-29
Issued / Original Publication Date: 2014-01-20
Decision / Authorization Date: 2013-11-14
Updated Date: 2024-12-16
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00152
Product Type: Drug
Control Number: 149814
DIN(s): 02392550, 02392569
Manufacturer: Lundbeck Canada Inc.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2011-09-08
Issued / Original Publication Date: 2012-12-10
Updated Date: 2012-08-24
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00164
Product Type: Drug
Control Number: 148693
DIN(s): 02380242
Manufacturer: Hoffmann-La Roche Ltd.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2011-07-18
Issued / Original Publication Date: 2012-05-30
Updated Date: 2012-02-15
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00071
Product Type: Drug
Control Number: 144404
DIN(s): 02389630, 02389649
Manufacturer: Pfizer Canada Inc.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2011-06-28
Issued / Original Publication Date: 2012-11-06
Updated Date: 2012-07-12
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00185
… increased risks of breast, prostate and colorectal cancer. The Reconsideration Panel stated that IGF-1 levels …
Product Type: Drug
Control Number: 131836
DIN(s): 02423677
Manufacturer: Theratechnologies Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2011-06-17
Issued / Original Publication Date: 2014-07-11
Decision / Authorization Date: 2014-04-29
Updated Date: 2023-07-24
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00312
Product Type: Drug
Control Number: 145155
DIN(s): 02384256, 02384264
Manufacturer: Pfizer Canada Inc.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2011-06-08
Issued / Original Publication Date: 2012-07-26
Updated Date: 2012-04-25
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00004
Product Type: Drug
Control Number: 145491
DIN(s): 02381710, 02381729
Manufacturer: Eisai Ltd.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2011-03-31
Issued / Original Publication Date: 2012-08-21
Updated Date: 2012-03-14