Review decisions
Showing 620 results of 688 total
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00194
… treatment of patients with metastatic non-small cell lung cancer (NSCLC) with a BRAF V600 mutation. Regulatory … the treatment of patients with metastic non-small cell lung cancer (NSNLN) with a BRAF V600 mutation whose disease has … Cutaneous melanoma is the most aggressive form of skin cancer. Systematic treatment options for unresectable or …
Product Type: Drug
Control Number: 157590
DIN(s): 02409607, 02409615, 02540053
Manufacturer: GlaxoSmithKline Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2012-07-31
Issued / Original Publication Date: 2013-10-09
Decision / Authorization Date: 2013-07-16
Updated Date: 2025-03-06
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00276
… profile of Grastofil is favourable for the following: Cancer Patients Receiving Myelosuppressive Chemotherapy … Grastofil is indicated in adult and pediatric patients with cancer receiving myelosuppressive chemotherapy. A complete … and consolidation treatment for acute myeloid leukemia. Cancer Patients Receiving Myeloablative Chemotherapy …
Product Type: Drug
Control Number: 156897
DIN(s): 02441489, 02454548
Manufacturer: Apotex Inc.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2012-07-16
Issued / Original Publication Date: 2016-04-27
Decision / Authorization Date: 2015-12-07
Updated Date: 2024-05-31
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00192
… (5 in placebo, 0 in Striverdi Respimat 5 µg), and lung cancer (0 in placebo, 1 in Striverdi Respimat 5 µg). Serious …
Product Type: Drug
Control Number: 155649
Manufacturer: Boehringer Ingelheim Canada Ltd./Ltée.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2012-06-28
Issued / Original Publication Date: 2013-08-09
Decision / Authorization Date: 2013-06-11
Updated Date: 2023-05-29
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00170
… to MMAE. Non-clinical studies have demonstrated the anti-cancer activity of brentuximab vedotin. Data from these studies suggest that this anti-cancer activity is due to the binding of the ADC to … Non-clinical data suggest that Adcetris exerts its anti-cancer activity through the binding of the ADC to …
Product Type: Drug
Control Number: 154851
DIN(s): 02401347
Manufacturer: Seattle Genetics, Inc.
Submission Type: New Drug Submission (New Active Substance) - Notice of Compliance with Conditions
Date Filed / Submission Date: 2012-04-11
Issued / Original Publication Date: 2013-04-03
Decision / Authorization Date: 2013-02-01
Updated Date: 2025-05-28
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00200
… of serious heart-related problems, fatal blood clots and cancer), containing new safety information for health … Risks of Serious Heart-related Problems, Blood Clots, Cancer and Death. SNDS # 258173 2021-10-29 Issued NOC … and increased risk of serious heart-related issues and cancer), containing information about product safety for …
Product Type: Drug
Control Number: 154642
DIN(s): 02423898, 02470608, 02480786
Manufacturer: Pfizer Canada Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2012-04-03
Issued / Original Publication Date: 2014-06-11
Decision / Authorization Date: 2014-04-17
Updated Date: 2026-01-12
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00212
… the supervision of a physician qualified in the use of cancer therapies and with a full understanding of the risks … different studies of vismodegib in patients with different cancers. A safety study report was provided. In summary, …
Product Type: Drug
Control Number: 154608
DIN(s): 02409267
Manufacturer: Hoffmann-La Roche Ltd.
Submission Type: New Drug Submission (New Active Substance) - Notice of Compliance with Conditions
Date Filed / Submission Date: 2012-04-02
Issued / Original Publication Date: 2013-08-22
Decision / Authorization Date: 2013-07-12
Updated Date: 2025-07-29
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