Review decisions
Showing 270 results of 342 total
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00232
… therapies ( Assessing the potential risk of pancreatic cancer ). New safety review started by Health Canada Not … safety data in this population. Pancreatitis and Pancreatic Cancer In the Phase II/III clinical studies, acute … with regards to a possible increased risk of pancreatic cancer associated with use of the DPP-4 inhibitors and …
Product Type: Drug
Control Number: 158335
DIN(s): 02417189, 02417197, 02417200
Manufacturer: Takeda Canada Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2012-08-29
Issued / Original Publication Date: 2014-02-10
Decision / Authorization Date: 2013-11-27
Updated Date: 2025-03-04
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00189
… for the treatment of patients with metastatic colorectal cancer (CRC) who have been previously treated with … for the treatment of patients with metastatic colorectal cancer (CRC) who have been previously treated with … for the treatment of patients with metastatic colorectal cancer (CRC) who have been previously treated with …
Product Type: Drug
Control Number: 157970
DIN(s): 02403390
Manufacturer: Bayer Inc.
Submission Type: New Drug Submission (New Active Substance) - Priority Review
Date Filed / Submission Date: 2012-08-15
Issued / Original Publication Date: 2013-05-07
Decision / Authorization Date: 2013-03-11
Updated Date: 2026-03-09
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00228
… naïve) patients with metastic non-small cell lung cancer (NSCLC) with a BRAF V600 mutation. Regulatory … treatment of patients with metastatic non-small cell lung cancer (NSCLC) 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: 157665
DIN(s): 02409623, 02409658, 02539993
Manufacturer: GlaxoSmithKline Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2012-08-03
Issued / Original Publication Date: 2014-02-13
Decision / Authorization Date: 2013-07-18
Updated Date: 2025-06-06
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00198
… death were reported as cardiac disorders, followed by lung cancer. Of the 5 cardiovascular deaths, 2 were sudden … death were classed as cardiac disorders, followed by lung cancer. Of the 5 cardiovascular deaths, 2 were sudden …
Product Type: Drug
Control Number: 157598
DIN(s): 02409720
Manufacturer: Almirall, S.A.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2012-07-31
Issued / Original Publication Date: 2013-09-24
Decision / Authorization Date: 2013-07-29
Updated Date: 2023-09-25
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