Review decisions
Showing 240 results of 342 total
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00279
… due to SAEs (fatal gastrointestinal hemorrhage and prostate cancer). The other withdrawals were due to angioedema …
Product Type: Drug
Control Number: 179850
DIN(s): 02449781, 02492989, 02492997, 02530821
Manufacturer: GlaxoSmithKline Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2014-11-19
Issued / Original Publication Date: 2016-03-01
Decision / Authorization Date: 2015-12-03
Updated Date: 2025-08-15
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00337
… and abdominal bloating in adults with chronic, non-cancer pain. Due to insufficient evidence of efficacy to …
Product Type: Drug
Control Number: 179333
Manufacturer: Sucampo Pharma Americas, LLC
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2014-10-31
Issued / Original Publication Date: 2015-12-24
Decision / Authorization Date: 2015-10-14
Updated Date: 2023-06-30
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00242
… or signaling of immune cells). However, no Repatha-related cancer signals were observed in any tissue in a lifetime …
Product Type: Drug
Control Number: 178234
DIN(s): 02446057, 02459779
Manufacturer: Amgen Canada Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2014-09-25
Issued / Original Publication Date: 2016-01-29
Decision / Authorization Date: 2015-09-10
Updated Date: 2025-06-10
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00236
… was investigated in both healthy volunteers and cancer patients and included a food-effect study. The …
Product Type: Drug
Control Number: 176043
DIN(s): 02443066, 02443074
Manufacturer: Boehringer Ingelheim Canada Ltd./Ltée.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2014-07-09
Issued / Original Publication Date: 2015-08-21
Decision / Authorization Date: 2015-06-25
Updated Date: 2024-08-08
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00227
… with unresectable locally advanced or metastatic urothelial cancer (mUC) with no prior systemic therapy for mUC. The … (MSI-H) or mismatch repair deficient (dMMR) colorectal cancer progressed after first line treatment or endometrial cancer progressed after prior therapy with no satisfactory …
Product Type: Drug
Control Number: 175884
DIN(s): 02456869
Manufacturer: Merck Canada Inc.
Submission Type: New Drug Submission (New Active Substance) - Notice of Compliance with Conditions
Date Filed / Submission Date: 2014-06-26
Issued / Original Publication Date: 2015-07-23
Decision / Authorization Date: 2015-05-19
Updated Date: 2022-10-28
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00206
… locally advanced or metastatic non-small cell lung cancer. Regulatory Decision Summary published. SNDS # 207972 … to curative therapy) or metastatic non-small cell lung cancer (NSCLC) who have progressed on or who were intolerant … to curative therapy) or metastatic non-small cell lung cancer (NSCLC) who have progressed on or who were intolerant …
Product Type: Drug
Control Number: 175702
DIN(s): 02436779
Manufacturer: Novartis Pharmaceuticals Canada Inc.
Submission Type: New Drug Submission (New Active Substance) - Notice of Compliance with Conditions
Date Filed / Submission Date: 2014-06-16
Issued / Original Publication Date: 2015-06-17
Decision / Authorization Date: 2015-03-27
Updated Date: 2026-01-26
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00261
… of phenylbutyrate, was administered intravenously to cancer patients. Symptoms, chiefly somnolence and dizziness, …
Product Type: Drug
Control Number: 175573
DIN(s): 02436663
Manufacturer: Medunik Canada
Submission Type: New Drug Submission (New Active Substance) - Priority Review
Date Filed / Submission Date: 2014-06-13
Issued / Original Publication Date: 2015-05-01
Decision / Authorization Date: 2015-01-26
Updated Date: 2025-08-27
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00248
… be used in patients with HER 2 positive metastatic breast cancer. In addition, two minor revisions were also proposed …
Product Type: Drug
Control Number: 158730
DIN(s): 02415666, 02415674, 02415682
Manufacturer: Boehringer Ingelheim Canada Ltd./Ltée.
Submission Type: New Drug Submission
Issued / Original Publication Date: 2014-05-12
Updated Date: 2021-11-02
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00193
… ways to lymphomas but is not considered to be a form of cancer. The global incidence of CD is rare and estimated at … ways to lymphomas but is not considered to be a form of cancer. In the multicentric form of Castleman's disease … patients. Symptomatic disease was defined with National Cancer Institute Common Terminology Criteria Adverse Event …
Product Type: Drug
Control Number: 174291
DIN(s): 02435128, 02435136
Manufacturer: Janssen Inc.
Submission Type: New Drug Submission (New Active Substance) - Priority Review
Date Filed / Submission Date: 2014-04-28
Issued / Original Publication Date: 2015-05-15
Decision / Authorization Date: 2014-12-03
Updated Date: 2026-02-16
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00252
… Chronic lymphocytic leukemia (CLL) is a hematologic cancer characterized by an accumulation of monoclonal mature … Chronic lymphocytic leukemia (CLL) is a hematologic cancer characterized by an accumulation of monoclonal mature … available to most physicians treating patients with blood cancers in Canada, it is possible to identify patients with …
Product Type: Drug
Control Number: 174029
DIN(s): 02434407, 02486733, 02486741, 02486768, 02486776, 02540215
Manufacturer: Janssen Inc.
Submission Type: New Drug Submission (New Active Substance) - Priority Review
Date Filed / Submission Date: 2014-04-17
Issued / Original Publication Date: 2015-03-18
Decision / Authorization Date: 2014-11-17
Updated Date: 2026-02-26