Review decisions
Showing 580 results of 688 total
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SSR00046
… the brain, with the use of YERVOY (ipilimumab), an anti-cancer agent. The review was prompted by a published case … medicine used to treat melanoma (a kind of skin cancer) that has spread or cannot be removed by surgery. It …
Issued / Original Publication Date: 2014-12-01
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/SSR00051
… the immune system to attack the body (autoimmunity), blood cancers (leukemia), and a severe decline in the number of …
Issued / Original Publication Date: 2014-10-09
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SSR00053
… with Acquired Immunodeficiency Syndrome (AIDS), certain cancers, tuberculosis or organ transplantation may be at …
Issued / Original Publication Date: 2014-09-30
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SSR00054
… with chemotherapy to treat colon, rectal, or lung cancers. It is also conditionally approved to be used to treat a particular type of brain cancer called glioblastoma. AVASTIN is given through a … patients being treated with AVASTIN for various types of cancer. Health Canada also received 27 reports of …
Issued / Original Publication Date: 2014-09-29
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
Summary Safety Review - NEUPOGEN (filgrastim) and NEULASTA (pegfilgrastim) - Capillary Leak Syndrome
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SSR00056
… marrow transplant, and in persons who had received anti-cancer drugs. International data A search of the … All the cases were reported to have also involved an anti-cancer therapy. Twenty-seven cases occurred after receiving …
Issued / Original Publication Date: 2014-07-29
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