Review decisions
Showing 590 results of 688 total
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/SSR00059
… drugs are used for treating nausea and vomiting due to cancer therapy. This review identified a potential risk of … for the treatment of nausea and vomiting associated with cancer therapy in adults. However, individual drugs in this … of the intestine store about 90% of the body's serotonin. 6 Cancer therapy can damage the intestine and trigger the …
Issued / Original Publication Date: 2014-05-14
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
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00201
Product Type: Drug
Control Number: 161312
Manufacturer: Bayer Inc.
Submission Type: New Drug Submission
Issued / Original Publication Date: 2014-03-04
Updated Date: 2020-10-06
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00222
… 33, 45, 52 and 58 and oropharyngeal and other head and neck cancers caused by HPV types 16, 18, 31, 33, 45, 52, and 58. … to add an indication for prevention of anal dysplasia and cancer caused by human papillomavirus (HPV) types contained … included in the vaccine: Cervical, vulvar, and vaginal cancer caused by HPV types 16, 18, 31, 33, 45, 52, and 58 …
Product Type: Drug
Control Number: 170006
DIN(s): 02437058
Manufacturer: Merck Canada Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2014-02-13
Issued / Original Publication Date: 2015-08-11
Decision / Authorization Date: 2015-02-05
Updated Date: 2025-10-30
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00244
… submission was the potential risk of developing thyroid cancer with the use of Trulicity. Thyroid C‑cell tumors have … no evidence of adverse effects to the pancreas, pancreatic cancers must be considered a potential safety risk, as is … receptor agonists (e.g. liraglutide). The risk of thyroid cancer is captured in the Warnings and Precautions box and …
Product Type: Drug
Control Number: 168671
DIN(s): 02448572, 02448580, 02448599, 02448602, 02530163, 02530171
Manufacturer: Eli Lilly Canada Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2014-02-10
Issued / Original Publication Date: 2016-02-05
Decision / Authorization Date: 2015-11-10
Updated Date: 2025-06-24
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00221
Product Type: Drug
Control Number: 164021
DIN(s): 02416441
Manufacturer: Janssen Inc.
Submission Type: New Drug Submission
Issued / Original Publication Date: 2014-01-28
Updated Date: 2020-10-08