Review decisions
Showing 540 results of 688 total
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00334
… the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire and Multiple Myeloma … (ICH) S9 guideline on Nonclinical Evaluation for Anticancer Pharmaceuticals (2009), stand-alone safety pharmacology studies in patients with advanced cancer are not necessary. The non-clinical toxicology …
Product Type: Drug
Control Number: 190498
DIN(s): 02456796, 02456818, 02456826
Manufacturer: Takeda Canada Inc.
Submission Type: New Drug Submission (New Active Substance) - Priority Review
Date Filed / Submission Date: 2015-12-14
Issued / Original Publication Date: 2016-10-21
Decision / Authorization Date: 2016-08-04
Updated Date: 2025-03-05
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SSR00008
… (HPV types 6, 11, 16, and 18), which cause 70% of cervical cancers, 90% of genital warts, and 80-90% of anal cancers. The safety of all vaccines, including Gardasil, is … (HPV types 6, 11, 16, and 18), which cause 70% of cervical cancers, 90% of genital warts, and 80-90% of anal cancers. …
Issued / Original Publication Date: 2015-12-09
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00080
… a Subsequent Entry Biologic (SEB), for the indications in cancer patients who receive chemotherapy and in patients … and effective in adult and pediatric (>18 years of age) cancer patients who receive chemotherapy and in patients … A single arm, non-comparable clinical study in breast cancer patients shows that the safety profile of Grastofil …
Product Type: Drug
Control Number: 156897
DIN(s): 02441489
Manufacturer: Apotex Inc.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2012-07-16
Decision / Authorization Date: 2015-12-07
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00340
… to Adynovate. There was one death due to an unrelated cancer. The most common adverse events related to Adynovate …
Product Type: Drug
Control Number: 189709
DIN(s): 02459035, 02459043, 02459051, 02459078, 02498537, 02498545, 02498553, 02498561, 02498588, 02498596, 02498618, 02498626
Manufacturer: Baxalta Canada Corporation
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2015-12-02
Issued / Original Publication Date: 2016-12-30
Decision / Authorization Date: 2016-11-17
Updated Date: 2023-11-01
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SSR00009
… used to treat metastatic kidney and advanced soft tissue cancers. Health Canada's safety review on the possible … heart (pericardial effusion) in patients taking the anti-cancer drug Votrient (pazopanib). Pericardial effusion is a … cases of this issue. Use in Canada Votrient is an anti-cancer drug (a tyrosine kinase inhibitor). Votrient is used …
Issued / Original Publication Date: 2015-11-30
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SSR00010
… Canada, Avastin is used alone or with other drugs to treat cancers of the large bowel, lung or brain. During routine … vocal cord necrosis after using Avastin with another anti-cancer drug. As a result of this report, Health Canada … Canada Avastin, when given in combination with other anti-cancer drugs, is used to treat patients with a specific type …
Issued / Original Publication Date: 2015-11-30
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00332
… anaplastic lymphoma kinase ALK-positive non-small cell lung cancer (NSCLC). The submission was reviewed and considered … to curative therapy) or metastatic non-small cell lung cancer (NSCLC) who have progressed on or are intolerant to … to curative therapy) or metastatic non-small cell lung cancer. The submission was reviewed and considered …
Product Type: Drug
Control Number: 189442
DIN(s): 02458136
Manufacturer: Hoffmann-La Roche Ltd.
Submission Type: New Drug Submission (New Active Substance) - Notice of Compliance with Conditions
Date Filed / Submission Date: 2015-11-12
Issued / Original Publication Date: 2016-10-31
Decision / Authorization Date: 2016-09-29
Updated Date: 2026-02-09
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00071
… electrocardiogram monitoring, the risk of pancreatic cancer and thyroid neoplasms will also be assessed in the … outcomes trial EXSCEL. The risk of medullary thyroid cancer will also be assessed in a registry of at least 15 …
Product Type: Drug
Control Number: 167695
DIN(s): 02448610
Manufacturer: AstraZeneca Canada Inc.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2013-12-17
Decision / Authorization Date: 2015-10-30
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00180
Product Type: Drug
Control Number: 172616
Manufacturer: Bristol-Myers Squibb Canada Co.
Submission Type: New Drug Submission
Issued / Original Publication Date: 2015-10-27
Updated Date: 2020-10-13
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00059
… and is consistent with that reported in other studies with cancer populations. Cardiovascular events are a potential risk in cancer patients receiving Xgeva. Pharmacovigilance actions … is not an identified risk or listed as a potential risk in cancer patients receiving Xgeva therapy. However, with a …
Product Type: Drug
Control Number: 176891
Manufacturer: Amgen Canada Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2014-07-31
Decision / Authorization Date: 2015-10-19