Review decisions
Showing 490 results of 688 total
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00404
… epithelial ovarian, fallopian tube and primary peritoneal cancer. The submission was reviewed and considered … epithelial ovarian, fallopian tube and primary peritoneal cancer. The submission was reviewed and considered … authorized for Avastin, including: Metastatic Colorectal Cancer, Locally Advanced, Metastatic or Recurrent Non-small …
Product Type: Drug
Control Number: 201427
DIN(s): 02470748, 02470756
Manufacturer: Amgen Canada Inc.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2016-12-21
Issued / Original Publication Date: 2018-10-17
Decision / Authorization Date: 2018-04-30
Updated Date: 2025-06-17
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00432
… (MDS) and Acute Myeloid Leukemia (AML) in breast and lung cancer patients when used in conjunction with chemotherapy … biologic drug, in patients with Stage II/III breast cancer receiving myelosuppressive chemotherapy in the … were evaluated in 194 patients with Stage II/III breast cancer receiving six cycles of a chemotherapy regimen of …
Product Type: Drug
Control Number: 200807
DIN(s): 02484153
Manufacturer: BGP Pharma ULC
Submission Type: New Drug Submission
Date Filed / Submission Date: 2016-12-05
Issued / Original Publication Date: 2019-05-29
Decision / Authorization Date: 2018-12-24
Updated Date: 2024-04-24
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SSR00138
… serious scarring of the liver (cirrhosis) and liver cancer. Health Canada carried out a review of the potential …
Issued / Original Publication Date: 2016-12-01
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00387
… include sunburn, photo-aging, and an increased risk of skin cancer (particularly with PUVA). Several pharmaceutical …
Product Type: Drug
Control Number: 200590
DIN(s): 02469758, 02487314
Manufacturer: Janssen Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2016-11-25
Issued / Original Publication Date: 2018-03-23
Decision / Authorization Date: 2017-11-10
Updated Date: 2024-08-13
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SSR00137
… with intravenous bisphosphonate products, especially in cancer patients. Health Canada is working with manufacturers … too large and weak (Paget's disease of bone); the spread of cancer to bone (bone metastases); an increase in calcium levels in the blood due to cancer (hypercalcemia of malignancy); and blood cell (plasma …
Issued / Original Publication Date: 2016-11-25
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00336
… 28 (71%) underwent liver transplantation, for cirrhosis or cancer (13 patients), acute hepatic failure (2) or …
Product Type: Drug
Control Number: 190564
DIN(s): 02457717, 02457725, 02457733, 02470055
Manufacturer: Mendelikabs Inc.
Submission Type: New Drug Submission
Issued / Original Publication Date: 2016-11-18
Updated Date: 2020-10-15
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SSR00135
… in Canada to manage nausea and vomiting associated with cancer treatment or surgery. Health Canada is aware that … in Canada to manage nausea and vomiting associated with cancer treatment or surgery. Health Canada is aware that …
Issued / Original Publication Date: 2016-11-16
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SSR00139
… used in adult patients to treat an aggressive type of skin cancer (unresectable or metastatic melanoma). It works by … Zelboraf (vemurafenib) slows down or stops the growth of cancer cells by targeting specific proteins (proteins from … used in adult patients to treat an aggressive type of skin cancer (unresectable or metastatic melanoma) that has a …
Issued / Original Publication Date: 2016-11-14
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SSR00122
… (HPV) types 16 and 18 that cause cervical and anal cancer. Health Canada reviewed the risk of a rare disorder … (HPV) types 16 and 18 that cause cervical and anal cancer. Cervarix has been sold in Canada since February …
Issued / Original Publication Date: 2016-10-27
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SSR00128
… treatment be more effective. Methotrexate is used to treat cancer or to treat arthritis. A safety review was carried … are also available. Methotrexate is a drug used to treat cancer and also arthritis at a lower dose. Methotrexate is … methotrexate is used to treat life-threatening stages of cancers, and in patients with disease in the joints …
Issued / Original Publication Date: 2016-10-24